Cancer Treatment
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@bmsnews @abbvie
What’s next in Treatments
for Cancer Patients with Solid Tumors?
June
20, 2024 - Investorideas.com, a
go-to investing platform, releases an industry snapshot looking at the future 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.
Research
released this year predicts, “The
solid tumor therapeutics market size will grow from USD 222.71 Billion in 2023
to USD 885.44 Billion in 10 years. Increasing investments of pharmaceutical
companies in Research & Development will drive the solid tumor therapeutics
market's growth. North America emerged as the largest market for the global
Solid Tumor Therapeutics market, accounting for 44% of the total market share
globally.”
Current
drugs available including Merck & Co., Inc.’s (NYSE:MRK) Keytruda® (pembrolizumab) and Bristol Myers Squibb’s (NYSE: BMY)
Opdivo® (nivolumab), solve part of the problem but the success rates call for
additional solutions.
Aethlon Medical,
Inc. (Nasdaq: AEMD) announced this week that, on June, 13, 2024, the Human Research Ethics
Committee (HREC) of the Central Adelaide Local Health Network (CALHN) 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 Keytruda® (pembrolizumab) or Opdivo® (nivolumab)
(AEMD-2022-06 Hemopurifier® Study). The approval is valid for three years,
until June 13, 2027. The trial will be conducted by Prof. Michael Brown and his
staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital,
located in Adelaide, Australia.
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 exosomes from the plasma of cancer patient
samples.
This article featuring Aethlon Medical, Inc. is
paid for news dissemination
Read this article
featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/06201Cancer-Treatment-Stocks.asp
"The approval from the Human Research Ethics
Committee at Central Adelaide Local Health Network marks a significant
milestone for Aethlon, as they deemed that our clinical study meets the
requirements of the Australia’s National Statement on Ethical
Conduct in Human Research,” 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, NAMSA
and ReSQClinical Research. The next steps include submission to the
Therapeutic Goods Administration, the national health regulatory agency of Australia,
obtaining approval from the CALHN Research Governance Committee, and conducting
a site initiation visit to facilitate patient enrollment. Following this
Ethics Board approval, we plan to submit to the Ethics Committees at
two additional sites in Australia and one in India.”
The primary endpoint of the approximate 18-patient,
safety, feasibility and dose-finding trial is safety. The trial
will monitorany 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 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.
In May, Bristol Myers Squibb (NYSE:BMY) announced that the US Food and Drug Administration (USFDA) has reassigned the
previously announced Prescription Drug User Fee Act (PDUFA) goal date of the
Biologics License Application (BLA) for the subcutaneous formulation of Opdivo®
(nivolumab) co-formulated with Halozyme’s proprietary recombinant human
hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) across
all previously approved adult, solid tumor Opdivo indications as monotherapy,
monotherapy maintenance following completion of Opdivo® plus Yervoy
(ipilimumab) combination therapy, or in combination with chemotherapy or
cabozantinib. The updated goal date is December 29, 2024.
From news: The application is based on results from CheckMate-67T,
the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate
and demonstrate non-inferior pharmacokinetics, efficacy and consistent safety
vs. its intravenous formulation. If approved, subcutaneous nivolumab has the
potential to be the first and only subcutaneously administered PD-1 inhibitor.
From news: CheckMate-67T is a Phase 3 randomized, open-label
trial evaluating subcutaneous administration of Opdivo® co-formulated with
Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or
subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous
Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma
(ccRCC) who have received prior systemic therapy. This trial presents an
opportunity to potentially bring a subcutaneous formulation of Opdivo® to
patients. A total of 495 patients were randomized to either subcutaneous
nivolumab or intravenous Opdivo®. The co-primary endpoints of the trial are
time-averaged serum concentration over 28 days (Cavgd28) and trough serum
concentration at steady-state (Cminss) of subcutaneous nivolumab vs.
intravenous Opdivo®. Objective response rate (ORR) is a key secondary endpoint.
According
to Merck & Co., Inc. (NYSE:MRK), “KEYTRUDA is not chemotherapy
or radiation therapy-it is an immunotherapy and it works with your immune
system to help fight cancer. KEYTRUDA can cause your immune system to attack
normal organs and tissues in any area of your body and can affect the way they
work. These problems can sometimes become serious or life-threatening and can
lead to death. You can have more than one of these problems at the same time.
These problems may happen anytime during treatment or even after your treatment
has ended.”
Looking at key developments in the
solid tumor market, BrainyInsights
reported that In November
2023, AbbVie (NYSE:ABBV)
acquired ImmunoGen. The main objective behind this acquisition was to build and
expand a strong portfolio base for the Solid Tumor Therapeutics Market. This
acquisition will further boost AbbVie’s entry into the commercial market for ovarian
cancer.
In May, AbbVie showcased
its “Robust Solid Tumor Pipeline at ASCO 2024 with New Data from Its Innovative
Antibody-Drug Conjugate (ADC) Platform.”
From the
news: "Building
upon our strong commitment to patients and existing leadership in hematological
malignancies, we are rapidly advancing a differentiated pipeline in solid
tumors," said Daejin Abidoye, M.D., Vice President, Head of Solid Tumors,
Oncology Development, AbbVie. "Our ADC platform allows us to utilize
selected biomarkers such as c-Met and SEZ6 to induce targeted cancer cell death
by delivering potent anti-cancer agents. The data we are presenting at ASCO
demonstrate the clinical potential of this approach across a wide range of
difficult-to-treat tumors."
From the
news: Data from the dose-escalation
and colorectal cancer (CRC) dose-expansion cohort of an ongoing first-in-human
Phase 1 study (NCT05029882) of ABBV-400, a potential best-in-class c-Met
directed ADC, will be presented in an oral presentation. The preliminary data
show that among 122 heavily pre-treated advanced CRC patients, promising
antitumor activity was observed at 2.4 and 3.0 mg/kg doses administered once
every 3 weeks, with confirmed objective response rate (ORR) of 18% (n=40) and
24% (n=41) respectively in those groups. In patients with higher c-Met
expression, ORR was enriched to >35% at doses ≥2.4 mg/kg. The most common
Gr≥3 treatment-emergent adverse events (TEAEs) were anemia (35%), neutropenia
(7%) and febrile neutropenia (6%). TEAEs leading to discontinuation occurred in
25 (20.5%) patients. Additional data will be presented at the meeting.
From the
news: ABBV-400 is also
being evaluated in a Phase 1b basket study (NCT06084481) in advanced solid
tumors as a monotherapy and a Phase 2 study (NCT06107413) in second line
metastatic CRC in combination with fluorouracil, folinic acid, and bevacizumab.
From
their Solid Tumor market
report, BrainyInsights also says, A huge chunk of pharmaceutical
companies continue to make significant contributions to the development of
experimental drugs and technologies. The pharmaceutical sector, for instance,
is significantly invested in research and development. Pharmaceutical firms
invest in future research to bring high-quality, pharmaceuticals to the
marketplace. Major pharma firms are boosting their R&D efficiency by
investing heavily in R&D, to ensure long returns on investments, as well as
by collaborating with R&D centres worldwide. for instance: According to
Statista, Roche is expected to be the world’s largest company which is
investing heavily in R&D, that is, USD 14 Billion followed by Johnson &
Johnson (USD 12.2 Billion), Merck & Co (USD 11.4 Billion), Pfizer (USD 10.5
Billion) and Novartis (USD 10 Billion), by the year 2026.
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.
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