On August 12, 2020 KAHR Medical, a cancer immunotherapy company developing novel bi-functional fusion proteins, reported that the U.S. Food and Drug Administration has cleared its investigational new drug (IND) application for the Company’s lead product, DSP107, a second generation CD47x41BB targeting compound that simultaneously target cancer cells, weaken their innate defenses and activate an effective, local response of both innate and adaptive immunity (Press release, KAHR Medical, AUG 12, 2020, View Source [SID1234563454]).
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Under this IND, the Company intends 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 centers in the United States and site activation activities are currently underway.
"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," said Yaron Pereg, PhD, CEO, KAHR Medical. "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," added Dr. Pereg.
The planned Phase I/II study will evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of DSP107 in advanced solid tumors. 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. The study will be conducted under a clinical collaboration with Roche.
About DSP107
DSP107 targets CD47-overexpressing tumors, simultaneously blocking macrophage inhibitory signals and delivering an immune costimulatory signal to tumor antigen-specific, activated T-cells. CD47 is overexpressed on many cancer cells and binds SIRPα on immune phagocytic cells to produce a "don’t eat me" signal. DSP107 binds CD47 on cancer cells, blocking interaction with SIRPα and thus, blocking the "don’t eat me signal". Simultaneously, DSP107 binds 41BB on T-cells, stimulating their activation. These activities lead to targeted immune activation through both macrophage and T-cell mediated tumor destruction.