Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Non-Muscle Invasive Bladder Cancer (SURF302)
Tyra Biosciences (NASDAQ: TYRA) has received FDA clearance for its IND application to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC). The company has appointed Dr. Erik Goluboff as SVP of Clinical Development to lead this program.
The Phase 2 study, SURF302, will evaluate TYRA-300, an oral FGFR3-selective inhibitor, in up to 90 participants across multiple U.S. sites. Participants will be randomized to receive either 50mg or 60mg once-daily doses. The primary endpoint is complete response rate at three months, with secondary endpoints including time to recurrence, duration of response, and safety measures.
TYRA-300 targets FGFR3, which is altered in 60-80% of IR NMIBC cases. The first patient is expected to be dosed in Q2 2025. The drug will also be evaluated in two other Phase 2 studies: BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial carcinoma.
Tyra Biosciences (NASDAQ: TYRA) ha ricevuto l'approvazione della FDA per la sua domanda IND per procedere con uno studio clinico di Fase 2 di TYRA-300 nel carcinoma vescicale non muscoloinvasivo di basso grado e rischio intermedio (IR NMIBC). L'azienda ha nominato il Dr. Erik Goluboff come SVP dello Sviluppo Clinico per guidare questo programma.
Lo studio di Fase 2, SURF302, valuterà TYRA-300, un inibitore selettivo di FGFR3, in fino a 90 partecipanti in più siti negli Stati Uniti. I partecipanti saranno randomizzati per ricevere dosi giornaliere di 50mg o 60mg. L'endpoint primario è il tasso di risposta completa a tre mesi, con endpoint secondari che includono il tempo alla recidiva, la durata della risposta e le misure di sicurezza.
TYRA-300 mira a FGFR3, che è alterato nel 60-80% dei casi di IR NMIBC. Si prevede che il primo paziente venga trattato nel secondo trimestre del 2025. Il farmaco sarà anche valutato in altri due studi di Fase 2: BEACH301 per l'achondroplasia pediatrica e SURF301 per il carcinoma uroteliale metastatico.
Tyra Biosciences (NASDAQ: TYRA) ha recibido la aprobación de la FDA para su solicitud IND para proceder con un ensayo clínico de Fase 2 de TYRA-300 en cáncer vesical no músculo invasivo de bajo grado y riesgo intermedio (IR NMIBC). La compañía ha nombrado al Dr. Erik Goluboff como SVP de Desarrollo Clínico para liderar este programa.
El estudio de Fase 2, SURF302, evaluará TYRA-300, un inhibidor selectivo de FGFR3, en hasta 90 participantes en múltiples sitios de EE. UU. Los participantes serán asignados al azar para recibir dosis diarias de 50mg o 60mg. El objetivo primario es la tasa de respuesta completa a los tres meses, con objetivos secundarios que incluyen el tiempo hasta la recurrencia, la duración de la respuesta y las medidas de seguridad.
TYRA-300 se dirige a FGFR3, que está alterado en el 60-80% de los casos de IR NMIBC. Se espera que el primer paciente reciba la dosis en el segundo trimestre de 2025. El fármaco también se evaluará en otros dos estudios de Fase 2: BEACH301 para la acondroplasia pediátrica y SURF301 para el carcinoma urotelial metastásico.
Tyra Biosciences (NASDAQ: TYRA)는 저등급 중간 위험 비근육 침투 방광암(IR NMIBC)에 대한 TYRA-300의 2상 임상시험을 진행하기 위한 IND 신청서에 대해 FDA 승인을 받았습니다. 회사는 이 프로그램을 이끌기 위해 Dr. Erik Goluboff를 임상 개발 수석 부사장으로 임명했습니다.
2상 연구인 SURF302는 여러 미국 현장에서 최대 90명의 참가자를 대상으로 TYRA-300, 경구 FGFR3 선택적 억제제를 평가할 것입니다. 참가자들은 매일 50mg 또는 60mg의 용량을 무작위로 받게 됩니다. 주요 평가는 3개월 후 완전 반응률이며, 보조 평가는 재발 시간, 반응 지속 시간 및 안전성 측정을 포함합니다.
TYRA-300은 IR NMIBC 사례의 60-80%에서 변형된 FGFR3를 목표로 합니다. 첫 번째 환자는 2025년 2분기에 투약될 것으로 예상됩니다. 이 약물은 또한 소아 연골무형성증을 위한 BEACH301과 전이성 요로세포 환암을 위한 SURF301이라는 두 개의 다른 2상 연구에서도 평가될 것입니다.
