IND Submission

IND Submission

Details:

Compilation of Regulatory Documentation:

  • Preclinical Data Integration:
    • Collated comprehensive safety, efficacy, and pharmacokinetic (PK) data from GLP toxicology studies and preclinical efficacy evaluations.
    • Included detailed findings from rodent and non-rodent models that demonstrated VE3’s tolerability and tumor suppression capabilities.
  • Manufacturing Information:
    • Provided full documentation of the Good Manufacturing Practice (GMP) production process for VE3.
    • Submitted data on API purity, stability, and batch-to-batch consistency to ensure quality control for clinical use.
  • Investigational Brochures and Clinical Protocols:
    • Prepared investigator brochures summarizing VE3’s mechanism of action, preclinical results, and anticipated clinical benefits.
    • Developed Phase 1 clinical trial protocols outlining objectives, dose escalation plans, endpoints, and safety monitoring procedures.

Regulatory Review Strategy:

  • FDA Interaction:
    • Engaged in pre-IND meetings with the FDA to clarify regulatory expectations, address potential concerns, and ensure alignment on submission requirements.
    • Leveraged feedback to refine submission documents and streamline the approval process.
  • Global Regulatory Submissions:
    • Began preparing documentation for other key markets (e.g., EU, Canada, Japan) to expand VE3’s regulatory reach.

Key Submission Components:

  1. General Investigational Plan:
    • Overview of the proposed clinical trials, including patient populations, study design, and expected outcomes.
  2. Chemistry, Manufacturing, and Controls (CMC):
    • Detailed description of the drug substance, formulation, and packaging processes.
  3. Nonclinical Pharmacology and Toxicology:
    • Summary of preclinical studies supporting VE3’s safety and efficacy.
  4. Clinical Trial Protocols:
    • Plans for initial human trials, including dose escalation strategies and safety monitoring.

Achievements:

  1. Regulatory Readiness:
    • Compiled a robust IND package that addressed all critical areas for regulatory approval.
    • Successfully aligned preclinical findings with regulatory requirements for a seamless transition to clinical trials.
  2. FDA Pre-IND Engagement:
    • Secured early feedback from regulatory authorities, reducing the likelihood of delays or deficiencies during the review process.
  3. Global Market Expansion:
    • Initiated plans to pursue regulatory approval in international markets, positioning VE3 for widespread clinical testing and commercialization.

Strategic Impact:

The IND submission represents a major milestone, enabling Theranib to initiate first-in-human clinical trials. This phase also strengthens investor confidence and demonstrates the company’s ability to navigate complex regulatory pathways.