– Lunit’s ASCO 2024 presentations to highlight advances including HER2 ultra-low detection and AI-powered ICI response prediction models for NSCLC, demonstrating the impact of Lunit SCOPE suite on precision oncology

SEOUL, South Korea, May 24, 2024 /PRNewswire/ — Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the presentation of seven studies at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, from May 31 to June 4. Lunit will present detailed findings on several innovative studies, including the identification of HER2 ultra-low expression in breast cancer using AI-based quantification, and a deep learning-based model integrating chest CT and histopathology analysis for predicting immunotherapy response in non-small cell lung cancer (NSCLC).

In a poster presentation, Lunit’s AI-powered HER2 analyzer, Lunit SCOPE HER2, demonstrated the ability to identify HER2 ultra-low expression and differentiate it from true HER2-negative cases in breast cancer patients using continuous subcellular quantification from HER2 immunohistochemistry (IHC) images.

According to findings presented at ASCO 2022, HER2-targeted antibody-drug conjugates (ADCs) can effectively target tumor cells even in HER2-low breast cancers. This highlights the importance of accurately identifying HER2-low and HER2 ultra-low expression in breast cancer, especially for patients previously classified as HER2-negative. In response, Lunit developed an AI-based whole-slide image (WSI) analyzer for IHC-stained slides to differentiate between true HER2-negative and HER2 ultra-low cases. The AI model evaluated over 67 million tumor cells and 119 million non-tumor cells from 401 WSIs, identifying a significant proportion of HER2 ultra-low cases among pathologist-assessed HER2 score 0 cases. This AI-powered analysis could expand and refine treatment options for patients with HER2-targeted therapies, as demonstrated by the 23.6% of HER2 score 0 cases identified as HER2 ultra-low by AI, and the 51.9% of HER2 score 1+ cases classified as HER2 low by AI, comparable to the 52.3% objective response rate to a HER2-targeted ADC observed in another clinical trial.

In another study, Lunit developed and validated an AI model that analyzes patients’ chest CT images alone and in combination with pathology images to predict Immune Checkpoint Inhibitor (ICI) response in NSCLC patients. Lunit’s deep learning-based chest CT prediction model, developed using data from 1,876 NSCLC patients treated with ICIs, predicted treatment response based on pre-treatment chest CT scans, along with PD-L1 status and immune phenotype. The model demonstrated significant predictive power as an independent biomarker. Patients predicted as responders by the AI model showed significantly longer median time to the next treatment (TTNT; 7 months vs. 2.5 months) and a longer overall survival (OS; 16.5 months vs. 7.6 months) compared to patients predicted as non-responders. Combining the AI CT model with histopathologic biomarkers such as PD-L1 expression and tumor-infiltrating lymphocytes (TILs) further enhanced prediction accuracy, highlighting the complementary strengths of imaging and pathology data in improving predictive models for ICI response.

A collaborative study with Stanford University School of Medicine examined the association of immune phenotypes with outcomes after immunotherapy in metastatic melanoma, highlighting the heterogeneity of immune phenotypes across melanoma subtypes.

Another study with Northwestern University utilized AI-powered analysis of tertiary lymphoid structures (TLS) in H&E whole-slide images to predict immunotherapy response in NSCLC patients. This demonstrated AI’s potential in identifying predictive biomarkers for survival outcomes.

“At ASCO 2024, Lunit proudly presents seven groundbreaking studies that illustrate our pioneering role in AI-driven precision oncology,” said Brandon Suh, CEO of Lunit. “From HER2 quantification to predictive models for immunotherapy response, our work is transforming oncology by making cancer treatment not just personalized but predictive, ensuring the best possible outcomes for patients worldwide.”

In addition to the studies above, Lunit will present three more studies at this year’s ASCO, demonstrating the diverse capabilities of the Lunit SCOPE suite. The studies include comprehensive histopathomic prediction models for early breast cancer, and hypothetical test-and-control group generation for treatment selection in TPS-high NSCLC.

Visit Lunit at booth IH22 to discover how the Lunit SCOPE suite is revolutionizing oncology research and clinical practice.

Presentations at ASCO 2024 featuring Lunit SCOPE include:

• “Identification of HER2 ultra-low based on an artificial intelligence (AI)-powered HER2 subcellular quantification from HER2 immunohistochemistry images“ (1115, Poster Board #93)
• “Deep learning–based chest CT model to predict treatment response to immune checkpoint inhibitors in non-small cell lung cancer independently and additively to histopathological biomarkers“ (8536, Poster Board #400)
• “Artificial intelligence (AI) –powered H&E whole-slide image (WSI) analysis to predict recurrence in hormone receptor positive (HR+) early breast cancer (EBC)“ (571, Poster Board #163)
• “Immune phenotype profiling based on anatomic origin of melanoma and impact on clinical outcomes of immune checkpoint inhibitor treatment“ (9569, Poster Board #353)
• “Artificial intelligence (AI) -powered H&E whole-slide image (WSI) analysis of tertiary lymphoid structure (TLS) to predict response to immunotherapy in non-small cell lung cancer (NSCLC)“ (3135, Poster Board #280)
• “Updated safety, efficacy, pharmacokinetics, and biomarkers from the phase 1 study of IMC-002, a novel anti-CD47 monoclonal antibody, in patients with advanced solid tumors“ (2642, Poster Board #121)
• “Relationship between immune phenotype and treatment selection of Chemo-IO vs. IO-only in TPS-high NSCLC using hypothetical test-and-control group generation based on survival data extracted from phase III trials“ (e13569)

About Lunit

Founded in 2013, Lunit is a medical AI company on a mission to conquer cancer. We harness AI-powered medical image analytics and AI biomarkers to ensure accurate diagnosis and optimal treatment for each cancer patient. Our FDA-cleared Lunit INSIGHT suite for cancer screening serves over 3,000 hospitals and medical institutions across 40+ countries.

Our clinical findings are featured in top journals, including the Journal of Clinical Oncology and the Lancet Digital Health, and presented at global conferences such as the ASCO and RSNA.

In 2024, Lunit acquired Volpara Health Technologies, setting the stage for unparalleled synergy and accuracy, particularly in breast health and screening technologies.

Headquartered in Seoul, South Korea, with a global network of offices, Lunit leads in medical AI innovation. Discover more at lunit.io.

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PALO ALTO, Calif., May 24, 2024 /PRNewswire/ — Mega Matrix Corp. (“MPU” or the “Company”) (NYSE American: MPU), today announced that Yuder PTE, LTD, the Company’s indirect majority-controlled subsidiary and operator of FlexTV, has formed a strategic cooperation with Foxmedia Co., Ltd., 100% controlled subsidiary of Neorigin Co.(KOSDAQ: 094860) and the operator of TopReels, the leading short drama platform in South Korea.

