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Turning Point Therapeutics (NASDAQ: TPTX) announced the FDA granted an eighth regulatory designation and third Breakthrough Therapy designation for its lead drug candidate, repotrectinib, aimed at treating ROS1-positive metastatic NSCLC patients previously treated with a ROS1 tyrosine kinase inhibitor. The application was supported by efficacy data from about 50 patients in the TRIDENT-1 study. The company noted steady enrollment progress across all cohorts and plans for a pre-NDA meeting with the FDA to discuss topline data.
Turning Point Therapeutics, Inc. (NASDAQ: TPTX) has entered an exclusive license agreement with LaNova Medicines to develop and commercialize LM-302 (TPX-4589), a novel antibody drug conjugate targeting Claudin18.2, for gastrointestinal cancers. LaNova will receive $25 million upfront and up to $195 million in milestone payments. TPX-4589 is currently in two Phase 1 trials and has shown potential against gastric and pancreatic cancers. The agreement may expand to include up to three more ADC programs, emphasizing the growing significance of Claudin18.2 in oncology.
Turning Point Therapeutics (TPTX) and Zai Lab announced topline results from the Phase 1/2 TRIDENT-1 study regarding repotrectinib in China. The study revealed a confirmed objective response rate (cORR) of 91% in a TKI-naïve cohort (10/11 patients) and a cORR of 36-67% in three TKI-pretreated cohorts. The duration of response (DOR) in the TKI-naïve cohort was 3.6 to 7.5 months with a median DOR follow-up of 3.7 months. The companies plan to discuss further findings with health authorities and present detailed results in a medical conference later this year.
Turning Point Therapeutics (TPTX) announced promising results from the TRIDENT-1 study for ROS1-positive advanced non-small cell lung cancer. In a cohort of 71 TKI-naïve patients, the confirmed objective response rate (cORR) reached 79%, with a substantial estimated progression-free survival (PFS) of 82% at 12 months. TKI-pretreated patients showed varied cORRs with the highest at 59% for those with a specific mutation. The company anticipates a pre-NDA meeting with the FDA this quarter, strengthening its position in the oncology market.
Turning Point Therapeutics (NASDAQ: TPTX) has appointed Brian Sun, M.S., J.D. as the new Senior Vice President and General Counsel, effective April 11, 2022. Mr. Sun, currently at Sorrento Therapeutics, brings extensive legal expertise in the biotech sector. His leadership is expected to enhance the company’s vision in precision oncology, which includes the development of investigational drugs like repotrectinib for treating non-small cell lung cancer. The company emphasizes its commitment to innovation in cancer therapies.
Turning Point Therapeutics (TPTX) has achieved its enrollment goal of 40 patients for the EXP-6 cohort in the TRIDENT-1 study, focusing on NTRK-positive TKI-pretreated advanced solid tumors. The company plans to hold its second pre-NDA meeting in early 2023 to discuss the registration timeline for this patient population. Upcoming data releases are expected for ROS1-positive NSCLC cohorts in Q2 2022. Repotrectinib has received Breakthrough Therapy and Fast-Track designations from the FDA, emphasizing its significance in treating advanced solid tumors.
Turning Point Therapeutics (NASDAQ: TPTX) has announced participation in two upcoming investor conferences. CFO Paolo Tombesi will engage in one-on-one meetings at the 34th Annual Roth Conference on March 15. Following this, President and CEO Athena Countouriotis, M.D., will present a company overview at the Oppenheimer 32nd Annual Healthcare Conference on March 16 from 12:40 to 1:10 p.m. ET, accessible via webcast on the company’s website. TPTX is focused on developing innovative precision oncology therapies targeting genetic drivers of cancer.
Turning Point Therapeutics (NASDAQ: TPTX) has announced a change in the schedule for a fireside chat with President and CEO Athena Countouriotis, M.D. The session will now occur on Tuesday, March 8, from 2:50 to 3:20 p.m. ET. Interested parties can access the chat via webcast on the company’s Investors page. The company focuses on precision oncology, developing therapies for cancer with its lead candidate, repotrectinib, addressing ROS1 and TRK oncogenic drivers. It also has a robust pipeline targeting various cancer-related genetic alterations.
Turning Point Therapeutics (NASDAQ: TPTX) announced that President and CEO Athena Countouriotis will participate in a fireside chat at the 42nd Annual Cowen Healthcare Conference. The session is scheduled for March 8, 2022, from 11:10 a.m. to 11:40 a.m. ET, accessible via webcast on their investor page. The company focuses on precision oncology, developing therapies targeting genetic drivers of cancer, with key candidates including repotrectinib for non-small cell lung cancer and several others in its pipeline.
Turning Point Therapeutics (TPTX) reported a revenue of $30.8 million for 2021, primarily from licensing agreements with Zai Lab for repotrectinib and elzovantinib in Greater China. R&D expenses surged to $193 million for the year, reflecting ongoing investments in several clinical programs, including repotrectinib's TRIDENT-1 trial. The company holds approximately $982 million in cash, expected to sustain operations into H2 2024. Upcoming milestones include topline data for repotrectinib and a pre-NDA meeting with the FDA in Q2 2022.
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