TP Therapeutics has netted $80 million and a new CEO as it looks to move its lead candidate targeting drug-resistant tumors, repotrectinib (TPX-0005), into phase 2 research early next year.
Chief Medical Officer Athena Countouriotis, M.D., who joined the company in May as an executive VP, was promoted to CEO and appointed to the board of directors.
Meanwhile, Co-founder Peter Li, Ph.D., who has served as chairman and CEO since the company was launched in 2013, has moved to head up TP Therapeutics Asia as the company looks to expand into the region.
In addition, TP’s president and chief scientific officer, Co-founder Jean Cui, Ph.D.—who helped invent Pfizer’s ALK and ROS1 inhibitor, Xalkori (crizotinib)—will become the company’s chairman.
So why the change at the top? As the company begins to move toward potentially registrational trials and discussions with the FDA, TP has begun searching for “somebody who has more experience, with not only private companies but also public companies, and bringing drugs to market,” Countouriotis told FierceBiotech.
“That was the phenotype we were looking for,” she said.
And while the chances of Countouriotis taking the helm were discussed earlier this year when she was brought on to lead the development and regulatory program, the company did undergo a formal search for CEO.
“My focus has been the same, which is to continue to advance repotrectinib closer to potential registration and work very closely with Jean to advance the pipeline,” Countouriotis said.
With the $80 million, TP hopes to build a lifecycle around repotrectinib. The company’s preclinical data has it considering combination studies with EGFR inhibitors such as Tagrisso in related NSCLC patients that have already progressed.
Over the next 18 months, the company hopes to have three active clinical assets in its pipeline, with IND filings for a dual CSF1R/MET inhibitor and an RET inhibitor program planned for the first and second halves of 2019, respectively.
It also plans to continue aggressively hiring; the company has nearly doubled in staff since Countouriotis joined about five months ago. She said she doesn't aim to fill the open CMO slot immediately but instead plans to hire someone with strong clinical development experience in a position akin to an R&D head, but perhaps with a wider scope.
The mezzanine funding round, expected to carry the company through 2020, was led by Foresite Capital and venBio Partners, while new investors HBM Healthcare Investments (Cayman) Ltd. and Nextech Invest joined the company’s returning backers, including Cormorant Asset Management, Lilly Asia Ventures, Orbimed Advisors and SR One.
Previously, Countouriotis served for about 11 months as senior VP and CMO at Adverum Biotechnologies after having the same roles at Halozyme Therapeutics. She departed Adverum around the same time as its CEO, Amber Salzman, Ph.D.
Countouriotis joined TP just before it unveiled its first-in-human study data from an ongoing phase 1 study of repotrectinib, which targets solid tumors with ALK, ROS or NTRK genetic mutations. In a poster presentation (PDF) for ASCO’s annual meeting, the company described observations of “preliminary antitumor activity.”
Repotrectinib is designed to have a much smaller physical structure than other ROS1 inhibitors, allowing it to bypass various resistance mechanisms seen in refractory patients, the company said.
According to updated data presented at the World Conference on Lung Cancer, 8 out of 10 ROS1-positive NSCLC patients that had not received TKI therapy demonstrated an objective response across all doses. Three out of 17 TKI-pretreated patients did the same.
In its ASCO presentation, the study data saw no responders in heavily pretreated ALK-positive NSCLC patients who had received a median of two TKI treatments. TP said the lack of activity may be influenced by doses, and further dose exploration is ongoing.
The planned phase 2 portion of the phase 1/2 study aims to enroll about 300 patients with ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors that have already received a tyrosine kinase inhibitor and have developed resistance to or did not respond to the drug, as well as those who have not received a TKI treatment.