Pharma Focus Asia

Agastiya Biotech receives FDA Orphan Drug Designation for AB001 for Pancreatic cancer and Acute Myeloid Leukemia (AML)

Wednesday, May 04, 2022

Agastiya Biotech and Vopec Pharmaceuticals announce that the US FDA has granted Orphan Drug Designations for Pancreatic Cancer and AML for its novel small molecule, AB001.  

AB001 is a small molecule PD-L1 checkpoint inhibitor that also targets aberrant intracellular signaling pathways in the tumor microenvironment, such as Wnt/beta-catenin, PI3K, and RAS. This dual mechanism has been shown in the animal model to work across multiple cancer types, including solid and liquid tumors and, also, on non-PDL1+ cancers. The research offers potential proof for the drug-ability of the so far undruggable beta-catenin and clear advantages of AB001 over Gemcitabine which is the standard of care for pancreatic cancer. Furthermore, AB001 exerts anti-leukemia activity in preclinical models of acute lymphoblastic leukemia, likely through inhibiting VEGFR2-mediated signaling pathways, and suggests potential benefits and clinical application of AB001 in treating Leukemia patients.

Agastiya's founder Dr. Baskaran Pillai says, "Chemo drugs are efficient in killing tumor cells. However, due to its high toxicity, it also ends up harming normal cells, weakening the patient's health and energy. AB001 preclinical studies have proved that it is able to kill cancer cells without harming normal cells. Additionally, AB001 targets cancer stem cells, thereby disrupting drug resistance and relapse mechanisms."

Dr. MG Dinesh, Chief Scientific Officer, states, "On the advice of Dr. Pillai, I researched the preventative efficacy of AB001 on 5 different cancer cell lines. The prophylactic studies show that AB001 prevents various oncogenes from becoming mutated into tumors and maintains the tumor suppressor genes in the active state after induction with a chemical carcinogen."

Cancer prevention is one of the important Moonshot project goals of President Biden. "Our India-US collaboration marks an important milestone in cancer therapeutics." Says Sonja Benkovich, interim-CEO.

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