Cancer immunotherapy that is given to attention long time has recently made tremendous progress. Novartis’s Kymriah and Gilead’s Yescarta, two star CAR-T products, were approved by the European Union (EU) and became the first chimeric antigen receptor T cell therapy approved by EU. As soon as the news came out, the stock price rose. As of Monday, Gilead’s share price rose by 1.23 US dollars.
The EU recommends the approval of Kymriah for the treatment of B-cell acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL), as well as Yescarta for DLBCL and primary mediastinal B-cell lymphoma (PMBCL).
Eric Althoff, Novartis spokesperson, said that the company will open a pharmaceutical factory in Switzerland in the future to expand production. In addition, Novartis has reached a cooperation agreement with CELLforCURE for the production of CAR-T products, and has also established a CAR-T production plant with the German Fraunhofer Institute.
A Gilead spokesperson said that the patients involved in the company’s early testing program have already used Yescarta. Moreover, the company is still discussing cost issues with some countries, trying to save money for patients by medical insurance or other methods.
In fact, these two Car-T drugs have been quite smooth on the way to approval, which have been supported by the Human Medical Products Committee.
Unlike conventional small molecule or biological therapy, CAR-T therapy is a living T cell therapy product. The principles of Kymriah and Yescarta are to genetically modify a patient’s T cells to express a chimeric antigen receptor (CAR) that targets the antigen CD19, an antigen protein expressed on the surface of various blood tumor cells, including B cell lymphoma and leukemia cells.
In the US market, Kymriah and Yescarta were approved in August and October 2017, respectively. Up to date, Kymriah has approved indications for B-ALL children and young adult patients who are refractory or relapsed at least 2 times, and adult patients with refractory or relapsed large B-cell lymphoma (LBCL) who has received two or more systemic treatments, including DLBCL, high-grade B-cell lymphoma (HGBL) and high-grade B-cell lymphoma (HGBL). Yescarta’s approved indications are treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) who have previously received two or more systemic therapies, including DLBCL, PMBCL, and high-grade B-cell lymphoma (HGBL) as well as DLBCL derived from follicular lymphoma (FL) (ie, transformed FL, TFL).
According to Novartis’s 2018H1 report, Kymriah’s sales in the first half of this year totaled were only $28 million while Gilead Yescarta’s sales for the same period were as high as $108 million. Up to now, Yescarta has been admitted to more than 60 cancer centers in the United States, with a target patient coverage rate of 80%. At present, both are also actively preparing for the manufacture and sale of their respective CAR-T products in the European market. In July this year, Novartis and the French biotechnology company CELLforCURE reached a cooperation agreement to produce CAR-T therapy. According to the agreement, after Novartis transferred the innovative manufacturing technology to CELLforCURE, the latter will begin to produce Novartis’ CAR-T products from the beginning of 2019, supplying the entire European market. Gilead also revealed that the company will build a 117,000 square meter manufacturing plant in the Netherlands to support the company’s products in the European market, and the new plant is expected to be put into use in 2020.
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