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news.Apthera, a biotechnology company focused on peptide-based cancer immunotherapy, has decided to go forward with a lyophilized form of the E75 peptide component of its NeuVax product.
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NeuVax contains the E75 peptide which is one of the rare T-cell peptides that has been documented to elevate or boost pre-existing anti-cancer immunity in cancer patients. This commercially viable formulation is expected to provide the company a stable drug product to conduct worldwide Phase III clinical trials and prepare for commercial sales.
The company has entered into alliances with two international contract manufacturing organizations for Phase III clinical trial and commercial supply of key components of NeuVax.
The first is a supply agreement for the active pharmaceutical ingredient, HER2/neu peptide p369-377 or E75, and the second, an agreement with a provider of drug formulation development and manufacturing services to the pharmaceutical industry.
Apthera expects to finalize both the scope and role of its existing and secondary manufacturers of the drug substance and drug product in the near future.
Charles Morgan, president and CEO of Apthera, said: Creating a highly stable, lyophilized ‘off the shelf’ peptide formulation allows us to offer patients a product that does not involve the difficult and costly production of individual ‘autologous’ cancer vaccines. This achievement will help realize the commercial potential of this new product in the fight against breast cancer and other malignancies.