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Clinical Trial News

Former Pfizer CSO Mikael Dolsten Joins Two Biotech Boards, Advancing Gene Editing and Mast Cell Therapeutics

Gene EditingRare Disease
  • Dr. Mikael Dolsten, former Pfizer Chief Scientific Officer, has joined the boards of Arbor Biotechnologies and MC Sciences as both companies advance novel therapeutic platforms.
  • Dolsten's 16-year tenure at Pfizer included advancing over 150 drug candidates into clinical studies and leading regulatory approval of 36 medicines and vaccines.
  • Arbor Biotechnologies is progressing its lead gene editing program ABO-101 for primary hyperoxaluria type 1 into clinical trials.
  • MC Sciences is developing first-in-class mast cell-targeting therapeutics for diseases including chronic urticaria, systemic mastocytosis, and asthma.

Real-World Study Reveals Only 8% of Patients Continue GLP-1 Obesity Treatment After Three Years

Real World Evidence
  • Prime Therapeutics' three-year analysis of 5,780 commercially insured adults found only 8.1% remained on GLP-1 obesity medications throughout the study period.
  • High-potency obesity-approved drugs like semaglutide (Wegovy) showed better persistence at 14.3% compared to daily liraglutide at 2.5% over three years.
  • One-year persistence rates improved dramatically from 33.2% in 2021 to 62.7% in 2024, largely attributed to resolved drug shortages and better clinical management.
  • The study highlights the critical need for comprehensive care management programs and behavioral interventions to support long-term obesity treatment success.

Invetech and AiCella Form Strategic Partnership to Integrate AI into Cell Therapy Manufacturing

AI
  • Invetech and AiCella announced a strategic collaboration to combine custom automation expertise with artificial intelligence to optimize cell therapy production processes and maximize patient treatment responses.
  • The partnership aims to help therapy developers identify critical process parameters earlier, reduce manufacturing variability, and accelerate the development of scalable, patient-ready therapies.
  • AiCella's AI platform will be embedded directly into the development and manufacturing lifecycle to generate data-driven insights about which parameters most influence therapeutic efficacy.
  • The collaboration targets the $10B+ cell therapy manufacturing market by integrating real-world process and clinical data with advanced machine learning models.

Kymera Therapeutics Raises $250.8 Million to Advance Targeted Protein Degradation Pipeline

  • Kymera Therapeutics completed a $250.8 million public offering at $44.00 per share to fund its targeted protein degradation programs for immunological diseases.
  • The clinical-stage biotechnology company is pioneering oral small molecule degraders that address disease targets inaccessible to conventional therapeutics.
  • Proceeds will advance Kymera's preclinical and clinical degrader pipeline designed for large patient populations with significant unmet medical needs.
  • The company has advanced the first degrader into clinical trials for immunological diseases, marking a milestone in the targeted protein degradation field.

Hong Kong Establishes Independent Drug Regulatory Authority by End 2026, Ending Reliance on Foreign Approvals

Drug Approval
  • Hong Kong will launch its own drug and medical device regulator by late 2026, marking a significant shift from the current secondary evaluation system that requires approval from at least two overseas regulators.
  • The Hong Kong Centre for Medical Products Regulation will implement primary evaluation in phases starting 2026, enabling fast-track approval of homegrown drugs and medical devices based on clinical trial data without foreign regulatory dependence.
  • Since 2023, 11 life-saving drugs including cancer treatments have been approved under the interim "1+" mechanism requiring only one overseas regulator's approval, demonstrating progress toward regulatory independence.
  • The city plans to apply for membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use in 2027 to achieve international recognition of its regulatory framework.

