Biotech and Medical
Tech Stocks and the Hunt for Cancer Treatments
November
14, 2024 - Investorideas.com, a
go-to investing platform covering biotech and medical technology stocks releases
a news snapshot from stocks in the sector looking at the advancement of
treatments for solid tumors as global cancer incidence rates rise.
Recent
news from Aethlon Medical,
Inc. (Nasdaq:AEMD), Tango
Therapeutics, Inc. (NASDAQ: TNGX),
Adaptimmune Therapeutics plc (NASDAQ: ADAP) and
Fate Therapeutics, Inc. (NASDAQ: FATE)
showcases new potential treatment options as clinical trials advance.
Looking
at the harsh reality of the rise of cancer globally, the BBC reported earlier
this year, “One study found that the global incidence of early-onset cancer had increased by 79% between 1990 and 2019, with the number of
cancer-related deaths in younger people rising by 29%. Another report in The Lancet Public Health described
how cancer incidence rates in the US have steadily risen between the
generations across 17 different cancers, particularly in Generation Xers and
Millennials.”
According
to a recent article in Biospace,”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.”
Yesterday,
Aethlon Medical,
Inc. (Nasdaq:AEMD),
a
medical therapeutic company focused on developing products to treat cancer and
life-threatening infectious diseases.
reported financial results for its fiscal
second quarter ended September 30, 2024
Aethlon
also provided an update on recent developments, including the enrollment of a
second patient in its Australian
safety, feasibility and dose-finding clinical trial of the Hemopurifier®.
Paid
news dissemination for Aethlon Medical
Read this news, featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/11141AEMD-Cancer-Treatments.asp
This news follows up on news from Monday, November 11th that the company had achieved a key
milestone with enrollment of the first patient in its Australian 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 patient was enrolled on October 29,
2024, by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit,
CALHN, Royal Adelaide Hospital in Australia.
From the November
13th news:
During the second
quarter, and subsequently, the company advanced its oncology trial efforts in
Australia, while implementing cost-cutting measures to streamline operations.
Management is pleased to report positive progress on these initiatives,
specifically:
Clinical
Trials:
The first two patients have now been enrolled at the Royal Adelaide Hospital in
Adelaide, Australia. Additionally, Pindara Private Hospital, in the Gold Coast
section of Australia, received ethics committee approval, was trained on
Aethlon’s Hemopurifier®, and is now open for patient enrollment. The company
has also trained a third hospital in Australia, but has not yet received ethics
committee approval for that institution and it has not yet begun patient
enrollment.
In
September, Aethlon received ethics committee approval from Medanta Medicity
Hospital in Gurugram, India, for a similar nine to 18-patient, safety,
feasibility and dose-finding trial of the Hemopurifier. The company is
completing the necessary logistical steps before the site can open for patient
enrollment.
Management
Change:
In October, Aethlon’s board of directors appointed James Frakes to serve as the
company’s permanent Chief Executive Officer, after having served as Interim
Chief Executive Officer since November 2023.
Operational
Efficiency: Strategic cost-cutting initiatives have allowed for
optimized resource allocation, enabling continued focus on high-impact areas of
the oncology trial.
“During the second
fiscal quarter and subsequent period, we continued advancing our oncology
trials, earlier this week announcing enrollment of the first patient at Royal
Adelaide Hospital, and now updating this news to report enrollment of a second
patient. This represents a critical milestone for the safety, feasibility and
dose-finding trials of the Hemopurifier in patients with solid tumors who have
failed treatment with anti-PD-1 antibodies,” stated James Frakes, Chief
Executive Officer and Chief Financial Officer of Aethlon Medical. "We now
have two sites open for patient enrollment in Australia, have received ethics
committee approval from a site in India, and we expect to continue to enroll
subjects in our Hemopurifier cancer trial. As previously announced, we believe
these studies will help inform future oncology efficacy trials. Additionally,
we have made strategic cost-cutting measures to optimize company resources, in
order to focus on the high-impact oncology trials in both Australia and India.”
As a reminder, the
primary endpoint of the approximate nine to 18-patient, safety, feasibility and
dose-finding trials, is safety. The trials 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 antibody 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 subsequent efficacy and safety trials,
including a Premarket Approval (PMA) study required by the FDA and other
regulatory agencies.
Currently, only
approximately 30% of patients who receive pembrolizumab or 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 EVs in cancer patient
plasma samples.
The company also continues to explore
opportunities to expand the use of the Hemopurifier as a treatment for
life-threatening viral infections. In vitro, it has shown effectiveness in
capturing viruses such as Ebola, Marburg virus, Zika, Lassa, MERS-CoV,
Cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile,
H1N1 swine flu, H5N1 bird flu, and the reconstructed 1918 Spanish flu virus.
