PIONYR Immunotherapeutics Announces Key Leadership Team Addition and Clinical Candidates Targeting Tumor-Associated Macrophages

- Alicia Levey, Ph.D., joins as Senior Vice President and Chief Business Officer – - Two first-in-class Myeloid Tuning™ antibodies with novel mechanisms in the tumor microenvironment headed for the clinic - South San Francisco, CA (August 27, 2019) — PIONYR Immunotherapeutics, Inc., a company developing antibody therapeutics that increase the body's antitumor immunity by turbocharging the immune system within the tumor microenvironment, today announced the appointment of Alicia Levey, Ph.D., as Senior Vice President and Chief Business Officer. PIONYR also announced that its lead development candidates, PY314 and PY159 targeting TREM2 and TREM1, respectively, are on track to complete IND-enabling studies and are expected to enter clinical development in 2020. "Dr. Levey joins PIONYR at a key inflection point as we build our immuno-oncology pipeline and prepare to advance two development candidates into the clinic. Our two programs target TREM2 and TREM1, both of which play a critical role in immunosuppression in solid tumors," said Steven P. James, president and CEO of PIONYR. "Backed by deep experience in immuno-oncology research and development, our leadership team is uniquely positioned to bring these novel antibodies with unique mechanisms of action to patients in need, notably those who have failed prior immuno-oncology treatments such as checkpoint inhibitors." Myeloid Tuning™ Capable of Depleting and Reprogramming Macrophages Research conducted at PIONYR demonstrates that its approach, called Myeloid Tuning™, is capable of rebalancing the tumor microenvironment (TME) to promote anti-tumor immunity. PIONYR's Myeloid Tuning therapies are expected to treat patients who currently do not benefit from checkpoint inhibitor therapies. PIONYR's development candidates, PY314 and PY159 target TREM2 and TREM1, respectively, and provide an orthogonal approach for treating solid tumors. TREM2 is a transmembrane protein enriched on tumor-associated macrophages (TAMs). These immunosuppressive cells use multiple pro-tumor mechanisms to subvert anti-tumor immune responses. By selectively depleting TREM2-positive TAMs, PY314 generates a pro-inflammatory TME that leads to long-term cures in multiple mouse tumor models, including in PD-1-resistant models, both as monotherapy and in combination with anti-PD-1. Further, PY314 was shown to be well tolerated in nonclinical studies and is currently in GMP production. A significant correlation exists between TREM2 expression levels and poor patient survival probability in a broad array of solid tumors, suggesting that TREM2 levels may be a biomarker for patient selection. TREM1 is expressed not only on TAMs but also on tumor-associated neutrophils (TANs) and myeloid derived suppressor cells (MDSCs) in numerous solid tumor types. PY159 targets TREM1 to reprogram or repolarize suppressive myeloid cells to produce pro-inflammatory cytokines (including IFN-gamma, CXCL9, and CXCL10), as well as to upregulate immune-stimulatory cell surface proteins. PY159 may therefore be particularly useful in targeting immune "cold" tumors. PY159 has demonstrated excellent single-agent efficacy as well as efficacy in combination with checkpoint inhibitors in multiple mouse tumor models. PY159 was well tolerated in preclinical studies and is currently being scaled up for GLP production. Growing Management Team As Senior Vice President and Chief Business Officer, Dr. Levey will lead PIONYR's business development function including strategic partnering, alliance management, portfolio strategy and commercial assessment. Prior to joining PIONYR, Dr. Levey served as Vice President and Chief Business Officer of Tempest Therapeutics following her roles as Vice President of Business Development at Inception Sciences, Operating Principal at Versant Ventures and Project Leader at Boston Consulting Group. She has led the sourcing, negotiations and execution of numerous venture financings and strategic transactions with companies such as Celgene, Bayer and Shire, among others. Dr. Levey is co-founder of Akrotome Imaging, and she earned a Ph.D. in Cancer Biology at Stanford and a B.A. in Molecular, Cellular and Developmental Biology at University of Colorado. In addition to Steve James as CEO and Dr. Levey as CBO, PIONYR's executive team includes Michel Streuli, Ph.D., CSO; Leonard Reyno, M.D., CMO; Monte Montgomery, CFO; Kevin Baker, Ph.D., SVP Preclinical; and Evan Greger, VP of CMC/Process Development. In December 2017, PIONYR announced the closing of a $69 million Series B financing. This brought total funding since the company's founding in 2015 to $78 million. PIONYR'S investors include OrbiMed, NEA, Sofinnova, SV Health Investors, Vida Ventures, Trinitas Capital, Mission Bay Capital, and Osage University Partners. About PIONYR Immunotherapeutics PIONYR was co-founded by Professors Max Krummel and Sachdev Sidhu. Dr. Krummel has been a pioneer in immuno-oncology since the mid-1990s and is the co-inventor of YERVOY® (ipilimumab), the first marketed checkpoint inhibitor, which was approved in 2011 to treat melanoma. Dr. Sidhu is a protein engineer and key player in early antibody phage-display technology platforms, formerly at Genentech, and is now head of protein engineering and antibody discovery at the University of Toronto. 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. For further information, please visit www.pionyrtx.com.