On June 18, 2025 Cebiotex reported that the clinical trial to evaluate the safety, pharmacokinetics and efficacy of CEB-01 in locally resectable abdominal tumours of children has been green lighted by the regulatory authorities (Press release, Cebiotex, JUN 18, 2025, View Source [SID1234653973]). This is a basket trial designed for pediatric patients under 18 years of age diagnosed with de novo or recurrent soft tissue sarcoma, neuroblastoma, or other rare tumors such as Wilms’ tumor or germ cell tumors.

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Why it matters
It marks the first time that the potent active substance SN-38 is being evaluated in these patients as a local chemotherapy, with the goal of controlling tumor recurrence and addressing an unmet medical need. This step brings us closer to delivering new therapeutic options to children with rare cancers.

Thank You
This milestone reflects the commitment to developing innovative surgical treatments for children of our team and collaborators in Hospital Sant Joan de Déu Barcelona, i4KIDS I i4KIDS-EUROPE and Ship2B Ventures.

On June 18, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL’s registrational PATHFINDER 2 study (Press release, Grail, JUN 18, 2025, View Source [SID1234653986]). PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri multi-cancer early detection (MCED) test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer.

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In the previously published PATHFINDER study, adding Galleri to standard of care cancer screening more than doubled the overall number of cancers detected by screening. In PATHFINDER 2, adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection than in PATHFINDER.

In PATHFINDER, Galleri demonstrated a positive predictive value (PPV), or likelihood that a positive Galleri test was confirmed to be cancer, of 43%; specificity of 99.5%; and 88% cancer signal origin (CSO) accuracy. Data from evaluable PATHFINDER 2 participants with 12 months of follow-up showed a substantially higher PPV than that observed in the PATHFINDER study. CSO accuracy and specificity were consistent with that observed in the PATHFINDER study.

There were no serious safety concerns reported in PATHFINDER 2.

"We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial’s prevalent screening round," said Josh Ofman, MD, MSHS, President at GRAIL. "We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward. We look forward to sharing the detailed PATHFINDER 2 data at a medical congress later this year."

PATHFINDER 2 study results will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premarket approval application (PMA), along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA bridging analyses to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The PMA for Galleri is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. GRAIL expects to complete the PMA modular submission in the first half of 2026.

Detailed results from the PATHFINDER 2 study will be submitted for presentation at a leading international oncology meeting before the end of the year.

About the PATHFINDER 2 Study (NCT05155605)
PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and effectiveness of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Secondary objectives include utilization of guideline-recommended cancer screening procedures after use of the MCED test, and participant reported outcomes (PRO) over several time points, including an assessment of participants’ anxiety and satisfaction with the MCED test.

On June 18, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapeutics for rare and inflammatory diseases, reported encouraging preclinical results from a multi-dose study of HT-KIT, its investigational oncology candidate targeting the c-KIT pathway (Press release, Hoth Therapeutics, JUN 18, 2025, View Source;dose-dependent-liver-activity-with-no-observed-toxicity-supports-ind-pathway-302484836.html [SID1234653987]).

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The study demonstrated a clear dose-responsive effect on liver mass with no observable toxicity or organ pathology, reinforcing the favorable safety profile of HT-KIT as the Company prepares for further toxicology studies and regulatory advancement.

Key Preclinical Findings (HT-KIT):

Liver weight increased from 1.11g at 0 mg/kg to 1.32g at 3.0 mg/kg, consistent with pharmacological engagement.
Kidney and spleen weights remained stable, indicating no off-target or systemic toxicity.
Thymus and other critical organ weights were within normal range across all groups.
No gross pathology or visible lesions observed in any treated animal.
"These clean and compelling safety results validate our confidence in HT-KIT," said Robb Knie, CEO of Hoth Therapeutics. "A dose-dependent biological signal without organ damage strongly supports our plan to move forward with GLP studies and an IND submission."

Hoth Therapeutics expects to initiate GLP toxicology studies, with plans to submit an Investigational New Drug (IND) application soon after.

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.