Tyra Biosciences, a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced that it has initiated the SURF201 Phase 1 study of TYRA-200 and provided positive updates on its oral FGFR3-selective inhibitor, TYRA-300.
TYRA-200
TYRA initiated the SURF201 study and has dosed the first patient with TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The SURF201 study is currently enrolling and dosing adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations. The Phase 1 clinical study of TYRA-200, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752), is a multi-center, open label study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of TYRA-200 and determine the optimal and maximum tolerated doses (MTD), as well as evaluate the preliminary antitumor activity of TYRA-200.
TYRA-300
SURF301 Study. The SURF301 Phase 1/2 study for oncology (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552) continues to advance. The study is a multi-center, open label study designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. The Phase 1 portion of SURF301 will provide data to inform multiple doses and schedules of TYRA-300 in future studies in metastatic urothelial carcinoma (mUC), non-muscle invasive bladder cancer (NMIBC) and achondroplasia. The SURF301 Phase 1 Part A portion continues to dose escalate and has cleared multiple dose cohorts that are above the anticipated dose(s) planned for use in the Phase 2 pediatric achondroplasia study. Current expansion cohorts in Part B are at dose level(s) anticipated to be evaluated in oncology. TYRA expects to submit initial results from its SURF301 Phase 1 portion for presentation at a scientific congress in 2024.
Planned Phase 2 Achondroplasia (ACH) Study. TYRA is planning to initiate a randomized Phase 2 clinical trial with multiple dose cohorts of TYRA-300 for children with achondroplasia. The primary objective of this study will be to assess safety and tolerability in children with achondroplasia and determine the dose(s) for further development. Secondary objectives will include evaluating change in growth velocity, growth proportionality and pharmacokinetics, as well as an assessment of quality of life and evaluation of biomarkers indicating dose-response relationships to TYRA-300. TYRA's expectation is that the study will initially evaluate treatment naïve children ages 5-12 to determine optimal dose ranges and will also include a separate analysis of children ages 5-12 with achondroplasia who have not responded to a prior growth accelerating therapy. We also expect to conduct studies in younger children in additional cohorts as data on safety, pharmacokinetics, and dose become available. TYRA plans to submit an Investigational New Drug (IND) application to the US FDA in the second half of 2024 for the initiation of the Phase 2 study.
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 dysplasias, including achondroplasia. In oncology, 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). SURF301 (NCT05544552) was designed to determine the optimal and MTD and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations. In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results, and the Company expects to submit an IND in the second half of 2024 for the initiation of a Phase 2 clinical study in pediatric achondroplasia. In July 2023, TYRA-300 was granted Orphan Drug Designation for the treatment of achondroplasia from the FDA.
About TYRA-200
TYRA-200 is an investigational, oral, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations currently in development for the treatment of cancer. TYRA-200 is being evaluated in a multi-center, open label Phase 1 clinical study, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors). SURF201 (NCT06160752) was designed to determine the optimal and MTD and the RP2D of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.
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