Latest news with #StacyLindborg
Yahoo
15-05-2025
- Business
- Yahoo
IMUNON Announces Six-Month Data Showing Durability of Protection for Next-Generation DNA Vaccine Platform in Phase 1 Clinical Trial in COVID-19
Company's PlaCCine® technology platform demonstrates better durability and other advantages compared to mRNA vaccines Results further validate PlaCCine as a novel vaccine platform with potential applications in COVID-19 and other infectious diseases with epidemic implications LAWRENCEVILLE, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapies and evaluating an adaptation of the platform's potential as a next-generation vaccine, today announced new data from its first Phase 1 proof-of-concept clinical trial of IMNN-101, an investigational DNA plasmid vaccine based on the Company's proprietary PlaCCine® technology platform, for protection against COVID-19. Results in 24 healthy volunteers demonstrated IMNN-101's durability of protection at six months after a single dose targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen variant. IMNN-101 induced up to a 3-fold median increase in the serum neutralizing antibody (NAb) titers from baseline at six months, with initial evidence of a stronger immune response in two higher dose cohorts (2.0 mg and 1.0 mg) compared to a lower dose cohort (0.5 mg). The highest observed increase among the participating volunteers was 8-fold from baseline. IMNN-101 continues to be safe and well tolerated, with no serious adverse effects reported. 'It is very encouraging to see strong evidence supporting the favorable immunogenicity, durability and safety of IMNN-101 at six months in trial participants, all of whom were previously vaccinated or infected multiple times, further validating the significant potential of our PlaCCine technology platform to support development of an effective treatment for COVID-19, new variants and emerging pathogens with epidemic potential,' said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. 'Our platform is designed to support development of vaccines with several competitive advantages, including vaccine stability at workable temperatures and ease of manufacturing compared to available mRNA vaccines. We are currently involved in discussions about the further development of our PlaCCine platform for prophylactic vaccines, which we hope will lead to a long-term strategic partnership to advance these promising technologies as efficiently as possible.' In the Phase 1 trial, designed to demonstrate the advantages of IMUNON's technology compared to approved messenger RNA (mRNA) vaccines, IMNN-101 was administered as a single dose vaccine without a booster dose in study participants who were previously vaccinated against the Omicron XBB1.5 variant. Study participants had high baseline immune characteristics, presumably from prior infection and multiple previous vaccinations against COVID-19, and ongoing infection. Modest increases in T-cell responses were observed in trial participants who received multiple immunizations prior to the study. 'I have seen firsthand how COVID-19 continues to impact patients, especially those with underlying health conditions. While existing vaccines have saved countless lives, there is a need for more updated and widely available options to keep pace with potential variants, and particularly with applications in unaddressed and emerging infectious diseases. Expanding our vaccine toolkit is essential to reduce hospitalizations and prevent long-term complications. These latest data indicate that IMNN-101 may offer a safe, effective and advantageous treatment option for patients in the future,' said Ai-ris Collier, M.D., Co-Director of the Clinical Trials Unit, Center for Virology and Vaccine Research Center, Beth Israel Deaconess Medical Center. Results from the Phase 1 trial build on data previously announced in February 2025, which showed IMNN-101 induced a persistent 2- to 4-fold increase in serum NAb titers from baseline through Week 4, further increasing NAb titers between Week 2 and Week 4. The immune response was also observed against the XBB1.5 variant and many newer variants following treatment, demonstrating the IMNN-101 vaccine's cross-reactivity. The Phase 1 clinical data of IMNN-101 is consistent with strong evidence of immunogenicity and protection for the PlaCCine platform in rodents and non-human primates, with prior preclinical results showing comparable protection efficiency (>95%) to a commercial mRNA vaccine in non-human primates. About PlaCCine® and IMNN-101 IMNN-101 utilizes the Company's PlaCCine® technology platform, a proprietary composition of a DNA plasmid that regulates the expression of key pathogen antigens and a novel synthetic DNA delivery system. The plasmid-based expression vector accommodates single or multiple antigens through its flexible vector design, offers manufacturing flexibility compared to viral, mRNA or protein vaccines, and the synthetic delivery system protects DNA from degradation and facilitates DNA uptake after injection with acceptable safety. About the Phase 1 PoC Clinical Trial This U.S. Phase 1 proof-of-concept (PoC) study enrolled 24 participants to evaluate three escalating doses of IMNN-101 with eight participants at each dose. All participants were treated at DM Clinical Research in Philadelphia. For this study, IMNN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance with the FDA's Vaccines and Related Biological Products Advisory Committee's June 2023 announcement of the framework for updated COVID-19 doses. The primary objectives of the study are to evaluate safety and tolerability in healthy adults. Secondary objectives include evaluating IMNN-101's immunogenicity and associated durability. