On February 20, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained regulatory approval today from the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of unresectable alveolar soft part sarcoma (Press release, Chugai, FEB 20, 2025, View Source;category= [SID1234650398]). Tecentriq is the first immune checkpoint inhibitor in Japan for the treatment of this disease.

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"We are very pleased that we can offer Tecentriq as a new treatment for unresectable alveolar soft part sarcoma in adults and children over 2 years. This very rare disease, which occurs most often in the adolescents and young adults (AYA) generation, is known to have a poor prognosis with no standard treatment if it becomes unresectable. We will continue our efforts to provide information on the proper use of Tecentriq in order to contribute to the patients with unresectable alveolar soft part sarcoma," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results from a phase II ALBERT study initiated by investigators in Japan including National Cancer Center Hospital and an overseas phase II clinical study conducted by the National Cancer Institute (NCI), which evaluated the efficacy and safety of Tecentriq in patients with unresectable alveolar soft part sarcoma.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

Approval Information *Newly added description
Indications: unresectable alveolar soft part sarcoma
Dosage and administrations: The usual adult dosage is 1200 mg atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. The usual dose for children over 2 years old is 15 mg/kg (weight) (max 1200 mg) atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.

About the ALBERT study1
The ALBERT study is a domestic Phase II, multicenter, open-label, single-arm study led by physicians including National Cancer Center Hospital in Japan to evaluate the efficacy and safety of Tecentriq in patients aged 16 years and older with unresectable alveolar soft part sarcoma. The study enrolled 20 patients to investigate safety and efficacy.

The ALBERT study is being conducted as a substudy of the MASTER KEY project, which promotes the development of treatments for rare cancers through industry-academia collaboration with the National Cancer Center Hospital.

About alveolar soft part sarcoma
Alveolar soft part sarcoma is one of the ultra-rare cancers accounting for less than 1% of soft tissue sarcomas. It is estimated to occur in 15-40 Japanese people annually. It most commonly affects the limbs, mainly the thighs, and is more common among adolescents and young adults (15-35 years old, AYA (Adolescent and Young Adult) generation). Unresectable alveolar soft part sarcoma has a poor prognosis, and no standard treatment has been established.

About Tecentriq
Tecentriq is a cancer immune checkpoint inhibitor targeting PD-L1, which is a protein expressed on tumor and tumor-infiltrating immune cells. PD-L1 blocks T cell activity by binding with PD-1 and B7.1 receptors on T cell surface. By inhibiting PD-L1, Tecentriq may enable the activation of T cells and boost immune response against cancer cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 4 indications (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, and hepatocellular carcinoma).

On February 19, 2025 Orano reported exceptional 2024 results driven by Back End export contracts. Solid outlook for 2025 (Press release, Orano, FEB 19, 2025, View Source;orano-2024-annual-results.pdf?sfvrsn=90050233_6&_gl=1*183v0pa*_gcl_au*NDY0NzQ5OTM3LjE3NTE2MDU1ODk. [SID1234654232]).

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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.

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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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."