Shanghai, China, August 27, 2021 – JW Therapeutics (stock code: 2126.HK), an innovative biotechnology company focusing on the developing, manufacturing and commercializing cell immunotherapy products, today announced 2021 interim results.
Research and Development Progress
Our Core Product Candidate — relma-cel
Third-line large B-cell lymphoma (“LBCL”)
The China National Medical Products Administration (NMPA) is evaluating our New Drug Application (NDA) relating to relma-cel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. We currently expect to receive NMPA approval of our NDA in the second half of 2021. If approved on the timeline that we currently anticipate, relma-cel will be the first CAR-T product approved as a Category 1 biologics product in China.
Relma-cel’s potential to be a superior CAR-T therapy is based on its potential best-in-class safety profile and competitive efficacy. Our Phase II registrational clinical trial of relma-cel as a third-line treatment for LBCL demonstrated efficacy results of best objective response rate (“ORR”) of 75.9% and best complete response rate (“CRR”) of 51.7% as of the data cut-off date of June 17, 2020. In 59 treated patients, 5.1% and 3.4% of the patients experienced CRS and NT of Grade 3 or above, respectively. We believe that these data demonstrate the potential best-in-class safety profile and competitive efficacy of relma-cel.
In addition, we are advancing relma-cel into second treatment for LBCL, and we commenced a single-arm Phase I trial in China to explore the further clinical potential for relma-cel.
Third-line follicular lymphoma (3L FL)
In September 2020, the NMPA granted Breakthrough Therapy Designation for relma-cel as a treatment for FL. We completed patient enrollment during the first half of 2021, and we anticipate to submit our supplementary NDA (“sNDA”) over the next year. If approved on the timeline that we currently anticipate, relma-cel would be the first CAR-T product approved for treatment of FL in China.
Third-line mantle cell lymphoma (3L MCL)
We have started a single-arm Phase II registrational trial in China, patient enrollment began in January 2021 and is currently on schedule.
Third-line chronic lymphocytic leukemia (3L CLL)
We intend to conduct a single-arm early phase trial in China to evaluate relma-cel in high-risk r/r CLL patients. We expect to conduct this study in the second half of 2021 and 2022.
Third-line acute lymphoblastic leukemia (3L ALL)
We intend to conduct a single-arm Phase I/II registrational trial in China to evaluate relma-cel in pediatric and young adult patients with r/r ALL after at least two prior lines of therapy. We currently expect to submit an investigational new drug (IND) application to the NMPA with respect to this trial in 2022.
Other Pipeline Products
We have filed, and the NMPA has accepted for review, an IND application relating to JWCAR129 as a treatment for multiple myeloma (MM), and we have commenced an investigator-initiated trial of JWCAR129 for this indication.
JWATM204/214
We have completed technical transfer of the product manufacturing and release assays for the JWATM204 program, and we anticipate initiating IND-enabling studies for the program by the end of 2021. Through our partnerships with Eureka and Lyell, we also plan to combine Lyell’s technology in T-cell anti-exhaustion functionality with JWATM204 to create JWATM214, a next-generation innovative autologous cell therapy for HCC treatment.
JWATM203/213
As with JWATM204, we also plan to combine Lyell’s technology in T-cell anti-exhaustion functionality with JWATM203 and Eureka’s ARTEMIS? technology platform to create JWATM213, an additional autologous cell therapy for HCC treatment.
Manufacturing
- we received a production license from Jiangsu Province authorities for our new commercial manufacturing facility in Suzhou. Currently, two of these modules have been constructed and qualified and are in full GMP operations, and our manufacturing facility currently has the capacity to support autologous CAR-T treatment of up to 2,500 patients per year.
-
We have had a 99% success rate for the manufacturing of relma-cel since commencement of our LBCL registrational clinical trial, RELIANCE study results show that relma-cel demonstrated high rates of durable disease response and low rates of CAR-T associated toxicities.
-
We are developing a set of new technologies and platforms to enable the next generation CAR-T product and manufacturing processes with shorter production cycle time, higher quality, better product characterization and improved product efficacy and safety, at a lower cost.
-
We have established a manufacturing cost reduction development strategy of short term to long term, to realize significant cost reduction by improving the use efficiency of raw materials, replacing imported materials with domestic supplies and implementing new technologies, and simplifing and/or replace/combine unit operations; and to potentially shorten production cycle time and possibly improve product characteristics and clinical outcome.
Commercialization
- We have established a 90 people commercial team with a clear business model. To support hospitals ready to use our products, we conducted training and dry run to help physicians and nurses to understand more about relma-cel usage instructions, vein to vein process, etc. Meanwhile, Shanghai Pharma KDL (上藥康德樂) has been selected as our national distributor and will provide professional delivery service for each patient. To improve affordability, we are targeting to establish a multi-layer insurance system by cooperating with different medical and health insurance partners.
2021 Interim Financial Highlights
Research and Development Expenses
Our research and development expenses increased from RMB82.3 million for the six months ended June 30, 2020 to RMB185.5 million for the six months ended June 30, 2021. This increase was primarily due to the increase in research and development staff costs, research and development materials and testing and clinical fees.
Loss for the Period
Our loss for the period decreased from RMB650.0 million for the six months ended June 30, 2020 to RMB280.7 million for the six months ended June 30, 2021. For the six months ended June 30, 2021, we did not record any losses or gains on fair value changes of preferred shares since all preferred shares were converted to ordinary shares as of November 3, 2020 (the “Listing Date”).
Cash and Cash Equivalents
As at June 30, 2021, our cash and cash equivalents amounted to RMB2,206 million.
Future Perspectives
- Drive full-scale commercialization of relma-cel and build upon our significant first mover advantage;
-
Solidify our leadership in hematological cancers by developing relma-cel for earlier lines of treatment and additional indications, as well as clinical development of JWCAR129;
-
Leverage our integrated cell therapy platform to expand into the solid tumor market;
-
Continuously enhance our manufacturing and supply chain through innovation and scale;
- Grow our business through in-licensing opportunities, partnerships and selective acquisitions, as well as in-house research and development.
# # #
About JW Therapeutics
JW Therapeutics (HKEx: 2126) is an innovative biotechnology company focusing on the developing, manufacturing and commercializing cell immunotherapy products. Co-founded by Juno Therapeutics (a Bristol Myers Squibb company) and WuXi AppTec in 2016, JW Therapeutics is committed to becoming an innovation leader in cell immunotherapy. The company has built a top world-class platform for technology and product development in cell immunotherapy, as well as a promising product pipeline covering both hematologic malignancies and solid tumors, to bring hope of cure for Chinese and global patients, and to lead the healthy and standardized development of China’s cell immunotherapy industry. For more information, please visit dudj.cn.
?