Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO23), which is taking place virtually and in-person in Chicago, Illinois from June 2 to 6.

Notable research includes an oral presentation of results from the final pre-specified overall survival analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib (LENVIMA^?) plus pembrolizumab (KEYTRUDA^?) versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (Abstract #4502). A post hoc analysis from the REFLECT trial evaluating lenvatinib monotherapy versus sorafenib in the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) will also be shared in a poster presentation (Abstract #4078).

“The outlook for advanced renal cell carcinoma has evolved in recent years, and the final analysis from the pivotal CLEAR trial to be presented at ASCO represents another step forward for patients and an opportunity to provide their physicians with long-term data,” said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. “New data for lenvatinib and from our oncology pipeline showcase Eisai’s continued commitment to driving innovation and exploring novel therapeutic modalities in our ambition to live out our human health care concept, our corporate mission to meet the needs of more people who face a cancer diagnosis.”

Additional data from Eisai’s pipeline include a poster presentation of findings from a phase 1b study of E7386, a CREB-binding protein (CBP) / β-catenin interaction inhibitor, in combination with lenvatinib in patients with advanced HCC (Abstract #4075), and the small cell lung cancer cohort of a phase 1b/2 trial evaluating E7389-LF, a new liposomal formulation of eribulin, in combination with nivolumab (Abstract #8593). Insights from preclinical testing of farletuzumab ecteribulin (FZEC), formerly known as MORAb-202, and MORAb-109, antibody drug conjugates (ADC), in rare gynecologic cancers will also be published online (Abstract # e17634).

Furthermore, Bliss Biopharmaceutical Co., Ltd. (BlissBio) will present a poster at the conference with results from the first-in-human study of BB-1701, a HER2-targeting ADC (Abstract #3029). Eisai entered into a joint development agreement with BlissBio for BB-1701 with option rights for a strategic collaboration in April 2023. A Phase 1/2 clinical study of BB-1701 in the U.S. and China for HER2-expressing solid tumors is currently underway.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of presentations is included below. These abstracts will be made available on Thursday, May 25, 2023 at 4:00 PM Central Daylight Time (CDT).

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
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TOKYO and CAMBRIDGE, Mass., May 16, 2023 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI?), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain.

The NDS is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.

Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase II data that demonstrated that lecanemab reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of lecanemab’s clinical benefit in a confirmatory trial. The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

In the U.S., Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on January 6, 2023. On March 3, 2023, the FDA accepted Eisai’s sBLA based on the Clarity AD clinical data, and the lecanemab application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application on June 9, 2023. In Japan, Eisai submitted an application for manufacturing and marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. Priority Review was granted by the Ministry of Health, Labour and Welfare (MHLW) on January 26, 2023. Eisai utilized the PMDA’s prior assessment consultation system, with the aim of shortening the review period for lecanemab. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023, which was accepted on January 26, 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022, and Priority Review was granted on February 27, 2023.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

* ??Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.¹

^1? S?derberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab – Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease. Neurotherapeutics (2022). https://doi.org/10.1007/s13311-022-01308-6. Accessed February 9, 2023

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd. (Headquarters: Zhejiang Province, China, “BlissBio”), for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration.

BB-1701 is an ADC that is composed of Eisai’s in-house developed anticancer agent eribulin, and anti-HER2 antibody using a linker, and is expected to have anti-tumor effects on breast, lung and other solid tumors that express HER2. The linker-payload, which uses eribulin as a payload, is a proprietary technology platform developed by Eisai’s U.S. research base Exton Site, and Eisai is investigating the possibilities of using this platform to link to various antibodies. Under a license agreement signed by the two companies in 2018, Eisai has granted BlissBio global exclusive development rights for several ADCs to use eribulin as the payload. Based on the status of the Phase I/II clinical trials of BB-1701 currently being conducted by BlissBio, the both companies have decided to co-develop this drug.

