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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.

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

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 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

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

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

NCT04045795CompletedPhase 1
Sanofi
Posted 8/6/2019

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

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

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

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

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

SWOG S2302 Pragmatica-Lung Trial Fails to Show Survival Benefit but Sets New Standard for Streamlined Cancer Research

Monoclonal Antibody
  • The SWOG S2302 Pragmatica-Lung trial found that ramucirumab plus pembrolizumab combination did not significantly extend overall survival compared to standard care in advanced non-small cell lung cancer patients.
  • The phase 3 study achieved rapid enrollment of 838 patients with exceptional diversity, including 22% non-White individuals and 15% from rural areas, demonstrating the effectiveness of pragmatic trial design.
  • Despite negative efficacy results, the trial established a paradigm-shifting model for future cancer research by completing development in 200 days and enrollment in 21 months.
  • The investigational combination may serve as a viable non-chemotherapy alternative with comparable efficacy but potentially different toxicity profile for some patients.

Outlook Therapeutics Launches First Approved Ophthalmic Bevacizumab in Europe for Wet AMD Treatment

Monoclonal AntibodyDrug Approval
  • Outlook Therapeutics has commercially launched LYTENAVA™ (bevacizumab gamma) in Germany and the UK, marking the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment in Europe.
  • The launch addresses a significant market need, with approximately 2.8 million injections of repackaged off-label bevacizumab administered annually in Europe for retinal diseases.
  • LYTENAVA™ has potential to mitigate certain risks associated with current off-label use of repackaged bevacizumab, while the company plans additional European launches throughout 2025 and 2026.
  • The company has partnered with Cencora to support global commercial distribution and market access, with a BLA resubmitted to the FDA for potential U.S. approval.

ImmunAbs Receives FDA Clearance for Phase 2 Trial of IM-101 Complement Inhibitor in Myasthenia Gravis

Monoclonal AntibodyFDA ApprovalRare Disease
  • ImmunAbs Inc. announced FDA clearance of its IND application to initiate a Phase 2 clinical trial evaluating IM-101, a novel complement C5 inhibitor, for treating Myasthenia Gravis.
  • The multicenter, randomized, double-blind, placebo-controlled study will enroll up to 90 patients to assess monthly IM-101 dosing effectiveness and safety.
  • IM-101 demonstrated excellent safety profile in Phase 1 trials with no dose-limiting toxicity and superior efficacy in complement inhibition compared to existing treatments.
  • The company believes comprehensive inhibition of both classical and alternative complement pathways is essential for achieving deeper therapeutic responses in MG patients.

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