- Initiated SURF201 Phase 1 Study;
dosed first patient with TYRA-200-
- Cleared
multiple dose cohorts in SURF301 and continues to dose escalate
with TYRA-300-
- Received FDA feedback on TYRA-300 Phase
2 ACH study: IND submission planned for 2H 2024-
CARLSBAD,
Calif., Dec. 22, 2023 /PRNewswire/ -- Tyra
Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology
company focused on developing next-generation precision medicines
that target large opportunities in Fibroblast Growth Factor
Receptor (FGFR) biology, today announced that it has initiated the
SURF201 Phase 1 study of TYRA-200 and provided positive updates on
its oral FGFR3-selective inhibitor, TYRA-300.
"As we approach the end of 2023, I believe TYRA
is in our strongest position to date. We now have multiple
clinical-stage programs with TYRA-300 and TYRA-200, and we believe
that the emerging profile from SURF301 supports our objective to
deliver a best-in-class agent with TYRA-300 to improve outcomes in
children with achondroplasia and patients with cancer," said
Todd Harris, CEO of TYRA. "In 2024,
we are excited to build on our recent progress and continue to
advance our pipeline toward milestones that we believe will drive
significant value for patients and shareholders."
TYRA-200
- TYRA initiated the SURF201 study and has dosed the first
patient with TYRA-200, an FGFR1/2/3 inhibitor with potency against
activating FGFR2 gene alterations and resistance mutations. The
SURF201 study is currently enrolling and dosing adults
with unresectable locally advanced/metastatic intrahepatic
cholangiocarcinoma and other advanced solid tumors with activating
FGFR2 gene alterations. The Phase 1 clinical study of TYRA-200,
SURF201 (Study in PrevioUsly treated and
Resistant FGFR2+ Cholangiocarcinoma and Other
Advanced Solid Tumors) (NCT06160752), is a multi-center, open label
study designed to evaluate the safety, tolerability, and
pharmacokinetics (PK) of TYRA-200 and determine the optimal and
maximum tolerated doses (MTD), as well as evaluate the preliminary
antitumor activity of TYRA-200.
TYRA-300
- SURF301 Study. The SURF301 Phase 1/2 study for oncology
(Study in Untreated
and Resistant FGFR3+ Advanced Solid Tumors)
(NCT05544552) continues to advance. The study is a multi-center,
open label study designed to determine the optimal and maximum
tolerated doses (MTD) and the recommended Phase 2 dose of TYRA-300,
as well as to evaluate the preliminary antitumor activity of
TYRA-300. The Phase 1 portion of SURF301 will provide data to
inform multiple doses and schedules of TYRA-300 in future studies
in metastatic urothelial carcinoma (mUC), non-muscle invasive
bladder cancer (NMIBC) and achondroplasia. The SURF301 Phase 1 Part
A portion continues to dose escalate and has cleared multiple dose
cohorts that are above the anticipated dose(s) planned for use in
the Phase 2 pediatric achondroplasia study. Current expansion
cohorts in Part B are at dose level(s) anticipated to be evaluated
in oncology. TYRA expects to submit initial results from its
SURF301 Phase 1 portion for presentation at a scientific congress
in 2024.
- Planned Phase 2 Achondroplasia (ACH) Study. TYRA is
planning to initiate a randomized Phase 2 clinical trial with
multiple dose cohorts of TYRA-300 for children
with achondroplasia. The primary objective of this study will
be to assess safety and tolerability in children with
achondroplasia and determine the dose(s) for further development.
Secondary objectives will include evaluating change in growth
velocity, growth proportionality and pharmacokinetics, as well as
an assessment of quality of life and evaluation of biomarkers
indicating dose-response relationships to TYRA-300. TYRA's
expectation is that the study will initially evaluate treatment
naïve children ages 5-12 to determine optimal dose ranges and will
also include a separate analysis of children ages 5-12 with
achondroplasia who have not responded to a prior growth
accelerating therapy. We also expect to conduct studies in younger
children in additional cohorts as data on safety, pharmacokinetics,
and dose become available. TYRA plans to submit an Investigational
New Drug (IND) application to the US FDA in the second half of 2024
for the initiation of the Phase 2 study.
