NEW YORK – Jerusalem-based KAHR Medical announced on Wednesday that the US Food and Drug Administration has accepted an investigational new drug application for the company's dual-signaling protein DSP107, and the company will now begin evaluating the agent's safety, pharmacokinetics, and pharmacodynamics in a Phase I/II clinical trial for patients with advanced solid tumors.
Though the trial's primary aim will be to assess the drug's safety and tolerability, the company also plans to collect patients' blood samples following eight cycles of treatment with DSP107 and use flow cytometry to determine the agent's effect on different T-cells, B-cells, NK cells, and monocytes, as well as their expression of activation markers.
DSP107 is a second generation CD47 and 41BB targeting compound designed to simultaneously block macrophage inhibitory signals and deliver an immune costimulatory signal to tumor antigen-specific, activated T-cells while binding to 41BB on T-cells so as to stimulate their activation.
The Phase I/II clinical trial evaluating DSP107, for which KAHR Medical has collaborated with Roche, is segmented into two parts. Part one will evaluate DSP107 as a monotherapy in patients with advanced solid tumors who lack additional treatment options, and will also evaluate the agent together with atezolizumab (Genentech's Tecentriq) in additional cohorts of patients to determine the safety and maximum tolerated dose of the combination. Part two of the trial will evaluate DSP107 both alone and in combination with atezolizumab as a treatment for patients with non-small cell lung cancer who have previously achieved stable disease or better on previous treatment with anti-PD-1 or PD-L1 agents.
"Receiving clearance from the FDA to advance our lead immuno-oncology program to the clinic marks a significant milestone for KAHR as we transform into a clinical-stage company," Yaron Pereg, CEO of Jerusalem, Israel-based KAHR Medical, said in a statement. "DSP107, with its unique dual mechanism of action and its excellent safety profile with no hematological toxicities has the potential to become a best-in-class CD47 therapy. We are proud of our significant progress in recent years and look forward to initiating the Phase I/II study in the upcoming weeks for the benefit of patients suffering from challenging-to-treat cancers."