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Clinical Trial News

ImmunityBio's CD19 CAR-NK Therapy Achieves Complete Responses in Late-Stage Waldenstrom Macroglobulinemia

  • ImmunityBio's QUILT-106 Phase I trial demonstrated complete responses in the first two heavily pretreated Waldenstrom macroglobulinemia patients using CD19 CAR-NK cell therapy.
  • One patient achieved complete response with CD19 CAR-NK monotherapy, while a second patient achieved complete response with the therapy combined with rituximab, with ongoing remission at six months.
  • This represents the first study to show potential for complete responses using chemotherapy-free immunotherapy in late-stage WM patients, validating natural killer cell therapeutic approaches.
  • The treatment was well-tolerated with no significant toxicities and administered entirely in an outpatient setting across three sites in South Africa.

Study for Subjects with Relapsed/Refractory Non-Hodgkin Lymphoma

NCT06334991RecruitingPhase 1
ImmunityBio, Inc.
Posted 8/23/2024

Two-Dose Dalbavancin Matches Standard Therapy for Complicated Staphylococcus aureus Bloodstream Infections

  • A NIH-supported Phase 2b trial found that two doses of dalbavancin given seven days apart was equally effective as standard 4-6 week IV antibiotic therapy for complicated S. aureus bloodstream infections.
  • The study enrolled 200 hospitalized adults across 23 medical centers and showed dalbavancin had similar clinical success rates while reducing complications associated with long-term PICC lines.
  • With nearly 120,000 S. aureus bloodstream infections and 20,000 deaths annually in the US, this simplified treatment regimen offers clinicians a vital new therapeutic option.
  • The findings provide the clearest evidence to date for dalbavancin's safety and effectiveness in treating these severe infections, potentially improving patient quality of life and reducing treatment burden.

DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia

NCT04775953CompletedPhase 2
National Institute of Allergy and Infectious Diseases (NIAID)
Posted 4/22/2021

PolyPid Appoints Dr. Nurit Tweezer-Zaks as Chief Medical Officer Following Positive Phase 3 Results

Drug Approval
  • PolyPid Ltd. has appointed Dr. Nurit Tweezer-Zaks as Chief Medical Officer, effective August 18, 2025, following positive Phase 3 SHIELD II trial results for their lead product candidate D-PLEX100.
  • Dr. Tweezer-Zaks transitions from the company's Board of Directors to lead medical strategy as PolyPid prepares for New Drug Application submission expected in early 2026.
  • The appointment comes at a pivotal time as the company advances its pipeline including D-PLEX100 for preventing abdominal colorectal surgical site infections and a recently unveiled GLP-1 program.

Avendus Fund and SBI Life Invest ₹300 Crore in Indian CRDMO Aragen Life Sciences

  • Avendus Future Leaders Fund and SBI Life Insurance jointly invested ₹300 crore in Aragen Life Sciences, India's leading contract research, development, and manufacturing organization.
  • The investment acquired approximately 2.5% stake in Aragen at a valuation of ₹12,200 crore ($1.4 billion), marking the fund's second investment after La Renon Healthcare.
  • Aragen provides integrated R&D and manufacturing services for both small molecules and biologics, serving global pharmaceutical and biotech clients from discovery through commercialization.
  • India's CRDMO market represents $8-9 billion of the global $112 billion market, positioning the country as an attractive hub for pharmaceutical outsourcing amid geopolitical uncertainties.

Southern Research Opens $98 Million Biotechnology Center in Birmingham to Accelerate Drug Discovery

Drug Discovery
  • Southern Research opened a new $98 million biotechnology center in downtown Birmingham, expanding its 150,000 square foot facility to advance drug discovery and combat chronic illnesses, cancer, and infectious diseases.
  • The facility is expected to create 100 direct jobs and generate $80 million in economic growth over the next 3-5 years while serving clients including the U.S. Department of Defense and pharmaceutical companies.
  • Alabama officials positioned Birmingham as "the biotech valley of this country," with the Alabama Legislature contributing $45 million to the project alongside funding from local governments and federal economic development programs.
  • The nonprofit research organization, operating in Birmingham since 1941, will focus on discovering new molecules and medicines while assisting pharmaceutical clients in therapeutic development for high-impact diseases.

