NAYA Biosciences (“NAYA”) (NASDAQ: NAYA), a life science portfolio
company dedicated to bringing breakthrough treatments to patients
in oncology, autoimmune diseases, and fertility, today
announced an update regarding its clinic trial plans. The
Company received regulatory approval from the Israeli Ministry of
Health in July 2024 and subsequent institutional review board
clearance to initiate patient enrollment in up to 7 academic
centers for its clinical trial evaluating the safety and efficacy
of NY-303, its GPC3-targeting NK Engager bispecific antibody, as a
monotherapy for the treatment of hepatocellular carcinoma in
patients not responding to first-line immunotherapy.
“With the completion of the recent merger, we can now begin our
focus on planning for the initiation of clinical trials with our
lead GPC3-targeting NK engager bispecific antibody, which is a
significant milestone for NAYA Biosciences,” commented NAYA
Biosciences President and NAYA Therapeutics CEO Dr. Daniel Teper.
“We are passionate about bringing new options to patients not
responding to first line immunotherapy and expect that positive
Phase I safety and preliminary efficacy data will support
accelerated clinical development in HCC as well as exploration in
additional solid and pediatric tumors.”
The Phase 1 part of the trial will consist of a dose-escalation
where patients responding to treatment will continue weekly
administration as long as no disease progression is observed. Key
endpoints include safety, pharmacokinetics, activity markers,
preliminary clinical efficacy, and time-to-progression. NAYA is
planning to start patient recruitment in early 2025 at leading
medical centers in Israel including Hadassah Hospital, Sheba
Medical Center, and Sourasky Medical Center.
The Phase 2a part of the trial is anticipated to be expanded to
the United States and Europe subject to additional regulatory
approvals and will evaluate NY-303 at two dose levels selected in
Phase I. Key efficacy endpoints will include objective response
rate and progression-free survival.
“Hepatocellular carcinoma is a leading cause of cancer death
worldwide with a rapidly increasing global trend,” commented NAYA
Therapeutics Chief Medical Officer Dan Chiche, MD. “Currently, less
than 30% of patients treated with current standard of care respond
to immunotherapy (confirmed objective response) and mean
progression-free survival is less than 7 months. NY-303’s dual
targeting of NK cells and GPC3 is a unique, novel mechanism of
action supported by scientific data showing potential to unlock
non-response to checkpoint inhibitors.”
About HCC
Hepatocellular carcinoma (HCC) is the most common form of
primary liver cancer, often developing in individuals with chronic
liver conditions like hepatitis B or C, cirrhosis, and Metabolic
Dysfunction-Associated SteatoHepatitis (MASH). HCC is a global
health challenge, with over 900,000 new cases annually, making it
the sixth most common cancer worldwide. The incidence of HCC in the
United States has been steadily rising. Survival rates for HCC are
often low due to late detection. The five-year survival rate for
liver cancer in the United States is around 20%, but this varies
widely depending on the stage at diagnosis. For early-stage HCC,
where surgical resection or liver transplantation is possible,
survival rates can improve dramatically, while advanced stages have
far poorer outcomes. Globally, survival rates are similarly low,
with wide variation based on healthcare access and screening
programs. Recent advances in immunotherapy such as immune
checkpoint inhibitors are offering new hope for patients with
advanced HCC but new treatment approaches are still critical for
improving survival and quality of life for patients.
About NY-303
NY-303 is a first-in-class therapeutic candidate that leverages
the engagement and activation of natural killer (NK) cells using a
bispecific antibody targeting both GPC3, an oncofetal protein
uniquely expressed on liver cancer cells, and NKp46, a cell surface
receptor on natural killer (NK) cells that plays a central role in
NK cell activation and the elimination of target cells. The unique
mechanism enables NY-303 to turn the tumor form a “cold” into a
‘hot’ stage making liver cancer cells susceptible against
immunotherapy to target and destroy cancer cells. This innovative
approach is especially promising for patients with liver cancer,
such as hepatocellular carcinoma (HCC), who face limited treatment
options and poor survival rates but also for other GPC3-expressing
tumors like lung squamous cell carcinoma, ovarian cancer, and
pediatric cancer.
Currently, liver cancer therapies include surgery, liver
transplantation, targeted drugs, and immunotherapies like
checkpoint inhibitors, but the prognosis remains grim, especially
for advanced-stage disease. With a global five-year survival rate
of around 20%, and even lower in more advanced cases, there is a
critical need for more effective therapies.
NY-303 represents a new opportunity for liver cancer patients by
harnessing the body’s immune system to specifically attack tumor
cells and engage NK-cells. Unlike traditional treatments, this
therapy is designed to offer potent anti-cancer effects with a
potentially safer profile, reducing the side effects often
associated with chemotherapy and other conventional treatments and
overcoming non-responding tumors against immunotherapies. For
patients with HCC, NY-303 could significantly improve outcomes by
offering a more precise, targeted approach to eradicating cancer,
which is critical given the high recurrence rates and challenges in
treating advanced liver cancer. As part of the next generation of
immunotherapies, NY-303 may redefine treatment possibilities and
offer renewed hope to those facing this difficult diagnosis.
About NAYA BiosciencesNAYA Biosciences (NASDAQ:
NAYA) is a life science portfolio company dedicated to bringing
breakthrough treatments to patients in oncology, autoimmune
diseases, and fertility. Our hub & spoke model
harnesses the shared resources of a parent company and agility of
lean strategic franchises, enabling efficient acquisition,
development, and partnering of assets and allowing for
optimized return on investment by combining scalable, profitable
commercial revenues with the upside of innovative clinical-stage
therapeutics.
NAYA’s expanding portfolio of assets currently includes NY-303,
a GPC3 and NKp46 targeting bispecific antibody for the treatment of
hepatocellular carcinoma (HCC) with a unique mode of action
targeting non-responders to the current immunotherapy standard of
care (approximately 70% of the current treatable market) cleared to
enroll patients in a Phase 1/2a monotherapy trial in early 2025,
NY-338, a CD38 and NKp46 targeting bispecific antibody for the
treatment of multiple myeloma and autoimmune diseases with a
differentiated safety and efficacy profile, and INVOcell®, an
FDA-approved fertility device which has demonstrated comparable
success rates to traditional In Vitro Fertilization
(IVF).
Safe Harbor StatementThis release includes
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. The Company invokes
the protections of the Private Securities Litigation Reform Act of
1995. All statements regarding our expected future financial
position, results of operations, cash flows, financing plans,
business strategies, products and services, competitive positions,
growth opportunities, plans and objectives of management for future
operations, as well as statements that include words such as
"anticipate," "if," "believe," "plan," "estimate," "expect,"
"intend," "may," "could," "should," "will," and other similar
expressions are forward-looking statements. All forward-looking
statements involve risks, uncertainties, and contingencies, many of
which are beyond our control, which may cause actual results,
performance, or achievements to differ materially from anticipated
results, performance, or achievements. Factors that may cause
actual results to differ materially from those in the
forward-looking statements include those set forth in our filings
at www.sec.gov. We are under no obligation to
(and expressly disclaim any such obligation to) update or alter our
forward-looking statements, whether as a result of new information,
future events or otherwise.
NAYA Investor & Media ContactAnna
Baran-DjokovicSVP, Investor
Relations+1-305-615-9162anna@nayabiosciences.com
INVO BioScience (NASDAQ:INVO)
過去 株価チャート
から 11 2024 まで 12 2024
INVO BioScience (NASDAQ:INVO)
過去 株価チャート
から 12 2023 まで 12 2024