Medical Tech and
Biotech Stocks to Watch and the Treatments for Solid Tumors; (Nasdaq: $AEMD)
(Nasdaq: $ELEV) (NASDAQ: $ADAP) (NYSE American: $OSTX) (NYSE: $BMY) (OTC: $NVSEF)
(NYSE: $GSK) (NYSE: $MRK)
August
12, 2024 - Investorideas.com, a
go-to investing platform covering biotech and medical technology issues a
snapshot on recent news and developments for the treatment of solid cancer
tumors, featuring Aethlon Medical, Inc. (Nasdaq:AEMD), a
medical therapeutic company focused on developing products to treat cancer and
life-threatening infectious diseases.
The
Brainy Insights
estimates that the USD 222.71 Billion solid tumor therapeutics market will
reach USD 885.44 Billion by 2033.
Looking
at the current list of FDA approved drugs to
treat solid tumors anywhere in the body as reported by Cancer.Gov, the market
is currently dominated by big Pharma. Some of the currently approved drugs
include Bristol Myers Squibb’s (NYSE: BMY)
Augtyro (Repotrectinib), Dabrafenib Mesylate from Novartis AG (OTC: NVSEF), Dostarlimab-gxly
by GlaxoSmithKline (NYSE GSK) and Keytruda
(Pembrolizumab) by Merck & Co., Inc (NYSE:MRK).
Even
with FDA approval these drugs are not the Holy Grail and don’t offer 100%
effectiveness for all patients, or lasting results.
But
there are other alternatives on the horizon coming from smaller innovative companies,
and not all of the solutions are drugs.
Aethlon Medical, Inc’s. (Nasdaq:AEMD) answer
is the Hemopurifier®. In human studies,
the Hemopurifier® has demonstrated the removal of life-threatening viruses and
in pre-clinical studies, the Hemopurifier® has demonstrated the removal of
harmful exosomes from biological fluids, utilizing its proprietary lectin-based
technology. This action has potential applications in cancer, where exosomes
may promote immune suppression and metastasis, and in life-threatening
infectious diseases. The Hemopurifier® is a U.S. Food and Drug Administration
(FDA) designated Breakthrough Device indicated for the treatment of individuals
with advanced or metastatic cancer who are either unresponsive to or intolerant
of standard of care therapy, and with cancer types in which exosomes have been
shown to participate in the development or severity of the disease. The
Hemopurifier® also holds an FDA Breakthrough Device designation and an open
Investigational Device Exemption (IDE) application related to the treatment of
life-threatening viruses that are not addressed with approved therapies.
This news is paid advertisement/ news
disseminated on behalf of/issued on behalf of Aethlon Medical Inc.
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featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/08121Stocks-Treatment-for-Solid-Tumors.asp
Aethlon
Medical, Inc. just announced that, on August 6, 2024, the Bellberry Human
Research Ethics Committee (BHREC) granted full ethics approval to the Pindara
Private Hospital for a 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 Merck’s (NYSE:MRK) Keytruda®
(pembrolizumab) or Bristol Myers Squibb’s (NYSE:MRK) Opdivo®
(nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for one
year, until August 6, 2025. The trial will be conducted by Dr. Marco Matos and
his staff at the Pindara Private Hospital, located in Queensland, Australia.
"We
are quite pleased that the BHREC accepted our responses to their thoughtful
questions during their review and determined that our study meets the
requirements of the National Statement application. Dr. Matos and his research
team have a proven track record of enrollment in device trials in oncology
patients that provides momentum to these trials,” stated Dr. Steven LaRosa, MD,
Chief Medical Officer of Aethlon Medical. “This is the second ethics committee
approval we have received for our oncology trial in Australia after receiving
approval from the ethics committee for Royal Adelaide Hospital in June.”
Dr.
LaRosa continued, “The next step is to receive approval from the Research
Governance Office at each hospital which reviews indemnities and insurance.
Once these approvals are obtained, Aethlon, in concert with our Australian
Contract Research Organization, ReSQ, will conduct Site Initiation Visits
(SIVs), after which patient enrollment may proceed.”
More from the news: Currently,
only approximately 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 exosomes in cancer
patient plasma samples.
The
primary endpoint of the approximate 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.
Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the
discovery and development of selective cancer therapies to treat patients
across a range of solid tumors with significant unmet medical needs, last week announced
promising initial data from the dose escalation portion of the ongoing Phase 1
clinical trial of EO-3021 in patients with advanced, unresectable or metastatic
solid tumors likely to express Claudin 18.2, including gastric,
gastroesophageal junction (GEJ), pancreatic or esophageal cancers.
"Gastric and GEJ cancers are devastating diseases, which occur
frequently in the U.S. and globally and which, despite recent advancements,
still have high levels of mortality," said Kohei Shitara, M.D., Chief,
Department of Gastrointestinal Oncology, National Cancer Center Hospital East
in Kashiwa, Japan and principal investigator on the Phase 1 clinical trial.