About TYRA-300
TYRA-300 is the Company's lead precision medicine
program stemming from its in-house SNÅP platform. TYRA-300 is an
investigational, oral, FGFR3-selective inhibitor currently in
development for the treatment of cancer and skeletal dysplasias,
including achondroplasia. In oncology, TYRA-300 is being evaluated
in a multi-center, open label Phase 1/2 clinical study, SURF301
(Study in Untreated and Resistant
FGFR3+ Advanced Solid Tumors). SURF301 (NCT05544552) was
designed to determine the optimal and MTD and the recommended Phase
2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary
antitumor activity of TYRA-300. SURF301 is currently enrolling
adults with advanced urothelial carcinoma and other solid tumors
with FGFR3 gene alterations. In skeletal dysplasias, TYRA-300 has
demonstrated positive preclinical results, and the Company expects
to submit an IND in the second half of 2024 for the initiation of a
Phase 2 clinical study in pediatric achondroplasia. In July 2023, TYRA-300 was granted Orphan Drug
Designation for the treatment of achondroplasia from the
FDA.
About TYRA-200
TYRA-200 is an investigational, oral, FGFR1/2/3
inhibitor with potency against activating FGFR2 gene alterations
and resistance mutations currently in development for the treatment
of cancer. TYRA-200 is being evaluated in a multi-center, open
label Phase 1 clinical study, SURF201 (Study in
PrevioUsly treated and Resistant FGFR2+
Cholangiocarcinoma and Other Advanced Solid Tumors). SURF201
(NCT06160752) was designed to determine the optimal and MTD and the
RP2D of TYRA-200, as well as to evaluate the preliminary antitumor
activity of TYRA-200. SURF201 is currently enrolling adults with
advanced/metastatic intrahepatic cholangiocarcinoma and other
advanced solid tumors with activating alterations in FGFR2.
About Tyra Biosciences
Tyra Biosciences, Inc. (Nasdaq: TYRA) is a
clinical-stage biotechnology company focused on developing
next-generation precision medicines that target large opportunities
in FGFR biology. The Company's in-house precision medicine
platform, SNÅP, enables rapid and precise drug design through
iterative molecular SNÅPshots that help predict genetic alterations
most likely to cause acquired resistance to existing therapies.
TYRA's initial focus is on applying its accelerated small molecule
drug discovery engine to develop therapies in targeted oncology and
genetically defined conditions. TYRA is based in Carlsbad, CA.
For more information about our science, pipeline
and people, please visit www.tyra.bio and engage with us on
LinkedIn.
Forward-Looking Statements
TYRA cautions you that statements contained in
this press release regarding matters that are not historical facts
are forward-looking statements. The forward-looking statements are
based on our current beliefs and expectations and include, but are
not limited to: the potential to develop next-generation precision
medicines and a best-in-class agent and the potential safety and
therapeutic benefits of TYRA-300, TYRA-200 and other product
candidates; the ability to drive significant value for patients and
shareholders; the expected timing, design (including dosing levels)
and phase of clinical development of TYRA-300 and TYRA-200,
including timing of a submission of an IND for TYRA-300 in
pediatric achondroplasia and submission of initial results from the
SURF301 Phase 1 portion of the study to a scientific congress; and
the potential for SNÅP to develop therapies in targeted oncology
and genetically defined conditions. Actual results may differ from
those set forth in this press release due to the risks and
uncertainties inherent in our business, including, without
limitation: we are early in our development efforts, have only
recently begun testing TYRA-300 and TYRA-200 for oncology in
clinical trials and the approach we are taking to discover and
develop drugs based on our SNÅP platform is novel and unproven and
it may never lead to product candidates that are successful in
clinical development or approved products of commercial value;
potential delays in the commencement, enrollment, and completion of
preclinical studies and clinical trials; interim results of a
clinical trial do not predict final results and clinical outcomes
may materially change as patient enrollment continues, following
more comprehensive reviews of the data, and as more patient data
become available; results from preclinical studies or early
clinical trials not necessarily being predictive of future results;
our dependence on third parties in connection with manufacturing,
research and preclinical testing; acceptance by the FDA of INDs or
of similar regulatory submissions by comparable foreign regulatory
authorities for the conduct of clinical trials of TYRA-300 in
pediatric achondroplasia; unexpected adverse side effects or
inadequate efficacy of our product candidates that may limit their
development, regulatory approval, and/or commercialization; the
potential for our programs and prospects to be negatively impacted
by developments relating to our competitors, including the results
of studies or regulatory determinations relating to our
competitors; regulatory developments in the United States and foreign countries; we
may use our capital resources sooner than we expect; and other
risks described in our prior filings with the Securities and
Exchange Commission (SEC), including under the heading "Risk
Factors" in our annual report on Form 10-K and any subsequent
filings with the SEC. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof, and we undertake no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date hereof. All forward-looking statements are qualified
in their entirety by this cautionary statement, which is made under
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
Contact:
Amy Conrad
aconrad@tyra.bio
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