HiFiBiO Therapeutics will take a pioneering approach to clinical development of its pipeline of antibody candidates by using patient stratification biomarkers identified by the company’s proprietary Drug Intelligent Science (DIS®)
CAMBRIDGE, Mass., SHANGHAI, and PARIS – May 15, 2020 – Scientists at HiFiBiO Therapeutics have generated preclinical data packages for novel monoclonal antibodies that demonstrate favorable clinical development profiles as new cancer immunotherapeutic options. The team will present highlights in three poster sessions at the forthcoming American Association for Cancer Research (AACR) Virtual Annual Meeting II, June 22-24, 2020. Taken together, these three programs from the HiFiBiO Therapeutics pipeline are evidence of the maturation of the company’s unique and comprehensive capabilities to uncover disease mechanisms and indications at the single-cell level; apply a deep understanding of immune system biology to select antibodies that present the best prospects for clinical development; and match these high-quality antibodies to the patients who are most likely to derive benefit.
“We are pleased to have the opportunity to present our work to the oncology research community at AACR and to share our innovative approach to transform the drug discovery and development paradigm by combining a deep understanding of immune-modulation with a world-leading single-cell platform and integrated analytics. By applying this approach over the past two and a half years, we have built a sustainable pipeline with high-quality candidates moving rapidly towards clinical studies,” said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics.
The three HiFiBiO Therapeutics pipeline programs being presented at the AACR meeting are:
HFB301001 is a 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, does not result in reduced expression 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. Applying innovative biomarker strategy by leveraging its cutting-edge single-cell platform, HiFiBiO Therapeutics is developing the HFB301001 clinical candidate targeting certain patient populations which confer sensitivity towards treatment.
HiFiBiO Therapeutics has discovered and is pursuing the development of a first-in-class anti-TNFR2 monoclonal antibody capable of co-stimulating T cell proliferation and inducing strong in vivo anti-tumor immunity. In tumors, TNFR2 is expressed on activated and exhausted T cells. Targeting TNFR2 has the potential to enhance anti-tumor immunity by stimulating T-cell activation and proliferation in the tumor microenvironment. HiFiBiO’s CelliGO™ platform enabled the identification of diverse anti-TNFR2 antibodies that target different epitopes of the receptor. The candidate HFB200301 preferentially binds to TCR-activated primary CD8 and CD4 T cells as compared to unstimulated T cells and enhances CD3/CD28-induced activation and proliferation. Single agent anti-tumor activity comparable to anti-PD-1 was observed in several mouse tumor models at well-tolerated doses. An acute NHP exploratory study revealed no safety concerns for this novel mechanism. The clinical candidate HFB200301 has favorable developability and PK profiles and is currently at CMC development stage.
Galactoside-binding lectin Galectin 9 (Gal-9) is a key pleiotropic immunosuppressive modulator present in the tumor microenvironment. High Gal-9 expression has been reported in several cancer types including hematological malignancies such as AML and ALL, as well as in multiple solid tumors. Neutralization of Gal-9 has the potential to enhance anti-tumor immune response in the tumor micro-environment. HiFiBiO Therapeutics has discovered and is pursuing the development of HFB200902, an anti-Gal-9 neutralizing antibody with first-in-class potential in AML and solid tumors. HFB200902 blocks the interaction of Gal-9 with TIM3 and CD44, two receptors that have been described to mediate Gal-9-immunosuppressive signals in effector and regulatory T cells. As a result, HFB200902 inhibits Gal-9 induced Th1 cell apoptosis and Treg expansion. Anti-tumor activity and increased survival were observed as single agent and in combination with anti-PD1 in a syngeneic tumor model.
HiFiBiO Therapeutics will take innovative approaches to clinical development of these and other candidates in its pipeline, by pairing these novel antibody candidates with patient stratification biomarkers identified using the company’s proprietary DIS® approach. This enables the company’s scientists to analyze individual patient cell samples to understand the complex functions and heterogeneity in immune system characteristics and responses among different patient groups, and to define predictive biomarkers that can be used to match the therapeutics to those patients who will most likely benefit from them.
“The challenges of achieving clinical success for immunotherapies are often related to the complex biology of the tumor microenvironment. Our pipeline focuses on targets with roles on multiple immune cell types, and our development strategy hinges on combining candidates with novel biomarkers to ensure a higher probability of clinical success,” commented Francisco Adrian, Senior Vice President of Global Research, HiFiBiO Therapeutics.
“Our single-cell technology paired with our unique data analysis capability enables us to identify novel biomarkers derived from particular immune cell types and mechanisms. Using this approach, we should be able to stratify patients using their profiled genotype and phenotype, which predict sensitivity or resistance to treatment with our antibody candidates,” said Andreas Raue, Senior Director of Drug Intelligent Science, HiFiBiO Therapeutics.
Registration for the virtual meeting is being offered by AACR free of charge; more information is available at AACR Virtual Annual Meeting II.
About HiFiBiO Therapeutics
HiFiBiO Therapeutics is an emerging multinational biotherapeutics company mobilizing the human immune system to combat disease. The company integrates deep-rooted biological expertise with its comprehensive single-cell profiling technologies to discover and accelerate a pipeline of antibody drugs to treat cancer and autoimmune disorders. In addition, HiFiBiO Therapeutics aspires to address unmet medical needs around the world through open-innovation partnerships with industry and academia. The company features a strong global footprint with cutting-edge laboratories on three continents in Cambridge, Mass., Paris and Shanghai. For more information, please visit www.hifibio.com.
HiFiBiO® and DIS® are trademarks of HiFiBiO and its affiliates.