Pionyr also receives FDA clearance of Investigational New Drug Application for second Myeloid Tuning program, PY159
South San Francisco, Calif., November 18, 2020 – Pionyr Immunotherapeutics, Inc., a company developing first-in-class antibody therapeutics that increase the body’s antitumor immunity by altering the composition and function of immune cells within the tumor microenvironment, today announced the initiation of a Phase 1 clinical study investigating PY314 in patients with solid tumors.
PY314 targets TREM2, a protein found on the surface of a subpopulation of immunosuppressive, pro-tumor myeloid cells. PY314 works by depleting TREM2-expressing immune suppressive tumor associated macrophages (TAMs), which leads to activation of productive anti-tumor immunity. In preclinical studies, PY314 treatment not only depleted TAMs, but also promoted infiltration of activated anti-tumor cytotoxic T lymphocytes into the tumor microenvironment.
“Pionyr moving PY314 into clinical development is a major milestone for our company and our scientific platform,” said Steven P. James, President and Chief Executive Officer, Pionyr. “This study initiation also comes shortly after receiving the FDA clearance of our Investigational New Drug (IND) Application for our second antibody program, PY159, which ‘turbocharges’ anti-tumor activity by targeting TREM1-expressing myeloid cells in the tumor microenvironment. With the acceptance of two INDs in two months, the start of the PY314 Phase 1 trial and the anticipated initiation of the PY159 trial by year end, we are rapidly advancing our mission of creating the new frontier of immuno-oncology therapies.”
The Phase 1 study will enroll patients at multiple academic centers in the US and will evaluate PY314 as both a single agent and in combination with an approved checkpoint inhibitor. Once safety is determined, additional patients will be recruited in predefined tumor types where TREM2 expression is most likely implicated as a driver of resistant metastatic disease. For more information on the study, please visit www.ClinicalTrials.gov.
“PY314 represents a potentially foundational therapeutic opportunity to expand immunotherapy options for patients with advanced solid tumors,” said Leonard Reyno, M.D., Senior Vice President and Chief Medical Officer, Pionyr. “We are excited to make this transition into a clinical-stage company and work with the leading clinical sites and investigators who have enthusiastically joined in this effort alongside us.”
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.