Sumitomo Pharma America Achieves Key Patient Enrollment Milestone for Pivotal Phase 2 Study of Enzomenib in the Treatment of Relapsed/Refractory Acute Leukemia

On June 10, 2026 Sumitomo Pharma America, Inc. (SMPA) reported that it has enrolled the required number of participants in its pivotal Phase 2 monotherapy trial for enzomenib, an investigational, oral selective menin inhibitor for the treatment of relapsed/refractory acute leukemia with KMT2A rearrangement, to allow for interim analysis. Achieving this milestone will enable SMPA to obtain results of the interim analysis by the end of calendar year 2026. These results will be promptly disclosed, with detailed data to be presented at an upcoming medical congress. If the primary endpoint is met, SMPA would then proceed with preparation for regulatory submission with the aim of obtaining approval in the US and Japan during FY2027.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Acute leukemias, especially at the relapsed/refractory stage, are profoundly difficult to treat, and are associated with very poor outcomes," said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. "Achieving this enrollment milestone is an important step in our efforts to bring a new, differentiated therapeutic option to acute leukemia patients and their families. My sincere thanks to the patients who are taking part in this study to further our scientific understanding of leukemia treatment."

In addition to this study, SMPA continues to enroll patients in its pivotal Phase 2 monotherapy study of enzomenib in patients with relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutation.

About Leukemia

Leukemia is a type of cancer that forms in blood-forming tissue, characterized by the uncontrolled growth of blood cells, usually white blood cells, in the bone marrow. Acute leukemia, a form of leukemia, requires immediate treatment as blood cells multiply rapidly leading to a sudden onset of symptoms.1 Approximately 30% of patients with AML have NPM1 mutations,2 and 5%-10% of patients with AML have KMT2A rearrangements.3

About Enzomenib (DSP-5336)

Enzomenib is an investigational, oral, small molecule inhibitor of the menin and lysine (K)-specific methyltransferase 2A (KMT2A) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and growth. Menin is a scaffold nuclear protein that plays key roles in gene expression and protein interactions involved in many biological pathways, including cell growth, cell cycle, genomic stability, and hematopoiesis.4,5 In preclinical studies, enzomenib has shown selective growth inhibition in human acute leukemia cell lines with KMT2A rearrangements or NPM1 mutations.4,6 Enzomenib reduced the expression of the leukemia-associated genes HOXA9 and MEIS1 and increased the expression of the differentiation gene CD11b in human acute leukemia cell lines with KMT2A rearrangements and NPM1 mutation.7,8 The safety and efficacy of enzomenib is currently being clinically evaluated in a Phase 1/2 dose-escalation/dose-expansion study in patients with relapsed or refractory acute leukemia (NCT04988555) and the registrational Phase 2 Horizen-1 R/R mono AML/ALL (KMT2Ar + NPM1m) study. The FDA granted Orphan Drug Designation for enzomenib for the indication of acute myeloid leukemia in June 2022. The FDA granted Fast Track Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in June 2024. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted Orphan Drug Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in September 2024.

(Press release, Sumitomo Dainippon Pharma, JUN 10, 2026, View Source [SID1234666545])

Matter Bio Announces FDA Clearance of IND Application for LM-LLO-TT in Pancreatic Ductal Adenocarcinoma

On June 10, 2026 Matter Bio, a biotechnology company developing next-generation immunotherapies for difficult-to-treat cancers, reported that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application for LM-LLO-TT, its attenuated Listeria monocytogenes-based immunotherapy candidate for the treatment of pancreatic ductal adenocarcinoma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FDA clearance allows Matter Bio to proceed with a first-in-human Phase 1/2a clinical trial designed to evaluate the safety, tolerability, dose optimization, and preliminary anti-tumor activity of LM-LLO-TT in patients with pancreatic ductal adenocarcinoma.

"This FDA clearance represents a major milestone for Matter Bio and marks our official transition into a clinical-stage company," said Christopher Bradley, CEO of Matter Bio. "Pancreatic ductal adenocarcinoma remains one of the most challenging cancers to treat, and we believe LM-LLO-TT has the potential to activate tumor-directed immune responses in a way that could meaningfully contribute to the next generation of cancer immunotherapy."

