On June 18, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, reported the presentation of new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational gene-based interleukin-12 (IL-12) immunotherapy based on the Company’s proprietary TheraPlas technology platform, for the treatment of newly diagnosed advanced ovarian cancer (Press release, IMUNON, JUN 18, 2025, View Source [SID1234653975]). Results are being highlighted in a poster presentation at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2025, taking place June 19-21, 2025, in Vienna, Austria.

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The Phase 2 OVATION 2 Study assessed 112 participants treated with IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT). IL-12 levels were sampled in the peritoneal fluid cavity, which is the primary tumor micro-environment. Results being presented at the ESMO (Free ESMO Whitepaper) Congress showed that treatment with IMNN-001 induced substantial increases in IL-12 and interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. Increases in IL-12, IFN-γ and TNF-α levels in the peritoneal cavity were approximately 27-, 62- and 36-fold following treatment, respectively, demonstrating the tumor-localized effect of IMNN-001 in women with advanced ovarian cancer. IMNN-001 continues to show a favorable safety profile.

"We are encouraged by these translational data being presented at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2025, which strongly complement the compelling overall survival results from the OVATION 2 trial presented at ASCO (Free ASCO Whitepaper) 2025," said Douglas V. Faller, M.D., Ph.D., Chief Medical Officer of IMUNON. "The clinical outcomes, showing a robust increase in overall survival for women with advanced ovarian cancer treated with IMNN-001 plus standard-of-care chemotherapy, align with these pharmacological and immunopathological findings. These results validate that IMNN-001 induces IL-12 and its downstream anti-tumor effectors, IFN-γ and TNF-α, exclusively at the tumor site with minimal systemic exposure, supporting our ongoing Phase 3 OVATION 3 trial."

At the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and in a peer-reviewed article in Gynecologic Oncology, IMUNON presented unprecedented overall survival data from the Phase 2 OVATION 2 Study. Treatment with IMNN-001 plus SoC chemotherapy in women with newly diagnosed advanced ovarian cancer demonstrated consistent, clinically meaningful improvements in overall survival, progression-free survival, chemotherapy response score, and surgical response, with a favorable safety profile. IMUNON is advancing the pivotal Phase 3 OVATION 3 Study of IMNN-001, with the first two trial sites initiated in May 2025.

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 (N/ACT) 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 N/ACT, 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 N/ACT plus IMNN-001 versus standard-of-care N/ACT. 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 N/ACT. 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 (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT 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.

On June 18, 2025 Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, reported positive topline data from the Phase 1/2a clinical trial (RAD-18-002) evaluating Radspherin in patients with peritoneal metastases originating from colorectal cancer (Press release, Oncoinvent, JUN 18, 2025, https://www.oncoinvent.com/press-release/oncoinvent-announces-positive-final-data-from-phase-1-2a-trial-of-radspherin-in-patients-with-colorectal-peritoneal-metastases/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234653958]).

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Reducing peritoneal recurrence in colorectal cancer is critically important because peritoneal metastases are associated with a particularly poor prognosis and significantly lower overall survival compared to other forms of recurrence[1]. The development of peritoneal metastases is not only linked to worse survival, but also to distressing symptoms, making disease management more challenging and often resulting in treatment interruptions and repeated hospitalizations.

Standard therapies for peritoneal metastases are limited, and the only treatment option with curative intent is surgery, which aims to remove as much tumor as possible in the peritoneal cavity. However, surgical resection leaves behind microscopic deposits of cancer cells, giving rise to new peritoneal metastases and disease progression. Radspherin, direct intraperitoneal targeting with the alpha-emitter radium-224, aims to eliminate these post-surgery micro-metastases and thereby prevent or delay peritoneal recurrence.