The Company and Neorigin Co. will jointly establish a $10 million content fund aimed at promoting joint investments, production, and distribution of original short drama projects. MPU COO Steven Gao, FlexTV CEO Zhenjun Cao, NEORIGIN CFO Jimmy Liu, and TopReels head Ryan Jeong attended the signing ceremony. This collaboration signifies that FlexTV and TopReels will engage in an in-depth partnership in the Korean market to create and deliver high-quality original short drama content, thereby enhancing the quality of the short drama platform.

FlexTV, as a short drama platform, has attracted the users from over 100 countries worldwide due to its deep insights into user needs and continuous innovation in content production. Its hit drama “Mr. Williams! Madame Is Dying” has drawn a large number of paying viewers from the U.S. and Europe markets. Future short drama productions will continue to feature exciting plot designs and outstanding visual effects. Currently, FlexTV’s target is to become the global leader in short drama platforms. The strategic cooperation with TopReels will help FlexTV expand its content variety, create premium productions, replicate those with million-dollar potential, and enhance its global influence.

Mr. Yucheng Hu, CEO of Mega Matrix Corp. said, “In this era, changes in users’ vertical screen consumption habits bring about new product opportunities, and the global short drama market holds high growth and high expectation potential. The European and American markets offer a broader range of topics and a strong user base accustomed to paying for content. For short dramas to go global, a robust content supply chain must be established to continuously provide users with high-quality content. TopReels has a stable content supply capability, and this strategic partnership is a critical step for FlexTV in building an overseas content ecosystem. It will help further increase content reserves, broaden content categories, and enhance global influence.”

TopReels head Ryan Jeong remarked: “Currently, Chinese short dramas, as a new type of film and television content, are sparking a wave of ‘CEO romance dramas’ worldwide, driven by the shared emotional expressions in Eastern and Western cultures. The strong alliance between TopReels and FlexTV is timely. This collaboration will fully leverage TopReels’ high-quality production resources and capabilities in Korea, adding more original categories and producing more premium global content.”

About Mega Matrix: Mega Matrix Corp. (NYSE AMEX: MPU) is a holding company and operates FlexTV, a short-video streaming platform and producer of short dramas, through Yuder Pte, Ltd., an indirect majority-controlled subsidiary of Mega Matrix. Mega Matrix is a Delaware corporation headquartered in Palo Alto, CA. For more information, please contact info@megamatrix.io or visit: http://www.megamatrix.io.

About NEORIGIN：Neorigin Co. (KOSDAQ: 094860) is a diversified global enterprise, with its main business areas encompassing IP operations, game distribution, short dramas, and cross-border e-commerce. With strong global distribution capabilities covering over 150 countries, NEORIGIN identifies and acquires IPs with market value for operation. The company has global distribution experience for games such as Fantasy Babies, Desperate Housewives, and My Own Angel. By acquiring the original IPs of Luna and Fantasy Babies, NEORIGIN has expanded its game portfolio. Additionally, the short drama and e-commerce platform businesses will significantly enhance the company’s value. https://www.neorigin.com/

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements that are purely historical are forward looking statements. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose,” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees for future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, are: the ability to manage growth; ability to identify and integrate future acquisitions; ability to grow and expand our FlexTV business; ability to execute the strategic cooperation with TopReels, ability to obtain additional financing in the future to fund capital expenditures; fluctuations in general economic and business conditions; costs or other factors adversely affecting the Company’s profitability; litigation involving patents, intellectual property, and other matters; potential changes in the legislative and regulatory environment; a pandemic or epidemic; ; the possibility that the Company may not succeed in developing its new lines of businesses due to, among other things, changes in the business environment, competition, changes in regulation, or other economic and policy factors; and the possibility that the Company’s new lines of business may be adversely affected by other economic, business, and/or competitive factors. The forward-looking statements in this press release and the Company’s future results of operations are subject to additional risks and uncertainties set forth under the heading “Risk Factors” in documents filed by the Company with the Securities and Exchange Commission, including the Company’s latest annual report on Form 10-K, and are based on information available to the Company on the date hereof. In addition, such risks and uncertainties include the Company’s inability to predict or control bankruptcy proceedings and the uncertainties surrounding the ability to generate cash proceeds through the sale or other monetization of the Company’s assets. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Disclosure Channels

We announce material information about the Company and its services and for complying with our disclosure obligation under Regulation FD via the following social media channels:

X (f/k/a Twitter):	twitter.com/MegaMatrixMPU
Facebook:	facebook.com/megamatrixmpu facebook.com/flextvus
LinkedIn:	linkedin.com/company/megamatrixmpu
TikTok:	tiktok.com/@flextv_english
YouTube:	youtube.com/@FlexTV_English

The Company will also use its landing page on its corporate website (www.megamatrix.io) to host social media disclosures and/or links to/from such disclosures. The information we post through these social media channels may be deemed material. Accordingly, investors should monitor these social media channels in addition to following our website, press releases, SEC filings and public conference calls and webcasts. The social media channels that we intend to use as a means of disclosing the information described above may be updated from time to time as listed on our website.

Contact: Info@megamatrix.io

Source: Mega Matrix Corp.

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SHANGHAI, May 24, 2024 /PRNewswire/ — May 23, Atour Lifestyle Holdings Limited (NASDAQ: ATAT), a leading hospitality and lifestyle company in China, has released its inaugural Environmental, Social, and Governance (ESG) report for 2023.

The report underscores the company’s sustainability efforts over the past year and reflects the steady integration of ESG principles into its day-to-day operations.

In essence, Atour is committed to reducing waste and making its operations more ecologically friendly. This is reflected in the company’s approach toward refurbishment and resource conservation.

During the reporting period, Atour launched two new products, Atour Light 3.0 and Atour 4.0 “With Nature,” a midscale hotel offering and an upper midscale variation. They underwent refurbishment using modular designs, with modular elements accounting for over 90% and 80% of the overall designs, respectively. This initiative significantly reduces maintenance costs and non-essential construction waste.

Sustainability practices extend beyond decoration. Atour hotels now are equipped with less carbon-intensive amenities, such as 100% biodegradable paper cups, as well as natural cotton beddings and natural bamboo paper products manufactured without bleach or fluorescents, easing the burden on the environment.

Additionally, Atour promotes water conservation across its some 1,210 hotels (as of the end of last year) using the dedicated-loop system for circulating hot water, resulting in a reduction of 12.67 tons of water consumption per room annually.

Atour prioritizes customer experience, introducing innovations from Atour APLUS services to Late Night Congee to ensure customers feel at home during their stays. Customers can expect a carefree experience and peace of mind, thanks to Atour’s commitment to purified indoor air, fire safety, cleanliness, hygiene, and strict user privacy protection.

Moreover, Atour has reinforced its support for franchisees through its “Six Commitments to Franchisees” and “Eight Supply Chain Procurement Commitments,” empowering them with a responsible supply network, rights guarantees, as well as training on sustainability. For instance, the company vows to address franchisees’ complaints within 48 hours and refund price differences/offer refunds.

Originating from Yaduo, a remote village in southwestern China, Atour has consistently given back to its place of inspiration by encouraging local villagers to grow tea, fueling economic development and rural revitalization.