LM-LLO-TT is designed to leverage an attenuated Listeria monocytogenes platform to stimulate targeted immune activity against tumor-associated antigens. The upcoming Phase 1/2a study will assess LM-LLO-TT in patients with pancreatic ductal adenocarcinoma, with the goal of establishing an appropriate dose and generating early clinical evidence to support further development.

The IND clearance follows Matter Bio’s previously announced IND submission and reflects continued execution of the Company’s development strategy for LM-LLO-TT.

"This milestone is the result of significant work across our scientific, clinical, regulatory, and manufacturing teams," said Dr. Sam Sharifi, CSO of Matter Bio. "We are grateful to our collaborators and advisors who have helped advance LM-LLO-TT to this important stage, and we look forward to initiating clinical evaluation."

(Press release, Matter Bio, JUN 10, 2026, View Source [SID1234666544])

Harbour BioMed Announces NMPA Acceptance of IND Application for HBM7004 for the Treatment of Advanced Solid Tumors

On June 10, 2026 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, reported that the National Medical Products Administration (NMPA) of China has accepted the Investigational New Drug (IND) application for HBM7004 for the treatment of advanced solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the Company’s HBICE platform. This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy with the potential to enhance both efficacy and safety. The development of HBM7004 further demonstrated the HBICE platform’s versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window.

"Following the recent FDA IND clearance for HBM7004, we are pleased that the NMPA has accepted the IND application for HBM7004 for the treatment of advanced solid tumors," said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. "HBM7004 exemplifies our strategy of leveraging our proprietary technology platforms to develop differentiated next-generation immunotherapies that address significant unmet medical needs in oncology. Supported by encouraging preclinical data, we look forward to working closely with regulatory authorities and advancing this program toward clinical evaluation in China."

(Press release, Harbour BioMed, JUN 10, 2026, View Source [SID1234666543])

Zemcelpro® (UM171 Cell Therapy) licensing and supply agreements announced for Canada

On June 10, 2026 ExCellThera Inc. ("ExCellThera"), a global leader in blood stem cell expansion and metabolic fitness technologies, together with its wholly owned subsidiary Cordex Biologics ("Cordex"), reported exclusive licensing and supply agreements granting Medexus the Canadian commercialization rights for Zemcelpro (dorocubicel), also known as UM171 Cell Therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Zemcelpro is a novel personalized cryopreserved hematopoietic 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. The product is used to treat hematological malignancies (blood cancers), such as leukemias and myelodysplasias. Given the product’s current stage of development in Canada, Medexus does not expect to begin commercializing the product before calendar year 2028 (depending on available regulatory pathways). As part of the regulatory process, Medexus intends to seek Health Canada approval of the brand name Zemcelpro.

"These agreements with Medexus represent today an important milestone and reflect our continued commitment to advancing Zemcelpro for patients with significant unmet medical needs," said David Millette, CEO of Cordex. "In addition to the strong commercial opportunity this partnership creates, we believe it has the potential to meaningfully improve access to innovative therapies for Canadian patients with high-risk blood cancers requiring allogeneic stem cell transplantation, where new treatment options remain critically needed."

Medexus is a leading specialty pharmaceutical company with extensive experience in hematology and oncology, making it a strong strategic fit for the partnership with Cordex.

Importantly, this agreement also represents a broader step forward in Cordex’s global commercialization strategy for Zemcelpro. Cordex continues to actively pursue additional strategic partnerships to support and accelerate the commercialization of Zemcelpro across Europe and other international markets.

"We believe there is substantial global interest in innovative therapies that address persistent unmet needs in blood malignancies and conventional stem cell transplantation, and we remain focused on identifying partners with the expertise, infrastructure, and shared vision necessary to expand patient access worldwide," said David Millette. "As we advance these discussions, our priority remains clear: bringing innovative and potentially life-changing therapies to patients who urgently need new treatment options while creating long-term value for our stakeholders."

