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Global Trial Aims to Improve Outcomes for Stage IV Non-Small Cell Lung Cancer

  • The TOURIST trial, the world's largest of its kind, is recruiting nearly 1,000 patients with stage IV non-small cell lung cancer (NSCLC) to assess the benefits of radiotherapy.
  • The trial, sponsored by The Christie NHS Foundation Trust, seeks to improve quality of life, reduce symptoms, and extend life expectancy for patients with advanced NSCLC.
  • Researchers will evaluate if modern radiotherapy techniques, combined with standard treatments, can provide additional benefits to patients with advanced NSCLC.
  • NSCLC accounts for 85-90% of all lung cancer cases, with approximately half of patients diagnosed at stage IV, highlighting the urgent need for improved treatment strategies.

Biomea Fusion to Present BMF-219 Diabetes Trial Data at ATTD-ASIA 2024

  • Biomea Fusion will present data from its COVALENT-111 and COVALENT-112 trials at the ATTD-ASIA 2024 conference in Singapore.
  • The presentations will include Phase II study designs for BMF-219 in type 2 and type 1 diabetes patients.
  • Case studies assessing BMF-219 in patients with poorly controlled severe insulin-deficient type 2 diabetes will also be highlighted.
  • BMF-219 is an investigational oral covalent menin inhibitor aimed at regenerating insulin-producing beta cells.

Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus

NCT06152042Active, Not RecruitingPhase 2
Biomea Fusion Inc.
Posted 12/28/2023

Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D)

NCT05731544Active, Not RecruitingPhase 1
Biomea Fusion Inc.
Posted 8/17/2022

Anixa Biosciences Bolsters Clinical Development with Suyasha Gupta Appointment

  • Anixa Biosciences has appointed Suyasha Gupta as Senior Director of Clinical Development to enhance its oncology programs.
  • Gupta will oversee ongoing Phase 1 trials for breast cancer vaccine and ovarian cancer CAR-T therapy, plus an upcoming Phase 2 breast cancer vaccine trial.
  • Gupta's experience includes managing late-stage oncology trials at Genentech, focusing on immunotherapy and biomarker strategies.
  • Anixa anticipates Gupta's expertise will accelerate the development of innovative cancer therapies, particularly in late-stage trials.

FluoGuide Submits Clinical Trial Application for Phase II Head and Neck Cancer Trial

  • FluoGuide A/S has submitted a Clinical Trial Application (CTA) for a phase II trial of FG001 in head and neck cancer (oral squamous cell carcinoma).
  • The trial, designated CT-005, is a single-center study designed to evaluate multiple endpoints of FG001 in patients undergoing surgery.
  • Enrollment is planned for 25-30 patients, with the first patient expected in Q1 2025, and interim data anticipated in H2 2025.
  • The trial aims to optimize FG001's positioning for regulatory approval and commercialization, potentially leading to a multi-site registration trial.

Rege Nephro Secures $150 Million in Series B Funding to Advance Kidney Disease Therapies

  • Rege Nephro has successfully raised $22.5 billion yen ($150 million) in Series B funding to advance clinical trials for kidney disease therapies.
  • The funding will support Phase II trials of RN-014, a retinoic acid receptor agonist, for Autosomal Dominant Polycystic Kidney Disease (ADPKD) and preparations for US trials.
  • Funds will also facilitate preclinical trials for RN-032, a cell therapy targeting Chronic Kidney Disease (CKD) using nephron progenitor cells.
  • The investment underscores confidence in Rege Nephro's iPSC-based technology and its potential to address unmet needs in kidney disease treatment.

Trinity Biotech's Next-Generation CGM Shows Positive Pre-Pivotal Trial Results

• Trinity Biotech's next-generation continuous glucose monitor (CGM) technology demonstrated positive analytical performance in a recent European pre-pivotal clinical trial. • The trial assessed enhancements made since Trinity Biotech acquired the technology, focusing on improvements to accuracy and user experience of the CGM device. • Key modifications, including a reduction in biosensor wire length, led to favorable mean absolute relative difference (MARD) compared to the previous Waveform device. • A second pre-pivotal trial is planned for Q4 2024, setting the stage for a pivotal trial in 2025, as Trinity Biotech aims to capture a significant share of the growing CGM market.

Investigator-Initiated RCT Cost Analysis: A Multi-Country Observational Study

  • A new observational study aims to collect detailed cost data from 100 investigator-initiated randomized controlled trials (RCTs) across Switzerland, Germany, and the UK.
  • The study will investigate cost patterns, including the largest cost items, for the entire RCT process, from planning to finalization, both in absolute terms and as a percentage of total costs.
  • Researchers will explore RCT costs across different medical fields, intervention types, and countries, while also examining planned versus actual costs to identify factors contributing to excess expenses.
  • The study seeks to uncover hidden costs associated with conducting RCTs, such as those related to protocol writing, trial committees, ongoing communication, and managing serious adverse events.

Industry Funding Linked to Increased Efficacy in Psychiatric Drug Trials

  • A new study reveals that psychiatric drugs appear approximately 50% more effective in manufacturer-funded clinical trials compared to independently sponsored trials.
  • The "sponsorship effect" highlights potential bias, where manufacturer-funded trials are more likely to report favorable outcomes for their drugs.
  • Publication bias, where positive results are more likely to be published, significantly contributes to the observed sponsorship effect in drug trials.
  • Preregistration of clinical trials has helped reduce this bias since 2005, but challenges remain in addressing previously approved drugs based on potentially biased evidence.

Context Therapeutics Acquires Rights to BioAtla's Nectin-4 x CD3 TCE, BA3362, for up to $133 Million

  • Context Therapeutics has acquired the exclusive worldwide license to BioAtla's BA3362, a Nectin-4 x CD3 T-cell engager (TCE), for up to $133 million, including upfront and milestone payments.
  • BA3362 leverages BioAtla's Conditionally Active Biologics (CAB) platform, designed to enhance anti-tumor potency while minimizing off-target toxicities by targeting Nectin-4.
  • BioAtla will receive up to $133 million, including $15 million upfront and in near-term milestones, plus potential clinical, development, and commercial milestones, and tiered royalties on net sales.
  • The acquisition aligns with Context Therapeutics' strategy to expand its pipeline of TCE assets, with first-in-human studies for BA3362 expected to begin in approximately 18 months.

Monopar Therapeutics Initiates Phase 1a Trial of uPAR-Targeted Radiopharmaceutical MNPR-101-Lu in Advanced Cancers

  • Monopar Therapeutics has commenced a Phase 1a clinical trial for MNPR-101-Lu, a novel radiopharmaceutical targeting urokinase plasminogen activator receptor (uPAR) in advanced solid tumors.
  • The open-label, dose-escalation study will initially enroll patients already participating in the MNPR-101-Zr imaging trial to identify those most likely to benefit from the therapy.
  • MNPR-101-Lu aims to selectively target and kill cancer cells expressing uPAR, which is found in various tumor types, while minimizing damage to healthy tissue.
  • This trial is potentially the world's first clinical trial of a uPAR-targeted therapeutic radiopharmaceutical, representing a significant advancement in targeted cancer therapy.

Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors

NCT06337084RecruitingPhase 1
Monopar Therapeutics
Posted 5/30/2024

Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors

NCT06617169RecruitingPhase 1
Monopar Therapeutics
Posted 10/8/2024

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