|Over a week ago|
Turning Point Therapeutics appoints Paolo Tombesi as CFO » 09:0206/2906/29/21
Turning Point Therapeutics (TPTX) named Paolo Tombesi as executive vice president and CFO, effective July 26. Tombesi brings 30 years of global financial and accounting experience to Turning Point from multiple prior financial leadership roles within biotech and pharmaceutical companies, most recently serving as CFO of Epizyme (EPZM).
|Over a month ago|
Turning Point Therapeutics granted FDA orphan drug designation for TPX-022 » 08:3806/1706/17/21
Turning Point Therapeutics announced that TPX-0022, the company's inhibitor of MET and the associated cancer signaling pathways of SRC and CSF1R, has been granted orphan drug designation by the Food and Drug Administration for the treatment of patients with gastric cancer, including gastroesophageal junction adenocarcinoma. TPX-0022 is a potent inhibitor of the MET tyrosine kinase and has the potential to modulate the tumor microenvironment to augment its therapeutic effect. Initial clinical data presented from the ongoing Phase 1 SHIELD-1 study in October 2020 showed TPX-0022 has been generally well-tolerated and demonstrated clinical activity in patients with MET-amplified gastric cancer.
Zai Lab announces first patient treated in China in Phase 2 TRIDENT-1 study » 07:3305/2805/28/21
Zai Lab (ZLAB) announced…
Zai Lab (ZLAB) announced dosing of the first patient in China in the registrational Phase 2 portion of TRIDENT-1 study of repotrectinib being conducted by its partner Turning Point Therapeutics (TPTX) and Zai Lab in patients with ROS1+ advanced non-small cell lung cancer and NTRK+ advanced solid tumors. Zai Lab has an exclusive license agreement with Turning Point for the development and commercialization of repotrectinib in Greater China. The registrational Phase 2 portion of TRIDENT-1 study is a multi-center trial evaluating repotrectinib for the treatment of patients with ROS1+ advanced NSCLC as well as patients with NTRK+ advanced solid tumors. The primary endpoint of the Phase 2 portion of the trial is overall response rate assessed by Blinded Independent Central Review. Secondary endpoints include duration of response, progression free survival, safety and tolerability. Zai Lab is enrolling patients in Greater China, while Turning Point is enrolling patients in other regions of the world. Turning Point disclosed on May 5 that the FDA recently guided that a type B meeting should be requested to discuss topline BICR results of cohort 1 of the registrational TRIDENT-1 study when responders have been followed for at least six months past onset of response. Turning Point believes it may be in a position to discuss the topline results from patients treated within EXP-1 with the FDA during the first quarter of 2022.
Turning Point Therapeutics appoints Mark Alles as chair of board » 09:0205/2505/25/21
Turning Point Therapeutics announced the appointment of former Celgene chairman and CEO, Mark Alles, to chair its board of directors. Garry Nicholson, who is currently the interim chair, will remain on the board.
Turning Point Therapeutics appoints Kumar Srinivasan as Chief Business Officer » 09:0305/1705/17/21
Turning Point Therapeutics (TPTX) announced the appointment of Kumar Srinivasan as executive vice president and Chief Business Officer, effective June 1. Srinivasan has over 20 years of experience in pharmaceutical and biotechnology companies, most recently as vice president and global head of business development for the BioPharmaceutical business unit of AstraZeneca (AZN). Srinivasan will be responsible for corporate strategy and business development, including collaborations and alliances. During his 9-year tenure at AstraZeneca, Srinivasan was responsible for all in- and out-licensing, business development and alliance management activities within several therapeutic areas on a regional and global scale. In addition, he previously held executive level business development roles at Wyeth; Vivoryon, a publicly traded biotech based in Germany; and Torrey Pines Therapeutics. Earlier in his career, he held scientific roles at biopharmaceutical companies, Sibia Neurosciences and Genta.
Turning Point 'significantly undervalued' with catalysts ahead, says Roth » 09:4105/0605/06/21
Turning Point Therapeutics showed "stellar progress" in Q1, including getting its third and fourth investigational new drug clearances, Roth Capital analyst Zegbeh Jallah tells investors in a research note. The analyst says that with the platform validation from Repotrectinib and multiple programs in the clinic, the stock is "significantly undervalued." Turning Point has sufficient cash into 2024 and "multiple catalysts ahead," contends Jallah, who keeps a Buy rating on the shares with a $175 price target.
|Over a quarter ago|
Turning Point combo data show 'expansive pipeline potential,' says Roth Capital » 10:3604/1304/13/21
Roth Capital analyst…
Roth Capital analyst Zegbeh Jallah keeps a Buy rating on Turning Point Therapeutics with a $175 price target after the company presented data from three of its four clinical programs at the recent American Association for Cancer Research meeting. The analyst highlights the MEK and PD-1 combo data, saying it broadens the use-case of Turning Point's tyrosine kinase inhibitors as "indicative of its expansive pipeline potential." Repotrectinib is a potent NTRK/ROS-1 inhibitor with potential for combo efficacy in KRAS mutant cancers, Jallah tells investors in a research note.
