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Latest oncology clinical development updates

Monday, February 02, 2026

OTW News Highlights this week

FDA grants Fast Track Designation for MC001 for Pancreatic Cancer

“Patients with pancreatic cancer urgently need more effective treatment options. Fast Track designation is expected to support the acceleration of MC001’s development and regulatory review, potentially shortening the path to patients,” said Seah H Lim, MD, PhD, Founder and Chief Executive Officer of Medicovestor. “We remain committed to generating the clinical evidence required to assess MC001’s safety and potential benefit.”

European Commission approves TECVAYLI (teclistamab) monotherapy for relapsed/refractory multiple myeloma

“Building on the recent approval of teclistamab plus daratumumab, this European Commission further reinforces the strength of bispecific-based immunotherapy approaches as early as second line,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Together, the MajesTEC-3 and MajesTEC-9 studies support the potential of teclistamab-based therapies to advance the treatment paradigm and improve outcomes for patients …

Rinatabart Sesutecan (Rina-S®) Demonstrates Statistically Significant Improvement in PFS and OS in Patients with Platinum-Resistant Ovarian Cancer

“As the first Phase 3 readout from our Rina-S program, the positive topline results from RAINFOL-02 mark a significant milestone for Genmab and strengthen our confidence in Rina-S’s potential for patients with platinum-resistant ovarian cancer. These results advance our ambition to become a leader in gynecologic oncology and reflect our commitment to improving the lives of patients with high unmet …

Vir Biotechnology and Gilead Sciences to Discover and Develop Novel PRO-XTEN® Dual-masked T-cell Engagers for Solid Tumors

“We believe TCEs have a powerful role to play in the future of immunotherapy to treat cancer. This collaboration with Gilead provides an opportunity to generate multiple differentiated candidates aimed at difficult-to-address solid tumors and to expand the potential impact of our science, while also advancing our own clinical oncology portfolio,” said Marianne De Backer, President and Chief Executive Officer …

University of California, Davis activated as a Clinical Trial Site for Ongoing Ph 1 CERTAIN-T Trial of CER-1236 in Hematologic Malignancies

“Activating UC Davis as a clinical site is a meaningful operational milestone for CERo and for the CERTAIN-T study,” said Kent Cunningham, Chief Executive Officer of SRX Global. “Bringing manufacturing and patient enrollment together at a single, highly regarded academic institution, streamlines logistics while strengthening the overall clinical trial footprint. This progress reinforces our conviction in CERo’s differentiated approach to …

Global Ph 2 Study of Ivonescimab in 1L Clear Cell RCC, Including Combination with Cadonilimab, initiated

Akeso, Inc. and its partner Summit Therapeutics Inc. jointly announced an international multicenter Phase II clinical study (SMT112-216 / AK112-216 / NCT07877194). Built on Akeso’s first-in-class immuno-oncology (IO) cornerstone therapy ivonescimab (PD-1/VEGF bispecific antibody), the study will assess the efficacy and safety of multiple treatment regimens, including the combination of ivonescimab with Akeso’s first-in-class bispecific antibody cadonilimab (PD-1/CTLA-4 bispecific antibody), …

Genmab and Incyte Announce Clinical Trial Collaboration in Metastatic CRC

“This collaboration supports our broader development strategy for petosemtamab as we explore its potential across treatment settings and in novel combinations,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer, Genmab. “Partnering with Incyte enables us to evaluate this investigational combination in patients with KRAS G12D-mutated metastatic colorectal cancer, reflecting our commitment to research collaborations aimed at expanding …

Akeso Announces Summit Therapeutics and ECOG-ACRIN Cancer Research Group Enter into Ph 2/3 Clinical Trial Collaboration to Evaluate Ivonescimab in 1L BTC

“We are delighted to see the global clinical development of ivonescimab further expand into the field of biliary tract cancer. Against the background of the positive OS results from the Phase III HARMONi-GI1 study of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy, the advancement of the Phase III EA2251 study by a leading cooperative oncology group in the United States …

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