In this single-arm trial of 47 patients, 36 received Radspherin at a 7 MBq dose. The primary endpoint—peritoneal recurrence-free survival (pRFS)—yielded remarkable results:

Only 27.8%(10 of 36) experienced peritoneal disease recurrence at 18 months, a marked reduction compared to published data for standard of care, where approximately 50% of patients typically see peritoneal recurrence at this stage[2]
At 18 months, 61.1%(22 of 36) of patients had experienced any recurrence, but notably, just 22.7% (5 of 22) had peritoneum as the first site of recurrence
Final data from all 47 treated patients across dose levels further reinforce the favorable safety profile of Radspherin
Additional results will be published upon completion of the full dataset analysis.

"It’s highly encouraging to see patients treated with Radspherin achieving outcomes that exceed expectations for this challenging population. As a clinician, I’m hopeful that this promising therapy will become an option I can offer to future patients in need," said Dr. Stein Gunnar Larsen, Principal Investigator at the Oslo University Hospital, Norway.

Prof. Dr. Wilhelm Graf, Principal Investigator at Uppsala University Hospital, Sweden, added: "Colorectal peritoneal metastases present a major therapeutic challenge with limited effective options, and these findings support the potential of a novel approach that demonstrates both clinical promise and a favorable safety profile."

"We are inspired and motivated by these compelling data. They reinforce our belief in Radspherin’s potential as a novel treatment targeting peritoneal metastases and justify continued advancement of the program," said Oystein Soug, CEO of Oncoinvent. "We extend our deepest gratitude to the patients, investigators, and clinical teams who made this trial possible."

Radspherin is currently investigated in an ongoing phase 2 trial evaluating the treatment of peritoneal carcinomatosis from ovarian cancer. A positive safety review of the lead-in cohort was announced in Q1 2025, and the trial is currently recruiting patients according to plan in European and US sites in the randomized phase.

About RAD-18-002

RAD-18-002 was an open label Phase 1/2a trial conducted in patients with colorectal peritoneal metastases. The trial was designed to evaluate dosing, safety and tolerability, and signal of efficacy of intraperitoneally administered Radspherin following complete surgical resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC). A total of 47 patients were enrolled across sites in Norway and Sweden, with 36 patients receiving the recommended dose of 7 MBq.

About Radspherin

Radspherin is an investigational radiopharmaceutical designed for the local treatment of cancer that has spread to body cavities. It consists of calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the decay of radium-224 emitting alpha-particles, a highly potent form of ionizing radiation. Radspherin is investigated in ongoing clinical studies to treat peritoneal carcinomatoses from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors.

On June 18, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno oncology company, reported it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for patent application number 16/637,909 which protects its oncolytic virotherapy CF33-CD19 and its combination with CD19 targeting CAR T cell therapies (Press release, Imugene, JUN 18, 2025, View Source [SID1234653957]).

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The patent titled "ONCOLYTIC VIRUS EXPRESSING A CAR T CELL TARGET AND USES THEREOF" (inventors Yuman Fong, Saul Priceman, Stephen Forman, Nanhai Chen and Anthony Park from the City of Hope) protects the method of composition and method of use of Imugene’s onCARlytics technology through to August 10 2038.

Leslie Chong, Managing Director and CEO of Imugene, said:

"Imugene receiving this US patent allowance for the CF33-CD19 onCARlytics platform is a crucial step forward for our IP position, with the US being the largest healthcare market in the world. This follows patent allowance in China, an equally large cell therapy market, earlier in 2025."

On June 17, 2025 NAYA Therapeutics, a clinical-stage biopharmaceutical company dedicated to pioneering the next generation of cancer immunotherapies, reported that it is expanding its comprehensive hepatocellular carcinoma (HCC) pipeline with the addition of NY-700, a first-in-class GPC3-targeted Astatine-211 (211At) alpha radioimmunotherapy aiming to address residual disease, micro-metastasis, and post-immunotherapy failures (Press release, NAYA Therapeutics, JUN 17, 2025, View Source [SID1234656502]). NAYA’s HCC franchise also includes NY-303, a GPC3/NKp46/CD16-targeting NK engager bifunctional antibody entering Phase I/II as monotherapy in patients not responding to immunotherapy, and NY-500, a PD-1/VEGF bifunctional antibody positioned as a first-line immunotherapy.

