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Affimed N.V. 6-K Filing: Promising Results in NSCLC Trials & Strong Financial Outlook

$AFMD
Form 6-K
Filed on: 2024-12-17
Source
Affimed N.V. 6-K Filing: Promising Results in NSCLC Trials & Strong Financial Outlook

Key Information from Affimed N.V. 6-K Filing

Company Overview:

  • Name: Affimed N.V.
  • Ticker: Nasdaq: AFMD
  • Address: Gottlieb-Daimler-Straße 2, 68165 Mannheim, Germany
  • Filing Date: December 17, 2024

Clinical Trial Updates:

  1. Trial Focus: AFM24-102 trial of AFM24 combined with atezolizumab for non-small cell lung cancer (NSCLC).
  2. EGFR Wild-type Cohort:
  • Patient Data:
    • 43 patients in the full analysis set; 33 in the per protocol set.
    • All patients had prior platinum-based therapy and checkpoint inhibitors.
  • Safety Profile:
    • Combination therapy was well tolerated.
    • Common adverse events included infusion-related reactions (54% of patients), manageable and resolved quickly.
    • 21% experienced elevations in ALT, 16% in AST.
  • Efficacy:
    • Objective Response Rate (ORR): 21% (1 complete response, 5 partial responses).
    • Tumor shrinkage observed in 48% of patients.
    • Disease Control Rate (DCR): 76%.
    • Preliminary median Progression-Free Survival (PFS): 5.6 months.
  1. EGFR Mutant Cohort:
  • Patient Data:
    • 28 patients in the full analysis set; 17 in the per protocol set.
    • All had prior EGFR-specific therapy.
  • Efficacy:
    • ORR: 24% (1 complete response, 3 partial responses).
    • DCR: 71%.
    • Tumor shrinkage in 41% of patients.
    • Median PFS: 5.6 months, with some patients on treatment for over 10 months.

Exposure-Response Analysis:

  • Post-hoc analysis indicates that higher exposure to AFM24 correlates with better efficacy outcomes.
  • High exposure group showed ORR of 46% and a median PFS of 7.4 months.

Financial Position:

  • Cash Position: Projected to end Q4 2024 with approximately €15 million.
  • Cash Runway: Projected into Q4 2025.

Forward-Looking Statements:

  • The report includes forward-looking statements regarding the potential of product candidates, clinical trial outcomes, regulatory approvals, and financial outlook.

Insights:

  • The combination treatment of AFM24 and atezolizumab shows promising results, particularly in patients who have not previously responded to other therapies.
  • Safety data is favorable, suggesting a manageable side effect profile, which is crucial for patient compliance and overall therapeutic success.
  • Financially, the company appears to have adequate funds to support ongoing trials into late 2025, which is essential for maintaining momentum in their clinical programs.
  • The analysis suggests potential for optimizing dosing strategies to enhance treatment efficacy based on exposure-response data.

This information is critical for investors and stakeholders assessing Affimed N.V.'s clinical progress and financial health.