ReCerise Signs New Research Collaboration Agreement towards Development of Innovative Treatment for Hepatocellular Carcinoma

On February 20, 2025 ReCerise Therapeutics Inc. ("ReCerise"), a company committed to research and development of first-in-class therapeutics in oncology, reported to have entered into a research partnership with the National Cancer Centre Singapore ("NCCS") to develop innovative treatments utilizing multi-omics data analyses in hepatocellular carcinoma (HCC) (Press release, ReCerise Therapeutics, FEB 20, 2025, View Source [SID1234650438]).

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This collaboration will be conducted under the PLANet programme (Precision Medicine in Liver Cancer across an Asia-Pacific Network), which was conceptualized and led by NCCS based on the intra-tumoral heterogeneity of liver tumors and its highly dynamic tumor microenvironment (TME). The longitudinal study performs comprehensive multi-omics profiling of tumor and blood samples from liver cancer patients. This collaboration will leverage the processed multi-omics data collected under the PLANet programme, and will be led by Prof. Pierce Chow Kah Hoe, a prominent global expert in the field of HCC. Prof Chow is a Senior Consultant Surgeon in the Division of Surgery and Surgical Oncology at Singapore General Hospital (SGH) and NCCS, and principal investigator of the PLANet programme.

HCC is a highly prevalent cancer with a poor prognosis due to late diagnosis and low response to existing immunotherapeutic treatment options. ReCerise was established with the purpose of investigating and developing new therapeutic modalities to address such unmet medical needs. So far, basic research and proof-of-concept studies on a liver specific protein have demonstrated promise as a potential solution. ReCerise hopes to expand upon this background knowledge by utilizing real-life evidence in collaboration with NCCS to investigate an HCC patient cohort and confirm the target’s expression and its effect on the liver microenvironment.

"We are excited to collaborate with NCCS to accelerate the development of an innovative new drug for the treatment of liver cancer that ReCerise has been working toward," said Yong-Bae Kim, CEO of ReCerise Therapeutics. "Through this joint research, we plan to conduct multi-faceted studies on the development potential of RCT1213, a hepatocellular carcinoma treatment candidate currently under development, by utilizing the various omics data and research database of Asian HCC patients at NCCS."

The research collaboration between these two parties is a research and development project funded by the Korean government and is subject to the management and supervision of the Korea Evaluation Institute of Industrial Technology (KEIT).

Tvardi Therapeutics to Participate in the TD Cowen 45th Annual Health Care Conference

On February 19, 2025 Tvardi Therapeutics, Inc. ("Tvardi"), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, reported that it will participate in the TD Cowen 45th Annual Health Care Conference (Press release, Tvardi Therapeutics, FEB 19, 2025, View Source [SID1234650382]). Tvardi management will host investor one-on-one investor meetings on March 3 – 5, 2025.

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TD Cowen’s 45th Annual Health Care Conference is taking place March 3 – 5, 2025, at the Marriott Copley Place in Boston, MA. The conference incorporates presentations, fireside chats, and innovative panel discussions hosted by members of the TD Cowen research team that focus on various aspects of the health care industry.

Ona Therapeutics Strengthens Leadership Team to Accelerate First-in-Class ADCs into Clinical Development Across Cancer Types

On February 19, 2025 Ona Therapeutics ("Ona"), a global biotech company pioneering first-in-class antibody-drug conjugates (ADCs), reported key leadership appointments to support its rapid growth and pipeline advancement (Press release, Ona Therapeutics, FEB 19, 2025, View Source [SID1234650399]). Dr. Aleix Prat, a global leader in drug and biomarker development, has been appointed Chair of the Advisory Board. Additionally, Dr. Jutta Amersdorffer has joined as Chief Medical Officer and Stéphane Durant des Aulnois as Chief Financial Officer. These appointments come at a pivotal time as Ona accelerates the development of its first-in-class ADC therapeutics, targeting novel tumor-specific markers to eliminate hard-to-treat, resistant cancer cells and advance its pipeline toward clinical development across multiple cancer types.

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Specialized in understanding the biology of hard-to-treat cancers and expertise in biotherapeutic discovery, Ona is developing a pipeline of ADCs tailored to exploit the molecular underpinnings of advanced cancer. Ona´s unique strategy is enabled by analyzing scarce real-world patient biopsies to uncover novel therapeutic targets that are fundamental to the particular biology of treatment-refractory advanced cancer. Its lead ADC, ONA-255, has broad potential to treat breast, gastric, and other solid tumors, and is advancing through IND-enabling studies to initiate clinical development by the end of 2025. In parallel, Ona is developing ONA-389, a second ADC that is positioned for the treatment of advanced microsatellite stable (MSS) colon and liver cancers. This promising therapeutic is set to begin IND-enabling studies in the second half of 2025.

Ona has appointed Dr. Aleix Prat, an internationally recognized leader in precision oncology with an outstanding track record in cancer research, biomarker development, and clinical trials, as Chair of the Advisory Board. In collaboration with Ona’s Advisor, Dr. Roger Gomis, he has been instrumental in identifying the target of ONA-255 and functionally validating it, working alongside the expert team at Ona. Their combined efforts have generated critical preclinical data to support the clinical development of ONA-255. This important data which has been exclusively licensed to Ona from FCRB-IDIBAPS, IRB Barcelona, UB and ICREA, bolsters the foundation for ONA-255’s progression. Dr. Prat serves as the Director of the Clínic Barcelona Comprehensive Cancer Center, Professor of Medicine at the University of Barcelona, and is Co-Founder and Chief Scientific Officer of REVEAL GENOMICS.

