TYRA-200 / Tyra Biosci - LARVOL DELTA

TYRA-200: Next generation inhibitor designed to potently target FGFR2 alterations and resistance mutations (ACS-Fall 2025) - "The therapeutic landscape for FGFR2-driven cancers was significantly advanced by the approval of pan-FGFR inhibitors futibatinib (Lytgobi) and pemigatinib (Pemazyre), which have demonstrated efficacy in treating locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. However, the effectiveness of these treatments has been hampered by the emergence of multiple resistance mutations, which are often polyclonal and affect critical regions in the FGFR2 kinase domain, such as the gatekeeper residue (V565), molecular brake (N550, E566, K642) and other key variants...TYRA-200 is undergoing evaluation in a Phase 1 clinical trial focused on patients with advanced or metastatic intrahepatic cholangiocarcinoma that have FGFR2 activating gene alterations and have exhausted standard therapies due to resistance. This study aims to assess the potential of TYRA-200 as a viable treatment alternative for these patients, representing a crucial step toward..."

Biliary Cancer • Cholangiocarcinoma • Solid Tumor • FGFR2

Tyra Biosciences Announces Poster Presentations at 2025 ASCO Gastrointestinal Cancers Symposium (PRNewswire) - "Tyra Biosciences, Inc...announced today that two abstracts were accepted for presentation at the 2025 ASCO Gastrointestinal Cancers Symposium (ASCO GI), taking place January 23-25, 2025, in San Francisco, CA."

P1 data • Preclinical • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Solid Tumor

A multicenter, open-label, first-in-human study of TYRA-200 in advanced intrahepatic cholangiocarcinoma and other solid tumors with activating FGFR2 gene alterations (SURF201). (ASCO-GI 2025) - P1 | "Part B dose expansion will further characterize the safety profile and evaluate the preliminary anti-tumor activity of TYRA-200 by RECIST v1.1 in pts with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma who have previously received an FGFR inhibitor(s) and have developed acquired FGFR2 kinase domain resistance mutations. The study is currently planned for approximately four centers in the US and is actively enrolling (NCT06160752)."

Clinical • Metastases • P1 data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

Tyra Biosciences Reports Second Quarter 2024 Financial Results and Highlights (PRNewswire) - "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."

Enrollment status • Biliary Tract Cancer • Cholangiocarcinoma

Tyra Biosciences, Inc. Announces $200 Million Private Placement Financing (PRNewswire) - "Tyra Biosciences, Inc...announced today that it has entered into a securities purchase agreement with institutional and accredited investors to sell securities in a private placement financing (the PIPE) for gross proceeds of approximately $200 million....'The additional funding strengthens our balance sheet at a time of strong momentum. We are focused on developing TYRA-300, an oral FGFR3-selective inhibitor, to become a best-in-class agent for achondroplasia, NMIBC and metastatic urothelial carcinoma, while advancing TYRA-200 and leveraging our SNÅP platform to discover new drug candidates.'"

Financing • Bladder Cancer • Genetic Disorders • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Tyra Biosciences Doses First Patient with TYRA-200 and Provides Positive Updates on TYRA-300 (PRNewswire) - "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."

Trial status • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

SURF201: Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Tyra Biosciences, Inc

Metastases • New P1 trial • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

Tyra Biosciences Reports Third Quarter 2023 Financial Results and Highlights (PRNewswire) - "TYRA continued to advance activities to support the initiation of the planned Phase 1 clinical study of TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The trial will be focused on intrahepatic cholangiocarcinoma resistant to prior FGFR inhibitors. TYRA remains on track to dose the first patient in this trial before year-end 2023."

New P1 trial • Cholangiocarcinoma

Tyra Biosciences Reports Second Quarter 2023 Financial Results and Highlights (PRNewswire) - "TYRA continued to advance activities for its planned Phase 1 clinical study of TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations, during the second quarter of 2023. The trial will be focused on intrahepatic cholangiocarcinoma resistant to prior FGFR inhibitors. TYRA remains on track to dose the first patient in this trial in the second half of 2023."

New P1 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

TYRA-200: Potent Against FGFR2 Fusions, Molecular Brake Mutations and Gatekeeper Resistance (CCF 2023) - No abstract available

FGFR2

Tyra Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights (PRNewswire) - "TYRA-200:...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. The trial will be focused on intrahepatic cholangiocarcinoma resistant to prior FGFR inhibitors. TYRA expects the first patient will be dosed in this trial in the second half of 2023."

IND • New P1 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

TYRA-200: Potent Against FGFR2 Fusions, Molecular Brake Mutations and Gatekeeper Resistance (AACR-NCI-EORTC 2022) - "Background: Approved pan-FGFR (fibroblast growth factor receptor) inhibitors and those in late-stage clinical development (pemigatinib, infigratinib, and futibatinib) have demonstrated a clinical benefit in metastatic FGFR2-fusion or rearranged intrahepatic cholangiocarcinoma (ICC). TYRA-200 is currently under development for FGFR2-altered advanced solid tumors, including ICC. Importantly, the data demonstrates that TYRA-200 retains potency across multiple resistance mutations which emerge during therapy, including gatekeeper and molecular brake mutations."

Biliary Cancer • Cholangiocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

Tyra Biosciences to Present Preclinical Data on TYRA-200, an FGFR1/2/3 Inhibitor, at 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (PRNewswire) - "Tyra Biosciences, Inc...announced that the Company will present preclinical data on TYRA-200 during a poster session at the 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place October 26-28, 2022, in Barcelona, Spain."

Preclinical • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Tyra Biosciences Reports Second Quarter 2022 Financial Results and Highlights (PRNewswire) - "TYRA continued to advance TYRA-200, an FGFR2 inhibitor with an initial focus on patients with intrahepatic cholangiocarcinoma. TYRA remains on track to submit an IND with the FDA for TYRA-200 in the second half of 2022."

IND • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Tyra Biosciences Reports Third Quarter 2021 Financial Results and Highlights (PRNewswire) - "In October 2021, TYRA nominated its product candidate, TYRA-200, for clinical development to treat patients with tumors due to activating mutations and gene alterations in FGFR2....TYRA has designed TYRA-200 to be active against multiple acquired resistant mutations that arise during treatment with other FGFR inhibitors, which remains a high unmet medical need, particularly in intrahepatic cholangiocarcinoma. TYRA anticipates filing an Investigational New Drug application (IND) for TYRA-200 with the U.S. Food and Drug Administration in the second half of 2022."

IND • Pipeline update • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology