On March 24, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the signing of a new Supply Agreement for copper-64 with UQ AIBN (Press release, Clarity Pharmaceuticals, MAR 24, 2025, View Source [SID1234651364]).

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The UQ AIBN Supply Agreement of copper-64 will support clinical trials with 64Cu-SAR-bisPSMA in Australia, offering this promising imaging agent to prostate cancer patients in need of novel diagnostic options. Additionally, the Agreement will support the rollout of 2 theranostic pre-clinical programs, 64/67Cu-SAR-bisFAP and 64/67Cu-SAR- trastuzumab.

With multiple clinical trials with 64Cu-SAR-bisPSMA, such as the ongoing registrational CLARIFY trial, Phase I/IIa theranostic SECuRE trial and the upcoming registrational Phase III AMPLIFY trial, as well as the Co-PSMA IIT, led by Prof Louise Emmett at St Vincent’s Hospital Sydney, the Agreement will provide additional capacity of copper-64 to ensure abundant and seamless supply of the isotope. The recent receipt of 2 Fast Track Designations (FTDs) by the US Food and Drug Administration (FDA) for the diagnostic 64Cu-SAR-bisPSMA product1,2 will enable Clarity to accelerate the development of its program with this optimised agent in the pre-prostatectomy setting as well as in patients with biochemical recurrence (BCR) of prostate cancer. The granting of these FTDs is indicative of the high unmet need in prostate cancer imaging despite the use of first-generation PSMA products in the market and is testament to the high quality of science and data Clarity is generating with this product.

64Cu-SAR-bisPSMA differentiates itself from the current generation of radio-diagnostics in 2 distinct ways. Firstly, the dimer "bis" molecule enables increased uptake and retention of the imaging agent in tumours3,4. Similar to Clarity’s platform SAR Technology, it has been developed in Australia, at the benchtop of Australian science, with the intent of overcoming the shortfalls of the current generation of prostate-specific membrane antigen (PSMA) targeting products. The clinical data that Clarity has generated to date confirms these results initially seen in preclinical development3,4. The second advantage is associated with the benefits of the copper-64 isotope, which has a half-life much longer (12.7 hours) than that of gallium-68 and fluorine-18 (less than 2 hours). This enables next-day imaging, a feature not available with the current-generation radio-diagnostics. Clarity’s clinical trials with 64Cu-SAR-bisPSMA to date have demonstrated a number of benefits of next-day imaging. In the Phase II COBRA study, next-day 64Cu-SAR-bisPSMA imaging enabled detection of lesions in up to 80% of participants in comparison to up to 58% on the same-day imaging, and the number of lesions detected on the next-day scans almost doubled in comparison to the same-day scans5.

In addition to the clinical benefits, the longer half-life of copper-64 enables manufacturing and logistical advantages. While the current-generation of radio-diagnostics require an expensive and extensive network of cyclotrons, radioisotope generators and radiopharmacies next to imaging sites due to their short half-life, resulting in a short shelf-life, copper-64 can be centrally produced in large volumes on existing cyclotrons. Copper-64 based diagnostics can then be manufactured and shipped as finished drug products to any treatment facility in the country, overcoming the many issues with product shortage and expiry, patient scheduling and limited geographic distribution of the current generation of products. Products like PYLARIFY are already hitting supply limits in the US due to limited cyclotron availability and the competing use of fluorine-18, which is prioritised for fluorodeoxiglucose (FDG). In contrast, copper-64 can be made on the same cyclotrons as fluorine-18, such as that at UQ AIBN, but at different times to fluorine-18, which has to be manufactured strictly in the morning in order to deliver it to patients before the half-life expires.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are pleased to continue building a successful Australian life-sciences story and benefiting Australian patients and their treating clinicians. We are proud to have been able to progress our technology from the benchtop at some of the most prominent institutes in Australia to Phase III trials at leading clinical sites in Australia and the US. This agreement with the UQ AIBN not only builds on years of close ties between Clarity and the Australian scientific and clinical communities but also reflects our strong focus on continued partnership and synergies that can be derived from these important collaborations. We are dedicated to continuing to work with the leading research and development (R&D) organisations in Australia and giving back to the scientific and clinical community in our country in order to get closer to our ultimate goal of improving treatment outcomes for people with cancer.

"UQ advanced imaging has been a long-standing collaborator of Clarity through a number of R&D initiatives, including being an active participant in the ARC Hub for AMTAR. We have experienced first-hand the strong scientific focus, drive for innovation and the collaborative community and look forward to continuing working together to bring novel products to patients in need of better diagnostic and treatment options.

