Immunotherapy
Clinical Trial News – Stocks to Watch; (Nasdaq: $AEMD), (NYSE: $BMY), (NYSE: $MRK), (Nasdaq:
$IMRX), (NASDAQ: $IOVA), (NASDAQ: $KZIA)
September
19, 2024 - Investorideas.com, a
go-to investing platform, releases the second
of a two-part series looking at news and developments for the treatment of cancer
and solid tumors focusing on
immunotherapy, featuring Aethlon Medical,
Inc. (Nasdaq: AEMD), a
medical therapeutic company focused on developing products to treat cancer and
life-threatening viral infections. Aethlon’s Hemopurifier® is a clinical stage
immunotherapeutic device designed to combat cancer.
Stocks mentioned in
this article: Aethlon Medical,
Inc. (Nasdaq: AEMD), Bristol Myers Squibbs (NYSE: BMY),
Merck & Co. (NYSE:MRK), Immuneering
Corporation (Nasdaq: IMRX),
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) and
Kazia Therapeutics Limited (NASDAQ: KZIA),.
According
to News-Medical.net,
“Immunotherapy, which works by enabling the body's immune system to recognize
and destroy cancer cells improves long-term overall survival in patients with
advanced melanoma in results from large international studies reported at ESMO
2024. Researchers leading the longest
follow-up study to date suggest that immunotherapy offers the potential for
cure in patients who respond to this treatment. Further clinical trials
reported at ESMO 2024 show improved long-term survival with immunotherapy given
before and after surgery in women with early-stage, hard-to-treat breast cancer
(triple negative breast cancer) and in patients with muscle-invasive bladder
cancer.”
"The
main message from all of these studies is that immunotherapy continues to keep
its promise and hope of long-term survival for many patients with different types
of cancer," said Dr. Alessandra Curioni-Fontecedro, Professor of Oncology
at the University of Fribourg and Director of Oncology at the Hospital of
Fribourg, Switzerland, (not involved in the study). "At ESMO 2024 we are
seeing many studies in many different cancers showing that immunotherapy can
work for a long time."
According
to recent news from Aethlon Medical,
Inc.,
“At present, approximately only 30% of cancer patients who receive
pembrolizumab or nivolumab treatment for solid tumors will have lasting clinical
responses to these agents. Extracellular vesicles (EVs) produced by tumors have
been implicated in resistance to anti-PD-1 therapies as well as the spread of
cancers. The Aethlon Hemopurifier® has been designed to bind and remove these
EVs from the bloodstream, which may improve therapeutic response rates to
anti-PD-1 antibodies. In preclinical
studies, the Hemopurifier® has been shown to reduce the number of EVs in cancer
patient plasma samples.”
Paid News Dissemination of behalf
of AEMD
Read this article
featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/09191Immunotherapy-Clinical-Trials.asp
Following
the news of cancer
trials activated in Australia earlier this week, Aethlon Medical,
Inc.
(Nasdaq: AEMD) today
announced that, on September 9, 2024, the Medanta Institutional Ethics Committee (MIEC) granted full ethics
approval for Aethlon's safety, feasibility and dose-finding clinical trial of
the Hemopurifier® in cancer patients with solid tumors who have stable or
progressive disease during anti-PD-1 monotherapy treatment, such as Merck & Co., Inc.'s (NYSE:MRK) Keytruda®
(pembrolizumab) or Bristol Myers
Squibb's (NYSE: BMY) Opdivo®
(nivolumab) (AEMD-2022-06 Hemopurifier® Study). The approval is valid for one
year, followed by annual reviews. This trial has previously been reviewed by
the Institutional Review Board at Medanta. Additionally, the company previously
received a No Objection Certificate (NOC) from DCGI (the Indian Regulatory
Authority) for the proposed oncology trial. The trial will be conducted by Dr.
