On June 18, 2025 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported a significant milestone: the treatment of the second patient with the Hemopurifier in its Australian safety, feasibility and dose-finding clinical trial of the Hemopurifier (Press release, Aethlon Medical, JUN 18, 2025, View Source [SID1234653988]). This trial is designed for patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda (pembrolizumab) or Opdivo (nivolumab) (AEMD-2022-06 Hemopurifier Study). The patient was treated with the Hemopurifier June 11, 2025 by Genesis Care and Royal North Shore Hospital/University of Sydney. Professor Stephen Clarke, Medical Oncologist, is the Principal Investigator for the study and the Hemopurifier session was supervised by Dr. Emma O’Lone.

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Ongoing progress has been made in our Australian Oncology trial of the Hemopurifier in participants with solid tumors not responding to anti-PD-1 agents. We have now completed Hemopurifier treatments in 2 participants in the first cohort. Our first participant completed the Hemopurifier treatment at Royal Adelaide Hospital on January 29, 2025. Participant # 2 was treated with the Hemopurifier at Royal North Shore/University of Sydney on June 2, 2025. Both participants completed the 4-hour Hemopurifier treatment without device deficiencies or immediate complications. As of June 10, 2025, both patients have completed the pre-specified 7-day safety follow-up period that will be presented to an independent Data Safety Monitoring Board (DSMB) following the treatment of a third patient in the cohort.

The DSMB will review safety data on this first cohort and provide a recommendation to Aethlon Medical Senior Leadership about advancing to the second treatment cohort where 3 participants will receive 2 Hemopurifier treatments during a one-week period. We would expect data on extracellular removal by the Hemopurifier and effects on anti-tumor T cell activity on participants in the first cohort in approximately three months following enrollment of the third patient.

"We are pleased that both patients treated with the Hemopurifier thus far have tolerated the 4-hour treatment without immediate complications. We look forward to enrolling the third participant to trigger a safety review of the first cohort by the DSMB," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical.

Currently, only approximately 30-40% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples.

The primary endpoint of the approximately 18-patient, safety, feasibility, and dose-finding trial is the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run-in period of PD-1 antibody, Keytruda or Opdivo monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2, or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.

About the Hemopurifier

The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation. The Hemopurifier is an extracorporeal device that is used in concert with a blood pump. The device incorporates plasma separation, size exclusion, and affinity binding to an affinity resin containing a plant lectin. Mannose on the surface of enveloped viruses and extracellular vesicles binds to the plant lectin within the device. Extracellular vesicles released from solid tumors have been implicated in the spread of cancers known as metastasis as well as in the resistance to immunotherapy and chemotherapeutic agents. Removal of enveloped viruses and extracellular vesicles has been observed in in vitro studies and in human subjects. The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard-of-care therapy. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.

On June 18, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel immuno-oncology payload antibody drug conjugates (ADCs) for the treatment of cancer, reported the Intellectual Property India (IPI) has issued Patent No. 562,919 titled,"Thailanstatin Analogs" (Press release, Akari Therapeutics, JUN 19, 2025, View Source [SID1234654005]).

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The issued patent covers claims for the Company’s potent immuno-oncology PH1 payload, proprietary non-cleavable and cleavable linkers and ADC technology which has applications across various cancer targets.

"We believe our innovative ADC payload PH1 has the potential to provide therapies that disrupt cellular function, trigger cancer cell death and most importantly, enhance the immune system to fight cancer beyond the cells targeted by the ADC molecule. The issuance of this patent further strengthens our global intellectual property estate and importantly, provides additional patent protection around our CMC manufacturing activities for this PH1payload and related analogs. Importantly, as cancer rates and diagnosis continue to rise significantly in India, we believe the need for innovative cancer therapies continue to increase. We are pleased to bolster our intellectual property portfolio to include this key market for future opportunities to potentially help cancer patients with our immuno-oncology ADCs," commented Abizer Gaslightwala, President and CEO of Akari Therapeutics.

The issued India patent is a divisional patent of the Company’s R&D toxin portfolio on PH1 and builds on the portfolio of previously issued patents (Patent No. US 10,815,246 B2, Patent No. US 10,301,319 B2 and Patent No. US 11,691,982 B2). Grant Patent right for PCT/US2018/051721 family was issued by China National Intellectual Property Administration in August 2023, and in Israel in September 2023. Corresponding foreign patent applications are pending and currently undergoing examination in Patent Cooperation Treaty ("PCT")countries – Brazil, Canada, member states of the European Patent Organisation ("EPO"), Hong Kong, Japan, New Zealand, Singapore, & South Africa.

