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Clinical Trial News

Hanmi's BH3120 Shows Promise in Phase 1 Trials for Advanced Solid Tumors

  • Hanmi Pharmaceutical's BH3120, a novel dual-targeting antibody, is progressing through Phase 1 trials, showing no dose-limiting toxicities in advanced solid tumor patients.
  • The ongoing trial assesses BH3120 as a monotherapy and in combination with pembrolizumab (KEYTRUDA) for safety and tolerability in metastatic solid tumors.
  • Preclinical data suggests BH3120's unique mechanism may offer improved efficacy and safety compared to other 4-1BB-targeting antibodies, potentially overcoming prior limitations.
  • Hanmi's Pentambody platform underpins BH3120's design, enabling simultaneous binding to PD-L1 on cancer cells and 4-1BB on immune cells for enhanced anti-tumor activity.

Vagus Nerve Stimulation Shows Promise as 'Neural Tourniquet' to Reduce Surgical Bleeding

  • Researchers are developing a 'neural tourniquet' that uses vagus nerve stimulation to enhance blood clotting and reduce bleeding during surgery and postpartum.
  • Electrical stimulation of the vagus nerve activates immune cells in the spleen, preparing platelets to respond more effectively to injuries and reduce blood loss.
  • Clinical trials are underway to assess the efficacy of vagus nerve stimulation in healthy subjects, with preclinical data showing up to a 75% reduction in traumatic blood loss.
  • This proactive approach could revolutionize surgical practices by preventing excessive bleeding, potentially decreasing maternal deaths and surgical complications.

Effective Sponsor Oversight Critical for CRO Partnerships in Clinical Trials, Industry Leaders Emphasize

• Clinical trial sponsors and CROs must establish optimal oversight balance, with experts warning that both excessive and insufficient monitoring can impede trial success and efficiency.
• Industry leaders at Veeva's Clinical Operations Outsourcing 2024 Forum stress the importance of early collaboration agreements and transparent communication between sponsors and CROs.
• As clinical trials become increasingly complex, particularly in specialized therapies, the need for efficient sponsor oversight becomes more crucial for ensuring trial quality and regulatory compliance.

Cassava Sciences Announces Corporate Update on Alzheimer's Drug Simufilam

  • Cassava Sciences will hold a conference call and webcast on November 25th to provide a corporate update.
  • The update will likely cover the ongoing Phase 3 clinical trials of Simufilam for Alzheimer's disease.
  • Simufilam is an investigational oral small molecule drug targeting filamin A protein.
  • Cassava Sciences owns worldwide rights to Simufilam and related technologies.

Neurotech International Advances NTI164 Drug Trials with Ethics Approval for Pharmacokinetic Study

  • Neurotech International has secured ethics approval to commence a pharmacokinetic study of NTI164 in healthy adults, a crucial step for regulatory compliance.
  • The study will provide essential data on the drug's metabolism and excretion, supporting its development for neurological disorders.
  • This advancement marks significant progress in Neurotech's clinical trials and regulatory efforts for NTI164 in the U.S. and Australia.

Innovent Highlights Promising Clinical Data on Novel Oncology Molecules at ESMO Asia 2024

  • Innovent Biologics is set to present clinical data on multiple novel oncology molecules at the ESMO Asia Congress 2024, showcasing its commitment to innovative cancer therapies.
  • Updated Phase 1 results of IBI343, a TOPO1i CLDN18.2 ADC, will be presented, demonstrating encouraging efficacy and safety in previously-treated pancreatic cancer patients.
  • Additional studies feature combinations of sintilimab with chemotherapy and other agents, targeting various cancers including colorectal, liver, and non-small cell lung cancer.
  • Innovent's robust pipeline and advanced technology platforms in immuno-oncology and antibody-drug conjugates aim to transform cancer treatment options for patients worldwide.

Jacobio Pharmaceuticals Initiates Clinical Trial for Novel Cancer Drug

  • Jacobio Pharmaceuticals has commenced a clinical trial for a new cancer drug, marking a significant step in their oncology program.
  • The trial aims to evaluate the safety and efficacy of the drug in a specific patient population, contributing to the advancement of cancer treatment options.
  • This development underscores Jacobio's commitment to innovative research and development in the pharmaceutical sector, potentially addressing unmet medical needs.
  • The initiation of this trial represents a key milestone for Jacobio, with potential implications for future cancer therapies and patient outcomes.

Toripalimab Plus Chemotherapy Shows Promise in Advanced Pancreatic Cancer

  • A phase Ib/II study reveals that toripalimab combined with gemcitabine and nab-paclitaxel (GnP) demonstrates promising efficacy in patients with advanced pancreatic ductal adenocarcinoma (PDAC).
  • The combination therapy achieved an objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 90.3% in the intent-to-treat population.
  • Spatial analysis of the tumor microenvironment (TME) identifies immune niches, particularly IN-8, as potential predictors for immunotherapy response, characterized by interactions between dendritic cells (DCs), cytotoxic T lymphocytes (CTL), and T helper cells (Th).
  • Baseline serum IL-8 levels may serve as a predictive biomarker for treatment response, with lower levels associated with better outcomes in patients undergoing chemotherapy combined with immunotherapy.

Innovent Highlights IBI343 Data in Pancreatic Cancer at ESMO Asia 2024

  • Innovent will present clinical data on novel oncology molecules at the ESMO Asia Congress 2024, showcasing advancements in cancer treatment.
  • Updated Phase 1 results of IBI343, a TOPO1i CLDN18.2 ADC, will be presented, demonstrating encouraging efficacy and safety in previously-treated pancreatic cancer.
  • The company is also presenting data on combination therapies involving sintilimab and anlotinib in various cancer types, including colorectal and lung cancer.
  • Innovent is dedicated to transforming cancer treatment by delivering innovative, effective, and safe therapeutic options for doctors and patients.

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