Celsion Corporation Issues Letter to Stockholders
Discusses Broad-based DNA Vaccine Initiative, OVATION 2 Study,
and Phase III OPTIMA Study Conclusions
- Further details on the Company’s vaccine initiative using its PLACCINE DNA vaccine platform technology for preventing or treating infectious agents that have the potential for global pandemics, including the SARS-CoV-2 virus and its variations;
- Expectations for clinical development programs with GEN-1, the company’s DNA-mediated IL-12 immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer;
- An update on the status of the Phase III OPTIMA Study with ThermoDox® plus radiofrequency ablation (RFA) in patients newly diagnosed with primary liver cancer, or hepatocellular carcinoma (HCC) and the decision to stop following patients in the Study; and
- A review of the company’s strong financial condition and three-year operating runway.
The full text of the letter follows.
To My Fellow Stockholders:
Let me explain why, starting with TheraPlas and its adaptation to the PLACCINE platform.
Through its first investigational product GEN-1, Celsion’s TheraPlas technology has demonstrated it can safely and effectively deliver and activate a DNA plasmid in patients. More than 90 patients have been treated in our oncology program with results demonstrating excellent safety, and with data clearly showing the activation of an immune response. We now believe that an adaption of the TheraPlas technology can do the same as a much-needed vaccine for the near future. We are calling this version of our proprietary plasmid and DNA delivery technology the PLACCINE platform. PLACCINE is the subject of our recently filed provisional patent that was announced on
Focus on Immunotherapies and Infectious Disease Vaccines
Future vaccine technology will need to address viral mutations and the challenges of efficient manufacturing, distribution, and storage. We believe an adaptation of our TheraPlas technology, PLACCINE, has the potential to meet these challenges, and perhaps more. Our approach is described in our provisional patent filing and is summarized as a DNA vaccine technology platform characterized by a single plasmid DNA with multiple coding regions. The plasmid vector is designed to express multiple pathogen antigens along with a potent immune modifier. It is delivered via a synthetic delivery system and has the potential to be easily modified to create vaccines against a multitude of infectious diseases, addressing:
- Viral Mutations: PLACCINE may offer broad-spectrum and mutational resistance (variants) by targeting multiple antigens on a single plasmid vector.
- Enhanced Efficacy: The potent immune modifier IL-12 may improve humoral and cellular responses to viral antigens and can be incorporated in the plasmid.
- Durable Efficacy: PLACCINE delivers a DNA plasmid-based antigen that can result in durable antigen exposure and a robust vaccine response to viral antigens.
- Storage & Distribution: PLACCINE allows for stability that is compatible with manageable vaccine storage and distribution.
- Simple Dosing & Administration: PLACCINE is a synthetic delivery system that should require a simple injection that does not require viruses or special equipment to deliver its payload.
We are conducting preliminary research associated with our recently announced proprietary DNA vaccine platform provisional patent filing. At the same time, we are redoubling our efforts and R&D resources in the immuno-oncology program.
GEN-1, OVATION 2 and Immunotherapy
The Phase II OVATION 2 Study with GEN-1, our DNA-mediated IL-12 immunotherapy, is the first product designed using the Company’s TheraPlas platform technology. The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT and eight weekly cycles of GEN-1, patients undergo interval debulking surgery, which is then followed by three adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments. The goal of our treatment strategy is to delay progression and improve overall survival (OS). 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).
We have enrolled one-third of the study patients with advanced ovarian cancer at 19 active centers. I am proud to say that by the end of the first quarter, we expect that all 25 clinical sites in the
As a reminder, based on favorable safety data from 15 randomized patients in the Phase I portion of the OVATION 2 Study, in
OPTIMA Study Analyses and ThermoDox® Status
Since the surprising and incredibly disappointing second interim analysis results of the Phase III OPTIMA Study in HCC announced on
As a reminder, we had previously stated that it would be highly unlikely the DMC’s recommendation would be reversed by subsequent data analyses. And while the analyses did identify certain patient subgroups that appear to have had a clinical benefit, we concluded that it would not be in our best interest to pursue these retrospective findings as the regulatory hurdles supporting further discussion will be significant.
A single disappointing study does not mean an end to the future of ThermoDox®.
Strong Balance Sheet
Furthermore, we were pleased in early February to have received written notice from the Listing Qualifications Staff of
While 2020 brought the challenges of navigating the COVID-19 pandemic, we are heartened by the promise of our platform technologies to improve the lives of patients. We look forward to an active and potentially highly rewarding future, and to updating you on our progress.
On behalf of all our employees, I thank our stockholders for their continued support.
Chairman, President and Chief Executive Officer
About Celsion Corporation
Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon current beliefs, expectation, and assumptions and include statements regarding the platform having the potential to provide broad protection against coronavirus disease 2019 (COVID-19), and possible future mutations of SARS-CoV-2 or other coronaviruses. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of the Company’s platform to provide broad protection against COVID-19, and possible future mutations of SARS-CoV-2 or other coronaviruses, the issuance of a patent to the Company for use of its technology platform for treating or preventing infection with the SARS-CoV-2 virus that causes COVID-19, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time and risk of failure of conducting clinical trials; the need for
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Source: Celsion CORP