Tyra Biosciences Doses First Patient in Phase 2 Study of TYRA-300 in Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)
Tyra Biosciences (Nasdaq: TYRA) has initiated patient dosing in the Phase 2 SURF302 clinical trial of TYRA-300 for low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC). TYRA-300 is being developed as the first oral treatment for IR NMIBC and represents a potential first-in-class, FGFR3-selective inhibitor.
The SURF302 study (NCT06995677) will evaluate up to 90 participants across multiple U.S. sites, with patients randomized to receive either 50 mg or 60 mg once-daily doses. The trial's primary endpoint is the complete response (CR) rate at three months, with initial data expected in 1H 2026. Secondary endpoints include time to recurrence, duration of response, recurrence-free survival, progression-free survival, and safety measures.
Notably, TYRA-300 targets FGFR3, a gene mutated in approximately 70% of low-grade IR NMIBC cases. The drug is designed to minimize toxicities associated with inhibition of other FGFR types while remaining effective against FGFR3 gatekeeper mutations. The company also plans to evaluate TYRA-300 in pediatric achondroplasia through the BEACH301 Phase 2 study later this year.
[ "First patient dosed in Phase 2 SURF302 trial for IR NMIBC", "TYRA-300 is the only oral treatment in development for IR NMIBC", "Drug targets FGFR3 mutations present in ~70% of low-grade IR NMIBC cases", "Potential to reduce disease recurrence and surgical interventions", "Additional market opportunity in pediatric achondroplasia with BEACH301 Phase 2 study" ]Tyra Biosciences (Nasdaq: TYRA) ha iniziato la somministrazione ai pazienti nella sperimentazione clinica di Fase 2 SURF302 di TYRA-300 per il cancro alla vescica non muscolo-invasivo a basso grado e rischio intermedio (IR NMIBC). TYRA-300 è sviluppato come primo trattamento orale per IR NMIBC e rappresenta un potenziale inibitore selettivo FGFR3 di prima classe.
Lo studio SURF302 (NCT06995677) valuterà fino a 90 partecipanti in diversi centri negli Stati Uniti, con pazienti randomizzati a ricevere dosi giornaliere di 50 mg o 60 mg. L'endpoint primario è il tasso di risposta completa (CR) a tre mesi, con dati iniziali attesi nel primo semestre 2026. Gli endpoint secondari includono il tempo alla recidiva, la durata della risposta, la sopravvivenza libera da recidiva, la sopravvivenza libera da progressione e le misure di sicurezza.
TYRA-300 si rivolge specificamente a FGFR3, un gene mutato in circa il 70% dei casi di IR NMIBC a basso grado. Il farmaco è progettato per minimizzare le tossicità associate all'inibizione di altri tipi di FGFR, mantenendo efficacia contro le mutazioni del gatekeeper FGFR3. L'azienda prevede inoltre di valutare TYRA-300 nell'acondroplasia pediatrica attraverso lo studio BEACH301 di Fase 2 entro la fine dell'anno.
Tyra Biosciences (Nasdaq: TYRA) ha iniciado la dosificación de pacientes en el ensayo clínico de Fase 2 SURF302 de TYRA-300 para el cáncer de vejiga no músculo invasivo de bajo grado y riesgo intermedio (IR NMIBC). TYRA-300 se está desarrollando como el primer tratamiento oral para IR NMIBC y representa un posible inhibidor selectivo FGFR3 de primera clase.
El estudio SURF302 (NCT06995677) evaluará hasta 90 participantes en múltiples sitios de EE. UU., con pacientes asignados al azar para recibir dosis diarias de 50 mg o 60 mg. El objetivo principal es la tasa de respuesta completa (CR) a los tres meses, con datos iniciales esperados en el primer semestre de 2026. Los objetivos secundarios incluyen tiempo hasta la recurrencia, duración de la respuesta, supervivencia libre de recurrencia, supervivencia libre de progresión y medidas de seguridad.
TYRA-300 se dirige específicamente a FGFR3, un gen mutado en aproximadamente el 70% de los casos de IR NMIBC de bajo grado. El fármaco está diseñado para minimizar las toxicidades asociadas con la inhibición de otros tipos de FGFR, manteniendo eficacia contra las mutaciones del guardián FGFR3. La compañía también planea evaluar TYRA-300 en acondroplasia pediátrica mediante el estudio BEACH301 de Fase 2 a finales de este año.
