Business Wire

Takeda and MD Anderson Announce Collaboration to Accelerate the Development of Clinical-Stage, Off-The-Shelf CAR NK-Cell Therapy Platform

Share

The University of Texas MD Anderson Cancer Center and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced an exclusive license agreement and research agreement to develop cord blood-derived chimeric antigen receptor-directed natural killer (CAR NK)-cell therapies, ‘armored’ with IL-15, for the treatment of B-cell malignancies and other cancers.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191105005250/en/

Under the agreement, Takeda will receive access to MD Anderson’s CAR NK platform and the exclusive rights to develop and commercialize up to four programs, including a CD19-targeted CAR NK-cell therapy and a B-cell maturation antigen (BCMA)-targeted CAR NK-cell therapy. Takeda and MD Anderson will also conduct a research collaboration to further develop these CAR NK programs.

“Our vision is to improve upon existing treatments by developing armored CAR NKs that could be administered off-the-shelf in an outpatient setting—enabling more patients to be treated effectively, quickly and with minimal toxicities,” said Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. “With their expertise in hematologic malignancies and commitment to developing next-generation cell therapies, Takeda is the ideal collaborator to help our team advance CAR NK-cell therapies to patients in need of treatments.”

A Novel Approach to Delivering Off-the-Shelf CARs in an Outpatient Setting
MD Anderson’s allogeneic CAR NK platform isolates NK cells from umbilical cord blood and engineers them to express CARs against specified cancer targets. CAR NK cells are modified with a retroviral vector to deliver genes and enhance their effectiveness to attack specific tumors. A CD19 CAR increases the cells’ specificity for B-cell malignancies while the immunocytokine IL-15 enhances the proliferation and survival of the CAR NK cells in the body.

In contrast to current CAR T-cell therapies that utilize a patient’s own genetically modified T-cells and require a multi-week manufacturing process, CAR NK cells are intended to be manufactured from a non-related donor source and stored for off-the-shelf use, allowing treatment to be delivered more rapidly.

It is anticipated that the CD19 CAR NK-cell therapy could be administered in an outpatient setting. In an ongoing phase 1/2a clinical study treating patients with relapsed and refractory B-cell malignances, the CD19 CAR NK-cell therapy has not been associated with the severe cytokine release syndrome (CRS) or neurotoxicity observed with existing CAR-T therapies.

The development of MD Anderson’s CAR NK platform is led by Dr. Rezvani and is further supported by the adoptive cell therapy platform, Chronic Lymphocytic Leukemia Moon Shot® and B-Cell Lymphoma Moon Shot®, all part of the institution’s Moon Shots Program®, a collaborative effort to rapidly develop scientific discoveries into meaningful clinical advances that save patients’ lives.

Takeda: Accelerating the Development of Multiple Next-Generation CAR Platforms
“MD Anderson’s CAR NK platform represents the curative potential of cell therapies, which is why we are establishing the CD19 CAR NK as our lead cell therapy candidate in oncology,” said Andy Plump, M.D., Ph.D., President of Research and Development at Takeda. “We need to work swiftly and with purpose, and as such, we intend to initiate a pivotal study of the CD19 CAR NK in 2021.”

In addition to CAR NK-cell therapies, Takeda and its partners are investigating multiple approaches to improving the safety, efficacy and accessibility of first-generation CAR T-cell therapies including gamma delta CAR Ts, induced pluripotent stem cell-derived CAR Ts, CAR Ts targeting solid tumors, and other next-generation approaches. Takeda plans to advance five oncology cell therapies to the clinic by the end of FY20.1 These platforms are being developed both with partners and by applying the expertise of Takeda’s translational cell therapy engine which provides bioengineering, chemistry, manufacturing and control (CMC), clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

Takeda is responsible for the development, manufacturing and commercialization of CAR NK products resulting under the agreement. MD Anderson will receive an upfront payment and is eligible to receive development and commercial milestones for each target as well as tiered royalties on net sales of any such CAR NK product.

