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JW Therapeutics Presents Data from Pivotal Trial of Relma-cel at the 62nd ASH Annual Meeting

SHANGHAI, Dec. 7, 2020 /PRNewswire/ -- JW Therapeutics (stock code: 2126.HK), a leading clinical stage cell therapy company, presented data from the pivotal study (RELIANCE Trial) of relmacabtagene autoleucel ("relma-cel") under IND pathway at the 62nd American Society of Hematology (ASH) Annual Meeting, taking place virtually December 5th – 8th, 2020.

The RELIANCE Trial was the first study of a CAR-T therapy manufactured in China for the treatment of patients with relapsed or refractory ("r/r") B-cell lymphoma in China. Compared with other anti-CD19 CAR-T therapies approved in the US and EU, relma-cel shows similar efficacy and pharmacokinetic profiles while providing the potential for an improved toxicity profile in heavily-pre-treated patients with r/r LBCL of poor risk features.

Dr. James Li, Co-Founder, Chairman and CEO of JW Therapeutics commented: "The presentation reinforced relma-cel's significant competitive advantage in the CAR-T market in China, highlighting its competitive efficacy and safety profiles. We are confident that these data will provide strong support to relma-cel's ongoing New Drug Application (NDA) in China and we look forward to bringing this innovative CAR-T therapy to patients as soon as possible."



Summary of Pivotal Study Data of Relma-cel

In JWCAR029 pivotal study (RELIANCE Trial), 69 patients were screened, and 59 with r/r large B cell lymphoma were enrolled and treated with relma-cel, with median age of 56.0 years (18-75).  The median doses administered in low and high dose groups were 99.7×106 (range, 80.1-101.3) and 150.0×106 (range, 120.0-156.4) CAR+ T cells, respectively.

As of June 17, 2020 data cut-off, Best Overall Response Rate was 75.9% (95% CI, 62.8- 86.1) with Best Complete Response Rate of 51.7% (95% CI, 38.2-65.1) in 58 evaluable patients. With a median follow-up of 8.9 months, median OS were not reached, and 6 month DOR, PFS and OS were 60.0%, 54.2% and 90.8%, respectively.

Of 59 treated patients, 28 patients (47.5%) experienced CRS of any grade. Grade 3 and 4 CRS was observed in 2 patients (3.4%) and 1 patient (1.7%), respectively. The median onset of CRS was at 4.5 days (range 1 to 5) after infusion with a median duration of 7.0 days (range 1 to 18). Neurologic events occurred in 12 patients, with only 3 (5.1%) having severe grade events (all Grade 3). Median onset of NT was at 8.5 days after infusion, with a median duration of 12.5 days (range 1 to 49). CRS and NT were generally manageable and all cases resolved except one patient who died at day 8 of sepsis and ongoing grade 4 CRS.

The RELIANCE Trial provided the first demonstration of licensure-quality CAR-T manufacturing and clinical trial data generation in r/r patients originating in China. These results with relma-cel demonstrate similar preliminary response rates while providing the potential for an improved toxicity profile in heavily-pre-treated patients with r/r LBCL having poor risk features relative to other CD19-specific CAR-Ts approved in the US and EU.

About Relmacabtagene autoleucel ("relma-cel")

Relmacabtagene autoleucel ("relma-cel"), JW Therapeutics' lead product, is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory ("r/r") B-cell lymphoma. The New Drug Application (NDA) for relma-cel as a third-line treatment for diffuse large B-cell lymphoma ("DLBCL") was accepted for review by China's National Medical Products Administration ("NMPA") in June 2020 and was granted priority review status in September 2020. Moreover, the NMPA also granted Breakthrough Therapy Designation for relma-cel as a treatment for follicular lymphoma. Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.

About JW Therapeutics

Co-founded by Juno Therapeutics and Wuxi AppTec, JW Therapeutics is a leading clinical and pre-clinical stage cell therapy company in China with an integrated platform focusing on developing, manufacturing and commercializing breakthrough cell-based immunotherapies for hematological cancers and solid tumors.

JW Therapeutics' vision is to develop innovative cell therapies for the China market to transform the treatment of cancer for Chinese patients. The company has built a comprehensive and differentiated cell therapy pipeline covering both hematological cancers and solid tumors. Its lead product, Relmacabtagene autoleucel ("relma-cel"), an anti-CD19 CAR-T therapy for relapsed or refractory ("r/r") B-cell lymphoma, is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.

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Forward-Looking Statements

This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Stock Exchange of Hong Kong Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of October 22, 2020, and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims, and certain compliance risks, even sanctions from disputable market activities. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our ongoing restructuring plan. Our business performance could affect or limit the ability of our board of directors to declare a dividend or the ability to pay a dividend or repurchase our shares.

Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of Securities of Stock Exchange of Hong Kong Limited: JW Therapeutics cannot guarantee that it will be able to develop, or ultimately market Relmacabtagene autoleucel ("relma-cel") successfully. Shareholders and potential investors of JW Therapeutics are advised to exercise due care when dealing in the shares of JW Therapeutics.


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JW Therapeutics Presents Data from Pivotal Trial of Relma-cel at the 62nd ASH Annual Meeting

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Last Updated: 07-Dec-2020