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Through the agreement, Lonza will use its fully integrated end-to-end program, Ibex Design, to manufacture cGMP material for the mAb while supporting the process from gene to IND.
Lonza and aTyr Pharma, a US-based biotherapeutics company, announced on April 14, 2021 that they have entered into an agreement for the manufacture of ATYR2810, aTyr’s monoclonal antibody (mAb) that targets the neuropilin-2 (NRP2) protein. The mAb is currently in preclinical development for the treatment of cancer.
Through the agreement, Lonza will use its fully integrated end-to-end program, Ibex Design, to manufacture current good manufacturing practice (CGMP) material for the mAb while supporting the process from gene to investigational new drug (IND) filing, Lonza said in a company press release. Additionally, Lonza will offer drug substance and drug product for toxicological studies in animals and early clinical development in humans; full process support, including cell line development, process development, and supply chain simplification; and drug substance and drug product manufacturing at its sites in Visp and Stein, Switzerland.
“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, in the press release.
“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,” added Sanjay S. Shukla, president and CEO, aTyr, in the press release. “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 advance ATYR2810 to in-patient trials in cancer, including certain aggressive tumors where NRP2 is implicated.”