Tahoe Therapeutics and Alloy Therapeutics Inc. are forming a jointly seeded new company focused on developing first-in-class antibody-drug conjugates (ADCs) for patients with hard-to-treat cancers. The joint venture will advance two ADC programs directed at novel tumor targets discovered by Tahoe using its proprietary Mosaic platform and large-scale, perturbative single-cell datasets.
Dispatch Biotherapeutics Inc. has obtained IND clearance from the FDA for DISP-10, enabling the initiation of a phase I study in patients with solid tumors. Initial clinical evaluation will begin in gastrointestinal cancers, with plans to expand into multiple additional solid tumor indications following clinical proof of concept.
Antibody-drug conjugates (ADCs) are promising biotherapeutics composed of an antibody plus a cytotoxic payload via a chemical linker, thus allowing the delivery of cytotoxic payload to target cancer cells. Among cancer glycoproteins studied in cancer research, mucin-1 (MUC1) is among the most extensively researched.
A2 Biotherapeutics Inc. has gained IND clearance from the FDA for A2B-543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced or metastatic solid tumors.
Remegen Ltd. has synthesized antibody-drug conjugates consisting of anti-CDCP1 antibodies covalently linked to cytotoxic drugs through linkers reported to be useful for the treatment of cancer.
Ottimo Pharma Ltd. has obtained IND clearance from the FDA and advanced OTP-01 (jankistomig), an anti-PD-1/VEGFR2 antibody, into phase I for solid tumors. The first patient has been dosed and the study is open at sites in the U.S. and Australia.
Haisco Pharmaceutical Group Co. Ltd. has disclosed antibody-drug conjugates consisting of antibodies covalently linked to antitumor drugs through a linker reported to be useful for the treatment of cancer.
Crescent Biopharma Inc. has announced regulatory clearances of IND applications for CR-001 (SKB-118), a PD-1 x VEGF bispecific antibody, and CR-003 (SKB-105), an integrin β-6 (ITGB6)-targeted antibody drug-conjugate (ADC), both being developed for the treatment of advanced solid tumors.
Ernexa Therapeutics Inc. has successfully completed a pre-IND meeting with the FDA, setting a pathway toward submitting an IND and initiating a first-in-human trial for the treatment of ovarian cancer, expected in the second half of this year.