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing of enrollment of the Company's clinical trials, the potential of any therapies or vaccines developed by the Company to fulfill unmet medical needs, the market potential for the Company's products, if approved, the potential efficacy and safety profile of our product candidates, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'estimate,' 'intend' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Contacts: Media Investors Jenna Urban Peter Vozzo CG life ICR Healthcare 212-253-8881 443-213-0505 jurban@ in to access your portfolio
Associated Press
15-05-2025
- Business
- Associated Press
IMUNON Announces Six-Month Data Showing Durability of Protection for Next-Generation DNA Vaccine Platform in Phase 1 Clinical Trial in COVID-19
Company's PlaCCine® technology platform demonstrates better durability and other advantages compared to mRNA vaccines Results further validate PlaCCine as a novel vaccine platform with potential applications in COVID-19 and other infectious diseases with epidemic implications LAWRENCEVILLE, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapies and evaluating an adaptation of the platform's potential as a next-generation vaccine, today announced new data from its first Phase 1 proof-of-concept clinical trial of IMNN-101, an investigational DNA plasmid vaccine based on the Company's proprietary PlaCCine® technology platform, for protection against COVID-19. Results in 24 healthy volunteers demonstrated IMNN-101's durability of protection at six months after a single dose targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen variant. IMNN-101 induced up to a 3-fold median increase in the serum neutralizing antibody (NAb) titers from baseline at six months, with initial evidence of a stronger immune response in two higher dose cohorts (2.0 mg and 1.0 mg) compared to a lower dose cohort (0.5 mg). The highest observed increase among the participating volunteers was 8-fold from baseline. IMNN-101 continues to be safe and well tolerated, with no serious adverse effects reported. 'It is very encouraging to see strong evidence supporting the favorable immunogenicity, durability and safety of IMNN-101 at six months in trial participants, all of whom were previously vaccinated or infected multiple times, further validating the significant potential of our PlaCCine technology platform to support development of an effective treatment for COVID-19, new variants and emerging pathogens with epidemic potential,' said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. 'Our platform is designed to support development of vaccines with several competitive advantages, including vaccine stability at workable temperatures and ease of manufacturing compared to available mRNA vaccines. We are currently involved in discussions about the further development of our PlaCCine platform for prophylactic vaccines, which we hope will lead to a long-term strategic partnership to advance these promising technologies as efficiently as possible.' In the Phase 1 trial, designed to demonstrate the advantages of IMUNON's technology compared to approved messenger RNA (mRNA) vaccines, IMNN-101 was administered as a single dose vaccine without a booster dose in study participants who were previously vaccinated against the Omicron XBB1.5 variant. Study participants had high baseline immune characteristics, presumably from prior infection and multiple previous vaccinations against COVID-19, and ongoing infection. Modest increases in T-cell responses were observed in trial participants who received multiple immunizations prior to the study. 'I have seen firsthand how COVID-19 continues to impact patients, especially those with underlying health conditions. While existing vaccines have saved countless lives, there is a need for more updated and widely available options to keep pace with potential variants, and particularly with applications in unaddressed and emerging infectious diseases. Expanding our vaccine toolkit is essential to reduce hospitalizations and prevent long-term complications. These latest data indicate that IMNN-101 may offer a safe, effective and advantageous treatment option for patients in the future,' said Ai-ris Collier, M.D., Co-Director of the Clinical Trials Unit, Center for Virology and Vaccine Research Center, Beth Israel Deaconess Medical Center. Results from the Phase 1 trial build on data previously announced in February 2025, which showed IMNN-101 induced a persistent 2- to 4-fold increase in serum NAb titers from baseline through Week 4, further increasing NAb titers between Week 2 and Week 4. The immune response was also observed against the XBB1.5 variant and many newer variants following treatment, demonstrating the IMNN-101 vaccine's cross-reactivity. The Phase 1 clinical data of IMNN-101 is consistent with strong evidence of immunogenicity and protection for the PlaCCine platform in rodents and non-human primates, with prior preclinical results showing comparable protection efficiency (>95%) to a commercial mRNA vaccine in non-human primates. About PlaCCine® and IMNN-101 IMNN-101 utilizes the Company's PlaCCine® technology