Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - March 24, 2026) - Investorideas.com, a go-to investing platform, releases an industry snapshot looking at advancements in novel immunotherapeutics, featuring Aethlon Medical, Inc. (NASDAQ: AEMD), a clinical-stage biotechnology company developing the investigational Aethlon Hemopurifier, an extracorporeal device for oncology and other indications.
Advancements in Novel Immunotherapeutics in The Oncology Battle
To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/6292/289695_0e46dab6145c8910_001full.jpg
Novel immunotherapeutics have transformed oncology, moving away from broad, non-specific treatments toward highly personalized strategies that harness the patient's immune system to precisely target cancer cells.
The novel immunotherapeutics market is experiencing rapid growth, valued at approximately USD 150-168 billion in 2025 and projected to exceed USD 300 billion by 2033-2035.
Developing a Novel Immunotherapeutic Device to combat cancer and life-threatening viral Infections, Aethlon Medical, Inc. (NASDAQ: AEMD) just announced that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing clinical trial, AEMD-2022-06, has completed its scheduled safety review of the second cohort participant data and recommended advancing to the third and final cohort. They also stated that "no safety concerns were noted with Hemopurifier device/procedure."
From the news:
The trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab," is being conducted to assess the Hemopurifier's safety, feasibility, and optimal dosing.
The DSMB- comprised of independent medical experts in nephrology and oncology- reviewed data from participants enrolled in the second cohort, in which patients received two Hemopurifier treatments over a one-week period. Based on their evaluation, the DSMB found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile. To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier device or treatment have been reported.
"The DSMB's continued positive recommendation supports the safety profile observed to date and allows us to advance into the third and final cohort of this study," said Steven LaRosa, M.D, Chief Medical Officer of Aethlon Medical. "We are encouraged by the gathering momentum of the trial and having a final data set and clinical study report to share with potential investors, partners and regulatory agencies."
Enrollment for Cohort 3 is now open. In this final cohort, participants will receive three Hemopurifier treatments over a one-week period further evaluating safety, feasibility and dosing parameters at the study's three active clinical sites in Australia. This trial is designed to enroll approximately 9 to 18-patients with solid tumors who have stable or progressive disease, while receiving treatment that includes Pembrolizumab (Keytruda) or Nivolumab (Opdivo).
The primary endpoint of this trial is the incidence of adverse events and clinically significant changes in safety laboratory tests of Hemopurifier- treated patients. In addition to safety monitoring, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles (EVs) and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These findings are expected to inform the design of a future efficacy and safety, Premarket Approval (PMA), study required by regulatory authorities.
Aethlon Medical, Inc. remains committed to advancing the Hemopurifier for use in oncology and will continue to provide updates as the clinical trial progresses.
The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived EVs from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both vitro studies and human subjects.
TuHURA Biosciences, Inc. (NASDAQ: HURA), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, just announced Dr. Craig L. Tendler will provide strategic, operational and other related services consistent with those of a Chief Medical Officer (CMO). He will also continue with his current role as a member of the Board of Directors. Dr. Tendler will work with the Company to oversee clinical development strategy and operations of the company's pipeline, including its VISTA inhibiting antibody, TBS-2025.
From the news:
"Craig has been an active and valued member of our Board and enthusiastically agreed to provide strategic, operational and other related services consistent with those of a CMO. His decades of clinical and regulatory experience in accelerating drug development across therapeutic areas, notably in hematologic malignancies, will be of particular value to our TBS-2025 program," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "I am confident that his recent leadership role and strategic contributions to JNJ's menin inhibitor, bleximenib in NPM1 mutated AML, will prove invaluable to our regulatory pathway and development of TBS-2025 in AML and other blood related cancers. I look forward to working with Craig as we unlock the value in VISTA and other clinical programs."
Dr. Craig Tendler added, "I am excited about the potential benefits of TBS-2025 for blood- related cancers where the negative checkpoint, VISTA, has been implicated in playing a critical immunosuppressive role in both therapy failure and poor overall survival in AML, particularly in the molecularly defined subset of NPM1 mutated AML. We have already received preliminary feedback from the Division of Hematologic Malignancies I of the FDA on the early development plan and will continue to work closely with the Agency to accelerate the clinical development of TBS-2025, both as monotherapy and in combination with menin inhibitors, an area where I have substantial experience."
TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda (pembrolizumab) compared to Keytruda plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.
On March 16th, AstraZeneca (NYSE: AZN) reported that Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the European Union (EU) for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The regimen includes two cycles of Imfinzi in combination with chemotherapy before and after surgery, followed by Imfinzi monotherapy.
