Car Modification

Kind 8-Okay Century Therapeutics, For: Aug 25


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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8-Okay

 

 

CURRENT REPORT

Pursuant to Part 13 or 15(d)

of the Securities Trade Act of 1934

 

Date of Report (Date of earliest occasion reported):
August 25, 2022

 

 

Century Therapeutics, Inc.

(Precise title of registrant as laid out in its constitution)

 

 

Delaware   001-40498   84-2040295
(State or different jurisdiction of
incorporation or group)
  (Fee File Quantity)   (I.R.S. Employer
Identification No.)

 

3675 Market Avenue

Philadelphia, Pennsylvania

  19104
(Handle of principal government workplaces)   (Zip Code)

 

Registrant’s phone quantity, together with
space code: (267) 817-5790

 

Not Relevant

(Former title or former tackle, if modified since
final report)

 

 

Test the suitable field beneath if the Kind 8-Okay submitting is meant
to concurrently fulfill the submitting obligation of the registrant below any of the next provisions (see Normal Instruction A.2.
beneath):

 

¨ Written communications pursuant to Rule 425 below the Securities Act (17 CFR 230.425)
¨ Soliciting materials pursuant to Rule 14a-12 below the Trade Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) below the Trade Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) below the Trade Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Part 12(b) of the Act:

 

Title of Every Class   Buying and selling Image   Title
of Trade on Which Registered
Frequent Inventory, par worth $0.0001 per share   IPSC   Nasdaq World Choose Market

 

Point out by test mark whether or not the registrant is an rising development
firm as outlined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Trade
Act of 1934 (§240.12b-2 of this chapter).

Rising development firm x

 

If an rising development firm, point out by test mark if the registrant
has elected to not use the prolonged transition interval for complying with any new or revised monetary accounting requirements supplied pursuant
to Part 13(a) of the Trade Act.

 

 

 

On August 25, 2022, Century Therapeutics, Inc. (the “Firm”)
issued a press launch saying the U.S. Meals and Drug Administration notified the Firm that its ELiPSE-1 research could proceed to evaluate
CNTY-101 in sufferers with relapsed or refractory CD19 optimistic B-cell malignancies. A replica of the press launch is furnished as Exhibit 99.1
to this Present Report on Kind 8-Okay and is included herein by reference.

 

Merchandise 9.01 Monetary Statements and Displays

 

(d) Displays

 

 

 

SIGNATURES

 

Pursuant to the necessities of the Securities Trade Act of 1934,
the registrant has duly triggered this report back to be signed on its behalf by the undersigned hereunto duly approved.

 

  CENTURY THERAPEUTICS, INC.
     
  By: /s/ Osvaldo Flores, Ph.D.
  Title: Osvaldo Flores, Ph.D.
  Title: President and Chief Government Officer

 

Date: August 25, 2022

 

 

Exhibit 99.1

Kind 8-Okay Century Therapeutics, For: Aug 25

 

Century Therapeutics Receives Examine Might Proceed
Notification from FDA for CNTY-101, the First Allogeneic Cell Remedy Product Candidate Engineered to Overcome Three Main Pathways of
Host vs Graft Rejection

 

– Investigational New Drug Utility for
CNTY-101, a CAR-iNK product candidate concentrating on CD19 for B-cell malignancies, cleared by FDA –

 

– First cell product candidate engineered with
six precision gene edits together with a CD19-CAR, Allo-Evasion
TM expertise, IL-15 cytokine assist and a security change

 

– Section 1 ELiPSE-1 trial evaluating CNTY-101
in relapsed or refractory CD19 optimistic B-cell malignancies anticipated to start in 2H22 –

 

PHILADELPHIA, August 25, 2022 — Century Therapeutics, Inc.,
(NASDAQ: IPSC), an modern biotechnology firm creating induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology,
introduced as we speak that the corporate has been notified by the U.S. Meals and Drug Administration (FDA) that the Firm’s ELiPSE-1 medical
research could proceed to evaluate CNTY-101 in sufferers with relapsed or refractory CD19 optimistic B-cell malignancies. CNTY-101 is the primary
allogeneic cell remedy product candidate engineered with 4 highly effective and complementary functionalities, together with a CD19 CAR for tumor
concentrating on, IL-15 assist for enhanced persistence, Allo-EvasionTM expertise to stop host rejection and improve persistence
and a security change to offer the choice to eradicate the drug product if ever needed. CNTY-101 is manufactured from a clonal iPSC
grasp cell financial institution that yields homogeneous product, through which all infused cells have the meant modifications.

