Athenex Announces U.S. FDA Allowance of Investigational New Drug Application for PT01 (Pegtomarginase)
Pegtomarginase is a PEGylated genetically modified human arginase that targets cancer growth and survival by removing the supply of an amino acid, arginine. A significant proportion of cancer types lack the ability to synthesize arginine due to deficient expression of certain metabolic enzymes of the urea cycle, including argininosuccinate synthetase 1 (ASS1), argininosuccinate lyase (ASL) or ornithine transcarbamylase (OTC). By depleting circulating arginine, growth of cancers with a disrupted urea cycle can be halted and cell death can be induced. Healthy cells capable of producing sufficient arginine would be largely unaffected. Previous arginine depleting therapies employed enzymes that were derived from non-human origin, which can trigger the development of neutralizing antibodies, or had multiple PEGylation sites with multiple positional isomers in the product.
“We are excited to further explore this innovative approach to treating a broad range of cancers using this biologic product,” stated Dr.
Arginine Deprivation Therapy:
Arginine is an essential amino acid to many tumor types for survival and growth. Many cancers have deficient expression of certain metabolic enzymes such as argininosuccinate synthetase 1 (ASS1), argininosuccinate lyase (ASL) or ornithine transcarbamylase (OTC), which are needed to synthesize arginine. Such cancers, also known as arginine-auxotrophic cancers, depend on external sources of arginine, making arginine deprivation therapy a potentially viable strategy for tumor treatment.
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different platform technologies: (1) Orascovery, based on non-absorbed P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan; and multiple locations in Chongqing, China. For more information, please visit www.athenex.com.
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and need to raise additional capital to continue as a going concern; competition; intellectual property risks; risks relating to doing business in China; the uncertain impact of inspections to be performed by the
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Source: Athenex, Inc.