Policy & Regulation
KAHR wins FDA clearance to initiate Phase I/II clinical trial of DSP107 for treating solid tumors
13 August 2020 -

Cancer immunotherapy company KAHR Medical reported on Wednesday the receipt of clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for its lead product, DSP107, for the treatment of solid tumors.

DSP107 is a second generation CD47x41BB targeting compound that simultaneously targets cancer cells, weakens their innate defenses and activates an effective, local response of both innate and adaptive immunity.

DSP107 targets CD47-overexpressing tumors, simultaneously blocking macrophage inhibitory signals and delivering an immune costimulatory signal to tumor antigen-specific, activated T-cells.

Under a clinical collaboration with Roche, KAHR plans to initiate a Phase I/II clinical trial to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of DSP107 as a monotherapy and in combination with Roche's PD-L1-blocking checkpoint inhibitor (CPI) atezolizumab (Tecentriq) in patients with advanced solid tumors.

The study will be conducted at multiple centres in the US. The preliminary efficacy of both DSP107 monotherapy and combination therapy with atezolizumab will also be evaluated in patients with advanced non-small-cell lung carcinoma (NSCLC) who progressed after treatment with PD-1/PD-L1 inhibitors.