-TYRA-300 is the first oral, FGFR3-selective agent to be evaluated in the clinic-

CARLSBAD, CA, USA I November 29, 2022 I Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, today announced the initiation of its SURF301 Phase 1/2 clinical study, with first patient dosed with TYRA-300. TYRA-300, the Company’s lead product candidate stemming from its SNÅP platform, is an oral, FGFR3-selective inhibitor for the treatment of metastatic urothelial carcinoma of the bladder and urinary tract.

“We are pleased to dose our first patient with TYRA-300 in the SURF301 study, which represents an important milestone for TYRA and marks our transition into a clinical-stage company,” said Todd Harris, CEO of TYRA.  “The SURF301 study was designed to enable a potential path for rapid development of TYRA-300.  Importantly, we believe that TYRA-300 represents an outsized opportunity in bladder cancer with the potential to address important unmet needs in FGFR resistant and FGFR naïve populations, and the desire for a tolerable, targeted oral drug is very high.”

The Phase 1/2 clinical study of TYRA-300, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors), is a multi-center, open label study designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300.

Hiroomi Tada, M.D., Ph.D., Chief Medical Officer of TYRA, added, “We are excited to initiate SURF301 and evaluate the therapeutic potential of TYRA-300, which we thoughtfully designed to overcome tumor resistance and improve clinical outcomes. We intend to report progress from SURF301, including initial efficacy, PK/PD and biomarker results as mature data becomes available.”

The SURF301 study is currently enrolling adults with advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations.  For more information on the SURF301 study, please visit the Patients page of our website or visit www.clinicaltrials.gov and search for NCT05544552.

“The treatment paradigm for patients with bladder cancer remains complex.  First-line therapeutic options have initial efficacy, but significant gaps remain to treat the thousands of patients whose cancer recurs due to intrinsic and acquired resistance,” commented Jonathan E. Rosenberg, MD, Chief of the Genitourinary Medical Oncology Service, Division of Solid Tumor Oncology and the Enno W. Ercklentz Chair at Memorial Sloan Kettering Cancer Center (MSK).

Dr. Rosenberg has a consulting relationship with TYRA.

About Tyra Biosciences

Tyra Biosciences, Inc. is a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer. TYRA’s proprietary in-house discovery platform, SNÅP, enables the rapid and precise refinement of structural design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. Leveraging SNÅP, TYRA is developing a pipeline of selective inhibitors of Fibroblast Growth Factor Receptors (FGFR), which are altered in approximately 7% of all cancers. TYRA-300 is an FGFR3 selective inhibitor for oncology.  TYRA-200 is an FGFR1/2/3 inhibitor with potency against FGFR2 fusions, molecular brake mutations and gatekeeper resistance that TYRA is developing initially in intrahepatic cholangiocarcinoma. TYRA is also targeting achondroplasia and other FGFR3-related skeletal dysplasias and FGFR4 and RET (REarranged during Transfection kinase) 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.

SOURCE: Tyra Biosciences