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.

Termination of a Material Definitive Agreement.

On February 19, 2025, GlycoMimetics, Inc. (the "Company") reported to have received a notice from Apollomics (Hong Kong) Limited ("Apollomics"), terminating the Collaboration and License Agreement between the Company and Apollomics that was effective as of January 2, 2020 (the "Agreement"), which termination will become effective ninety (90) days following delivery of the notice in accordance with the terms of the Agreement (Filing, GlycoMimetics, FEB 19, 2025, View Source [SID1234650535]). Under the Agreement, the Company exclusively licensed development and commercialization rights for uproleselan and GMI-1687 to Apollomics in Mainland China, Hong Kong, Macau and Taiwan. Following termination, the Company will not have any material financial or other obligations under the Agreement.

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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."

Vir Biotechnology to Participate in TD Cowen 45th Annual Health Care Conference

On February 19, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that members of the executive team are scheduled to participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4 at 8:50 a.m. PT / 11:50 a.m. ET in Boston, Massachusetts (Press release, Vir Biotechnology, FEB 19, 2025, View Source [SID1234650397]).

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A live webcast of the fireside chat will be made available under Events & Presentations in the Investors section of the Vir Biotechnology website and will be archived for 30 days.

Reverb Therapeutics Raises USD $12 Million Seed Round Financing to Harness Cytokine Signaling With its Amplify•R™ Platform

On February 19, 2025 Reverb Therapeutics, a leader in harnessing the natural immune system and cytokine signaling to treat life-threatening diseases, reported it has closed a USD $12 Million financing led by founding investor Amplitude Ventures (Press release, Reverb Therapeutics, FEB 19, 2025, View Source [SID1234650396]). Other participants in the round include the Multiple Myeloma Research Foundation’s venture philanthropy arm, the Myeloma Investment Fund, KdT Ventures, Finchley Healthcare Ventures, InBC Investment Corp. (InBC), and Seido Capital.

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Reverb’s novel Amplify•R platform combines bispecific antibody engineering with data-driven modelling of antibody interactions to modulate the actions of endogenous cytokines and redirect them to tissues of interest. This approach avoids the hurdles that have blocked other attempts to enlist cytokines to treat disease, which include systemic toxicity, immunogenicity, and manufacturing issues. Reverb’s initial focus is on the treatment of cancer and autoimmune diseases.

In vivo preclinical studies have established proof-of-concept for the Amplify•R platform’s ability to redirect endogenous cytokines and shrink tumors. The data supports a growing body of evidence for the potency of bispecific antibodies redirecting cytokines to PD-1-positive cells. Reverb’s lead AMP01 program blocks PD-1 while delivering endogenous IL-15, a key protein that expands and activates cytotoxic T cells.

"We are excited to have the backing of this standout group of investors as we advance the Amplify•R platform," said David de Graaf, Ph.D., CEO of Reverb Therapeutics. "The Amplify•R platform has broad potential across many cytokines. With this funding, we will take our lead IL-15 bispecific program to the candidate stage and will develop additional bispecific programs spanning other cytokines and additional cellular targets."

"Since its launch, Reverb has made significant progress in demonstrating the superiority of the Amplify•R platform," said Bharat Srinivasa, Ph.D., principal at Amplitude Ventures. "The preclinical data generated to date are extremely exciting and we believe that the Amplify•R platform will enable Reverb to succeed where many attempts using exogenous cytokines ran into insurmountable obstacles."

With the financing complete, Reverb welcomes two new members to its board of directors:

Maude Tessier, Ph.D., is a longtime biopharma executive, two-time chief business officer and an experienced company builder

Stephan Kontos, Ph.D., a biotech executive and entrepreneur, chairs the scientific advisory board at Anokion.