- Proof-of-concept manufacturing to be provided
by Cellares for a key Lyell CAR T-cell therapy using Cellares'
exclusive Cell Shuttle
- Collaboration to evaluate potential utilization of the Cell
Shuttle for future Lyell CAR T-cell clinical trials and
commercialization
SOUTH
SAN FRANCISCO, Calif., Sept. 11,
2023 /PRNewswire/ -- Cellares, the first
Integrated Development and Manufacturing Organization (IDMO)
dedicated to clinical and industrial-scale cell therapy
manufacturing, and Lyell Immunopharma (NASDAQ: LYEL), a
clinical‑stage T-cell reprogramming company advancing a diverse
pipeline of cell therapies for patients with solid tumors, today
announced Lyell will evaluate Cellares' automated manufacturing
platform, the Cell Shuttle™, through Cellares' Technology Adoption
Partnership (TAP) program. As part of the collaboration, the
companies have agreed on a proof-of-concept technology transfer
process for the manufacture of Lyell's LYL797 CAR T-cell therapy,
using the Cell Shuttle.
CAR T-cell therapy is a personalized immunotherapy that takes a
patient's own T cells and modifies them to recognize and kill
cancer cells that have a specific biomarker. LYL797 is an
investigational CAR T-cell therapy in development for the treatment
of solid tumors that express ROR1, a protein present on the surface
of various solid tumors. LYL797 is enhanced with Lyell's novel
genetic and epigenetic reprogramming technologies designed to
generate highly tumor-reactive, longer-lasting functional T cells.
Lyell is enrolling patients with triple-negative breast cancer and
non-small cell lung cancer in a Phase 1 clinical trial evaluating
LYL797.
"We are excited to work with Cellares to evaluate their
innovative automated manufacturing processes as part of our overall
manufacturing strategy to efficiently, rapidly, and
cost-effectively scale manufacturing capacity for our CAR T-cell
product candidates for future clinical trials and potential
commercialization," said Stephen
Hill, Chief Operating Officer of Lyell. "We are impressed
with the progress Cellares has made with their manufacturing
capabilities, and the commitment and vision of the Cellares team to
apply these technologies to help deliver new and potentially
transformative therapies to patients."
Cellares' TAP program offers cell therapy developers a swift and
low-risk pathway to embrace the company's automated manufacturing
technology for their pipeline products. Lyell is utilizing this
program to assess the automated manufacturing process and generate
data that validates the Cell Shuttle's viability as a manufacturing
option for CAR T-cell therapies. Cellares partners with prominent
cell therapy developers through its TAP program to integrate the
Cell Shuttle as a GMP manufacturing solution in both clinical and
commercial stages at their IDMO Smart Factories.
"By integrating LYL797 into our TAP program, we seek to
demonstrate the ability to seamlessly adapt Lyell's CAR T-cell
manufacturing process to our Cell Shuttle platform," said Fabian
Gerlinghaus, CEO of Cellares. "This collaboration represents a
significant step towards fulfilling our vision of accelerating
access to life-saving cell therapies, reducing process failure
rates, and meeting total patient demand through the efficient
utilization of the Cell Shuttle platform at global scale."
Cellares' innovative manufacturing technology transforms
autologous and allogeneic cell therapy processes, covering nearly
90% of cell therapy modalities. Through their TAP program, Cellares
can facilitate the automation and tech transfer of manual processes
onto the Cell Shuttle manufacturing platform in just six months.
This program allows cell therapy developers to seamlessly integrate
their processes onto a Cell Shuttle at any stage of development -
from pre-clinical to post-regulatory approval. With automation,
standardization, and software-defined manufacturing (SDM),
subsequent tech transfers become instant to any other Cell Shuttle
in any IDMO Smart Factory worldwide.
Please visit cellares.com/partnering/ to learn more about the
TAP program and request a meeting with a business development
representative.
