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Aptose and Hanmi Enter New Loan Agreement to Advance Development of Tuspetinib in Triplet Therapy for AML

On June 20, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), reported that it has entered into a new loan agreement (the "Loan Agreement") with Hanmi Pharmaceutical Co. Ltd. ("Hanmi") (Press release, Aptose Biosciences, JUN 20, 2025, View Source [SID1234654018]). The Loan Agreement is an uncommitted facility for up to US$8.5million, administered through multiple advances for the purpose of continued clinical development of TUS.

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The Loan Agreement constitutes a "related-party transaction" within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") as Hanmi is a related party of the Company under Canadian securities laws. However, the Company is relying on the exemption from the formal valuation and minority shareholder approval requirements contained in MI 61-101 on the basis of the "financial hardship" exemption therein.

"Aptose is incredibly grateful for Hanmi’s continued support tuspetinib," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Our data to date in the TUS+VEN+AZA triplet reveal promising antileukemic activity and safety across diverse AML populations – some with the greatest unmet needs."

Tuspetinib is a convenient once daily oral agent that potently targets SYK, mutated and wild type forms of FLT3, mutated KIT, JAK1/2, and RSK2 kinases, while avoiding many typical toxicity concerns observed with other agents. The ongoing TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of azacitidine and venetoclax in newly diagnosed patients with AML who are ineligible to receive induction chemotherapy. Aptose recently reported early data from the first two dose cohorts that have demonstrated safety, CRs and minimal residual disease (MRD) negativity across patients with diverse mutations.

Anixa Biosciences to Host an Investor Webcast on June 26, 2025

On June 20, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it will host an investor webcast presentation on June 26, 2025 at 2:00 PM EDT (Press release, Anixa Biosciences, JUN 20, 2025, View Source [SID1234654017]).

During the webcast, Dr. Amit Kumar, Anixa’s Chairman and CEO, will conduct an introductory presentation that will cover key aspects of Anixa’s business including an overview of the Company’s therapeutic portfolio, its business strategy, market opportunity and near-term milestones. After the formal presentation, investors will have an opportunity to ask relevant questions through an interactive Q&A portal.

To listen to the webcast or to ask questions during the live event, please pre-register at the following link: View Source

An archived version of the webcast and presentation will be available on the Company’s website, View Source

Brenus Pharma and InSphero Have Developed 3D Tumor Spheroids Mimicking in vivo Human Colorectal Cancer Conditions and Confirming STC-1010’s Efficacy

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.

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.

Zemcelpro® (UM171 Cell Therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells

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.

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, 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.

Whitehawk Therapeutics to Participate in H.C. Wainwright "HCW@Home" Series

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]).

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.