Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology
company developing induced pluripotent stem cell (iPSC)-derived
cell therapies in immuno-oncology, today announced a new internal
portfolio prioritization and capital allocation strategy that is
expected to extend cash runway into 2026. The resulting changes
include de-prioritizing investment in CNTY-103 for glioblastoma as
well as a discovery program in hematologic malignancies. The
Company will focus on CNTY-101 and will prioritize key programs,
including one follow-on product candidate for lymphoma, CNTY-102,
and CNTY-107, a product candidate for Nectin-4+ tumors. In
addition, Century will continue its partnered programs with Bristol
Myers Squibb with no impact to previous guidance on timelines.
The strategic initiative allows the Company to reduce its
headcount by approximately 25 percent, providing an estimated
greater than 3-year cash runway to fund operations. These strategic
changes will allow the Company to focus on delivering upon key
milestones in the development of candidates that the Company
believes have a higher probability of technical success and
best-in-class potential. As a result of the operational
restructuring, lab operations in Seattle and Hamilton will be
closed and research activities will be consolidated in
Philadelphia.
“As our confidence in the disruptive potential of our technology
platform and prioritized pipeline programs continues to increase,
we have implemented these cost saving measures to right size the
organization and further extend our cash runway to enable
achievement of key milestones,” said Lalo Flores, Ph.D., Chief
Executive Officer, Century Therapeutics. “As a result, we are
losing many valued colleagues, which is an incredibly difficult
decision, and we would like to thank each of them for their
contributions.”
Concurrent with today’s announcement, the Company also announced
that Hy Levitsky, M.D., Ph.D., President of Research and
Development, has tendered his resignation, effective January 31,
2023. Dr. Levitsky’s leadership responsibilities will be assumed by
Luis Borges, Ph.D., Chief Scientific Officer and Adrienne Farid,
Ph.D., Chief Operations Officer and Head of Early Development.
“I am pleased to have been part of the Century team during its
formative years and I am tremendously proud of the progress the
Company has made, leaving it well positioned for future success,”
said Dr. Levitsky. “I leave Century with continued confidence in
the vision for next-generation iPSC-derived cell therapies.”
“On behalf of the entire team, I would like to thank Hy Levitsky
for his valuable contributions to the Company,” Dr. Flores
said.
Strategy Update
Based on the outcomes of the strategic portfolio prioritization,
the Company will focus on the following:
CNTY-101: lead product candidate targeting CD19 for
relapsed/refractory B-cell lymphoma
- CNTY-101 is an iPSC-derived chimeric antigen receptor
iPSC-derived NK (CAR-iNK) cell therapy candidate that has been
engineered to include core Allo-Evasion™ edits, express a CD19
CAR, soluble IL-15, and an EGFR safety switch. The first sites
for the ELiPSE-1 Phase 1 trial are activated and are currently
recruiting patients. The first patient is expected to be enrolled
imminently.
CNTY-102: multi-specific product candidate for
relapsed/refractory B-cell lymphoma and other B-cell
malignancies
- CNTY-102 is an iPSC-derived CAR gamma delta iT cell therapy
candidate that will simultaneously target CD19 and a second
antigen. This product candidate is designed to increase depth and
durability of response by eliminating the effect of CD19 antigen
loss that has been observed as a factor limiting treatment
durability.
CNTY-107: gamma delta iT product candidate for the treatment of
solid tumors expressing Nectin-4
- CNTY-107 is a first-in-class iPSC-derived Nectin-4 CAR gamma
delta T-cell therapy product candidate that will be engineered with
multiple features to provide several mechanisms for tumor killing.
As presented at the Company’s virtual Research and Development Day
on November 11, 2022, the product candidate will include core
Allo-Evasion™ edits and other features to provide cytokine
support, enhance tumor cell killing and cell fitness.
The Company continues its strategic research collaboration with
Bristol Myers Squibb for CNTY-104 in acute myeloid leukemia and
CNTY-106 in multiple myeloma. These programs are not impacted by
the restructuring.
About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is harnessing the power of
adult stem cells to develop curative cell therapy products for
cancer that we believe will allow us to overcome the limitations of
first-generation cell therapies. Our genetically engineered,
iPSC-derived iNK and iT cell product candidates are designed to
specifically target hematologic and solid tumor cancers. We are
leveraging our expertise in cellular reprogramming, genetic
engineering, and manufacturing to develop therapies with the
potential to overcome many of the challenges inherent to cell
therapy and provide a significant advantage over existing cell
therapy technologies. We believe our commitment to developing
off-the-shelf cell therapies will expand patient access and provide
an unparalleled opportunity to advance the course of cancer care.
For more information on Century Therapeutics please visit
www.centurytx.com.
Century Therapeutics Forward-Looking
Statement
This press release contains forward-looking statements within
the meaning of, and made pursuant to the safe harbor provisions of,
The Private Securities Litigation Reform Act of 1995. All
statements contained in this press release, other than statements
of historical facts or statements that relate to present facts or
current conditions, including but not limited to, statements
regarding our clinical development plans and timelines are
forward-looking statements. These statements involve known and
unknown risks, uncertainties and other important factors that may
cause our actual results, performance, or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. In some cases, you can identify forward-looking
statements by terms such as “may,” “might,” “will,” “should,”
“expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplate,” “believe,” “estimate,”
“predict,” “forecast,” “potential” or “continue” or the negative of
these terms or other similar expressions. The forward-looking
statements in this press release are only predictions. We have
based these forward-looking statements largely on our current
expectations and projections about future events and financial
trends that we believe may affect our business, financial
condition, and results of operations. These forward-looking
statements speak only as of the date of this press release and are
subject to a number of risks, uncertainties and assumptions, some
of which cannot be predicted or quantified and some of which are
beyond our control, including, among others: our ability to
successfully advance our current and future product candidates
through development activities, preclinical studies, and clinical
trials; our ability to obtain FDA acceptance for our future IND
submissions and commence clinical trials on expected timelines, or
at all; our reliance on the maintenance of certain key
collaborative relationships for the manufacturing and development
of our product candidates; the timing, scope and likelihood of
regulatory filings and approvals, including final regulatory
approval of our product candidates; the impact of the COVID-19
pandemic, geopolitical issues and inflation on our business and
operations, supply chain and labor force; the performance of third
parties in connection with the development of our product
candidates, including third parties conducting our future clinical
trials as well as third-party suppliers and manufacturers; our
ability to successfully commercialize our product candidates and
develop sales and marketing capabilities, if our product candidates
are approved; and our ability to maintain and successfully enforce
adequate intellectual property protection. These and other risks
and uncertainties are described more fully in the “Risk Factors”
section of our most recent filings with the Securities and Exchange
Commission and available at www.sec.gov. You should not rely on
these forward-looking statements as predictions of future events.
The events and circumstances reflected in our forward-looking
statements may not be achieved or occur, and actual results could
differ materially from those projected in the forward-looking
statements. Moreover, we operate in a dynamic industry and economy.
New risk factors and uncertainties may emerge from time to time,
and it is not possible for management to predict all risk factors
and uncertainties that we may face. Except as required by
applicable law, we do not plan to publicly update or revise any
forward-looking statements contained herein, whether as a result of
any new information, future events, changed circumstances or
otherwise.
For More Information: Company: Elizabeth
Krutoholow – investor.relations@centurytx.comInvestors: Melissa
Forst/Maghan Meyers – century@argotpartners.comMedia: Joshua R.
Mansbach – century@argotpartners.com
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