Novel Immunotherapeutics Stocks In The News (Nasdaq:AEMD), (Nasdaq:HURA) (NYSE: AZN) (Nasdaq: ELTX)
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.
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:
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.
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.
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
/BIS/Stock_List
Aethlon Medical Inc. (Nasdaq:AEMD) is a featured medical tech stock on Investorideas
/CO/AEMD/
About Aethlon Medical, Inc.Aethlon Medical, Inc. (Nasdaq: AEMD) is a clinical-stage medical device company headquartered in San Diego, California. Aethlon is advancing the Hemopurifier, to address unmet needs in oncology and infectious disease, using a novel platform designed to selectively remove circulation pathogenic targets from biologic fluids.
For more information, visit and follow the Company on LinkedIn.
About Hemopurifier®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.
The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for:
- The treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and The treatment of life-threatening viruses not addressed with approved therapies.
The Hemopurifier is being developed under an open Investigational Device Exemption (IDE) for both indications.
Additional information can be found at.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Forward-looking statements in this press release include but are not limited to statements regarding advancement and completion of the Company's clinical trial; patient enrollment and timing; the safety, tolerability and dosing of the Hemopurifier; the potential biological or clinical effects of the Hemopurifier; the ability of the study to inform future trials; and the Company's development plans, regulatory pathway and potential applications of the Hemopurifier. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to suchinclude, without limitation,the number ofpatients who receive pembrolizumab or nivolumab that will have lasting clinical responses to these agents;device deficiencies or immediate complications;the possibility of novel treatment strategies;how the Hemopurifier may reduce tumor-derived extracellular vesicles and enhance T cell activity against tumors; the efficacy of continued clinical trials; development under IDE for indications; and/or the number of patients enrolled in each cohort. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2024, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances findings described herein are preliminary in nature, have not been peer-reviewed, and may not be replicated in subsequent studies or clinical trials.
Company Contact:
Jim Frakes
Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
...
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
...
Aethlon Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas More info on AEMD at Investorideas Visit: /CO/AEMD/
Get News Alerts on Aethlon Medical
Get more biotech and medical tech news, articles, podcasts and stock directoriesAbout Investorideas - Big Investing Ideas
Investorideas is the go-to platform for big investing ideas. From breaking stock news to top-rated investing podcasts, we cover it all
Follow us on X @investorideas
Follow us on Facebook
Follow us on YouTube
Sign up for free stock news alerts at Investorideas
/Resources/Newsletter
Legal Disclaimer:
MENAFN provides the
information “as is” without warranty of any kind. We do not accept
any responsibility or liability for the accuracy, content, images,
videos, licenses, completeness, legality, or reliability of the information
contained in this article. If you have any complaints or copyright
issues related to this article, kindly contact the provider above.
Comments
No comment