- In a preclinical HCH model, TYRA-300
demonstrated increases in long bone length and binding
against the HCH altered protein-
-TYRA remains on track to submit ACH
Investigational New Drug Application (IND) in 2H24-
CARLSBAD, Calif., July 2, 2024
/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 preclinical proof-of-concept results with TYRA-300, an
investigational oral FGFR3 selective inhibitor, in
hypochondroplasia (HCH). The results were presented at the
6th Annual Achondroplasia & Skeletal Dysplasia
Research Conference (Pharmachon 2024), held June 28-30, 2024, in Baltimore, MD.
HCH is a skeletal dysplasia closely related to achondroplasia
(ACH), the most common form of dwarfism. HCH is most commonly
caused by the N540K mutation (~70-80%) in the FGFR3 gene.
There are currently no approved therapeutic options for HCH.
The design of TYRA-300 may inhibit the alteration driving
FGFR3-related skeletal dysplasias including ACH, HCH and
others.
"The new preclinical data presented at Pharmachon 2024 are very
encouraging and continue to support our belief that TYRA-300 has
the potential to become a best-in-class agent with the potential to
address unmet medical needs for people with skeletal dysplasias,"
said Todd Harris, CEO of TYRA.
"Developing TYRA-300 in HCH is a natural extension of our plans in
ACH, and we look forward to submitting our IND in the second half
of this year to support our planned Phase 2 study in pediatric
achondroplasia."
In an Fgfr3Asn534Lys/+ preclinical model, TYRA-300
was evaluated in FGFR3 wild-type and mutant animals to evaluate its
potential effect on long bone length and skull size compared to
vehicle-treated mice. TYRA-300 was administered daily at 1.8
mg/kg/day for 21 days starting at Day 3. TYRA-300 increased the
length of the appendicular skeleton in the FGFR3 mutated mice:
femur by 3.70% compared to the vehicle (p<0.01); tibia by 3.75%
compared to the vehicle (p<0.05); humerus by 3.22% compared to
the vehicle (p<0.05); and ulna by 5.03% compared to the vehicle
(p<0.01). TYRA-300 also increased the size of the foramen
magnum by 5.88% (p<0.05) in mice. TYRA-300
demonstrated binding against the FGFR3 N540K altered protein and
isoform selectivity for FGFR3 over other isoforms, as previously
reported.
"The improvements in growth plate function observed in
the hypochondroplasia mouse model provide strong
proof-of-concept supporting further development of TYRA-300 for
hypochondroplasia," said Dr. Michael
Bober, VP, Clinical Development and Medical Affairs of
TYRA. "This adds to the evidence of TYRA-300 becoming a
potential precision medicine for FGFR3 mediated skeletal
dysplasia."
Susana Noval Iruretagoyena,
Director, Fundación ALPE, commented, "It's an exciting time for
research in skeletal dysplasia and movement into hypochondroplasia.
Like with achondroplasia, it will be important for companies to
study more outcomes beyond height for these families."
The presentation from the 6th Annual Achondroplasia
& Skeletal Dysplasia Research Conference can be accessed
here.
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), which was designed to determine the recommended Phase 2
dose (RP2D) of TYRA-300, as well as to evaluate preliminary
antitumor activity. In skeletal dysplasias, TYRA-300 has
demonstrated positive preclinical results in achondroplasia and
hypochondroplasia, 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 and January 2024, the FDA
granted Orphan Drug Designation (ODD) and Rare Pediatric
Designation (RPD) to TYRA-300, respectively, for the treatment of
achondroplasia.
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, the potential for TYRA-300 to become a best-in-class
agent and the potential safety and therapeutic benefits of
TYRA-300, including the potential to inhibit the alteration driving
FGFR3-related skeletal dysplasias, address unmet medical needs for
people with skeletal dysplasias and become a precision medicine for
FGFR3 mediated skeletal dysplasia; the potential to develop
TYRA-300 in HCH; and the expected timing and phase of clinical
development of TYRA-300, including timing of submission of an IND
for TYRA-300 in pediatric achondroplasia. 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 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, data readouts and completion of preclinical studies and
clinical trials; results from preclinical studies or early clinical
trials not necessarily being predictive of future results, and the
potential for proof-of-concept results to fail to result in
successful subsequent development of TYRA-300; 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; an accelerated development or approval pathway may
not be available for TYRA-300 or other product candidates and any
such pathway may not lead to a faster development process; later
developments with the FDA may be inconsistent with the minutes from
our prior meetings, including with respect to the proposed design
of our planned Phase 2 study 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; unfavorable results from preclinical studies; we may
not realize the benefits associated with ODD, including that orphan
drug exclusivity may not effectively protect a product from
competition and that such exclusivity may not be maintained, or
from the RPD Designation, including receipt of a Priority Review
Voucher or any value therefrom; regulatory developments in
the United States and foreign
countries; 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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