From the news:
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the positive results from the MATTERHORN Phase III trial, which were published in The New England Journal of Medicine.
Gastric cancer is the fifth leading cause of cancer death globally, with nearly one million people diagnosed each year. In 2024, there were roughly 15,500 drug-treated patients in the EU with early-stage and locally advanced gastric or GEJ cancer.
Josep Tabernero, MD, PhD, head of the Medical Oncology Department at Vall d'Hebron University Hospital and director of the Vall d'Hebron Institute of Oncology (VHIO) in Barcelona, Spain, and principal investigator in the trial, said: "Despite curative-intent surgery and chemotherapy, patients with resectable gastric and gastroesophageal cancers still face high recurrence rates and an urgent need for improved long-term survival. In MATTERHORN, nearly 70 per cent of patients were still alive three years after treatment with the durvalumab-based perioperative regimen. This EU approval brings patients the first immunotherapy regimen to extend survival in this early setting and is poised to become the new standard of care."
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "This approval marks our third perioperative approval in Europe for an Imfinzi-based regimen, underscoring AstraZeneca's commitment to transforming outcomes in early-stage disease, where cure is possible. For patients with early gastric and gastroesophageal cancers, this immunotherapy-based regimen delivers a durable survival benefit that increases over time."
In a planned interim analysis, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone (based on an event-free survival [EFS] hazard ratio [HR] of 0.71; 95% confidence interval [CI] 0.58-0.86; p<0.001). Estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm. An estimated 78.2% of patients treated with the Imfinzi-based perioperative regimen were event-free at one year, compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively.
In the final overall survival (OS) analysis, results showed the Imfinzi and FLOT perioperative regimen demonstrated a statistically significant and clinically meaningful survival improvement, reducing the risk of death by 22% compared to chemotherapy alone (based on a HR of 0.78; 95% CI 0.63-0.96; p=0.021). An estimated 69% of patients treated with the Imfinzi-based regimen were alive at three years compared with 62% in the comparator arm. At each subsequent prespecified OS landmark, the survival curves indicated increasing separation, signaling a greater magnitude of benefit over time for the Imfinzi-based regimen. An OS benefit was observed regardless of tumour PD-L1 status. OS results from MATTERHORN were presented in a Proffered Paper session at the European Society for Medical Oncology (ESMO) Congress 2025.
Elicio Therapeutics, Inc. (NASDAQ: ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, recently reported financial results for the year ended December 31, 2025 and provided recent corporate and clinical updates.
"In 2025, we made meaningful progress advancing ELI-002 7P in KRAS-mutant pancreatic cancer," said Robert Connelly, Chief Executive Officer of Elicio. "We remain focused on completing the Phase 2 AMPLIFY-7P trial and reaching the event-driven primary DFS analysis expected in 1H 2026. We are encouraged by the continued observation of fewer disease progressions and deaths to date than projected in the 2:1 randomized trial, as well as by the durability of T-cell responses and clinical observations reported to date, which reinforce our confidence in ELI-002 7P's potential to favorably impact outcomes. With capital expected to carry us beyond the anticipated DFS readout, we believe we are well positioned to deliver this important milestone and continue advancing our Amphiphile ("AMP") platform in KRAS-mutant PDAC. We remain highly interested in the potential to expand the development of ELI-002 7P to neoadjuvant and metastatic PDAC and other KRAS+ tumors, with the goal of creating meaningful long-term value for patients and shareholders."
Revolutionizing cancer treatment, novel immunotherapeutics are evolving as AI enters the sector. The market is also rapidly evolving with high-growth areas like CAR T-cell therapy, which is expected to see massive expansion.
Research biotech and medical device/ tech stocks at Investorideas.com
https://www.investorideas.com/BIS/Stock_List.asp
Aethlon Medical Inc. (NASDAQ: AEMD) is a featured medical tech stock on Investorideas.com
https://www.investorideas.com/CO/AEMD/
About Investorideas.com - Where you find the best investing Ideas
Investorideas.com is the go-to platform for big investing ideas. From breaking stock news to top-rated investing podcasts, we cover it all.
Disclaimer/Disclosure: This news article featuring AEMD is a paid for news release on Investorideas.com. Our site does not make recommendations for purchases or sale of stocks, services or products. This is not investment opinion: Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp. Learn more about publishing your news release and our other news services and prices on the Investorideas.com newswire https://www.investorideas.com/News-Upload/. Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp.
Follow us on X @investorideas
Follow us on Facebook https://www.facebook.com/Investorideas
Follow us on YouTube https://www.youtube.com/c/Investorideas
Contact Investorideas.com
800-665-0411
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/289695
Source: Econ Corp Services DBA Investorideas.com