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"We are excited to enter the rapidly growing field of radiopharmaceuticals with a first-in-class targeted alpha therapy with potential key advantages over existing alternatives," commented NAYA CEO Dr. Daniel Teper. "We believe that our GPC3-targeted Astatine-211 alpha radioimmunotherapeutic has the potential to transform HCC patient outcomes as a monotherapy in metastatic patients and in combination with immunotherapy at earlier stages of the disease. NAYA is committed to leveraging rapidly-scaling Astatine-211 global supply networks to ensure worldwide patient access. With its three novel and complementary HCC candidates addressing different stages of the disease, NAYA is positioned for leadership in one of the largest, fastest-growing solid tumor indications in which a majority of patients still fail to respond to standard-of-care."

NY-700 consists of an Astatine-211 isotope conjugated to our GPC3-internalizing antibody through a proprietary linker. Astatine-211, an alpha emitter radionuclide with a short half-life, high tumor specificity, and short-range cytotoxicity, shows promise to address the limitations of existing alpha emitters such as Actinium 225, which include bone marrow toxicity and decay management. GPC3 is expressed on up to 90% of HCC cells but not on healthy adult cells, enhancing precision targeting. HCC models have demonstrated that internalization of the GPC3 ligand allows intracellular delivery of the payload, inducing localized DNA damage and increasing cytotoxicity. Initial clinical data with GPC3-targeting Actinium 225 radioconjugates has shown promising efficacy in HCC.

On June 17, 2025 eXmoor Pharma, the integrated cell and gene therapy CDMO with embedded consultancy expertise, and Signadori Bio, a French biotechnology company developing next-generation cancer therapies, reported a new collaboration to accelerate the development of gene-modified monocyte-derived macrophage cell therapy targeting solid tumours (Press release, Signadori Bio, JUN 17, 2025, View Source [SID1234656408]).

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Signadori Bio, a Sofinnova Partners-backed spin-out, is advancing a promising gene-modified monocyte therapy platform aimed at overcoming the challenges of treating solid cancers, developed at the Gustave Roussy Institute, one of the world’s leading oncology centres.

Under the agreement, eXmoor Pharma will undertake a comprehensive technology translation and development programme at its Cell & Gene Therapy Centre, supporting Signadori Bio in the critical transition from discovery through to GMP-compliant manufacturing of their lead candidate. eXmoor will also provide an interim Head of CMC to integrate into Signadori Bio’s leadership team and support a structured programme of technology translation, process development and CMC planning.

This collaborative approach is designed to guide the therapy through key development milestones, with a focus on progressing the lead candidate toward GMP-compliant manufacturing and readiness for first-in-human clinical trials.

The partners will operate under a shared decision-making framework, aligning scientific, technical and commercial planning with Signadori Bio’s investment trajectory. The programme is set to transition into full process development with a long-term view toward GMP manufacturing, leveraging eXmoor’s GMP manufacturing capabilities.

Angela Osborne, CEO of eXmoor Pharma, commented:

"We are delighted to partner with Signadori Bio on such a promising and sophisticated cell therapy programme. Their approach to targeting solid tumours with gene-modified monocytes is innovative and well-grounded in translational science. At eXmoor, we are committed to supporting cell and gene therapy pioneers through the complex journey from discovery to clinical impact. This collaboration reflects our shared belief in the potential of advanced therapies to deliver meaningful outcomes for patients."

Matthieu Coutet, CEO of Signadori Bio and Partner at Sofinnova Partners, said:

"Partnering with eXmoor is a decisive step in our mission to bring next-generation monocyte-based therapies to patients with solid tumours. Their deep expertise in early-stage process development and GMP translation is exactly what we need at this critical inflection point. I’m also very pleased to welcome Evelien Stalmeijer as interim Head of CMC. Her leadership and experience will be key as we accelerate our path toward the clinic. We’re excited to work hand-in-hand with a team that understands the complexity and urgency of advancing pioneering science into impactful therapies."