Strengthened Executive Team with Key Hire.TYRA continued to use its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions including FGF19 +/FGR4-driven cancers, and RET (REarranged during Transfection kinase) driven cancers.
#FULL HIGHLIGHTS TRIAL#
TYRA expects the first patient will be dosed in this trial in the second half of 2023. The trial will be focused on intrahepatic cholangiocarcinoma resistant to prior FGFR inhibitors. In March 2023, TYRA announced that the FDA cleared its IND to proceed with a Phase 1 clinical study of TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. Food and Drug Administration (FDA) to enable a Phase 2 study of TYRA-300 in pediatric achondroplasia in 2024. TYRA expects to submit an Investigational New Drug application (IND) to the U.S.TYRA-300 increased body length in mice by 17.6% compared to the vehicle (p<0.0001) and increased the length of the femur (+24.4%), tibia (+38.3%) and L4-L6 (+23.9%) in mice (p<0.0001). In an FGFR3 Y367C/+ model, TYRA-300 was administered daily at a 1.2 mg/kg dose for 15 days. In the study, TYRA-300 was evaluated in FGFR3 wild-type and mutant preclinical models to measure increases in growth and bone length, compared to vehicle-treated mice.TYRA-300, an investigational agent, is a once-daily oral FGFR3 selective inhibitor whose design may have a meaningful impact on achondroplasia and other skeletal dysplasias. In March 2023, TYRA announced the expansion of development of TYRA-300 into achondroplasia (ACH) based on positive preclinical results in a study performed in collaboration with the Imagine Institute in Paris, France. Expanded Development into Achondroplasia.SURF301 ( NCT05544552) was 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. In November 2022, TYRA announced that patient dosing had commenced in its Phase 1/2 SURF301 clinical study of TYRA-300. Initiated SURF301 Phase 1/2 Study for Oncology.
Further, we have made steady progress utilizing our SNÅP discovery engine and expect to nominate additional clinical candidates."Īlan Fuhrman, CFO of TYRA, added, "TYRA is in a very strong financial position to begin 2023, with $251.2 million in cash and cash equivalents at year-end 2022, representing more than two years of expected cash runway to support our current development plans across our precision medicine platform."įourth Quarter 2022 and Recent Corporate Highlights "We believe TYRA-300 has the potential to become a best-in-class agent and we look forward to advancing it in both oncology and achondroplasia.
"2022 was a momentous year for TYRA – we achieved significant milestones, evolved into a clinical-stage company, and leveraged our expertise in FGFR biology to expand our therapeutic focus beyond oncology to include genetically defined conditions," said Todd Harris, CEO of TYRA. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, today reported financial results for the quarter and year ended December 31, 2022, and highlighted recent corporate progress. Well-capitalized with cash and cash equivalents of $251.2 million as of YE 2022-ĬARLSBAD, Calif., Ma/PRNewswire/ - Tyra Biosciences, Inc. Cleared IND for TYRA-200 Phase 1 study first patient dosed expected in 2H 2023. Expanded pipeline beyond oncology into genetically defined conditions with TYRA-300 for achondroplasia. Initiated patient dosing with TYRA-300 in SURF301 oncology study.
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