Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment, including Sonnet BioTherapeutics and Adagene.
Sonnet BioTherapeutics evolved into a clinical biopharmaceutical company after FDA approves its Investigational New drug (IND) application for its therapeutic SON-1010. The upcoming Phase I clinical trial will occur in the second quarter of 2022. The trial will be a multiple ascending dose study designed to evaluate the safety and tolerability of SON-1010 as primary endpoints. Adagene announced that the FDA has granted it clearance to proceed with a Phase Ib/II clinical trial of its anti-CTLA-4 monoclonal antibody, AD126, in combination with pembrolizumab, a humanized antibody used in cancer immunotherapy. AIM ImmunoTech is moving forward with its Phase II clinical trial of Ampligen (rintatolimod) after the FDA lifted its clinical hold on AIM’s IND application. Ampligen is intended for the treatment of locally advanced pancreatic cancer. Wugen is moving its candidate WU-CART-007 into Phase I/II clinical trials. WU-CART-007, a CAR-T cell therapy, is intended to treat relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (R/R T-ALL/LBL). Read more here.