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Latest oncology clinical development updates

Sunday, January 25, 2026

OTW News Highlights this week

US FDA IND Clearance and Australian Regulatory Clearance granted for [²²⁵Ac]Ac-FL-261 Ph 1 Clinical Trial

"These regulatory clearances represent an important milestone for FL-261 and our strategy to expand targeted alpha therapy into various solid tumors," said Debora Barton, MD, Chief Medical Officer of Full-Life Technologies. "Ac-FL-261 is designed to selectively target c-MET-expressing tumors by delivering potent alpha radiation directly into the tumor sites. We look forward to advancing FL-261 into its Phase 1 trial …

FDA IND clearance to initiate a first-in-human Ph 1 trial of lead peptide-drug conjugate program TS-104

“This financing, together with FDA clearance of the IND, marks an important inflection point for TwoStep and positions us to advance TS-104, our lead peptide-drug conjugate, through Phase 1 clinical development in oncology. This trial will provide the first clinical evaluation of the multi-specific targeting approach at the heart of TwoStep and begin to assess its potential to broaden the …

Complete Full Cohort Ph 1 Results for JNJ-1900 (NBTXR3) in Inoperable, Recurrent NSCLC Announced

“The Nanobiotix team is encouraged by these full-cohort findings in one of the most difficult settings in lung cancer,” said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. “If a physics-based approach can improve local control in tissue that has already failed radiation, and do so at a reduced dose, then the conditions in earlier settings, where full-dose radiotherapy reaches …

Dabogratinib Shows 79% Response Rate in Ph 2 Bladder Cancer Trial

"We are extremely excited to report initial results from SURF302 today as we work to advance what we believe could become the first once-daily oral therapy for patients with low-grade IR NMIBC," said Todd Harris, Ph.D., Chief Executive Officer of TYRA Biosciences. "These results belong first and foremost to the patients participating in SURF302 and the investigators and study teams …

US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit with HCB101

"For us, this starts with the patient," said Scott Liu, Ph.D., Founder and Chairman of HanchorBio. "When a patient is benefiting from an investigational therapy and has limited treatment options, we believe every appropriate avenue to continue access should be considered. HCB101 was created to make a meaningful difference, and this milestone reflects the patient-first principle guiding our FBDB™ platform."

Harbour BioMed Partner, Solstice Oncology, announces $225 Million Series A Financing to Advance Porustobart, a Neoadjuvant Immuno-Oncology Therapy

"We are pleased to see Solstice Oncology launch with strong support from leading investors and advance porustobart into the neoadjuvant setting," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "As the originator of porustobart and a partner of Solstice, we look forward to supporting the continued development of this differentiated CTLA-4 antibody and exploring its potential to …

First Lead Candidate under Amended Strategic Collaboration for Development of Masked CD3 T Cell Engagers Utilizing SAFEbody® Technology

"We are pleased with the progress of this collaboration and the first lead selection. We look forward to delivering transformational therapies to patients through this highly productive partnership," said Peter Lebowitz, M.D., Ph.D., Chief Executive Officer of Third Arc Bio.

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