About Cellares
Cellares is the first Integrated
Development and Manufacturing Organization (IDMO) and takes an
Industry 4.0 approach to mass manufacturing the living drugs of the
21st century. The company is both developing and operating
integrated technologies for cell therapy manufacturing to
accelerate access to life-saving cell therapies. The company's Cell
Shuttle integrates all the technologies required for the entire
manufacturing process in a flexible and high-throughput platform
that delivers true walk-away, end-to-end automation. Cell Shuttles
will be deployed in Cellares' Smart Factories worldwide to meet
total patient demand for cell therapies at global scale. Partnering
with Cellares enables academics, biotechs, and pharma companies to
accelerate drug development and scale out manufacturing, lower
process failure rates, lower manufacturing costs, and meet global
patient demand.
The company is headquartered in South
San Francisco, California with its commercial-scale IDMO
Smart Factory in Bridgewater, New
Jersey. The company is backed by world-class investors and
has raised over $355 million in
financing.
For more information about Cellares, please visit
cellares.com.
About Lyell Immunopharma, Inc.
Lyell is a
clinical-stage T-cell reprogramming company advancing a diverse
pipeline of cell therapies for patients with solid tumors. Lyell is
currently enrolling a Phase 1 clinical trial evaluating a
ROR1-targeted CAR T-cell therapy in patients with relapsed
refractory triple-negative breast cancer and non-small cell lung
cancer (NSCLC) and a second Phase 1 clinical trial evaluating
reprogrammed tumor infiltrating lymphocytes (TIL) in patients with
advanced melanoma, NSCLC and colorectal cancer. The technologies
powering its product candidates are designed to address barriers
that limit consistent and long-lasting responses to cell therapy
for solid tumors: T-cell exhaustion and lack of durable stemness,
which includes the ability to persist and self-renew to drive
durable tumor cytotoxicity. Lyell is applying its proprietary ex
vivo genetic and epigenetic reprogramming technologies to address
these barriers in order to develop new medicines with improved
durable clinical outcomes. Lyell is based in South San Francisco, California with
facilities in Seattle and
Bothell, Washington. To learn
more, please visit www.lyell.com.
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements expressed or implied in this press release include, but
are not limited to, statements regarding: Lyell's advancement of
its pipeline of cell therapies; the planned collaboration between
Cellares and Lyell and technology transfer process for the
manufacture of Lyell's LYL797 CART-cell therapy; the potential
clinical benefits and therapeutic potential of Lyell's product
candidates; expectations around patient profiles and enrollment
from Lyell's Phase 1 trials for LYL797; Lyell's anticipated
progress, manufacturing strategy, clinical trials and potential
commercialization; the anticipated benefits and timing of Cellares'
automated manufacturing platform; and other statements that are not
historical fact. These statements are based on Lyell's current
plans, objectives, estimates, expectations and intentions, are not
guarantees of future performance and inherently involve significant
risks and uncertainties. Actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, but are not limited to, risks and
uncertainties related to: the effects of geopolitical instability;
macroeconomic conditions and the lingering effects of the COVID-19
pandemic; Lyell's ability to submit planned INDs or initiate or
progress clinical trials on the anticipated timelines, if at all;
Lyell's limited experience as a company in enrolling and conducting
clinical trials, and lack of experience in completing clinical
trials; Lyell's ability to manufacture and supply its product
candidates for its clinical trials; the nonclinical profiles of
Lyell's product candidates not translating in clinical trials; the
potential for results from clinical trials to differ from
nonclinical, early clinical, preliminary or expected results;
significant adverse events, toxicities or other undesirable side
effects associated with Lyell's product candidates; the significant
uncertainty associated with Lyell's product candidates ever
receiving any regulatory approvals; Lyell's ability to obtain,
maintain or protect intellectual property rights related to its
product candidates; implementation of Lyell's strategic plans for
its business and product candidates; the sufficiency of Lyell's
capital resources and need for additional capital to achieve its
goals; and other risks, including those described under the heading
"Risk Factors" in its Annual Report on Form 10-K for the year ended
December 31, 2022, filed with the
Securities and Exchange Commission (SEC) on February 28, 2023, and the Quarterly Report on
Form 10-Q for the quarter ended June 30,
2023, filed with the SEC on August 8, 2023.
Forward-looking statements contained in this press release are made
as of this date, and Lyell undertakes no duty to update such
information except as required under applicable law.
Media Contact:
Consort Partners for Cellares
cellares@consortpartners.com
Media Contact, Lyell
Immunopharma
Ellen
Rose
Senior Vice President, Communications and Investor Relations
erose@lyell.com
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