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Climb Bio's CLYM116 Shows Superior Performance in IgA Nephropathy Preclinical Study

Monoclonal Antibody
  • Climb Bio's CLYM116 demonstrated deeper IgA reduction and 2-3 times longer half-life compared to first-generation anti-APRIL antibody sibeprenlimab in nonhuman primate studies.
  • The novel "sweeper" monoclonal antibody achieved >70% maximal IgA reduction with high subcutaneous bioavailability (~85%) and favorable tolerability profile.
  • Phase 1 trial initiation is expected in Q4 2025, targeting the estimated $10-20 billion IgA nephropathy market in the US alone.

RAPT Therapeutics Receives FDA Clearance to Advance RPT904 Phase 2b Trial for Food Allergy Treatment

Monoclonal Antibody
  • RAPT Therapeutics received FDA clearance for its IND application to initiate a Phase 2b clinical trial of RPT904, a next-generation anti-IgE monoclonal antibody for food allergy treatment.
  • The prestIgE trial will evaluate RPT904's safety and efficacy in approximately 100 participants with food allergies to peanut, milk, egg, walnut, or cashew over 24-48 weeks.
  • RPT904 is designed as a half-life extended bio-better version of omalizumab, targeting the same epitope but with improved pharmacokinetic properties.
  • The company plans to initiate the Phase 2b trial by the end of 2025, advancing toward a potential best-in-class therapeutic option for the underserved food allergy community.

Amneal Submits BLA for Omalizumab Biosimilar to Challenge $4.1 Billion XOLAIR Market

Monoclonal Antibody
  • Amneal Pharmaceuticals has submitted a Biologics License Application to the FDA for a biosimilar to XOLAIR (omalizumab), developed in partnership with Kashiv BioSciences.
  • The submission positions Amneal for potential first-wave entry into the $4.1 billion annual U.S. omalizumab market, representing a significant growth catalyst for the company.
  • Omalizumab is a humanized monoclonal antibody targeting free IgE, indicated for multiple conditions including asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria.
  • Amneal expects five biosimilar launches from 2026 to 2027, positioning biosimilars as a key growth driver alongside their three currently marketed biosimilar products.

ME Therapeutics Secures U.S. Patent for G-CSF Antibody Cancer Therapy and Advances Multi-Platform Pipeline

Monoclonal AntibodyCAR-T
  • ME Therapeutics received U.S. Patent No. 12,421,308 for its lead G-CSF antibody candidate H1B11-12, which targets immune suppression in the tumor microenvironment.
  • The company is advancing cell line development to meet GMP standards in preparation for clinical trials while expanding its research team with two new associate research scientists.
  • Preclinical testing shows promising results for the company's therapeutic mRNA program, with the lead candidate demonstrating immune cell recruitment into tumors.
  • The company's in vivo CAR program has confirmed in vitro activity of tumor-targeted CARs, representing a next-generation approach to reprogram cells within the tumor microenvironment.

Tiziana Life Sciences Advances IL-6 Receptor Antibody TZLS-501 Following Novartis' $1.4B Tourmaline Acquisition

Monoclonal Antibody
  • Tiziana Life Sciences announces advancement of TZLS-501, a fully human anti-IL-6 receptor monoclonal antibody targeting both membrane-bound and soluble forms of IL-6R with dual mechanism of action.
  • The company's decision follows Novartis' recent $1.4 billion acquisition of Tourmaline Bio, validating increased industry interest in IL-6 pathway therapeutics for inflammatory diseases.
  • TZLS-501 shows potential for treating multiple conditions including rheumatoid arthritis, acute respiratory distress syndrome, idiopathic pulmonary fibrosis, and various cancers by reducing both receptor signaling and circulating cytokine burden.
  • Tiziana plans to pursue non-dilutive funding strategies for TZLS-501 development while maintaining focus on its lead program, intranasal foralumab for multiple sclerosis.

Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients

NCT06802328available
Tiziana Life Sciences LTD

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

NCT06292923RecruitingPhase 2
Tiziana Life Sciences LTD
Posted 11/15/2023

Leap Therapeutics to Present Final DeFianCe Phase 2 Results for Sirexatamab in Advanced Colorectal Cancer at ESMO 2025

Monoclonal Antibody
  • Leap Therapeutics will present final clinical results from the DeFianCe Phase 2 study evaluating sirexatamab (DKN-01) plus bevacizumab and chemotherapy versus standard care in advanced microsatellite stable colorectal cancer.
  • The randomized trial tested sirexatamab, an anti-DKK1 monoclonal antibody, as second-line therapy in patients who received one prior systemic treatment for advanced disease.
  • Results will be presented at the European Society for Medical Oncology Congress 2025 in Berlin on October 19, highlighting potential advances in colorectal cancer treatment.