Tyra Biosciences (NASDAQ: TYRA) a reçu l'approbation de la FDA pour sa demande IND afin de procéder à un essai clinique de Phase 2 de TYRA-300 dans le cancer de la vessie non musculo-invasif de bas grade et à risque intermédiaire (IR NMIBC). La société a nommé le Dr. Erik Goluboff en tant que SVP du Développement Clinique pour diriger ce programme.
L'étude de Phase 2, SURF302, évaluera TYRA-300, un inhibiteur sélectif de FGFR3, chez jusqu'à 90 participants répartis sur plusieurs sites aux États-Unis. Les participants seront randomisés pour recevoir des doses quotidiennes de 50mg ou 60mg. Le critère principal est le taux de réponse complète à trois mois, avec des critères secondaires incluant le temps jusqu'à la récidive, la durée de la réponse et des mesures de sécurité.
TYRA-300 cible FGFR3, qui est altéré dans 60 à 80 % des cas d'IR NMIBC. Le premier patient devrait être traité au deuxième trimestre de 2025. Le médicament sera également évalué dans deux autres études de Phase 2 : BEACH301 pour l'achondroplasie pédiatrique et SURF301 pour le carcinome urotélial métastatique.
Tyra Biosciences (NASDAQ: TYRA) hat die Genehmigung der FDA für seinen IND-Antrag erhalten, um mit einer Phase-2-Studie zu TYRA-300 bei niedriggradigem, intermediärem Risiko nicht muskelinvasivem Blasenkarzinom (IR NMIBC) fortzufahren. Das Unternehmen hat Dr. Erik Goluboff zum SVP der Klinischen Entwicklung ernannt, um dieses Programm zu leiten.
Die Phase-2-Studie, SURF302, wird TYRA-300, einen oralen FGFR3-selektiven Inhibitor, an bis zu 90 Teilnehmern an mehreren Standorten in den USA bewerten. Die Teilnehmer werden randomisiert, um entweder 50mg oder 60mg einmal täglich zu erhalten. Der primäre Endpunkt ist die vollständige Ansprechrate nach drei Monaten, während sekundäre Endpunkte Zeit bis zum Wiederauftreten, Dauer der Antwort und Sicherheitsmaßnahmen umfassen.
TYRA-300 zielt auf FGFR3, das in 60-80% der IR NMIBC-Fälle verändert ist. Der erste Patient wird voraussichtlich im 2. Quartal 2025 behandelt. Das Medikament wird auch in zwei weiteren Phase-2-Studien evaluiert: BEACH301 für pädiatrische Achondroplasie und SURF301 für metastasierendes Urothelkarzinom.
- FDA IND clearance received for Phase 2 trial of TYRA-300
- TYRA-300 targets FGFR3, present in 60-80% of IR NMIBC cases
- Potential first-in-class drug with improved toxicity profile compared to existing treatments
- Initial efficacy data not expected until after Q2 2025
- Multiple competing studies required for different indications may increase development costs
Insights
The FDA IND clearance for TYRA-300's Phase 2 study represents a crucial regulatory milestone for Tyra Biosciences. The trial design targeting FGFR3-altered low-grade IR NMIBC is particularly compelling for several reasons:
The study's scope with 90 participants across multiple U.S. sites, evaluating two dosing cohorts (50mg and 60mg QD), provides robust statistical power. The primary endpoint of complete response rate at three months, coupled with comprehensive secondary endpoints including RFS and PFS, will offer clear efficacy signals.
What's particularly noteworthy is TYRA-300's selective FGFR3 inhibition mechanism, targeting the most frequently altered gene in NMIBC (60-80% alteration rate). This selective approach could potentially offer superior safety compared to pan-FGFR inhibitors while maintaining efficacy.
In simpler terms: Think of TYRA-300 as a precise key that fits only one specific lock (FGFR3), rather than a master key that fits multiple locks but might cause more problems. This could mean fewer side effects while still effectively treating the cancer.
This development carries significant market implications. The bladder cancer therapeutics market represents a substantial opportunity, with NMIBC accounting for about 75% of bladder cancer cases. TYRA-300's potential first-in-class position in this indication could capture significant market share.
The appointment of Dr. Goluboff adds considerable credibility to the program. His experience at industry giants like Genentech/Roche and AstraZeneca, combined with extensive clinical practice, strengthens TYRA's development strategy. The company's triple-pronged approach with TYRA-300 across NMIBC, achondroplasia and metastatic urothelial carcinoma demonstrates smart pipeline diversification.
The Q2 2025 timeline for first patient dosing provides a clear catalyst for investors to monitor. With a market cap of
-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-
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
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
"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
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
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
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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FAQ
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