platform, a proprietary composition of a DNA plasmid that regulates the expression of key pathogen antigens and a novel synthetic DNA delivery system. The plasmid-based expression vector accommodates single or multiple antigens through its flexible vector design, offers manufacturing flexibility compared to viral, mRNA or protein vaccines, and the synthetic delivery system protects DNA from degradation and facilitates DNA uptake after injection with acceptable safety. About the Phase 1 PoC Clinical Trial This U.S. Phase 1 proof-of-concept (PoC) study enrolled 24 participants to evaluate three escalating doses of IMNN-101 with eight participants at each dose. All participants were treated at DM Clinical Research in Philadelphia. For this study, IMNN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance with the FDA's Vaccines and Related Biological Products Advisory Committee's June 2023 announcement of the framework for updated COVID-19 doses. The primary objectives of the study are to evaluate safety and tolerability in healthy adults. Secondary objectives include evaluating IMNN-101's immunogenicity and associated durability. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing of enrollment of the Company's clinical trials, the potential of any therapies or vaccines developed by the Company to fulfill unmet medical needs, the market potential for the Company's products, if approved, the potential efficacy and safety profile of our product candidates, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'estimate,' 'intend' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Contacts:
Yahoo
13-05-2025
- Business
- Yahoo
Q1 2025 Imunon Inc Earnings Call
Stacy Lindborg; President, Chief Executive Officer and Board Director; Imunon Inc Operator Good morning. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to the Imunon's first quarter 2025 financial results conference call. (Operator Instructions) I would now like to turn your call over to Peter Vozzo of ICR Healthcare Investor Relations, representative for Imunon. Please go ahead. Thank you, Dave. Good morning, everyone, and welcome to Imunon's first quarter 2025 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, beliefs or other similar expressions. These statements are based on current expectations that are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as the date of this live broadcast, May 12, 2025. Imunon undertakes no obligation to revise or update comments made during this call, except as required by law. With that said, I would like to turn the call over to Dr. Stacy Lindborg, President and Chief Executive Officer. Stacy? Stacy Lindborg Thank you, Peter, and good morning, everyone. Joining me on this call is Dr. Douglas V. Faller, Imunon's, Chief Medical Officer: and Dave Gaiero, our Interim Chief Financial Officer, who will review our financial results for the first quarter of 2025. Michael Tardugno, the Executive Chairman of our Board and Khursheed Anwer, our Chief Scientific Officer are also both on the line and will be available for Q&A. I want to start by saying that we may be close for the first time to unlocking the power of interleukin-12 to effectively treat cancer in one of the worst forms, ovarian cancer. Our work in developing treatments for ovarian cancer, a disease that continues to challenge scientists and clinicians and researchers, underscores our commitment to addressing unmet medical needs and driving long-term value. I'm amazed at the number of discussions I've had since joining Imunon in both personal and professional settings where people have shared impact from ovarian cancer at a close and personal level. Its devastation has no limits in taking the lives of women, young and old, in their prime. We continue to make significant strides towards our goal of transforming the treatment landscape for women diagnosed with advanced ovarian cancer. To that end, I'm pleased to report that we have initiated the first clinical site in our Phase 3 pivotal study of Imunon-001. If the results from our highly successful Phase 2 study are replicated in Phase 3, patients and doctors may potentially have a meaningful life extending therapy that recruits and empowers body's immune system to effectively target this disease. Our Phase 3 study, known as OVATION 3, is being recognized by the medical community as a critical step towards the goal of delivering a new frontline treatment for women with limited options and unmet urgent medical needs. This recognition is exemplified by the acceptance of our new OVATION 2 results for an oral presentation at the upcoming ASCO Annual Meeting and for publication in the peer-reviewed journal Gynecologic Oncology. It also underscores the scientific community's strong and historic evidence of Imunon-001's anti-cancer potential. We believe we have much to offer the future of oncology treatment, and I hope you are as excited as we are. Now, I'd like to report on our recent progress and review our clinical and regulatory status of Imunon-001. We continue to work with our trial investigators to begin enrolling participants, all of whom have shown unwavering interest in the Phase 3 trial and are committed to advancing the study. The confirmatory Phase 3 trial OVATION 3 will assess the efficacy of Imunon-001, plus the standard-of-care versus the standard-of-care, which is neoadjuvant and adjuvant chemotherapy alone. The standard-of-care for women who are newly diagnosed and