Lexington, Mass.–Mar. 6, 2020 – Pulmonomy, an inhalation therapeutics-focused subsidiary of TotalClarity, Inc., today announced a collaboration agreement with Cellix Bio for exclusive global rights to develop CLX-159 for the treatment of Invasive Pulmonary Aspergillosis (IPA) and Allergic Bronchopulmonary Aspergillosis (ABPA).
Under the terms of the agreement, Pulmonomy will pay Cellix Bio an upfront research and development funding fee, and potential payments tied to development milestones, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty on global sales of CLX-159.
Pulmonomy plans to submit an IND application for CLX-159 as a first line treatment for Invasive Pulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis to the US FDA in the first quarter of 2021. Under the terms of the agreement, Pulmonomy will undertake and fund future regulatory and commercial activities to bring CLX-159 to market and commercialize the product within the agreement’s territories.
“CLX-159 has the potential to become an important new first line treatment for Invasive Pulmonary Aspergillosis (IPA), and we look forward to submitting an IND early next year,” said Shekhar Shastri, Chief Executive Officer of TotalClarity, Inc. “As a recently established specialty pharma company, Pulmonomy has ambitious growth plans, and CLX-159 is a strong strategic fit with our pipeline of high-impact drug candidates, especially in the inhalation therapeutics as we expand our focus and capability in pulmonary and infectious disease areas.”
“Patients at risk for infection are rising rapidly due to a number of risk factors, predisposing them to Invasive Fungal Infections (IFI). The development program between Cellix Bio and Pulmonomy is aimed at addressing this epidemiological trend,” said Dr. Regis DeSilva, Chief Medical Officer of TotalClarity, Inc., the parent company of Pulmonomy.
“Our agreement with Pulmonomy marks a critical step in the execution of our company strategy. We have a solid foundation to potentially generate near-term capital and long-term value for this important asset CLX-159 globally,” said Mahesh Kandula, Chief Executive Officer of Cellix Bio. “This CLX-159 partnership would amount to potential payments over the next 18 months in addition to potential payments from our other licensed pipeline assets, which could provide substantial additional funding to support our CLX-159 development strategy for North America. We look forward to working with the experienced commercial and regulatory team at Pulmonomy as they seek to successfully commercialize CLX-159 in North America and Europe.”
Pulmonomy, Inc. is a specialty pharmaceutical company and is a wholly-owned subsidiary of TotalClarity, Inc. The company has commercial operations in the US and India. Currently, Pulmonomy has a portfolio of eight pre-clinical drug candidates in its pipeline, and the company has ambitious plans to expand this through acquisition and in-licensing. For more information please visit www.Pulmonomy.com.
About Cellix Bio
Cellix Bio, Pvt. Ltd. is a biopharmaceutical company committed to developing targeted therapies through novel drug-design insights to provide improvements in patient outcomes where significant unmet medical needs exist. Cellix Bio’s unique insights into drug-design chemistry and related disease biology are what Pulmonomy is seeking to leverage in the clinical development strategy of its therapeutics candidates. For more information, please visit www.cellixbio.com.
Shekhar Shastri, +1 781.499.2510