Takeda Opens New R&D Cell Therapy Manufacturing Facility to Support Expansion of Next-Generation Clinical Programs
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. The facility provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200915005224/en/
“We are collaborating with some of the best scientists and innovators around the world establishing a highly differentiated immuno-oncology pipeline leapfrogging into new modalities and mechanisms with curative potential,” said Chris Arendt, Ph.D., Head of Takeda’s Oncology Therapeutic Area Unit. “With three oncology cell therapy programs in the clinic and two more targeted to enter the clinic in fiscal year 2021, we are working with urgency and purpose for patients. This new facility helps us rapidly scale our manufacturing capabilities so we can simultaneously advance multiple highly differentiated cell therapy programs.”
Oncology cell therapy is a type of immunotherapy that uses genetically modified immune cells to find and kill cancer cells. Because cell therapies are engineered from living cells, they need to be manufactured in a highly regulated environment to maintain cleanliness, consistency and contamination control. Each oncology cell therapy platform has unique process requirements for how they are formulated, manufactured, transported and ultimately administered to patients. Next-generation cell therapy is one of the multiple investigational platforms that Takeda is researching in oncology as part of its focus on redirected immunity. Takeda’s pipeline of diverse immuno-oncology programs harnesses innate immunity, including through innovative cell therapies, immune engager platforms, innate immuno-modulation, novel-scaffold immune check point platforms and oncolytic viruses.
A Purpose-Built Facility to Rapidly Advance Cell Therapy Research & Development
The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (cGMP) facility is designed to meet all U.S., E.U. and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world. It will be instrumental in building Takeda’s cell therapy capabilities and capacity to advance multiple next-generation oncology cell therapy platforms and programs with world-class collaborators including Nobel Laureate Shinya Yamanaka, M.D., Ph.D., Kyoto University (induced pluripotent stem cells), Adrian Hayday, Ph.D., Gamma Delta Therapeutics (gamma delta T-cells), Koji Tamada, M.D., Ph.D., Noile-Immune Biotech (armored CAR-Ts), Michel Sadelain, M.D., Ph.D., Memorial Sloan Kettering Cancer Center (next-generation CARs), and Katy Rezvani, M.D., Ph.D., The University of Texas MD Anderson Cancer Center (CAR-NK).
Takeda and MD Anderson are developing a potential best-in-class allogeneic cell therapy product (TAK-007), a Phase 1/2 CD19-targeted chimeric antigen receptor-directed natural killer (CAR-NK) cell therapy with potential for off-the-shelf use being studied in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Two additional Phase 1 studies of Takeda cell therapy programs were also recently initiated: 19(T2)28z1xx CAR T cells (TAK-940), a next-generation CAR-T signaling domain developed in partnership with Memorial Sloan Kettering Cancer Center (MSK) to treat relapsed/refractory B-cell cancers, and a cytokine and chemokine armored CAR-T (TAK-102) developed in partnership with Noile-Immune Biotech to treat GPC3-expressing previously treated solid tumors. Dr. Sadelain and MSK have intellectual property rights and associated interests related to the content of this release by virtue of licensing agreements between MSK and Takeda.
Harnessing the Power of Takeda’s Cell Therapy Translational Engine
Proactive and deep collaboration between research and development and commercial manufacturing is critical to developing and delivering next-generation cell therapies. Takeda’s Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development and commercialization. It provides bioengineering, chemistry, manufacturing and control (CMC), data management, analytical and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.
“The proximity and structure of our cell therapy teams allow us to quickly apply what we learn across a diverse portfolio of next-generation cell therapies including CAR NKs, armored CAR-Ts and gamma delta T cells, among others,” said Stefan Wildt, Ph.D., Head of Pharmaceutical Sciences and Translational Engine, Cell Therapies at Takeda. “Insights gained in manufacturing and clinical development can be quickly shared across our global research, manufacturing and quality teams, a critical ability in our effort to deliver potentially transformative treatments to patients as fast as we can.”
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, Rare Diseases, Neuroscience, and Gastroenterology (GI). 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.
For more information, visit https://www.takeda.com.
