On June 19, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved ADC cancer treatments, reported that Dave Lennon, PhD, President and CEO, and David Dornan, PhD, Chief Scientific Officer, will participate in the virtual H.C. Wainwright "HCW@Home" series on Thursday, June 26, 2025, at 10 AM ET (Press release, Whitehawk Therapeutics, JUN 19, 2025, View Source [SID1234654008]).

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To register in advance, please use this link. A live webcast of the event can be accessed by visiting the "Investors & News" page on the Whitehawk Therapeutics website and will be available for replay for approximately 30 days following the event.

On June 19, 2025 ExCellThera Inc. (ExCellThera), a world leader in blood stem cell expansion and metabolic fitness, reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending granting conditional marketing authorization for Zemcelpro for the treatment of adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available (Press release, ExCellThera, JUN 19, 2025, View Source [SID1234654009]). The European Commission (EC) is expected to make a final decision within approximately two months following CHMP recommendation, and the decision will apply to all 27 European Union (EU) Member States, Iceland, Norway and Liechtenstein.

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Zemcelpro, also known as UM171 Cell Therapy, is a novel cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

If approved, Zemcelpro is expected to be the first and only therapy in the EU with marketing authorization for adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available. Every year in Europe there are over 10,000 new cases of patients with haematological malignancies, including leukemias and myelodysplastic syndromes, requiring bone marrow transplant, and a number of these patients do not have access to suitable donor cells for different reasons, including the absence or unavailability of suitably matched donors.

The positive CHMP opinion was based on the conditional Marketing Authorization Application (MAA) for Zemcelpro. Additional filings are planned for Zemcelpro with other health authorities, including in the US, Canada, the UK, and Switzerland.

"Each year, thousands of people in Europe are diagnosed with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation, and it’s an upsetting reality that a number of them don’t have access to suitable donor-derived stem cells," said Dr. Guy Sauvageau, CSO and Founder of ExCellThera.

"With today’s positive opinion, we are closer to bringing the life-changing potential of Zemcelpro to patients with at-risk haematological malignancies in the EU," said David Millette, CEO of ExCellThera. "We are proud to bring our transformative cell therapy innovation to patients who continue to have unmet medical needs."

The safety of Zemcelpro is consistent with the well-characterized safety profile of conventional allogeneic blood stem cell transplantation for haematological malignancies following myeloablative conditioning.

ExCellThera extends its sincere gratitude to the patients and investigators who have contributed to the clinical development of Zemcelpro.

About Zemcelpro

Zemcelpro, also known as UM171 Cell Therapy, is a novel cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

Zemcelpro, developed by Cordex Biologics, a wholly owned subsidiary of ExCellThera, has been evaluated in 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA.

Zemcelpro has been tested in Phase 2 trials in patients with high and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible.

The use of Zemcelpro in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being explored.

The product is not yet approved for marketing by the EMA and remains subject to European Commission decision. Its safety and efficacy have not been established by other regulatory agencies, such as the FDA and Health Canada.

On June 19, 2025 Brenus Pharma, a French biotech developing next-generation first-in-class immunotherapies, and InSphero, a Swiss leader in 3D cell-based assay technologies, reported promising data at the European Association for Cancer Research 2025 annual congress (Press release, Brenus Pharma, JUN 19, 2025, View Source [SID1234654010]). These data confirm the use of 3D tumor spheroids for potency testing of STC-1010, Brenus’ lead candidate for colorectal cancer.

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Funded through the EUROSTARS program, the collaboration led to vitrified 3D colorectal cancer spheroids using tumor cell lines co-cultured with fibroblasts. The vitrification method preserves morphology, stromal integrity, and viability after thawing, enabling realistic evaluation of STC-1010’s therapeutic potential under conditions mimicking in vivo human tumors.

Previous studies showed that STC-1010 antigens were effectively processed by monocyte-derived dendritic cells (mMo-DCs), activating CD8+ T cells. These T cells induced apoptosis in both 2D and 3D colorectal cancer models and released anti-tumor cytokines (IFNγ and Granzyme B). These data reinforce the therapeutic potential of STC-1010.

"This collaboration has enabled us to assess the highly representative and scalable 3D model into our SGC platform. It’s a major step forward in our ability to assess potency and accelerate the development of STC-1010 and future candidates." Benoit Pinteur, CSO of Brenus Pharma.

"We are proud to support Brenus with our cryopreserved 3D tumor models. This work illustrates how advanced in vitro systems can bring immunotherapies closer to clinical reality." Jan Lichtenberg, CEO of InSphero.

On June 19, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported further data from the ongoing ACCENT trial investigating the Company’s best-in-class FAK inhibitor narmafotinib in advanced pancreatic cancer (Press release, Amplia Therapeutics, JUN 19, 2025, View Source [SID1234653983]). A second patient of the 55 patients enrolled in the trial has recorded a confirmed complete response (CR). This finding follows the announcement earlier this week1 of a separate patient who achieved a pathological CR in the trial.

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A confirmed complete response is a formal designation of response where there is a complete disappearance of all tumour lesions that is maintained for >2 months. This is a rare outcome in advanced pancreatic cancer where the disease has spread to other parts of the body. For example, the seminal study demonstrating efficacy of the chemotherapies gemcitabine and Abraxane in advanced pancreatic cancer reported only one (1) CR out of 431 patients.

Amplia CEO and MD Dr Chris Burns commented: "To see a second complete response in the ACCENT trial is really wonderful news, particularly given how rare these are observed in advanced pancreatic cancer. Along with the pathological CR announced earlier in the week, this outcome further demonstrates the promising activity narmafotinib, on top of standard-of-care, is showing in pancreatic cancer."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies.

About the ACCENT Trial

The ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.

The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed in November 2023, determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics and preliminary efficacy when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.

The second stage (Phase 2a) of the trial is designed to assess efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed.

The trial is being conducted at seven sites in Australia and five sites in South Korea.

More information about the ACCENT trial can be found via the ACCENT trial site, the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.

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.