The US Food and Drug Administration has given the go-ahead to a Jerusalem-based medical research company to begin trials on a new cancer drug designed to combat advanced solid tumors. The path is now clear for KAHR Medical to begin phase I and II clinical trials of their drug DSP107 in patients, to assess the safety and efficacy of the drug both by itself and in combination with another drug, atezolizumab, owned by Roche. “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. KAHR specializes in developing immuno-oncology drugs – that is, drugs that use the body’s own immune system to fight various types of cancer. In particular, it’s duel signaling proteins (DSP) technology enables the creation of targeted biological chemicals with two functional ends. These ends can simultaneously block and/or activate natural biological signals, directing cells to work in the patient’s benefit. In the case of DSP107, the drug simultaneously targets cancer cells, weakens their defense mechanisms, and activates the body’s innate and adaptive immune systems to work against the cells. It is used to target tumor cells which over-express CD47, a protein known for its “don’t eat me” signal, which tells the body’s immune system cells not to kill off healthy cells. In this way, the tumor cells effectively trick the immune system into not dealing with the tumor, allowing it to progress. But DSP107 binds to the CD47 on cancer cells, blocking them from working and effectively turning off the “don’t eat me” signal. At the same time, the drug activates T-cells (a type of cell central to alerting the immune system to the need to act) which are specific to the tumor, in effect telling the body’s immune system to target the cancer cells. In this way, the drug both boosts the immune response, and breaks down the cancer cells protection against the immune system, allowing the patient’s body to naturally defeat the cancerous tumor. “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,” Dr. Pereg said. In February of this year, KAHR raised $18 million in a funding round from a global syndicate of investors, including Flerie Invest AB, Oriella Limited, Hadasit Bio-Holdings (HBL), Pavilion Capital and Mirae Asset Venture Investment. The funding round came just six months after the company announced their clinical collaboration with Roche to evaluate DSP107.