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Turning Point Therapeutics (NASDAQ: TPTX) has announced that it will present early clinical data for repotrectinib in pediatric and young adult patients with advanced solid tumors at the upcoming SIOP 2021 conference on October 23, 2021. This presentation will detail findings from the Phase 1/2 CARE study, focusing on patients harboring ALK, ROS1, or NTRK alterations. The company's lead candidate, repotrectinib, aims to address critical limitations in cancer therapies and has shown promising antitumor activity in previous trials.
Turning Point Therapeutics (TPTX) recently presented early clinical data from its TRIDENT-1 Phase 1/2 study of repotrectinib for NTRK-positive advanced solid tumors. The results show a confirmed objective response rate (cORR) of 48% in TKI-pretreated patients and 41% in TKI-naïve patients. A significant 62% cORR was observed in patients with solvent front mutations. The FDA has granted Breakthrough Therapy designation for repotrectinib in this patient population. The company anticipates a Type B meeting with the FDA in early 2022 to discuss potential registration steps.
Turning Point Therapeutics, Inc. (NASDAQ: TPTX) announced promising interim clinical trial data for its lead drugs, repotrectinib and elzovantinib, at the AACR-NCI-EORTC conference. The TRIDENT-1 study showed confirmed objective response rates (cORR) of 30-39% in ROS1+ advanced non-small cell lung cancer (NSCLC) patients pretreated with prior TKIs, with a notable 53% cORR in those with the G2032R mutation. Elzovantinib also demonstrated a cORR of 36% in MET TKI-naïve NSCLC patients. The company plans to engage with the FDA for further development, indicating strong momentum in its clinical pipeline.
Turning Point Therapeutics (NASDAQ: TPTX) announced that the FDA granted a seventh regulatory designation to its lead drug candidate, repotrectinib. This Breakthrough Therapy designation targets patients with advanced solid tumors having an NTRK gene fusion, who've progressed after receiving one or two prior TRK inhibitors. The company plans to engage with the FDA for potential registration discussions in H1 2022. CEO Athena Countouriotis emphasized the unmet medical need for these patients and highlighted forthcoming clinical data presentations.
Turning Point Therapeutics, Inc. (NASDAQ: TPTX) announced details of its data presentations at the Virtual International Conference on Molecular Targets and Cancer Therapeutics, set for October 7-10. Key presentations include updates from ongoing clinical trials for its lead candidate, repotrectinib, targeting advanced solid tumors, and TPX-0022, a novel inhibitor, with significant sessions scheduled on October 8. A webcast and conference call will be held on October 7 at 8 a.m. ET to discuss these clinical data, hosted by company executives.
Turning Point Therapeutics (NASDAQ: TPTX) announced the acceptance of a late-breaker abstract for oral presentation at the Virtual International Conference on Molecular Targets and Cancer Therapeutics from Oct. 7-10, 2021. The presentation will focus on early clinical data for repotrectinib in NTRK-positive advanced solid tumors. Additionally, two abstracts detailing clinical data for repotrectinib in ROS1-positive non-small cell lung cancer and TPX-0022 in patients with MET alterations will also be presented. These developments highlight TPTX's commitment to advancing precision oncology therapies.
Turning Point Therapeutics (NASDAQ: TPTX) announced participation in two upcoming healthcare conferences. President and CEO Athena Countouriotis will present a company overview at the Wells Fargo Virtual Healthcare Conference on Sept. 9, at 2:00 p.m. ET, and at the H.C. Wainwright 23rd Annual Global Investment Conference on Sept. 13, at 7:00 a.m. ET. Both presentations will be webcast on the company's Investors page. Turning Point is focused on developing precise cancer therapies, including their lead candidate, repotrectinib, targeting genetic drivers of cancer.
Turning Point Therapeutics (NASDAQ: TPTX) announced the initiation of the Phase 1b/2 TRIDENT-2 study, investigating its lead drug repotrectinib in combination with trametinib for patients with KRAS G12D mutated advanced solid tumors. The study aims to evaluate safety, tolerability, and efficacy, following promising preclinical results that demonstrated enhanced effectiveness over single-agent trametinib. The research addresses the challenges in targeting KRAS mutations, which are prevalent in various cancers, and aims to provide a potential new treatment option for affected patients.
Turning Point Therapeutics (NASDAQ: TPTX) announced that the FDA granted Fast-Track designation for its lead drug candidate, repotrectinib, aimed at treating ROS1-positive advanced non-small cell lung cancer patients who have undergone prior treatment with one ROS1 tyrosine kinase inhibitor. This marks the sixth regulatory designation for repotrectinib. The Fast-Track designation allows for more frequent FDA meetings and may accelerate drug approval processes. The company remains dedicated to delivering innovative cancer therapies while navigating the challenges posed by the ongoing pandemic.
Turning Point Therapeutics (NASDAQ: TPTX) announced significant advancements in its clinical trials and financial results for Q2 2021. Enrollment in the TRIDENT-1 study has reached approximately 300 patients, with over 50 in the ROS1-positive cohort. The FDA granted Fast Track designation for TPX-0022 in advanced gastric cancer. Financially, the company reported Q2 revenue of $5.2 million, driven by collaboration milestones, and a net loss of $56.3 million. With cash reserves of $1.1 billion, the company projects operational funding through 2024.
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