 

“This IND clearance is a big milestone for Century as
we execute on our imaginative and prescient to merge two disruptive platforms, precision gene modifying and the highly effective potential of iPSCs, to probably
transfer the allogeneic cell remedy discipline ahead, and proceed on our path to turning into a pacesetter within the area,” stated Lalo Flores,
Chief Government Officer, Century Therapeutics. “We consider that CNTY-101, our first and wholly owned product candidate, will probably be
essentially the most technically superior and differentiated CD19-targeted cell product when it enters the clinic, which is anticipated to happen
later this 12 months. We sit up for assessing the potential of Allo-EvasionTM to stop immunological rejection and improve
persistence of a number of dosing of CNTY-101 regimens with the goal to extend the proportion of sufferers that obtain sturdy responses.”

 

“CNTY-101 is the primary allogeneic cell product candidate with
six genetic modifications included utilizing sequential rounds of CRISPR-mediated homologous recombination and restore that has obtained
IND clearance by the FDA,” stated Luis Borges, Chief Scientific Officer, Century Therapeutics. “We consider CNTY-101 will show
the ability of Century’s iPSC expertise and cell engineering expertise platforms. This accomplishment is a testomony to the experience
and dedication of our group as we proceed to make progress creating our pipeline of iPSC-derived NK and T cell product candidates.”

 

The Section 1 trial, ELiPSE-1 (NCT05336409), is meant to evaluate
the protection, tolerability, pharmacokinetics and preliminary efficacy of CNTY-101 in sufferers with relapsed or refractory CD19-positive
B-cell malignancies. All sufferers will obtain an preliminary normal dose of conditioning chemotherapy consisting of cyclophosphamide (300
mg/m2) and fludarabine (30mg/m2) for 3 days. Schedule A of the trial features a single-dose escalation of CNTY-101 and subcutaneous IL-2.
Schedule B will consider a three-dose schedule per cycle of CNTY-101. Sufferers who show a medical profit are eligible for added
cycles of remedy with or with out extra lymphodepletion pending FDA consent. We anticipate initiation of the Section 1 trial later
this 12 months.

 

 

Kind 8-Okay Century Therapeutics, For: Aug 25

 

About Allo-EvasionTM

 

Century’s proprietary Allo-EvasionTM expertise is
used to engineer cell remedy product candidates with the potential to evade identification by the host immune system to allow them to be
dosed a number of occasions with out rejection, enabling elevated persistence of the cells throughout the remedy interval and probably main
to deeper and extra sturdy responses. Extra particularly, Allo-EvasionTM 1.0 expertise incorporates three gene edits designed
to keep away from recognition by affected person/host CD8+ T cells, CD4+ T cells and NK cells. Knockout of beta-2-microglobulin or β2m, designed
to stop CD8+ T cell recognition, knock-out of the Class II Main Histocompatibility Advanced Transactivator, or CIITA, designed
to stop CD4+ T cell recognition, and knock-in of the HLA-E gene, designed to allow increased expression of the HLA-E protein to stop
killing of CNTY-101 cells by host NK cells. Allo-EvasionTM expertise could enable the implementation of extra versatile and efficient
repeat dosing protocols for off-the-shelf product candidates.

 

About CNTY-101

 

CNTY-101 is an investigational off-the-shelf most cancers immunotherapy
product candidate that makes use of iPSC-derived pure killer (NK) cells with a CD19-directed chimeric antigen receptor (CAR) and consists of
Century’s core Allo-EvasionTM edits designed to beat the three main pathways of host versus graft rejection – CD8+
T cells, CD4+ T cells and NK cells. As well as, the product candidate is engineered to precise IL-15 to offer homeostatic cytokine
assist, which has been proven pre-clinically to enhance performance and persistence. Additional, to probably enhance security, the iNK
cells have been engineered with an EGFR security change, and proof-of-concept research have demonstrated that the cells may be rapidly eradicated
by the administration of cetuximab, an antibody in opposition to EGFR accepted by the U.S. Meals and Drug Administration (FDA) for sure cancers.
Initiation of the Section 1, ELiPSE-1 trial in relapsed or refractory CD19-positive B-cell malignancies in a number of facilities within the United
States is anticipated to start within the second half of 2022.