As the report indicates, Atour purchased a cumulative 150 tons of processed tea leaves worth/for RMB 37 million from the villagers, benefiting some 1,400 households. As part of its charitable engagements, it also donated a batch of clothes with a value of around RMB 2 million to the needy and supported targeted poverty alleviation efforts.

In urban areas, Atour contributes to societal well-being by offering resting places in its Shanghai headquarters for frontline workers such as couriers, delivery rider, and sanitation workers during their downtime.

Ten years after its birth, Atour prides itself on creating a diverse, equitable, and inclusive workplace for its employees. Currently, over 58% of its 4,248 employees are female, and the company employs 17 people with physical disabilities and 162 members of ethnic minorities.

On the corporate governance front, Atour has established an ESG working group tasked to report directly to its Executive Committee. The ultimate goal is to implement a coherent sustainability strategy throughout its corporate hierarchy, thereby embedding ESG concepts into Atour’s mission and core values.

Recognizing board diversity as a pillar for sustained growth, Atour aims to include factors like one’s gender, age, culture and professional background when nominating future board members. Currently, there are three independent directors and two female directors on the eight-member board.

In aligning with its strategic vision to boast a network of 2,000 premier hotels by 2025 and deliver the optimum “Chinese experience,” Atour is set to invest more resources and energies in the realm of ESG.

“Looking ahead, we aim to enhance our sustainable development initiatives and capacities consistently, turning our original aspirations of warmth and generosity into increased resilience through concrete measures,” said Mr. Haijun Wang, founder and CEO of Atour.

“We remain committed to creating an intimate ambience where people can warmly connect and contributing to a greener ecology and a kinder, more compassionate society.”

About Atour Lifestyle Holdings Limited

Atour Lifestyle Holdings Limited (NASDAQ: ATAT) is a leading hospitality and lifestyle company in China, with a distinct portfolio of lifestyle hotel brands. Atour is the leading upper midscale hotel chain in China and is the first Chinese hotel chain to develop a scenario-based retail business. Atour is committed to bringing innovations to China’s hospitality industry and building new lifestyle brands around hotel offerings.

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Download high-res images & broadcast-quality vision of Vivid Sydney 2024 HERE

Tickets available from vividsydney.com

SYDNEY, May 24, 2024 /PRNewswire/ — Vivid Sydney 2024 has kicked off its 14th year with a spectacular opening night, as the festival transforms Sydney’s glittering harbour, iconic landmarks and cityscape with a showcase of creativity and innovation for the next 23 nights.

The Southern Hemisphere’s leading multi-artform festival will run from Friday 24 May to Saturday 15 June, featuring the world’s most innovative artists, culinary talent, contemporary musicians and thought leaders as part of its 2024 program under the theme of Humanity.

The ‘Lights On’ moment wowed onlookers with over 30 light installations and 3D projections across the famed 8km Vivid Sydney Light Walk, highlighted by the Sydney Opera House featuring the breathtaking new digital artwork, Lighting of the Sails: Echo (2024). Created by multidisciplinary Australian artist and 2023 Archibald Prize Winner Julia Gutman, with creative technologists Pleasant Company, the projection on the Sydney Opera House Sails digitises centuries-old fabric making techniques into an animated, modern epic.

NSW Premier Chris Minns said:

“The bright lights of Vivid Sydney are officially on.

“For the next 3 weeks Sydney will showcase the magical lights, art and fun of Vivid Sydney. There is something for the whole family, so I encourage everyone to come along and make the most of Vivid Sydney this year.”

Minister for the Arts, Minister for Music and the Night-time Economy, and Minister for Jobs and Tourism John Graham said:

“Since 2009, Vivid Sydney has been a global platform showcasing our vibrant culture, bustling nightlife and creative talents.

“Going from strength to strength in its 14th year, Vivid Sydney shows the world our colourful creative side. Vivid Sydney shows the world we have big dreams.

“With the majority of this year’s festival being free, we’re looking forward to welcoming visitors back again in the millions.

“Tonight, we begin 23 days of Light, 23 days of Music, Ideas and Food. 23 days of shared experiences. For the next 23 days, Sydney will be beautiful by day, Vivid Sydney by night.”

Vivid Sydney Festival Director Gill Minervini said:

“Vivid Sydney is the original festival of light, art and culture, and we’re proud to be celebrating its 14th year with an incredible line-up of light, music, ideas and food under 2024’s theme of Humanity.

“It is such a privilege and honour to direct this year’s program and we’re so excited to bring festival-goers a calibre of Australian and international talent that not only maintains the standard we’ve set in previous years but takes the program to new heights. Vivid Sydney 2024 is a must-see, and we can’t wait to welcome all Australians and global visitors alike for the next 23 nights!”

Staged across the Sydney CBD, Vivid Sydney festival locations and venues include Circular Quay, the Sydney Opera House, The Rocks, State Library of New South Wales, Walsh Bay Arts Precinct, Barangaroo, Darling Harbour, University of Technology Sydney, The Goods Line, Wynyard Tunnels, Royal Botanic Garden Sydney, Carriageworks, and more. 

For more information and tickets visit vividsydney.com.

VIVID SYDNEY HIGHLIGHTS

VIVID LIGHT

As the sun goes down each evening during Vivid Sydney, the city will transform with light installations, 3D projection artworks and ticketed events for visitors to immerse themselves in a new world of colour and light across the 8km Vivid Sydney Light Walk.

• Vivid Sydney has again partnered with Cinewav, enabling visitors to listen to the soundtracks to select projection artworks wherever they are on the Vivid Sydney Light Walk
• From almost anywhere in the city, visitors will witness a 40km stretch of rainbow lasers emanating from the Sydney Tower, a universal symbol of hope by US artist Yvette Mattern titled Global Rainbow
• One of Australia’s most-beloved artists, Reg Mombassa will reimagine the classic Aussie road trip on Customs House for Gumscape with Road and Creatures
• Celebrated Chinese Australian artist Guan Wei’s signature iconography will transform the Museum of Contemporary Art for Sea, Sand and Stars
• Nest, a collaboration between Leila Jeffreys and Melvin J. Montalban, features a large-scale circular projection at the Stargazer Lawn in Barangaroo, spotlighting the ritualistic mating dance of the brolga and humanity’s connection with nature
• Step up to the Omnivisu view finder in Tumbalong Park, and let your eyes become the literal windows to our city’s soul
• Horizon from Spanish artists Playmodes is a hypnotic, full-body experience complete with trance-like sounds and strobing lights at Harbour Park, Barangaroo
• Towering over 15 metres tall, PORTAL from Lucid Creates frames Barangaroo Headland with a glowing display of light and atmospheric sounds
• The Vivid Sydney 2024 drone show Love is in the Air will feature more than 700 drones over three separate nights for another fan-favourite Vivid Sydney spectacle over the harbour
• Dark Spectrum: A New Journey returns to the Wynyard Tunnels in new and fantastic ways to take us on a journey of light and sound
• The internationally acclaimed multi-sensory experience of light, colour and sound, Lightscape, returns to The Royal Botanic Garden Sydney

VIVID MUSIC

Vivid Music will ignite the city with a curated program of live performances, concerts and DJ sets across diverse venues, with something for the whole family, at any age.

