• CBL-514 is the first product to treat cellulite at the raised areas.
• Currently, there is no effective and safe cellulite treatment on the market. The global market for cellulite treatment is estimated to expand to $7.37 billion in 2034.
• CBL-0201EFP Phase 2 study demonstrated CBL-514 statistically significant efficacy in reducing cellulite severity scores at 4 and 12 weeks after treatment.
• Over 50% of participants experienced at least one level of improvement in cellulite severity 12 weeks after the final CBL-514 treatment evaluating with the modified Hexsel Cellulite Severity Scale among 4 levels of severity.
• CBL-514 is under development for multiple indications, including Cellulite, Local Fat Reduction (currently in Phase 2b), and Durum’s disease (currently in Phase 2), which brought Caliway the Fast Track Designation and the Orphan Drug Designation by the FDA in Feb. 2024.

NEW TAIPEI CITY, April 26, 2024 /PRNewswire/ — Caliway Biopharmaceuticals (Caliway) today announced the topline results of the CBL-0201EFP Phase 2 study, which met all the primary and secondary efficacy endpoints in the ITT (Intent-to-treat) and PP (per-protocol) analysis population, demonstrating CBL-514’s statistically and clinically significant efficacy in improving cellulite severity with favorable safety and tolerance profiles.

CBL-514, Caliway’s lead pipeline, is a multi-indication lipolysis injection that can reduce subcutaneous adiposity by inducing adipocyte apoptosis. Among all the current cellulite treatment products, CBL-514 is the first and only product to treat cellulite in the raised areas.

Apart from cellulite treatment, CBL-514 is also under Phase 2 study for subcutaneous fat reduction and Dercum’s disease. Moreover, the U.S. FDA granted CBL-514 Fast Track Designation and Orphan Drug Designation based on the CBL-0201DD Phase 2 study results for Dercum’s disease in February 2024.

CBL-0201EFP Phase 2-stage 1 Topline Results: Significant Reductions in Cellulite Severity Across Three Dosage Groups

CBL-0201EFP Phase 2 study is an open-labeled study to evaluate the safety, tolerability, and efficacy of CBL-514 injection for the treatment of Edematous Fibrosclerotic Panniculopathy (EFP, cellulite). The efficacy was assessed using the modified Hexsel Cellulite Severity Scale (Modified HCSS), with the highest score (9) indicating the most severe cellulite severity and the lowest score (0) indicating no cellulite. The severity level of cellulite will be scored as mild (1-3), moderate (4-6), or severe (7-9), which will be determined by the total scores.

In the CBL-0201EFP Phase 2-stage 1 dose-finding study, a total of 12 participants were enrolled in 3 sequential escalating CBL-514 dose groups, 40mg, 60mg, and 80mg, to receive 1 CBL-514 treatment administered on both sides of the posterolateral thighs.

The statistical analysis revealed significant reductions in cellulite severity across three dosage groups. Follow-up assessments at 2 and 4 weeks post single treatment on both thighs showed statistically significant improvements in cellulite severity for all dosage groups, with the high-dose group of 80 mg showing the most promising efficacy, reducing cellulite severity score (mean±SD) of -2.0±0.9 points (p= 0.00049，95%CI: -2.77, -1.23) and -2.6±1.5 (p= 0.00169，95%CI: -3.88, -1.37) at 2 and 4 weeks after treatment.

CBL-0201EFP Phase 2-stage 2 Topline Results: Over 50% of Participants Demonstrated at least One Level of Improvement Among 4 Cellulite Severity Levels

In the CBL-0201EFP Phase 2-stage 2 study is a single-arm study, a total of 23 participants were enrolled to receive up to 2 CBL-514 treatments based on cellulite severity on the thighs, with a maximum single dose not exceeding 320 mg administered at 4-week intervals.

The baseline of participants’ average cellulite severity score (mean±SD) is 6.5 ± 1.0 points. Four weeks after the final CBL-514 treatment, using Modified HCSS score of 1 ~9 in 4 severity levels, there was a reduction in cellulite severity with a mean change of -1.3 ± 1.3 points (p < 0.00001, 95% CI: -1.70, -0.90), demonstrating CBL-514’s statically significant efficacy in cellulite severity improvement at both 4 weeks (p < 0.00001) and 12 weeks (p < 0.00001) after CBL-514 treatment. Moreover, over 50% of participants experienced at least one level of improvement in cellulite severity at the 12 weeks after the final CBL-514 treatment.

In addition to the primary efficacy endpoint, a secondary efficacy endpoint assessed by the Global Aesthetic Improvement Scale (GAIS) demonstrated notable improvements in cellulite. Following the final treatment, both the Principal Investigator (PI) and participants assessed over 95% of individuals as having improved cellulite appearance at the four-week mark.

