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CHO Plus Secures $10.4M BARDA Contract to Develop Cell Lines for Filovirus Monoclonal Antibody Production

Monoclonal Antibody
  • CHO Plus received a $10.4 million project agreement from BARDA's BioMaP Consortium to develop high productivity Chinese hamster ovary cell lines for manufacturing filovirus monoclonal antibodies over 30 months.
  • The company will partner with Avid Bioservices to scale up monoclonal antibody production for eventual industrial scale requirements to support biodefense initiatives.
  • The project focuses on producing therapeutic monoclonal antibodies against highly contagious and lethal filoviruses as part of BARDA's strategic biodefense preparedness efforts.

Kashiv BioSciences Partners with MS Pharma for MENA Launch of Omalizumab Biosimilar ADL-018

Monoclonal Antibody
  • Kashiv BioSciences and MS Pharma have entered into an exclusive licensing and supply agreement for ADL-018, a biosimilar candidate to Xolair (omalizumab), targeting the MENA region market worth approximately $60 million in 2024.
  • ADL-018 is designed to treat multiple conditions including chronic spontaneous urticaria, severe allergic asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergies.
  • MS Pharma will handle licensing, distribution, and commercialization across MENA countries, with regulatory submissions planned for Q4 2025 and potential local manufacturing at their Saudi Arabia biologics facility.

CivicaScript Announces Low-Cost Ustekinumab Biosimilar Distribution to Expand Access to Inflammatory Disease Treatment

Monoclonal Antibody
  • CivicaScript will distribute ustekinumab-aauz biosimilar starting January 1, 2026, targeting chronic inflammatory conditions including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
  • The nonprofit company will offer transparent pricing with 12-week supplies priced at $985 for 90mg and $575 for 45mg, significantly lower than typical biosimilar costs.
  • The biosimilar is produced by Fresenius Kabi and is interchangeable with reference product Stelara, representing CivicaScript's first biosimilar addition to its specialty generic portfolio.
  • This launch marks a strategic expansion for CivicaScript, which has already launched four specialty generic products in 2025 and plans to add more biosimilars over the coming years.

Vitiligo Treatment Pipeline Shows Promise with JAK Inhibitors and Novel Immunotherapies in Phase 3 Trials

Monoclonal AntibodyTargeted Therapy
  • Over 18 companies are actively developing 20+ pipeline therapies for vitiligo treatment, with JAK inhibitors leading the charge in late-stage clinical trials.
  • AbbVie's Upadacitinib and Pfizer's Ritlecitinib have both advanced to Phase 3 trials, demonstrating promising repigmentation results in vitiligo patients.
  • Novel approaches include Clinuvel's Afamelanotide in Phase 3 trials and Amgen's AMG 714 anti-IL-15 monoclonal antibody in Phase 2 development.
  • The pipeline reflects a paradigm shift towards targeted therapies and personalized medicine approaches, offering new hope for patients with this challenging autoimmune condition.

SynOx Therapeutics Completes Enrollment in Phase 3 Trial of Emactuzumab for Rare Joint Tumor

Monoclonal AntibodyRare DiseaseOrphan Drug
  • SynOx Therapeutics has completed patient enrollment in its registrational Phase 3 TANGENT trial evaluating emactuzumab for tenosynovial giant cell tumors (TGCT), with top-line results expected in Q1 2026.
  • The study enrolled patients significantly ahead of projected timelines across multiple global sites, reflecting strong interest in this potentially best-in-class CSF-1 receptor inhibiting monoclonal antibody.
  • Emactuzumab has demonstrated substantial efficacy in earlier clinical studies with an objective response rate of approximately 71% and has received Fast Track Designation from the FDA.
  • TGCT is a rare, debilitating joint tumor that affects over 50% of patients with tumor recurrence within three years after surgery, representing a significant unmet medical need.