• Exclusive to Vivid Sydney, Tekno Train by Paul Mac is a one-of-a-kind event that will transform a Sydney Trains ride into a moving, sensory sound and light experience
• The reimagined 100-year-old substation Machine Hall will be open to the public for the very first time during Vivid Sydney 2024, pulsating with performances from Deerhoof, Jen Cloher, CLUB4A and No Fixed Address 
• On Thursday, Friday and Saturday nights of the festival, Tumbalong Park in Darling Harbour will become the Vivid Sydney go-to for free and contemporary music right in the heart of the Light Walk for Tumbalong Nights. The 12-night line-up features artists such as Christine Anu, Sneaky Sound System, Forest Claudette, Teenage Jones, , tiffi, Budjerah, grentperez, and more, plus DJs and kids programming on Saturday nights all free of charge
• Comedy darling Rhys Nicholson and ARIA award winning musician Georgia Mooney will transform Mary’s Underground into an intimate cabaret lounge for the Vivid Sydney Supper Club featuring live performances and appearances from MO’JU, Don’t Thank Me Spank Me, Montaigne, Brendan Maclean, Mark Humphries and more each Friday and Saturday from 9pm to 1am
• Diverse and multi-sensory experiences at Carriageworks, with an electrifying line-up including Electric Fields, Yves Tumor, Yasiin Bey and many more.
• The Vivid LIVE at Sydney Opera House line-up features more than 40 Australian and international artists. Arca, Air, Underworld, Fever Ray, Devonte Hynes, Snoh Alegra, Sky Ferreira, Thelma Plum and many more will take to the stages of the world-famous building in a program curated by Sydney Opera House’s Head of Contemporary Music Ben Marshall

VIVID IDEAS

The Vivid Ideas program sparks curiosity with new ways to experience ideas through the exploration of humanity, community, authenticity, respect, love and lessons learnt from the natural world – with theatre, installations and engaging discussions just the beginning.

• From the football team that united Australia in 2023, Tony Gustavsson, head coach of the CommBank Matildas, and Mackenzie Arnold, celebrated CommBank Matildas goalkeeper and captain of West Ham United, will be hosted in an insightful conversation – Champions of Change – facilitated by Matildas alumni and now journalist Grace Gill at Sydney Town Hall
• Golden Globe® and Emmy Award® winning actress and comedian Amy Poehler will step inside the Sydney Opera House for a special and unmissable In Conversation Ideas event and a special first look at Disney and Pixar’s Inside Out 2
• After The Fact will offer opportunities to engage in free weeknight discussions on current affairs with writers, journalists, ex-politicians, social commentators, artists and academics – including Annabel Crabb, Rhoda Roberts AO, Kim Williams AM, Lucy Turnbull AO, Charles Firth and more
• Unique experiences including A THOUSAND WAYS: An Encounter, Window Dressing and Shifting Perspectives will offer immersive moments to connect with both strangers and ourselves
• The Golden Age of Humanity will showcase nine selected films over nine starry nights at Surry Hills’ beloved Golden Age Cinema – curated by nine great Australians including Amar Singh, Saxon Mullins, Kylie Kwong AM, Kate McClymont AM, Craig Foster AM and more

VIVID FOOD

• Vivid Chef Series returns to hatted restaurants Fred’s, AALIA, The Porter House, Firedoor and The Charles Brasserie & Bar as they host unmissable foodie collaborations with Michelin-starred chefs including Max Coen, Ivan Brehm, Selassie Atadika, Niklas Ekstedt and Sally Abé
• Vivid Fire Kitchen is also back in 2024 with delectable offerings at its new location on The Goods Line, bringing together the world’s hottest culinary concepts, curated drinks and cocktails from Archie Rose and Starward, and entertainment with demonstrations from local and international pitmasters including California-favourite Shalamar Lane, Christine Manfield, Mindy Woods, Lennox Hastie, Jess Pryles, and more
• Making its debut at Vivid Sydney 2024, the Messina Milk Bar will be an illuminated full-scale pop-up with a menu of gelato-infused chocolate bars, dixie cups, tailor-made milkshakes and spiders from the cult-gelato innovators at Messina
• A Culinary Canvas by Danielle Alvarez is set to showcase women in Australian gastronomy at the incredible Yallamundi Rooms at the Sydney Opera House
• Plates with Purpose will offer a taste of Ukraine at Kyiv Social, courtesy of head chef, Borys Chernyk who brings over 30 years of experience in Ukrainian fine dining
• Visitors can explore over 20 top chefs and restaurateurs at the VividPlace Food Trail or indulge in a bespoke bar snack and cocktail experience at Aurorae at Bennelong Bar, offering an incredible view of the lights across Sydney Harbour

VIVID SYDNEY PARTNERS

Vivid Sydney thanks its Partners for their support of Vivid Sydney 2024.

• Kia returns as major partner for a third year, presenting two visually immersive activations on the Vivid Sydney Light Walk – EV9 “Kia Kinetic” at Circular Quay and EV5 “Kia Kaleidoscope” at Darling Harbour.
• Australian Traffic Network (ATN) will partner with Vivid Sydney to deliver the Love is in the Air drone shows, with three shows on 8, 9 and 15 June planned to wow audiences during the festival.
• Sony Music Entertainment Australia returns for a second year and presents two ticketed immersive light events, Dark Spectrum: A New Journey, at the Wynyard Tunnels with Mandylights and Culture Creative, and Lightscape at the Royal Botanic Garden Sydney, in collaboration with Culture Creative.
• Samsung also comes onboard as a Major Partner of Vivid Sydney 2024, presenting Chorus of Light, an immersive activation on the Vivid Sydney Light Walk, designed to tap into our desire for connection through the enablement of barrier-free communication, inspired by Samsung Galaxy AI technology. 
• Airbnb is the inaugural Vivid Sydney Community Partner, supporting the Vivid Sydney Volunteer Program.
• Official partner Sennheiser presents the Sennheiser Mirrorbox, an audio experience merging AI analysis, sound design and visual elements to explore the relationship between sound and human identity.
• Estee Lauder will partner with Vivid Sydney as an Official Partner, activating during the festival with Beauty Sleep, integrating elements of beauty and science.
• Supporting Partners include City of Sydney and Nova 96.9.
• Supplier partners include Cinewav, Event Engineering, Mandylights, Technical Direction Company, Transdev and Kennards Hire.
• Returning for the second year, the Local Business Program Partner is Experience Oz Australia.
• Vivid Sydney program partners include Carriageworks, Disney, Museum of Contemporary Art and Sydney Opera House.
• The Vivid Sydney 2024 Charity Partner is Médecins Sans Frontières (MSF), which translates to Doctors Without Borders. 
• Vivid Sydney locations include Barangaroo, Darling Harbour, The Rocks, Barangaroo House, Golden Age Cinema, Machine Hall, University of Technology Sydney, State Library of New South Wales, North Sydney Council and Walsh Bay Arts Precinct.