treatment naive is paclitaxel and carboplatin chemotherapy, both neoadjuvant and adjuvant to interval debulking surgery. The study will enroll women at least 18 years of age newly diagnosed with advanced ovarian cancer. Study participants will be randomized 1:1, and there will be a subgroup of women positive for homologous recombination deficiency, HRD, which, as many of you will know, includes the familiar mutations BRCA1 or BRCA2. Participants within this sub-group will receive PARP inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival or OS. Secondary endpoints include surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints including quality of life measures, which will aid as we engage in payer and pricing discussions in the future, as we entertain approvals and access around the world. The advantage of overall survival as the primary endpoint is that it is a definitive endpoint. There will be no need for a second confirmational study to support approval. And if results are positive, the Phase 3 trial is also expected to support EU registration as a direct result of the selection of the overall survival of the primary endpoint. And you'll recall that we have orphan status established in Europe along with US Orphan Drug Designation. The initial core set of clinical trial sites currently activating are highly encouraged by Imunon-001's data and are enthusiastic about OVATION 3. These include sites that were part of both the Phase 1 OVATION 1 study and the Phase 1/2 OVATION 2 study. And we're excited to bring new sites on board to accelerate enrollment of the trial. The strength of our data is the key point of discussion, and we believe it will drive surgeons' interest and patient recruitment. There is optimism that Imunon-001 could potentially be a new product on the horizon and reset the standard-of-care for the frontline treatment of women newly diagnosed with advanced ovarian cancer if the safety and efficacy from OVATION 2 are confirmed in Phase 3. We have a strategy and statistical plan which allows for a 500-patient trial in an all-comer population of newly diagnosed patients, as well as a plan to focus on a 250-patient sub-group defined by a biomarker identifying patients who are HRD positive. Both are strong options and have 95% power or higher, and both are capable of supporting an FDA approval for Imunon-001. As we shared in our last call, we will focus initially on the HRD positive sub-group defined by a biomarker through a central lab. This highly cost-effective strategy allows us to enroll half the number of patients with an opportunity to achieve a readout sooner. We expect the study budget will be approximately 40% lower than the full study budget and could read out two years earlier. This population represents one half of the neoadjuvant ovarian cancer market and would be an important advancement for patients. We would likely trigger a broadening of the inclusion criteria at a later date budget permitting to reach the 500 patient all-commerce trial. Our strategy includes an interim analysis at high probability for success milestones. As we advance Imunon-001 in the Phase 3 OVATION 3 trial, we do not want its achievements in OVATION 2 to go unnoticed. As previously announced, data from the OVATION 2 study will be reviewed in an oral presentation during ASCO's Annual Meeting next month. Dr. Premal Thaker, who is Interim Chief of Gynecologic Oncology. David & Lynn Mutch, Distinguished Professor of Obstetrics & Gynecology, also Director of Gynecologic Oncology Clinical Research all at Washington University School of Medicine. She will lead the discussion in the oral presentation. As I mentioned earlier, review of the full data from OVATION 2 will be published in the highly esteemed journal Gynecologic Oncology on June 3, being released simultaneous to the ASCO presentation. Having our data presented in two of the premier global platforms in gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer as well as the strength and potential of Imunon's TheraPlas platform technology. With that, I'd like to turn the call over to Dr. Douglas Faller, who will discuss the Phase 3 OVATION 3 study, including key points from his recent and ongoing discussions with study investigators as we initiate sites. Douglas? Thank you, Stacy. This is clearly a very exciting time for Imunon. In addition to the presentation of the results from our OVATION 2 trial at an oral session of ASCO in a few weeks and the simultaneous journal publication which Stacy mentioned, we've also been invited to present new translational data from the OVATION 2 trial at the International ESMO Gynecological Conference in June. The new data that we will present demonstrate that Imunon-001 technology performs exactly as it was designed, delivering highly potent IL-12 gene therapy directly to the site of the tumor while keeping systemic exposure to IL-12 extremely low. This is the proprietary biochemical basis for both Imunon's anti-cancer activity and just as important, its safety. We initiated the first clinical site in our registrational OVATION 3 trial last week with the second site to be initiated in two days. More site initiations are planned in the coming weeks. It is gratifying to me as a clinician and informative to note that these leading hospitals and internationally known principal investigators were also major participants in OVATION 2. Their enthusiasm actually their insistence for joining OVATION 