Advancements in Novel Immunotherapeutics in The Oncology Battle

Rhea-AI Summary

Aethlon Medical (NASDAQ: AEMD) announced the independent DSMB completed a safety review of cohort 2 in its AEMD-2022-06 trial on March 24, 2026 and recommended advancing to cohort 3. No device-related SAEs or DLTs were reported and cohort 3 enrollment is open to receive three Hemopurifier treatments over one week.

The study (9–18 patients) evaluates safety, feasibility and dose-finding in patients with solid tumors receiving pembrolizumab or nivolumab, with primary endpoints focused on adverse events and safety labs.

Positive

• DSMB recommended advancement to cohort 3 after safety review
• No device-related SAEs or DLTs reported to date
• Cohort 3 will evaluate three treatments over one week
• Study designed to measure EV reduction to inform future PMA study

Negative

• Planned cohort size is small: 9–18 patients
• Trial is early-stage; no efficacy or approval data yet

News Market Reaction – AEMD

-6.09%

7 alerts

-6.09% News Effect

-11.6% Trough in 6 min

-$245K Valuation Impact

$3.78M Market Cap

0.4x Rel. Volume

On the day this news was published, AEMD declined 6.09%, reflecting a notable negative market reaction. Argus tracked a trough of -11.6% from its starting point during tracking. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $245K from the company's valuation, bringing the market cap to $3.78M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Immunotherapeutics market size: USD 150–168 billion Projected market size: Exceeds USD 300 billion Trial sample size: 9–18 patients +5 more

8 metrics

Immunotherapeutics market size USD 150–168 billion Global novel immunotherapeutics market value in 2025

Projected market size Exceeds USD 300 billion Forecast global novel immunotherapeutics market by 2033–2035

Trial sample size 9–18 patients Planned enrollment for AEMD solid tumor Hemopurifier trial

Cohort 3 dosing 3 treatments in 1 week Hemopurifier regimen for final cohort in Australian solid tumor study

Risk reduction 29% reduction Imfinzi perioperative regimen vs chemotherapy for disease progression/recurrence/death

EFS hazard ratio HR 0.71 (95% CI 0.58–0.86) Event-free survival in MATTERHORN trial for Imfinzi regimen

3-year overall survival 69% vs 62% Three-year OS for Imfinzi-based regimen vs chemotherapy alone

Drug-treated patients 15,500 patients Estimated EU drug-treated early/locally advanced gastric or GEJ cancer patients in 2024

Market Reality Check

Price: $2.11 Vol: Volume 44,231 is 0.54x th...

low vol

$2.11 Last Close

Volume Volume 44,231 is 0.54x the 20-day average of 82,053, suggesting modest participation in the move. low

Technical Shares at $2.30 are trading below the 200-day MA of $7.37, indicating a longer-term downtrend despite the positive safety update.

Peers on Argus

AEMD gained 6.48% on its oncology trial safety update, while peers showed mixed ...

1 Up

AEMD gained 6.48% on its oncology trial safety update, while peers showed mixed moves, with names like BJDX up 9.84% and VTAK down 7.03%, pointing to a stock-specific reaction rather than a broad medical devices move.

Historical Context

5 past events · Latest: Mar 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 12	Strategic review, trial	Positive	+4.8%	Engaged advisor for strategic options and advanced Australian oncology trial safety review.
Feb 23	Conference presentation	Neutral	-1.5%	Announced investor conference presentation with management fireside chat and Q&A.
Feb 12	Q3 results update	Neutral	-1.0%	Reported fiscal Q3 loss, cash of ~$7.0M, and R&D plus clinical program progress.
Feb 04	Earnings call timing	Neutral	-3.9%	Set date and time for fiscal Q3 results release and conference call with replay.
Dec 05	Dilutive financing	Negative	-8.2%	Announced at-the-market private placement and warrant inducement for $3.3M gross proceeds.

Pattern Detected

Price reactions have generally aligned with news tone, with negative financing news drawing the sharpest downside and operational/strategic updates producing modest gains or limited moves.

Recent Company History

Over the past few months, Aethlon has combined ongoing operating losses with active capital markets and clinical progress. A December 2025 private placement raised $3.3 million, followed by January 2026 warrant and resale registration steps. February filings showed a quarterly net loss of about $2.0 million but nine‑month net loss improving to $5.3 million, with cash near $7.0–7.1 million. The Australian solid‑tumor trial advanced from Cohort 1 to Cohort 2, and by March 12, 2026, a strategic review advisor was engaged. Today’s DSMB-backed safety progress in the same trial fits this pattern of gradual clinical advancement alongside financial constraints.

