KAHR and Cancer Focus Fund Announce First Patient Dosed in Phase 1b Clinical Trial of Anti-CD47 Product Candidate DSP107 in Blood Cancers

KAHR, a clinical stage oncology company developing novel dual-targeting fusion protein therapeutics, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance promising cancer therapies, today announced that the first patient has been dosed in a Phase 1b clinical trial of DSP107, KAHR’s CD47x41BB targeting fusion protein, in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The clinical trial is being funded by a previously announced investment from Cancer Focus Fund.

“Initiating our second clinical trial of DSP107 is another significant milestone for KAHR, and we appreciate the Cancer Focus Fund’s support in making it possible,” said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR. “This trial in challenging blood cancers complements our ongoing Phase 1/2 clinical trial in patients with advanced solid tumors. DSP107’s distinctive mechanism of action and data observed from our preclinical studies and clinical trials to date suggest that it may have the potential to achieve significant anti-tumor effects across cancer types.”

“KAHR’s dual-targeting fusion proteins exemplify the type of novel cancer therapeutics we seek to support,” said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. “We are optimistic that DSP107 could be an excellent example of how our partnership with MD Anderson and innovative drug developers has the potential to facilitate important cancer clinical trials, help advance significant new therapies and ultimately improve the lives of cancer patients, while also rewarding our public and private backers.”

The two-part open label, dose escalation study is being conducted at MD Anderson and led by Naval Daver, MD, associate professor of Leukemia. It is evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of DSP107 as monotherapy and in combination with azacitidine or with azacitidine plus venetoclax in patients with relapsed/refractory AML or in MDS patients who have failed prior therapeutic regimens. The first part of the trial is a dose escalation study to explore the safety, efficacy, pharmacokinetic and pharmacodynamic profile of DSP107 when administered as monotherapy and in combination with azacitidine. In the second part of the trial, venetoclax will be added to the combination regimen.

Dr. Pereg added, “We continue to make good progress in the ongoing Phase 1/2 trial of DSP107 as a monotherapy and in combination with atezolizumab in patients with advanced solid tumors under our clinical collaboration agreement with Roche. We have completed enrollment of the monotherapy dose-escalation cohorts and are now treating patients with the combination of DSP107 and atezolizumab.

Results accumulated to date demonstrate favorable preliminary safety profile, with no dose limiting toxicities and no hematological or hepato-toxicities. Importantly, data from tumor biopsies before and after treatment show increased immune cell infiltration into the tumor with increased tumor necrosis.”

About DSP107

DSP107 is a dual-targeting fusion protein that binds both cancer cells and immune cells, linking them together for increased anti-tumor immune system activation, including weakening the tumor’s defenses and activating local innate and adaptive anti-tumor immune responses. 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 by macrophages. Simultaneously, DSP107 binds 4-1BB, a co-stimulatory receptor expressed on T-cells that stimulates their activation. These activities result in targeted macrophage and T-cell mediated immune activation and tumor destruction. DSP107 is in a Phase 1/2 clinical trial for solid tumor cancers and a Phase 1b trial for blood cancers.

About KAHR

KAHR develops novel, dual-targeting fusion protein therapeutics engineered to activate both the innate and adaptive immune systems simultaneously and localize that response in the tumor microenvironment. KAHR’s lead drug candidate, DSP107, is a CD47x4-1BB targeting compound. DSP107 is being tested in a Phase 1b clinical trial in blood cancers and a Phase1/2 clinical trial in advanced solid tumors. KAHR’s preclinical pipeline also includes DSP502, a TIGITxPD1 targeting fusion protein, and DSP216, an HLA-GxCD47 targeting fusion protein. For more information, please visit kahrbio.com/.

About Cancer Focus Fund

The Cancer Focus Fund LP is a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center. The fund provides investment support to advance promising cancer therapies that are close to being tested in humans, as well as the clinical trial expertise and infrastructure of MD Anderson and strategic partners Ochsner Health System Precision Cancer Therapies Program New Orleans and the LSU Feist Weiller Cancer Center Shreveport. The fund’s objective is to leverage this unique combination to provide investors with superior risk-adjusted returns. Along with the fund’s partner at MD Anderson, the Cancer Focus Fund provides both capital and translational research expertise with the goal of accelerating the development of novel cancer therapies that result in better outcomes for patients while generating returns for investors.

Disclosures

The University of Texas MD Anderson Cancer Center’s relationship with Cancer Focus Fund, and all research conducted at MD Anderson related to Cancer Focus Fund, has been identified as an institutional financial conflict of interest by MD Anderson’s Institutional Conflict of Interest Committee and therefore is managed under an Institutional Conflict of Interest Management and Monitoring Plan.