On May 28, 2024 Cellectis (the "Company") (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 updates and reported financial results for the three-month period ending March 31, 2024 (Press release, Cellectis, MAY 28, 2024, View Source [SID1234644826]).
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"We are thrilled to have announced the closing of the additional equity investment of $140 million by AstraZeneca. This followed AstraZeneca’s initial payment of $105 million, composed of a $80 million equity investment and a $25 million upfront payment under our research collaboration.
Following AstraZeneca’s additional investment, we expect our cash runway to fund operations into 2026. We will continue to focus our efforts and expenses on advancing its core clinical trials BALLI-01, NATHALI-01 and AMELI-01, which remain wholly owned assets, while building, within our owned preclinical pipeline and in collaboration with AstraZeneca, the next generation of medicines to address areas of high unmet patient needs.
We strongly believe that gene edited cell and gene therapy products are revolutionizing medicine across a number of therapeutic areas and will become a large part of molecular medicine of the future." said André Choulika, Ph.D., Chief Executive Officer at Cellectis.
Pipeline Highlights
UCART Clinical Programs
Cellectis continues to focus on the enrollment of patients in the BALLI-01 study (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), in the NATHALI-01 study (evaluating UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL), and in the AMELI-01 study (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML).
We expect to provide updates in the advancements of BALLI-01 and NATHALI-01 by year-end 2024.
Partnerships
Licensed Allogeneic CAR T-cell Development Programs
Anti-CD19 program
Allogene’s investigational oncology products utilize Cellectis technologies. Servier, which has an exclusive license to the anti-CD19 investigational products from Cellectis, has granted Allogene an exclusive sublicense to these products in the U.S., European Union and the United Kingdom.
Allogene announced the execution with Servier of an amendment to the sublicense to expand the licensed territory to the European Union and the United Kingdom.
Allogene announced that it continues to focus on the development of its investigational product cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A), as part of the first line (1L) treatment plan for LBCL patients who are at risk of relapse following 1L chemoimmunotherapy. Allogene announced that start-up activities for the ALPHA3 trial are ongoing with a planned study initiation in mid-2024.
Allogene further announced that enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel.
Anti-CD70 program
The anti-CD70 program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this program.
Allogene announced that a Phase 1 data update of the ongoing TRAVERSE trial with ALLO-316 in RCC from approximately 20 patients with CD70 positive RCC is planned by YE 2024.
Corporate Updates
Collaboration and Investment Agreements with AstraZeneca
On May 6, 2024, Cellectis announced the completion of the subsequent investment of $140M in Cellectis by AstraZeneca (LSE/STO/Nasdaq: AZN).
AstraZeneca subscribed for 10,000,000 "class A" convertible preferred shares and 18,000,000 "class B" convertible preferred shares, in each case at a price of $5.00 per convertible preferred share, issued by the board of directors of Cellectis.
AstraZeneca owns approximately 44% of the share capital and 30% of the voting rights of the Company (based on the number of voting rights currently outstanding).