"The AIBN houses an on-site cyclotron and state-of-the-art radiochemistry facilities, supplying copper-64 every week. Securing a strong supply chain is pivotal as we ramp up our clinical trials and look to generate sufficient data for the approval of 64Cu-SAR-bisPSMA. This centralised distribution strategy with the AIBN supplying copper-64 for the manufacturing of our innovative 64Cu-SAR-bisPSMA diagnostic agent will ensure that patients and clinicians have secure and seamless access to the product as we continue to generate exciting data in our trials.

"We are also committed to exploring new ways in which we can leverage our unique advantages in the development of Targeted Copper Theranostics (TCTs) to bring new products for indications with high unmet needs. As such, the Supply Agreement will also support the recently announced development of SAR-bisFAP and SAR-trastuzumab theranostic programs."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.

On March 24, 2025 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Ticker: ALOPM), a clinical-stage company developing innovative therapies to overcome immune evasion and drug resistance, reported the submission to Swiss authorities of the study protocol for its Phase 1b/2a clinical trial REVERT (RIPK2 for rEsistant and adVanced mElanoma tReatmenT) with OPM-101, its RIPK2 inhibitor in advanced melanoma patients with resistance to anti-PD-1 (Press release, Oncodesign Precision Medicine, MAR 24, 2025, https://www.businesswire.com/news/home/20250324831272/en/Oncodesign-Precision-Medicine-OPM-Announces-Protocol-Submission-for-its-Phase-1b2a-Study-REVERT-for-OPM-101-in-Combination-with-Pembrolizumab-in-Patients-with-Advanced-Melanoma-Resistant-to-Anti-PD1 [SID1234651382]). This submission of the study protocol follows the announcement of positive results from the Phase 1 study in October 2024.

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OPM-101 is a first-in-class RIPK2 inhibitor administered orally, with the potential to treat several cancers. This milestone underscores OPM’s commitment to addressing significant unmet medical needs in oncology.

Globally, melanoma accounts for approximately 325,000 new cases and more than 57,000 deaths annually, with the highest incidences observed in regions such as Europe, North America, and Oceania. In Europe, the incidence of melanoma is rising, and there is an increasing focus on improving treatments for patients who develop resistance to immune checkpoint inhibitors (ICIs) like anti-CTLA4 and anti-PD1/PD-L1 therapies. Although ICIs have become a cornerstone of advanced melanoma treatment for several years, approximately 40-60% of patients experience resistance or progression, creating a pressing need for innovative therapeutic options.

In experimental cancer models, the addition of OPM-101 to anti-PD-1 antibody therapy has been shown to significantly enhance anti-tumor efficacy and promote greater sensitivity to PD-1 blockade, delaying or reducing loss of response to ICI therapy and demonstrating durable responses in preclinical models studied to date. The OPM team has shown that the underlying mechanisms of OPM-101 involve enhanced tumor antigen presentation and recognition, associated with remodelling of CD8+ T cell infiltration into the tumor stroma. Moreover, OPM-101 alone has also demonstrated significant antitumor activity based on its immunomodulatory properties.

REVERT Study Objectives and Design

This Phase 1b/2a clinical trial is an international, multicenter, open-label study designed to assess the safety and preliminary efficacy of OPM-101 in combination with pembrolizumab in metastatic melanoma patients treated with anti-PD-1 monotherapy or combination therapy (except with anti-LAG-3), and who have developed resistance to this treatment.

The trial will include around 45 patients at 10-13 sites in Switzerland, France, Italy and Spain, and will be conducted through two main phases:

Phase 1b: to assess the safety of OPM-101 in combination with pembrolizumab in patients who have developed resistance to this treatment by anti-PD1, and to select the recommended dose to be used in the second part of the study. This phase will involve a minimum of 6 patients.
Phase 2a: to assess the Disease Control Rate (DCR), safety and key biomarkers associated with immune response with the selected dose of OPM-101 in combination with pembrolizumab in patients who have developed resistance to anti-PD-1. This phase will be conducted on an expanded sample of around 35 patients.
The Phase 1b/2a study builds on the safety data from the Phase 1 study conducted in healthy volunteers (VS) in 2023-2024, which demonstrated a favorable safety profile for OPM-101 and robust pharmacokinetic and pharmacodynamic properties.

