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Scinai Immunotherapeutics Surges 104% Following Italian Regulatory Clearance for Pincell Acquisition

Monoclonal AntibodyOrphan DrugRare Disease
  • Scinai Immunotherapeutics shares soared 104% to $5.15 after receiving Italian government clearance under Golden Power regulation to potentially acquire 100% of Italian biotech Pincell S.r.l.
  • The acquisition would add PC111, a monoclonal antibody targeting the Fas/FasL pathway for severe skin conditions including Pemphigus, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis, which has received Orphan Drug Designation from the European Medicines Agency.
  • While the regulatory approval removes a major hurdle, the deal remains contingent on additional conditions including a €12 million grant decision expected by mid-July to early August 2025.
  • The move represents a significant expansion opportunity for Scinai, which operates dual business units in inflammation/immunology drug development and contract manufacturing services.

Biocytogen Secures Japan Patent for RenMab Platform, Strengthening Global IP Portfolio for Fully Human Antibody Discovery

Monoclonal AntibodyGene Editing
  • Biocytogen Pharmaceuticals has received a Japan Patent Office invention patent for its RenMab fully human antibody mouse platform technology, marking a significant milestone in global intellectual property expansion.
  • The RenMab platform uses proprietary SUPCE technology to replace murine immunoglobulin genes with human counterparts, enabling generation of fully human antibodies without additional humanization steps.
  • The company has established licensing agreements with over 20 companies including Merck KGaA, Janssen/Johnson & Johnson, and BeiGene, generating over 1,000,000 fully human antibody sequences against more than 1,000 therapeutic targets.
  • Biocytogen's RenMice platform has secured patent grants in nearly 10 countries with nearly 40 patent applications under examination across 15 countries and regions.

Mediar Therapeutics Initiates Phase 2 Trial of First-in-Class Anti-WISP1 Antibody for Idiopathic Pulmonary Fibrosis

Monoclonal AntibodyRare Disease
  • Mediar Therapeutics has dosed the first patient in its Phase 2 WISPer trial evaluating MTX-463, a first-in-class anti-WISP1 antibody for idiopathic pulmonary fibrosis treatment.
  • The randomized, double-blind, placebo-controlled study will measure changes in forced vital capacity at 24 weeks as its primary endpoint in IPF patients.
  • MTX-463 targets the myofibroblast, the key pathogenic cell driving fibrosis progression, representing a novel therapeutic approach for this devastating disease.
  • The company has entered a global licensing agreement with Eli Lilly to advance MTX-463 through the Phase 2 trial, while independently developing two additional fibrosis programs.

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06967805RecruitingPhase 2
Mediar Therapeutics
Posted 5/5/2025

Kiniksa Pharmaceuticals Advances KPL-387 Phase 2/3 Trial for Recurrent Pericarditis

Monoclonal Antibody
  • Kiniksa Pharmaceuticals announced the trial design for its Phase 2/3 clinical study of KPL-387, a monoclonal antibody targeting IL-1R1, in recurrent pericarditis patients.
  • The trial will enroll up to 165 participants across dose-focusing and pivotal portions, with initiation planned for mid-2025 and Phase 2 data expected in the second half of 2026.
  • KPL-387 offers a potential monthly subcutaneous dosing profile, which could expand treatment options for recurrent pericarditis patients currently facing limited therapeutic alternatives.

Rakuten Medical Secures AMED Funding for Novel PD-L1 Photoimmunotherapy RM-0256

Monoclonal AntibodyOrphan Drug
  • Rakuten Medical's RM-0256, an anti-PD-L1 antibody conjugated with light-activatable dye IR700, has been selected for funding by Japan's AMED under its orphan drug support program.
  • The novel photoimmunotherapy demonstrates a triple mechanism of action in preclinical studies, targeting PD-L1-expressing tumor cells while activating anti-tumor immunity and providing checkpoint blockade.
  • The therapy addresses an urgent medical need for patients with unresectable, advanced, or recurrent malignant epithelial tumors who develop resistance to current treatments.
  • With approximately 22,000 individuals affected by malignant epithelial tumors annually in Japan, RM-0256 represents a potential breakthrough for multiple solid tumor types including melanoma, breast, and urologic cancers.

Zigakibart Shows Sustained 60% Proteinuria Reduction in 100-Week IgA Nephropathy Study

Monoclonal Antibody
  • Zigakibart, an investigational anti-APRIL monoclonal antibody, demonstrated sustained efficacy with 60% proteinuria reduction from baseline at 100 weeks in IgA nephropathy patients.
  • Over half of patients (55%) achieved proteinuria below 500 mg/24h, with 31% reaching deeper remission below 300 mg/24h, while kidney function remained stable across all patient subgroups.
  • The treatment showed a reassuring safety profile with mostly mild to moderate adverse events and no treatment-related serious infections or discontinuations throughout the study period.
  • These represent the longest duration of kidney function stabilization reported for an anti-APRIL agent in IgA nephropathy, supporting zigakibart's potential as a disease-modifying therapy.

Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)

NCT03945318Active, Not RecruitingPhase 1
Novartis Pharmaceuticals
Posted 4/8/2019

A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

NCT05174221Active, Not RecruitingPhase 1
Takeda
Posted 11/9/2022

A Study of Zigakibart in Adults With IgA Nephropathy

NCT05852938Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 7/6/2023

New Research Reveals Complex Effects of Ozempic on Muscle Mass and Strength

Monoclonal Antibody
  • Clinical trials demonstrate that GLP-1 agonist drugs like semaglutide (Ozempic) can lead to a 13.9% loss of lean muscle mass, equivalent to approximately 20 years of age-related muscle decline.
  • A new preclinical study from University of Utah found that while Ozempic-induced weight loss decreased lean mass by 10% in mice, most loss came from organs like the liver rather than skeletal muscle.
  • Research indicates muscle strength can decline even when muscle size remains unchanged, raising concerns particularly for adults over 60 who face higher baseline risks for muscle loss.
  • Prevention strategies include regular resistance training, adequate protein intake, and aerobic exercise, though researchers emphasize the need for more human clinical studies to validate findings.

Biocytogen and Nanjing Chia Tai Tianqing Receive IND Approval for Second-Generation Anti-IGF-1R Antibody NTB003 in Thyroid Eye Disease

Monoclonal Antibody
  • Biocytogen and Nanjing Chia Tai Tianqing received IND approval from China's NMPA for NTB003, a second-generation fully human anti-IGF-1R monoclonal antibody targeting Thyroid Eye Disease.
  • NTB003 demonstrates enhanced molecular affinity, improved druggability, and extended half-life compared to first-generation anti-IGF-1R therapeutics, with potent signal-blocking activity in vitro studies.
  • Clinical studies of anti-IGF-1R biologics have shown rapid therapeutic response and favorable outcomes in reducing proptosis and diplopia while improving quality of life in TED patients.
  • Nanjing Chia Tai Tianqing will lead clinical development and commercialization in China, while Biocytogen handles global out-licensing outside China.

Chinese Drug Combination Outperforms Keytruda in Advanced Lung Cancer Trial

Monoclonal Antibody
  • A Chinese-developed drug combination of Benmelstobart and Anlotinib demonstrated superior efficacy over pembrolizumab (Keytruda) in treating PD-L1-positive advanced non-small cell lung cancer patients.
  • The combination therapy increased median progression-free survival by 3.9 months to 11 months total, with a 30% reduction in disease progression and death risk compared to the current standard treatment.
  • Results from the Phase III CAMPASS study involving over 500 patients were presented at the American Society of Clinical Oncology annual meeting as a Late-Breaking Abstract.
  • The achievement marks a potential shift from Chinese pharmaceutical companies being followers to leaders in international cancer treatment development.

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.

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