CD20 x CD19

Jan. 15, 2025 -- Hinge Bio, Inc., a privately-held biotechnology company, today announced the close of a Series A’ financing led by Point72. Joining Point72 are Ridgeback Capital, InVivium Capital, and Lightswitch Capital, among others. The proceeds will support entry of the Company’s lead product candidate, HB2198, into a Phase 1 clinical trial in patients living with Systemic Lupus Erythematosus (“Lupus”) as well as development of additional therapeutics from Hinge Bio’s proprietary GEM-DIMER™ platform to treat diseases with high unmet need. “Hinge Bio is committed to developing life-changing medicines for patients with intractable diseases,” said Chief Executive Officer Barry Selick, Ph.D. “These funds will enable early clinical demonstration of the safety and efficacy of HB2198 in Lupus patients as well as the pre-clinical evaluation of a variety of other constructs of interest to both patients as well as pharmaceutical company partners.” Hinge Bio’s lead candidate from its GEM-DIMER™ platform, HB2198, is expected to enter clinical development during 2025. The program seeks to treat B cell-mediated autoimmune disorders by targeting both CD19 and CD20 with enhanced natural killer cell engagement. Pre-clinical in vivo studies have demonstrated deeper and more rapid B cell depletion than has been reported for other antibody-based therapies. The therapeutic goal of HB2198 is to achieve a reset of the immune system through rapid and deep B cell depletion in both peripheral blood and lymphoid tissues, with the convenience, accessibility, cost and safety benefits of an off-the-shelf antibody-based therapeutic. “Hinge’s GEM-DIMER technology has broad applicability across therapeutic areas and constructs, and we believe HB2198 only begins to show the promise of Hinge’s platform,” said Alex Silverstein, Portfolio Manager at Point72. “The talented team at Hinge is well positioned to develop exciting medicines that have the potential to both improve upon current standards of care and harness novel pathways. We believe HB2198 can be a best-in-disease therapeutic for multiple indications that can be broadly, safely, and easily used by healthcare practitioners from academic centers to community practices.” Added Dr. Wayne Holman, Founder & CEO of Ridgeback Capital, "Hinge has developed a platform to create best in class medicines against known and novel targets. The lead program is a B-cell depleting medicine that we believe will be as efficacious as a CD19 CART in autoimmune disease with the safety and tolerability of a simple monoclonal antibody. This would allow for a profound benefit and immune reset across a wide range of autoimmune diseases with a simple short term IV or SubQ therapy. This may transform autoimmune disease and leapfrog competing platforms such as CART and T-cell engagers in the B cell depletion field." Hinge Bio, Inc. is a privately held development-stage biotechnology company leveraging its proprietary GEM-DIMER™ platform to design and develop therapeutics leading to better treatment outcomes for patients living with autoimmune, inflammatory, and infectious disease, as well as cancer. The GEM-DIMER™ technology platform enables the creation of multivalent, multispecific antibody-based therapeutics that are designed to bind their targets cooperatively allowing for dramatically enhanced biological activity and unique functionality. GEM-DIMER™ technology was invented by Hinge Bio’s Chief Scientific Officer, Daniel Capon, Ph.D., the co-inventor of recombinant Factor VIII for hemophilia, and three foundational technologies that have transformed biological therapy: Fc fusion proteins (Genentech, Inc.), scFv-Zeta Chimeric Antigen Receptors for T cell therapy (Cell Genesys, Inc.), and genetically-modified mice producing repertoires of fully human antibodies capable of recognizing human disease targets (Abgenix, Inc.). Hinge Bio is advancing a pipeline of programs with an initial focus on autoimmune disease. Founded in 2006 by Wayne Holman, MD, Ridgeback Capital is a private investment company that is focused on investing in life science companies at all stages from formation through public market. Ridgeback Capital has a long track record of supporting innovation. The focus of the portfolio is to fund paradigm changing people, ideas, technologies, and companies that will have a broad reaching impact toward the betterment of society. The content above comes from the network. if any infringement, please contact us to modify.

Plus, news about Inflammasome Therapeutics, Johnson & Johnson and Verastem: Autoimmune disease startup nabs $30M: Hinge Bio de-stealthed with a Series A on Wednesday, led by hedge fund titan Steve Cohen’s firm Point72. The round will help get Hinge’s lead program, HB2198, into a Phase 1 trial for lupus. HB2198 is designed to target both CD19 and CD20 and “reset” the immune system by depleting B cells. — Max Gelman Keros halts all dosing in Phase 2 trial: The company said it ​​voluntarily stopped giving patients cibotercept (KER-012) to all patients in the trial after seeing additional heart-related side effects. Keros previously halted two of three dosing arms last month in the pulmonary arterial hypertension study. Keros stock $KROS fell 20% premarket. — Max Gelman Eye disease biotech toplines five-patient dataset: Inflammasome said its treatment for geographic atrophy reduced lesion growth by an average of 66% after three months. Patients received an injection into the eye of the program, called a K8 implant. Researchers intend to give patients a second injection after three months and will expand the trial to 30 patients. — Max Gelman Johnson & Johnson files bladder cancer drug device in the US : The pharma is seeking approval of TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The product uses a silicone tube to deliver gemcitabine directly to the bladder. One of its pivotal trials yielded a complete response rate of 83.5%, but the other was stopped early after an interim look showed TAR-200 was no better than chemo. — Elizabeth Cairns Verastem licenses GenFleet’s oral KRAS inhibitor for $5M upfront : VS-7375 is a selective KRAS G12D (ON/OFF) inhibitor in Phase 1 trials in China in advanced KRAS G12D-mutant solid tumors. Verastem will get rights outside China , Hong Kong, Macau and Taiwan, and plans to start a US Phase 1/2a trial in mid-2025. The US biotech will provide $1.5 million of research support over the first three years, and milestone and option payments could total $620 million, according to a filing , with royalties on top. — Elizabeth Cairns

