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Latest oncology clinical development updates

Thursday, January 22, 2026

OTW News Highlights this week

Regulatory Update on Tovecimig in BTC Following FDA Feedback Provided

“While this is not the response we expected, we respect the FDA’s feedback and our priority is to work with the Agency to determine the best path forward to support our planned BLA submission and address this pressing unmet need,” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer of Compass. “We remain confident that the COMPANION-002 findings, including the statistically …

SOT106 granted fast Track Designation in osteosarcoma and orphan Drug Designation granted in soft tissue sarcoma

“These additional designations mark another important milestone for SOT106 and reflect the growing momentum behind our ADC portfolio,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “Patients with sarcoma continue to face limited treatment options, underscoring the need for innovative targeted therapies. As we advance SOT106 toward the clinic, we believe it has the potential to become an …

Nature Medicine Publication of ASPEN-06 Ph 2 Data Demonstrates Strong Responses and Durable Clinical Benefit with Evorpacept in HER2-Positive Gastric Cancer

"Publication of our ASPEN-06 data in Nature Medicine, a prestigious peer-reviewed scientific journal, further validates the clinical potential of evorpacept and reinforces our biomarker-driven development strategy," said Barbara Klencke, M.D., Chief Medical Officer of ALX Oncology. "Data from ASPEN-06 demonstrated that patients whose tumors retained HER2 expression and had high CD47 expression experienced the greatest benefit from evorpacept-based therapy, supporting …

New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line RRMM

“The continued analyses of the unprecedented MajesTEC-3 trial challenge long-held expectations of what may be possible in multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “Our ambition is to build on this progress by fundamentally changing the long-term trajectory of multiple myeloma and, ultimately, creating a future in which this …

Pivotal Ph 3 THIO-104 NSCLC Trial expanded into Spain and Portugal

“Expanding THIO-104 into Spain and Portugal represents another important step in the execution of our pivotal Phase 3 program,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “Clinical trial participation can provide patients with access to investigational therapies in markets where access to newly approved lung cancer treatments has historically lagged. By establishing THIO-104 sites in Spain …

Henlius and Amberstone Partner to Develop Next-Generation Conditionally Activated TCEs for Solid Tumours

Shanghai Henlius Biotech, Inc. (2696.HK) today announced that it has entered into a global collaboration and license agreement with Amberstone Biosciences ("Amberstone"), a U.S.-based biotechnology company dedicated to developing next-generation tumour-activated antibody therapeutics. The collaboration will leverage Amberstone’s proprietary T-MATE™ (Tumour Microenvironment Activated ThErapeutics) platform to develop conditionally activated T-cell engagers (TCEs) based on up to two targets designated by …

InnoCare Announces Strategic Research Collaboration and License Agreement with Lilly to Develop New Medicines

“We are excited to leverage our R&D platform to collaborate with a global pharmaceutical leader like Lilly,” said Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare. “We are dedicated to expanding our partnership and innovation footprint.”

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