Leveraging its innovative payload platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates across a wide range of cancer tumor targets. These initial candidates have shown significant tumor-killing activity in preclinical models with the ability to robustly activate the immune system to drive durable, and sustained outcomes.

On June 18, 2025 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, reported presentations at the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, to be held June 21 to 24, 2025, in New Orleans, LA (Press release, Blue Earth Diagnostics, JUN 18, 2025, View Source [SID1234653989]).

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The company will unveil new clinical data on its prostate-specific membrane antigen (PSMA)-targeted PET agent and share clinical results that demonstrate potential applications of 18F -fluciclovine in detection of multiple myeloma* and for patients with negative PSMA scans. "Physicians must be equipped with accurate, actionable molecular imaging to guide more informed clinical decisions," said Marco Campione, President and CEO of Blue Earth Diagnostics. "At SNMMI, we look forward to sharing new analyses and scientific information about POSLUMA and Axumin with the molecular imaging community – highlighting our commitment to delivering innovative solutions for improved patient care."

Blue Earth Diagnostics will be presenting seven abstracts around POSLUMA at SNMMI, including an analysis on the prognostic value of baseline 18F-flotufolastat PET bone tumor metrics for the occurrence of severe hematologic toxicity in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA-I&T.

The Company will also present clinical data around Axumin, highlighting the role of 18F-fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT, and potential applications in multiple myeloma.

Blue Earth Diagnostics invites participants at the 2025 SNMMI Annual Meeting to attend the presentations below and to visit the Company at Exhibit Booth 1513.

POSLUMA (flotufolastat F 18)

DATE: Sunday, June 22, 2025
Title: Impact of Baseline 18F-Flotufolastat PET Bone Tumor Volume for Prognosticating Severe Hematologic Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Receiving 177Lu-Labeled PSMA-Targeted Radioligand Therapy
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Oral presentation
Session Time: 5:00 – 5:30 PM CT
Abstract ID.: 251321

DATE: Sunday, June 22, 2025
Title: Prognostic 18F-Flotufolastat PET Parameters for Outcome Assessment of 177Lu-labeled PSMA-targeted Radioligand Therapy in Metastatic Castration-resistant Prostate Cancer
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1324

DATE: Sunday, June 22, 2025
Title: Follow-up 18F-Flotufolastat PET after negative baseline PET in Patients with Suspected Biochemical Recurrence of Prostate Cancer after Radical Prostatectomy
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1319

DATE: Sunday, June 22, 2025
Title: 18F-Flotufolastat PET/MRI in Suspicious Prostate Cancer: Correlation with Histopathological Biopsy Results
Presenter: Nicola Gabler, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1318

DATE: Sunday, June 22, 2025
Title: Real-World Experience on the Diagnostic Efficacy of 18F-Flotufolastat PET/CT in Preoperative N-Staging as Assessed by Readers of Varying Experience Levels
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1457

DATE: Sunday, June 22, 2025
Title: Impact of PSMA-PET based eligibility criteria using 18F-rhPSMA-7.3 (Flotufolastat) on outcome of Lutetium PSMA radioligand therapy
Presenter: Sonia Grigorascu, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 251150

DATE: Sunday, June 22, 2025
Title: Prognostic Value of 18F-rhPSMA-7.3 (Flotufolastat-F18) PET Using Visual RECIP During Taxane-based Chemotherapy in Prostate Cancer
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1821

Axumin (fluciclovine F 18) and investigational 18F-fluciclovine
DATE: Sunday, June 22, 2025
Title: 18F-Fluciclovine PET/CT detects more lesions with higher quantitative PET parameters than 18F-FDG PET/CT in multiple myeloma*
Presenter: Liza Lindenberg, M.D., Associate Research Physician, National Cancer Institute, Molecular Imaging, Bethesda, Maryland
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 251312

DATE: Monday, June 23, 2025
Title: Do racial differences impact salvage radiotherapy outcomes for prostate cancer recurrence?
Presenter: Ismaheel Lawal, Senior Research Fellow, Emory University, Department of Radiology and Imaging Sciences, Atlanta, Georgia
Session Type: Poster presentation
Session Time: 12:30 – 1:15 PM CT
Abstract ID.: 251471

DATE: Tuesday, June 24, 2025
Title: Role of 18F-Fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT
Presenter: Nadine Mallak, M.D., Associate Professor, Oregon Health and Science University, Department of Diagnostic Radiology Molecular Imaging & Therapy, Body Imaging Director, PET/MRI, Clinical, Portland, Oregon
Session Type: Poster presentation
Session Time: 9:30 – 9:40 AM CT
Abstract ID.: 251638

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 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.