"There is a particular need for highly selective therapies that benefit
patients with Claudin 18.2-expressing tumors. To that end, I am excited by the
initial data with EO-3021, which suggest it could change the treatment paradigm
for a significant portion of patients with gastric or GEJ cancer. I am excited
to evaluate EO-3021 in the expansion portion of this Phase 1 clinical
trial."
"We are pleased to share initial data from our Phase 1 clinical
trial of EO-3021," said Dr. Valerie Malyvanh Jansen, MD, Ph.D, Chief
Medical Officer of Elevation Oncology. "EO-3021 was designed to maximize
efficacy while minimizing the potential for free MMAE, with the goal of
offering patients an improved safety profile and physicians a more readily
combinable agent. We are encouraged to see the benefits of EO-3021's
site-specific conjugation translate clinically, with minimal MMAE-associated
toxicities observed in our Phase 1 trial. Coupled with the promising anti-tumor
activity reported in patients with gastric or GEJ cancer, the data suggest that
EO-3021 is a potential best-in-class Claudin 18.2 antibody drug conjugate. We
look forward to advancing into monotherapy dose expansion and initiating our
combination cohorts in the months ahead, as well as reporting additional data
from our ongoing trial in the first half of 2025."
Adaptimmune
Therapeutics plc (NASDAQ: ADAP), a
company working to redefine the treatment of solid tumor cancers with cell
therapy, on August 2nd announced US Food and Drug
Administration (FDA) accelerated approval of TECELRA® (afamitresgene
autoleucel) for the treatment of adults with unresectable or metastatic
synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P,
-A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the
MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic
devices. This indication is approved under accelerated approval based on
overall response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of clinical
benefit in a confirmatory trial. TECELRA is the first engineered cell therapy
for a solid tumor cancer approved in the U.S., and the first new therapy option
in more than a decade for synovial sarcoma, a rare, soft tissue cancer that
most commonly impacts young adults.
Adrian
Rawcliffe, Adaptimmune's Chief Executive Officer said, "The approval of
TECELRA is a momentous step in Adaptimmune’s journey to redefine the way cancer
is treated and the culmination of a decade of groundbreaking R&D. I want to
thank the patients, caregivers, investigators, and clinical teams as well as
everyone at Adaptimmune and our partners who made possible this watershed
moment for cell therapy and for people with synovial sarcoma. We are committed
to advancing our robust clinical pipeline to serve more patients in need and
plan to progress lete-cel, the next late-stage investigational treatment in our
sarcoma franchise, with a rolling BLA submission to the FDA next year."
More from the news: The
approval of TECELRA was based on results of the SPEARHEAD-1 (Cohort 1) trial,
which included 44 patients. The major efficacy outcome was overall response
rate (ORR) determined by independent review and supported by duration of
response. TECELRA treatment resulted in an ORR of 43% with a complete response
rate of 4.5%. The median duration of response was 6 months (95% CI: 4.6, not
reached). Among patients who were responsive to the treatment, 39% had a
duration of response of 12 months or longer.
OS
Therapies, Inc. (NYSE American:OSTX), a
clinical-stage oncology-focused immunotherapy company developing cancer
vaccines and antibody drug conjugate (ADC) therapeutic candidates, announced in late
July, positive data from a Phase 1 clinical trial of
OST-HER2 in patients with HER2-expressing solid tumors in breast cancer and
other cancers. Additionally, the Company announced positive preclinical
efficacy data for OST-HER2 in multiple models of breast cancer.
More from the news: The FDA
has granted Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation
(ODD), and Fast Track Designation (FTD) for OST-HER2 in Osteosarcoma. OST-HER2,
a biologic therapeutic candidate, is a Lm (Listeria monocytogenes) vector-based
off-the-shelf immunotherapeutic vaccine designed to prevent metastasis, delay
recurrence, and increase overall survival in patients with osteosarcoma and
other solid tumors. The proposed OST-HER2 mechanism of action is based on
innate and adaptive immune stimulating responses activated by the Lm vector.
This treatment generates T cells that can eliminate or slow potential
micrometastases that can grow into recurrent osteosarcoma and other solid
tumors, including breast cancer. T cell responses home in on HER2 expressed by
the tumor and then kill the cell, releasing additional tumor targets. There are
currently no approved adjuvant treatments for recurrent osteosarcoma in the
United States.
The
anticipated $885.44 Billion market by 2033 is a big pie and investors following
the treatment of solid tumors have alternatives to big Pharma as the smaller
players bring new solutions to market.
If successful, we may see acquisitions like the Bristol Myers Squibb’s (NYSE: BMY) $4.1
billion acquisition of Turning Point Therapeutics for Augtyro.
Research biotech and medical device/ tech
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