For more information and to keep updated about the program, go to vividsydney.com.

NOTES TO EDITORS:

Visit the Vivid Sydney News Room to download the full 2024 Vivid Sydney Lights On content package including a VNR with grabs from Minister for Jobs and Tourism John Graham, Vivid Sydney Festival Director Gill Minervini and Vivid Sydney artists, as well as high-res imagery and broadcast-quality b-roll video footage: www.vividsydney.com/news-room.

ABOUT VIVID SYDNEY

Vivid Sydney, the Southern Hemisphere’s leading multi-artform festival, transforms Sydney into a vibrant hub of creativity, innovation and community connection. Over 23 nights, light installations, music, ideas and food inspire global audiences and drive cultural exchange. The 2024 theme, ‘Humanity,’ sparks reflection and engagement, attracting visitors and fuelling economic growth. Proudly owned by Destination NSW, Vivid Sydney showcases NSW’s cultural vibrancy and positions it as a global leader in artistic innovation.

ABOUT DESTINATION NSW 

Destination NSW is the champion and voice for the visitor economy within the NSW Government. Spearheading a whole-of-government approach to visitor economy growth, Destination NSW influences and shapes the visitor economy through strategic research, policy and thought leadership, stakeholder engagement and consultation, commercial partnerships and investment in visitor experiences, business support, marketing and events. Destination NSW is also the major investor in Business Events Sydney (BESydney) for the purpose of securing more international and domestic conventions, incentive travel reward programs, corporate events and exhibitions.

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• The ELECTRA and ELEVATE studies were designed to overcome different resistance mechanisms and improve patient outcomes with oral-oral combination options.
• Updated results from the ELECTRA study, evaluating elacestrant in combination with abemaciclib regardless of metastatic site, show a safety profile consistent with previous results. Recommended phase 2 dose for this combination is presented.
• Updated analysis from the ELEVATE study demonstrates that all evaluable elacestrant plus targeted therapy combination arms are consistent with the known safety profiles of everolimus, alpelisib, ribociclib and palbociclib plus standard of care endocrine therapy. Recommended phase 2 dose for the combination of elacestrant and everolimus is presented.

FLORENCE, Italy and NEW YORK, May 24, 2024 /PRNewswire/ — The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, will present updated results from phase 1b/2 ELECTRA and ELEVATE clinical studies evaluating elacestrant (ORSERDU®) in combination with other treatments. Both the ELECTRA and ELEVATE studies were designed to overcome different resistance mechanisms observed in estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC) and improve patient outcomes through novel oral-oral combination treatment options. Data will be presented at the 2024 American Society of Clinical Oncology (ASCO), on June 2 from 9 a.m. to 12 p.m. CT.

The ELECTRA study is evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- metastatic breast cancer with brain metastases; however, the phase 1b portion of this study was conducted in all metastatic sites, including brain metastases. The updated phase 1b results continue to show a satisfactory safety profile, consistent with prior findings, and promising activity in patients with ER+, HER2- advanced or mBC regardless of metastatic site. Based on the results of this portion of the study, the recommended phase 2 dose (RP2D) will be reported as part of the data presentation. Currently, the phase 2 portion of ELECTRA is ongoing at the RP2D to further characterize the efficacy and safety in patients with ER+, HER2- metastatic breast cancer with brain metastases, since both elacestrant and abemaciclib cross the blood-brain barrier.

“It is encouraging to see that, even in the early stages of the trial, the combination of elacestrant plus abemaciclib indicates a tolerable and manageable safety profile for the patients in the clinical trial,” said Erika Hamilton, MD, Director of Breast Cancer Research and Executive Chair of the Breast Cancer Research Executive Committee for Sarah Cannon Research Institute. “The study continues to demonstrate elacestrant’s potential in combination with other therapies and we look forward to analyzing more data from this combination for this patient population in need of new options.”

The ELEVATE study is evaluating elacestrant in combination with CDK4/6 inhibitors (palbociclib, abemaciclib and ribociclib) and with inhibitors of the PI3K/AKT/mTOR pathway (everolimus, alpelisib and capivasertib). The updated Phase 1b results show that the combinations evaluated are consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy. Based on the results of this portion of the study, the RP2D will be reported for elacestrant in combination with everolimus. Additional cohorts, including elacestrant plus capivasertib, are currently under evaluation to further characterize the safety, assess efficacy and determine the RP2D for each combination arm. Phase 2 for the combination of elacestrant and abemaciclib in ER+, HER2- metastatic breast cancer, irrespective of the metastatic site, is already ongoing.

“As we evaluate the various combinations of elacestrant plus CDK4/6 and PI3K/AKT/mTOR inhibitors, we continue to see consistent and manageable safety findings across all arms of the trial, and so far, elacestrant does not appear to add any incremental toxicity to the combination regimens in which it is being studied,” Hope S. Rugo, MD, Professor of Medicine and Winterhof Family Endowed Professor in Breast Cancer, Director, Breast Oncology and Clinical Trials Education, University of California San Francisco.  “These data build on our understanding of elacestrant’s role in metastatic breast cancer and reinforce its potential as an endocrine therapy backbone in combination regimens.”

“Since its approval in 2023, ORSERDU has had a meaningful impact as an endocrine therapy for people who are living with ER+, HER2- metastatic breast cancer harboring ESR1 mutations,” said Elcin Barker Ergun, CEO of the Menarini Group. “The data we are presenting at ASCO highlight elacestrant’s potential to further enhance patient outcomes when combined with other compounds.”

About The Elacestrant Clinical Development Program
Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease.

About ORSERDU (elacestrant)
U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Full prescribing information for the U.S. can be found at www.orserdu.com.

Important Safety Information
Warning and Precautions

Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively.  Monitor lipid profile prior to starting and periodically while taking ORSERDU.

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman.  Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose.

Adverse Reactions

Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).

The most common adverse reactions (>10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite(15%), diarrhea(13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).

Drug interactions

Concomitant use with CYP3A4 Inducers and/or inhibitors:  Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.

Use in specific populations

Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.

Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).

The safety and effectiveness of ORSERDU in pediatric patients have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com.

About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. (“Stemline”) a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU® (elacestrant) in the U.S. and Europe, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the U.S. and E.U. to date. Stemline also commercializes NEXPOVIO® (selinexor) in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers.

Logo – https://mma.prnasia.com/media2/2296569/Menarini_Industrie_Farmaceutiche_Riunite_Logo.jpg?p=medium600

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The unique event, which is among the first global events created to build excitement for the upcoming Olympic Games, sees French and Singaporeans athletes and artists coming together to revitalise the iconic skate park in Singapore

SINGAPORE, May 24, 2024 /PRNewswire/ — In the lead up to the Paris 2024 Olympic Games, the Embassy of France in Singapore is organising a special two-day celebration of sports and arts aptly titled Artletics – making it among the first celebratory events organised around the world to drum up excitement for the global sports meet.

