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Genmab and BioNTech Advance Two Phase 1/2 Cancer Trials Testing Novel Antibody Therapies

Monoclonal Antibody
  • Genmab and BioNTech are conducting two separate clinical trials evaluating novel antibody therapies for solid tumors, including GEN1055 monotherapy and combination treatments.
  • The first trial tests GEN1055 alone and with pembrolizumab for malignant solid tumors, while the second evaluates GEN1042 combined with radiotherapy for metastatic cancers.
  • Both studies follow dose escalation and expansion phases to determine optimal dosing and assess safety and preliminary efficacy in cancer patients.
  • The trials represent significant advances in exploring new therapeutic combinations that could potentially improve outcomes for patients with advanced solid tumors.

Novartis Secures Canadian Public Reimbursement for Cosentyx in Hidradenitis Suppurativa

Monoclonal Antibody
  • Novartis successfully concluded negotiations with the pan-Canadian Pharmaceutical Alliance for public reimbursement of Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa.
  • Quebec becomes the first Canadian province to provide public reimbursement for Cosentyx in hidradenitis suppurativa, marking an important milestone for patient access.
  • The agreement addresses a significant unmet medical need for patients with this chronic, painful inflammatory skin condition who have historically had limited treatment options.
  • Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A and has been studied clinically for more than 14 years.

Sernova and Eledon Partner to Advance Type 1 Diabetes Bio-hybrid Organ Therapy with Novel Immunosuppression

Monoclonal Antibody
  • Sernova Biotherapeutics and Eledon Pharmaceuticals announced a collaboration to evaluate tegoprubart, an anti-CD40L antibody, in Sernova's Phase 1/2 Cell Pouch Bio-hybrid Organ clinical trial for type 1 diabetes.
  • Tegoprubart will replace tacrolimus in Cohort C of the trial, potentially offering superior islet cell protection with reduced toxicity compared to standard immunosuppression.
  • Previous study results showed three patients achieved insulin independence with tegoprubart, demonstrating islet engraftment three to five times higher than tacrolimus-based treatments.
  • The partnership combines Sernova's retrievable Cell Pouch technology with Evotec's stem cell-derived islet clusters and Eledon's novel immunosuppressive approach to advance a potential functional cure for type 1 diabetes.

Ultragenyx and Mereo BioPharma Advance Setrusumab Phase 3 Studies for Osteogenesis Imperfecta Toward Year-End Analysis

Monoclonal AntibodyRare Disease
  • Ultragenyx and Mereo BioPharma announced that the Phase 3 Orbit study evaluating setrusumab (UX143) in pediatric and young adult patients with osteogenesis imperfecta is progressing toward final analysis around the end of 2025.
  • The Data Monitoring Committee confirmed setrusumab demonstrates an acceptable safety profile and recommended continuing the study to final analysis after at least 18 months of therapy.
  • The companies are developing setrusumab, a fully human monoclonal antibody targeting sclerostin, for a rare genetic bone disorder affecting approximately 60,000 people globally with no approved treatments.
  • Final analyses for both the Orbit study (p<0.04 threshold) and Cosmic study (p<0.05 threshold) are expected around the end of the year.

LEO Pharma's Tralokinumab Meets All Endpoints in Phase 3b Hand Atopic Dermatitis Trial

Monoclonal Antibody
  • LEO Pharma announced positive 16-week interim results from the phase 3b ADHAND trial, with tralokinumab meeting all primary and secondary endpoints for moderate to severe atopic dermatitis on the hands.
  • The IL-13 targeting monoclonal antibody showed statistically significant improvements in skin clearance, itch and pain reduction, and severity scores compared to placebo.
  • More than 50% of patients with moderate-to-severe atopic dermatitis have hand involvement, representing a significant unmet medical need in this difficult-to-treat area.
  • The treatment was generally well-tolerated with no new safety signals identified, with most adverse events being non-serious and mild to moderate in severity.