The transaction includes royalties on Canadian net sales and milestone payments, creating a shared economic interest in the product’s long-term commercial success. Cordex will continue to manage the clinical program and will be responsible for the manufacturing and supply of Zemcelpro to Medexus.

About Zemcelpro

Zemcelpro (dorocubicel), also known as UM171 Cell Therapy, is a novel personalized 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 has recently received conditional marketing authorization from the European Commission for the treatment of adults with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation following myeloablative conditioning, for whom no other suitable donor cells are available. For complete product information, including warnings and precautions for use and adverse reactions (and their appropriate management), please refer to the EU Summary of Product Characteristics (SmPC) for Zemcelpro.

Additional regulatory filings are planned for Zemcelpro with other health authorities, including in the US, Canada, the UK, and Switzerland.

Zemcelpro has been evaluated in over 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 investigated.

The product safety and efficacy have not yet been established by other regulatory agencies, such as the U.S. FDA, the MHRA and Health Canada.

(Press release, ExCellThera, JUN 10, 2026, View Source [SID1234666542])

Aethlon Medical Announces Fiscal Year End March 31, 2026 Financial Results and Corporate Update

On June 10, 2026 Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a clinical-stage medical therapeutic company focused on developing products to treat cancer and life-threatening viral infections for which there is no treatment, reported financial results for its fiscal year ended March 31, 2026, and provided an update on recent developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key Highlights

Advanced the Australian oncology study through completion of the first two cohorts and entered the third and final dosing cohort, representing a key clinical milestone toward generating data to inform future development and dosing strategy.

Recently treated the first participant in Cohort 3 at Royal North Shore Hospital in Australia. The participant completed three Hemopurifier treatments over a one-week period, marking continued enrollment momentum and execution of the study’s final treatment arm.

Advanced preclinical research evaluating Hemopurifier applications in additional disease areas, including rheumatoid arthritis and chronic kidney disease, supporting the expansion of the platform’s potential addressable market beyond oncology and infectious disease.

Continued to strengthen the intellectual property portfolio supporting the Hemopurifier platform, including the issuance of patents in the United States and Europe covering potential applications for long COVID and other coronavirus-related conditions, extending patent protection into the 2040s and enhancing long-term platform value.
"Fiscal 2026 was a year of meaningful execution for Aethlon as we advanced our Australian oncology study through the first two cohorts and recently initiated Cohort 3. Advancement into the final cohort represents an important clinical milestone as we work toward generating data that may help define the optimal treatment regimen and guide future development decisions. We also strengthened the Hemopurifier platform through expansion of our intellectual property portfolio and advancement of preclinical research supporting potential applications beyond oncology. Combined with our continued focus on managing operating expenses, these achievements position us to pursue multiple value-creating opportunities across our clinical and research programs." said James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical.

Clinical Update

Clinical Progress in Cancer Trial

Enrollment and treatment of participants in Cohort 2 of the Australian oncology trial have been completed. An independent Data Safety Monitoring Board reviewed the data, identified no safety concerns based on its review of available data, and recommended advancing to the third and final cohort. Screening is actively underway at the three investigative sites for this final cohort where 3-6 participants will be treated with 3 Hemopurifier sessions during a 1-week period. The first participant in Cohort 3 of the study has been enrolled and received three Hemopurifier treatments without any device deficiencies or immediate complications and is now in the follow-up period. Successful enrollment and treatment of the first participant in Cohort 3 maintains the study’s clinical momentum and moves the Company closer to completing enrollment and generating data from all planned dosing regimens.

Serial Extracellular Vesicle and T cell measurements on participants in cohort 2 have been measured by the central lab at the University of Sydney. Formal statistical analyses comparing the effects of the three different Hemopurifier dosing regimens on these parameters will be performed by a CRO at the completion of the trial. This nine-to-18 patient study is designed to evaluate the safety and feasibility of the Hemopurifier treatments and determine the appropriate dosing in participants with solid tumors whose disease is stable or progressing while on a treatment that includes the anti-PD-1 agents, Keytruda or Opdivo.

