SHANGHAI, April 7, 2024 /PRNewswire/ — Dizal (688192.SH) today announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.

This Breakthrough Therapy Designation (BTD) approval was based on results from the global multi-center phase I/II study (WU-KONG1). At 2023 ESMO, Dizal reported main study results, showing sunvozertinib as a single agent with confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months.

Sunvozertinib was previously granted  BTDs by both the US FDA and the China Center for Drug Evaluation (CDE) for relapsed or refractory patients  It was subsequently approved in China in 2023 for the treatment of patients who failed 1^st line treatment. NDA submissions for US and EU approvals in the same setting is anticipated later in 2024.

“We are delighted with the FDA’s decision granting the Breakthrough Therapy Designation to sunvozertinib for first-line treatment, coming on the heels of earlier BTD approval in later lines of therapy — a clear indication of sunvozertinib’s transformative potential in the treatment of patients with EGFR exon20ins NSCLC. Multiple clinical trials have consistently demonstrated sunvozertinib’s significant clinical benefits to our patients. As a single, oral agent, it offers apparent advantages in both safety and patient compliance over chemotherapies and infusion.” said Xiaolin Zhang, PhD, CEO of Dizal, “Now enrollment for the global pivotal study in relapsed and refractory setting (WU-KONG1 PART B) has been completed, and we are going to report the study results as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. A randomized global phase III study in the first line setting (WU-KONG28) is well underway. This new BTD will enable us work more closely with the FDA and accelerate its clinical development and regulatory submission.”

Affecting roughly 2%-4% of NSCLC patients, EGFR Exon20ins mutations have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. There has been a persistent lack of safe and effective targeted treatment options for this mutation, leading to limited survival benefits for patients.

Sunvozertinib’s innovative molecular structure enables it to overcome the inherent difficulties of targeting EGFR Exon20ins mutations, offering improved efficacy, safety, and ease of administration. Supported by findings yielded in the multicenter phase 2 pivotal study WU-KONG6, sunvozertinib was approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy, validating its potent and well-tolerated profile in previously treated NSCLC patients with EGFR Exon20ins mutations.

About Breakthrough Therapy Designation

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and regulatory review of drugs for serious or life-threatening conditions. To qualify, new drugs must demonstrate promising preliminary clinical results indicating substantial improvement on clinically significant endpoints over existing treatments. Drugs designated as breakthrough therapies benefit from a suite of accelerated development policies, including close guidance by FDA experts throughout the clinical development process, significantly improving communication efficiency. Upon submission of a marketing application, such drugs may also be eligible for priority review if they meet relevant criteria.

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA for the treatment of advanced NSCLC with EGFR exon20ins mutations after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins mutations. The primary endpoint of the study, which was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins mutations.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug related TEAEs (treatment emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 PART B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR Exon20ins mutations.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).

About Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs around the world. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies and one already launched. 

To learn more about Dizal, please visit www.dizalpharma.com, or follow us at Linkedin or Twitter.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, and “intend” and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal’s competitive environment, and political, economic, legal, and social conditions.

Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect.

Contacts

Investor Relations: ir@dizalpharma.com
Business Development: bd@dizalpharma.com

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KUALA LUMPUR, Malaysia, April 7, 2024 /PRNewswire/ — Global lifestyle retailer MINISO opened its first Malaysian IP collection store at the Berjaya Times Square mall, Kuala Lumpur, on March 30. The new store is a perfect pink vision with an eye-catching design inspired by MINISO’s Barbie collaboration. With a wide selection of trendy new IP products and a vibrant in-store atmosphere, it embodies MINISO’s Joy Philosophy and will create memorable moments for Malaysian shoppers. The new store broke MINISO’s Malaysia sales records for two consecutive days after its opening.

With a floorspace of 200m² and over 3,000 SKUs, the new store stocks beloved old favorites and exciting new designs. It will bring more fresh and fashionable Barbie IP products to Malaysia for the first time, including the new Barbie Ballet Eau de Parfum collection. The store also offers many other popular IP collaboration ranges including Disney, Care Bears, and Pokémon, as well as MINISO original designs across diverse categories including toys, dolls, perfumes, cosmetics, blind boxes and more.

