Clinical Trial News
Moderna Pivots Beyond COVID-19 with RSV Vaccine Launch, Reports Better-Than-Expected Q4 Profits
- Moderna surpassed Wall Street expectations with a profitable Q4 2023, despite annual revenue dropping to $6.7 billion, marking a two-thirds decline from 2022 due to decreased COVID-19 vaccination rates.
- The company forecasts $4 billion in sales for 2024, banking on its RSV vaccine candidate currently under FDA review with a decision expected by mid-May.
- Following manufacturing restructuring to adapt to endemic COVID-19 market conditions, Moderna is diversifying its portfolio with RSV, influenza, and combination vaccines to drive growth beyond 2025.
Evaluation of an Artificial Intelligence-Based Clinical Trial Matching System for Hepatocellular Carcinoma
A study evaluated the effectiveness of a Clinical Trial Matching System (CTMS) integrated with the Chinese Electronic Health Record (EHR) system for screening patients with hepatocellular carcinoma (HCC) for clinical trials. The CTMS, utilizing artificial intelligence (AI) technologies like natural language processing (NLP) and machine learning (ML), demonstrated high specificity and good sensitivity in matching patients to clinical trials, significantly reducing the time required for screening compared to manual methods.
Highlighted Clinical Trials:
CStone Pharmaceuticals
Posted 12/13/2019
India's Indigenous CAR T-Cell Therapy Revolutionizes Cancer Treatment at One-Tenth Global Cost
- India has successfully developed NexCAR19, its first indigenous CAR T-cell therapy for blood cancers, priced at approximately Rs 40 lakh ($50,000) compared to $400,000 in the United States.
- Clinical trials involving 64 patients with advanced lymphoma or leukemia showed promising results, with 67% experiencing significant cancer reduction and about half achieving complete remission.
- Unlike U.S. approved therapies that use mouse-derived antibody fragments, India's "humanized" CAR T-cells caused fewer severe side effects, with no reported neurologic complications and only 5% experiencing severe cytokine release syndrome.
FDA Reluctant to Enforce Clinical Trial Transparency, Citing Resource Constraints
- The FDA has responded to a petition seeking stricter enforcement of clinical trial registration and results reporting, indicating a preference for voluntary compliance.
- The agency expressed concerns that levying fines or issuing non-compliance notices would strain its resources, making such actions unlikely.
- The FDA did grant a request to create a dashboard displaying notices sent to entities failing to register trials or report results, enhancing transparency.
- Despite calls for tougher measures, the FDA will continue to rely on its regulatory discretion when considering penalties for disclosure violations.
GSK Acquires Boston Pharmaceuticals' Efimosfermin for Liver Disease in $2 Billion Deal
- GSK has agreed to acquire Boston Pharmaceuticals' phase 3-ready liver disease candidate efimosfermin alfa for $1.2 billion upfront, with potential milestone payments bringing the total to $2 billion.
- Efimosfermin, a once-monthly FGF21 analog therapeutic, has demonstrated significant ability to reverse liver fibrosis and halt disease progression in patients with moderate-to-advanced MASH in phase 2 trials.
- The acquisition expands GSK's hepatology pipeline and offers potential combination therapy options with GSK's siRNA therapeutic GSK'990, targeting steatotic liver disease which affects approximately 5% of the global population.
FDA Places Clinical Hold on RAPT Therapeutics' Zelnecirnon Trials Following Liver Failure Case
- The FDA has placed a clinical hold on RAPT Therapeutics' zelnecirnon (RPT193) trials for atopic dermatitis and asthma due to a serious adverse event.
- The adverse event was a case of liver failure in a patient participating in the atopic dermatitis trial, with potential links to zelnecirnon under investigation.
- RAPT Therapeutics has halted dosing and enrollment in the affected trials and is actively investigating the case, while the oncology trial remains unaffected.
- Approximately 350 patients have been enrolled across three zelnecirnon trials, with no other instances of liver toxicity observed to date.
Spectral Medical and Baxter Extend Partnership for PMX in Septic Shock Treatment
- Spectral Medical and Baxter Healthcare Corporation have extended their exclusive supply and distribution agreement for PMX, a therapy for septic shock, by 10 years post-FDA approval.
- The agreement ensures Baxter remains Spectral's exclusive partner for distributing PMX products in the U.S. and Canada, pending FDA approval, enhancing commercialization prospects.
- Baxter's commitment includes a milestone payment to Spectral following the enrollment of 90 patients in the PMX-focused Tigris Trial, highlighting support for PMX's clinical development.
- The Tigris Trial, a confirmatory study of PMX, is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics to evaluate PMX's efficacy in endotoxic septic shock.
FDA Grants Fast Track Designation to Immuneering's IMM-1-104 for Pancreatic Cancer
- The FDA has granted Fast Track designation to Immuneering's IMM-1-104 for pancreatic ductal adenocarcinoma after one prior line of therapy.
- This designation aims to expedite the development and review of IMM-1-104, addressing a critical unmet need in pancreatic cancer treatment.
- IMM-1-104 is being developed by Immuneering, a clinical-stage oncology company, for patients who have failed initial treatment regimens.
- Immuneering's stock experienced a surge following the announcement, reflecting investor optimism about the drug's potential impact.
Roche's Glofitamab Expands Treatment Horizons for Multiple B-Cell Lymphomas
- Glofitamab (Columvi), Roche's bispecific monoclonal antibody, receives approval for treating relapsed/refractory DLBCL in patients who are ineligible for or have failed CAR-T therapy.
- The drug demonstrates promising potential across multiple B-cell malignancies, including CLL, mantle cell lymphoma, and follicular lymphoma, through its innovative CD20-CD3 targeting mechanism.
- Administered intravenously, Glofitamab represents a significant advancement in lymphoma treatment, particularly for patients who have exhausted traditional therapeutic options.
Atropos Health and SEQSTER Partner to Revolutionize Healthcare Data Analytics with AI-Powered Patient Registries
- Atropos Health and SEQSTER have formed a strategic partnership to combine patient registry capabilities with AI analytics, creating a comprehensive digital health data platform.
- The collaboration aims to accelerate healthcare insights by connecting previously disparate data sources through cloud technology and artificial intelligence, emphasizing patient data ownership and consent.
- The partnership introduces real-time data processing and federated technology solutions, enabling personalized healthcare delivery across different geographical regions and health systems.