By David Bautz, PhD
READ THE FULL IMNN RESEARCH REPORT
Enterprise Replace
Topline Knowledge from OVATION 2 Trial Anticipated in Mid-2024
Imunon, Inc. (NASDAQ:IMNN) is at present conducting the Section 1/2 OVATION 2 trial of IMNN-001, the corporate’s IL-12 gene-mediated immunotherapy that’s primarily based on the TheraPlas expertise. The OVATION 2 examine is evaluating the dosing, security, efficacy, and organic exercise of intraperitoneal IMNN-001 together with neoadjuvant chemotherapy (NACT) in sufferers with newly recognized superior epithelial ovarian, fallopian tube, or main peritoneal most cancers. Full enrollment of 110 sufferers for the trial was reached in September 2022. Being a Section 1/2 trial, it’s not powered for significance. It was designed with an 80% confidence interval to indicate an roughly 33% enchancment in PFS when evaluating the remedy arm (NACT+IMNN-001) with the management arm (NACT solely).
Interim knowledge from the intent-to-treat inhabitants present efficacy traits in PFS, with a delay in illness development within the remedy arm of roughly 33% in contrast with the management arm. Preliminary OS knowledge confirmed an identical development, with an roughly 9-month enchancment within the remedy arm in comparison with the management arm. A non-prespecified subgroup evaluation confirmed that sufferers handled with a PARP inhibitor (PARPi) as upkeep remedy had longer PFS and OS in the event that they have been additionally handled with IMNN-001 in contrast with sufferers handled with NACT solely. The PARPi subgroup was not pre-defined earlier than initiation of the OVATION 2 trial as PARPi’s have been first permitted after the OVATION 2 trial had initiated.
The median PFS within the PARPi+NACT group and the PARPi+NACT+IMNN-001 group was 15.7 months and 23.7 months, respectively. The median OS within the PARPi+NACT group was 45.6 months and had not but been reached within the PARPi+NACT+IMNN-001 group. These knowledge are preliminary, however sufferers handled with PARPi’s together with IMNN-001 seem to have the best profit and can probably catch the attention of the corporate shifting ahead.
Further constructive traits have been seen in secondary end result measures, together with an roughly 25% larger R0 tumor resection rating and a doubling of the CRS 3 chemotherapy response rating to roughly 30% within the remedy arm in comparison with 14% within the management arm. Security knowledge from the trial continues to indicate that IMNN-001 is nicely tolerated on this setting.
In October 2023, Imunon reported that the primary affected person was enrolled within the Section 1/2 medical trial of IMNN-001 together with bevacizumab in superior ovarian most cancers on the College of Texas MD Anderson Most cancers Heart. The trial is predicted to enroll 50 sufferers with Stage III/IV superior ovarian most cancers. Sufferers present process frontline neoadjuvant remedy can be randomized 1:1 to obtain commonplace chemotherapy plus bevacizumab or chemotherapy plus bevacizumab and IMNN-001. The first endpoint is detection of minimal residual illness (MRD) by re-assessment laparoscopy (SLL) and the secondary endpoint is PFS. Preliminary SLL knowledge are anticipated inside one 12 months following the completion of enrollment whereas closing PFS knowledge are anticipated roughly three years following completion of enrollment. To this point, 4 sufferers have been enrolled within the examine and Memorial Sloan Kettering Most cancers heart has been added as a medical web site within the first quarter of 2024.
Section 1 Trial of IMNN-101 Underway
On Might 15, 2024, Imunon introduced that the primary web site was activated and prepared for affected person recruitment for the Section 1 medical trial of IMNN-101, the corporate’s seasonal COVID-19 vaccine. The examine is deliberate to enroll 24 topics evaluating three escalating doses of IMNN-101. For this examine, IMNN-101 was designed to guard in opposition to SARS-CoV-2 Omicron XBB1.5 variant, which was in accordance with the FDA’s Vaccines and Associated Organic Merchandise Advisory Committee’s June 2023 announcement. The first aims of the examine are to judge security and tolerability of the vaccine in wholesome adults. Secondary aims embody neutralizing antibody response, mobile responses, and their related sturdiness. We anticipate topline outcomes earlier than the tip of 2024.
