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Latest oncology clinical development updates
Monday, February 09, 2026
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OTW News Highlights this week
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“The PI3K/AKT/mTOR, or PAM, pathway is one of the most important targets in cancer, but comprehensively inhibiting it has stymied researchers and drug developers for nearly two decades,” said Brian Sullivan, CEO and co-founder of Celcuity. “REVTORPYK addressed this 20-year challenge by becoming the first pan-PI3K, mTORC1/2 inhibitor approved by the FDA. We are thankful for the opportunity to make …
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“The Company is reviewing the contents of the letter and intends to work closely with the FDA to determine the appropriate path forward. While we are disappointed by this outcome, we remain committed to patients with hepatocellular carcinoma and to advancing the development of rivoceranib and camrelizumab,” said Dong-Gun Kim, Chief Executive Officer of Elevar Therapeutics. “We will engage with …
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“Acceptance of our IND application is a defining milestone, transitioning CoRegen into a clinical-stage company, and one made possible by the extraordinary dedication of our team,” said Suneet Varma, Chairman of the Board, CoRegen. “Their sheer rigor and scientific depth have brought us to this moment - the initiation of our first-in-human clinical studies - advancing an approach we believe …
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“These peer-reviewed results validate the scientific foundation of our DeltEx platform and highlight the transformative potential of γδ T cells in treating solid tumors,” said William Ho, Chief Executive Officer and Co-founder of IN8bio. “Glioblastoma remains one of the most devastating cancers, and patients urgently need new treatment options. By enabling immune cells to remain active alongside conventional chemotherapy and …
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Dr. Ding Lieming, Chairman and CEO of Betta Pharmaceuticals, stated: "The publication of the ELEVATE study in NEJM represents high recognition from the international medical community of the scientific value and clinical significance of this research. It is not only an important milestone for Betta but also a landmark achievement showcasing Chinese clinical oncology research on the global academic stage, …
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"This is a defining milestone for Zelluna and marks the beginning of the clinical evaluation of our proprietary TCR-NK platform," said Namir Hassan, Chief Executive Officer of Zelluna. "Dosing the first patient in ZIMA-101 is the culmination of years of scientific innovation, preclinical research and manufacturing development, and represents the transition from laboratory science to treating patients for the first …
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"Our Confirmatory Registration Study marks a definitive milestone toward establishing Multikine as the new immunotherapy standard of care for newly diagnosed head and neck cancer with low or zero levels of PD-L1," said Geert Kersten, CEO of CEL-SCI. "Enrollment will span premier clinical centers across the U.S., Europe, Asia, and South America, targeting the exact population where our previous Phase …
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“Allotera reflects who we are becoming as a company: a pivotal-stage cell therapy company focused on bringing off-the-shelf CAR-T therapies to patients with T-cell cancers,” said Kumar Srinivasan, Ph.D., M.B.A., Chief Executive Officer of Allotera Therapeutics. “With Sofi-cel advancing in T-RRex, a global pivotal study, this financing strengthens our ability to execute across clinical development, manufacturing, and patient-community engagement as …
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“Since Agenus was founded 32 years ago, our mission has been to harness the immune system to improve outcomes and, where possible, cure cancer,” said Garo H. Armen, Ph.D., Founder, Chairman and Chief Executive Officer of Agenus. "Our plan to prioritize neoadjuvant BOT+BAL in MSS colon cancer reflects both the strength of the emerging clinical evidence and the opportunity to …
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Author
Managing Editors
Social Media Managers
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Disclaimer: The OTW team takes care to share authentic information. In case of any discrepancies please write to newsletter@onco-this-week.com. Our website is an aggregator for open-source oncology news. The information on our website is provided without any representations or warranties. OTW is a part of RLS Consultants, which is a global consulting and training firm focusing exclusively on the healthcare and life sciences industries. RLS is a leading provider of opportunity assessment services, utilizing its comprehensive expertise in strategic market research, forecasting, and modeling, as well as pricing and market access to facilitate commercial assessments. RLS does not have any influence on any news reported on OTW. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of RLS. The content on our website is intended strictly for news and information purposes only and should not be treated as a substitute for medical advice, diagnosis, or treatment. News shared on OTW should not be utilized in real-world analytic products as they are based only on limited and dated open-source information.
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