Gigagen Inc., a subsidiary of Grifols SA, has received clearance from the FDA of its IND application to conduct a phase I trial of GIGA-2339 for the treatment of hepatitis B virus (HBV) infections.

Actinium Pharmaceuticals Inc. has received FDA clearance of an IND application to study Iomab-ACT for targeted conditioning prior to a bone marrow transplant (BMT) in patients with sickle cell disease. 

Tiximed Inc. has received IND clearance for its inhibitor of thioredoxin-interacting protein (TXNIP), TIX-100, in individuals with type 1 diabetes. TIX-100 is a potent and specific inhibitor of TXNIP.

Zymeworks Inc. has received IND clearance from the FDA for ZW-191, the company’s novel folate receptor-α (FRα)-targeted topoisomerase I (TOPO1) inhibitor antibody-drug conjugate (ADC). Clinical development is set to begin this year, with filings to initiate studies outside the U.S. to be made in the second half of this year.

Myogenica Inc., a University of Minnesota startup company, has obtained IND approval from the FDA for Myopaxon, an induced pluripotent stem cell (iPSC)-derived muscle stem cell product to regenerate skeletal muscle. A planned study will evaluate intramuscular injections of Myopaxon in non-ambulatory adult patients with Duchenne muscular dystrophy.

Artelo Biosciences Inc.’s IND application for ART-26.12, for the treatment of chemotherapy-induced peripheral neuropathy, has been granted clearance by the FDA allowing the company to initiate a first-in-human phase I study. Results are expected in the first half of next year.

Rgenta Therapeutics Inc. has received IND clearance by the FDA for RGT-61159, which is being developed for adenoid cystic carcinoma, colorectal cancer and other solid tumors, as well as acute myeloid leukemia.

Abata Therapeutics Inc. has obtained FDA clearance for its IND application enabling initiation of a first-in-human study of ABA-101 in patients with progressive multiple sclerosis (MS). A phase I study will open later this year.

Signet Therapeutics Inc. has received IND clearance from the FDA for SIGX-1094 as a potential treatment for diffuse gastric cancer. A phase I trial is planned in patients with diffuse gastric cancer and other advanced solid tumors.