 

About Century Therapeutics

 

Century Therapeutics, Inc. (NASDAQ: IPSC) is harnessing the ability
of grownup stem cells to develop healing cell remedy merchandise for most cancers that we consider will enable us to beat the restrictions of
first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to particularly
goal hematologic and strong tumor cancers. We’re leveraging our experience in mobile reprogramming, genetic engineering, and manufacturing
to develop therapies with the potential to beat lots of the challenges inherent to cell remedy and supply a big benefit
over present cell remedy applied sciences.   We consider our dedication to creating off-the-shelf cell therapies will increase
affected person entry and supply an unparalleled alternative to advance the course of most cancers care. For extra info on Century Therapeutics
please go to https://www.centurytx.com/.

 

 

Kind 8-Okay Century Therapeutics, For: Aug 25

 

Ahead-Wanting Statements

 

This press launch comprises forward-looking statements throughout the
that means of, and made pursuant to the secure harbor provisions of, The Personal Securities Litigation Reform Act of 1995. All statements
contained on this press launch, apart from statements of historic info or statements that relate to current info or present situations,
together with however not restricted to, statements relating to our medical growth plans and timelines are forward-looking statements. These
statements contain recognized and unknown dangers, uncertainties and different necessary elements that will trigger our precise outcomes, efficiency,
or achievements to be materially completely different from any future outcomes, efficiency or achievements expressed or implied by the forward-looking
statements. In some instances, you may establish forward-looking statements by phrases corresponding to “could,” “may,” “will,”
“ought to,” “anticipate,” “plan,” “goal,” “search,” “anticipate,” “might,”
“intend,” “goal,” “challenge,” “ponder,” “consider,” “estimate,”
“predict,” “forecast,” “potential” or “proceed” or the detrimental of those phrases or different
related expressions. The forward-looking statements on this presentation are solely predictions. We’ve got primarily based these forward-looking statements
largely on our present expectations and projections about future occasions and monetary developments that we consider could have an effect on our enterprise,
monetary situation, and outcomes of operations. These forward-looking statements converse solely as of the date of this press launch and
are topic to plenty of dangers, uncertainties and assumptions, a few of which can’t be predicted or quantified and a few of that are
past our management, together with, amongst others: our capability to efficiently advance our present and future product candidates via growth
actions, preclinical research, and medical trials; our capability to acquire FDA acceptance for our future IND submissions and begin
medical trials on anticipated timelines, or in any respect; our reliance on the upkeep of sure key collaborative relationships for the
manufacturing and growth of our product candidates; the timing, scope and chance of regulatory filings and approvals, together with
ultimate regulatory approval of our product candidates; the impression of the COVID-19 pandemic, geopolitical points and inflation on our enterprise
and operations, provide chain and labor drive; the efficiency of third events in reference to the event of our product candidates,
together with third events conducting our future medical trials in addition to third-party suppliers and producers; our capability to efficiently
commercialize our product candidates and develop gross sales and advertising and marketing capabilities, if our product candidates are accepted; and our capability
to take care of and efficiently implement ample mental property safety. These and different dangers and uncertainties are described
extra totally within the “Danger Components” part of our most up-to-date filings with the Securities and Trade Fee and obtainable
at www.sec.gov. You shouldn’t depend on these forward-looking statements as predictions of future occasions. The occasions and circumstances
mirrored in our forward-looking statements is probably not achieved or happen, and precise outcomes might differ materially from these projected
within the forward-looking statements. Furthermore, we function in a dynamic business and economic system. New danger elements and uncertainties could emerge
now and again, and it isn’t potential for administration to foretell all danger elements and uncertainties that we could face. Besides as required
by relevant regulation, we don’t plan to publicly replace or revise any forward-looking statements contained herein, whether or not on account of
any new info, future occasions, modified circumstances or in any other case.

 

 

Kind 8-Okay Century Therapeutics, For: Aug 25

 

For Extra Info:

 

Firm: Elizabeth Krutoholow – [email protected]

 

Traders: Melissa Forst/Maghan Meyers – [email protected]

 

Media: Joshua R. Mansbach – [email protected]

 

 

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