SAN DIEGO–(BUSINESS WIRE)–Janux Therapeutics, a biopharmaceutical company developing novel T cell engager immunotherapies, today announced the appointment of Charles Winter as Senior Vice President of Chemistry, Manufacturing, and Controls (CMC). In this role, he will lead all aspects of process development and manufacturing, from preclinical through commercialization. Mr. Winter has more than 25 years of bioprocess experience at leading biotechnology and pharmaceutical companies, including Genentech, Gilead, Denali Therapeutics, AnaptysBio, and Synthorx (now a Sanofi company). At these companies, Mr. Winter played key roles in bringing more than 20 molecules into clinical development and six to market, including Avastin®, Herceptin®, Rituxan®, and Xolair®.
“Charles has a proven track record in establishing and scaling manufacturing for a variety of innovative, novel therapeutics from preclinical development to commercialization,” said David Campbell, Ph.D., President and CEO of Janux Therapeutics. “At Janux, Charles will oversee the entire development and manufacturing processes for our TRACTr drug pipeline as we work towards advancing our first drug candidates into the clinic next year.”
Janux’s proprietary Tumor Activated T Cell Engager (TRACTr) technology was created to overcome specific limitations of current T cell immuno-oncology therapies by enabling tumor-specific target engagement and anti-tumor immune response, while minimizing toxicity to normal tissues. Because the technology is modular in design, new drug candidates can be rapidly identified and developed. Janux’s preclinical pipeline includes TROP2-TRACTr and PSMA-TRACTr for the treatment of solid tumors.
“Janux was very thoughtful when it designed its T cell engager technology to not only maximize the therapeutic window of safety and efficacy but also to develop a straightforward, scalable manufacturing process for its drug candidates,” said Mr. Winter. “I look forward to establishing and ramping up CMC for Janux as the company prepares to initiate its first clinical trials next year.”
Mr. Winter started his career at Genentech, where he spent 17 years in increasing roles of responsibility in bioprocess development and CMC leadership from preclinical through development and commercialization. After Genentech, he was Director of Biologics Development at Gilead, building biologics development and CMC platforms, capabilities, and strategies. Mr. Winter then became Vice President of Manufacturing and Technology for JHL Biotech in Taiwan, running its cGMP contract manufacturing plant. Prior to joining Janux, he held senior leadership roles running outsourced CMC programs at Denali Therapeutics, Synthorx (now a Sanofi company), and AnaptysBio.
About T Cell Engagers and Janux’s TRACTr Technology
T cell engagers are an emerging class of immunotherapies that bind to a tumor cell and recruit a patient’s T cells to eradicate tumor cells. Although previous T Cell engager therapies utilizing other technologies have displayed substantial anti-tumor efficacy, they have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy. Janux’s TRACTr technology is designed to overcome these limitations by integrating tumor-specific activation with crossover pharmacokinetics to produce differentiated T cell engager therapeutics. In preclinical studies, Janux TRACTr drug candidates have demonstrated substantial activity, but have not displayed the associated liabilities related to cytokine release, healthy tissue toxicities, or systemic immune activation.
About Janux Therapeutics
Janux Therapeutics is a biopharmaceutical company developing novel immunotherapies with the company’s proprietary TRACTr technology. Janux’s TRACTr technology employs a modular design to rapidly engineer drug candidates against specific targets. The Janux TRACTr development pipeline targets multiple solid tumor indications, including colorectal, gastroesophageal, prostrate, NSCLC, triple negative breast, and ovarian cancers. Janux’s technology can be applied to immunotherapies that target all three stages of an anti-tumor immune response. Combining Janux’s tumor-specific activation with multi-stage anti-tumor signaling has the potential to significantly improve safety, expand the therapeutic dosing window, and maximize patient responses. For more information, visit www.januxrx.com.