On January 11, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported 2021 milestone targets for its pipeline of four drug candidates, including data updates from multiple clinical studies and the initiation of new clinical studies (Press release, Turning Point Therapeutics, JAN 11, 2021, View Source [SID1234573833]). The company also updated its cash position as of Dec. 31, 2020.

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"Following a pivotal year in 2020, we believe we have even greater opportunities in 2021 to further advance our pipeline by potentially modifying our SHIELD-1 study to a registrational Phase 1/2 design, adding three new clinical trials, including two anticipated combination studies and a Phase 1 study of our fourth drug candidate, our novel ALK-inhibitor TPX-0131, and reporting initial or updated data from our three clinical stage drug candidates," said Athena Countouriotis, M.D., president and chief executive officer. "At the same time, we have continued to invest in our discovery engine and look forward to the second half of the year when we plan to outline our focus and goals to further expand the pipeline."

2020 Achievements and 2021 Milestone Targets

Repotrectinib, ROS1 and TRK Inhibitor

In 2020, repotrectinib was granted breakthrough-therapy designation (BTD) and received its second and third fast-track designations. In addition, the company signed an exclusive license agreement with Zai Lab to develop and commercialize repotrectinib in greater China and reported early interim data from the Phase 2 TRIDENT-1 registrational study.

2021 Milestone Targets:

Present updated data from the TRIDENT-1 study in TKI-naive patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) in a mini-oral presentation on Jan. 31 at the World Conference on Lung Cancer

Provide an update on the overall Phase 2 TRIDENT-1 registrational study timeline in the first quarter

Initiate the Phase 2 TRIDENT-2 combination study in patients with KRAS mutant NSCLC mid-year

Provide clinical data updates from certain cohorts of the Phase 2 TRIDENT-1 study in the second half
TPX-0022, MET/SRC/CSF1R Inhibitor

In 2020, Turning Point advanced its clinical development of TPX-0022 and reported initial data from the Phase 1 SHIELD-1 study in an oral presentation during the plenary session at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) medical symposium.

Earlier today, the company announced the broadening of its collaboration with Zai Lab to include an exclusive licensing agreement for TPX-0022 in greater China.

2021 Milestone Targets:

Initiate the Phase 2 portion of SHIELD-1, pending FDA feedback, in the second half

Initiate the Phase 2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor in the second half

Provide a clinical data update from the Phase 1 portion of the SHIELD-1 study in the second half
TPX-0046, RET Inhibitor

In 2020, Turning Point presented preclinical data highlighting the potent inhibition of TPX-0046 against wildtype RET and RET mutations, and continued its ongoing Phase 1 study of TPX-0046.

2021 Milestone Target:

Report early interim data from initial patients enrolled in the dose finding portion of the TPX-0046 Phase 1 study in the first half
TPX-0131, ALK Inhibitor

In 2020, Turning Point nominated TPX-0131 as its ALK inhibitor drug candidate, advanced its IND enabling studies, and presented preclinical data highlighting its ability to overcome ALK resistant mutations refractory to approved ALK inhibitors.

2021 Milestone Targets:

Submit the IND for TPX-0131 in the first quarter
Initiate a Phase 1 clinical study of TPX-0131 in the first half
Early Discovery Pipeline

In 2020, Turning Point named Siegfried Reich as chief scientific officer and made investments to advance its research strategy.

2021 Milestone Target:

Outline research strategy, focus and milestones for future development candidates in the second half
Financial

In 2020, Turning Point completed follow-on stock offerings generating gross proceeds of $374 million and $460 million. The company enters 2021 with approximately $1.1 billion in cash, cash equivalents and marketable securities as of Dec. 31, 2020, which is expected to fund operations into 2024.