3 speaks to their belief in the safety and potential benefit of Imunon-001 in the women they care for. They want to join with us in this crucial step towards bringing Imunon-001 forward as a novel and innovative therapeutic in ovarian cancer. Our highly experienced clinical development team is excited to have initiated the OVATION 3 trial and is eagerly planning the expansion of the trial over the next six months. I'll now turn the call back to Stacy. Stacy Lindborg Thanks, Douglas. As we look towards financing our Phase 3 clinical trial, our goal is twofold: one is to ensure that we have done the best possible job for all stakeholders including our shareholders; and two, to raise capital in an amount that allows us to achieve our product development goals. And dilution is top-of-mind as we consider these options. Moreover and importantly, we have taken steps to conserve cash and align our critical needs with available capital on hand, while adding to the balance sheet through optimal opportunities. We're actively working on value-added financing and partnerships which will help secure a cash runway that supports our clinical timelines and long-term strategic objectives. Focusing on both technologies, TheraPlas and PlaCCine, we are having discussions with potential partners that have significant investment in oncology as well as vaccine development, some of these under CDA. We are also exploring geographic partnerships and ways to accelerate development of Imunon-001 in other parts of the world. And finally, we intend to leverage the data from the proof-of-concept trial, using our novel PlaCCine vaccine technology to sell or license that technology. Our PlaCCine technology offers several advantages and strong advantages over other vaccine platforms such as exceptional stability being viable for one year at 4-degree centigrade refrigerated temperatures and one month at 37 degree Celsius. The platform also has the ability for rapid adaptation to new pathogens or variants, longer lasting protection or durability, meaning it could be less frequent booster shots and cost-effective manufacturing. We shared insights from the PlaCCine proof-of-concept trial and the preclinical trials in this month, this last month April 2025 at both the AACR Annual Meeting and at the World Vaccine Congress and are following up with companies in the vaccine space. We are actively working on value-added financing and partnerships, which will help secure a cash runway. We will provide updates when we're able, and our goal is to cover OVATION 3 trial cost through corporate partnerships and equity. I'd now like to turn the call over to Dave Gaiero to review our financial results for the first quarter. Dave? Thank you, Stacy. Details of Imunon's first quarter 2025 financial results are included in the press release we issued this morning and in our Form 10-Q, which we filed before the market opened this morning. As of March 31, 2025, Imunon had $2.9 million in cash and cash equivalents. We remain focused on securing near-term financing to strengthen the company's financial condition and advance OVATION 3. Research & development costs were $2.2 million for the first quarter of 2025, compared with $3.3 million for the same period in 2024. The decrease was due primarily to lower costs associated with the Phase 1 proof-of-concept PlaCCine DNA vaccine trial and the development of PlaCCine DNA vaccine technology platform. General & administrative expenses were $2 million for the first quarter of 2025 compared to $1.7 million for the same period in 2024. The increase was primarily due to higher employee-related expenses. Net loss for the first quarter of 2025 was $4.1 million or $0.28 per share compared to a net loss of $4.9 million or $0.52 per share for the same period in 2024. With that financial review, I turned the call back to Stacy. Stacy Lindborg Thank you, Dave. With that, I'd like to open the call to your questions. Operator? Operator (Operator Instructions) Emily Bodnar, HC Wainwright. Stacy Lindborg Hello, Emily. Hi. Thanks for taking the questions. Hello, and congrats on the progress. I guess first one I'll ask about the ASCO presentation, so congrats, obviously on getting an oral presentation. Is there anything new in terms of like sub-group analysis or any new data analysis that we should be expecting at the ASCO presentation? And will you potentially have the median OS for the HRD positive patients by then? Stacy Lindborg So we are by nature of ASCO's embargo, Emily, I know you'll understand that not able to talk about the content of the presentation. They're very careful with what is shared in advance. We will be sharing new information and that I think is really quite central to being accepted as an oral presentation. Although I think the full body of evidence that we've been discussing merits a view at this level and at a platform like ASCO. So we're incredibly excited for the presentation and look forward to hearing Dr. Thaker's perspective on the data. Okay. Makes sense. And then, maybe just follow-up on the Phase 3 design. How many sites are you expecting to have in total for the trial for that, I guess, first half portion that you were discussing? And then are you having OS as a dual primary endpoint for HRD positive and the ITT population or how are you kind of splitting up the statistical plan? Thanks. Stacy Lindborg I'll have -- Doug, why don't you take a step in. Sure. The analysis for the Phase 