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CytoDyn Initiates Phase II Trial of Leronlimab in Relapsed/Refractory Colorectal Cancer

Monoclonal AntibodyOncology
  • CytoDyn has dosed the first patient in a Phase II clinical trial evaluating leronlimab, a CCR5 antagonist, in patients with relapsed/refractory microsatellite stable colorectal cancer.
  • The study is being conducted across eight clinical sites in partnership with Syneos Health, with Dr. Ben Weinberg from Georgetown University serving as lead principal investigator.
  • The trial builds on prior research showing potential clinical benefit of leronlimab in relapsed colorectal cancer and promising survival rates in metastatic triple-negative breast cancer.
  • Colorectal cancer represents a significant global health burden with approximately 1.9 million new cases and over 900,000 deaths annually worldwide according to WHO data.

Bio-Techne Partners with USP to Enhance Quality Standards for Monoclonal Antibody and Gene Therapy Development

Monoclonal Antibody
  • Bio-Techne Corporation announced a distribution agreement with the U.S. Pharmacopeia (USP) to sell monoclonal antibody and AAV reference standards alongside its analytical solutions globally.
  • The collaboration addresses critical quality challenges in biotherapeutic development, particularly as more than 160 antibody therapies have been approved worldwide and biosimilar competition increases.
  • Gene therapy represents one of the fastest-growing biopharmaceutical sectors, offering cures for previously incurable genetic diseases despite facing development challenges including low yields and analytical complexities.
  • The partnership combines USP's well-characterized reference standards with Bio-Techne's MauriceFlex analytical system to provide integrated characterization solutions for complex biologics from development through product release.

Glenmark Launches Tevimbra, First Immuno-Oncology Drug in India for Lung and Esophageal Cancer Treatment

Monoclonal AntibodyDrug ApprovalOncology
  • Glenmark Pharmaceuticals has launched Tevimbra (tislelizumab), marking the company's first entry into immuno-oncology in India following CDSCO approval.
  • The anti-PD-1 monoclonal antibody is indicated for first-line treatment of locally advanced or metastatic NSCLC in combination with chemotherapy and second-line treatment as monotherapy.
  • Tevimbra is already approved in 46 countries including the US and EU, with over 1.5 million patients treated globally and worldwide sales of $625 million in 2024.
  • The drug targets NSCLC, which represents over 80% of lung cancer cases, and ESCC, the most common esophageal cancer subtype in India.

Lundbeck's Lu AG13909 Receives Orphan Drug Designation for Congenital Adrenal Hyperplasia Treatment

Monoclonal AntibodyRare Disease
  • Lundbeck received orphan drug designation from both the FDA and EMA for Lu AG13909, a novel humanized monoclonal antibody targeting ACTH for congenital adrenal hyperplasia treatment.
  • The first-in-class anti-ACTH antibody represents an innovative therapeutic approach for CAH, a rare genetic disorder affecting approximately 1 in 14,000-18,000 live births worldwide.
  • An expanded Phase I/II clinical trial is currently enrolling adults with classic CAH across North America and seven European countries, with monthly intravenous dosing.
  • Animal studies demonstrated significant and durable reductions in corticosterone/cortisol and aldosterone levels with no adverse effects after six months of treatment.

iBio Advances AI-Driven Obesity Pipeline with Myostatin and Activin E Antibody Therapies

Monoclonal AntibodyPrecision Medicine
  • iBio will present promising preclinical data on its long-acting Myostatin antibody IBIO-600 and Activin E targeting therapies for obesity and cardiometabolic diseases.
  • The company will announce a third target in its AstralBio Collaboration during a June 24 conference call, expanding its precision antibody therapy pipeline.
  • iBio's AI-driven approach combines proprietary 3D modeling with computational biology to develop next-generation antibody medicines with potentially better tolerability and sustainable efficacy.
  • The biotech company is positioning itself to address significant unmet medical needs in obesity treatment through targeted, longer-lasting therapeutic approaches.

