NASDAQ:IMNN
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Business Update
Positive Results from OVATION 2 Trial Support Advancing IMNN-001 to Phase 3 Study
On July 30, 2024, Imunon, Inc. (NASDAQ:IMNN) announced positive topline results from the Phase 2 OVATION 2 trial of IMNN-001 in patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. IMNN-001 is a DNA-based immunotherapeutic drug that consists of an interleukin (IL)-12 plasmid that allows for targeted expression of IL-12 to avoid toxicities and poor pharmacokinetics of systemically administered IL-12.
Interim data released in September 2023 showed a 9-month improvement in survival and a hazard ratio (HR) of 0.86, however as the overall survival (OS) data have matured, the improvement in survival increased to 11.1 months with a hazard ratio of 0.74, as shown in the following table.
A summary of the topline results is presented below. In addition to the 11.1-month increase in OS in the intent-to-treat (ITT) population, there was also a 15.7-month increase in OS by IMNN-001 in patients who had at least 20% of protocol-specified treatments in both arms. As a reminder, the OVATION 2 study was not powered for statistical significance.
We anticipate the full data set to be presented at an upcoming scientific conference and the full results will be submitted for publication in a peer-reviewed medical journal. The company is within days of requesting an ‘End-of-Phase 2’ meeting with the FDA to clarify the parameters of the upcoming Phase 3 trial, which we estimate will begin in the first quarter of 2025. While the pace of the trial will be dictated by a number of different parameters, including funding and patient enrollment, currently the company estimates a topline data readout at the end of 2028. We anticipate further details about the design of the Phase 3 study following the meeting with the FDA and as it gets closer to initiating.
MRD Study Continues
Imunon also provided an update on the study evaluating IMNN-001 on minimal residual disease (MRD) as determined by laparoscopy when administered in combination with Avastin and neoadjuvant chemotherapy (NACT). The study is being principally funded by the Break Through Cancer foundation and initiated at the University of Texas MD Cancer Center under the leadership of Dr. Amir Jazaeri. To date, seven patients have been enrolled and received treatment with a target enrollment of 50 patients. Thus far, the company is pleased with the rate of enrollment and now that two additional clinical sites will be used in the trial, Memorial Sloan Kettering is open for enrollment and Johns Hopkins will be opening for enrollment soon, the enrollment rate may increase further. Dr. Jazaeri will also be initiating a pilot study to testing circulating tumor DNA (ctDNA) in patients that have completed the treatment protocol.
Phase 1 Trial of IMNN-101 Underway
In May 2024, Imunon announced that the first site was activated and ready for patient recruitment for the Phase 1 clinical trial of IMNN-101, the company’s seasonal COVID-19 vaccine. The study is planned to enroll 24 subjects evaluating three escalating doses of IMNN-101. For this study, IMNN-101 was designed to protect against SARS-CoV-2 Omicron XBB1.5 variant, which was in accordance with the FDA’s Vaccines and Related Biological Products Advisory Committee’s June 2023 announcement. The primary objectives of the study are to evaluate safety and tolerability of the vaccine in healthy adults. Secondary objectives include neutralizing antibody response, cellular responses, and their associated durability. We anticipate topline results before the end of 2024. At that point, the company will be actively seeking a partner to continue development of IMNN-101.
Financial Update
On August 14, 2024, Imunon announced financial results for the second quarter of 2024. As expected, the company did not report any revenue during the second quarter of 2024. R&D expenses in the second quarter of 2024 were $2.8 million compared to $3.1 million in the second quarter of 2023. The decrease was primarily due to lower costs associated with the PLACCINE technology development along with lower CMC costs. G&A expenses in the second quarter of 2024 were $2.2 million compared to $2.3 million for the second quarter of 2023. The decrease was primarily due to lower non-cash stock-based compensation and employee-related costs.
As of June 30, 2024, Imunon had approximately $5.3 million in cash, cash equivalents, investments, and interest receivable. Subsequent to the end of the quarter, the company raised net proceeds of approximately $9.0 million from a registered direct offering of 5.0 million shares at a price of $2.00 per share. We estimate that the company has sufficient capital to fund operations into the third quarter of 2025. Imunon currently has approximately 14.4 million common shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 20.9 million.
Conclusion
The topline results of the OVATION 2 trial were very encouraging and consistently show that IMNN-001 is having a positive effect on the lives of advanced ovarian cancer patients as exhibited by the increase in overall survival, particularly in patients that received more doses of drug and those that were on PARP inhibitor therapy. We look forward to the outcome of the ‘End-of-Phase 2’ meeting with the FDA and additional details of the upcoming Phase 3 study of IMNN-001.
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