A&G Pharmaceutical and Celltrion Announce Bioprocess Development and Manufacturing Agreement
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A&G Pharmaceutical, Inc. and Celltrion, Inc. have entered into an agreement for clinical production of an A&G theranostic monoclonal antibody.
Celltrion will perform bioprocess development, scale-up, and cGMP manufacturing and provide all clinical materials to support toxicology studies as well as Phase I and Phase II U.S. clinical studies on A&G's anti-GP88 monoclonal antibody.
The anti-GP88 antibody is currently in preclinical development by A&G as a cancer therapeutic.
The agreement provides Celltrion exclusive commercialization rights in Asia, including Japan, to anti-GP88 oncology therapies.
In return, A&G will receive clinical materials and milestones worth up to $6.4 million as well as royalties on any future anti-GP88 cancer therapeutic product sales by Celltrion in Asia.
A&G retains all commercialization rights to its anti-GP88 monoclonal antibody in North America, Europe, and the rest of the world.
Under the terms of a separate investment agreement, A&G will also receive a $2 million equity investment from Celltrion.
GP88 is a biomarker produced by cancer cells that is found in 80% of breast cancers and is not present in normal tissue. A&G is developing a monoclonal antibody that neutralizes the function of GP88.
Used as monotherapy or in combination with other anti-cancer agents, this new antibody drug has the potential to be therapeutically effective in the majority of breast cancers, with additional potential application in prostate cancer, ovarian cancer, and other cancers.
"GP88 represents an exciting new theranostic approach for cancer treatment and an outstanding potential market opportunity," said Jung-Jin Seo, CEO of Celltrion.
"We look forward to the partnership between A&G's groundbreaking oncology research and drug development and Celltrion's biomanufacturing and Asian commercialization capabilities."
"We are delighted to partner with Celltrion, a company with a world-class reputation and outstanding expertise in large-scale manufacturing of antibodies and other biopharmaceutical products," said Ginette Serrero, PhD, CEO of A&G.
"We look forward to working with them to advance this promising novel cancer therapy."
