BEIJING – CAR T therapy developer JW Therapeutics (Shanghai) Co. Ltd. raised another $100 million this week after securing $90 million in series A round in 2018. The funds will continue to go toward its lead program, JWCAR-029, a CAR T-cell product targeting CD19 that is now in a phase II study.

The series B round was co-led by CPE and Mirae Asset. New investors, namely CR-CP Life Science Fund and Oriza Holdings, joined other existing investors, including Loyal Valley Capital, Temasek, Sequoia Capital China, Arch Venture Partners, Juno Therapeutics (a Bristol Myers Squibb Co. company) and Wuxi Apptec. JW Therapeutics said it will use the proceeds to advance JWCAR-029, build its pipeline and establish commercialization capabilities to support product launch.

The company was created under a partnership between Juno Therapeutics, of Seattle, and Shanghai-based contract research service platform Wuxi Apptec in February 2016 to focus on cell-based immunotherapy.

There has been speculation that JW Therapeutics intends to file for an IPO with the Hong Kong Stock Exchange this year. Its founder, Wuxi Apptec, went public in Hong Kong in 2018.

Best-in-class potential

Lead product JWCAR-029 is designed to treat B-cell malignancies, with a focus on relapsed and refractory B-cell non-Hodgkin lymphoma (NHL). The company said it is a CD19-directed 4-1BB CAR T-cell product with a 4-1BB co-stimulatory domain, in which CD4 and CD8 CAR T cells are produced together and transfused in a non-fixed ratio.

“It is a product based on Juno's cutting-edge technology and developed at JW, targeting B-cell malignancies,” Wenjun Sun, vice president of business development at JW Therapeutics, previously told BioWorld. “JWCAR-029 potentially can be a best-in-class product in CD19 CAR T candidates.”

According to Frost & Sullivan, eight Chinese companies, including JW Therapeutics, have moved their CD19-directed CAR T-cell candidates to clinical trials in China, and one company is advancing its candidate to the NDA stage.

JW Therapeutics was the first company to receive the IND approval in China. Last year, the company presented phase I data of JWCAR-029 at the 61st American Society of Hematology (ASH) meeting.

In a single-arm, open-label, dose-escalation phase I trial in relapsed and refractory B-cell NHL, data from 29 patients demonstrated high response rates and a favorable safety profile of JWCAR-029. Among those 29 patients, the objective response rate (ORR) was 58.6% and complete response (CR) was 55.2% at six months. For the 20 patients with diffuse large B-cell lymphoma (DLBCL), the ORR and CR each were 45%, respectively, at six months.

In the trial, 17 patients reported cytokine release syndrome (CRS), but no grade 4 or 5 CRS was observed. Grade 1 and 2 neurotoxicity was observed in five patients, but no grade 3 or above neurotoxicity was reported.

JW Therapeutics has initiated a phase II trial to further assess the safety and efficacy of JWCAR-029 in DLBCL and follicular lymphoma (FL) patients, which is now recruiting. Subjects will be followed for two years after infusion, and the trial is expected to complete in the first quarter of 2022.

Lily Sun, communications officer at JW Therapeutics, told BioWorld that JWCAR-029 is in a pivotal study with a study design that integrates the outcomes of the traditional phase II and III trials. She also said the company expects to prepare for phase II data presentation in 2021-2022.

“Currently the study is only in China and we are thinking about future business expansion and commercial penetration outside of China,” Sun added.

Currently, JW Therapeutics has an R&D center in Shanghai to focus on translational research in cancer immunology, cell therapy process development and quality system. It also has a commercial CAR T-cell manufacturing plant in Suzhou.

CAR T updates in China

Chinese cell therapy developers are making strides in both the capital markets and new regulatory territory.

Last week, Legend Biotech Corp. (NASDAQ:LEGN) made a strong debut on Nasdaq to raise $423.8 million to advance its BCMA-targeting CAR T candidate, LCAR-B38M. Cellular immunotherapy firm Immunotech Biopharm Ltd. is also expected to go public on the HKEX this month with support from CCB International and Guosen Securities (HK).

On the regulatory front, China is expected to see its first approved CAR T therapy soon. Fosun Kite Biotechnology Co. Ltd. said in March that Chinese regulators have accepted the NDA filing for FKC-876 (axicabtagene ciloleucel), an autologous CD19-directed CAR T-cell injection for treating adult patients with relapsed and refractory large B-cell lymphoma. The product has been marketed as Yescarta in the U.S.

Chinese regulators also granted IND approval to Wuhan Bio-Raid Biotechnology Co. Ltd.’s anti-CD30 CAR T therapy candidate, BRD-01, in April. Meanwhile, Carsgen Therapeutics Co. Ltd. won FDA trial approval for its claudin18.2-targeted CAR T-cell therapy, CT-041, in May.

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