On September 9, 2019 KAHR Medical, a biopharmaceutical company developing a novel drug platform based on bi-functional, immunotherapeutic fusion proteins known as DSP (Dual Signaling Proteins), reported a new clinical collaboration with Roche (Press release, KAHR Medical, SEP 9, 2019, View Source [SID1234539390]). The collaboration will explore KAHR’s lead program, DSP107, a SIRPα-41BBL DSP, in combination with Roche’s PD-L1-blocking checkpoint inhibitor (CPI) atezolizumab (Tecentriq) in patients with advanced NSCLC who are refractory to checkpoint inhibitors. KAHR expects to file an Investigational New Drug (IND) application with the U.S. Food Drug Administration (FDA) and begin a Phase I/II trial in H1 2020 to evaluate DSP107 as a monotherapy and in combination with atezolizumab.
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"We are extremely pleased to collaborate with Roche to study the potential of atezolizumab in combination with DSP107, our lead drug candidate," said Yaron Pereg, PhD, CEO, KAHR Medical. "The combined approach of DSP107 alongside immune-checkpoint inhibition has already shown promise in preclinical studies. We look forward to examining the potential of DSP107 with atezolizumab in treating NSCLC patients with limited treatment options."
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. In combination with atezolizumab, DSP107 has the potential to enhance anti-tumor immune response.
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 be evaluated in patients with advanced NSCLC who are refractory to PD-1/PD-L1 inhibitors. KAHR will be the sponsor of the study and Roche will provide the clinical supply of atezolizumab.