The safety and tolerability profiles of CBL-514 demonstrated in both stages of the study were favorable and consistent with previous clinical studies of CBL-514. Most adverse events were mild to moderate injection site reactions, including injection site bruising, pain, swelling, and warmth, and were resolved within 28 days post-treatment.

These findings underscore the potential of CBL-514 as a highly effective treatment option for reducing cellulite severity, offering renewed confidence and satisfaction to those affected by this common cosmetic concern.

Following up, Caliway will further develop the cellulite severity scale for future CBL-514 clinical studies to evaluate cellulite improvement efficacy based on the U.S. FDA’s instruction.

About Cellulite (Edematous Fibrosclerotic Panniculopathy, EFP)

Cellulite is characterized by the nonpathological appearance of the dimpled skin surface (likened to orange peel, cottage cheese, or mattress appearance), which occurs on the thighs and buttocks. The relief alterations of cellulite include depressions and raised areas. The depressions are caused by skin retraction by subcutaneous fibrous septa, while raised areas are projections of fat and subcutaneous structures to the skin surface. According to the American Society of Plastic Surgeons (ASPS) report, around 80 to 90% of women experience cellulite dimpling.

The current treatment for cellulite includes non-invasive (medical devices and collagenase drug) and invasive options. However, their efficacy remains limited and temporary. Additionally, most products would cause significant side effects after administration, including severe bruising, pain, and hyperpigmentation, making most patients reluctant to receive them. The clinical need for cellulite treatment remains unmet. The global market for cellulite treatment is estimated to expand to $7.37 billion in 2034.

About the CBL-0201EFP Phase 2 Study

CBL-0201EFP Phase 2 study is an open-labeled study assessing the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite. The study has an integrated design consisting of a single ascending dose (SAD) part in Stage 1 followed by a single-arm design in Stage 2.

The Stage 1 study (clinicaltrial.gov ID: NCT05632926) included a total of 12 participants enrolled in 3 sequential escalating CBL-514 dose groups, 40mg, 60mg, and 80mg. Eligible participants will be sequentially assigned to receive 1 course of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.

The Stage 2 study (clinicaltrial.gov ID: NCT05836779) included a total of 23 participants enrolled in 1 selected CBL-514 dose. Eligible participants will be sequentially assigned to receive up to 2 courses of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.

About CBL-514

CBL-514, a potentially first-in-class small-molecule drug, is a lipolysis injection that can induce adipocyte apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas in animal studies without causing any systematic side effects on the central nervous system and cardiovascular system, and respiratory system. Caliway’s preclinical studies showed that CBL-514 upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio, and then induces dose-dependent adipocyte apoptosis in vivo and in vitro.

Caliway is investigating multiple indications for CBL-514, including non-invasive subcutaneous fat reduction, Dercum’s disease, cellulite, and lipoma treatment.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven by the discovery of breakthrough small-molecule therapeutics with a focus on medical aesthetics and inflammatory disease.

Listed on the emerging stock market in Taiwan (TPEX6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: http://www.Caliway.com.tw/en

Disclaimer

This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change.

For additional contact: info@caliway.com.tw

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Two new drama brands focusing on literary work adaptations and short series respectively
Using generative AI to optimize content production and empower creators

BEIJING, April 25, 2024 /PRNewswire/ — iQIYI, an innovative market-leading online entertainment service in China, announced an exciting lineup of over 300 new titles across genres at the iQIYI 2024 World Conference held on April 23-24. The company also introduced two new drama series brands and forged multiple strategic partnerships aimed at fueling growth with its premium content offerings and IP development.

The conference explored iQIYI’s comprehensive content strategy, spanning drama series, films, variety shows, documentaries, animations, and sports programming, meticulously tailored to cater to the evolving needs of the audiences. Yu GONG, Founder and CEO of iQIYI, highlighted the company’s commitment to realism in content creation and delivering high-quality and diverse offerings. Gong also emphasized the opportunities presented by generative AI advancements and demographic shifts in China, particularly the evolving entertainment requirements of children and the elderly population.

Expansive Offerings with New Drama Brands

Following the success of the suspense-laden ‘Light On Theater,’ the romance-infused ‘Sweet On Theater’ and the humor-packed ‘Laugh On Theater,’ iQIYI is expanding its offerings with the introduction of two new drama series brands. ‘Dajia Theater,’ meaning ‘master of literature,’ will bring to life literary masterpieces and portray the real-life stories of ordinary people with productions such as Chinese Peach and Plum, Fathers and Sons, One Day Three Autumns and This Thriving Land. Meanwhile, the newly introduced ‘Weichen Theater,’ meaning ‘tiny dust,’ will specialize in premium mini-series that reflect new aesthetics and auditory experiences, featuring works like To the Wonder and What a Wonderful World.

