On January 4, 2022 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported business objectives for its products pipeline and in-house manufacturing for 2022 (Press release, Cellectis, JAN 4, 2022, View Source [SID1234598060]).
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"In 2022 we will be focusing on pursuing recruitments into our core ongoing clinical trials BALLI-01, AMELI-01, MELANI-01 and on filing an investigational new drug application (IND) for the first dual allogeneic UCART20x22." said Dr André Choulika, CEO of Cellectis. "Furthermore, we are on-track to start dosing patients with our in-house manufactured investigational medicinal products (IMPs) during 2022. Our two manufacturing sites in Raleigh, NC and Paris, France are now fully operational. This focus allows us to extend our cash runway (excluding our subsidiary Calyxt, Inc.) into early 2024."
Cellectis 2022 expected milestones:
UCART Clinical Development Programs
BALLI-01 (for UCART22)
Cellectis targets to enroll patients at Dose Level 3 (DL3) with Fludarabine, Cyclophosphamide and Alemtuzumab (FCA) preconditioning regimen and to start dosing with IMPs manufactured in-house second half of 2022.
UCART22 is an allogeneic CAR-T cell product candidate targeting CD22 being evaluated in patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r B-ALL) in the BALLI-01 Phase 1, multi-center dose-escalation clinical study.
AMELI-01 (for UCART123)
Cellectis targets to enroll patients at Dose Level 2 (DL2) and eventually escalate to higher dose levels with FCA preconditioning regimen.
UCART123 is an allogeneic CAR-T cell product candidate targeting CD123 being evaluated in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in the AMELI-01 Phase 1, multi-center dose-escalation clinical study.
MELANI-01 (for UCARTCS1)
Cellectis targets to enroll patients at Dose Level 1 (DL1) with Fludarabine and Cyclophosphamide (FC) preconditioning regimen.
UCARTCS1 is an allogeneic CAR-T cell product candidate targeting CS1 being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the MELANI-01 Phase 1, multi-center dose-escalation clinical study.
UCART Preclinical Programs
UCART20x22
Cellectis targets to file an IND for UCART20x22 and to initiate a Phase 1 trial in 2022.
UCART20x22 is the first allogeneic dual CAR-T cell product candidate, which is being developed for patients with r/r B-cell Non-Hodgkin Lymphoma (NHL).
Manufacturing Facility
Paris starting materials manufacturing facility is now fully operational, focusing on plasmids and mRNA production for our TALEN gene editing technology.
Qualification of the facility, equipment and systems was completed in Q3 2021 at Cellectis Raleigh cGMP manufacturing facility.
Manufacture and release of batches of product candidates UCART22 and UCART20x22 have started in Q3 2021 at our Raleigh cGMP manufacturing facility.
Cash position
Cellectis extends its cash runway (excluding Calyxt, Inc.) into early 2024, with a cash position of $201 million as of September 30, 2021[1]
Cellectis’ 2022 corporate presentation is available on the company’s website.
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[1] $201 million in cash, cash equivalents, current financial assets and restricted cash