Item 1.01. | Entry into a Material Definitive Agreement. |
On June 23, 2022, Turning Point Therapeutics, Inc. (the “Company”) entered into a strategic collaboration agreement (the “Agreement”) with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”). Under the terms of the Agreement, the Company will provide funding and support for preclinical and clinical studies to be conducted by MD Anderson in several solid tumors, including non-small cell lung cancers, gastrointestinal malignancies and endocrine cancers (the “Studies”).
The initial focus of the Studies will be the Company’s lead drug candidate, repotrectinib, a next-generation kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors that is currently being studied in a registrational Phase 1/2 study (TRIDENT-1). The Studies will also include two additional drug candidates, elzovantinib (TPX-0022), a kinase inhibitor targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced solid tumors harboring genetic alterations in MET (SHIELD-1), and TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer (FORGE-1).
Pursuant to the Agreement, the Company has agreed to provide total funding in an amount of $10.0 million for the performance of the Studies, such funding to be provided in increments of $1.0 million on a twice-yearly basis. The Studies will be overseen by a joint steering committee, which will provide technical, scientific, clinical and regulatory guidance, discuss and approve study budgets, and monitor the progress of the Studies.
Under the terms of the Agreement, all Inventions will be solely owned by the Company, except with respect to the use of Proprietary Materials of MD Anderson that does not involve the use of the Company’s Study Drug or Proprietary Materials (each as defined in the Agreement).
The term of the Agreement runs five years or until the Studies are completed, whichever is later, unless terminated earlier in accordance with the terms set forth in the Agreement.
The foregoing description of the material terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Agreement, a copy of which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022.