Companies To Watch: Imunon
By Ben Comer, Chief Editor, Life Science Leader
Using targeted therapy to transform the standard of care in advanced ovarian cancer
Snapshot
With the recent sign-off from the FDA on protocols for a pivotal Phase 3 trial of IMNN-001 in advanced ovarian cancer, Imunon is poised to bring its IL-12 DNA plasmid vector (encased in a nanoparticle delivery system) into late-stage clinical trials. Originating from Imunon's TheraPlas platform technology, IMNN-001 is an immunotherapy delivered directly — via injection into a catheter implanted under the skin — to the tumor microenvironment. Administered with neoadjuvant and adjuvant (before and after) chemotherapy, IMNN-001 aims to become the first new frontline treatment in advanced ovarian cancer in over 25 years, says Imunon CEO Stacy Lindborg, Ph.D. Additionally, the TheraPlas platform — which came to Imunon through the company’s acquisition of EGEN in 2014 — is “flexible,” allowing it to create similar therapies with the same or different payloads for different cancer types, explains Lindborg.
What’s At Stake
Toxicity related to the systematic delivery of IL-12, a well-known and widely researched anti-tumor cytokine, has limited its usefulness. IMNN-001 is now entering Phase 3 because of the therapy’s “ability to harness the body’s immune system to fight cancer, but to also avoid the toxicity issues created through systemic delivery,” says Lindborg.
In addition to local administration via a novel delivery mechanism, another aspect of IMNN-001’s development and clinical data sticks out. IMNN-001’s inclusion criteria, in earlier trials and in the forthcoming Phase 3 trial, target newly diagnosed patients with advanced ovarian cancer, who have not yet had surgery or been treated with chemotherapy. This is significant because the majority of drug development work in ovarian cancer has been focused on the maintenance period, following standard-of-care surgery and chemotherapy. Patients that respond to chemotherapy may be more likely to respond to maintenance therapy, however, the immune system is dampened by chemo, says Lindborg. For IMNN-001, treatment naïve ovarian cancer patients may be “the optimal window for our product,” before the immune system is weakened by surgery and chemo, she says.
Ovarian cancer patients with homologous recombination deficiency (HRD), which can stem from mutations in the BRCA 1 or BRCA 2 gene, experienced an even larger effect in the Phase 2 trial, notes Lindborg. The median overall survival for all trial participants receiving IMNN-001 plus neoadjuvant and adjuvant chemotherapy increased by 13 months compared with the standard of care alone, a result “which has never been seen before.” The estimated 500 patient Phase 3 trial will, like the Phase 2 trial, include a broad population, but also will be sufficiently powered for the HRD positive subgroup.
In addition to the Phase 3 OVATION 3 trial for IMNN-001, Imunon is working with Break Through Cancer to test IMNN-001 in combination with Avastin (or a biosimilar) for newly-diagnosed advanced ovarian cancer. Separately, the company is working to test a product developed with its PlaCCine platform, which was derived from the TheraPlas platform. PlaCCine was designed for the development of nucleic acid vaccines for infectious diseases and cancer, using an intramuscular (in the arm) delivery.
Lindborg cites the recent hiring of Douglas Faller, M.D., Ph.D. as chief medical officer, as well as Khursheed Anwer, Ph.D., MBA, EVP and chief science officer (who came to Imunon, along with the TheraPlas platform, via the EGEN acquisition) as two key experts that will help the company move forward. Imunon will need to raise additional funds to support the completion of its Phase 3 trial — the current runway extends through “late June” — but Lindborg highlights efficiencies built in through the process of bringing production of all active pharmaceutical ingredient in-house. “We have produced the product and are ready to treat patients, well into the year of enrollment that we’ve assumed [for the Phase 3 trial], with additional product soon to be added to that stockpile,” says Lindborg.
Vital Statistics
Employees: ~30
Headquarters: Lawrenceville, New Jersey
Funding: Imunon is “actively working” to raise funds for the completion of its Phase 3 trial and aims to bring institutional investors in through a financing, to join a group of predominantly retail investors already on board, says Lindborg.
Latest Updates:
March 2025: Finalized Phase 3 study design with FDA for IMNN-001 in newly diagnosed advanced ovarian cancer.
February 2025: Announced new immunogenicity data from Phase 1 trial of PlaCCine-created DNA vaccine for COVID-19.
February 2025: Appointed Douglas Faller, M.D., Ph.D. as chief medical officer.