On September 2, 2021 KAHR, a cancer immunotherapy company developing novel multifunctional immuno-recruitment proteins, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for KAHR’s Phase 1b clinical trial of DSP107, a first-in-class CD47x41BB targeting fusion protein, in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (Press release, KAHR Medical, SEP 2, 2021, View Source [SID1234587211]).
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Under this IND, the Company intends to initiate a Phase 1b open label, dose escalation study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of DSP107 as monotherapy and in combination with azacytidine or with azacytidine plus venetoclax in patients with AML and MDS. The trial, expected to commence in the fourth quarter of 2021, will be conducted at The University of Texas MD Anderson Cancer Center with the previously announced investment by the Cancer Focus Fund, LP, an investment fund established in collaboration with MD Anderson to provide funding and clinical expertise to advance promising cancer therapies.
"The FDA clearance to commence our Phase 1b clinical trial for DSP107 in hematological cancers is a significant milestone for KAHR as we advance into the clinic with our second clinical study for our lead program with the backing and support of the Cancer Focus Fund," said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR. "In parallel, we are making excellent progress with DSP107’s dose-escalation and expansion study as a monotherapy and in combination with atezolizumab in patients with advanced solid tumors. We look forward to the topline results from the dose-escalation monotherapy part of the solid tumors study in addition to the initiation of the Phase 1b clinical trial in blood cancers, both expected in the fourth quarter of this year."
"KAHR’s multi-functional immuno-recruitment fusion proteins exemplify the innovative approach to cancer we seek to support," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "Achieving FDA clearance for the commencement of the Phase 1b clinical trial showcases KAHR’s ability to execute its regulatory strategy, and we look forward to the launch of the trial."
KAHR develops smart immune-recruitment cancer drug candidates that are designed to activate a targeted immune response by converting cancer camouflage into beacons for the immune system to attack. The Company’s lead product candidate, DSP107, is a first-in-class CD47x41BB targeting compound that simultaneously binds cancer cells and immune cells, linking them together for maximal activation of the immune system against the tumor. DSP107 is designed to weaken the tumor’s defenses on one hand, and activate an effective, local response of both innate and adaptive immunity on the other hand. Specifically, DSP107 binds to and inhibits CD47, an immune checkpoint protein overexpressed in many cancer types that enables the tumor to evade immune recognition and attack. 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.