Akeso Pharmaceuticals Inc. has raised the bar for next-generation immuno-oncology, reporting more than 23 months median overall survival in pancreatic cancer with its PD-1/CTLA-4 bispecific antibody cadonilimab, as emerging competitors begin to post earlier signals across solid tumors at the American Association for Cancer Research annual meeting in San Diego April 17 to 22.

Netris Pharma SA has delivered positive phase Ib data showing its first-in-class netrin-1 inhibitor NP-137 alleviates resistance to chemotherapy in pancreatic cancer. This could represent an important advance in treating these tumors, which are notoriously resistant to chemotherapy.

And the positive news continues to flow for Revolution Medicines Inc. On the heels of a successful phase III trial for RAS inhibitor daraxonrasib in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC) – not to mention the firm pricing the largest follow-on offering in biopharma history – Revolution presented updated phase I/II data at the American Association for Cancer Research (AACR) meeting detailing impressive findings in first-line PDAC patients.

Optimism rose for what could be the first CAR T therapy in autoimmune disease as Kyverna Therapeutics Inc. made public a positive primary analysis from its registrational trial, KYSA-8, of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome. Kyverna plans to submit a BLA to the U.S. FDA in the first half of this year.

Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.

Xuanzhu Biopharmaceutical Co. Ltd. reported positive data from a local phase III study of dirozalkib (Xuan Fei Ning), an ALK inhibitor approved in China to treat patients with advanced non-small-cell lung cancer.

“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for idiopathic pulmonary fibrosis (IPF) in January.

Shanghai Junshi Biosciences Co. Ltd reported early clinical signals across its next-generation immuno-oncology pipeline, including response rates of up to 71% in metastatic colorectal cancer and 45.5% in hepatocellular carcinoma, at the American Association for Cancer Research meeting in San Diego.

Xeltis BV has secured CE mark approval for Axess, its restorative vascular access conduit for hemodialysis. The company also released 12-month data from its EU pivotal trial on the technology, which showed strong durability outcomes, including 79% secondary patency and a very low patency‑related reintervention rate of 1.3 per patient-year, as well as a substantial reduction in infection burden.

With rezpegaldesleukin (rezpeg) phase IIb data in alopecia areata holding strong over time, backers of Nektar Therapeutics Inc. are hopeful that the biologic can do for the hair loss market what Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) did in atopic dermatitis.