Other Recent Developments

During fiscal 2026, we strengthened our intellectual property portfolio through the issuance of patents in both the United States and Europe covering 2 potential applications of the Hemopurifier for coronavirus-related conditions; excessive clotting known as coagulopathy during acute COVID-19 infection and symptoms of Long COVID. These patents extend protection for certain applications of the Hemopurifier into the 2040s.

In addition, we advanced our preclinical extracellular vesicle (EV) research activities, including studies evaluating removal of EVs in plasma samples from patients with rheumatoid arthritis and chronic kidney disease. These efforts support the Company’s ongoing evaluation of the Hemopurifier’s potential applications across multiple disease categories and may create future opportunities to expand the platform into large markets characterized by significant unmet medical need.

Separately, we continued our evaluation of Hemopurifier compatibility with a simplified blood treatment system being developed by Stavro Medical. Initial testing assessing flow rates and transfer of fluid through the Hemopurifier has been completed, and future studies evaluating removal of surrogate markers for extracellular vesicles by the Hemopurifier using the system are under consideration. We believe this approach could expand potential treatment settings for the Hemopurifier in the future and may improve the scalability and accessibility of treatment if successfully developed and validated.

Subsequent to fiscal year-end, an interview published in IEEE Spectrum featuring Aethlon’s Chief Medical Officer and a physician involved in the treatment of an Ebola virus disease patient with the Hemopurifier during the 2014 outbreak highlighted the Company’s experience with Ebola treatment efforts. In connection with renewed public health interest surrounding recent Ebola outbreaks, we also confirmed the continued availability of our FDA-authorized expanded access (compassionate use) protocol and shared the protocol as well as past in vitro and in vivo data with organizations involved in global and U.S. emerging pathogen preparedness efforts, including the World Health Organization’s R&D Blueprint expert panel and the National Emerging Special Pathogen Training and Education Center.

Financial Results for the Fiscal Year Ended March 31, 2026

As of March 31, 2026, the Company had approximately $5.0 million in cash and cash equivalents, providing resources to support ongoing clinical and research activities.

Subsequent to fiscal year-end, the Company strengthened its balance sheet by raising approximately $1.85 million in net proceeds through its at-the-market program.

Consolidated operating expenses declined 21.9% year-over-year to approximately $7.3 million, reflecting continued expense discipline and operational efficiency while advancing the Company’s clinical and research priorities compared to $9.3 million for the fiscal year ended March 31, 2025. The decrease was primarily due to $1.1 million reduction in payroll and related expenses, a $500,000 reduction in general and administrative expenses and a $400,000 reduction in professional fees.

Consistent with the reduction in operating expenses, the operating loss for the fiscal year decreased to approximately $7.3 million for fiscal 2026 from $9.3 million in the prior fiscal year.

Other income was approximately $142,000 for the fiscal year ended March 31, 2026, primarily reflecting interest income earned on cash balances, compared to other expense of approximately $4 million in the prior fiscal year. The prior-year amount included approximately $4.7 million of non-cash financing-related charges.

Net loss attributable to our common stockholders was $7.2 million for the fiscal year ended March 31, 2026, compared to net loss of $13.4 million for the fiscal year ended March 31, 2025.

The consolidated balance sheets for March 31, 2026, and March 31, 2025, and the consolidated statements of operations for the fiscal years ended March 31, 2026, and 2025, are included at the end of this release.

Conference Call

Management will host a conference call today, Wednesday, June 10, 2026, at 4:30 p.m. ET to review the Company’s financial results and recent corporate developments. Following management’s formal remarks, there will be a question-and-answer session.

Interested parties can register for the conference call by navigating to View Source Please note that registered participants will receive their dial-in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through July 10, 2026. The replay can be accessed via Aethlon Medical’s website or by dialing 1-855-669-9658 (USA or Canada) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 7883435.

(Press release, Aethlon Medical, JUN 10, 2026, View Source [SID1234666541])