Xiaohui WANG, Chief Content Officer at iQIYI, emphasized the company’s steadfast commitment to fostering creative diversity and innovation among its studios. By actively encouraging the development of distinctive styles, iQIYI strives to deliver a wide array of premium content that boldly pushes the boundaries of artistic expression and storytelling. The company remains dedicated to producing high-quality content that delves into profound themes and introduces fresh narratives, thereby catering to users’ growing demand for elevated aesthetic and emotional experiences.

Multi-dimensional IP Development and New Partnership

At the conference, iQIYI showcased its strategic focus on cultivating IPs through various approaches, such as partnerships, seasonal releases, and integrative experiences.

The platform announced it has formed a partnership with Stephen CHOW’s Bingo Group to produce innovative content that spans formats and genres surrounding popular IPs.

iQIYI also emphasized its dedication to developing IPs through seasonal releases, both in dramas and variety shows, by announcing several highly anticipated dramas like Ordinary Greatness 2 and The Fearless 2, as well as new seasons of popular variety IPs such as Hi! Young Farmers 2024, The Rap of China 2024, and The Detectives’ Adventures Season 4. Additionally, it introduced new original shows like Burning Moon and My Zone.

In addition to the popular dramas and variety shows, iQIYI also plans to release 29 thrilling films, while accelerating the creation of Chinese animation and enriching its library of children’s IPs. Furthermore, sports enthusiasts will be captivated by iQIYI’s impressive lineup, featuring prestigious global events such as the 2024 UEFA European Championship, the Premier League, the UEFA Champions League, and prominent golf and tennis Grand Slam tournaments.

As part of its evolving IP development strategy, the platform aims to craft more interactive and immersive experiences that seamlessly integrate various content formats such as drama series, variety shows, and animations. By extending these experiences into physical parks and VR immersive theaters, iQIYI seeks to enrich the value of its IPs and foster deeper viewer engagement across a diverse range of platforms and touchpoints.

Senior Vice President Gang WU emphasized that premium IPs not only help brands enhance recognition but also foster growth across economic cycles. With its premium content offerings and valuable user base, iQIYI has integrated marketing efforts across content, social, and consumption domains, enabling brands at various stages of development to capitalize on its platform’s strengths.

Unleashing Creativity with Generative AI

Wenfeng LIU, Chief Technology Officer, shed light on how generative AI is transforming the company’s content creation process. In the planning phase, for instance, generative AI empowers creators by harnessing trained models that can accurately identify compelling plot points within scripts. During production, the application of generative AI has significantly enhanced virtual production, sound design, and digital asset creation. A prime example is iQIYI’s proprietary AI-powered IQ Stage virtual shooting system, which has successfully supported the filming of The Story of Mystics, a drama series showcasing extensive virtual shooting with a wide array of scenes.

Liu believes that AI-generated content should not be misinterpreted as competing with professionally produced content and user-generated content. Instead, creators across all content categories can leverage generative AI’s capabilities to produce higher-quality content, leading to accelerated industry iteration and significantly increased innovation opportunities.

Throughout this process, iQIYI aims to amplify the value of creators by harnessing the leverage of generative AI, enabling them to unleash their unique creativity and exceptional aesthetics, resulting in the creation of even more captivating content.

CONTACT: iQIYI Press, press@qiyi.com

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SUZHOU, China and ROCKVILLE, Md., April 25, 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 results from four clinical studies of the company’s three key drug candidates have been selected for presentations, including an Oral Report, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The three drugs are 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.

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. This year’s ASCO Annual Meeting will take place both online and in-person at the McCormick Place, Chicago, IL, the United States, on May 31–June 4, 2024 (local time).

“Entering the seventh consecutive year for our studies to be selected for presentations at the ASCO Annual Meeting, we are honored to have the opportunity to once again showcase our capabilities in global innovation and clinical development at this top international scientific meeting,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “Our presentations this year include an Oral Report featuring updated data of olverembatinib in patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST), an indication that currently has no effective treatment. Furthermore, we will release detailed data of lisaftoclax in patients with acute myeloid leukemia (AML) and in patients with Waldenstrom macroglobulinemia (WM), as well as those of APG-2449 in patients with non-small cell lung cancer (NSCLC). We look forward to sharing the detailed results from those studies with our colleagues at the meeting. Moving forward, we will remain dedicated to those global clinical development programs of key candidates to hopefully bring more treatment options to patients in need.”

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

Olverembatinib
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
Format: Oral Report
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.

APG-2575 (Lisaftoclax)
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
Format: Poster Presentation
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.

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
Format: Poster Presentation
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.

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
Format: Poster Presentation
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.

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, 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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