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Latest oncology clinical development updates

Sunday, January 25, 2026

OTW News Highlights this week

FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study

“We are thrilled with the response provided by the FDA and believe this feedback could support a highly efficient path to potentially transition REO 033 from its ongoing randomized Part A directly into a pivotal Part B,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Importantly, the feedback provides alignment around the potential use of response rate to support an …

NMPA CDE clears IND application for AK157D1 for Ph 1 study in solid tumor patients

Akeso, Inc. today announced that its investigational next-generation B7-H3-targeting antibody-drug conjugate (ADC), AK157D1, has received clinical trial clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The clearance allows initiation of a Phase I study in patients with advanced malignant solid tumors. Development of AK157D1 in combination with Akeso's proprietary bispecific antibodies ivonescimab and …

Ph 3 INTerpath-001 Trial of Intismeran Autogene + KEYTRUDA Met RFS and DMFS Endpoints in Patients With Completely Resected Stage IIB-IV Melanoma

“By intervening earlier in the course of disease, when many cancers are considered most treatable, the goal of adjuvant therapy given after surgery is to increase the possibility of cure for more patients,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “These first Phase 3 findings for intismeran in combination with KEYTRUDA as adjuvant therapy reinforce the promise of …

EVX-03 program discontinued to focus on initial clinical testing of EVX-05

“We are delighted to transform our discoveries in glioblastoma into a promising new vaccine program with EVX-05, which could hold a significant therapeutic potential in area of massive unmet medical need. We have an outstanding collaboration with Duke University and now see the huge benefits of combining their extensive disease understanding and clinical expertise with the unique target discovery capabilities …

SUPRAME topline data disclosure for the final PFS analysis expected in H1 2027, followed by BLA submission in 2027

“The Phase 3 SUPRAME trial continues to enroll patients on schedule across sites in North America and Europe. In parallel, the data from the Phase 1b anzu-cel study continue to mature. We are now observing that aggregate progression and death events in the SUPRAME trial are occurring more slowly than originally modeled. Based on these results and FDA feedback, we …

AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in LBCL

“We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio,” said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. “Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved …

Akiram Therapeutics and ITM Sign Lutetium-177 Supply Agreement to Support Development of AKIR001 for the Treatment of Solid Tumors

“We are pleased to partner with ITM, a leading global producer and supplier of n.c.a. Lu-177, as we continue advancing AKIR001 through clinical development,” said Marika Nestor, chief executive officer of Akiram Therapeutics. “This agreement helps secure an important component for the continued development of AKIR001 and marks a significant step in advancing the program designed to address a primary …

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