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HiFiBiO Strengthens its Senior Leadership Team in Preparation for First-in-Human Studies of Two Lead Immunoncology Programs and a Sustainable Pipeline

(From left to right) Christos Hatzis, PhD, Vice President, Head of Clinical Pharmacogenomics, John Pallante, Vice President, Head of Clinical Operations, and Edward Rocnik, PhD, Executive Director, Head of CMC have joined the company’s senior leadership team.

CAMBRIDGE, Mass. – August 9, 2021 – HiFiBiO Therapeutics has onboarded three new senior leaders to help drive the clinical success of the company’s two lead immunoncology programs, HFB2003, an anti-TNFR2 agonist, and HFB3010, an OX-40 agonist, as well as accelerate other earlier stage pipeline programs.

Dr. Christos Hatzis joins as Vice President, Head of Clinical Pharmacogenomics to drive the company’s clinical biomarker and translational strategy through the Drug Intelligent Science (DIS™) platform. Additionally, he will work closely with the DIS™ team on translational efforts for preclinical assets. Dr. Hatzis is an engineer by training with extensive translational and immune-oncology experience and an entrepreneurial mindset. Prior to HiFiBiO, Christos served as the Tumor Strategy Lead in Translational Medicine at Bristol-Myers Squibb where he provided scientific and strategic leadership for solid tumor programs. Before BMS, he served as an Associate Professor for the Department of Internal Medicine (Medical Oncology) at Yale University School of Medicine, where he still holds an Adjunct faculty position.

John Pallante joins as Vice President, Head of Clinical Operations where he will oversee the preparation and execution of our global clinical trials alongside our partners and collaborators. Mr. Pallante has over 15 years of clinical operations experience, most recently serving as the Global Head of Clinical Quality Management and Training at Novartis Institutes for BioMedical Research.

Dr. Edward Rocnik joins as Executive Director, Head of CMC where he will work closely with external CDMOs and internal research and development teams to oversee all manufacturing activities. Dr. Rocnik brings over 12 years of experience in various CMC and research related roles, including analytical lead on several biologics programs supporting multiple regulatory submissions. Most recently, he served as Director, Head of Late-Stage Analytical Development, Cell Therapies at Takeda.

“With the addition of Christos, John, and Ed, we have established a top-tier senior leadership team to advance our single-cell DISTM platform and sustainable pipeline of innovative therapeutics into the next stage of development,” said CEO Liang Schweizer. “Their decades of experience in translational clinical oncology, operations, and manufacturing strongly complement our existing scientific and business leadership. I look forward to working closely with each of them to execute HiFiBiO’s vision and mission to deliver curative immunotherapies to each and every patient.”

 

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation and proliferation of CD4 and CD8 T-cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity alone and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS™ platform to select patients who may benefit the most from HFB200301 treatment.

 

HFB3010 (OX40)

HFB301001 is a second-generation novel, fully human IgG1 class OX-40 agonistic antibody with an optimized pharmacological profile. In contrast to previous anti-OX-40 antibodies, the agonistic activity of HFB301001 is further enhanced in the presence of the endogenous ligand OX-40L. HFB30101 does not result in reduced levels of OX-40 on T-cells and leads to superior anti-tumor activity in a human OX-40 knock-in mouse model compared to a benchmark antibody. HiFiBiO is also applying a biomarker strategy by leveraging its DIS™ platform to select patients who may benefit the most from HFB301001 treatment.

 

About HiFiBiO Therapeutics

HiFiBiO Therapeutics is transforming the field of immunotherapy by combining proprietary single-cell profiling technologies with advanced data intelligence and deep knowledge of immune system biology. This approach enables the development of novel antibody therapies that are paired with biomarkers to predict patient response. HiFiBiO Therapeutics is working actively to address unmet medical needs around the world through its own innovative pipeline programs and open-innovation partnerships with world-renowned industry and academic researchers. The company’s strong global footprint features cutting-edge laboratories on three continents, in Cambridge, Mass., Paris, Shanghai, Hangzhou, and Hong Kong. To learn more, please visit www.hifibio.com.

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