Turning Point initiates Phase 1/2 Forge-1 study of TPX-0131 » 09:0904/1204/12/21
Turning Point Therapeutics announced initiation of its Phase 1/2 FORGE-1 study of TPX-0131, a potent inhibitor of the anaplastic lymphoma kinase and multiple resistant mutations of ALK. The investigational new drug application for TPX-0131 is Turning Point's third IND to be cleared by the FDA in less than 2 years, and FORGE-1 is the company's fourth clinical study to initiate during the same period of time. The study was initiated in Australia, with U.S. site activations now planned. ALK alterations are estimated to be responsible for 3% to 5% of non-small cell lung cancer cases annually in the U.S. and EU5 countries. In preclinical studies, TPX-0131 potently inhibits wildtype ALK and is more potent in comparison to approved ALK inhibitors against many clinically observed resistance mutations, including the G1202R solvent front mutation, L1196M gatekeeper mutation, and multiple compound mutations. In addition, TPX-0131 has shown brain tissue penetration after repeat oral dosing. The Phase 1 dose finding portion of the FORGE-1 study will enroll patients with locally advanced or metastatic TKI-pretreated ALK-positive NSCLC. Patients with up to 2 prior ALK TKIs and 1 prior platinum-based chemotherapy will be enrolled. The study endpoints include safety and tolerability, determination of the maximum tolerated dose and/or the recommended Phase 2 dose, and objective response rate by RECIST 1.1.
Turning Point Therapeutics announces new preclinical data for three drugs » 09:0404/0904/09/21
Turning Point Therapeutics announced new preclinical data supporting the ongoing development of three of its drug candidates, repotrectinib, TPX-0022 and TPX-0131. The findings will be presented this weekend at the American Association for Cancer Research annual meeting, which is convening virtually through April 14. For lead drug candidate, repotrectinib, poster presentations will highlight new preclinical combination data with MEK and MEK/Raf inhibitors, as well as repotrectinib's potency against wildtype and mutant TRKA/B/C as compared to approved TRK inhibitors. The preclinical studies found that repotrectinib combinations with approved MEK inhibitor, trametinib, or investigational MEK/Raf inhibitor, VS-6766, were more effective than single-agent treatment in patient-derived KRAS mutant G12D/V lung and G12D/V/R pancreatic cancer models. Based on the findings and additional preclinical support presented previously, Turning Point anticipates the first cohort of its planned Phase 1/2 TRIDENT-2 study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS mutant G12D advanced solid tumors. For MET/SRC/CSF1R inhibitor TPX-0022, the company will present preclinical data demonstrating potential utility in combination with immune checkpoint inhibitors. In a syngeneic xenograft tumor model, TPX-0022 treatment downregulated immunosuppressive cytokines, increased anti-tumor M1 macrophages, and enriched levels of CD8+ cytotoxic T cells. TPX-0022 had single agent in vivo efficacy and enhanced the efficacy of an anti-PD-1 inhibitor. With the new data, Turning Point is evaluating a potential additional combination study of TPX-0022 and an anti-PD-1 checkpoint inhibitor. In the second half of 2021, the company plans to provide a clinical data update from the Phase 1 dose finding portion of its ongoing SHIELD-1 study and initiate its planned Phase 1b/2 SHIELD-2 clinical study of TPX-0022 in combination with an EGFR targeted therapy. For its ALK-inhibitor, TPX-0131, Turning Point will present preclinical data showing its potential to cross the blood-brain barrier and its potency against wild type ALK and a broad spectrum of acquired ALK resistance mutations, including the G1202R solvent front mutation, L1196M gatekeeper mutation, and the G1202R/L1196M and /L1198F compound mutations. Turning Point plans to initiate a Phase 1/2 study in patients with ALK-positive TKI-pretreated advanced non-small cell lung cancer in the Q2.
Turning Point Therapeutics management to meet virtually with Wedbush » 10:5504/0604/06/21
Virtual Meeting to be…
Virtual Meeting to be held on April 7 at 11:30 am hosted by Wedbush.