Channeling Barbie’s fashionista fame, MINISO turned up the style in designing the new store. Awash in a sea of pink, the store features dazzling Barbie-inspired aesthetic elements including pink palm trees and mirrors, and a Barbie fragrance area to enjoy the new perfumes. The store’s design reflects MINISO’s creative approach to IP collaboration, wowing visitors to the store with a joyful mood and exciting shopping experience.

On the store’s opening day, the brand brought its own MINISO Fashion Week to the mall where shoppers were met by dozens of models dressed in pink suits handing out flyers, distributing gifts and taking photos with shoppers. Outside the store, a Barbie pop-up with a pink photo booth attracted visitors, while 50 lucky shoppers won MINISO Barbie IP-themed goodie bags in a lucky draw. Visitors were also delighted by the appearance of popular influencers Angelloweee and Cahaya icha who walked the store’s pink carpet and posed for photos with fans.

“We’re thrilled to have opened our first MINISO IP collection store in Malaysia. We will bring more stores nationwide offering our signature design-led, fun and affordable products, including IP collaborations and original designs,” said Bella Tu, General Manager of MINISO Overseas Directly Operated Markets and Vice President of MINISO. “Our new Barbie-inspired IP collection store is a perfect example of our innovative approach to IP collaborations, as we look for new ways to spread our Joy Philosophy and capture the imaginations of young Malaysian consumers.” 

The opening of the new store at the Berjaya Times Square mall comes as MINISO pursues continued expansion in Malaysia. MINISO currently has stores in high-potential locations nationwide such as IOI City (Putrajaya), Nu Sentral (Nu Sentra), Setia (Selangor) and Mid-valley (Kuala Lumpur). As one of its key expansion markets, MINISO currently has over 1300 stores across Asia (excluding China), with huge development potential remaining in all overseas markets. In 2024, MINISO hopes to deliver a net increase of 550-650 overseas stores, with the vast majority expected to be in Asia (excluding China) and LATAM countries, followed by Europe and North America, spreading the brand’s Joy Philosophy to even more consumers around the world.

About MINISO

MINISO Group is a global lifestyle brand offering a variety of design-led lifestyle products. The Company serves consumers primarily through its large network of MINISO stores, and promotes a relaxing, treasure-hunting and engaging shopping experience full of delightful surprises that appeals to all demographics. Aesthetically pleasing design, quality and affordability are at the core of every product in MINISO’s wide product portfolio, and the Company continually and frequently rolls out products with these qualities. Since the opening of its first store in China in 2013, the Company has built its flagship brand “MINISO” as a globally recognized retail brand and established a massive store network worldwide.

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SHANGHAI and HONG KONG, April 6, 2024 /PRNewswire/ — Antengene Corporation Limited (“Antengene“, SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), taking place from April 5^th to April 10^th at the San Diego Convention Center in San Diego, California, the United States. The posters showcased four of Antengene’s high-potential emerging programs, including ATG-042, tracking to a H1 2025 IND filing; ATG-022, in Phase II dose expansion studies in China and Australia; AnTenGager^TM platform, Antengene’s proprietary T-cell engager (TCE) platform; and ATG-102, which could be the first IND candidate from AnTenGager^TM platform.

ATG-042, an oral small molecule MTAP^null-selective PRMT5 inhibitor holding the promise as a best-in-class drug. Study results showed that ATG-042 has the potential to elegantly target tumor cells while sparing healthy cells, with an attractive developability profile. ATG-022 is an Claudin 18.2 antibody-drug conjugate. The detailed updated data of the Claudin 18.2 (CLDN18.2) companion diagnostic antibody candidate for ATG-022 showed that the antibody has higher sensitivity compared to commercially available kits. AnTenGager^TM, Antengene’s proprietary TCE platform with the ability to induce target-dependent T-cell activation, has potent anti-tumor effects and lower risk of cytokine release syndrome (CRS). ATG-102, a LILRB4 x CD3 TCE, is being developed for the treatment of acute myeloid leukemia (AML).

