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BioInvent Advances BI-1910 Anti-TNFR2 Antibody with Population Modeling Data at PAGE 2025

Monoclonal Antibody
  • BioInvent successfully developed a population model to characterize BI-1910 pharmacokinetics and pharmacodynamics across a broad dose range, supporting optimal dose selection for upcoming Phase 2a studies.
  • The anti-TNFR2 agonist antibody demonstrated stable disease in six out of 12 evaluable patients during Phase 1 dose escalation, with favorable pharmacokinetics and robust target engagement inducing T cell proliferation.
  • Phase 2a studies of BI-1910 as both single agent and in combination with pembrolizumab are planned to initiate in the second half of 2025, targeting hepatocellular cancer and other solid tumors.

Leyden Labs Secures €20 Million EIB Funding to Advance Pan-Influenza Nasal Spray Development

Monoclonal Antibody
  • Dutch biotechnology company Leyden Labs has secured €20 million in venture debt financing from the European Investment Bank to advance development of its pan-influenza nasal spray PanFlu, which aims to provide first-in-class influenza protection including against Avian Flu H5.
  • The funding is part of HERA Invest, a €110 million European Union initiative focused on pandemic preparedness, biodefense, and antimicrobial resistance, highlighting Europe's commitment to strengthening respiratory virus protection capabilities.
  • Leyden Labs' novel approach delivers broadly protective antibodies directly to respiratory mucosa through nasal sprays, designed to work before viruses reach systemic circulation and maintain efficacy even when viruses mutate.
  • The company's Mucosal Protection Platform represents a potential paradigm shift in viral prophylaxis, offering protection for immunocompromised patients who may not respond adequately to traditional vaccines.

Jasper Therapeutics to Present Briquilimab Clinical Data at EAACI Congress 2025

Monoclonal Antibody
  • Jasper Therapeutics will present four abstracts on briquilimab at the EAACI Congress 2025 in Glasgow, featuring initial clinical data from the SPOTLIGHT Phase 1b/2a study.
  • The company will showcase results from the 180mg cohort evaluating briquilimab in cold urticaria and symptomatic dermographism patients who remain symptomatic despite antihistamine treatment.
  • Briquilimab is a novel anti-c-Kit monoclonal antibody that depletes mast cells through apoptosis, targeting the underlying inflammatory source in chronic urticaria and asthma.
  • The presentations will include both clinical trial data and preclinical studies demonstrating briquilimab's efficacy in mast cell-driven diseases including chronic spontaneous urticaria.

Zydus Lifesciences Secures Exclusive Rights to Agenus' BOT/BAL Cancer Immunotherapy for India and Sri Lanka

Monoclonal AntibodyOncology
  • Zydus Lifesciences has signed an exclusive licensing agreement with US-based Agenus Inc to commercialize the investigational cancer therapy combination of Botensilimab (BOT) and Balstilimab (BAL) in India and Sri Lanka.
  • The BOT/BAL combination therapy is currently in advanced clinical trials and has demonstrated significant clinical activity across nine cancer types in over 1,200 patients, including late-stage and neoadjuvant settings.
  • Under the agreement, Zydus will pay Agenus a 5% royalty on net sales following regulatory approval and will take responsibility for clinical development and regulatory approvals in the specified territories.
  • Zynext Ventures, the venture capital arm of Zydus, has also made a strategic investment in Agenus to accelerate development of the BOT/BAL programme and expand into high-unmet need indications.

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer

NCT06251973RecruitingPhase 2
Memorial Sloan Kettering Cancer Center
Posted 2/1/2024

Sanofi's Sarclisa Shows Non-Inferior Efficacy with Novel On-Body Injector in Phase 3 Multiple Myeloma Trial

Monoclonal Antibody
  • The IRAKLIA phase 3 study demonstrated that Sarclisa administered subcutaneously via an on-body injector achieved non-inferior efficacy compared to intravenous infusion, with objective response rates of 71.1% versus 70.5% respectively.
  • Patients receiving subcutaneous Sarclisa experienced significantly fewer systemic infusion reactions (1.5% versus 25%) and reported higher satisfaction rates (70% versus 53.4%) compared to intravenous administration.
  • The innovative delivery system using Enable Injections' enFuse device successfully delivered 99.9% of injections with no significant safety concerns, potentially transforming multiple myeloma treatment administration.
  • Data from both IRAKLIA and IZALCO studies will form the basis for global regulatory submissions across all currently approved treatment lines for multiple myeloma.