3 has always been predicated on analyzing the HRD population first. This is the population in which we think from OVATION 2 data including data that will be presented at ASCO in which we have the highest effect in terms of activity. And so the population that would be read out first whether we proceed it with the entire HRD and HRP or whether we focus on HRD alone, as Stacy mentioned, the readout does not change. There are two interim analyses and a final analysis if needed all based on HRD events. You asked the question -- Stacy Lindborg A number of sites. A number of sites. We are projecting about 45 sites at this point. Stacy Lindborg Yeah. Emily, just to recap, so the overall survival of the primary is not dual and it is consistent for all populations as the primary. Got it. Okay. Thank you. Operator James Molloy, Alliance Global Partners. Hello. This is Laura Suriel on for Jim Malloy. Thank you for taking my questions and congrats on the progress. So for OVATION 3, what's the current status that you have on like the inventory and the manufacturing capabilities for this trial especially with the 250 to 500 patient enrollment plan that you have set up? Stacy Lindborg Yeah. Great question and I'll take the opportunity just to reiterate that for this trial, we have pulled the manufacturing of the core active pharmaceutical ingredients in-house. And we are prepared and are monitoring various enrollment plans and ensuring that we have and will have continue to have product available. So we have had product that has passed all of the release specifications and has been ready to sit for weeks now and are well prepared for the weeks and months ahead. Got it. Thank you. And then also the clinical trial that you have in collaboration with the Breakthrough Cancer Foundation, what's the current status of this trial here? And are you still on track to have preliminary results announced later on this year? Stacy Lindborg You just had a call with the PIs, can you just give some insight from that? We have a meeting with the principal investigators every two weeks. And the last one was a couple of days ago on Friday. We've initiated another site, University of Oklahoma and very excited about that. Johns Hopkins has managed to re-staff its clinical research group. And so they're excited about starting to screen patients. We are expecting to have data at the end of this year, yes. All right. Thank you for the answers. Thanks for taking the questions. Stacy Lindborg Thank you. Operator This concludes our question-and-answer session of the call. I now want to turn the call back over to Imunon's President and CEO for including remarks, Dr. Lindborg. Stacy Lindborg Thank you. I want to reiterate our near-term focus, which is on securing funds to strengthen the company's financial condition and advancing our Phase 3 trial and in the process, advancing Imunon-001. We expect to have an update on this front by the end of this quarter. And as referenced earlier, our goal is to cover the OVATION 3 trial cost, and we want to and will be seeking corporate partnering and equity financing. We expect this will be an iterative process driven by catalysts to further investor confidence and follow-on financings. And as our work in providing a new treatment option for women with ovarian cancer progresses and as the population's exposure to potential pandemics increases, we remain very excited about reporting data from ongoing clinical studies in the months ahead. We look forward to keeping you appraised of our progress and thanks again for joining us today and for your interest in Imunon. Operator The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
06-05-2025
- Business
- Associated Press
IMUNON Announces Data from Phase 1/2 Trial Evaluating Intraperitoneal IMNN-001 in Combination with Neoadjuvant Chemotherapy in Newly Diagnosed Patients with Advanced Epithelial Ovarian Cancer to be Published in Gynecologic Oncology
Data from OVATION 2 trial will also be reviewed in an oral presentation at ASCO Annual Meeting on June 3, 2025 LAWRENCEVILLE, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- IMUNON , Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced that data from the company's Phase 1/2 OVATION 2 trial evaluating intraperitoneal IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian cancer will be published in the peer-reviewed journal Gynecologic Oncology . The review of full data, entitled: OVATION-2: A Randomized Phase I/II study Evaluating the Safety and Efficacy of IMNN-001 (IL-12 gene therapy) with Neo/Adjuvant Chemotherapy in Patients Newly- Diagnosed with Advanced Epithelial Ovarian Cancer, is scheduled for publication on June 3, 2025. As previously announced, data from the OVATION 2 study will also be reviewed in an oral presentation during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2025 in Chicago, Illinois. Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, is lead author on the publication and will lead the discussion in the oral presentation at the ASCO meeting. 'We are very pleased that the data from our OVATION 2 study will be presented in the highly esteemed peer-reviewed journal Gynecologic Oncology and in an oral presentation at the ASCO meeting,' said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. 