On November 29, 2022 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, reported the initiation of its SURF301 Phase 1/2 clinical study, with first patient dosed with TYRA-300 (Press release, Tyra Biosciences, NOV 29, 2022, View Source [SID1234624568]). 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.
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"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.
Conference Call & Webcast Information
TYRA will host a conference call and webcast today, November 29, 2022 at 9:00 a.m. ET. The conference call can be accessed by dialing 1-888-317-6003 for domestic callers and 1-412-317-6061 for international callers. Please provide the operator with the passcode 8739737 to join the conference call. The conference call will also be available via webcast under the "For Investors" section of TYRA’s website at www.tyra.bio. An archive of the teleconference and webcast will also be made available on TYRA’s website following the call.