- The stock price of Celsion Corporation (NASDAQ: CLSN) is trading at over 50% pre-market. This is why it happened.
The stock price of Celsion Corporation (NASDAQ: CLSN) — a clinical stage development company focused on DNA based immunotherapy and next generation vaccines — is trading at over 50% pre-market as of 8:18 AM ET. Investors are responding to Celsion announcing that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer. And GEN-1 was designed using TheraPlas, Celsion’s proprietary, synthetic, non-viral nanoparticle delivery system platform.
Fast Track designation is intended for facilitating the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need. And according to the FDA, a Fast Track Drug must show some advantage over available therapy, including: Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes; Avoiding serious side effects of an available therapy and; Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
GEN-1 is the subject of Celsion’s Phase II OVATION 2 Study — which combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. And NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy.
Following NACT, patients undergo interval debulking surgery, followed by 3 adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments, the goal of which is to delay progression and improve overall survival. And the OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (standard of care + GEN-1) with the control arm (standard of care alone).
As Celsion previously announced, it has shared with the FDA data from the Phase I portion of the Phase I/II OVATION 2 Study that showed successful tumor resections with 7 out of 8 patients (88%) in the GEN-1 treatment arm having a complete tumor resection (R0) — which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. And the NACT-only treatment arm had an R0 resection rate of 50%.
Patients in the company’s completed Phase 1b dose-escalation OVATION I Study showed compelling objective response rates with 100% of patients in high-dose cohorts experiencing a complete or partial response and 67% of patients in lower-dose cohorts experiencing a complete or partial response. Further, R0 resections in the high-dose cohorts was 88%, compared with 33% in the low-dose cohorts.
Plus Celsion compared matched patient data in a synthetic control arm with results from the OVATION I Study. And patients in the GEN-1 arm virtually demonstrated a doubling of control of their cancer compared with the synthetic control arm. Findings are not statistically significant due to the small number of patients. This comparison showed positive data in progression-free survival (PFS) as follows:
GEN-1 Population / PFS Hazard Ratio (Confidence Interval)
Intent-to-treat, n=15 / 0.53 (95% CI 0.16, 1.73); log-rank p=0.29
Per-protocol, n=14 / 0.33 (95% CI 0.08, 1.37); log-rank p=0.11
“Fast Track designation is an important step in developing GEN-1 for advanced ovarian cancer. Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market. Fast Track allows for more frequent communication with the FDA to discuss development plans and clinical trial design. In addition, should criteria be met, Fast Track-designated drugs are eligible for rolling review, a process whereby the drug’s sponsor can separately submit sections of its New Drug Application to the FDA. They also are eligible for accelerated approval and priority review, under which drugs for serious conditions fulfilling an unmet medical need can be approved based on a surrogate endpoint. We are optimistic that GEN-1 represents a game-changer for women with advanced ovarian cancer who have limited treatment options.”
— Michael H. Tardugno, Celsion’s chairman, president and chief executive officer
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.