-TYRA appoints urologic oncologist,
Erik Goluboff, M.D., as SVP,
Clinical Development to lead NMIBC-
-First patient expected to be dosed in SURF302
in Q2 2025-
CARLSBAD, Calif., Jan. 10,
2025 /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, announced
today that the U.S. Food and Drug Administration (FDA) cleared its
Investigational New Drug (IND) application for TYRA-300 allowing
the company to proceed with a Phase 2 clinical trial of TYRA-300 in
low-grade, intermediate risk non-muscle invasive bladder cancer (IR
NMIBC). This program will be led by newly appointed Dr.
Erik Goluboff, SVP, Clinical
Development of TYRA, who brings more than thirty years of
experience as an academic urologic oncologist, principal
investigator, practicing urologist and most recently Principal
Medical Lead for GU/GI cancers at
Genentech/Roche.
TYRA-300 is a potential first-in-class, investigational, oral,
FGFR3-selective inhibitor designed to avoid the toxicities
associated with inhibition of FGFR1, FGFR2 and FGFR4, while being
agnostic for the FGFR3 gatekeeper mutations. FGFR3 is the
most frequently altered gene in NMIBC, with 60-80% of IR NMIBC
showing alterations. TYRA-300 is expected to be evaluated in three
Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric
achondroplasia (ACH) and SURF301 for metastatic urothelial
carcinoma (mUC).
SURF302 will be an open-label Phase 2 clinical study evaluating
the efficacy and safety of TYRA-300 in participants with
FGFR3-altered low-grade, IR NMIBC. The study will enroll up
to 90 participants at multiple sites primarily in the United
States. Participants will be randomized initially to
treatment with TYRA-300 at 50 mg once-daily (QD) (Cohort 1) or
treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review
of efficacy and safety, an additional dosing cohort may be
evaluated. The primary endpoint is complete response (CR)
rate at three months. Secondary endpoints include time to
recurrence, the median duration of response, recurrence free
survival (RFS), progression free survival (PFS), safety and
tolerability.
"Receiving FDA IND clearance is an important milestone in the
advancement of TYRA-300 and for patients with NMIBC who urgently
need better tolerated therapeutic options," commented Doug Warner, Chief Medical Officer of
TYRA. "We look forward to leveraging Erik's impressive
background to guide our development plans in NMIBC. We expect
to initiate patient dosing in the second quarter of this year, with
initial three-month CR data to follow."
Dr. Goluboff joins TYRA from Genentech/Roche, where he was
Principal Medical Lead for GU/GI cancers and was responsible for
driving business and pipeline opportunities in those
indications. Prior to Genentech/Roche, Dr. Goluboff held
positions of increasing responsibility at AstraZeneca, including
most recently as Global Clinical Head for
IMFINZI® (durvalumab) and tremelimumab for GU, GYN
and tumor agnostic. Before joining industry, he held urology
professorships at Columbia and
Mount Sinai and managed thousands of patients from diagnosis to
late line disease, medically and surgically, with bladder,
prostate, and kidney cancers. He was a principal investigator
for multiple clinical trials and has published over 100
peer-reviewed papers. He received his B.A. from Columbia University, an M.D. from Johns Hopkins, and an M.B.A. from NYU's Stern School of Business. Dr. Goluboff
completed his surgical internship at Johns Hopkins Hospital and his
urology residency and urologic oncology fellowship at
Columbia-Presbyterian Medical Center.
"For the last thirty years, I have dedicated my career to
helping patients with bladder cancer as a urologic oncologist, a
principal investigator running clinical trials, and as a drug
developer seeking new and more effective therapies for patients
with urologic cancers," added Dr. Goluboff. "I believe that
TYRA-300 is the most compelling agent in development for the
treatment of IR NMIBC, with a proven mechanism of action and more
attractive tolerability profile than pan-FGFR inhibitors,
which made joining TYRA a very exciting opportunity. I look
forward to advancing TYRA-300 through the Phase 2 SURF302 study and
delivering benefit to patients in need."
About Non-Muscle Invasive Bladder Cancer
In the United States, it is
estimated that there are more than 730,000 people living with
bladder cancer. Many of these patients have intermediate risk
non-muscle invasive bladder cancer (IR NMIBC) and experience
recurrence episodes throughout the course of their disease.
Treatment for IR NMIBC and disease recurrence is a surgical
procedure called transurethral resection of bladder tumor (TURBT)
combined with intravesical-administered chemotherapy. Repeat
TURBT procedures and intravesical-administered chemotherapy can
impact patients' quality of life and overall health, leading to a
significant unmet medical need for better tolerated therapeutic
options. TYRA-300 is the only orally administered
investigational agent in clinical development for IR
NMIBC.
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 dysplasia,
including achondroplasia and hypochondroplasia. In oncology,
TYRA-300 is being evaluated in metastatic urothelial cancer (mUC)
and intermediate risk non-muscle invasive bladder cancer (IR
NMIBC). In mUC, 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)
(NCT05544552). The study is designed to determine the optimal
and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to
evaluate the preliminary antitumor activity of TYRA-300. In
October 2024,
TYRA reported interim clinical proof-of-concept data in
mUC from SURF301. TYRA has received IND clearance from the U.S. FDA
to proceed with its SURF302 clinical trial in patients with IR
NMIBC. In skeletal dysplasia, TYRA-300 has demonstrated
positive preclinical results in achondroplasia and
hypochondroplasia, and TYRA has received IND clearance from
the U.S FDA to proceed with its BEACH301 clinical trial
in children with 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 expertise
in FGFR biology has created a differentiated pipeline with three
clinical-stage programs in targeted oncology and genetically
defined conditions. The Company's lead precision medicine
stemming from SNÅP, TYRA-300, is a potential first-in-class
selective FGFR3 inhibitor that is designed to avoid the toxicities
associated with inhibition of FGFR1, FGFR2 and FGFR4, while being
agnostic for the FGFR3 gatekeeper mutations. TYRA-300 is expected
to be evaluated in three Phase 2 studies: SURF302 for IR NMIBC,
BEACH301 for pediatric achondroplasia and SURF301 for metastatic
urothelial cancer. TYRA is also developing TYRA-200, an oral,
investigational, FGFR1/2/3 inhibitor, in the SURF201 study for
metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral,
investigational FGFR4/3-biased inhibitor for
FGF19+/FGFR4-driven cancers. 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: expected initiation of, and first patient dosing
in, the SURF302 study and the timing thereof; the design and goals
of the SURF302 study; the potential to develop next-generation
precision medicines and for TYRA-300 to be first-in-class, and the
potential safety and therapeutic benefits of TYRA-300; the expected
timing and phase of development of TYRA-300, including the expected
Phase 2 study in IR NMIBC; 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: later developments with
the FDA may be inconsistent with prior feedback from the FDA,
including with respect to the proposed initiation and design of our
planned Phase 2 study of TYRA-300 in IR NMIBC; 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,
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; interim results
of a clinical trial are not necessarily indicative of final results
and one or more of the clinical outcomes may materially change as
patient enrollment continues, following more comprehensive reviews
of the data, as follow-up on the outcome of any particular patient
continues and as more patient data becomes available, including the
risk that unconfirmed responses may not ultimately result in
confirmed responses to treatment after follow-up evaluations; 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; 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; 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;
regulatory developments in the United States and foreign
countries; our ability to obtain and maintain intellectual property
protection for our product candidates and proprietary technologies;
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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