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Axio BioPharma and Likarda Form Strategic Partnership to Integrate AI Manufacturing with Advanced Drug Delivery

  • Axio BioPharma and Likarda announced a strategic partnership combining AI-powered protein manufacturing with advanced drug delivery technologies to accelerate biologic drug development timelines.
  • The collaboration integrates Likarda's Core-Shell Spherification® hydrogel technology for encapsulation and controlled release with Axio's discovery-to-GMP manufacturing capabilities.
  • The partnership aims to enhance workflows for monoclonal antibodies, bispecifics, and Fc-fusions while providing clients with more efficient and scalable paths to clinical manufacturing.
  • Both companies emphasize integrating delivery technologies earlier in the development process to improve stability, efficacy, and patient outcomes while reducing development friction.

Pharmacist-Led Interventions Generate $9 Million in Cancer Care Cost Savings Through Remote Clinical Reviews

  • Clinical review pharmacists at The US Oncology Network identified 1,271 cost-saving interventions across 5,600 patients, with 1,180 accepted interventions generating nearly $9 million in total cost of care reductions.
  • The initiative focused on six primary strategies including pembrolizumab dose banding, monoclonal antibody dose rounding, and biosimilar therapeutic interchange, with drug costs representing 63% of patient total cost of care.
  • Each clinical review pharmacist position cost approximately $25,000 but delivered significant financial returns while streamlining medication protocols and saving provider time in value-based care models.
  • Research from University of California San Diego revealed that 9% of inpatient chemotherapy treatments were due to transportation or housing barriers, resulting in over $7 million in potentially avoidable hospital costs over five years.

High Placebo Response Rates Challenge Lupus Drug Development as Researchers Develop New Trial Strategies

  • High placebo response rates of approximately 40% in systemic lupus erythematosus trials are obscuring the true efficacy of investigational biologics, as patients continue receiving powerful background medications like glucocorticoids and hydroxychloroquine.
  • Researchers have identified four core strategies to address the "placebo problem," including stabilizing background therapy, applying central expert review, controlling rescue therapy, and acknowledging evolving standard-of-care treatments.
  • New trial design innovations include enriching study populations with high-disease-activity patients, employing more stringent sustained endpoints, and implementing adaptive features to better detect drug efficacy signals.
  • Clinical practice approaches now focus on realistic patient expectations for biologics like belimumab and anifrolumab, emphasizing gradual benefit timelines of 3-4 months and steroid-sparing goals rather than miracle cures.

PCI Pharma Services Unveils Advanced Sterile Manufacturing Facility to Boost Biologic Production Capacity

  • PCI Pharma Services is launching a new 50,000-square-foot sterile fill-finish facility in Bedford, NH, expected to reach full GMP production by summer 2025.
  • The facility features high-speed integrated fillers capable of producing up to 300,000 vials at speeds of 400 per minute, with twin 430-square-foot lyophilizers and fully isolated containment systems.
  • This marks PCI's third high-throughput sterile fill-finish facility built since 2021, enhancing capacity for late-phase clinical and commercial biologic drugs including monoclonal antibodies and fusion proteins.
  • The company is also establishing a Development Center of Excellence at the Bedford campus, expected to be operational by early 2026, handling both small molecules and biologics including antibody-drug conjugates.

Nemluvio Shows Sustained Long-Term Efficacy in Atopic Dermatitis with Two-Year Extension Data

  • New two-year data from the ARCADIA long-term extension study demonstrate that Nemluvio (nemolizumab) maintains sustained and increased improvements in itch, skin lesions, sleep, and quality of life in patients with moderate-to-severe atopic dermatitis.
  • At week 104, more than 85% of evaluable patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI), with approximately 85% achieving at least four-point improvement in itch scores.
  • The study reinforces Nemluvio's rapid onset of action at week 4 and demonstrates a consistent safety profile with no new safety signals identified during prolonged treatment up to two years.

Upstream Bio Presents Data Showing Verekitug's Superior Potency Through TSLP Receptor Targeting at EAACI Congress

  • Upstream Bio presented pharmacology modeling data at the EAACI Congress demonstrating verekitug's greater potency compared to tezepelumab through TSLP receptor targeting rather than ligand targeting.
  • The modeling data showed complete and sustained inhibition of the TSLP/TSLPR complex with verekitug across various doses, potentially leading to greater reduction in lung inflammation biomarkers.
  • Verekitug is the only monoclonal antibody currently in clinical development targeting the TSLP receptor and is being evaluated in Phase 2 trials for severe asthma, CRSwNP, and COPD.
  • The company expects top-line Phase 2 data in CRSwNP in Q3 2025 and severe asthma data in the first half of 2026.

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

  • 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

  • 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

  • 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.

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

  • 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.
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