Alveus Therapeutics Inc. has obtained IND clearance from the FDA for ALV-100, for chronic weight management, enabling initiation of a phase Ib study. Dosing has now commenced in the study.
Avacta Therapeutics (Avacta Group plc) has obtained IND clearance from the FDA for FAP-Exd (AVA-6103), a Precision peptide-drug conjugate based on exatecan.
China’s National Medical Products Administration (NMPA) has cleared Shanghai Henlius Biotech Inc. to initiate a phase Ib/II trial of HLX-701 in combination with cetuximab and chemotherapy for the treatment of patients with advanced RAS/BRAF wild-type colorectal cancer.
Neok Bio Inc. has obtained IND clearance from the FDA for NEOK-001, enabling initiation of a phase I trial for solid tumors. Dosing is expected to begin in the coming months, and initial clinical data are anticipated next year.
Boundless Bio Inc. has obtained IND approval from the FDA for its novel kinesin oral degrader program, BBI-940. A first-in-human trial (KOMODO-1) for metastatic breast cancer is expected to begin in the first half of this year.
D3 Bio Inc. has obtained IND clearance from the FDA for D3S‑003, enabling initiation of a first‑in‑human phase I trial in patients with advanced solid tumors harboring KRAS G12D mutations.
Adolore Biotherapeutics Inc. has announced that the FDA has granted orphan drug designation to the company’s Kv7-activating rdHSV-CA8* gene therapy for treatment of primary and secondary erythromelalgia.
GT Biopharma Inc. has filed an IND application with the FDA for GTB-5550 TriKE, a B7-H3-targeted natural killer (NK) cell engager for the treatment of B7-H3-expressing solid tumor cancers. Pending approval, the planned phase I basket trial will evaluate GTB-5550 administered subcutaneously in solid tumors.
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.
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