F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage
biopharmaceutical company dedicated to developing next generation
bispecific immunotherapies to transform the lives of patients with
cancer, today announced that the Company will present a
trial-in-progress update on FS222, a CD137/PD-L1 mAb2 bispecific
antibody, at the European Society of Medical Oncology
Immuno-Oncology (ESMO-IO) Congress 2021, taking place online only,
December 8-11, 2021.
The poster, entitled “A First-in-Human Study of
FS222, a CD137/PD-L1 tetravalent bispecific antibody, in patients
with advanced malignancies” is presented by Dr. Elena Garralda of
the Vall D’Hebron Institute of Oncology, Barcelona, Spain, and
describes the design of a first-in-human Phase 1 multi-center,
multi-part, open label study to evaluate the safety, tolerability,
pharmacokinetics, pharmacodynamics, immunogenicity and clinical
activity of FS222 in adult subjects with advanced malignancies
(NCT04740424). The poster may be viewed on the F-star website
here.
FS222 targets PD-L1, the immune checkpoint protein
that regulates the balance of activated T cells in the immune
system and is overexpressed on many solid tumors, and CD137, a
co-stimulatory molecule from the tumor necrosis factor receptor
superfamily (TNFRSF), which is widely known to be upregulated on
tumor-reactive CD8+ T cells or “killer T cells”. Currently, only a
minority of patients have been observed to have long-lasting
clinical benefit from therapies that block only the PD-(L)1
pathway.
The clinical study comprises an Accelerated Dose
Titration (ADT) component followed by a 3+3 dose escalation design
and dose expansion cohorts (Part A). Part B consists of tumor
specific efficacy expansion cohorts. Enrollment is ongoing at four
sites including Vall D’Hebron Institute of Oncology (VHIO),
Barcelona, Hospital Universitario 12 de Octubre (Madrid); South
Texas Accelerated Therapeutics (START), Hospital Universitario
Fundación Jimenéz Díaz, Madrid; and Clinica Universidad de Navarra
(CUN), Pamplona. The accelerated dose titration component of Part A
was completed successfully, and identification of optimal patient
groups, dose and schedule is on-going.
Louis Kayitalire, Chief Medical Officer of
F-star, said “We are encouraged by the emerging patient
data on FS222, one of F-star’s four programs currently in the
clinic. This has enabled us to start recruiting tumor types of
interest in dose expansion cohorts to gather additional safety,
pharmacokinetic, pharmacodynamic and preliminary efficacy data. We
see great potential with FS222, as we believe that it is uniquely
positioned to fulfill unmet medical needs in cancer with PD-L1 low
expression.”
About FS222FS222 was designed to
be a potent human CD137/PD-L1 tetravalent conditional agonist with
a unique combination of high affinity PD-L1 binding, and moderate
affinity, but with high avidity, binding to CD137 on activated T
cells to result in optimal receptor clustering. Previously, FS222
has been shown to exhibit a favorable safety profile in preclinical
safety studies.
FS222 simultaneously “releases the brake” on immune
control of cancer by blocking the PD-1/PD-L1 pathway and “hits the
gas” on immune activation by stimulating the CD137
pathway.
About F-star Therapeutics, Inc.
F-star Therapeutics, Inc. is a clinical-stage biopharmaceutical
company dedicated to developing next generation immunotherapies to
transform the lives of patients with cancer. F-star is pioneering
the use of tetravalent (2+2) bispecific antibodies to create a
paradigm shift in cancer therapy. The Company has four
second-generation immuno-oncology therapeutics in the clinic, each
directed against some of the most promising IO targets in drug
development, including LAG-3 and CD137. F-star’s proprietary
antibody discovery platform is protected by an extensive
intellectual property estate. F-star has over 500 granted patents
and pending patent applications relating to its platform technology
and product pipeline. The Company has attracted multiple
partnerships with biopharma targeting significant unmet needs
across several disease areas, including oncology, immunology, and
CNS.
For more information visit our website and follow
us on LinkedIn and Twitter.
Forward Looking Statements
Certain statements contained in this communication
regarding matters that are not historical facts, including the
potential ability of FS222 to fulfill unmet medical needs in cancer
with PD-L1 low expression, are forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended, and the Private Securities Litigation Reform Act of
1995, known as the PSLRA. These include statements regarding
management’s intentions, plans, beliefs, expectations or forecasts
for the future, and, therefore, you are cautioned not to place
undue reliance on them. No forward-looking statement can be
guaranteed, and actual results may differ materially from those
projected. F-star undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise, except to the extent required by law.
In some cases, you can identify forward-looking statements by
terminology such as “anticipates,” “believes,” “plans,” “expects,”
“projects,” “future,” “intends,” “may,” “will,” “should,” “could,”
“estimates,” “predicts,” “potential,” “continue,” “guidance,” or
the negative of these terms or other comparable terminology, which
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Such forward-looking statements are based on our expectations and
involve risks and uncertainties; consequently, actual results may
differ materially from those expressed or implied in the statements
due to a number of factors, including those more fully discussed in
F-star’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q
and other documents filed from time to time with the SEC.
Forward-looking statements included in this communication are based
on information available to F-star as of the date of this
communication. F-star does not assume any obligation to update such
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
For further information, please contact: For
investor inquiries Lindsey Trickett VP Investor Relations &
Communications +1 240 543 7970 lindsey.trickett@f-star.com
For media inquiriesHelen ShikShik Communications
LLC+1 617-510-4373helen@shikcommunications.com
F star Therapeutics (NASDAQ:FSTX)
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