Cellectis provides 2022 business targets and updates

0

NEW YORK, January 04, 2022 (GLOBE NEWSWIRE) – Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop vital cell and gene therapies, has announced business goals for its product pipeline and its in-house manufacturing for 2022.

“In 2022, we will focus on continuing to recruit in our main ongoing clinical trials BALLI-01, AMELI-01, MELANI-01 and on filing an application for a new investigational drug (IND) for the first allogeneic double UCART20x22 ”, said Dr André Choulika. , CEO of Cellectis. “Additionally, we are on track to begin dosing patients with our in-house manufactured investigational drugs (IMPs) during 2022. Our two manufacturing sites in Raleigh, North Carolina and Paris, France are now fully operational. This concentration allows us to extend our cash flow track (excluding our subsidiary Calyxt, Inc.) until the beginning of 2024. ”

Cellectis 2022 expected milestones:

UCART clinical development programs

BALLI-01 (for UCART22)

  • Cellectis aims to recruit Dose Level 3 (DL3) patients with a fludarabine, cyclophosphamide, and alemtuzumab (FCA) preconditioning regimen and begin dosing internally manufactured IMPs in the second half of the year. 2022.

    UCART22 is an allogeneic CAR-T cell targeting CD22 product candidate under evaluation in patients with relapsed or refractory acute lymphoblastic B-cell leukemia (r / r B-ALL) in the clinical study BALLI-01 phase 1 multicenter with dose escalation.

AMELI-01 (for UCART123)

  • Cellectis aims to recruit patients at dose level 2 (DL2) and potentially upgrade to higher dose levels with the FCA preconditioning regimen.

    UCART123 is an allogeneic CAR-T cell targeting CD123 product candidate under evaluation in patients with relapsed or refractory acute myeloid leukemia (r / r AML) in the multicentre phase 1 clinical study AMELI-01 with dose escalation.

MELANI-01 (for UCARTCS1)

  • Cellectis aims to recruit Dose Level 1 (DL1) patients with a fludarabine and cyclophosphamide (FC) preconditioning regimen.

    UCARTCS1 is an allogeneic product candidate of CAR-T cells targeting CS1 being evaluated in patients with relapsed or refractory multiple myeloma (r / r MM) in the multicenter phase 1 clinical study MELANI-01 with dose escalation.

UCART preclinical programs

UCART20x22

Manufacturing plant

  • The Paris raw materials manufacturing plant is now fully operational, focusing on the production of plasmids and mRNA for our TALEN® gene editing technology.
  • Installation, equipment and systems qualification was completed in the third quarter of 2021 at the Cellectis Raleigh cGMP manufacturing facility.
  • Manufacturing and batch release of UCART22 and UCART20x22 product candidates began in Q3 2021 at our cGMP manufacturing facility in Raleigh.

Cash position

  • Cellectis extends its treasury track (excluding Calyxt, Inc.) until early 2024, with cash of $ 201 million as of September 30, 20211

Cellectis’ 2022 corporate presentation is available on the company’s website.

About Cellectis
Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis uses an allogeneic approach to CAR-T immunotherapies in oncology, pioneering the concept of ready-to-use, ready-to-use CAR-T cells to treat cancer patients, and a platform to make the Therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 21 years of expertise in gene editing, Cellectis develops life-changing product candidates using TALEN®, its gene-editing technology, and PulseAgile, its system. pioneering electroporation to harness the power of the immune system to treat diseases with unmet medical needs.
As part of its commitment to healing, Cellectis remains committed to its goal of providing vital UCART product candidates for multiple cancers, including Acute Myeloid Leukemia (AML), Acute B-Cell Lymphoblastic Leukemia (B-ALL ) and multiple myeloma (MM). HEAL is a new platform focused on hematopoietic stem cells to treat blood disorders, immunodeficiencies and lysosomal overload diseases.
Cellectis is headquartered in Paris, France, with sites in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS).

For more information visit www.cellectis.com
Follow Cellectis on social networks: @cellectis, LinkedIn and YouTube.

For more information, please contact:

Media contacts:
Pascalyne Wilson, Director of Communication, +33776991433, [email protected]
Margaret Gandolfo, Senior Director, Communications, +1 (646) 628 0300

Investor Relations Contact:
Arthur Stril, Chief Business Officer, +33684439609, [email protected]

Ashley R. Robinson, LifeSci Advisors, +1 617 430 7577
[email protected]

Forward-looking statements
This press release contains “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “anticipate”, “target”, “Believe,” “intend”, “expect”, “plan”, “foresee”, “might” and “will”, or the negative of these and other similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, include statements about our research and development plans and priorities, our preclinical project development efforts, and the timing of our research and development. our data presentation. These forward-looking statements are made in light of the information currently available to us and are subject to numerous risks and uncertainties, particularly with regard to the numerous risks associated with the development of biopharmaceutical product candidates as well as the duration and severity of the pandemic of COVID-19. and government and regulatory measures implemented in response to the evolving situation. With respect to our cash flow track, our operating plans, including product development plans, may change due to a variety of factors, including factors that are currently unknown to us. In addition, many other important factors, including those described in our annual report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2020 and subsequent filings that Cellectis files with the Securities Exchange Commission from time to time. time, as well as other known and unknown risks and uncertainties may adversely affect these forward-looking statements and cause our actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.


1 $ 201 million in cash, cash equivalents, current financial assets and restricted cash

  • PRESS RELEASE_2022_milestones_ENGLISH_FINAL

Share.

Comments are closed.