Teva Partners with Formycon to Commercialize Stelara Biosimilar Fymskina in Germany

Monoclonal AntibodyDrug Approval
  • Formycon AG has entered into a distribution agreement with Teva's subsidiary Ratiopharm for the semi-exclusive commercialization of its Stelara biosimilar FYB202, branded as Fymskina, in Germany.
  • The market launch for Fymskina is scheduled for the third quarter of 2025, with Formycon handling manufacturing and supply while Ratiopharm manages commercialization.
  • Fymskina has already received European Commission approval for treating moderate to severely active Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis.
  • This partnership represents Formycon's strategic approach to expand market coverage through semi-exclusive partnerships, building on its existing global commercialization agreement with Fresenius Kabi.

Ambry Genetics' CARE Program Achieves 99.5% Accuracy in Hereditary Cancer Risk Assessment

Precision Medicine
  • Ambry Genetics' CARE Program demonstrated 99.5% accuracy in interpreting NCCN Clinical Practice Guidelines for hereditary cancer risk assessment in a peer-reviewed study published in the Journal of the National Comprehensive Cancer Network.
  • The digital tool successfully identified 398 out of 400 real-world patient cases that met hereditary cancer testing criteria, matching the assessments of certified genetic counselors.
  • The HIPAA-compliant platform integrates with electronic health records and streamlines hereditary cancer risk assessment, addressing the gap where approximately 5% of individuals have cancer predisposition gene mutations but most remain unaware.

LIfT BioSciences Expands U.S. Operations with New Houston Facility to Advance Novel Neutrophil Immunotherapy

  • LIfT BioSciences has secured access to 30,000 square feet of state-of-the-art laboratory and office space at Portal Innovations' Houston Helix Park facility in Texas.
  • The expansion strengthens the company's transatlantic operations and positions it to accelerate development of its first-in-class Immuno-Modulatory Alpha Neutrophils (IMANs) for solid tumor treatment.
  • The Houston location provides proximity to MD Anderson Cancer Center and access to Portal Innovations' venture development ecosystem including capital, infrastructure, and scientific networks.
  • LIfT's IMAN platform represents a novel allogeneic neutrophil immunotherapy designed to overcome treatment resistance in solid tumors through non-antigen specific killing mechanisms.

Updated COVID-19 Vaccines Show Strong Protection Against Severe Illness in Comprehensive CDC Study

Real World Evidence
  • A comprehensive CDC VISION Network study spanning over 345,000 emergency department encounters and 111,000 hospitalizations found that 2023-2024 COVID-19 vaccines reduced critical illness risk by 48% during the first seven to 299 days after vaccination.
  • The vaccines demonstrated maximum protection during the first two months after vaccination, with up to 68% reduction in severe cases against critical illness, though effectiveness waned over time particularly beyond six months.
  • The study reinforces the importance of updated COVID-19 vaccination for vulnerable populations, especially adults 65 and older, as vaccines continued to provide strong defense against hospitalization and death throughout the study period.
  • Updated vaccines reduced emergency department visits by 24% and hospitalizations by 29%, offering significant protection above and beyond previous infection or vaccination during XBB and JN.1 Omicron subvariant waves.

Bavarian Nordic Initiates First Clinical Trials of Mpox Vaccine in Infants and Pregnant Women

  • Bavarian Nordic has launched two groundbreaking clinical trials to evaluate the safety and immunogenicity of MVA-BN mpox vaccine in 344 infants aged 4-24 months and 359 pregnant or breastfeeding women.
  • Both studies are being conducted in the Democratic Republic of Congo, the epicenter of the ongoing mpox outbreak, where these vulnerable populations remain at high risk.
  • The trials are part of the PregInPoxVac research project and could support regulatory approval to expand MVA-BN vaccine access to the most vulnerable populations.
  • Results from a concurrent pediatric trial in children aged 2-11 years are expected in Q3 2025, potentially supporting broader age group approvals.

Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC

NCT06844487RecruitingPhase 3
Jean-Pierre Van geertruyden
Posted 5/29/2025

Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC

NCT06844500RecruitingPhase 3
Jean-Pierre Van geertruyden
Posted 6/23/2025

Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children from 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections

NCT06549530RecruitingPhase 2
Bavarian Nordic
Posted 10/21/2024

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