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
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. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports 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. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
+81 (0) 3-3278-2095
Media outside Japan
+1 (617) 374-7726
About Business Wire
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
ESMO 2020: Cabometyx ® (cabozantinib) in Combination With Opdivo ® (nivolumab) Demonstrates Significant Survival Benefits in Patients With Advanced Renal Cell Carcinoma in Pivotal Phase III CheckMate -9ER Trial19.9.2020 18:30:00 CEST | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the first presentation of results from the pivotal Phase III CheckMate -9ER trial, in which Cabometyx® (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), in previously untreated advanced renal cell carcinoma (RCC).1 Cabometyx® in combination with Opdivo® reduced the risk of death by 40% versus sunitinib (HR: 0.60 [98.89% Confidence Interval [CI]: 0.40–0.89]; p= 0.0010; median OS not reached in either arm). In patients receiving Cabometyx® in combination with Opdivo®, median progression-free survival (PFS), the trial’s primary endpoint, was doubled compared to those receiving sunitinib alone: 16.6 months versus 8.3 months respectively (Hazard Ratio [HR]: 0.51 [95% CI 0.41–0.64], p < 0.0001). In addition, Cabometyx® in combination with Opdivo® demonstrated a superior objective response rate, wit
Takeda Presents New Data Highlighting Scientific Advancements in Lung Cancer at ESMO Virtual Congress18.9.2020 12:55:00 CEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the company is presenting data from its lung cancer portfolio at the virtual European Society for Medical Oncology (ESMO) conference. Notably, insights from sub-analyses of the Phase 3 ALTA 1L study reinforce both the compelling evidence of intracranial efficacy with ALUNBRIG® (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) as well as associated quality of life (QoL) data. Takeda is also featuring updated 10-month follow-up results from the Phase 1/2 trial of mobocertinib (TAK-788), demonstrating mobocertinib achieved a duration of response (DoR) of more than one year in the trial’s study population of patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC). “We’re pleased to present our ongoing research in lung cancer at this year’s virtual ESMO congress, including new
Incyte Announces Encouraging Results From Phase 2 Trial of Retifanlimab (INCMGA0012) in Patients With Previously Treated, Advanced Squamous Cell Carcinoma of the Anal Canal18.9.2020 12:00:00 CEST | Press release
Incyte (Nasdaq:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with advanced squamous cell carcinoma of the anal canal (SCAC) who have progressed following standard platinum-based chemotherapy. The trial enrolled 94 patients, including those with well-controlled human immunodeficiency virus (HIV) infection (10%). Retifanlimab monotherapy resulted in a confirmed objective response rate (ORR) of 14% as determined by independent central review (ICR) using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status. Retifanlimab was generally well-tolerated with a safety profile as expected of a PD-1 inhibitor and no loss of HIV infection control. Key findings from POD1UM-202: N=94 ORR* (95% CI) 13.8% (7.6-22.5) Best OR*, n 1 CR 12 PR 33 SD DCR 48.9% DOR, median (95% CI), months 9.5 (5.6-NE) PFS, median (95% CI), months 2.3 (1.9-3.6) OS, median (95
Sigfox and Cube Infrastructure Managers Announce Major Partnership in IoT Infrastructure18.9.2020 09:30:00 CEST | Press release
Sigfox, the global 0G network1 and cloud provider for industrial data, is proud to announce a new strategic alliance with Cube Infrastructure Managers (Cube), through the sale of its German 0G network to Cube. Sigfox has grown its 0G IoT services by rolling out 0G networks across 72 countries and regions, which was largely achieved with partners called Sigfox Operators. These operators are the owners of the 0G networks, which they operate as exclusive connectivity providers of Sigfox IoT services, offering worldwide connectivity to customers. The sale of the German network to Cube will allow Sigfox to finance its continued innovation efforts in data value extraction and improvements in cloud algorithms to reduce energy consumption and allow the implementation of even more cost-effective devices and sensors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200918005116/en/ Cube Infrastructure Managers, the European infrastructu
Sensorion successfully raises approximately €31 (US$ 36.5) million in an oversubscribed private placement to US and European investors18.9.2020 08:00:00 CEST | Press release
Regulatory News: Not for release, publication or distribution, directly or indirectly, in or into the United States, Canada, Australia or Japan. This press release is not intended as an offer and is for informational purpose only Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN – the “Company”) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders announces today the success of its previously announced capital increase. The Company has placed 18,236,000 new ordinary shares with a nominal value of €0.10 each (the “New Shares”), for total gross proceeds of approximately € 31 million by means of an accelerated bookbuild offering to the benefit of categories of persons (the “Reserved Offering”). The issue price of the New Shares is €1.70 per share, representing a 3.5% discount to the weighted average share price on the day preceding the date on which the issuance price
ESMO 2020: Phase II CLARINET FORTE Results Show Increasing Dose Frequencies of Somatuline ® Autogel ® (lanreotide) Allows Patients with NETs to Delay Treatment Escalation by up to 8.3 Months18.9.2020 07:00:00 CEST | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the release of first efficacy and safety data from the CLARINET FORTE study, with the abstract to be presented as a mini-oral presentation at the 2020 European Society for Medical Oncology (ESMO) Congress, taking place virtually from 19-21 September 2020. The prospective single-arm, open-label, exploratory, international Phase II study investigated the efficacy and safety of increasing the dose frequency of Somatuline® Autogel®(lanreotide) in patients with pancreatic or midgut NETs with centrally-assessed progression within the last two years while on a standard lanreotide regimen for ≥24 weeks. An extension of progression-free survival (PFS) rates and encouraging disease-control rates (DCR) were recorded in both tumor types, with no new safety signals. “These results support a clinically meaningful benefit to a population of patients with high unmet medical need by potentially delaying escalation to more toxic treatmen
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