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 is participating in the 36th annual Society for
Immunotherapy of Cancer (SITC) 2021 Conference, taking place
November 12-14 in Washington, D.C. F-star’s Michelle Morrow, Ph.D.,
will speak at 9:15 a.m. on Sunday, November 14, during Session 300:
Novel Bispecifics, on “Dual Checkpoint Bispecifics: Next Generation
Cancer Therapy to Overcome Immune Evasion”. We are also excited to
announce that Matthew Lakins Ph.D., is lead author on poster
presentation #573, on preclinical data for FS120 combination with
PD-1
[https://investors.f-star.com/static-files/457405c6-e6e0-4dee-9596-2446e21b41d7],
a first-in-class dual-agonist tetravalent bispecific antibody
targeting OX40 and CD137. FS120 is currently being evaluated in a
Phase 1 monotherapy dose escalation clinical trial (NCT04648202)
which aims to identify a well-tolerated and pharmacologically
active dose of FS120 for exploration in future clinical studies as
monotherapy, and in combination with other agents.
In her presentation, Dr. Morrow explains how bispecific
antibodies can unlock new biology via mechanisms that combination
approaches cannot. F-star’s FS118 is a dual checkpoint inhibitor
targeting PD-L1 and LAG-3 that drives LAG-3 shedding and receptor
down-regulation, via bispecific activity. It is one of a range of
dual antagonist bispecific formats that are being explored in
clinical development, each with the potential to elicit unique
biological activity which may translate to different clinical
outcomes. FS118 is designed to provide unique pharmacology, causing
a dose-dependent increase of soluble LAG-3, and potentially
offering a more durable response in patients.
In the Phase 1 clinical trial, FS118 was well tolerated with no
treatment-related serious adverse events and no dose-limiting
toxicity, up to 20mg/kg. In addition to the ongoing checkpoint
inhibitor relapsed head and neck cancer study that is anticipated
to report data in mid-2022, F-star is initiating a clinical trial
in checkpoint inhibitor naïve, biomarker enriched NSCLC and DLBCL
patients in order to broaden the clinical reach of this exciting
LAG-3 & PD-L1 targeting bispecific antibody.
Michelle Morrow, Ph.D., Vice President,
Preclinical Translational Pharmacology,
F-star states, “Checkpoint inhibitors have changed
the way we now think about treating patients with cancer and a new
wave of target combinations looks to build on current success.
Bispecific dual checkpoint inhibitors have the potential to further
improve on the clinical outlook for patients as a next generation
of treatments. At F-star, we have designed bispecific antibodies
that may enable focused, potent and safe immune activation through
crosslinking, clustering and conditionality.”
Key findings from poster presentation on FS120 include:
- FS120 in combination with anti-PD-1 (pembrolizumab) was shown
to enhance T cell activity in multiple human primary immune assays.
In combination with an anti-PD-1, FS120 surrogate increased
antitumor efficacy in a mouse tumor model with pharmacodynamic
changes related specifically to T cell activation, when compared to
monotherapies, either alone or in combination.
- These data support the development of FS120 in combination with
Keytruda in patients with cancers that are resistant to checkpoint
inhibitor therapy.
Neil Brewis, Ph.D., Chief Scientific Officer,
F-star notes, “We continue to be encouraged by this
additional mechanistic preclinical data on FS120 demonstrating the
potential for FS120 to increase antitumor activity of anti-PD-1 in
patients with cancer. Our Phase 1 dose escalation study is ongoing
to determine a well-tolerated and optimal dosing regimen to
initiate the KEYTRUDA combination.”
About FS120In early clinical studies, agonist
antibodies targeting the T cell costimulatory receptors OX40 or
CD137 have shown immune-stimulatory effects. FS120 is a
first-in-class tetravalent bispecific dual agonist antibody
incorporating OX40 binding into the Fc-region (termed an Fcab) and
CD137 Fabs in a natural human IgG1 antibody and with silenced FcγR
activity for reduced toxicity, as shown in preclinical safety
studies. FS120 crosslinks and clusters both receptors eliciting a
robust immune stimulation and, in the case of FS120 surrogate,
robust antitumor activity in mouse tumor models, independent of
FcγR crosslinking1. FS120 has the potential to deliver
tumor-agnostic clinical efficacy with good tolerability.
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 the significant unmet needs
across several disease areas, including oncology, immunology, and
CNS.
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Forward Looking Statements
Certain statements contained in this communication regarding
matters that are not historical facts, 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,”
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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, but not limited to, the cash balances of
F-star, the ability of F-star to remain listed on the Nasdaq
Capital Market, F-star’s status as a clinical stage immuno-oncology
company and its need for substantial additional funding in order to
complete the development and commercialization of its product
candidates, that F-star may experience delays in completing, or
ultimately be unable to complete, the development and
commercialization of its product candidates, that F-star’s clinical
trials may fail to adequately demonstrate the safety and efficacy
of its product candidates, that preclinical drug development is
uncertain, and some of F-star’s product candidates may never
advance to clinical trials, that results of preclinical studies and
early stage clinical trials may not be predictive of the results of
later stage clinical trials, that F-star relies on patents and
other intellectual property rights to protect its product
candidates, and the enforcement, defense and maintenance of such
rights may be challenging and costly, and that F-star faces
significant competition in its drug discovery and development
efforts.
New factors emerge from time to time and it is not possible for
us to predict all such factors, nor can we assess the impact of
each such factor on the business or the extent to which any factor,
or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements.
These risks are 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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F star Therapeutics (NASDAQ:FSTX)
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