Obi Pharma Inc. has received FDA clearance for its IND application to conduct a phase I/II study of OBI-992, a novel antibody-drug conjugate (ADC) cancer therapy targeting TROP2. The trial will open shortly and aims to enroll patients with advanced solid tumors, including non-small-cell lung cancer, small-cell lung cancer and gastric cancer, although several other cancers are also potential targets.
Bispecific antibodies acting through CEACAM5/CD3 targeting have limited efficacy due to dose-limiting toxicities, insufficient T-cell activation and formation of anti-drug antibodies (ADAs). Researchers from Novimmune SA and Lampkap Bio Alpha AG have published data on a CEACM5/CD3 bispecific antibody, NILK-2301, which is formed by a heavy chain plus two different light chains (kappa and lambda body) as a potential immunotherapeutic with better efficacy and lower potential for ADA formation.
MSD had a banner year at the ESMO Asia Congress earlier this month, presenting 14 abstracts on eight different types of cancers, including gastric, esophageal, colorectal, biliary tract, kidney, urothelial, breast and gynecological cancers. Ten of these studies were focused on Asian-related data. Roche AG, meanwhile, presented Asia-specific results from the phase III Alina study in patients with ALK-positive early stage non-small-cell lung cancer.
Starpharma Holdings Ltd.’s DEP docetaxel phase II trial met its primary endpoints, demonstrating antitumor activity in multiple advanced, metastatic cancers, including pancreatic, gastro-esophageal, non-small-cell lung cancer and cholangiocarcinoma.
The spate of recent deals involving antibody-drug conjugates (ADC) continues in a field composed of record-breaking agreements in 2023. The newest of the deals were focused on Asia. GSK plc entered a license deal for the exclusive rights for clinical development and commercialization of Hansoh Pharmaceutical Co. Ltd.’s B7-H3-targeted ADC, HS-20093. Also, South Korea’s Dong-A ST Co. Ltd. is expanding into the ADC space by acquiring Abtis Co. Ltd. and its Abclick platform for ADC drug development.
Legochem Biosciences Inc. signed a $1.7 billion licensing deal with Janssen Biotech Inc. for its Trop2-directed antibody-drug conjugate (ADC), closing the biggest technology transfer deal in Korean biotech history after Chong Kun Dang Pharmaceuticals Corp.
Elpiscience Biopharma Ltd. is out-licensing to Astellas Pharma Inc. two preclinical bispecific macrophage engagers – ES-019, an anti-PD-L1/SIRPα bispecific antibody, and another unnamed program – in a deal worth up to $1.7 billion. The deal marks the Shanghai-based company’s first out-licensing deal, Elpiscience CEO Darren Ji told BioWorld, noting that Astellas will have global rights to both molecules with a potential to in-license two more.
Allorion Therapeutics Inc. could receive $40 million in up-front and near-term payments from Astrazeneca plc in the companies’ exclusive option and global license deal. The two plan to develop and commercialize an L858R mutated allosteric inhibitor for treating EGFR inhibitor-mutant non-small-cell lung cancer.
Researchers at Hitgen Ltd. and Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. have described Bcl-2-like protein 1 (Bcl-xL; Bcl-X; BCL2L1) inhibitors reported to be useful for the treatment of cancer and autoimmune diseases.
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