Ashok K. Vaid and his staff at the Department of Medical Oncology and
Hematology at Medanta Medicity Hospital in Gurugram, India. The Hemopurifier®
treatments will be performed by Dr. Puneet Sodhi from the Department of
Nephrology, who has conducted more Hemopurifier® treatments than anyone else in
the world.
"The
approval from the MIEC, coming closely on the heels of our two ethics committee
approvals in Australia, to conduct this early feasibility study, is another
important step in our plan to evaluate use of the Hemopurifier as a treatment
option in multiple tumor types, where cancer associated exosomes may promote
immune suppression and metastasis,” stated Steven LaRosa, MD, Chief Medical
Officer of Aethlon Medical. “We are very pleased that the MIEC accepted our
study protocol and look forward to working, again, with Medanta Hospital with
the expectation of recruiting patients in the fourth calendar quarter of this
year. We believe that the planned safety, feasibility and dose finding trial,
taking place in both India and Australia, in solid tumors in patients failing
treatment with anti-PD-1 antibodies, will help inform future oncology efficacy
trials.”
The
primary endpoint of the approximately nine to 18-patient, safety, feasibility
and dose-finding trial is safety. The trial will monitor any adverse events and
clinically significant changes in lab tests of Hemopurifier treated patients
with solid tumors with stable or progressive disease at different treatment
intervals, after a two-month run in period of PD-1 antibody, Keytruda® or
Opdivo® monotherapy. Patients who do not respond to the PD-1 therapy will be
eligible to enter the Hemopurifier® period of the study where sequential
cohorts will receive 1, 2 or 3 Hemopurifier® treatments during a one-week
period. In addition to monitoring safety, the study is designed to examine the
number of Hemopurifier® treatments needed to decrease the concentration of EVs
and if these changes in EV concentrations improve the body’s own natural
ability to attack tumor cells. These exploratory central laboratory analyses
are expected to inform the design of a subsequent efficacy and safety,
Premarket Approval (PMA), study required by regulatory agencies.
Immuneering
Corporation (Nasdaq: IMRX), a
clinical-stage oncology company seeking to develop and commercialize
universal-RAS/RAF medicines for broad populations of cancer patients, recently announced positive
initial response data from the first five patients treated with
IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first line
pancreatic cancer as part of its ongoing Phase 2a clinical trial.
Highlights:
-
In Phase 2a arm investigating IMM-1-104 in combination with modified
gemcitabine/nab-paclitaxel, complete or partial responses have been observed in
the first two patients (2/5) to date, for an initial response rate of 40% and
an initial disease control rate of 80%, with all five patients continuing on
treatment -
-
Initial data are at 240 mg QD (safety lead-in dose) of IMM-1-104; additional
patients have now been dosed at 320 mg QD in this arm; IMM-1-104 has been
well-tolerated to date in combination with gemcitabine/nab-paclitaxel -
-
Initial data are consistent with preclinical data presented at AACR, which
demonstrated that IMM-1-104 combined with chemotherapy induced deeper responses
than either agent alone -
-
Clear path forward expected for clinical development of IMM-1-104 in
combination with gemcitabine/nab-paclitaxel for pancreatic cancer, assuming
initial data is representative; FDA previously granted IMM-1-104 Fast Track
designation for the treatment of first- and second-line pancreatic ductal
adenocarcinoma -
-
Enrollment progressing in all Phase 2a arms with further data expected by year
end -
Continued from the
news:
“We are delighted to share today’s initial data on IMM-1-104 in combination
with modified gemcitabine/nab-paclitaxel. While the initial ORR of 40% and
Disease Control Rate of 80% are very encouraging – and both more than would be
expected for gemcitabine/nab-paclitaxel alone- we are still in the early stages
of this trial, with more scans for all five of these initial patients and for
additional patients planned to come. Nevertheless, it was encouraging to see a
complete response in the very first pancreatic cancer patient treated with
IMM-1-104 in this combination, with the patient now on treatment for over six
months,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “Looking
at the bigger picture, our Phase 2a trial aims to evaluate the efficacy of
IMM-1-104 in multiple settings across various tumor types, to identify the
highest priority opportunities for future development. If the early trends with
IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel continue, we
will have an exciting direction for potential future development of IMM-1-104,
which could greatly improve the prognosis for a drastically underserved patient
population.”