The results of Phase 1b will be used to determine the recommended dose for Phase 2a and to gather preliminary efficacy data on a limited number of patients. All data collected during this first phase will be reviewed and analyzed by an independent panel of experts forming the Data and Safety Monitoring Board (DSMB). During this open-label Phase 2a, efficacy data will be generated and reviewed on an ongoing basis, enabling trends in treatment efficacy to be identified before the interim analysis on the first 10 patients receiving the recommended dose and the final analysis on all patients. These efficacy data will be based on the analysis of images obtained for patient follow-up after 12 and 24 weeks of treatment, making it possible to define the Disease Control Rate (DCR) and the Objective Response Rate (ORR). In addition, circulating and tumor biomarkers of antitumor activity will be measured to document OPM-101’s mechanism of action.

The study is coordinated by Pr. Olivier Michielin, Head of the Precision Medicine Oncology Service and Head of the Department of Oncology at Geneva University Hospitals in Switzerland.

Phase 1b of the study will start at the same time in several hospitals in Switzerland. Submission of the application for authorization of the clinical study to the Swiss regulatory authorities (Swissmedic) and to the Ethics Committees of the centers involved in phase 1b of the study, was completed on March 24, 2025. The study is scheduled to start by July 2025.

For phase 2b, patients will be enrolled in additional centers in France, Italy and Spain. Submission of the application for clinical trial authorization in these selected European Union countries will take place in the 4th quarter of 2025, in order to obtain authorization to conduct the extension phase of the study, which could start in the first quarter of 2026.

Completion of this Phase 1b/2a clinical trial is expected by the end of 2027.

"In parallel with phase 1 VS, which enabled us to build a solid foundation around the PK/PD relationship of OPM-101 in humans, we have explored the antitumor activity of our compound alone and in combination with an anti-PD1 in mice. These preclinical results, reinforced by many recent international publications, have convinced us of its major potential in oncology, which is in fact the company’s primary mission.", said Philippe Genne, Chairman and CEO of Oncodesign Precision Medicine. "We are continuing to work on OPM-101’s innovative mechanism of action. In the current financial climate, this study is a major choice for OPM. We are also looking for a pharmaceutical partner to explore its potential in the treatment of IBD – Chronic Inflammatory Bowel Disease."

"Immunotherapy represents a real revolution for many patients suffering from many different types of cancer. This therapeutic approach is fundamentally changing the way we treat cancers by stimulating our immune system to attack and kill cancer cells. These approaches are the result of over a century of investigation and therapeutic advances. Immune checkpoint inhibitors (ICIs) such as anti-PD1s have been used for more than 10 years in several types of cancer, including melanoma and lung cancer. These therapies have proven highly effective with long-lasting responses, marking dramatic progress for many patients," added Jan Hoflack, Scientific Director of Oncodesign Precision Medicine. "Nevertheless, they come with a greater risk of toxicity including immune-related side effects, and a significant number of patients are or become resistant to these approaches. OPM-101, our RIPK2 inhibitor, has the potential to increase the response rate and reduce the side effects of these ICIs. This is what we will be evaluating in this Phase 1b/2a study in melanoma."

Prof. Olivier Michielin, Head of the Precision Oncology Service and Head of the Department of Oncology at the University Hospitals of Geneva, concluded: "Checkpoint inhibitors have revolutionized the management of melanoma. Despite high response rates in the advanced setting and clearly demonstrated long-term benefit, most patients progress under these treatments. Strategies to counteract the mechanisms of resistance to checkpoint inhibitors are therefore essential. OPM’s clinical trial is therefore extremely important, as it addresses exactly this population for whom we lack therapeutic options. What’s more, the prospect of being able to increase the efficacy of checkpoint inhibitors, while reducing toxicity, is of course extremely attractive and will be one of the hypotheses tested with OPM-101, as part of the study."

About OPM-101 in Oncology

OPM-101 is a first-in-class, potent, selective, orally available RIPK2 kinase inhibitor in oncology that has demonstrated the ability to maximize the immunogenicity of tumor cell death and activate a systemic anti-tumor immune response. Although initially linked to chronic inflammatory diseases, the RIPK2 pathway has been increasingly recognized since 2022 as a critical player in tumor progression. In preclinical studies, OPM-101 exhibited synergistic effects with anti-PD1 therapies, enhancing anti-tumor immunity and overcoming resistance in models treated with checkpoint inhibitors alone.

On March 24, 2025 Foghorn Therpaeutics presented its corporate presentation (Presentation, Foghorn Therapeutics, MAR 24, 2025, View Source [SID1234651365]).