Details of the posters:

ATG-042 (MTAP^null-selective PRMT5 Inhibitor)

Title: Preclinical characterization of ATG-042, a novel MTAP^null-selective PRMT5 inhibitor

Abstract: 4592 

Session Category: Experimental and Molecular Therapeutics

Session Title: HDAC and Methyltransferase Inhibitors

Date: April 9, 2024

Time: 9:00 AM – 12:30 PM (Pacific Time)

          12:00 AM – 3:30 AM, April 10, 2024 (Beijing Time)

Location: Poster Section 24

• This preclinical study was designed to test the in vitro/in vivo efficacy, and preclinical pharmacokinetic (PK) properties of ATG-042.
• According to the results, ATG-042 demonstrated a potent and selective inhibitory effect on the proliferation of MTAP knockout cells, showed high permeability, good metabolic stability, a low risk of drug-drug interaction (DDI), and high oral bioavailability. Importantly, ATG-042 demonstrated good brain penetrability. In CDX models, ATG-042 also potently and selectively inhibited tumor growth without inducing weight loss.
• These data suggest that ATG-042 is an orally administered, MTAP^null-selective PRMT5 inhibitor with potent efficacy against MTAP-null tumors, as well as demonstrating good tolerability and favorable preclinical PK profiles.

Companion Diagnostic Antibody for ATG-022 (Claudin 18.2 ADC)

Title: Development of a novel companion diagnostic immunohistochemistry antibody for Claudin 18.2-targeted therapies

Abstract: 1032

Session Category: Clinical Research

Session Title: Diagnostic Biomarkers 1

Date: April 7, 2024

Time: 1:30 PM – 5:00 PM (Pacific Time)

           4:30 AM – 8:00 AM, April 8, 2024 (Beijing Time)

Location: Poster Section 42

• Despite the substantial correlation between the expression of CLDN18.2 and the efficacy of therapies targeting CLDN18.2, no companion diagnostic (CDx) antibodies specific to CLDN18.2 have been approved to date. This poster presents the discovery and validation of a novel, highly sensitive immunohistochemistry (IHC) antibody that selectively identifies CLDN18.2.
• According these data, the monoclonal antibody (mAb) clone 43F11 showed positive cell surface IHC staining on CLDN18.2-expressing cells following fixation but demonstrated no staining on CLDN18.1-expressing cells. Moreover, the 43F11 antibody accurately identified the expression level of CLDN18.2 in an IHC assay, utilizing tumor tissues and patient-derived xenograft (PDX) samples with predetermined expression levels of CLDN18.2. When compared to the commercially available IHC antibody EPR19202, the 43F11 antibody demonstrated greater sensitivity, enabling positive staining on cancer tissues with significantly lower expression levels of CLDN18.2.
• These data suggest that the 43F11 antibody possesses superior sensitivity compared to the benchmark antibody and has the potential to serve as an effective patient stratification tool.

AnTenGager^TM Platform

Title: AnTenGager^TM, a novel “2+1” T cell engager platform, enables conditional T cell activation with reduced risk of CRS

Abstract: 6343

Session Category: Clinical Research

Session Title: Antibodies 2

Date: April 9, 2024

Time: 1:30 PM – 5:00 PM (Pacific Time)

           4:30 AM – 8:00 AM, April 10, 2024 (Beijing Time)

Location: Poster Section 41

• This poster presents an in-depth overview of the design and mechanism of action for the proprietary AnTenGager^TM T cell engager (TCE) platform. These TCEs are specifically designed to produce an anti-cancer effect with a lower risk of systemic CD3 activation and cytokine release syndrome (CRS), potentially paving the way for use in solid tumors.
• AnTenGagers TCE constructs are designed to induce cytotoxicity by forming a T cell receptor (TCR)-independent immune synapse. AnTenGagers do this by simultaneously binding tumor associated antigens (TAAs) on cancer cells and specific conformational epitopes on CD3+ T-cells.
• Presented data show that AnTenGagers are able to effectively bind to specific CD3 confirmational epitopes and demonstrate higher cytotoxicity compared to benchmark compounds.
• AnTenGagers are compatible with a range of TAAs, and that AnTenGagers have improved cytotoxicity compared to benchmark compounds, as demonstrated in cellular assays and a murine myeloma model. Data from the murine models also showed that AnTenGagers resulted in significantly lower concentrations of pro-inflammatory cytokines, further supporting a lower risk of CRS.
• AnTenGagers also have good “developability” properties based on good stability under stress conditions.
• Together, these data support the potential for AnTenGagers to be used in solid tumors, based on their ability to simultaneously bind TAAs and specific CD3+ confirmational epitopes, resulting in higher TAA-dependent cytotoxicity compared to benchmarks and the reduced risk of CRS, opening the door to a broad new class of cancer therapies.

