Corporate Overview
May 2024
Forward-looking statements
This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbour provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this document, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding possible or assumed future results of operations, business strategies, research and development plans, regulatory activities, market opportunity, competitive position and potential growth opportunities 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 presentation 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 presentation 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 reliance on
the maintenance on 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 regulatoryapproval of our product candidates; our ability to successfully integrate operations with Clade Therapeutics, geopolitical issues and inflation on our business andoperations, supply chain and labor force; the performance of thirdparties 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 ourproduct candidates anddevelop 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 morefully 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.
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Century Therapeutics: Building an industry-leading, next- generation allogeneic iPSC-derived cell therapy platform
LIMITLESS POTENTIAL…
PRECISION DESIGN…
ENDURING IMPACT…
Foundational investments in iPSC technology, genetic editing, protein engineering, and manufacturing
Progressing differentiated clinical programs based on Allo-EvasionTM technology in oncology and autoimmune and inflammatory diseases
Well-capitalized into 2026 to enable delivery on key milestones and clinical data
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Overview of Foundational Platform Technologies
Century's singular focus:
To deliver best-in-classiPSC-derived cell therapies
Century platform enables the incorporation of critical features we believe can only be realized via iPSC-derived cell therapies
Single cell cloning of engineered | ||
Infinite replicative capacity at the | iPSC allows selection of a fully | Platform capable of fully leveraging |
iPSC stage enables potentially unlimited | characterized clone for master cell | multiple advances in synthetic biology |
genomic editing via CRISPR HDR | bank, ensuring safety and functional | into a single product |
reproducibility of the final drug product |
Cell expansion during multiple stages of | Production from a master cell bank - | Differentiation conditions developed for |
differentiation yields large cell harvests, | generating multiple immune effector | |
derived from a single donor - enables larger | ||
decreasing risk of cell exhaustion, | cells, including NK cells, CD4+ T cells (Th | |
batch sizes and lower cost of goods than | ||
reducing COGs and providing robust drug | and Treg), CD8+ T cells, monocytes / | |
donor-derived or autologous | ||
inventory that is potentially infinitely | macrophages | |
replenishable |
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Century's next-generation allogeneic iPSC technology platform:
Versatility and unprecedented control
Allo-EvasionTM
Homeostasis/ persistence
Modulation of TME
Safety switch
Integration of advances in
synthetic biology
Product design
SINGLE CELL CLONING POST
GENE EDITING AND
iPSC CHARACTERIZATION
Engineered | ||
iPSC MCB | Consistency | iT cell |
Yield | ||
Fitness: No exhaustion |
Manufacturing
DIFFERENTIATION
iNK cell
Rapid Integration of major advances in product functionality and manufacturability
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Precision CRISPR MAD7 mediated sequential gene editing of iPSC cells generates uniform product candidates
Sequential selection steps
Multiple gene edits | |
iPSC | (KO/KI) |
bank | iSPC Precision Engineering |
Engineered iPSC
Master Cell Bank
(MCB)
Advantages of Century's Platform
Precise CRISPR mediated homology directed repair reduces off-target integration
Stepwise and efficient gene editing avoids risky multiplex modification and structural variants
Quality control through generation of homogenous MCB establishes genomic product integrity
Manufacturing begins at the MCB, confirmed to be free from genetic aberrations
CRISPR-mediated HDR (MAD 7)
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Potential to drive durable responses with engineering to resist immune rejection
Allo-EvasionTM edits + repeat dosing = potential greater durability
With Allo-EvasionTM engineering | Without Allo-EvasionTM engineering |
Next-wave of allogeneic cell therapies must solve for challenge of rejection
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Advancing our leadership in Allo-EvasionTM technology
Continuous improvement in holistic immune protection designed to overcome major pathways of host vs. graft rejection
Allo-EvasionTM 1.0 | Allo-EvasionTM 3.0 | Allo-EvasionTM 5.0 |
Core edits disarm host cells from
eliminating therapy
CD8+
T Cell
Fc
NK cell
1 | β2M KO | |
(HLA-I) | ||
CD4+ | 2 CIITA | Pan NK |
T Cell | KO | Inhibitory |
(HLA-II) | ligand | |
Deletion of β2M, a protein required to express HLA-1 on the cell surface prevents recognition by CD8 T cells
Knock out of CIITA eliminates HLA-II expression to escape elimination by CD4 T cells
Knock-in of HLA-E prevents killing by NK cells
Allo-EvasionTM 1.0 edits plus the incorporation of:
Knock-in of HLA-G improves protection against killing by NK cells
Deletion of β2M, a protein required to express HLA-1 on the cell surface prevents recognition by CD8 T cells
Knock out of CIITA eliminates HLA-II expression to escape elimination by CD4 T cells
Pan-NK inhibitory ligand to provide broader protection against killing by NK cells
IgG degrading protease designed to protect against humoral immunity
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Foundational investments in iPSC manufacturing
Established in-house manufacturing
- Century 53,000 ft2 GMP facility
- Designed to produce multiple immune cell types
- Accelerates learnings and enables faster product iteration
- Two sites (FCDI GMP manufacturing, Century in-house manufacturing) provide optionality and maximizes flexibility
Developing fit-for-purpose products
- Increased process and product consistency
- Scalable platforms and optimized processes to maximize yield, reduce COGs, and meet demand
- Increases in cell fitness, as cells do not undergo excessive expansion cycles which often result in cell exhaustion
- Homogeneity of the manufacturing process produces a product candidate that can be readily characterized
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Century Therapeutics Inc published this content on 09 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 May 2024 11:43:10 UTC.