Novel
Immunotherapeutics Stocks in the News (Nasdaq:$AEMD), (Nasdaq: $HURA), (NYSE: $AZN),
(Nasdaq: $ELTX)
Novel immunotherapeutics
Transforming Oncology
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.
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.”
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of behalf of AEMD
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featuring AEMD in full at https://www.investorideas.com/CO/AEMD/news/2026/03242-immunotherapeutics-oncology-aemd-hura-azn-eltx.asp
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.
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Aethlon
Medical Inc. (Nasdaq:AEMD) is a featured medical tech stock on
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