The company’s COVID-19 trial in India remains open to accommodate any potential
COVID-19 admissions to the intensive care units at the two participating sites,
Medanta Medicity Hospital and Maulana Azad Medical College. So far, one patient
has been treated. The company is actively evaluating COVID-19 admissions and
potential enrollment against the ongoing costs of maintaining the trial.
Tango
Therapeutics, Inc. (NASDAQ: TNGX), a
clinical-stage biotechnology company committed to discovering and delivering
the next generation of precision cancer medicines, also recently reported its
financial results for the third quarter ended September 30,
2024, and provided business highlights.
From the news "We
have made great progress with our PRMT5 development program, including positive
data from the TNG462 phase 1/2 clinical trial that showcase the best-in-class
potential of TNG462 in multiple tumor types, including pancreatic and non-small
cell lung cancers (NSCLC). Based on these early data, we are advancing TNG462
into trials with multiple targeted and standard of care combinations, including
two RAS (ON) tri-complex inhibitors from Revolution Medicines. Given that
nearly all MTAP-deleted pancreatic cancer has a co-occurring RAS mutation, we
believe this could be a powerful approach to changing the treatment landscape
for this challenging cancer," said Barbara Weber, M.D., President and
Chief Executive Officer of Tango Therapeutics. "As part of the expanded
capabilities needed to rapidly move TNG462 development forward, Dr. Maeve
Waldron-Lynch, M.D. is joining Tango as Senior Vice President, Head of Clinical
Development. Dr. Waldron-Lynch has extensive late-stage oncology clinical
development and regulatory experience and will be invaluable as we prepare to
advance TNG462 to registration."
Yesterday,
Adaptimmune Therapeutics plc (NASDAQ: ADAP), a
company working to redefine the treatment of solid tumor cancers with cell
therapy, announced data from
the primary analysis of its pivotal Phase 2 IGNYTE-ESO trial of lete-cel in
people with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) who
received previous anthracycline-based therapy. The primary analysis data are
being presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual
Meeting which takes place from November 13-16, 2024 in San Diego.
From the news: Based
on these positive data, Adaptimmune plans to initiate a rolling Biologics
License Application (BLA) submission for lete-cel for the treatment of advanced
or metastatic synovial sarcoma and MRCLS by the end of 2025. Lete-cel builds on
the potential of Adaptimmune's sarcoma franchise to change the way solid tumors
are treated using cell therapies, more than doubling the addressable patient
population eligible for Adaptimmune cell therapies to also include NY-ESO-1
positive synovial sarcoma and MRCLS solid tumors.
On November 9th,
Fate
Therapeutics, Inc. (NASDAQ: FATE), a
clinical-stage biopharmaceutical company dedicated to bringing a first-in-class
pipeline of induced pluripotent stem cell (iPSC)-derived cellular
immunotherapies to patients with cancer and autoimmune disorders, presented
initial clinical and new preclinical data for FT825 / ONO-8250, a
multiplexed-engineered, chimeric antigen receptor (CAR) T-cell product
candidate targeting human epidermal growth factor receptor 2 (HER2), at the
2024 Society of Immunotherapy of Cancer (SITC) 39th Annual Meeting being held
in Houston, TX on November 6-10, 2024. FT825 / ONO-8250 incorporates a novel
H2CasMab-2 binding domain targeting HER2 that is designed to overcome
on-target, off-tumor toxicity and to recognize variants associated with poor
clinical outcomes and tumor escape. In an ongoing Phase 1 study in advanced
solid tumors, three patients were treated with FT825 / ONO-8250 in the first
low-dose cohort as monotherapy, and no dose-limiting toxicities (DLTs) and no
events of any grade of cytokine release syndrome (CRS), immune effector
cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease
(GvHD) were observed. The multi-center, Phase 1 study is currently being
conducted under a strategic collaboration with Ono Pharmaceutical Co., Ltd.
(Ono).
From the news: “FT825
/ ONO-8250 integrates seven novel synthetic controls of CAR T-cell function
designed to overcome multiple mechanisms that impede the safe and effective
treatment of solid tumors. We are very pleased with initial Phase 1 clinical
observations from the first low-dose cohort, which showed a favorable safety
profile, product expansion, and maintenance of an activated CAR T-cell state,”
said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics.
“In addition, new preclinical data for FT825 / ONO-8250 presented today at SITC
highlighted the cancer-selective recognition profile of its novel HER2 antigen
binding domain, including its potential to target variants uniquely expressed
on tumor cells. Under our collaboration with Ono, we are excited to further
assess the potential of FT825 / ONO-8250 to benefit patients with hard-to-treat
advanced solid tumors who currently have limited treatment options.”
While
there are a lot of unanswered questions regarding the global rise in cancer
rates, companies like Aethlon Medical, Inc. (Nasdaq: AEMD) are
moving forward in the race for solutions with their Hemopurifier clinical
trials.
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