IMNN-101 is predicated on the corporate’s PlaCCine expertise. It’s a DNA vaccine that addresses a variety of limitations of present vaccines, together with the sturdiness of antigen expression, stability, and suppleness to adapt to mutating viruses. Imunon beforehand reported constructive preclinical outcomes for the PlaCCine expertise:
• In February 2024, Imunon introduced the publication of a peer-reviewed article titled “Sturdy immunogenicity & safety in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a practical polymer” (Sood et al., 2024). Within the examine, the spike antigens from COVID-19 variants D614G (pVAC15), Delta (pVAC16), or each (pVAC17) have been cloned into DNA vectors. The plasmids have been formulated with a practical polymer that resulted in protein expression for as much as 85 days. Comparative research between PlaCCine vectors and Moderna’s mRNA vaccine (mRNA-1273) demonstrated that vaccination with PlaCCine induced antibody responses that have been corresponding to these induced by mRNA-1273. Immunization with pVAC17 resulted within the induction of cross neutralizing antibodies and safety in mice in opposition to each a D614G and Delta problem.
• In February 2024, Imunon introduced constructive outcomes from a stay virus problem examine carried out by the Wistar Institute with IMNN-101 in opposition to the SARS-CoV-2 variant XBB.1.5. That variant was declared the variant of concern for the 2023-2024 vaccine by the U.S. FDA Vaccines and Associated Organic Merchandise Advisory Committee. The examine carried out by the Wistar Institute confirmed that IMNN-101 elicited strong IgG and neutralizing antibody responses in a dose-dependent method after a single injection and that difficult the mice with stay virus 21 days after the second vaccination confirmed full response.
New President and CEO
On Might 8, 2024, Imunon introduced the appointment of Dr. Stacy Lindborg as President and Chief Govt Officer (CEO). Dr. Lindborg has served on Imunon’s board of administrators since 2021. She has practically 30 years of pharmaceutical and biotech business expertise. Beforehand, she served as co-CEO of BrainStorm Cell Therapeutics, the place she’s going to stay as a member of the board of administrators. Previous to that, she was Vice President & International Analytics and Knowledge Sciences Head at Biogen. Her profession started at Eli Lilly & Firm the place over 16 years she assumed positions of accelerating duty, together with Head of R&D technique. Dr. Lindborg acquired an MA and PhD in statistics, and a BA in psychology and math from Baylor College. She has authored greater than 90 manuscripts printed in peer-reviewed journals, together with 20 first-authored.
Monetary Replace
On Might 13, 2024, Imunon introduced monetary outcomes for the primary quarter of 2024. As anticipated, the corporate didn’t report any income through the first quarter of 2024. R&D bills within the first quarter of 2024 have been $3.3 million in comparison with $2.6 million within the first quarter of 2023. The rise was primarily resulting from larger medical and regulatory prices. G&A bills within the first quarter of 2024 have been $1.7 million in comparison with $3.1 million for the primary quarter of 2023. The lower was primarily resulting from decrease non-cash stock-based compensation, authorized prices, employee-related prices, consulting charges, and insurance coverage prices.
As of March 31, 2024, Imunon had roughly $9.8 million in money, money equivalents, investments, and curiosity receivable. We estimate that the corporate has ample capital to fund operations to the tip of 2024. Imunon at present has roughly 9.4 million frequent shares excellent and, when factoring in inventory choices and warrants, a completely diluted share depend of roughly 10.6 million.
Conclusion
We look ahead to the outcomes of the OVATION 2 trial, which we anticipate in mid-2024. These outcomes can be used to plan a Section 3 examine, which the corporate is hoping to provoke within the first quarter of 2025. As well as, we anticipate outcomes from the Section 1 trial of IMNN-101 earlier than the tip of 2024. We’ve elevated our estimate for the variety of shares to be bought for the corporate’s subsequent financing, which has decreased our valuation to $10 per share.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to obtain our articles and studies emailed on to you every morning. Please go to our web site for added info on Zacks SCR.
DISCLOSURE: Zacks SCR has acquired compensation from the issuer instantly, from an funding supervisor, or from an investor relations consulting agency, engaged by the issuer, for offering analysis protection for a interval of a minimum of one 12 months. Analysis articles, as seen right here, are a part of the service Zacks SCR supplies and Zacks SCR receives quarterly funds totaling a most charge of as much as $40,000 yearly for these providers supplied to or relating to the issuer. Full Disclaimer HERE.