On April 14, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, and Lonza reported that the companies have entered into an agreement for the manufacture of ATYR2810, aTyr’s monoclonal antibody targeting Neuropilin-2 (NRP2) that is currently in preclinical development for cancer (Press release, aTyr Pharma, APR 14, 2021, View Source [SID1234578046]).
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Under the terms of the agreement, Lonza will utilize its Ibex Design, a fully integrated end-to-end program, to manufacture cGMP material for ATYR2810. The agreement will cover the early stages from gene to Investigational New Drug (IND) and will provide both drug substance (DS) and drug product (DP) to support toxicological studies in animals and early clinical development in humans.
The scope will include process support, including cell line development, process development, and supply chain simplification, to DS and DP manufacturing at Lonza’s Visp and Stein (CH) sites.
"As we prepare to advance ATYR2810 to clinical stage development, we are pleased to work with Lonza, a partner with extensive and proven capability in antibody manufacturing, for the production of our first anti-NRP2 antibody," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "Having recently initiated IND-enabling activities for ATYR2810 following some compelling preclinical data in triple-negative breast cancer, strengthened by additional data in lung cancer, this agreement with Lonza reflects our commitment to this program and will support our efforts to eventually advance ATYR2810 to in-patient trials in cancer, including certain aggressive tumors where NRP2 is implicated."
"We look forward to supporting aTyr as they advance their novel therapeutic antibody from preclinical stages into the clinic. This collaboration signifies our commitment and flexibility in accommodating the specific and unique needs of small biotech companies," said Jennifer Cannon, Senior Vice President, Global Head of Mammalian Biologics, Lonza.
About ATYR2810
aTyr is developing ATYR2810 as a potential therapeutic for certain aggressive tumors where Neuropilin-2 (NRP2) is implicated. ATYR2810 is a fully humanized monoclonal antibody that is designed to specifically and functionally block the interaction between NRP2 and one of its primary ligands, VEGF. ATYR2810 is the first Investigational New Drug (IND) candidate to arise from aTyr’s in-house research program designing monoclonal antibodies to selectively target the NRP2 receptor and its associated signaling pathways. NRP2 is a cell surface receptor that is highly expressed in certain tumors, in the lymphatic system and on key immune cells implicated in cancer progression. Increased NRP2 expression is associated with worse outcomes in many cancers. Preclinical data suggest that ATYR2810 could be effective against certain types of solid tumors. ATYR2810 is currently undergoing IND-enabling studies.