- The collaboration aims to bring Pionyr’s third pipeline development candidate for a novel Myeloid TuningTM target in to clinical development
- Lonza to provide cell line development, process development, drug substance and drug product manufacturing for Pionyr’s monoclonal antibody candidate intended for oncology indications
- Lonza’s cell line development program will be tailored to accommodate the specific needs of Pionyr and to ensure optimal yield and throughput
Quote from Henit Lapid, Head Mammalian Commercial Development and Marketing, Lonza:
“The collaboration with Pionyr Therapeutics demonstrates Lonza’s flexibility to tailor its offering to accommodate the specific needs of our customers. Our team has created a cell line development program relying on a state-of-the-art platform technology that brings a faster and streamlined approach to selecting an ideal cell line.”
Quote from Evan Greger, Senior Vice President, Technical Operations, Pionyr Immunotherapeutics:
“Lonza is a well-suited partner for Pionyr as their capabilities represent a customizable end-to-end offering that will scale with us as our programs continue to advance.”
BASEL, SWITZERLAND and SOUTH SAN FRANCISCO, CA, March 29, 2021 – Pionyr Immunotherapeutics, Inc., a company developing first-in-class antibody therapeutics that increase the body’s anti-tumor immunity, and Lonza announced today that the companies have entered into a collaboration to manufacture Pionyr’s monoclonal antibody candidate intended for oncology indications.
Lonza will provide a gene to IND program tailored to suit the specific requirements of Pionyr’s products. The scope will include cell line development, process development, supply chain simplification, and de-risking, as well as drug substance (DS) manufacturing at Lonza’s Visp (CH) site, and drug product (DP) manufacturing at Stein (CH) to help Pionyr advance their programs into clinical development and testing. The cell line development to DP program will begin in Q2 2021. The cGMP batches of DS and DP are expected to be completed in 2022.
Developing a high-producing, stable cell line represents a critical path activity for the production of large quantities of therapeutic antibodies. This collaboration will allow Pionyr to take advantage of the Beacon platform. The platform provides the capacity to screen and monitor thousands of clones at once and in a short time, thereby optimizing and streamlining the cell line construction process.
The Pionyr and Lonza collaboration will initially focus on Pionyr’s third program named PY265 which is directed against an undisclosed target. Similar to Pionyr’s PY314 and PY159 programs (targeting TREM2 and TREM1 respectively), this third program is anticipated to be first-in-class and will have a distinct mechanism of action from other myeloid-directed therapeutics currently in development.
Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to prevent illness and enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. These enable our customers to commercialize their discoveries and innovations in the healthcare sector.
Founded in 1897 in the Swiss Alps, today Lonza operates across three continents. With approximately 14,000 full-time employees, we are built from high-performing teams and of individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 4.5 billion in 2020 with a CORE EBITDA of CHF 1.4 billion. Find out more at www.lonza.com.
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About Pionyr Immunotherapeutics
Pionyr is exploiting novel target discovery and antibody generation platform technologies to create the next generation of immuno-oncology therapeutics after checkpoint inhibitors. The company’s initial approach, termed “Myeloid Tuning,” is designed to enhance the immune system’s anti-tumor response by specifically altering the cellular infiltrate of the tumor microenvironment. Pionyr’s lead programs PY314 and PY159, targeting TREM2 and TREM1 respectively, are designed to selectively deplete and in some cases reprogram certain tumor-associated macrophages responsible for immunosuppression. In July 2020, Pionyr entered into a transformational alliance with Gilead Sciences whereby Gilead acquired a minority interest in the company, is providing funding for the company’s programs and has an exclusive option to acquire Pionyr upon completion of certain Phase 1b studies. Pionyr’s additional investors include New Enterprise Associates, OrbiMed, SV Health Investors, Sofinnova Ventures, Vida Ventures, Osage University Partners, Mission Bay Capital, and Trinitas Ventures. For more information, please visit www.pionyrtx.com.
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