CEL-SCI Corporation
Climate Impact & Sustainability Data (2022, 2024)
Reporting Period: 2022
Environmental Metrics
Climate Goals & Targets
Medium-term Goals:
- Discussions outside of U.S. with regard to Multikine® approval
Short-term Goals:
- Completion of CSR; FDA Biologics License Application (BLA) filing for Multikine®; Validation of the Company’s manufacturing facility
Environmental Challenges
- COVID-19 pandemic delayed data lock for Phase 3 trial, expansion of manufacturing facility, and potentially affected regulatory pathway.
Mitigation Strategies
- Continuously assessing business plans and impact of COVID-19; no further specifics provided.
Supply Chain Management
Climate-Related Risks & Opportunities
Reporting Period: 2024
Environmental Metrics
Climate Goals & Targets
Short-term Goals:
- Complete the 212-patient confirmatory Registration Study as quickly and perfectly as possible.
Environmental Challenges
- Securing FDA approval for Multikine as a first-line treatment for newly diagnosed head and neck cancer patients, given the stricter benefit/risk balance for this patient population compared to late-stage patients.
Mitigation Strategies
- Provided biological justifications, deep research of the literature, and stronger clinical evidence to the FDA; demonstrated to the FDA that patients can be selected before surgery using criteria at diagnosis; showed that the selection criteria arise from Multikine's biological mechanism of action; demonstrated the safety of treating patients with Multikine; and showed that patients meeting the selection criteria are likely to see a significant survival benefit.