MD Anderson and Takeda will continue research for the additional targets and CAR NK platform under the direction of a joint research committee. MD Anderson will implement an Institutional Conflict of Interest Management and Monitoring Plan for this research.

About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 50 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report’s “Best Hospitals” survey. It has ranked as one of the nation’s top two hospitals for cancer care since the survey began in 1990, and has ranked first 15 times in the last 18 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com

Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. In particular, this press release contains forecasts and management estimates related to the financial and operational performance of Takeda, including statements regarding forecasts for Revenue, Operating profit, Adjusted EBITDA, Profit before income taxes, Net profit attributable to owners of Takeda, Basic earnings per share, Amortization and impairment and other income/expense, Underlying Revenue, Underlying Core Earnings margin, Underlying Core EPS and Net Debt. Without limitation, forward looking statements often include the words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or words or terms of similar substance or the negative thereof. Any forward-looking statements in this document are based on the current assumptions and beliefs of Takeda in light of the information currently available to it. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takeda’s business, including general economic conditions in Japan, the United States and worldwide; competitive pressures and developments; applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; changes in exchange rates; claims or concerns regarding the safety or efficacy of marketed products or products candidates; and post-merger integration with acquired companies, any of which may cause Takeda’s actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takeda’s results, performance, achievements, or financial position, see “Item 3. Key Information—D. Risk Factors” in Takeda’s Registration Statement on Form 20-F filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Neither Takeda nor its management gives any assurances that the expectations expressed in these forward-looking statements will turn out to be correct, and actual results, performance or achievements could materially differ from expectations. Persons receiving this press release should not place undue reliance on forward looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make. Past performance is not an indicator of future results and the results of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takeda’s future results.


1 Takeda’s 2020 fiscal year begins April 1, 2020 and ends March 31, 2021.

Contact information

MD Anderson Cancer Center
Clayton Boldt
+1 (713) 792-9518
cboldt@mdanderson.org

Takeda Pharmaceuticals
Media in Japan
Kazumi Kobayashi
+81 (0) 3-3278-2095
kazumi.kobayashi@takeda.com

Media Outside Japan
Chris Stamm
+1 (617) 374-7726
chris.stamm@takeda.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

ENHERTU® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer20.1.2021 10:00:00 EETPress release

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. In Europe, approximately 531,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2 positive.1,2,3 The impact of the disease is significant, with breast cancer responsible for more than 141,000 deaths per year in Europe.1 “One in five women with breast cancer have HER2 positive disease and those with previously-treated metastatic disease often progress quickly,” said Professor Fabrice André, Head of Research, Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France. “One of the biggest challenges in this setting has been identifying treatment strategies that produce

Bureau Veritas Further Expands Cybersecurity Offer by Joining Forces With Secura20.1.2021 10:00:00 EETPress release

Bureau Veritas , a world leader in testing, inspection and certification, announced today that it has completed the acquisition of Secura B.V. (starting with a majority stake), an independent service company specializing in cybersecurity services. Secura will be a cornerstone in the cybersecurity strategy of Bureau Veritas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210119006117/en/ Rising demand in digital security and new regulations drive a growing need for conformity assessments. As a result, Testing, Inspection and Certification (TIC) services for cybersecurity are an emerging market with substantial expected growth and significant momentum. In this promising new conformity market, Secura is a recognized cybersecurity player with a strong orientation toward TIC activities. Established in 2000 in the Netherlands, Secura has 100 employees located in two technological centers in Eindhoven and Amsterdam. The company pos

Wiztopic and Euronext Corporate Services Sign a Commercial Partnership20.1.2021 10:00:00 EETPress release

Wiztopic, the cloud-based provider of software solutions for corporate communications, public relations and investor relations professionals, today announced a commercial partnership with Euronext Corporate Services, a subsidiary of Euronext, providing companies with innovative solutions and tailor-made advisory services in the areas of governance, compliance, communication, and investor relations. This strategic alliance will simplify the access to highly complementary solutions for their respective customers. The combination of Euronext Corporate Services and Wiztopic’s solutions constitutes a suite of best-in-class digital communication solutions to satisfy the increasingly sophisticated needs of time-poor corporate communication, PR and IR professionals. Euronext Corporate Services’ clients will benefit from Wiztrust’s blockchain certification platform to secure their financial communications and avoid fake news. "This partnership solidifies Wiztrust as the European platform for ce