'Having our data presented in two of the premier global platforms in gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer and the strength and potential of IMUNON's TheraPlas® platform technology.' About the Phase 2 OVATION 2 Study OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response. About IMNN-001 Immunotherapy Designed using IMUNON's proprietary TheraPlas® platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer. About Epithelial Ovarian Cancer Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed Phase 2 development. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. The Company has completed enrollment for a first-in-human study of its COVID-19 booster vaccine (IMNN-101) which remains ongoing. IMUNON will continue to leverage these modalities and to advance the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions, and to further strengthen IMUNON's balance sheet through attractive business development opportunities. For more information, please visit . Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing for commencement and potential outcome of a Phase 3 trial of IMNN-001, the timing and enrollment of the Company's clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company's products, if approved, the potential efficacy and safety profile of our product candidates, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'estimate,' 'intend' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Contacts:
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IMUNON Finalizes Phase 3 Study Design with FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer
LAWRENCEVILLE, N.J., March 24, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) is aligned with the protocol for the Phase 3 pivotal trial, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer. The company is currently initiating trial sites and working with trial investigators to begin enrolling study participants. 'We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,' said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. 'The Phase 2 OVATION 2 study data are highly encouraging, demonstrating that IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment, and we continue to observe strong improvements with additional monitoring and follow-up of patients. We look forward to potentially replicating these unprecedented results in the Phase 3 OVATION 3 study. We are currently initiating trial sites and are focused on enrolling study participants as quickly as possible as we work towards our goal of bringing thousands of women with advanced ovarian cancer a first-in-class and much-needed treatment option.' The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard of care (SoC) NACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3 or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD) including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints. In December 2024, IMNN-001 plus NACT boosted median overall survival to 46 months—outpacing standard-of-care NACT by 13 months—up 2 months from the prior 11-month mark after 7 additional months of follow-up, with an excellent safety profile showing no cytokine release syndrome or serious adverse events. In the same month, the company also announced a positive outcome from a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding current good manufacturing practice (cGMP) production of IMNN-001 for the Phase 3 trial and potential commercialization. Production of IMNN-001 is conducted at IMUNON's in-house manufacturing facility located in Huntsville, Alabama. Conference Call and Webcast IMUNON is hosting a conference call to discuss the Phase 3 OVATION 3 pivotal trial of IMNN-001 on Tuesday, March 25, 2025, at 2:00 p.m. ET. Company management will be joined by: Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and the OVATION 2 Study Chair L.J. Wei, Ph.D., Professor of Biostatistics, Harvard T.H. Chan School of Public Health To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Phase 3 protocol call. A live webcast of the call will also be available here. The call will be archived for replay until April 8, 2025. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 9074731. An audio replay of the call will also be available here for 90 days. About the Phase 2 OVATION 2 Study OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response. About IMNN-001 Immunotherapy Designed using IMUNON's proprietary TheraPlas® platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer. About Epithelial Ovarian Cancer Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed Phase 2 development. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. The Company has completed enrollment for a first-in-human study of its COVID-19 booster vaccine (IMNN-101) which remains ongoing. IMUNON will continue to leverage these modalities and to advance the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions, and to further strengthen IMUNON's balance sheet through attractive business development opportunities. For more information, please visit wishes to inform readers that forward-looking statements in this news release are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing for commencement and potential outcome of a Phase 3 trial of IMNN-001, the timing and enrollment of the Company's clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company's products, if approved, the potential efficacy and safety profile of our product candidates, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'estimate,' 'intend' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. 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