In collaboration with local partner Art Outreach and supported by the Singapore Tourism Board, the event happening on 25 and 26 May sees urban sports athletes and urban artists from both countries converging at the 18-year-old Somerset Skate Park to immerse Singaporeans in a joint showcase of their talents.

The event’s focus on urban sports gives a nod to the inclusion of the category into the upcoming Paris 2024 Olympic Games, which includes sports like BMX, skateboarding and breaking. It also runs parallel to the plans to transform the Place de la Concorde in Paris into an urban sports space. The unique collaboration also serves as a bridge between France and Singapore, deepening cultural ties through a shared passion for artistic expression and athleticism.

Ambassador of France to Singapore Her Excellency Minh-di Tang said, ‘Artletics embodies the spirit of street culture and celebrates artists and athletes striving for excellence, creativity and team spirit in the city where they leave lasting legacies and drive positive change in society. These core values pay homage to what the Olympic Games stand for, which France is hosting for the third time this year. Through Artletics, we want to showcase the best of French and Singaporean artistry, athleticism and sportsmanship, strengthening the cross-cultural partnerships our countries have enjoyed for many years.”

Somerset Skate Park transformed into a vibrant urban playground

Artletics caps off a month-long line up of programmes under the vOilah! France Singapore Festival – an annual cultural festival organised by the Embassy of France in Singapore to demonstrate French creativity and innovation through the power of cross-cultural collaborations.

In the spirit of enabling cultural exchanges, the Somerset Skate Park in the heart of Orchard Road is transformed into a dynamic space as orchestrated by urban artists from Singapore and France.

Three visual artists from Singapore – Zero, Spaz, and Simpleproblembeings – worked alongside French muralist Elsa Martino and graffiti artist Kekli to enliven the space by decorating the walls and the ramps of the skate park with vibrant designs. Supported by Singapore’s urban art collective RSCLS, these artists also will lead the public in engaging art jam sessions to partake in a collaboration of community artwork.

First to utilise the redecorated space are French skateboarding athlete Max Berguin, Champion of the France Street Skateboard 2023 and Singaporean urban sport communities in the field of skateboarding, breaking, BMX, bike trials, parkour and yo-yo who will be displaying their talents to spectators.

The event also features adrenaline-inducing urban sports showcases, opportunities for the public to take part in workshops conducted by local urban sports groups, as well as music sets in the evening by Singaporean DJs Kiat and Intriguant.

“Artletics is a vibrant celebration of the creative spirit that bridges French and Singaporean cultures through youth, urban sports and art,” said Mae Anderson, Chairman of Art Outreach. “We are thrilled to see French and Singaporean artists and skateboarders come together, transforming Somerset Skate Park into a collaborative canvas. We hope this event serves as a great opportunity for everyone to experience the power of art, athletics, while fostering a sense of belonging, inclusion and community spirit.”

More details of the festival and the programme can be found at www.voilah.sg/artletics.

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About vOilah! 2024

vOilah! 2024 returns from 25 April to 26 May 2024. Presented by the Embassy of France in Singapore, this year’s edition will focus on celebrating the dreams and passions of artists and athletes, bringing experiences that make life more vibrant through strong connections between the French and Singaporean communities.

This year, visitors can look forward to 19 programmes covering audiovisual arts, performing arts, visual arts, lifestyle, sports, education, science, music. With the support of more than 50 partners, vOilah! 2024 is a culmination of vibrant and dynamic experiences that will strengthen an appreciation of arts, culture and innovative collaborations between our countries.

For more information, visit www.voilah.sg/artletics/

About Art Outreach

Art Outreach, established in 2003, passionately promotes art appreciation and strengthens the local art ecosystem. We also empower practitioners through professional development support and an incubatory art space. Our year-round programmes, tailored to diverse audiences, include educational talks, art tours, exhibitions, and workshops, fostering a deeper understanding and appreciation of art and artists within the community. By supporting a wide range of artists and art shows, we actively promote plurality and advocacy within the arts, championing inclusivity and celebrating a rich tapestry of artistic expression. Art Outreach has been an IPC charity since inception, and has been a multiple-year recipient of the Commissioner of Charities governance award. We are led by a deeply committed board and nurture a dynamic and cohesive team culture.

For more information, please visit www.artoutreachsingapore.org/

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SUZHOU, China and ROCKVILLE, Md., May 24, 2024 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that its four abstracts selected for presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting are now available on ASCO’s official website. These abstracts report on the company’s three lead drug candidates, including olverembatinib (HQP1351), the first and only China-approved third-generation BCR-ABL inhibitor; lisaftoclax (APG-2575), a BCL-2 selective inhibitor; and APG-2449, a FAK/ALK/ROS1 inhibitor.

Updated results from the four studies will be presented in Oral Reports or Posters at the ASCO Annual Meeting taking place on May 31 – June 4, 2024 in Chicago, IL. The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community.

“It is our pleasure to present the latest data on our key drug candidates at the ASCO Annual Meeting for the seventh consecutive year,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “These encouraging results once again highlight Ascentage Pharma’s robust capabilities in global innovation and clinical development. Going forward, we will further expedite our clinical development programs globally in the hope of benefitting more patients in China and around the world as soon as possible.”

These four clinical studies to be presented at this year’s ASCO Annual Meeting are as follows:

The details of these abstracts are as follows:

Oral Report

Olverembatinib (HQP1351)

Updated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) and paraganglioma

Abstract#: 11502

Session Title: Sarcoma

Date and Time: June 3, 2024, Monday, 3:00 PM – 6:00 PM (Central Time)

First Author: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.

Highlights:

Background: SDH-deficient GIST is a rare type of GIST, mainly observed in the stomach of children, adolescents, and young adults under 30 years of age. No active targeted therapies have been identified in this subset of GIST. Olverembatinib, approved in China for the treatment of patients with chronic myeloid leukemia, has shown promising clinical efficacy in SDH-deficient GIST. In this abstract, the study reports updated efficacy data of olverembatinib in SDH-deficient GIST and preliminary efficacy data in paraganglioma, an SDH-deficient-related tumor.

Introduction: The aim of this study was to evaluate the safety and efficacy (per RECIST v1.1) of olverembatinib in patients with SDH-deficient GIST and other solid tumors. Olverembatinib was administered orally once every other day (QOD) in 28-day cycles.

Patient enrollment and methods: As of December 27, 2023, 26 patients with SDH-deficient GIST (confirmed by immunohistochemistry [IHC] assay) had received ≥1 dose of olverembatinib (median [range] age, 30 [13-56] years), and 25 of them had received 1-4 tyrosine kinase inhibitors (TKIs; 42.3% of patients received ≥3 TKIs). Olverembatinib was administered OQD in doses ranging from 30 to 50 mg (30 mg [n = 6]; 40 mg [n = 14]; 50 mg [n = 6]). This study also enrolled 6 patients with paraganglioma.

