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Regeneron licenses lymphoma drug to China’s Zai Labs

$190m deal gives Zai rights to drug in mainland China, Hong Kong, Taiwan and Macau

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Regeneron has licensed its much-anticipated REGN1979 drug for non-Hodgkin’s lymphoma (NHL) to China’s Zai Labs for $30m upfront and $160m in milestone payments.

The agreement gives Zai rights to the bispecific antibody in mainland China, Hong Kong, Taiwan and Macau, according to the US biotech, which says the collaboration will also help it recruit patients for its regional phase 2 trial of REGN1979 in B-cell NHL.

REGN1979 is the lead candidate in Regeneron’s bispecific antibody pipeline and targets CD20 and CD3 and showed a 93% response rate in a study involving patients with two forms of NHL – diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) – at last year’s European Haematology Association (EHA) congress.

The drug triggers lymphoma cell death by binding to them (via the CD20 end of the molecule), and recruiting cytotoxic T cells (via CD3) to attack them.

It has been shown to have efficacy in patients who have previously tried and failed CAR-T treatment with Novartis’ Kymriah (tisagenlecleucel) and Gilead/Kite’s Yescarta (axicabtagene ciloleucel).

Regeneron is competing with Roche in a race to being a CD20/CD3 bispecific to market, and the deal with Zai gives it a potential advantage in China, now the second-largest pharma market in the world.

Roche’s candidate is mosunetuzumab, which generated some buzz at the American Society for Haematology (ASH) conference last December with data showing a 37% response rate in heavily pre-treated relapsed-refractory NHS patients, including a complete response rate of 19%.

Both Regeneron and Roche are hoping that their bispecific drugs could eventually be used in preference to CAR-Ts, which are a cumbersome treatment based on harvesting a patient’s own white blood cells, genetically modifying them and reinfusing them to fight the cancer.

Along with its payment pledges, Zai will also contribute to the cost of running some of REGN1979’s trials and will make payments to the US biotech based on net sales.

“Zai's support will not only help bolster enrolment into global REGN1979 trials, but will also enable this promising investigational medicine to reach patients faster in this key region, if approved,” said Israel Lowy, head of clinical and translational sciences at Regeneron’s oncology unit.

REGN1979 is currently being investigated as a treatment for late stages of FL, DLBCL and other lymphomas in a phase 1 trial, as well as a phase 2 study that Regeneron thinks could potentially support regulatory approvals.

Article by
Phil Taylor

9th April 2020

From: Research

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