Radiance Biopharma Inc. bought its way into the ROR1 antibody-drug conjugate (ADC) space through a potential $1 billion-plus licensing deal, including a $15 million up-front payment, with CSPC Megalith Biopharmaceutical Co. Ltd. for rights to RB-164 (SYS-6005) in the U.S. and select countries.
Cour Pharmaceuticals Development Co. Inc. has obtained IND clearance from the FDA for CNP-103, a nanoparticle in development to address the underlying autoimmunity of type 1 diabetes. A first-in-human phase Ib/IIa trial will begin later this year and will enroll adults (aged 18-35 years) and pediatric patients (aged 12-17) who have stage III or newly diagnosed (within the last 6 months) type 1 diabetes as well as C-peptide >0.2 ng/mL.
Auron Therapeutics Inc. has received FDA clearance of its IND application for its oral KAT2A/B degrader AUTX-703 in hematological malignancies. A phase I proof-of-concept trial in acute myeloid leukemia (AML) will open enrollment this quarter, supported by a recently completed $27 million series B financing.
To realize the promise of cell therapy for neurodegenerative disorders, S.Biomedics Co. Ltd. is looking to expand clinical trials of TED-A9, its stem cell therapy for Parkinson’s disease (PD), to the U.S., having reaped positive results from a domestic phase I/IIa trial in November 2024.
HCW Biologics Inc. has received clearance of its IND application from the FDA to initiate a first-in-human phase I trial to evaluate HCW-9302 in patients with moderate to severe alopecia areata.
Ocugen Inc. has received IND clearance from the FDA for OCU-500, an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor and conduct a phase I trial of OCU-500 administered via inhalation into the lungs and intranasally as a spray.
To realize the promise of cell therapy for neurodegenerative disorders, S.Biomedics Co. Ltd. is looking to expand clinical trials of TED-A9, its stem cell therapy for Parkinson’s disease (PD), to the U.S., having reaped positive results from a domestic phase I/IIa trial in November 2024.
Axcynsis Therapeutics Pte Ltd. has gained IND clearance from the FDA for AT03-65 for the treatment of patients with CLDN6-positive solid tumors. Axcynsis is planning to initiate a phase I trial in the U.S. during the current quarter in patients with advanced CLDN6-positive solid tumors.
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