Efficacy results:

• In the 26 patients with SDH-deficient GIST, the median (range) duration of treatment was 15.6 (1.8-42.3) months. 6 of those patients achieved partial responses (PR); another 18 patients achieved stable diseases (SD) lasting > 4 cycles. The clinical benefit rate (CBR, complete response [CR] + PR + SD > 4 cycles) was 92.3% (24/26) and the longest treatment duration was 40 months. After a median (range) follow-up of 17.0 (4.1-57.5) months, the median (range) progression-free survival (PFS) was 25.7 months (12.1-not reached [NR]).
• Among the 6 patients with paraganglioma, 5 achieved SDs > 4 cycles, with a CBR of 83.3% and a median (range) PFS of 8.25 (1.87-NR) months.

Safety results: The adverse event profile was the same as previously reported (Qiu H, et al, J Clin Oncol 41:11540), with no newly emergent safety issues observed.

Conclusions: Olverembatinib was well tolerated. In patients with SDH-deficient GIST, olverembatinib demonstrated a CBR exceeding 90% and significantly prolonged the estimated median PFS, indicating the potential benefit of this treatment and providing a benchmark for future studies in this rare subtype of GIST.

Poster Presentations

Lisaftoclax (APG-2575)

Safety and efficacy of lisaftoclax, a novel BCL-2 inhibitor, in combination with azacitidine in patients with treatment-naïve or relapsed or refractory acute myeloid leukemia

Abstract#: 6541

Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: June 3, 2024, Monday, 9:00 AM – 12:00 PM (Central Time)

First Author: Huafeng Wang, MD, PhD, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.

Highlights:

Background and introduction: Early studies showed that lisaftoclax in combination with various agents can synergistically induce apoptosis in acute myeloid leukemia (AML). This poster presents follow-up safety and efficacy data from a Phase Ib/II study of lisaftoclax combined with azacitidine (AZA) in adults with AML.

Patient enrollment and methods:

• This study enrolled elderly (≥75 years)/unfit treatment-naïve (TN) patients with AML who were intolerant of standard induction chemotherapies and patients (≥18 years) with relapsed/refractory (R/R) AML. Lisaftoclax (400/600/800 mg) was administered orally once daily in 28-day cycles. In the first treatment cycle, a daily ramp up schedule was used to prevent tumor lysis syndrome (TLS). AZA was administered once daily on D1-D7 at 75 mg/m².
• As of January 25, 2024, 76 patients with AML were enrolled, including 37 patients with R/R AML and 39 elderly/unfit patients with TN AML who were intolerant of standard induction chemotherapies. The median (range) age was 66 (20-81) years, and 61.8% of the patients were male.

Efficacy results:

• In patients with R/R AML treated with lisaftoclax combined with AZA, the overall response rate ([ORR]=CR + CRi + morphologic leukemia-free state [MLFS] + PR) was 72.7%, the composite complete remission rate (CRc = CR + CRi) was 45.5%. In the 600 mg cohort (n=30), the median duration of treatment was 3.8 months, the ORR was 76.7%, the CRc was 50.0%, the median time to CRc was 2.5 months, the median PFS was 10.2 months, and the median overall survival (OS) was 14.7 months.
• Among patients with TN AML treated with lisaftoclax combined with AZA, the ORR was 64.1%, the CRc was 51.3%. In the 600 mg cohort (n=29), the median duration of treatment was 3.3 months, the median time to CRc was 1.9 months. The median PFS was not reached.
• 600 mg lisaftoclax combined with AZA was established as the recommended Phase II dose (RP2D).

Safety results: All patients treated with lisaftoclax combined with AZA reported treatment-emergent adverse events (TEAEs), with 89.5% experiencing Grade 3/4 TEAEs and 43.4% experiencing serious adverse events (SAEs). Common TEAEs included neutropenia (60.5%), thrombocytopenia (60.5%), diarrhea (42.1%), hypokalemia (40.8%), pyrexia (35.5%), and vomiting (30.3%). Grade ≥ 3 TEAEs reported in ≥ 10% of patients included neutropenia (57.9%), thrombocytopenia (50.0%), anemia (27.6%), pneumonia (17.1%), and febrile neutropenia (10.5%). No TLS was reported. The 30-/60-day mortality rates were 1.3% and 3.9%, respectively.

Conclusions: These data support a promising role for the new Bcl-2 inhibitor lisaftoclax combined with AZA for the treatment of elderly/unfit TN patients with AML intolerant of standard induction chemotherapies and patients with R/R AML, especially given a potentially favorable safety profile in terms of TLS, the incidence of neutropenic fever, and low early mortality. A Phase III randomized, double-blind study is being conducted to determine whether lisaftoclax combined with AZA improves the survival of elderly/unfit TN patients with AML intolerant of standard induction chemotherapies.

Updated efficacy and safety results of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenström macroglobulinemia (WM)

Abstract#: 7078

Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: June 3, 2024, Monday, 9:00 AM– 12:00 PM (Central Time)

First Author: Masa Lasica, MBBS, FRACP, FRCPA, St Vincent’s Hospital, Melbourne, Victoria, Australia.

Highlights:

Background: Lisaftoclax is a novel, oral, highly selective, potent Bcl-2 inhibitor. Lisaftoclax can overcome resistance to ibrutinib in ibrutinib-insensitive RPCI-WM1 models. In other non-Hodgkin lymphoma (NHL) models (including DOHH2 follicular lymphoma models and OCI-LY1 diffuse large B-cell lymphoma [DLBCL] models), lisaftoclax combined with ibrutinib has a strong synergistic antitumor effect.

Introduction: This is an open-label, multicenter, global Phase Ib/II study designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of lisaftoclax monotherapy or in combinations with agents such as ibrutinib/rituximab in patients with WM.

Patient enrollment and methods:

• In this study, patients with WM were enrolled in 3 arms, including Arm A: lisaftoclax monotherapy in patients resistant or intolerant to prior treatment with Bruton’s tyrosine kinase inhibitors (BTKis); Arm B: lisaftoclax combined with ibrutinib in treatment-naïve patients with WM; and Arm C: lisaftoclax combined with rituximab in BTKi-naïve patients with relapsed/refractory WM.
• Lisaftoclax was orally administered once daily in 28-day cycles. Lisaftoclax was gradually escalated from the starting dose of 400 mg to 1,200 mg. As of January 25, 2024, a total of 46 patients were enrolled in the study (Arm A [n=14] at doses of up to 1,000 mg; Arm B [n=24] at doses of up to 1,200 mg; Arm C [n=8] at doses of up to 800 mg).