Tyra Biosciences (나스닥: TYRA)가 저등급 중간 위험 비근육 침습성 방광암(IR NMIBC)을 대상으로 한 TYRA-300의 2상 SURF302 임상시험에서 환자 투약을 시작했습니다. TYRA-300은 IR NMIBC에 대한 최초의 경구 치료제로 개발 중이며, 잠재적인 1세대 FGFR3 선택적 억제제입니다.
SURF302 연구(NCT06995677)는 미국 내 여러 기관에서 최대 90명의 참가자를 대상으로 진행되며, 환자들은 50mg 또는 60mg의 1일 1회 투여군으로 무작위 배정됩니다. 주요 평가변수는 3개월 시점의 완전 반응(CR)률이며, 초기 데이터는 2026년 상반기에 발표될 예정입니다. 2차 평가변수로는 재발까지의 시간, 반응 지속 기간, 무재발 생존율, 무진행 생존율 및 안전성 지표가 포함됩니다.
특히 TYRA-300은 약 70%의 저등급 IR NMIBC 환자에서 변이가 발견되는 FGFR3 유전자를 표적으로 합니다. 이 약물은 다른 FGFR 유형 억제와 관련된 독성을 최소화하면서 FGFR3 게이트키퍼 돌연변이에 효과적으로 작용하도록 설계되었습니다. 회사는 또한 올해 말 BEACH301 2상 연구를 통해 소아 연골무형성증에 대한 TYRA-300 평가도 계획하고 있습니다.
Tyra Biosciences (Nasdaq : TYRA) a commencé l'administration du traitement aux patients dans l'essai clinique de phase 2 SURF302 de TYRA-300 pour le cancer de la vessie non invasif de bas grade à risque intermédiaire (IR NMIBC). TYRA-300 est développé comme le premier traitement oral pour l'IR NMIBC et représente un inhibiteur sélectif FGFR3 potentiellement de première classe.
L'étude SURF302 (NCT06995677) évaluera jusqu'à 90 participants dans plusieurs sites aux États-Unis, avec une randomisation des patients pour recevoir soit 50 mg, soit 60 mg une fois par jour. Le critère principal est le taux de réponse complète (CR) à trois mois, avec des données initiales attendues au premier semestre 2026. Les critères secondaires incluent le temps jusqu'à la récidive, la durée de la réponse, la survie sans récidive, la survie sans progression et les mesures de sécurité.
Notamment, TYRA-300 cible FGFR3, un gène muté dans environ 70 % des cas d'IR NMIBC de bas grade. Le médicament est conçu pour minimiser les toxicités associées à l'inhibition d'autres types de FGFR tout en restant efficace contre les mutations du gardien FGFR3. La société prévoit également d'évaluer TYRA-300 dans l'achondroplasie pédiatrique via l'étude de phase 2 BEACH301 plus tard cette année.
Tyra Biosciences (Nasdaq: TYRA) hat mit der Dosierung von Patienten in der Phase-2-Studie SURF302 für TYRA-300 bei niedriggradigem, intermediärem Risiko nicht-muskelinvasivem Blasenkrebs (IR NMIBC) begonnen. TYRA-300 wird als erste orale Behandlung für IR NMIBC entwickelt und stellt einen potenziellen First-in-Class, FGFR3-selektiven Inhibitor dar.
Die SURF302-Studie (NCT06995677) wird bis zu 90 Teilnehmer an mehreren Standorten in den USA einschließen, wobei die Patienten randomisiert entweder 50 mg oder 60 mg einmal täglich erhalten. Der primäre Endpunkt ist die vollständige Ansprechrate (CR) nach drei Monaten, erste Daten werden für das erste Halbjahr 2026 erwartet. Sekundäre Endpunkte umfassen Zeit bis zum Rückfall, Ansprechdauer, rezidivfreies Überleben, progressionsfreies Überleben und Sicherheitsparameter.
TYRA-300 zielt gezielt auf FGFR3 ab, ein Gen, das bei etwa 70 % der Fälle von niedriggradigem IR NMIBC mutiert ist. Das Medikament ist so konzipiert, dass es die mit der Hemmung anderer FGFR-Typen verbundenen Toxizitäten minimiert und gleichzeitig gegen FGFR3-Gatekeeper-Mutationen wirksam bleibt. Das Unternehmen plant zudem, TYRA-300 im Rahmen der BEACH301 Phase-2-Studie später in diesem Jahr bei pädiatrischer Achondroplasie zu evaluieren.