ATG-102 (LILRB4 x CD3 T Cell Engager)

Title: ATG-102, a novel LILRB4 x CD3 T cell engager, targeting two non-overlapping epitopes of LILRB4, for the treatment of monocytic AML

Abstract: 2372

Session Category: Clinical Research

Session Title: Antibodies 1

Date: April 8, 2024

Time: 9:00 AM – 12:30 PM (Pacific Time)

          12:00 AM – 3:30 AM, April 9, 2024 (Beijing Time)

Location: Poster Section 38

• The use of TCEs to treat AML (acute myeloid leukemia) has been limited the difficulty in identifying specific antigens that are expressed on AML and leukemic stem cells but not normal hematopoietic stem cells. The preferential expression of LILRB4 on M4/M5 subtype acute myeloid leukemia (AML) cells renders it a highly attractive target for the treatment of AML. These data show that an AnTenGager^TM based TCE, which binds to two distinct epitopes of the LILRB4 receptor, can induce potent T-cell dependent cellular cytotoxicity (TDCC) to produce potent anti-tumor efficacy in vitro and in vivo.
• The poster outlines the design and structural characteristics of ATG-102 comprised of two LILRB4 epitopes and an anti-CD3 single chain fragment variable (scFv) inserted in the hinge region on one of the LILRB4 heavy chains. Characterization data include:

-Binding epitope and affinity studies showing that ATG-102 binds to the target TAA epitopes as well as conformational CD3 epitopes. 
-T cell binding and T-cell dependent cytotoxicity assays show that compared to the benchmark, ATG-102 demonstrated less non-specific T cell binding or activation, whilst inducing more potent TDCC against LILRB4+cells and enhanced in vivo anti-AML efficacy.

• These data highlight the structural characteristics of ATG-102 and demonstrate potent in vitro and in vivo anti-tumor efficacy which support further clinical evaluation of ATG-102.

About Antengene

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of “Treating Patients Beyond Borders”.

Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 11 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO^® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore and Australia.

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, we undertake 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. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company’s Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange.

Investor Contacts: 
Donald Lung
E-mail: Donald.Lung@antengene.com  
Mobile: +86 18420672158

PR Contacts:
Peter Qian
E-mail: Peter.Qian@antengene.com 
Mobile: +86 13062747000

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PARIS, April 6, 2024 /PRNewswire/ — At the Gamers Assembly in Poitiers, France, Optic 2000 & AUSTRALIEGAD set the best video game players an ambitious challenge: to take on a blind player, equipped with an innovative device, in one of the most legendary games. It was an inspiring experience, designed to change the way people look at visual impairment.

“OPTIC 2000 CHALLENGER”

Optic 2000 is committed to supporting the development of technological innovation to help visually impaired people live independently. Since 2023 the company has been supporting the start-up Artha and its mobility aid for the visually impaired: a belt that transforms images into impulses.

https://www.instagram.com/p/C5B8SoFN3oW/?hl=fr

This weekend, Optic 2000 and Artha launched the “Optic 2000 Challenger” challenge with Salim Ejnaïni, the first visually impaired player equipped with an Artha belt, taking on able-bodied players on the famous Trackmania game. 

This partnership reflects Optic 2000’s commitment to low vision and its desire to innovate on a daily basis to support and promote the independence of visually impaired people.

“As well as being proud to be behind this major first, it’s a great opportunity to help change the way people view visual impairment. Our mission is to support our customers throughout their lives, to provide them with the best possible visual comfort.”

Benoit Jaubert, Managing Director of Groupement Optic 2000.

A stand dedicated to raising public awareness

This major event was also an opportunity to raise public awareness of visual impairment and the risks of overexposure to screens.

On the Optic 2000 stand, visitors could find out more about how to protect their eyesight and opticians were available on site to carry out eye tests.

• The public could also enjoy an inclusive experience with a workshop designed to raise awareness of visual impairment: by wearing special glasses simulating visual problems (macular degeneration, glaucoma, etc.), visitors could slip into the shoes of a visually impaired person whilst playing a game to raise awareness and understanding of this handicap.

Throughout the weekend, AUSTRALIEGAD’s cameras followed Salim behind the scenes at the Optic 2000 Challenger, from preparation to the tournament itself. The video will be available next week on the OPTIC 2000 networks.

Media Contact: jallain@australiegad.com 

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