Efficacy results:

• The median (range) durations of treatment were 11 (1-28), 23.5 (1-34), and 11.5 (5-33) months for Arms A, B, and C, respectively.
• The objective response rates (ORRs; PR, very good partial response [VGPR], CR) were 41.7%, 90.9%, and 37.5% for Arms A, B, and C, respectively.
• In Arm A, patients with wild-type CXCR4 (n =7) had better overall response to lisaftoclax than the CXCR4^mut group (n = 3).
• In Arms B and C, no significant differences between patients with/without CXCR4^mut were observed.

Safety results:

• In Arm B, 1 dose-limiting toxicity (DLT, grade 3 clinical TLS), attributed to pre-existing renal impairment, occurred at 1,200 mg; and 1 grade 3 laboratory TLS, primarily attributed to dehydration and concomitant symptomatic therapies, occurred at 1,000 mg. Abnormal electrolytes was resolved without recurrence after 1 day of drug interruption.
• Grade ≥ 3 lisaftoclax-related adverse events (AEs) included neutropenia (15.2%), thrombocytopenia (4.3%), decreased leukocytes (4.3%), TLS (4.3%), anemia (2.2%), weight loss (2.2%), and septic shock (2.2%).
• Ventricular arrhythmia was not observed.
• One patient required dose reduction because of neutropenia.
• The maximum-tolerated dose (MTD) was not reached.
• Lisaftoclax combined with ibrutinib showed a PK exposure comparable to lisaftoclax or ibrutinib alone, indicating no potential drug-drug interactions (DDIs).

Conclusions: Lisaftoclax alone and combined with ibrutinib or rituximab was well tolerated and demonstrated measurable effects in patients with treatment-naïve or BTKi-treatment-failed WM.

APG-2449

Updated study results of novel FAK/ALK/ROS1 inhibitor APG-2449 in patients (pts) with non-small-cell lung cancer (NSCLC) resistant to second-generation ALK inhibitors.

Abstract#: 3124

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Date and Time: June 1, 2024, Saturday, 9:00 AM – 12:00 PM (Central Time)

First Author: Yuxiang Ma, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.

Highlights:

Background: ALK inhibitors increase FAK pathway gene expression in ALK⁺ NSCLC cell lines, with the highest induced expression in drug-tolerant persister cells. This suggests that FAK pathway activation is involved in the mechanism that leads to ALK TKI resistance in ALK⁺ NSCLC. APG-2449 is an orally active FAK inhibitor and a third-generation ALK/ROS1 TKI that has shown potent antitumor activity in preclinical models and clinical studies. This poster reports further safety and efficacy data of APG-2449.

Patient enrollment and methods:

• This study comprises a dose-escalation portion and a dose-expansion portion. 1,200 mg daily (QD) was determined as the RP2D. There are two cohorts in the dose-expansion portion: Cohort 1 included patients with NSCLC who were resistant to second-generation ALK TKIs; Cohort 2 included patients with NSCLC who were ALK or ROS1 TKI naïve.
• As of December 9, 2023, a total of 144 patients with NSCLC, mesothelioma, or ovarian cancer were treated with APG-2449 at doses ranging from 150 – 1,500 mg. The median (range) age of patients was 53 (21-78) years and 53.5% were female.

Efficacy results:

• The ORRs of APG-2449 in patients with ROS1 and ALK TKI-naïve NSCLC (n=36) were 68.2% (15/22) and 78.6% (11/14), respectively. Of the 22 patients with NSCLC resistant to second-generation ALK inhibitors and without targetable bypass gene mutations (e.g., KRAS G12C, BRAF V600E), 9 achieved PRs (9/22; 40.9%). Among the patients treated with RP2D, 12 had brain metastasis at baseline, 9 of whom achieved intracranial PR, resulting in an intracranial ORR of 75.0%.
• Biomarker analysis found that in patients with NSCLC that was resistant to second-generation ALK TKIs, PFS was correlated with phosphorylated FAK (pFAK) levels in the tumor tissue, suggesting that patients with higher pFAK levels were more likely to benefit from APG-2449.

Safety results: A total of 129 (89.6%) patients had treatment‑related adverse events (TRAEs), the most frequent of which were elevated serum creatinine (49.3%), increase in alanine aminotransferase (42.4%), increase in aspartate aminotransferase (36.1%); nausea (28.5%); vomiting (23.6%); diarrhea (22.9%); and decreased leukocyte count (22.2%). In all, 20 (13.9%) TRAEs were grade ≥ 3.

Conclusions: APG-2449 demonstrated preliminary efficacy in patients with NSCLC whose disease was TKI naïve and resistant to second-generation ALK inhibitors, especially in brain metastases. Biomarker analysis showed that high pFAK expression levels in baseline tumor tissue correlated with improved APG-2449 treatment responses in patients with NSCLC resistant to second-generation ALK TKIs.

*Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.

*Lisaftoclax and APG-2449 are investigational drugs that have not been approved in any country and region.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials, including 5 global registrational phase III studies, in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.

Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company’s first approved product in China, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates.

Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

Forward-Looking Statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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Portal Will Enable Participants and Attendees to Book Rooms for November Event in Baku

BAKU, Azerbaijan, May 24, 2024 /PRNewswire/ — Azerbaijan, the host of COP29, today unveiled its interactive accommodation portal, the system that will enable participants and attendees to book hotel rooms and other lodging for the United Nations Climate Change Conference being held in Baku in November.

COP29 Launch of accommodation platform

In a press conference at the COP29 Office, Azada Huseynova, Deputy Chair of the State Tourism Agency of the Republic of Azerbaijan, said the accommodation system has been designed to ensure that a range of room types and locations will be available to people who want to attend the event.

The accommodation platform will be available for reservations https://cop29-accommodation.bnetwork.com from 17:00 today, on 23^rd May, 2024.

“We will be ready to welcome the world to Baku. We have studied the experiences of previous COP host countries and how they approached their accommodation programs and have integrated some elements of those practices into our plans as COP host country,” Ms. Huseynova said. “We have put in place the infrastructure that will ensure that participants from around the world can make their accommodation booking in a smooth and speedy way.”

The State Tourism Agency is working with hotels, on-line accommodation marketplaces, and other residential and lodging locations in the city and region, to ensure that the event will be able to host the full complement of attendees comfortably and enjoyably.      

The lodging made available in the system today is the first phase of a comprehensive rollout. Further phases will release additional rooms at additional hotels and lodging facilities.

The hotels included in the platform have been selected on the basis of quality, location and transportation services that will be arranged for the event. The Agency audited more than 300 accommodation establishments, and approximately 200 have been classified and received a star rating. About 40 hotels that did not earn a star classification were given a period to improve facilities and performance before being re-audited.

Ms. Huseynova also provided details of a customer service training program being undertaken by the State Tourism Agency in advance of COP29. Approximately 2,000 employees from about 300 establishments in the cities of Baku and Sumgayit, and the wider Absheron region are participating.

In addition, the Agency plans to provide training and certification to 200 tourist guides, and training to a further 1,000 tourism volunteers, who will be assigned to hotels to support guests during COP29.

COP29 Launch of accommodation platform

COP29 Launch of accommodation platform

COP29 Launch of accommodation platform

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