Earlier
this year, Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a
commercial biotechnology company focused on innovating, developing and
delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients
with cancer, announced updated
clinical data for lifileucel in combination with
pembrolizumab in frontline advanced melanoma, as well as translational data, from
the recent 2024 ASCO Annual Meeting held earlier this year in Chicago, IL and
online.
Clinical
Data in Frontline Advanced Melanoma (Cohort 1A in IOV-COM-202 Trial)
Positive
results from Cohort 1A in the IOV-COM-202 trial were published in an abstract1
and will be highlighted in an upcoming oral presentation at ASCO. Unprecedented
response rates, as well as deep and durable responses, were observed in
patients with frontline advanced melanoma who were naïve to immune checkpoint
inhibitor (ICI) therapy. These results strongly support the ongoing Phase 3
TILVANCE-301 clinical trial.
National
Cancer Institute reported ”In an event more than three
decades in the making, the Food and Drug Administration (FDA) has approved
lifileucel (Amtagvi), the first treatment for cancer that uses immune cells
called tumor-infiltrating lymphocytes, or TILs. Announced on February 16, the
agency’s decision also makes lifileucel the first cellular therapy to be
approved for a solid tumor, the skin cancer melanoma.”
Continued: “The
agency’s accelerated approval covers the use of lifileucel for people with
advanced melanoma that has gotten worse after treatment with certain
immunotherapy drugs or targeted therapies.
Continued: “As is
the case with CAR T-cell therapy, another type of cellular therapy, lifileucel
is made using a patient’s own T cells. And with both therapies, the cells are
collected at the hospital where the patient is being treated but are sent away
to be manufactured into the final treatment.”
Also
seeing the potential of immunotherapy, Kazia Therapeutics Limited (NASDAQ: KZIA), an
oncology-focused drug development company announced last week that an
agreement has been executed with QIMR Berghofer Medical Research Institute, one
of Australia's foremost cancer research centres, to obtain an exclusive license
to certain intellectual property rights in relation to combination therapies
consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP
inhibitor drugs (PI3K combination).
From the news: Under
the license agreement, Kazia receives an exclusive, worldwide, sub-licensable
and royalty-bearing licence to certain intellectual property for the
development of any drugs or product candidates within the PI3K inhibitor class
in combination with immunotherapy or PARP inhibitors. Paxalisib, Kazia's lead
product candidate, is a member of the PI3K inhibitor class.
Continued: The
exclusive license agreement follows a collaboration between Kazia and QIMR
Berghofer which began in December 2022 and has already led to the filing of
supportive patents which include the use of paxalisib as an immune modulator in
the treatment of diseases such as breast cancer.
The
idea of using a patient’s immune system to battle cancer makes sense and
dollars for the companies that are pioneering this approach. Let the clinical
trials begin!
Read
part one of the series of articles at Investorideas.com
https://www.investorideas.com/News/2024/biotech/09170Solid-Tumors-Market.asp
Research biotech and medical device/ tech
stocks at Investorideas.com
https://www.investorideas.com/BIS/Stock_List.asp
About Investorideas.com - Big 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. Our
original branded content includes podcasts such as Exploring Mining, Cleantech,
Crypto Corner, Cannabis News, and the AI Eye. We also create free investor
stock directories for sectors including mining, crypto, renewable energy,
gaming, biotech, tech, sports and more. Public companies within the sectors we
cover can use our news publishing and content creation services to help tell
their story to interested investors. Paid content is always disclosed.
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 Facebook https://www.facebook.com/Investorideas
Follow us on YouTube https://www.youtube.com/c/Investorideas
Contact
Investorideas.com
800-665-0411
Biotech Industry Stocks- investing ideas in biotechnology
stocks, medical technology and life sciences
No comments:
Post a Comment