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Clinical Trial News

Antabio's MEM-ANT3310 Completes Phase 1 Trial, Showing Promise Against Multidrug-Resistant Infections

  • Antabio's MEM-ANT3310, a novel antibacterial combination, has successfully completed its Phase 1 clinical trial in healthy volunteers, demonstrating good tolerability.
  • The trial assessed the safety, tolerability, and pharmacokinetics of ANT3310, a serine-beta-lactamase inhibitor, both alone and in combination with meropenem.
  • Results indicate that ANT3310 was well-tolerated with no serious adverse events and exhibited compatible pharmacokinetics with meropenem, supporting further patient studies.
  • MEM-ANT3310 is designed to combat antimicrobial resistance in severe hospital infections, particularly those caused by Gram-negative pathogens like CRAB, CRE, and Pseudomonas aeruginosa.

Vaxcyte's VAX-31 Demonstrates Positive Phase 1/2 Results, Advancing to Phase 3 for Pneumococcal Disease

  • Vaxcyte's VAX-31, a 31-valent pneumococcal conjugate vaccine, showed robust immune responses against all 31 serotypes in a Phase 1/2 study.
  • The vaccine was well-tolerated with a safety profile similar to Prevnar 20® (PCV20) in healthy adults aged 50 and older.
  • VAX-31 met or exceeded regulatory immunogenicity criteria for all 31 serotypes at middle and high doses, showing superiority for unique serotypes.
  • Vaxcyte plans to initiate a Phase 3 pivotal, non-inferiority study by mid-2025, with topline data expected in 2026, for adult indication.

Adaptimmune's Journey to Pioneering TCR-T Therapy for Cancer Treatment

Adaptimmune, a biotech company founded in 2008, has made significant strides in developing T-cell receptor (TCR)-T therapies for cancer. Despite challenges and rocky collaborations with pharmaceutical giants like GSK and Astellas, Adaptimmune achieved a major breakthrough with the FDA approval of its first engineered TCR-T therapy, afami-cel, for treating metastatic or unresectable synovial sarcoma. This approval marks several firsts in the field of cell therapy, offering new hope for patients with rare solid tumors.

BiomX's BX004 Shows Promise in Phase 1b/2a Trial for Cystic Fibrosis Patients with Pseudomonas aeruginosa Infections

• BiomX's BX004 phage cocktail demonstrated favorable safety and notable efficacy in cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections. • A subset of patients receiving BX004-A achieved negative P. aeruginosa sputum cultures compared to placebo, indicating a potential for bacterial eradication. • Lung function, measured by FEV1, improved in patients receiving BX004-A, particularly in those on continuous inhaled antibiotics and with lower initial lung function. • BiomX plans to initiate a Phase 2b trial to further evaluate BX004, with results expected in the third quarter of 2025, building on Fast Track and Orphan Drug designations.

Clinical Accelerator and Tau Medical Partner for Tricuspid Regurgitation Study

  • Clinical Accelerator collaborates with Tau Medical to conduct an Early Feasibility Study (EFS) of the 'Pivot Extend' device for tricuspid regurgitation (TR).
  • The study will evaluate the safety and efficacy of Pivot Extend in improving symptoms of severe TR in patients who are not candidates for surgery.
  • The Pivot Extend device offers a potentially less invasive approach to managing TR, addressing the limited treatment options currently available.
  • Clinical Accelerator will serve as the Contract Research Organization (CRO) for the study, which will take place in the Republic of Georgia.

Radiopharmaceutical Antibody-Drug Conjugates (rADCs) Emerge as Promising Cancer Therapies

  • rADCs are designed to deliver radiation directly to cancer cells, minimizing side effects compared to traditional radiation therapy.
  • Several companies are developing rADCs with various radioisotopes and antibodies, targeting cancers like prostate, breast, and lung cancer.
  • Clinical trials are underway to assess the efficacy and safety of rADCs, showing promising results in reducing tumor markers like PSA.
  • Challenges remain in supply chain logistics, dosimetry, and optimizing drug delivery to target tissues for effective cancer treatment.
NCT03288545Active, Not RecruitingPhase 1
Astellas Pharma Global Development, Inc.
Posted 10/11/2017
NCT06520345RecruitingPhase 3
Telix Pharmaceuticals (Innovations) Pty Limited
Posted 7/26/2024
NCT05194982RecruitingPhase 1
Sichuan Baili Pharmaceutical Co., Ltd.
Posted 11/29/2021
NCT01829711CompletedPhase 3
MedImmune LLC
Posted 4/29/2013
NCT03438396CompletedPhase 2
Seagen Inc.
Posted 6/12/2018
NCT04404283Active, Not RecruitingPhase 3
Seagen, a wholly owned subsidiary of Pfizer
Posted 8/20/2020
NCT04697628Active, Not RecruitingPhase 3
Seagen, a wholly owned subsidiary of Pfizer
Posted 2/22/2021

GSK's Depemokimab Shows Promise in Severe Asthma with Six-Month Dosing

• GSK presented Phase III trial data for depemokimab, an ultra-long-acting biologic, showing efficacy and safety in severe asthma patients with type 2 inflammation. • Depemokimab targets interleukin-5 (IL-5) and allows for six-month dosing intervals, potentially offering sustained suppression of disease drivers. • GSK also presented data on Nucala (mepolizumab) and Trelegy (fluticasone furoate/umeclidinium/vilanterol), exploring clinical remission as a treatment goal in asthma and COPD.

Valneva and Pfizer Report Positive Phase 2 Booster Results for Lyme Disease Vaccine Candidate VLA15

  • Valneva and Pfizer's Lyme disease vaccine candidate, VLA15, demonstrated a strong immune response one month after a second booster dose in pediatric and adult populations.
  • The Phase 2 study (VLA15-221) showed a significant anamnestic antibody response across all six serotypes, consistent with previous results after the first booster dose.
  • VLA15's safety profile remained favorable across all age groups and vaccinations, with no new safety concerns identified by the independent Data Monitoring Committee.
  • Pfizer aims to submit regulatory applications to the FDA and EMA in 2026, pending positive Phase 3 data, for what could be the first approved human Lyme disease vaccine.

Quality of Life Measures Gain Traction in Cancer Clinical Trials

  • A nationwide clinical trial is assessing the quality of life (QoL) in young Hodgkin lymphoma patients, marking a shift towards accessible and interpretable patient-reported outcomes.
  • The addition of brentuximab vedotin to chemotherapy showed clinical superiority and fewer negative effects on QoL compared to standard treatment, highlighting the importance of reducing late-term toxicities.
  • Researchers are collaborating with the NCI and FDA to integrate patient experience into the drug approval process, leveraging standardized QoL measurement tools like PROMIS.
  • The study emphasizes the need for thoughtful timing and methods for collecting patient-reported outcomes to improve participation rates and data quality in clinical trials.

QuantHealth's AI Platform Achieves 85% Accuracy in Clinical Trial Simulations, Driving Significant ROI for Pharma Partners

  • QuantHealth's AI-driven platform has successfully simulated over 100 clinical trials, achieving 85% accuracy in predicting trial outcomes.
  • The platform leverages data from 350 million patients and 700,000 drug entities to forecast individual patient responses and optimize trial design.
  • A partnership with a pharmaceutical company's respiratory disease team resulted in over $215 million in cost reductions and improved trial success likelihood.
  • QuantHealth's simulations have demonstrated accuracy rates exceeding national averages in Phase II and Phase III trials across multiple therapeutic areas.

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