- None.
- Initial efficacy data not expected until first half of 2026
- Study still needs to evaluate optimal dosing with potential for additional cohorts
Insights
Tyra's Phase 2 TYRA-300 trial for bladder cancer represents a significant clinical milestone targeting a large, underserved market with an oral treatment option.
Tyra Biosciences has reached a significant clinical milestone with first patient dosing in the Phase 2 SURF302 trial evaluating TYRA-300 in low-grade intermediate risk non-muscle invasive bladder cancer (IR NMIBC). This development is particularly noteworthy as TYRA-300 is positioned as the only oral therapy in clinical development for this indication, potentially offering a substantial improvement over current standard-of-care treatments.
The trial's design includes up to 90 participants randomized to two initial dosing cohorts (50mg and 60mg once daily), with the primary endpoint being complete response rate at three months. Data readout is expected in the first half of 2026, providing a clear timeline for a potential value-driving catalyst.
The scientific rationale is compelling - TYRA-300 targets FGFR3, a gene altered in approximately 70% of low-grade IR NMIBC cases. Unlike broader FGFR inhibitors, TYRA-300 is FGFR3-selective, potentially offering improved safety by avoiding toxicities associated with inhibiting other FGFR receptors. This targeted approach reflects the industry shift toward precision medicine.
For context, current IR NMIBC management typically involves repeated surgical procedures and intravesical therapies, creating a substantial burden for both patients and healthcare systems. An effective oral therapy could significantly reduce treatment burden and potentially improve compliance and outcomes. The parallel development of TYRA-300 in pediatric achondroplasia (BEACH301 study) demonstrates versatility in the company's pipeline approach and provides multiple paths to potential value creation.
-TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC-
-Initial 3-month complete response (CR) data expected to be reported in 1H 2026-
TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to minimize the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for FGFR3 gatekeeper mutations. FGFR3 is a frequently altered gene in IR NMIBC, with ~
"Our goal is to develop TYRA-300 as the first once-daily oral treatment designed to reduce disease recurrence, as well as surgical procedural intervention and intravesical therapy, for people living with IR NMIBC," said Dr. Erik Goluboff, SVP of Clinical Development at TYRA. "We believe we are well-positioned to contribute meaningful advancements to the field of bladder cancer with SURF302, and we anticipate that the clinical data will offer valuable insights with the potential to enhance patient outcomes."
SURF302 (NCT06995677) is 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.
"I am excited that the Phase 2 trial evaluating oral TYRA-300 in IR NMIBC is now underway," said Dr. Tom Jayram, Director of the Advanced Therapeutics Center at Urology Associates in
TYRA-300 will also be evaluated in pediatric achondroplasia in the BEACH301 Phase 2 study, which is open for enrollment and for which the Company now expects first child dosing in the second half of the year.
About Non-Muscle Invasive Bladder Cancer
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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 that has demonstrated interim clinical proof-of-concept results in metastatic urothelial cancer (mUC). TYRA-300's planned clinical development includes three Phase 2 clinical trials: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for mUC.
Please visit the Patients page of our website for more information on our clinical trials.
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 FGFR3 gatekeeper mutations. TYRA-300's planned clinical development includes 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 reporting of data from 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 a first-in-class, once-daily oral treatment, and the potential safety and therapeutic benefits of TYRA-300; the expected timing and phase of development of TYRA-300, including the expected timing of dosing for the BEACH301 study in pediatric achondroplasia; and the potential for SNÅP to develop therapies. 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: potential delays in the commencement, recruitment, enrollment, data readouts and completion of clinical trials and preclinical studies; 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 or final 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; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, 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; 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 our product candidates; 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
Contact:
Amy Conrad
aconrad@tyra.bio
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FAQ
What is the primary endpoint of Tyra Biosciences' SURF302 Phase 2 trial for TYRA-300?
How many patients will be enrolled in TYRA's Phase 2 SURF302 trial?
What dosing regimens are being tested for TYRA-300 in the SURF302 trial?
When will Tyra Biosciences (TYRA) report initial data from the SURF302 trial?
What percentage of IR NMIBC cases have FGFR3 mutations that TYRA-300 targets?
What other indications is TYRA-300 being developed for?
