- The collaboration aims to bring Pionyr's third pipeline development candidate for a novel Myeloid Tuning™ target 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, 29 March 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 early 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.