SRNE - Sorrento gets FDA go ahead for STI-6643 trial in solid tumor

The FDA has cleared Sorrento Therapeutics (SRNE) to initiate clinical trail of internally developed anti-CD47 monoclonal antibody, STI-6643.The initial clinical trial will be a basket trial entitled “A Phase 1B, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Patients with Selected Relapsed or Refractory Malignancies.” In preclinical evaluations, STI-6643 displayed decreased red blood cell binding and hemolysis, while maintaining potent anti-tumor activity in solid tumor disease models.Additionally, STI-6643 showed minimal T, B or NK cell depletion as opposed to other synthesized mAb clones, which could potentially result in improved efficacy by preserving infiltrating anti-tumor immune cells.Sorrento is also conducting preclinical studies to compare the safety and efficacy of lymphatic delivery of STI-6643 to established parenteral routes of administration using Sorrento’s Sofusa technology. STI-6643 is the second anti-CD47 antibody that has been developed from the G-MAB library.The other anti-CD47 antibody (IMC-002) discovered from the G-MAB

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Sorrento gets FDA go ahead for STI-6643 trial in solid tumor