CYNORA Announces Availability of Industry’s First Device Test Kits for TADF Deep Green Emitters for Next-Generation OLED Displays20.1.2021 09:00:00 EETPress release

Marking a new innovation trajectory for the OLED industry, CYNORA today announced that device test kits for its Thermally Activated Delayed Fluorescence (TADF)-based Deep Green emitter for next-generation OLED displays are now available to customers. The development is an industry-first milestone for TADF technology, and validates CYNORA’s roadmap commitment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210119006159/en/ cyUltimateGreen™ - CYNORA's TADF Deep Green Emitter Device Test Kit (Photo: Dr. Harald Flügge, CYNORA) Known as the cyUltimateGreen™, the product delivers efficiency of more than 20 percent, which meets current industry specifications of 150cd/A in top emission devices. It demonstrates lifetime of 400h LT95@15mA, and color point and spectra that match today’s DCI-P3 standard. In addition, the product shows compatibility with BT2020, a color standard that requires greater color purity than DCI-P3, and one th

Ipsen Appoints Gwenan White as Executive Vice President, Communications and Public Affairs20.1.2021 09:00:00 EETPress release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210119005966/en/ Gwenan White, Executive Vice President, Communications and Public Affairs, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) announced today the appointment of Gwenan White as Executive Vice President, Communications and Public Affairs, effective March 2021. Based in Boulogne, France, she will be responsible for designing, implementing and managing the communications and public affairs strategy for Ipsen at global level, reporting directly to David Loew, CEO, Ipsen. Gwenan will serve on the Executive Leadership Team. “Along with the ELT, we are very pleased to welcome Gwenan to Ipsen. She will be critical to the implementation of our new strategy, Focus. Together. For patients & society. Her background in communications and public affairs will help reinforce Ipsen’s position as partner and employer of choice and will contribute to d

CGTN:China’s Winter Sports in Full Swing as 2022 Winter Olympics Approaches20.1.2021 03:09:00 EETPress release

China's winter sports industry has gotten back on its feet despite last year's blow from the COVID-19 pandemic, and things are beginning to warm up, especially in Zhangjiakou and Beijing, both host cities of 2022 Winter Olympic Games. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210119006168/en/ With the Games approaching, the country is experiencing increased enthusiasm for skiing. In downtown Beijing, local residents can try skiing, biathlon and floor curling at home thanks to a special event hosted last month. Chinese President Xi Jinping is not falling behind. For two consecutive days, he inspected preparatory work for the Games in the two host cities. As a long-term winter sports fan, Xi met with athletes, coaches, representatives of operation teams, and construction staff in the Zhangjiakou competition zone in north China's Hebei Province. He arrived in the city on Tuesday by the recently launched Beijing-Zhangjiakou

Digital Vault Services GmbH launches its market solution for Digital Guarantees19.1.2021 22:42:00 EETPress release

Digital Vault Services GmbH (www.digitalvaultservices.com) is pleased today to announce the launch of Guarantee Vault, its solution for digital guarantees which went live on the 18 January 2021. Guarantee Vault is a central register for the issuance and safe keeping of digital guarantees. It gives banks & sureties the possibility to centrally issue and store instruments such as Bank Guarantees, Surety Bonds and Standby Letters of Credit in an electronic form. Sven Matzelsberger, Head of Treasury at Lindner Group KG stated “Guarantee Vault has been a true market collaboration between corporates, sureties and banks. Our shared experiences, collaborative spirit and common vision are at the heart and soul of what Guarantee Vault is. We proudly see this as a true market initiative, one that solves a wide spread common problem and brings efficiencies to all involved.“ Guarantee Vault is the result of a 2 year collaboration with 16 working group partners made up of major corporates, banks and

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom