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CN Bio and Pharmaron Partner to Advance Organ-on-a-Chip Technology for Drug Development

Drug DiscoveryMonoclonal Antibody
  • CN Bio has formed a strategic partnership with Pharmaron to validate and integrate its PhysioMimix organ-on-a-chip technology across drug discovery applications, reducing reliance on animal testing.
  • The collaboration will initially focus on disease modeling, toxicity testing, and ADME studies, with plans to expand into novel applications addressing unmet needs in pharmaceutical R&D.
  • This partnership aligns with recent FDA announcements to phase out animal testing requirements for monoclonal antibodies, as the global organ-on-a-chip market is projected to reach $388 million by 2028.

FDA Sets Q3 2025 Approval Dates for Three Breakthrough Therapies Targeting Rare Diseases

Drug ApprovalRare DiseaseMonoclonal AntibodyOrphan Drug
  • The FDA has established PDUFA target action dates for three promising therapies in Q3 2025: sepiapterin for phenylketonuria (July 29), apitegromab for spinal muscular atrophy (September 22), and paltusotine for acromegaly (September 25).
  • PTC Therapeutics' sepiapterin demonstrated a 63% reduction in blood phenylalanine levels in PKU patients, with 84% achieving therapeutic control and over 97% able to liberalize their protein-restricted diets.
  • Scholar Rock's apitegromab showed statistically significant motor function improvements in SMA patients already receiving standard care, while Crinetics' paltusotine achieved IGF-1 normalization in 83% of acromegaly patients switching from injectable treatments.
  • These approvals could provide significant therapeutic advances for patients with rare genetic disorders who currently have limited treatment options or face challenges with existing therapies.

Vaccinex's Pepinemab Shows Promise in Turning "Cold" Tumors "Hot" Through Enhanced Immune Response

Monoclonal Antibody
  • Vaccinex will present new clinical data at ASCO 2025 showing that neoadjuvant treatment with pepinemab induces mature tertiary lymphoid structures that correlate with improved pathologic response in head and neck cancer patients.
  • The SEMA4D-blocking antibody pepinemab demonstrates potential to transform immunologically "cold" tumors into "hot" immune centers by enhancing dendritic cell function and T cell interactions within organized immune structures.
  • Clinical studies reveal that pepinemab combination therapy enhanced tertiary lymphoid structure maturity and correlated with longer recurrence-free survival in metastatic melanoma patients without compounding toxicities.
  • The drug candidate shows promise for treating HPV-negative head and neck cancers and other immunologically resistant tumors that typically respond poorly to checkpoint inhibitor therapy alone.

Cemiplimab Shows Significant Survival Benefit in NSCLC Patients with Brain Metastases and High PD-L1 Expression

Monoclonal AntibodyDrug ApprovalOncology
  • First-line cemiplimab (Libtayo) monotherapy demonstrated a remarkable survival advantage over chemotherapy in advanced NSCLC patients with PD-L1 ≥50% and brain metastases, with median OS of 52.4 vs 20.7 months.
  • The EMPOWER-Lung 1 trial's 5-year follow-up data confirms cemiplimab's long-term clinical benefits across all PD-L1 expression levels, with the greatest benefit observed in patients with PD-L1 ≥90%.
  • Patients receiving cemiplimab experienced fewer grade ≥3 adverse events compared to chemotherapy (18.3% vs 39.9%), while also reporting improved quality of life measures including better emotional functioning and reduced fatigue.

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT03088540CompletedPhase 3
Regeneron Pharmaceuticals
Posted 5/29/2017

A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

NCT03789604Active, Not RecruitingPhase 3
CStone Pharmaceuticals
Posted 12/13/2018

FDA Approves First Lupus Nephritis Treatment: GSK's Benlysta Autoinjector for Pediatric Patients

Drug ApprovalMonoclonal Antibody
  • GSK received FDA approval for Benlysta's 200 mg/mL autoinjector for subcutaneous injection in patients five years and older with active lupus nephritis, marking the first FDA-approved treatment specifically for this severe kidney complication.
  • The approval provides pediatric lupus nephritis patients with a first-of-its-kind at-home subcutaneous treatment option, expanding beyond the previously available intravenous formulation.
  • Benlysta demonstrated clinical efficacy in the BLISS-LN trial, with 43% of patients achieving significant kidney function improvement compared to 32% in the control group.
  • The lupus nephritis indication is expected to drive Benlysta sales above the $1 billion blockbuster threshold, with GSK estimating around 60% of severe SLE patients in the US suffer from lupus nephritis annually.

Annexon's Tanruprubart Shows Rapid and Durable Improvements in Guillain-Barré Syndrome Phase III Trial

NeurologyMonoclonal Antibody
  • Tanruprubart demonstrated significant functional improvements in Guillain-Barré syndrome patients as early as one week after treatment, with patients 14 times more likely to show improved mobility versus placebo.
  • The monoclonal antibody targeting C1q protein maintained durable benefits through 26 weeks, with twice as many treated patients achieving full recovery compared to placebo.
  • If approved, tanruprubart could address a significant unmet need for the estimated 7,000 U.S. and 15,000 EU patients diagnosed with GBS annually, potentially representing a $1 billion market opportunity.

Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome

NCT04701164CompletedPhase 3
Annexon, Inc.
Posted 12/17/2020

FDA Announces Shift from Animal Testing to AI Models, Boosting Recursion Pharmaceuticals Stock 20%

AIDrug DiscoveryMonoclonal Antibody
  • The FDA announced plans to replace animal testing with AI models and other human-relevant methods for drug development, initially focusing on monoclonal antibodies before expanding to other drug types.
  • Recursion Pharmaceuticals stock surged approximately 20% following the FDA announcement, as the company operates one of the largest biopharmaceutical datasets with over 60 petabytes of data for AI-driven drug discovery.
  • The regulatory shift could increase interest from other drugmakers in partnering with Recursion, which already collaborates with four major pharmaceutical companies including Bayer, Merck KGaA, Genentech, and Sanofi.

Sanofi's Amlitelimab Shows Promising Results in Atopic Dermatitis Trial Following $1.45bn Kymab Acquisition

Monoclonal Antibody
• Sanofi's amlitelimab (formerly KY1005), acquired through its $1.45 billion Kymab purchase, demonstrated significant efficacy in a Phase 2a trial for moderate to severe atopic dermatitis with an 80% improvement in EASI scores at the low dose.
• The OX40 ligand-targeting antibody showed durable effects, with two-thirds of patients maintaining clear or almost clear skin 24 weeks after the final dose, positioning it as a potential complement to Sanofi's blockbuster Dupixent.
• Despite increasing competition in the atopic dermatitis market from biologics and JAK inhibitors, Sanofi is advancing amlitelimab to Phase 2b trials, emphasizing the need for diverse treatment options for this challenging condition.

Chinese Biotech Firms Surge in Global Oncology Licensing Deals, Commanding $30 Billion in 2024

Monoclonal AntibodyOncology
  • Chinese biopharmaceutical companies secured $30 billion in oncology licensing deals in 2024, with monoclonal antibodies and antibody-drug conjugates accounting for 89% of all molecule types.
  • The total deal value from Chinese biopharma was three times that of similar deals licensed from the US, reflecting growing global confidence in China's innovative capabilities.
  • Antibody-drug conjugates dominated the licensing activity, constituting 56% of total deal value at $19 billion, with over half involving bispecific ADCs.
  • Chinese biotech firms completed 33 overseas licensing deals worth $36.2 billion in the first quarter of 2025, up from 28 deals in the same period last year.

Real-World Studies Confirm Bevacizumab Biosimilars Deliver Cost Savings and Equivalent Clinical Outcomes in Metastatic Colorectal Cancer

Monoclonal AntibodyReal World EvidenceOncology
  • A Canadian population-based study found bevacizumab biosimilars Mvasi and Zirabev provided $6,379 CAD in annual cost savings per patient compared to originator Avastin while maintaining equivalent survival outcomes in metastatic colorectal cancer.
  • An Indian real-world analysis of 944 patients demonstrated comparable progression-free survival and overall survival between bevacizumab biosimilars and the reference product in first-line and second-line treatment settings.
  • Both studies support the cost-effectiveness and clinical equivalence of bevacizumab biosimilars, providing evidence for healthcare policy decisions and building confidence among oncologists treating metastatic colorectal cancer.

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