Under the terms of the joint development agreement, Eisai will make upfront and development milestone payments to BlissBio, conduct a Phase II clinical trial in breast cancer, and obtain option rights to develop and commercialize BB-1701 globally, excluding Greater China (China, Hong Kong, Macau, Taiwan). If Eisai exercises the option rights, an additional upfront payment will be made to BlissBio, as well as development and regulatory milestone payments, sales milestone payments and a certain amount of royalties on sales revenue of BB-1701 after the launch. If all development, regulatory and sales milestones are achieved, up to a total of $2 billion USD will be paid.

“BB-1701 is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma,” said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. “Our collaboration with BlissBio will accelerate the development of BB-1701 with the goal of bringing a new treatment option to patients globally.”

 

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Public Relations Department,
Eisai Co., Ltd.
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AS A GLOBAL DRUG DISCOVERY CENTER AIMING FOR CONNECTING HUMAN AND HUMAN, AND DATA, AND THE WORLD

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced the completion of a major renovation of its Tsukuba Research Laboratories (Ibaraki, Japan), which is a part of strategic investment to execute Eisai’s medium-term business plan “EWAY Future & Beyond”.

 

Eisai implements research and development activities under the DHBL (Deep Human Biology Learning) drug discovery and development system in our efforts to create new drugs based on innovative and efficient next-generation drug discovery concepts. For this purpose, we recognize diseases as Disease Continuum to redefine their concepts through comprehensive analysis on genomic, pathophysiological and clinical information associated with underlying causes of disease in order to enhance our understanding on human biology by acquiring data leading to next drug discovery with information, such as biomarkers and imaging data from patients on our drugs. Tsukuba Research Laboratories is positioned as a core facility in the DHBL drug discovery and development system. This renovation seeks to accelerate knowledge circulation by connecting each researcher with patients, other members within the Laboratories, other research sites across the world, and external researchers based on our key concept “Human Connected Laboratories: Laboratories Connecting Human and Human, and Data, and the World.” Total investment on this major renovation was 8.5 billion yen.

 

Main Idea of This Major Renovation

[Designs to Enhancing Connection with Patients]

In the Eisai Group, all employees around the world use 1% of their total business hours to interact with patients (socialization) to understand their thoughts and feelings. Accordingly, we have been working on the initiatives (hhc activities) to lead value creation for patients. To enhance the opportunities for closer interaction with people outside the company, such as further socialization with patients, at Tsukuba Research Laboratories, a traffic line from the front gate through the main building lobby to the courtyard is placed as interactive zone to enable various communications.

 

[Realizing Connections between Researchers and Data Driven Drug Discovery]

In favor of generating natural communication between researchers across different therapeutic areas on a daily basis, workspaces for biology researchers and data scientists are allocated on the same floor, and likewise workspaces for chemistry and pharmacokinetics/analytical researchers are placed on nearby floors to foster new connections and knowledge exchange. Further creative solutions are implemented in laboratories, including collective arrangement of structural openings and devices. These designs facilitate data driven drug discovery through knowledge exchange.

 

[Knowledge Circulation Generated from Links between Buildings]

Corridors linking multiple buildings embodying the concept of Knowledge Circulation are placed. A traffic line named “Knowledge Corridor” enables people to move all around the laboratory, with which research efficiency and convenience are considerably improved.

 

[Meeting Rooms Value Connection with the World]

Each meeting room is equipped with an IT environment that allows smooth communication with overseas offices, as well as systems able to deal with hybrid meeting which dominantly accepted in recent days.

 

Eisai will accelerate the drug discovery activities under the DHBL drug discovery system in order to fulfill unmet medical needs, and in our efforts to further contribute to improve the benefits of patients and the people in the daily living domain.

 

Media Inquiries:

Public Relations Department,

Eisai Co., Ltd.

+81-(0)3-3817-5120

[Notes to editors]

1. Outline of Tsukuba Research Laboratories

Location: 5-1-3 Tokodai, Tsukuba, Ibaraki

Groundbreaking of the renovation: December 2019

Completion of the renovation: February 2023 (Opening Ceremony: 6 April 2023)

Site area: 86,845.05 m²

Building area: 65,110.78 m²

Total investment on the renovation: 8.5 billion yen

 

An interactive zone for researchers and people outside company

 

A traffic line named “Knowledge Corridor”

 

A workplace for data scientists