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Latest oncology clinical development updates

Thursday, January 22, 2026

OTW News Highlights this week

CRL issued for ongoing ITM-11 NDA citing CMC and third-party commercial facility inspection-related items

“Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL,” said Dr. Andrew Cavey, chief executive officer of ITM. “Our pivotal COMPETE trial data package stands, and our goal remains unchanged as we work toward bringing ITM-11 to patients living …

FDA Clearance to Initiate Bria-PROS+ Clinical Study in Prostate Cancer

“We are pleased to announce FDA clearance of the IND for Bria-PROS+, our next-generation personalized immunotherapy for prostate cancer,” stated Dr. William V. Williams, BriaCell’s President & CEO. “Bria-PROS+ is designed to activate multiple components of the immune system, which we believe has the potential to support meaningful therapeutic benefit with a favorable safety profile. We look forward to advancing …

Topline Results from Intranasal NEO100 in Recurrent IDH1-mutant High-grade Glioma to be presented

NeOnc Technologies (NASDAQ: NTHI) is scheduled to report topline Phase 2a results for NEO100 on August 12, 2026. The results are from an open-label Phase 2a study evaluating intranasal NEO100 in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant high-grade glioma. The company is expected to provide efficacy and safety findings and discuss next regulatory steps.

First Patient Dosed in TeLuRide-008 Ph 2/3 Trial of EIK1001 in NSCLC

“Treating the first patient in TeLuRide-008 is a significant milestone for Eikon as we continue to advance EIK1001 in multiple indications, with the ultimate goal of delivering improved outcomes to patients with significant unmet need,” said Roy Baynes, M.D., Ph.D. Chief Medical Officer of Eikon. “Despite advancements in NSCLC, the current standard of care was established over a decade ago …

First Patient Dosed in Ph 1 Study of DISP-10 in Advanced GI Cancers

“Initiating this trial represents a meaningful step forward for patients with advanced GI cancers, reinforced by the FDA’s Fast Track designation for DISP-10,” said Mauro Avanzi, M.D., Ph.D., Chief Medical Officer of Dispatch Bio. “We look forward to advancing this study as we work to overcome the longstanding limitations of treating solid tumors with immunotherapy, including lack of a safe …

IMPACT Therapeutics Signs Exclusive License Agreement with Pharmanovia for Senaparib in Europe, Middle East and North Africa, Australia and New Zealand 

IMPACT Therapeutics is pleased to announce that it has entered into an exclusive partnership with Pharmanovia, a global specialty pharmaceutical company which partners with innovative biotech and large pharma to bring innovative specialty medicines to patients, to grant Pharmanovia the exclusive rights to manufacture, develop and commercialise senaparib in Europe, Middle East and North Africa, Australia and New Zealand for …

Amplia and Lilly to Evaluate Narmafotinib + Olomorasib in NSCLC

Dr Chris Burns, Amplia CEO and Managing Director commented: “This collaboration is an exciting new stage in the clinical progression of narmafotinib. We and others have shown that the combination of FAK and KRAS inhibition can lead to improved outcomes, and we are excited to advance with this clinical study to explore the combination potential with olomorasib, Lilly’s leading KRAS …

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