KAHR Medical, a cancer immunotherapy company developing novel bi-functional fusion proteins, announced today 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 CD47 and 41BB targeting compound that simultaneously target cancer cells, weaken their innate defenses and activate an effective, local response of both innate and adaptive immunity.
Under this IND, KAHR Medical 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 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.
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.
About KAHR Medical
Founded in 2005, KAHR Medical is a private company developing a novel drug platform based on bi-functional, immunotherapeutic fusion proteins, targeting multiple cancer indications. KAHR Medical develops the next generation of immuno-oncology drug candidates for the treatment of multiple types of cancer. Its proprietary technology enables the construction of targeted biological drugs generated by fusion of the active extracellular domains of a TNF-SF ligand and a type-I membrane protein. These Dual Signaling Proteins (DSPs) have two functional ends, which can simultaneously block and/or activate multiple reinforcing biological signals resulting in a synergistic outcome. The unique DSP composition ensures target activation and increased potency by assembling a high multimer protein structure which is essential for activation of the TNF receptor family.
Shareholders include Hadasit Bio-holdings, Flerie Invest AB, Korea Investment Partners, Oriella Limited a Consensus Business Group Limited subsidiary, HBLMirae Asset Venture Investments and DSC Investments. The company’s core technology is based on research by Prof. Mark Tykocinski, Dean of the Jefferson Medical School and Senior Vice President of the Thomas Jefferson University in Philadelphia and Prof. Michal Dranitzki-Elhalel, Head of Nephrology at the Hadassah Medical Center and KAHR Medical’s Chief Scientist Officer.
For more information, please contact: Tsipi Haitovsky, Global Media Liaison, KAHR Medical
+972-52-5989-892 Tsipihai5 at gmail.com
SOURCE: Cision PR Newswire