Recent Updates
Recently added Catalysts
ADAP

Astellas and Adaptimmune Enter into Agreement to Co-Develop and Co-Commercialize Stem-Cell Derived Allogeneic CAR-T and TCR T-Cell Therapies - Agreement covers the co-development and co-commercialization of up to three T

Key Takeaway: Astellas and Adaptimmune Enter into Agreement to Co-Develop and Co-Commercialize Stem-Cell Derived Allogeneic CAR-T and TCR T-Cell Therapies - Agreement covers the co-development and co-commercialization of up to three T-cell therapies - - Agreement leverages Astellas' Univer

Full Press Release Details

Astellas and Adaptimmune Enter into Agreement
to Co-Develop and Co-Commercialize Stem-Cell Derived Allogeneic CAR-T and TCR T-Cell Therapies
- Agreement covers the co-development and
co-commercialization of up to three T-cell therapies -
- Agreement leverages Astellas' Universal
Donor Cell Platform and Adaptimmune's stem-cell derived allogeneic T-cell platform -
- Astellas will pay Adaptimmune an upfront
payment, research funding, development and commercial milestones, and royalties on net sales on co-commercialized products -
TOKYO and PHILADELPHIA, PA, OXFORDSHIRE, United Kingdom, January
14, 2020 (GLOBE NEWSWIRE) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"),
through its wholly-owned subsidiary Universal Cells, Inc, and Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy
to treat cancer, announced that they have entered into a co-development and co-commercialization agreement to bring new stem-cell
derived allogeneic T-cell therapies to people with cancer.
Astellas and Adaptimmune will agree on up to three targets and
co-develop T-cell therapy candidates directed to those targets. These targets will exclude target specific T-cell products in pre-clinical
or clinical trials or those developed for other partners at Adaptimmune. The collaboration will leverage Adaptimmune's target identification
and validation capabilities for generating target-specific T-cell Receptors (TCRs), chimeric antigen receptors (CARs), and HLA-independent
TCRs that recognize surface epitopes independently of the HLA profile of the tumor cell. The collaboration will also utilize Astellas'
Universal Donor Cell and Gene Editing Platform it obtained through the acquisition of Seattle-based Universal Cells.
Adaptimmune has been collaborating with Universal Cells (now
an Astellas Company) since 2015 on development of gene-edited iPSC cell lines, for which Adaptimmune has rights to develop and
commercialize resulting T-cell therapy products using its proprietary process for generating T cells from stem cells without the
use of feeder cell lines.
Astellas will fund research up until completion of a Phase 1
trial for each candidate. Upon completion of the Phase 1 trial for each candidate, Astellas and Adaptimmune will elect whether
to progress with co-development and co-commercialization of the candidate, or to allow the other Party to pursue the candidate
independently through a milestone and royalty bearing licence, with the agreement allowing for either company to opt out. The companies
will each have a co-exclusive licence covering the co-development and co-commercialization of the product candidates within the
field of T-cell therapy. If a candidate is developed by one company only, the appropriate licences will become exclusive to the
"Astellas positions immuno-oncology as one of its strategic
areas of primary focus, and it is engaged in the development of novel therapies for cancer patients using a new modality/technology,"
stated Naoki Okamura, Representative Director Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer,
Astellas. "In addition to NK cells, T-cells are an important component of cell therapy for immuno-oncology, and we look forward
that this agreement with Adaptimmune will enable us to create new stem-cell derived allogeneic T-cell therapies for a variety of
cancers, including solid tumors, in the future. We will continue to dedicate our efforts in delivering novel treatments for diseases
with high unmet medical needs, pursuing cutting-edge science and technological advances."
"We are delighted to establish this significant co-development
partnership with Astellas, which builds upon and substantially extends an existing collaboration focused on gene editing of iPSC
cells," said Helen Tayton-Martin, Adaptimmune's Chief Business Officer and Co-Founder. "This new collaboration
encompass both CAR-T and TCR T-cell approaches, including our
novel HLA-independent TCR ("HiT") platform. It brings together highly complementary skills and expertise across the
two organizations, and will enable the accelerated development of new, off-the-shelf T-cell therapy products for people with cancer."
Astellas will also have the right to select two targets and
develop allogeneic cell therapy candidates independently. Astellas will have sole rights to develop and commercialize these products,
subject to necessary licenses and the payment of milestones and royalties.
Under the terms of the agreement, Adaptimmune may receive up
to $897.5 million in payments, including:
In addition, Adaptimmune will receive research funding of up
to $7.5 million per year.
Finally, Adaptimmune would receive tiered royalties on net sales
in the mid-single to mid-teen digits.
Under the terms of the agreement, Astellas may receive up to
$552.5 million, including:
In addition, Astellas would receive tiered royalties on net
sales in the mid-single to mid-teen digits.
To the extent that Astellas and Adaptimmune co-develop and co-commercialize
any T-cell therapy, they will equally share the costs of such co-development and co-commercialization, with the resulting profits
from co-commercialization also shared equally. Further details governing co-development and co-commercialization will be articulated
in a product-specific commercialization agreement.
The impact of this transaction on Astellas'
financial results in the fiscal year ending March 31, 2020 will be limited.
Adaptimmune is a clinical-stage biopharmaceutical company focused
on the development of novel cancer immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide
Enhanced Affinity Receptor) T cell platform enables the engineering
of T-cells to target and destroy cancer across multiple solid tumors. For more information, please visit http://www.adaptimmune.com.
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated
to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For
more information, please visit our website at https://www.astellas.com/en
Adaptimmune Forward-Looking Statements
This release contains "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking
statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ
materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and
timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic
candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties
that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as
risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 6, 2019, and our other SEC filings. The forward-looking statements contained in this
press release speak only as of the date the statements were made and we do not undertake any obligation to update such
forward-looking statements to reflect subsequent events or circumstances.
Cautionary Notes Regarding Forward-Looking Statements (Astellas)
In this press release, statements made with respect to current
plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about
the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of
the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause
actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited
to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange
rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively,
(v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive
markets, and (vi) infringements of Astellas' intellectual property rights by third parties.
Information about pharmaceutical products (including products
currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Adaptimmune Contacts:
S bastien Desprez - VP, Communications and Investor
Juli P. Miller, Ph.D. - Senior Director, Investor Relations
Contacts for inquiries or additional information:
Astellas Pharma Inc.
Corporate Communications
Last updated: Jan 14, 2020