A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

NCT05958407CompletedPhase 3
LEO Pharma
Posted 8/28/2023

AstraZeneca Launches PRIMULA Preg Study to Evaluate Anifrolumab Safety During Pregnancy in SLE Patients

Monoclonal Antibody
  • AstraZeneca has initiated the PRIMULA Preg study, a prospective observational cohort study to assess anifrolumab safety during pregnancy in patients with systemic lupus erythematosus.
  • The study fulfills an FDA post-marketing requirement and compares outcomes between pregnant SLE patients exposed to anifrolumab versus those who are not exposed.
  • Anifrolumab is a human monoclonal antibody targeting the type 1 interferon receptor, approved by FDA and EMA for treating moderate to severe SLE in adults.
  • The study began on August 29, 2025, and aims to provide crucial safety data that could potentially expand anifrolumab's market use during pregnancy.

Simcere Submits New Drug Application for Rademikibart in China's 70 Million Patient Atopic Dermatitis Market

Monoclonal Antibody
  • Simcere Pharmaceutical has submitted a New Drug Application to China's NMPA for rademikibart, targeting atopic dermatitis treatment in adults and adolescents.
  • The IL-4Rα-targeting monoclonal antibody addresses China's substantial atopic dermatitis market, estimated at 70 million patients.
  • Connect Biopharma stands to receive up to $110 million in milestone payments and tiered royalties from the exclusive licensing agreement established in 2023.

Jasper Therapeutics' Briquilimab Shows 89% Complete Response Rate in CSU Despite Manufacturing Setbacks

Monoclonal Antibody
  • Briquilimab demonstrated remarkable efficacy in chronic spontaneous urticaria (CSU) with 89% of patients achieving complete response by week 2 in valid cohorts of the BEACON Phase 1b/2a trial.
  • Manufacturing defects in drug lot A349954 affected 10 of 13 patients in high-dose cohorts, resulting in minimal therapeutic response and delaying Phase 2b trials until mid-2026.
  • The anti-KIT monoclonal antibody offers potential advantages over current treatments with quarterly dosing versus Xolair's weekly or biweekly injections, targeting a $500M+ annual revenue opportunity in CSU.
  • Jasper has pivoted to focus solely on CSU development while halting asthma and SCID programs to preserve cash runway amid manufacturing challenges.

AbCellera Advances Two First-in-Class Antibody Therapies to Phase 1 Trials Following Strategic Pivot

Monoclonal Antibody
  • AbCellera Biologics has received Health Canada authorization to begin Phase 1 trials for ABCL635, a first-in-class NK3R antagonist targeting menopause-related hot flashes, and ABCL575, an OX40L-targeting antibody for atopic dermatitis, both scheduled to start in Q3 2025.
  • The company's strategic shift from partnership-driven revenue to internal drug development resulted in Q1 2025 revenue declining to $4.2 million from $10 million year-over-year, while maintaining $811 million in total liquidity to fund operations through 2026.
  • ABCL635 targets a $2 billion menopause market with its monthly subcutaneous dosing profile, potentially offering advantages over existing daily oral therapies like Fezolinetant and Elinzanetant.
  • The company is completing an in-house GMP manufacturing facility by year-end 2025 to reduce third-party reliance and lower long-term production costs.

FDA Approves First Xolair Biosimilar Omlyclo for Allergic Diseases, Marking Milestone in Allergy Treatment Access

Monoclonal AntibodyDrug Approval
  • The FDA has approved Omlyclo (omalizumab-igec) as the first biosimilar interchangeable with Xolair for treating allergic asthma, chronic rhinosinusitis with nasal polyps, chronic urticaria, and food allergies.
  • Omlyclo demonstrated comparable efficacy and safety to Xolair in a Phase 3 clinical trial involving 619 adults with chronic spontaneous urticaria, with similar itch severity improvements and adverse event rates.
  • The biosimilar will not be available until September 2026 due to Xolair's patent exclusivity, but is expected to cost 15-35% less than the reference drug.
  • Pharmacists can substitute Omlyclo for Xolair without physician consultation due to its interchangeable designation, potentially broadening access to this important allergy medication.

To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

NCT04426890CompletedPhase 3
Celltrion
Posted 12/9/2020

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