Durham, North Carolina, and London, UK – December 1, 2009 -- Pique Therapeutics, Inc. and Technomark Life Sciences announced today that they have entered into a co-development and licensing agreement for Pique’s lead therapeutic candidate, PT 107, for the treatment of non-small cell lung cancer.
Pique and Technomark will conduct a randomized double-blind, placebo-controlled Phase 2 clinical trial, enrolling 100 patients with Stage IIIB/IV non-small cell lung cancer who have failed previous therapy. The Phase 2 trial seeks to confirm the safety of PT 107, and further evaluate the efficacy of the drug, with overall survival as the primary endpoint. Pique and Technomark will share the responsibilities and costs of the study, which will be conducted in India. Under the terms of the agreement, Pique will retain all rights to PT 107 in major global markets, including the United States, Europe, and Japan.
In exchange for Technomark’s contributions to the development program, Technomark will receive exclusive rights to PT 107 in selected emerging markets (e.g., India, China), and will pay Pique a percentage of sublicense fees, milestone payments, and royalties on PT 107 in these emerging markets. Technomark will also receive a portion of equity in Pique Therapeutics, based on the achievement of development milestones associated with the Phase 2 trial.
“We are very pleased to work with Technomark on the clinical development of our lead therapeutic candidate, PT 107,” said Christopher S. Meldrum, President of Pique Therapeutics. “Both parties recognize the enormous potential of this collaboration to advance a safer and more effective treatment option for patients with this terrible and highly prevalent disease.”
“We have followed the development of PT 107 for the past couple of years, and we are excited to realize this partnership with Pique focused on the treatment of a serious disease that affects millions of people around the world” said Allen Hakimi, Managing Director of Technomark Life Sciences. “Our co-development investment model is ideally suited to this relationship, because by leveraging Technomark’s global drug development capabilities, we look forward to maximizing the significant potential of PT 107 more quickly and bringing this promising new treatment to patients in need.”
About PT 107
Pique’s lead product, PT 107, is a first-in-class therapeutic vaccine for the treatment of non-small cell lung cancer and has completed Phase 1 clinical trials, where it was well tolerated, and exhibited a very good safety profile in cancer patients. PT 107 showed a dramatic improvement in median overall survival (11 months) for patients with second-line, late-stage non-small cell lung cancer, more than doubling the expected 4 to 6 months survival in these patients. Remarkably, over 30% of PT 107-treated patients survived 4 years or longer, while currently-approved treatments extend overall survival in this group of patients by approximately 2-3 months. PT 107 is also being studied in a two-arm, double-blind Phase 2 clinical trial in the United States.
About Pique Therapeutics
Pique Therapeutics is a biopharmaceutical company seeking to become the leader in the development and commercialization of new therapeutic vaccines, focused initially on the treatment of cancer, with products in development to treat lung, pancreatic, colorectal, and head & neck cancers. The Company was founded on the research of Eckhard R. Podack, M.D., Ph.D., who is Chair of the Department of Immunology and Microbiology at the University of Miami. Pique’s news and other information are available on the Company’s website, at www.piquetherapeutics.com.
About Technomark Life Sciences
Technomark Life Sciences is a specialty life sciences firm with a worldwide reputation for excellence spanning over two decades. With offices in Research Triangle Park (NC-USA), London (UK), Mumbai (India), and Nanjing (China), the Company specializes in product development, regional licensing and partnering, and CRO/CMO corporate growth. As a follow-on to its first venture capital fund in 2002, in 2009 Technomark began its co-development/co-funding business model and is actively seeking opportunities for investment. For more information please visit www.technomarkls.com.
