Presage Biosciences Inc. has announced that the FDA has issued a study may proceed notification for testing a pre-GMP drug candidate with the company’s Comparative In Vivo Oncology (CIVO) platform. Owned by Pure Biologics, the drug candidate, PBA-0405, is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.

Axelia Oncology Pty Ltd. was spun out of Ena Respiratory Pty. Ltd., which developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for nasal delivery to treat respiratory infections, including influenza and SARS-CoV-2. Although the pegylated TLR 2/6 agonist, INNA-051, was initially focused on antiviral activity, the company discovered that it also worked in oncology models, and Axelia was spun out to focus on oncology, CEO Phil Kearney told BioWorld.

CSPC Pharmaceutical Group Ltd. has announced FDA approval of an IND application for JMT-106, a bispecific fusion protein drug, for glypican-3 (GPC3)-positive solid tumors.

Biocytocgen Pharmaceuticals (Beijing) Co. Ltd. has entered into an exclusive option and license agreement with Radiance Biopharma Inc., granting Radiance an option to license from Biocytogen a first-in-class fully human anti-HER2/TROP2 bispecific antibody-drug conjugate (BsADC).

Corbus Pharmaceuticals Holdings Inc. has obtained FDA clearance of its IND application for CRB-601, a TGF-β-blocking monoclonal antibody targeting the integrin αvβ8. Enrollment in a first-in-human phase I study will open in the first half of this year.

Three months out from its first $1 billion deal with Biontech SE for an antibody-drug conjugate (ADC), Suzhou, China-based Medilink Therapeutics Co. Ltd. clinched another potential $1 billion ADC deal, but this time with Roche Holding AG.

Nuvation Bio Inc. has received FDA clearance of its IND application to evaluate NUV-1511 in a phase I/II study for solid tumors.

Immunome Inc. and Zentalis Pharmaceuticals Inc. have entered into an exclusive, worldwide license agreement.