Cancer’s
Solid Tumors Market – the Stocks to Watch
Stocks
mentioned-Aethlon Medical, Inc. (Nasdaq: $AEMD), Immuneering (Nasdaq: $IMRX),
Merck (NYSE: $MRK), AstraZeneca (Nasdaq: $AZN) Roche (OTCQX: $RHHBY)
September
17, 2024 - Investorideas.com, a
go-to investing platform, releases the first of a two-part series looking at news
and developments for the treatment of cancer and solid tumors featuring Aethlon Medical,
Inc. (Nasdaq: AEMD), a
medical therapeutic company focused on developing products to treat cancer and
life-threatening viral infections.
According
to Biospace.com “The
solid tumors market size reached a value of US$ 170.3 Billion in 2023. Looking
forward, the market is expected to reach US$ 375.4 Billion by 2034, exhibiting
a growth rate (CAGR) of 7.45% during 2024-2034. The market is driven by
advancements in targeted therapies, immunotherapies, as well as personalized
medicine.”
Taking
a unique approach to cancer treatment, Aethlon Medical,
Inc. (Nasdaq: AEMD) just announced that
the Cancer Clinical Trial Unit at Royal Adelaide Hospital was activated on
September 10, 2024 to begin screening and enrolling patients in its safety,
feasibility and dose-finding clinical trial of the Hemopurifier® in patients
with solid tumors who have stable or progressive disease during anti-PD-1
monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab)
(AEMD-2022-06 Hemopurifier Study). The trial will be conducted by Prof. Michael
Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide
Hospital in Australia.
The
Hemopurifier® is a clinical stage immunotherapeutic device which is designed to
combat cancer and life-threatening viral infections and for use in organ
transplantation.
The
activation follows the previously announced approval by the Human Research
Ethics Committee at Central Adelaide Local Health Network on June 13, 2024, and
the Research Governance office at Royal Adelaide Hospital, on September, 3
2024, as well as the notification of the Therapeutic Good Administration (TGA)
and completion of a Site Initiation Visit on September 9, 2024.
Paid
News Dissemination of behalf of AEMD
Read
this article, featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/09171Cancers-Solid-Tumors-Market.asp
"The
activation of the investigative site at the Royal Adelaide Hospital marks a
significant milestone for Aethlon, allowing the site to screen and enroll
patients in this important clinical trial,” stated Steven LaRosa, MD, Chief
Medical Officer of Aethlon Medical. “We look forward to working closely with
Prof. Brown and his staff, and with our Contract Research Organizations (CROs),
NAMSA and ReSQ Clinical Research, to begin enrollment and data collection.
Going forward, we plan to activate a second site in Australia and also expect
to receive an Ethics Committee approval for a clinical site in India.”
Currently,
only approximately 30% of patients who receive Merck & Co., Inc.'s (NYSE:MRK)
Keytruda®
(pembrolizumab) or Bristol Myers
Squibb's (NYSE: BMY)
Opdivo® (nivolumab) will have lasting clinical responses to these agents.
Extracellular vesicles (EVs) produced by tumors have been implicated in the
spread of cancers as well as the resistance to anti-PD-1 therapies. 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 exosomes from the
plasma of cancer patient samples.
The
primary endpoint of the approximately 18-patient, safety, feasibility and
dose-finding trial is the incidence of adverse events and clinically
significant changes in safety 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 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 whether
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 (Nasdaq:
IMRX) is a clinical-stage
oncology company seeking to develop and commercialize universal-RAS/RAF
medicines for broad populations of cancer patients with an initial aim to
develop a universal-RAS therapy. The Company aims to achieve universal activity
through Deep Cyclic Inhibition of the MAPK pathway, impacting cancer cells
while sparing healthy cells. Immuneering’s lead product candidate, IMM-1-104,
is an oral, once-daily Deep Cyclic Inhibitor currently in a Phase 1/2a trial in
patients with advanced solid tumors harboring RAS mutations. IMM-6-415 is an
oral, twice-daily Deep Cyclic Inhibitor currently in a Phase 1/2a trial in
patients with advanced solid tumors harboring RAS or RAF mutations.
The stock made big moves following news
September 12th. Immuneering
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.
“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.”
Looking at what is currently out there for patients
with solid tumors, according to cancer.gov, “The Food and Drug Administration (FDA) has approved three
new immunotherapy options for people with advanced endometrial cancer. The
approvals are for drugs called immune checkpoint inhibitors.”
The
first approval, announced on June 14, is for AstraZeneca’s (Nasdaq: AZN; (LSE:AZN) durvalumab (Imfinzi) given in
combination with chemotherapy to treat people with advanced endometrial cancer
whose tumors have certain genetic changes that cause them to have a
characteristic known as mismatch
repair deficiency (dMMR). Tumors that are dMMR are particularly
susceptible to immunotherapy.
The
second approval, announced on June 17, is for Merck & Co., Inc.'s (NYSE:MRK) pembrolizumab
(Keytruda) given along with chemotherapy,
regardless of whether tumors are dMMR. And on August 1, FDA approved dostarlimab
(Jemperli) plus chemotherapy for people with
advanced endometrial cancers regardless of dMMR status. Dostarlimab had
previously been approved, in 2023, for advanced endometrial cancers that are
dMMR.
Under the approvals, the combinations can be used as an
initial therapy or as treatment for cancer that has come back after certain
previous treatments.
In
large clinical trials, the addition of these immunotherapy drugs to
chemotherapy led to improvements in progression-free survival, which is how
long people live without their cancer growing.
Cancer.gov also reported, On August 5, the agency gave an accelerated
approval for Roche
Holding’s (OTCQX:RHHBY) trastuzumab
deruxtecan-often called T-DXd-to treat anyone with any advanced solid
cancer if their tumors produce high levels of the protein HER2, or
HER2-positive. To receive the drug, a patient must already have received
at least one prior treatment. The approval makes T-DXd the first cancer therapy
of its type, an antibody─drug conjugate, that can be used in
such a “tumor agnostic” manner. T-DXd is already approved to treat people with
several specific cancers, including breast and stomach.
Based on the current options and availability for
patients with solid tumors, innovation is key to advancements and alternatives
to traditional big pharma.
Aethlon Medical,
Inc. (Nasdaq: AEMD) says it initiated its
tumor-derived exosome research at a time when the medical community believed
exosomes were merely cellular debris with no biological function. Today, a
therapeutic to address tumor-derived exosomes represents a significant unmet
need in cancer care. Aethlon has demonstrated that the affinity mechanism of
the Hemopurifier® can capture tumor-derived exosomes and exosomal particles
underlying several forms of cancer, including breast, ovarian and metastatic
melanoma.
Also
in the future, AI may play a key role according to Biospace. “The integration of artificial intelligence (AI) and digital
health is revolutionizing the solid tumors market by enhancing diagnostics,
treatment planning, and patient management. AI algorithms can analyze vast
amounts of medical data, including imaging, pathology slides, and genomic
information, to identify patterns and provide insights that might be missed by
human clinicians. For instance, AI-powered imaging tools can detect early signs
of tumors with high accuracy, improving early diagnosis and treatment outcomes.”
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