Krystal Biotech Inc. has received FDA acceptance of its IND application for lead oncology drug candidate KB-707 for the treatment of locally advanced or metastatic solid tumor malignancies. KB-707 is a modified herpes simplex virus 1 (HSV-1) vector designed to deliver genes encoding both human IL-12 and IL-2 to the tumor microenvironment and promote systemic immune-mediated tumor clearance.
Cessation Therapeutics Inc. has obtained IND clearance from the FDA to initiate a first-in-human trial of CSX-1004 for the prevention of fentanyl overdose. The trial in healthy volunteers is expected to begin next month.
Epibone Inc. has received IND clearance from the FDA to begin testing its engineered allogenic osteochondral graft in humans. Clinical trials are set to open patient recruitment as soon as early next year.
Salarius Pharmaceuticals Inc. has received FDA clearance of its IND application to initiate a phase I trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL).
280Bio Inc. has received FDA approval of its IND application for the KRAS inhibitor YL-17231. 280Bio will start phase I enrollment in the U.S. in the fourth quarter of this year for the treatment of advanced cancer patients with RAS mutations in their tumors.
Ichnos Sciences Inc.’s first-in-class T-cell engaging trispecific antibody, ISB-2001, has been granted orphan drug designation by the FDA for the treatment of multiple myeloma.
Poseida Therapeutics Inc. has received FDA clearance of its IND application for P-CD19CD20-ALLO1, an allogeneic dual chimeric antigen receptor (CAR) T-cell product candidate being developed for relapsed or refractory B-cell malignancies in partnership with F. Hoffmann-La Roche Ltd. The company is actively focused on opening clinical sites for a phase I study in adults with relapsed or refractory B-cell malignancies.
The FDA has cleared C4 Therapeutics Inc.’s IND application for CFT-8919, an orally bioavailable Bidac (bifunctional degradation activating compound) degrader designed to be potent and selective against EGFR L858R for non-small-cell lung cancer (NSCLC).
Skyline Therapeutics (Shanghai) Co. Ltd. has received FDA clearance for its IND application for a phase I/IIa trial of SKG-0106, a one-time intravitreally delivered recombinant adeno-associated virus (AAV) gene therapy for the treatment of neovascular age-related macular degeneration (wet AMD). A global phase I trial will be initiated soon.
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