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

NCT05405166Active, Not RecruitingPhase 3
Sanofi
Posted 6/23/2022

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

NCT06356571RecruitingPhase 2
Sanofi
Posted 3/17/2025

Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

NCT04045795CompletedPhase 1
Sanofi
Posted 8/6/2019

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

NCT03652064Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/6/2018

Lenalidomide, Bortezomib and Dexamethasone Induction Therapy with Either Intravenous or Subcutaneous Isatuximab in Patients with Newly Diagnosed Multiple Myeloma

NCT05804032Active, Not RecruitingPhase 3
University of Heidelberg Medical Center
Posted 4/14/2023

A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

NCT03319667Active, Not RecruitingPhase 3
Sanofi
Posted 12/7/2017

A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

NCT05704049RecruitingPhase 2
Sanofi
Posted 4/5/2023

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

NCT03710603Active, Not RecruitingPhase 3
Stichting European Myeloma Network
Posted 12/14/2018

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

NCT02252172CompletedPhase 3
Janssen Research & Development, LLC
Posted 2/16/2015

Jade Biosciences to Present Preclinical Data on JADE101 Anti-APRIL Antibody for IgA Nephropathy at European Renal Congress

Monoclonal Antibody
  • Jade Biosciences will present new preclinical data on JADE101, an ultra-high affinity anti-APRIL monoclonal antibody, at the 62nd European Renal Association Congress in Vienna from June 4-7, 2025.
  • JADE101 is being developed for IgA nephropathy treatment and features half-life extension technology designed for dosing intervals of at least eight weeks.
  • The company expects to initiate a first-in-human clinical trial for JADE101 in the second half of 2025, targeting a chronic autoimmune kidney disease that can lead to end-stage kidney disease.

Terbium-161 Radioimmunotherapy Shows Superior Efficacy Against Lymphoma in Preclinical Studies

Targeted TherapyMonoclonal AntibodyOncology
  • Researchers at the Paul Scherrer Institute have developed a novel radioimmunotherapy using terbium-161 attached to CD30-targeting antibodies for lymphoma treatment.
  • The terbium-161 therapy demonstrated 2 to 43 times greater cancer cell killing efficacy compared to lutetium-177 in laboratory studies.
  • Preclinical mouse studies showed treated animals survived twice as long as controls, with some achieving complete cancer remission.
  • The therapy targets CD30 receptors present in approximately one-third of lymphoma patients and could address previously difficult-to-treat T-cell lymphomas.

Trastuzumab Deruxtecan Combination Reduces Disease Progression Risk by 44% in HER2-Positive Metastatic Breast Cancer

Monoclonal Antibody
  • A new treatment combining trastuzumab deruxtecan (T-DXd) with pertuzumab reduced the risk of disease progression or death by 44% compared to standard care in HER2-positive metastatic breast cancer patients.
  • The combination therapy achieved a median progression-free survival of 40.7 months versus 26.9 months with standard THP treatment, representing the first major advance in over a decade for this cancer type.
  • Complete cancer remission was observed in 15% of patients receiving the new combination compared to 8.5% with standard therapy, with results expected to be submitted to global regulators for approval.
  • The study involved nearly 400 patients and represents a potential new first-line standard treatment for HER2-positive metastatic breast cancer, which comprises 15-20% of all breast cancer cases.

ImmuneOncia's CD47 Antibody IMC-002 Shows 30% Response Rate in Advanced Hepatocellular Carcinoma Trial

Monoclonal Antibody
  • ImmuneOncia's next-generation CD47-targeting antibody IMC-002 demonstrated a 30% partial response rate when combined with lenvatinib in advanced hepatocellular carcinoma patients, significantly higher than the typical 10% seen with current second-line therapies.
  • The Phase 1b trial showed a favorable safety profile with 96% of adverse events being Grade 1-2, no neutropenia or thrombocytopenia, and median progression-free survival of 8.3 months.
  • AI-powered digital pathology analysis revealed a 60% objective response rate in patients with high CD47 expression versus no response in low-expression patients (p=0.018), supporting CD47 as a predictive biomarker.
  • Two patients have remained on treatment for over one year, with two of three partial responders being resistant to first-line immunotherapy, suggesting potential for sustained benefit in treatment-resistant cases.

Henlius Presents Comprehensive Serplulimab Data at ASCO 2025, Demonstrating Broad Efficacy Across Multiple Cancer Types

Monoclonal Antibody
  • Shanghai Henlius Biotech presented results from over ten studies of serplulimab (HANSIZHUANG) at the 2025 ASCO Annual Meeting, covering lung and gastrointestinal cancers with promising efficacy data.
  • The phase 3 ASTRUM-005 trial showed serplulimab plus chemotherapy achieved a median overall survival of 15.8 months versus 11.1 months for placebo in extensive-stage small cell lung cancer patients.
  • Multiple combination studies demonstrated high objective response rates, including 92% ORR in HER2-positive gastric cancer and 74.47% ORR in metastatic pancreatic cancer when combined with targeted therapies.
  • Real-world studies across various cancer types confirmed the safety profile and clinical effectiveness of serplulimab-based treatments in diverse patient populations.

Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

NCT06461910RecruitingPhase 2
Zekuan Xu
Posted 6/14/2024

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