On December 22, 2023 Tyra Biosciences, Inc. (the Company) reported that it has initiated and dosed the first patient in the SURF201 Phase 1 study of TYRA-200. 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 (Press release, Tyra Biosciences, DEC 22, 2023, View Source [SID1234638781]). SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752), is a Phase 1/2 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.
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In addition, the Part A Phase 1 portion of the SURF301 study of TYRA-300 in oncology 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 (ACH) study. Current expansion cohorts in Part B are at dose level(s) anticipated to be evaluated in oncology. The Company expects to submit initial results from the SURF301 Phase 1 portion for presentation at a scientific congress in 2024.
The Company also plans to submit an Investigational New Drug (IND) application to the FDA in the second half of 2024 for the initiation of a randomized Phase 2 clinical trial with multiple dose cohorts of TYRA-300 for children with ACH. The primary objective of this study is to assess safety and tolerability in children with ACH 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. The Company’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 ACH who have not responded to a prior growth accelerating therapy.