HONG KONG – China and U.S.-based Zai Lab Ltd. has inked a deal to develop and commercialize Turning Point Therapeutics Inc.’s lead drug candidate, repotrectinib, in the greater China markets.

As part of the deal, Zai Lab will have exclusive rights to develop and commercialize repotrectinib in mainland China, Hong Kong, Macau and Taiwan. In exchange, Turning Point will receive a $25 million up-front payment, with the potential to receive up to an additional $151 million in development, regulatory and sales-based milestone payments. The San Diego-based precision oncology company will also be eligible to receive mid-to-high teen royalties based on annual net sales of repotrectinib in greater China.

Repotrectinib is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small-cell lung cancer (NSCLC) and advanced solid tumors. It is currently in a phase II study in adults and a phase I/II study in pediatric patients, where it has shown antitumor activity and durable responses among kinase inhibitor treatment-naive and pretreated patients.

Though it is not approved for any indications just yet, Zai Lab has said it sees repotrectinib as a potential best-in-class small-molecule tyrosine kinase inhibitor of ROS1, TRK and ALK.

“Repotrectinib is uniquely positioned both in TKI-naïve and TKI-refractory settings, where there are no approved targeted therapies, with strong point of care credentials,” Samantha Du, founder and CEO of Zai Lab, told BioWorld.

She said she expects to open additional sites for the phase II study of repotrectinib that is currently active in 11 countries globally and enrolling patients with ROS1-positive advanced NSCLC and NTRK-positive solid tumors.

“Zai Lab will contribute patients to [the] global TRIDENT-1 phase II registrational study including ROS1-positive advanced NSCLC and NTRK-positive advanced solid tumors. Given the large patient pool and Zai Lab’s established clinical development infrastructure in the lung treatment area, this will help China development,” said Du. “Our shared goal is to accelerate the process and bring this potential best-in-class agent to patients as soon as possible.”

In addition, a joint development committee will also be established with members from each party to oversee the development of repotrectinib in the territory.

Zai Lab did not provide a deadline for the enrollment timeline or the end of clinical studies, but the company shared that repotrectinib already has an IND approval from China’s National Medical Products Administration.

“The clinical trials will depend on multiple factors, including feedback and guidance from regulatory agencies,” said Du.

The deal with Zai Lab marks a turning point for Turning Point, too, as it is the latter’s first strategic collaboration with a partner in China.

“With more than 700,000 newly diagnosed lung cancer patients every year in greater China, and the development and commercialization capabilities Zai Lab have shown over time in the region, we view Zai Lab as the ideal partner to help expand the potential reach of repotrectinib,” said Athena Countouriotis, president and CEO of Turning Point.

Turning Point’s collaboration with Zai Lab in China is likely to go further in the future.

“Zai Lab will obtain exclusive rights to develop and commercialize repotrectinib in greater China, which includes mainland China, Hong Kong, Taiwan and Macau for all indications,” said Du.

“Zai Lab will have the right of first negotiation to the next two products in the pipeline if Turning Point decides to seek a partner for these drug candidates in greater China. We will certainly explore opportunities in oncology that fit into our long-term strategy, and opportunities that address the unmet medical needs in these territories,” she added.

The deal with Turning Point is Zai Lab’s second this year. The first was in April with Regeneron Pharmaceuticals Inc. to develop REGN-1979, a CD20xCD3 bispecific antibody, in mainland China, Hong Kong, Taiwan and Macau. The candidate is in an ongoing phase II study as a treatment for B-cell non-Hodgkin lymphoma.

“Zai Lab’s goal is to become a leading global biopharma company with oncology being a particular area of focus for us,” Du said. “We have built a great pipeline and several disease area strongholds in solid tumors, and we believe expanding horizontally into hematological cancers and strengthening the disease area in lung cancer will leverage our capabilities.”

So far, 2020 has become quite a productive year for Zai Lab.

“Year to date, we have 12 CTAs approved and six FPIs [first patient ins]. In May, the FDA granted full approval of our partner, Deciphera Pharmaceuticals’ Qinlock (ripretinib) for the treatment of fourth-line gastrointestinal stromal tumor, which Zai Lab has exclusive rights to develop and commercialize in greater China,” said Du.

Shares of Zai Lab (NASDAQ:ZLAB) closed July 9 at $89.48, up $2.61 cents.

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