Meta-Analysis Confirms Safety and Efficacy of Biologic Switching in Psoriasis Treatment

  • A comprehensive meta-analysis of 24 randomized clinical trials involving 12,661 patients demonstrates that switching between biologic classes significantly improves psoriasis treatment outcomes, with PASI 90 responses showing substantial improvement (OR, 28.61; 95% CI, 12.89-63.47).
  • The study found that switching from anti-TNF-α or anti-IL-12/23p40 agents to anti-IL-23p19 agents led to the most notable therapeutic benefits, with faster short-term responses observed as early as week 4.
  • While no significant differences were observed in serious adverse events compared to baseline, infection rates were slightly elevated when switching from anti-TNF-α agents, particularly to anti-IL-23p19 (0.62%), anti-IL-17A (0.54%), or anti-IL-12/23p40 agents (0.39%).
  • The findings support interclass biologic switching as an effective treatment strategy for psoriasis patients, though researchers emphasize the need for vigilance regarding infection risk and call for larger studies with extended follow-up periods.

MET Inhibitor Shows Promise in Enhancing Small Cell Lung Cancer Treatment Response

  • A multicenter study led by Hospital del Mar Research Institute demonstrates that adding a MET gene inhibitor to standard chemotherapy and immunotherapy significantly improves treatment response in small cell lung cancer.
  • The combination therapy achieved complete response in six out of nine tumors in mouse models, with improved survival outcomes compared to standard treatment alone.
  • Researchers found that MET overexpression, present in half of SCLC patients, correlates with worse prognosis and treatment resistance.
  • The MET inhibitor works by modifying the tumor microenvironment to enhance T cell activity, rather than directly targeting the tumor itself.

AbbVie Invests $195 Million to Expand U.S. API Manufacturing Capacity in North Chicago

  • AbbVie announced a $195 million investment to expand active pharmaceutical ingredient (API) production capacity at its North Chicago, Illinois manufacturing facility.
  • The expansion is part of AbbVie's broader commitment to invest more than $10 billion in U.S. capital projects over the next decade to support pharmaceutical innovation.
  • Construction will begin in fall 2025 with full operations expected by 2027, creating at least 50 new full-time jobs within three years.
  • The new facility will enhance AbbVie's chemical synthesis capabilities to support domestic production of neuroscience, immunology, and oncology medicines.

Mabwell Initiates First US Clinical Trial of Nectin-4 ADC in Previously Treated Triple-Negative Breast Cancer

Oncology
  • Mabwell has dosed the first patient in a US clinical study of Bulumtatug Fuvedotin (BFv), a novel nectin-4-targeting ADC, at Memorial Sloan Kettering Cancer Center for triple-negative breast cancer patients previously treated with ADCs.
  • The multicenter trial (NCT06908928) addresses significant unmet medical needs in TNBC, where treatment options remain limited and many patients progress after topoisomerase inhibitor-based ADC therapy.
  • BFv utilizes next-generation site-specific conjugation technology with MMAE payload, demonstrating superior characteristics including lower toxin release in plasma and enhanced intratumoral drug concentration.
  • The drug has already received multiple FDA Fast Track designations and Orphan Drug designation, with Phase III studies ongoing in urothelial carcinoma and cervical cancer indications.

A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs

NCT06908928RecruitingPhase 1
Mabwell (Shanghai) Bioscience Co., Ltd.
Posted 8/11/2025

Sareum Partners with Receptor.AI to Accelerate AI-Driven Discovery of Brain-Penetrating TYK2/JAK1 Inhibitors for Neuroinflammatory Diseases

AIDrug Discovery
  • Sareum Holdings has entered a strategic collaboration with AI drug discovery firm Receptor.AI to accelerate development of blood-brain barrier-permeable TYK2/JAK1 inhibitors for neuroinflammatory conditions including multiple sclerosis and Parkinson's disease.
  • The partnership builds on Sareum's previous preclinical work that identified three TYK2/JAK1 compounds with meaningful brain penetration, including one showing particularly strong levels of free drug in the brain.
  • Receptor.AI will apply its proprietary AI platform for compound discovery and optimization using virtual screening and molecular design tools, while Sareum will handle synthesis, testing, and ADMET profiling.
  • The four-month project is expected to begin imminently, with Sareum retaining ownership of all intellectual property and compounds arising from the collaboration.

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