GUANGZHOU, China I January 14, 2025 I Bio-Thera Solutions, Ltd. today announced the publication of the Phase I clinical study results for BAT4406F , an ADCC-enhanced fully humanized anti-CD20 monoclonal antibody in Chinese patients with neuromyelitis optica spectrum disorders (NMOSD) in the journal CNS Neuroscience & Therapeutics. Neuromyelitis optica spectrum disorder (NMOSD) is a rare immune-mediated central nervous system (CNS) inflammatory demyelinating disease with high recurrence and disability, primarily characterized by severe optic neuritis (ON) and longitudinally extensive transverse myelitis (LETM). ON might result in a decrease in visual acuity, visual field defects, and even blindness. Spinal cord inflammation will also cause paralysis and bladder rectal damage. B-cell depletion therapy by monoclonal antibody (mAb) against CD20 can reduce the recurrence of NMOSD and slow the progression of neurological dysfunction and has a significant therapeutic effect. BAT4406F, a Class 1 innovative drugs developed by Bio-Thera, is a glycosylation-optimized fully anti-CD20 human mAb of IgG1 subclass with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) effect. In preclinical studies, BAT4406F has showed stronger B-cell depletion activity than the marketed anti-CD20 monoclonal antibodies including rituximab. In this first-in-human, open-label, dose-escalation Phase I clinical study of BAT4406F injection in Chinese NMOSD patients, the overall objective was to assess the tolerability, safety, pharmacokinetics (PK), pharmacodynamics, and immunogenicity of BAT4406F in NMOSD patients. The efficacy of BAT4406F in NMOSD was also preliminarily explored (ClinicalTrials.gov identifier: NCT04146285 ). Five fixed dose groups ranging from 20 mg to 750 mg were set. Fifteen eligible patients were enrolled in this trial and administered with a single intravenous infusion of BAT4406F followed by a 6-month observation period. No subjects experienced DLT at the studied doses. BAT4406F injection has shown favorable safety, with most of the adverse events (AE) of CTCAE Grade 1 or 2 in severity, and no Grade ≥3 adverse drug reactions (ADR) or serious adverse reactions occurred in any subjects. With the dose increase of BAT4406F, C max , AUC 0-t and AUC 0-inf showed an increasing trend, whereas the CL, l Z , and V d decreased. The mean elimination half-life (T 1/2 ) ranged from 9.0-16.4 days. PK profile of BAT4406F was generally nonlinear. BAT4406F led to a rapid and significant B-cell depletion in all dose groups. Single dose of BAT4406F administration maintains B lymphocyte at a low level, and the duration of B lymphocyte suppression and depletion depends on the dose. During the observation period, 13 (86.7%) subjects remained relapse free and 2 (13.3%) subjects relapsed. On day 180 postdose, 100 mg, 500 mg, and 750 mg groups had decreased expanded disability status scale (EDSS) scores compared to baseline. Three subjects were antidrug antibody (ADA) positive and all were neutralizing antibody (NAb)-negative. No obvious effects of ADA positivity on PK, safety, pharmacodynamics, or efficacy were observed. In this study, BAT4406F was well tolerated and showed an expected pharmacodynamic effect of significant and long-term depletion of CD19 + B lymphocytes. BAT4406F also demonstrated preliminary evidence of activity as a NMOSD maintenance treatment. Based on this Phase I study, a Phase II/III multicenter, randomized, double-blind, placebo-controlled trial of BAT4406F in Chinese NMOSD patients is currently undergoing ( NCT06044350 ). About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI® and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE / BAT1806 and Avzivi® / Pobevcy® in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter ( @bio_thera_sol ) and WeChat (Bio-Thera). 1. QLETLI ® is a registered trademark of Bio-Thera Solutions, Ltd. 2. POBEVCY ® is a registered trademark of Bio-Thera Solutions, Ltd. 3. BETAGRIN ® is a registered trademark of Bio-Thera Solutions, Ltd. 4. Avzivi ® is a registered trademark of Sandoz AG SOURCE: Bio-Thera Solutions