HiFiBiO Inc.

CAMBRIDGE, MA, USA I November 04, 2024 I HiFiBiO Therapeutics, a clinical stage biotechnology company focused on immune modulation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HFB200604 . HFB200604 is a best-in-class BTLA agonist monoclonal antibody, developed using HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform. The therapy is designed to restore immune tolerance in inflammatory and immunology diseases by stimulating BTLA signaling in immune cells. “HFB200604 represents our first autoimmune program to advance into clinical development, highlighting HiFiBiO’s innovative approach to rapidly translating patient insights into impactful therapies,” said Liang Schweizer, Ph.D., Founder, Chairperson, and CEO of HiFiBiO Therapeutics, “We are excited to leverage our DIS® platform to address the challenges of patient heterogeneity in inflammatory and immunology diseases, with the aim of achieving higher response rates.” Francisco Adrian, Ph.D., CSO of HiFiBiO Therapeutics, added “We are thrilled to bring our best-in-class BTLA agonist HFB200604 to patients suffering from inflammatory and immunology diseases. Our single-cell immune profiling data suggest that BTLA agonism could be a highly effective approach to reducing immune activation, and we look forward to translating compelling preclinical findings into meaningful clinical outcomes.” HiFiBiO plans to begin a single ascending dose (SAD) Phase 1 clinical study in a healthy volunteer cohort, followed by a multiple ascending dose (MAD) study in patients with selected inflammatory and immunology diseases identified through the HiFiBiO DIS® platform. HFB200604 HFB200604 is a best-in-class BTLA agonist monoclonal antibody designed to suppress activated T and B cells. Preclinical studies have shown that HFB200604 effectively inhibits T and B cell activation and demonstrated in vivo activities in a mouse model. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com SOURCE: HiFiBiO Therapeutics

CAMBRIDGE, MA – October 7, 2024 – HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company today announced its participation in the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 6-10 in Houston, Texas. The company will present a pioneering clinical development strategy, showcasing the predictive power of its Drug Intelligence Science (DIS®) platform to guide the Phase I development of two novel monoclonal antibodies: a first-in-class TNFR2 agonist HFB200301 (NCT05238883) and a best-in-class BTLA antagonist HFB200603 (NCT05789069). DIS® provides a single cell and AI/ML-driven approach to selecting the most promising tumor types, dose regimen, and patient population for clinical success. HiFiBiO’s unique DIS® approach enables the translation of complex clinical data including patient history, imaging, PK/PD, and genomic sequencing into meaningful patient selection strategies for enhanced clinical benefit. This patient-data guided translational strategy demonstrates the company’s deep commitment to innovative research and impactful therapies to address the highest unmet medical needs. Details on the poster presentations are as follows: Title: Predictive and Generative AI to guide the clinical development of HFB200301, a first-in-class TNFR2 agonist: Drug Intelligence Science (DIS®).​ Abstract Number: 1233 Session Date: Friday, 8 November 2024 Speaker: Spencer Huggett, PhD, HiFiBiO Inc. Title: Utilizing Drug Intelligence Science (DIS®) for tumor type selection and molecular characterization of HFB200603, a best-in-class B and T Lymphocyte Attenuator (BTLA) monoclonal antagonist. Abstract Number: 1224 Session Date: Saturday, 9 November 2024 Speaker: Spencer Huggett, PhD, HiFiBiO Inc. The initial data from these abstracts will be available on the SITC website starting on November 5 at 9 am EST. Additionally, the posters will be accessible on the HiFiBiO Therapeutics website following the live presentation. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com HiFiBiO® is a trademark of HiFiBiO Therapeutics and its affiliates

CAMBRIDGE, MA – August 22, 2024 – HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company today announced its participation in the 2024 Annual Congress of the European Society for Medical Oncology (ESMO), taking place September 13-17 in Barcelona, Spain. The company will present compelling Phase 1 trial data on two novel monoclonal antibodies: the first-in-class TNFR2 agonist HFB200301 (NCT05238883) and the best-in-class BTLA antagonist HFB200603 (NCT05789069). These programs have shown promise both as monotherapy and in combination with anti-PD-1, demonstrating the capability to elicit a robust anti-cancer immune response, even in IO refractory tumors. Harnessing its innovative Drug Intelligence Science (DIS®) platform, HiFiBiO is at the forefront of advancing these therapies by specifically selecting tumor types, optimizing dosing regimens, and identifying predictive biomarkers to increase the probability of clinical success. The insights gained from these Phase 1 trials will play a critical role in guiding Phase 2 dosing strategies and patient selection criteria. HiFiBiO’s novel immunotherapies and comprehensive translational strategy demonstrate the company’s deep commitment to innovative research and developing impactful therapies to address unmet medical needs. HiFiBiO is now applying this strategy to inflammation and immunology, with plans to submit an IND application for a novel BTLA agonist by the end of September. Details on the poster presentations are as follows: Title: Model-informed dose optimization of HFB200301, a TNFR2 agonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb tislelizumab (TIS), in patients (pts) with advanced solid tumors. Presentation Number: 1011P Session Date: Saturday, 14 September 2024 Speaker: Desamparados Roda Perez, MD, PhD, Hospital Clínico Universitario de Valencia View the poster here. Title: Phase I dose escalation study of HFB200603, a best-in-class BTLA antagonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb Tislelizumab (TIS) in adult patients (pts) with advanced solid tumors. Presentation Number: 1006P Session Date: Saturday, 14 September 2024 Speaker: María de Miguel, MD, PhD, MBA, START Madrid – CIOCC HM Sanchinarro View the poster here. The initial data from these abstracts will be available on the ESMO website starting on September 9 at 0:05 CEST. Additionally, the posters will be accessible on the HiFiBiO Therapeutics website following the live presentation. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com HiFiBiO® is a trademark of HiFiBiO Therapeutics and its affiliates