By Estel Grace Masangkay
TNI Biotech announced that it has expanded its collaboration with Hubei Qianjiang Pharmaceutical with the signing of a supplemental agreement focusing on its immunotherapy IRT-101 (MENK).
IRT-101 is an immunotherapy with methionine-enkephalin (MENK), developed for patients with dysfunctional immune systems. The therapy activates the lymphocytes to fight cancer cells and infectious diseases such as HIV/AIDS.
The companies have collaborated before in the development and regulatory advancement of IRT-101 MENK. This March, Qianjing agreed to fund clinical studies for the therapy while the partners pursued registration for manufacturing approval in China.
Under the new agreement, the partners will begin 3-month GLP Toxicology Studies in China within 30 days of signing the contract. The studies will be conducted according to FDA and international standards. TNI Biotech’s wholly owned subsidiary Cytocom will work with Qianjiang Pharmaceutical to ensure trial standards are acceptable and will help secure registration approval in China. Based on trial results, Qianjing will be responsible for meeting with the SFDA to identify any additional data needed to launch corresponding clinical trials for the drug in China. The partners will share revenue generated from MENK products developed through the partnership.
Mr. Ye Jige, Chairman and President of Hubei, said, “This collaboration with TNIB and Cytocom continues Hubei Qianjiang Pharmaceutical's strategy to develop new products and to speed up the product commercialization process for our partners. This is the first step of the collaboration.” Hubei will provide financing, manufacturing, and distribution capabilities to the partnership, while TNIB and Cytocom will leverage their drug development expertise.
Noreen Griffin, CEO of TNI Biotech, said, “This expansion of our agreement with Hubei today allows Cytocom to immediately move forward with our development plan for MENK. We expect our joint efforts will result in significant product and revenue opportunities for both Cytocom and Hubei.”