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On March 24, 2025 CEL-SCI Corporation (NYSE American: CVM) reported new data has been published from its prior Phase 3 study of Multikine* (Leukocyte Interleukin, Injection) in newly diagnosed, treatment naïve, resectable, locally advanced head and neck cancer patients in the highly regarded peer reviewed journal Pathology and Oncology Research (POR) (Press release, Cel-Sci, MAR 24, 2025, View Source [SID1234651383]). The article titled "Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study" included a comprehensive presentation of results from CEL-SCI’s Phase 3 trial, the largest study ever conducted for newly diagnosed locally advanced head and neck cancer.

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"We are pleased that the wealth of data resulting from our completed Phase 3 study is now published in this international oncology journal," stated CEL-SCI’s Chief Scientific Officer, Dr. Eyal Talor. "We believe the marked improvement in quality of life offered by Multikine neoadjuvant treatment appeared to have had a positive impact on patients’ quality of life, and in addition to its favorable safety profile, tolerability and efficacy, it is likely to improve adoption rates for Multikine following regulatory approval."

The new, previously unpublished findings included the following patient quality of life data:

Quality of life (QoL) was assessed and validated through use of two instruments, EORTC QLQ-C30 and EORTC QLQ-H&N 35 across all clinical sites.
EORTC QLQ-C30 is a 30-item questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related QoL of cancer patients.
EORTC QLQ-H&N 35 is a questionnaire designed to assess the QoL of head and neck cancer patients in conjunction with the general cancer-specific EORTC QLQ-C30.
QoL variables were assessed at baseline, before and after the Multikine treatment, and periodically during long-term follow up. These assessments included questions regarding pain in the mouth, jaw, and throat, problems swallowing, sense of smell and taste, ability for selfcare and mobility including walking, using the toilet, shortness of breath, emotional wellbeing including irritability and depression, and many other daily health assessment factors.
As a neoadjuvant therapy, patients were treated with Multikine before surgery. Pre-surgery objective early response to treatment with Multikine was confirmed by pathology at surgery. There were 45 objective early responders (which included 5 complete responders following 3-weeks of Multikine treatment) in the Multikine treated + standard of care group and zero (none reported by investigators) in the control group, which received the standard of care treatments only (i.e., surgery plus radiotherapy or surgery plus chemoradiotherapy; with cisplatin as the chemotherapeutic agent per the study protocol and NCCN Guidelines).
95.1% of complete responders to Multikine reported improved QoL
Complete responders reported a 100% (wherein all respondents scored the highest possible improvement from baseline) on 60% (39/65) of the QoL measures assessed including sleep, appetite, pain, emotional state, condition of mouth, sense of smell and taste, and social, family and public interactions.
QoL results for complete responders were measured and sustained for over 3 years following treatment with Multikine.
89.4% of partial responders to Multikine (those exhibiting greater than 30% reduction in tumor – confirmed by pathology at surgery) also reported improved assessed QoL measures from baseline.
About the Completed Phase 3 and Upcoming Confirmatory Registration Study

Based on the exceptional efficacy results and favorable safety profile for Multikine in a cohort of patients in the Phase 3 study, the U.S. Food and Drug Administration has given CEL-SCI the go ahead to initiate a confirmatory Registration Study of Multikine in newly diagnosed, previously untreated resectable stage 3 and 4 head and neck cancer patients who had no lymph node involvement and low PD-L1 tumor expression. There is a high unmet need in this patient population, for which no advancement in overall survival has been forthcoming in decades, despite many previous attempts by others.

Upon the Registration Study achieving full enrollment, CEL-SCI plans to seek early approval based on early tumor responses which were shown to correspond with survival rates. During the completed Phase 3 clinical trial, the 5-year overall survival rate of the target patient population (disease stage 3 and 4 patients who had no lymph node involvement and low PD-L1 tumor expression), which is the same population that will participate in the confirmatory study, increased to 73% when patients were treated with Multikine vs 45% for control patients who received only standard of care treatments.

About Pathology and Oncology Research (POR)

A Switzerland-based highly regarded international journal, POR is dedicated to keeping scientists informed of developments in its focused biomedical fields which span the gap between basic research and clinical medicine.

On March 24, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported 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 (Press release, IMUNON, MAR 24, 2025, View Source [SID1234651366]). The company is currently initiating trial sites and working with trial investigators to begin enrolling study participants.

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"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.