A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects with Tenosynovial Giant Cell Tumour

2023-510422-32-00Active, Not RecruitingPhase 3
Synox Therapeutics Limited
Posted 4/30/2024

A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Participants With Advanced Solid Tumors

NCT01494688CompletedPhase 1
Hoffmann-La Roche
Posted 12/20/2011

Shattuck Labs Secures $103 Million to Advance First-in-Class DR3 Antibody SL-325 Through Phase 2 Trials

Monoclonal Antibody
  • Shattuck Labs raised up to $103 million in an oversubscribed private placement led by OrbiMed to fund development of SL-325, a potential first-in-class DR3 blocking antibody for autoimmune diseases.
  • The funding will support multiple Phase 2 clinical trials of SL-325 in inflammatory bowel disease and other autoimmune conditions, with Phase 1 enrollment expected to begin in Q3 2025.
  • SL-325 targets the Death Receptor 3 (DR3) pathway and preclinical studies demonstrate superior activity over TL1A antibodies, potentially offering improved efficacy and reduced immunogenicity.
  • Combined with existing cash, the financing is expected to fund operations through 2029 and advance the company's lead program targeting TNF superfamily receptors.

SERB Pharmaceuticals to Acquire Y-mAbs Therapeutics for $412 Million, Expanding Rare Oncology Portfolio

Monoclonal AntibodyRare DiseaseDrug Approval
  • SERB Pharmaceuticals announced an all-cash acquisition of Y-mAbs Therapeutics for $8.60 per share, representing a 105% premium and $412 million equity value.
  • The acquisition includes DANYELZA (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in pediatric and adult patients.
  • DANYELZA expands SERB's rare oncology portfolio and provides outpatient treatment options for neuroblastoma patients who have shown partial response, minor response, or stable disease to prior therapy.
  • The transaction is expected to close by Q4 2025, with SERB leveraging its global footprint to expand DANYELZA's reach to new markets.

Polpharma Biologics and Fresenius Kabi Partner on Vedolizumab Biosimilar for Inflammatory Bowel Disease

Monoclonal Antibody
  • Polpharma Biologics has signed a global licensing agreement with Fresenius Kabi for PB016, a proposed biosimilar to Entyvio (vedolizumab) targeting moderate-to-severe ulcerative colitis and Crohn's disease.
  • Under the partnership, Polpharma Biologics will handle development and manufacturing while Fresenius Kabi manages global commercialization, excluding Middle East and North Africa markets.
  • The collaboration aims to expand access to affordable biologic therapies for chronic inflammatory conditions, building on Polpharma's growing biosimilar portfolio that includes ranibizumab and natalizumab.
  • The strategic partnership leverages Fresenius Kabi's extensive global reach and commercialization expertise to support broad distribution of PB016 upon regulatory approval.

Sarilumab Demonstrates Significant Quality of Life Improvements in Polymyalgia Rheumatica Phase 3 Trial

Monoclonal AntibodyDrug Approval
  • A phase 3 randomized controlled trial of 118 patients showed sarilumab 200 mg every two weeks with 14-week glucocorticoid taper significantly improved quality of life measures compared to placebo with 52-week taper in relapsing polymyalgia rheumatica.
  • Patients receiving sarilumab demonstrated clinically meaningful improvements in SF-36 Physical Component Summary scores (7.65 vs 2.87, p=0.020) and Mental Component Summary scores (3.04 vs -1.71, p=0.030) at week 52.
  • More than half of sarilumab-treated patients reached normative values in several SF-36 domains, an outcome not observed in the placebo group, supporting its use when glucocorticoid monotherapy proves inadequate.

Syndax Reports Strong Q2 2025 Results with Revuforj Revenue Growth and Pending FDA Approval for NPM1 AML

Monoclonal AntibodyDrug Approval
  • Syndax Pharmaceuticals reported $28.6 million in Revuforj net revenue for Q2 2025, representing a 43% increase over the first quarter despite approximately one-third of patients pausing treatment for stem cell transplants.
  • The FDA granted Priority Review to Syndax's supplemental New Drug Application for Revuforj in relapsed/refractory mutant NPM1 acute myeloid leukemia, with a PDUFA action date of October 25, 2025.
  • Niktimvo generated $36.2 million in net revenue during its first full quarter of launch, with Syndax recording $9.4 million in collaboration revenue from its 50% profit-sharing agreement with Incyte.
  • The company maintains $517.9 million in cash and investments, which management expects will fund operations to profitability alongside growing product revenues from both approved therapies.

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

NCT06585774RecruitingPhase 3
Incyte Corporation
Posted 1/21/2025

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

NCT06388564RecruitingPhase 2
Incyte Corporation
Posted 10/11/2024

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06132256RecruitingPhase 2
Syndax Pharmaceuticals
Posted 12/11/2023

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