With over 300 peer-reviewed publications and leadership roles in oncology research, clinical trials, and precision medicine initiatives, Dr. Prat has been at the forefront of developing and translating novel therapies and diagnostic tools into clinical practice.

Dr. Jutta Amersdorffer joins as Chief Medical Officer and brings extensive experience in translational medicine, clinical and medical development, and pharmacovigilance for innovative biologics. She previously held multiple managerial and senior clinical roles at Sandoz, MorphoSys, and Otsuka Novel Products. She holds a medical license and a Doctor of Medicine from the University of Munich and holds an MBA from the University of Applied Science.

Stéphane Durant des Aulnois has been appointed Chief Financial Officer. With over two decades of experience in finance, business development, investor relations, and private equity, Stéphane brings a wealth of expertise. He spent nine years at Ipsen, first as Vice President and Head of Investor Relations before advancing to CFO of Ipsen Iberia. His career also includes the role of CFO and Head of Alliances & Business Development at Lysogene, a Phase 3 gene therapy company listed on Euronext, roles in private equity at LaSalle Investment Management and Calyon Americas, and as a sell-side research analyst at Exane BNP Paribas. Stéphane simultaneously serves as CFO at Corteria Pharmaceuticals.

He holds an MSc in Accounting and Finance from the London School of Economics (LSE), an MSc in Management from Paris Dauphine University, and an Executive Leadership degree from Harvard Business School.

Valerie Vanhooren, Ph.D., Co-Founder and Chief Executive Officer at Ona Therapeutics, said: "ADCs have transformed cancer treatment; however, the technology has been applied to a limited number of tumor targets. These limitations restrict the number of patients who can benefit from treatments and highlight the critical need to identify new broadly expressed tumor targets. Ona’s tailor-designed ADCs have the potential to define new treatment paradigms and patient populations. With the expansion of our executive team and advisory board, Ona is well-positioned to execute our strategic vision to develop multiple first-in-class ADCs and advance our pipeline into clinical development to improve clinical results across multiple tumor types in patients."

Dr. Aleix Prat, New Chair of the Advisory Board at Ona Therapeutics, commented: "Ona’s cutting-edge technology has the potential to redefine treatments for aggressive and refractory cancers. As a strong advocate for precision oncology, I am committed to driving the development of novel, targeted therapies that improve patient outcomes. I am honored to contribute my expertise to this groundbreaking innovation."

Ultragenyx Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

On February 19, 2025 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare diseases, reported the grant of 23,760 restricted stock units of the company’s common stock to 10 newly hired non-executive officers of the company (Press release, Ultragenyx Pharmaceutical, FEB 19, 2025, View Source [SID1234650383]). The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of February 16, 2025, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates.

Radiance Biopharma Enters Exclusive License For ROR-1 Targeted Antibody Drug Conjugate

On February 19, 2025 Radiance Biopharma, Inc., ("Radiance" or the "Company"), a biotechnology company, reported that it has entered into an exclusive License agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) for development and commercialization of RB-164 (SYS6005): a novel clinical stage antibody drug conjugate (ADC) targeting ROR-1 (Press release, Radiance Biopharma, FEB 19, 2025, View Source [SID1234653104]). The agreement covers exclusive commercialization rights to RB-164 in the United States of America (USA), Canada, the European Union, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein, Albania, Montenegro, North Macedonia, Serbia, and Australia. CSPC will retain all rights to SYS6005 in the remaining global markets.

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ROR-1 is highly expressed in embryonic tissue, and a variety of hematological malignancies and solid tumors. ROR-1 expression is low in healthy adult cells but is closely related to disease progression and treatment response in cancer. This makes ROR-1 an attractive therapeutic target for anti-cancer drug development. RB-164 employs a novel Fc-silenced monoclonal antibody targeting ROR-1, site specific conjugation to deliver a homogeneous Drug-to-Antibody distribution and prevent retro-Michael elimination (high stability) which provides an improved pharmacokinetic and toxicology profile.

An Investigational New Drug (IND) application for RB-164 has been cleared by China’s regulatory agency, the National Medical Products Administration (NMPA). RB-164 is currently being investigated by CSPC in a Phase 1 dose escalation clinical trial in advanced liquid and solid tumors in China. Radiance and CSPC will work collaboratively to file an IND application with the USA Food & Drug Administration (FDA) to execute the clinical development of RB-164. Radiance will be responsible for the clinical development of RB-164 in the US and other licensed territories.

"We are excited to add RB-164, a promising clinical-stage Antibody Drug Conjugate targeting ROR-1, to our pipeline. This provides multiple shots on goal for potential therapeutic indications and strengthens Radiance’s development into a significant biopharma company," said Dr. Marc Lippman, MD, Chairman of the Board of Radiance.

Under the terms of the Exclusive License, Radiance will pay CSPC an upfront payment of $15 million, and up to $150 million in potential development and regulatory milestone payments and over $1 Billion in potential commercial milestone payments, as well as potential tiered royalties based on annual net sales.

"We believe that RB-164 has the potential to be a best-in-class ADC against the clinically validated target of ROR-1 for the treatment of liquid and solid malignancies," said Robert Brooks, JD, Chief Executive Officer of Radiance. "We look forward to expand our pipeline with a novel clinical stage medicine for patients with cancer and high unmet needs."

"This collaboration with Radiance exemplifies our commitment to bringing our innovative treatments to patients worldwide. We look forward to working together in advancing this ADC as a promising treatment option to those battling cancer," said Zhang Cuilong, Chief Executive Officer of CSPC.