On April 6, 2021 HiFiBiO Therapeutics reported that it will share with the scientific community preclinical data for novel monoclonal antibodies for clinical development as new cancer immunotherapeutic options (Press release, HiFiBiO Therapeutics, APR 6, 2021, View Source [SID1234577676]). Two of these programs, HFB3010 and HFB2003, are slated to enter Phase I clinical trials later this year.

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The team will present highlights in four poster sessions at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, April 10-15 and May 17-21, 2021. These four programs highlight the continual evolution of HiFiBiO Therapeutic’s robust pipeline and unique capability to develop novel antibodies to address unmet medical needs.

"We are excited to share the latest data from four of our programs with the oncology research community at AACR (Free AACR Whitepaper). These include our two most advanced oncology antibodies, HFB301001, a highly differentiated second-generation OX40 agonist, and HFB200301, a novel anti-TNFR2 agonist bridging innate and adaptive immunity. We also share the profile of antibody candidates against CXCR5 and Galectin-9 that hold exceptional promise for the treatment of hematological malignancies and solid tumors," said Francisco Adrian, Global Head of Research.

"Applying single-cell immuno-profiling insights from our groundbreaking DIS platform to our oncology trials is a step towards realizing one of greatest ambitions; to deliver significant benefit to patients through targeted immunotherapies. Our novel biomarker strategy by analyzing tumor immune profiles at the single cell level aims to enrich for responding patients in our upcoming HFB3010 and HFB2003 clinical studies," said Andreas Raue, PhD, Global Head of Drug Intelligent Science.

The four HiFiBiO Therapeutics pipeline programs being presented at AACR (Free AACR Whitepaper) are:

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, 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 treatment.

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 candidate antibody that binds potently and selectively to TNFR2, recognizes cyno TNFR2, and induces CD4 and CD8 T-cell activation and proliferation cooperatively with TNFα without requiring crosslinking. In vivo, HFB200301 demonstrates potent antitumor activity alone and combined with anti-PD-1. It is also well tolerated in mice and NHPs. HiFiBiO is also utilizing its DIS platform to implement a biomarker strategy for HFB2003.

HFB2009 (Gal-9)

Galactoside-binding lectin Galectin 9 (Gal-9) is a key pleiotropic immunosuppressive modulator present in the tumor microenvironment. HFB9-2, an anti-Gal-9 blocking antibody with demonstrated single agent anti-tumor activity in a mouse cancer model, offers improved survival in combination with anti-PD-1 therapy as compared to anti-PD-1 alone, and shows good tolerability in NHPs.

HFB1002 (GPCR)

CXCR5 is a GPCR expressed on B cells, as well as on follicular helper T cells. CXCR5 plays a key role in the migration of B cells to germinal centers and the production of autoantibodies. CXCR5 is implicated in autoimmune diseases, such as Sjögren syndrome, and in cancers such as B cell lymphomas and solid tumors, where it has been associated with metastasis and poor prognosis. HiFiBiO generated and characterized a novel anti-hCXCR5 blocker with potent ADCC activity to treat tumor and autoimmune diseases.