L.E.A.F. Pharmaceuticals Lead Investigational Product for Lung and Colorectal Cancers, LEAF-1401, Featured at the 2020 Virtual Annual Meeting of the American Society of Clinical Oncology (ASCO)

Treatment with LEAF-1401 exposes the tumor to 20-times more pentaglutamated pemetrexed than conventional pemetrexed.  Polyglutamated pemetrexed has been shown to be 80-times more potent than pemetrexed in inhibiting thymidylate synthase (TS), a key enzyme in the folate pathway. Pemetrexed (Alimta®) is today one of the leading backbone chemotherapies for lung cancer in the world.

VALLEY FORGE, Pennsylvania, June 9, 2020 /PRNewswire/ — L.E.A.F. Pharmaceuticals LLC (“LEAF”), a global pharmaceutical company focused on developing novel anticancer drugs, announced today that results from a preclinical study of LEAF-1401, the Company’s lead anticancer product, were presented at the 2020 Virtual Annual Meeting of ASCO held from May 29 – 31, 2020. ASCO is the world’s largest cancer conference which brings together, from around the world, both cancer researchers and cancer healthcare providers to review and discuss new cancer treatments being developed worldwide.  Treatment with LEAF-1401 resulted in 20-fold higher intratumoral exposure levels of pentaglutamated pemetrexed (the main active form of pemetrexed) and 30-fold higher intratumor exposure levels of pemetrexed itself, when compared to treatment with currently approved pemetrexed (Alimta®).

Details of the poster are as follows:

Poster #3524-254: Intratumoral Exposure Levels of Pentaglutamated Pemetrexed following Treatment with LEAF-1401 and Pemetrexed.

A copy of the poster is available on the LEAF website (click here).

LEAF-1401, a new generation onco-immuno antimetabolite designed to disrupt dysregulated 1-carbon metabolism in cancer and the immune system, is a liposomal formulation of gamma L-pentaglutamated pemetrexed.  Gamma L-polyglutamated pemetrexed has been shown to be 80-times more potent than pemetrexed in inhibiting thymidylate synthase.  In Oct 2018, LEAF received positive feedback following Pre-Investigational New Drug (Pre-IND) interactions with the United States Food and Drug Administration (US FDA) about LEAF-1401, where the Agency indicated that LEAF-1401 may be acceptable for development and registration under 505(b)(2) regulatory pathway. In addition, the Agency also provided guidance on how to establish a “bridge”, between this product and Alimta®, the US FDA approved listed drug, for the purpose of fulfilling the 505(b)(2) registration path requirements.

“The selection of LEAF-1401 by the ASCO Science Committee for presentation at this year’s annual ASCO meeting marked an important milestone in the recognition, by world’s leading cancer experts, of the future role this new investigational product is expected to play in the treatment of cancer,” says Founder, President, and CEO of L.E.A.F. Pharmaceuticals, Dr. Clet Niyikiza.

“Although pemetrexed remains a backbone of treatment regimens approved for lung cancer, an unacceptable number of lung cancer patients treated with pemetrexed alone or in combination with novel drugs, such as immunotherapy, eventually succumb to this disease,” says Dr. Victor Moyo, Executive Vice President, Global Head of Research and Development and Chief Medical Officer of L.E.A.F. Pharmaceuticals.  Dr. Moyo added, “The results from LEAF-1401 preclinical studies, in which significantly higher levels of pemetrexed and the more potent pentaglutamated pemetrexed are delivered to the tumor with an increased antitumor effect, point to a high likelihood that LEAF-1401 could achieve improved outcomes for patients with lung cancer.”

For more information, please visit www.leafpharmaceuticals.com.

About L.E.A.F. Pharmaceuticals

L.E.A.F. Pharmaceuticals is a global pharmaceutical company with a mission to discover, develop and commercialize innovative and safe therapies for cancer.  LEAF is committed to Lifting and Empowering All Families (L.E.A.F.) by developing and making accessible new cancer medicines for patients globally, especially the lesser served regions of the world.

Media Contact: Dr. Navreet Dhindsa
Corporate Communications
ndhindsa@leafpharmaceuticals.com
Phone: +1 781 305 4192

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