Phase 2 Study of DKN-01 in Colorectal Cancer

NCT05480306CompletedPhase 2
Leap Therapeutics, Inc.
Posted 8/30/2022

Ipca Laboratories Partners with BioSimilar Sciences for US Manufacturing of Cancer and Autoimmune Biosimilars

Monoclonal AntibodyOncology
  • Ipca Laboratories and BioSimilar Sciences PR LLC announced a definitive technology transfer and joint development agreement for next-generation monoclonal antibody biosimilars targeting cancer and autoimmune diseases.
  • The partnership will transfer late-stage development, clinical manufacturing, and commercial supply to BSS's 200,000-square-foot sterile facility in Puerto Rico, with the first biosimilar launch planned for 2027.
  • BSS will hold exclusive rights for the US and Canada markets, while Ipca will receive milestone fees and royalties on net sales once commercialized.
  • The collaboration leverages OcyonBio's sterile filling capacity of 60 million units annually and is expected to create hundreds of high-paying biotech jobs in Puerto Rico.

Ocrelizumab Demonstrates Superior Multiple Sclerosis Relapse Control in Large Real-World Registry Analysis

Monoclonal AntibodyReal World Evidence
  • Ocrelizumab showed significantly lower MS relapse rates compared to fingolimod (0.06 vs 0.14; p<0.001), natalizumab (0.07 vs 0.10; p<0.001), and alemtuzumab (0.12 vs 0.18; p<0.001) in a multi-registry analysis.
  • The study analyzed real-world data from over 16,000 patients across three major MS registries, with fingolimod patients showing more than twice the risk of relapse compared to ocrelizumab (HR 2.26, 95% CI 1.98–2.58).
  • Despite superior relapse control, ocrelizumab showed no differences in progression independent of relapse activity compared to other high-efficacy therapies, suggesting a ceiling effect for disability benefits through relapse suppression alone.

A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

NCT05314010Active, Not RecruitingPhase 3
Beijing Mabworks Biotech Co., Ltd.
Posted 8/18/2022

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)

NCT05123703Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/19/2022

A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

NCT03523858Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/28/2018

A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

NCT04075266Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 1/9/2020

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

NCT04035005Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 8/12/2019

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

NCT04548999Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/3/2020

A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

NCT01194570CompletedPhase 3
Hoffmann-La Roche
Posted 3/2/2011

Prellis Biologics Partners with Eli Lilly to Accelerate Antibody Discovery Using Novel Biological AI Platform

AIMonoclonal AntibodyDrug Discovery
  • Prellis Biologics announced a multi-target drug discovery collaboration with Eli Lilly combining Prellis' EXIS™ organoid platform with Lilly's development expertise.
  • The partnership leverages Prellis' proprietary lymph node organoid technology that generates diverse, high-affinity antibodies in 3-4 weeks using fully human artificial immune systems.
  • Prellis' biological AI platform represents the first system to design drugs by combining living human lymph node organoids with generative AI refinements.
  • The collaboration aims to accelerate discovery of fully human antibodies for multiple disease targets including GPCRs with enhanced therapeutic efficacy and manufacturability.

Triveni Bio Initiates Phase 2 Trial of Novel Anti-KLK5/7 Antibody TRIV-509 for Atopic Dermatitis

Monoclonal Antibody
  • Triveni Bio has dosed the first patient in a global Phase 2 proof-of-concept study of TRIV-509, a dual-specific monoclonal antibody targeting kallikreins 5 and 7 for moderate-to-severe atopic dermatitis treatment.
  • The company presented translational data at the 2025 EADV Congress showing TRIV-509 rapidly improved multiple disease markers in AD patient skin explants, including barrier function and inflammatory cytokine reduction.
  • TRIV-509 demonstrated superior efficacy compared to IL-4R inhibition in preclinical models and is positioned for convenient quarterly subcutaneous dosing to address treatment gaps for up to two-thirds of AD patients.
  • Triveni is also advancing TRIV-573, a next-generation bispecific antibody combining KLK5/7 and IL-13 inhibition, expected to enter clinical trials in the second quarter of 2026.

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