Laekna's LAE102 Shows Promising Safety Profile in First-in-Human Obesity Trial at ADA 2025

Monoclonal Antibody
  • Laekna presented positive Phase I results for LAE102, an ActRIIA-selective antibody targeting obesity, demonstrating favorable safety profile and prolonged target engagement in healthy volunteers.
  • The first-in-human study enrolled 64 participants and showed no serious adverse events, with LAE102 maintaining 2-to-3-fold increases in Activin A levels for 28 days post-administration.
  • Preclinical studies revealed LAE102 significantly induced muscle growth and reduced fat mass, with synergistic effects when combined with LAE103, positioning it as a potential next-generation weight-loss therapy.
  • The company has established a comprehensive ActRII receptor portfolio and secured clinical collaboration with Eli Lilly to accelerate global development of LAE102 for obesity treatment.

AltruBio's ALTB-268 Shows Promise in Preclinical Models of Inflammatory Diseases, Supporting Phase 2 UC Trial

Monoclonal Antibody
  • AltruBio presented new preclinical data at FOCIS 2025 demonstrating ALTB-268's efficacy in murine models of colitis and graft-versus-host disease through downregulation of T cell effector functions.
  • The immune checkpoint enhancer significantly improved survival and reduced disease severity in xenogeneic GvHD models while decreasing inflammatory cytokines and T cell infiltration in DSS-induced colitis models.
  • ALTB-268 is currently being evaluated in a Phase 2a biomarker study for biologics-refractory ulcerative colitis patients, with a larger Phase 2b randomized trial planned for 2026.
  • AltruBio secured up to $225 million in Series B financing to advance clinical development of their first-in-class PSGL-1 agonist antibody across multiple inflammatory conditions.

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics

NCT06109441RecruitingPhase 2
AltruBio Inc.
Posted 12/4/2023

A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers

NCT05723692CompletedPhase 1
AltruBio Inc.
Posted 1/17/2023

Immutep's IMP761 Shows 80% T Cell Suppression in Phase I Autoimmune Disease Trial

Monoclonal Antibody
  • Immutep's first-in-class LAG-3 agonist antibody IMP761 demonstrated 80% inhibition of T cell infiltration at 0.9 mg/kg dose with no treatment-related adverse events in healthy participants.
  • The placebo-controlled Phase I study will continue with higher single ascending doses of 2.5, 7, and 14 mg/kg to evaluate the drug's potential for treating autoimmune diseases.
  • IMP761 targets the LAG-3 immune checkpoint to silence dysregulated memory T cells, offering a potentially more targeted approach for rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis.
  • Additional Phase I data are expected in the second half of 2025 from the trial being conducted at the Centre for Human Drug Research in the Netherlands.

A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers

NCT06637865RecruitingPhase 1
Immutep S.A.S.
Posted 7/17/2024

Lundbeck's Eptinezumab Shows Strong Efficacy in Asian Chronic Migraine Patients in Phase III SUNRISE Trial

Monoclonal Antibody
  • H. Lundbeck A/S announced positive results from the SUNRISE phase III trial, demonstrating eptinezumab's efficacy in a predominantly Asian population with chronic migraine.
  • Patients receiving eptinezumab experienced significant reductions in monthly migraine days, with 300mg and 100mg doses showing -7.5 and -7.2 day reductions respectively versus -4.8 with placebo.
  • The trial met all primary and secondary endpoints, with patients four times more likely to achieve ≥75% reduction in migraine days within the first four weeks compared to placebo.
  • Based on these results, Lundbeck has initiated regulatory discussions to make eptinezumab available across Asia, addressing significant unmet medical needs in the region.

Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

NCT05064371CompletedPhase 3
H. Lundbeck A/S
Posted 9/21/2021

A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments

NCT04418765CompletedPhase 3
H. Lundbeck A/S
Posted 6/1/2020

Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

NCT04921384CompletedPhase 3
H. Lundbeck A/S
Posted 5/29/2021

A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

NCT05452239CompletedPhase 4
H. Lundbeck A/S
Posted 7/1/2022

Bio-Thera Solutions Receives Positive CHMP Opinion for Ustekinumab Biosimilar USYMRO

Monoclonal Antibody
  • The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for USYMRO (ustekinumab), Bio-Thera Solutions' biosimilar referencing Stelara.
  • The positive recommendation was based on comprehensive analytical, non-clinical and clinical data demonstrating biosimilarity through Phase 1 and Phase 3 studies in healthy volunteers and severe plaque psoriasis patients.
  • Bio-Thera partnered with Gedeon Richter in October 2024 for commercialization rights in the EU, UK and Switzerland following potential European Commission approval.
  • USYMRO targets IL-12 and IL-23 pathways involved in chronic inflammatory conditions including psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
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