Market Pulse Summary

The stock moved -6.1% in the session following this news. A negative reaction despite positive safet...

Analysis

The stock moved -6.1% in the session following this news. A negative reaction despite positive safety news would fit a pattern where investors focus more on financing risk than incremental clinical steps. Prior disclosures highlighted ongoing operating losses and reliance on capital markets, and the stock trades well below its $35.20 52‑week high. Even with DSMB backing of the Hemopurifier’s safety, concerns about cash levels and past dilutive financings could outweigh trial momentum and pressure the shares.

Key Terms

data safety monitoring board, serious adverse events, dose-limiting toxicities, extracorporeal, +4 more

8 terms

data safety monitoring board medical

"the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing clinical trial"

A data safety monitoring board is a group of experts who regularly review information from a research or testing process to ensure it is safe and ethical. Think of them as watchdogs that watch over ongoing projects to protect participants and ensure everything is proceeding correctly. Their oversight helps maintain trust and safety, which is important for investors who want to see responsible management and reliable results.

serious adverse events medical

"To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs)"

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

dose-limiting toxicities medical

"no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

extracorporeal medical

"an extracorporeal device for oncology and other indications"

Extracorporeal describes medical treatments or devices that act on blood, organs, or tissues outside the body for a period of time, such as filtering, oxygenating, or warming blood using a machine. Investors care because extracorporeal technologies form a distinct product market with specific regulatory paths, manufacturing needs, and recurring revenue from disposables; think of it like a laundromat for the body's fluids—specialized equipment doing work externally that patients and hospitals must repeatedly buy or use.

premarket approval (pma) regulatory

"future efficacy and safety, Premarket Approval (PMA), study required by regulatory authorities"

Premarket Approval (PMA) is the strict regulatory review process used by the U.S. authority for high-risk medical devices to prove they are safe and effective before they can be sold. For investors, a granted PMA is like receiving a key to a locked market: it can open exclusive sales opportunities, reduce near-term competition, and justify higher valuations, while also signaling that the company has cleared a costly, time-consuming hurdle.

phase 3 medical

"MATTERHORN Phase III trial, which were published in The New England Journal of Medicine"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

event-free survival medical

"event-free survival [EFS] hazard ratio [HR] of 0.71; 95% confidence interval"

Event-free survival measures the length of time after a treatment or diagnosis during which a patient does not experience a predefined negative outcome, such as disease progression, relapse, or death. For investors, longer event-free survival in clinical trials signals that a therapy may be effective and durable, improving its chances of regulatory approval and commercial success — think of it like a warranty period before problems reappear.

overall survival medical

"In the final overall survival (OS) analysis, results showed the Imfinzi and FLOT"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

AI-generated analysis. Not financial advice.

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

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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 16^th, 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.

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https://www.investorideas.com/CO/AEMD/

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FAQ

What did Aethlon Medical (AEMD) announce on March 24, 2026 about its Hemopurifier trial?

Aethlon Medical announced the DSMB cleared cohort 2 safety and recommended advancing to cohort 3. According to the company, no Hemopurifier-related SAEs or DLTs were observed and cohort 3 enrollment is now open to evaluate three treatments.

How many patients will AEMD enroll in the final cohort of the AEMD-2022-06 study?

The final cohort is designed to enroll approximately 9 to 18 patients. According to the company, participants will have solid tumors and be receiving pembrolizumab or nivolumab while undergoing Hemopurifier treatments.

What is the primary endpoint of Aethlon's AEMD-2022-06 Hemopurifier study (AEMD)?

The primary endpoint is incidence of adverse events and clinically significant changes in safety laboratory tests. According to the company, the trial focuses on safety, feasibility and dose-finding to support future PMA study design.

What treatment will participants receive in AEMD cohort 3 and where is the study conducted?

Cohort 3 participants will receive three Hemopurifier treatments over one week. According to the company, the study is active at three clinical sites in Australia and targets patients on pembrolizumab or nivolumab.

Has Aethlon shown that the Hemopurifier removes tumor-derived EVs and viruses in humans?

Removal of enveloped viruses and extracellular vesicles has been demonstrated in vitro and in human subjects. According to the company, the device combines plasma separation, size exclusion, and affinity binding to target mannose-rich surfaces.