FG-3165 / HiFiBiO, FibroGen - LARVOL DELTA

FibroGen Announces Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate FibroGen’s Immuno-Oncology Assets, FG-3165 (anti-Galectin 9) and FG-3175 (anti-CCR8), in Combination with LIBTAYO in Upcoming Clinical Trials (GlobeNewswire) - "FibroGen...announced a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate FibroGen’s immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron’s anti-PD-1 therapy, LIBTAYO (cemiplimab), in patients with solid tumors....Under the clinical study collaboration and supply agreement, Regeneron will provide drug supply to FibroGen, who will be the sponsor of each Phase 1 monotherapy and combination trial....FibroGen to evaluate FG-3165...as monotherapy treatment as well as in combination with LIBTAYO in patients with select solid tumors. FibroGen to evaluate FG-3175...as monotherapy treatment as well as in combination with LIBTAYO in patients with select solid tumors."

Licensing / partnership • Solid Tumor

FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors (GlobeNewswire) - "FibroGen...announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression....The FDA IND clearance enables FibroGen to initiate a Phase 1 clinical trial evaluating the safety and efficacy of FG-3165 in patients with select solid tumors. The trial is anticipated to begin enrollment in the second half of 2024."

IND • New P1 trial • Solid Tumor

FibroGen Reports First Quarter 2024 Financial Results (GlobeNewswire) - "IND submitted for FG-3165 (Galectin-9 targeting mAb) for solid tumors in April 2024....Total revenue for the first quarter of 2024 was $55.9 million, as compared to $36.2 million for the first quarter of 2023, an increase of 55% year over year."

Commercial • IND • Oncology • Solid Tumor

FibroGen Reports Third Quarter 2023 Financial Results (GlobeNewswire) - "Upcoming Milestones: (i) Expect topline clinical trial results from Phase 1 monotherapy trial of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting a novel epitope on CD46 for metastatic castration-resistant prostate cancer (mCRPC) by 1Q 2024; (ii) Anticipate the initiation of a Phase 2 trial of FG-3246 for mCRPC in 2H 2024; (iii) Anticipate the filing of two INDs: FG-3165 (anti-Gal9 antibody) in 1Q 2024 and FG-3175 (anti-CCR8 antibody) in 2H 2024."

IND • New P2 trial • P1 data • Prostate Cancer

FG-3165 is a novel galectin-9 neutralizing antibody that inhibits galectin-9-mediated dimerization of TIM-3 and galectin-9-induced apoptosis of CD4+ and CD8+ T cells (SITC 2023) - "Conclusions FG-3165 binds with sub-nanomolar affinity to human Gal-9, preventing Gal-9-induced dimerization of TIM-3, and inhibiting apoptosis of both cytotoxic T cells and T helper cells. These data indicate that neutralization of Gal-9 by FG-3165 may overcome an important immunosuppressive mechanism in the tumor microenvironment, positioning FG-3165 as a promising candidate for the treatment of solid tumors."

Oncology • Solid Tumor • ANXA5 • CD4 • CD8 • HAVCR2 • LGALS9

FibroGen Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "Early-Stage Oncology Pipeline: (i) Anticipate the initiation of a Phase 2 trial of FG-3246, a first-in-class ADC targeting a novel epitope on CD46 for mCRPC in 2H 2024; (ii) Anticipate the filing of two INDs: FG-3165 (anti-Gal9 antibody) in 1Q 2024 and FG-3175 (anti-CCR8 antibody) in 2H 2024."

IND • New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[VIRTUAL] HFB9-2, a novel Galectin 9 neutralizing antibody for the treatment of AML and other cancers (AACR 2021) - "The serum levels of Gal-9 increased over time following the increase of hCD45+ AML cells. Further analysis to evaluate the effect of Gal-9 neutralization in AML progression after primary and secondary engraftment with HFB9-2 are currently ongoing.The data presented here provide evidence that neutralization of Gal-9 with HFB9-2 blocks key immunosuppressive mechanisms known to favor cancer progression and to limit the efficacy of current immunotherapies, and together with the data obtained in AML patient samples position Gal-9 neutralization as a promising anticancer approach."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor • CD44 • HAVCR2 • PRKDC • PTPRC