UCART CS1 / UT MD Anderson Cancer Center, Cellectis - LARVOL DELTA

Preclinical activity of allogeneic SLAMF7-specific CAR T-cells (UCARTCS1) in multiple myeloma. (PubMed, J Immunother Cancer) - "These results demonstrate that UCARTCS1 has potent anti-MM activity against MM cell lines and primary MM cells, as well as in an MM xenograft model and support the evaluation of UCARTCS1 in patients with advanced MM."

CAR T-Cell Therapy • IO biomarker • Journal • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • SLAMF7

Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01) (clinicaltrials.gov) - P1 | N=11 | Terminated | Sponsor: Cellectis S.A. | N=18 ➔ 11 | Trial completion date: Dec 2024 ➔ Jun 2023 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Jun 2023; The trial was discontinued due to sponsor's decision and not a consequence of any safety concern.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

Cellectis Provides Business Update and Reports Financial Results for First Quarter 2023 (GlobeNewswire) - "To accelerate the speed of enrollment of patients in the MELANI-01 study, the Company would have had to invest meaningful amount of resources. To optimize its resources, the Company decided to focus its development efforts on the BALLI-01, AMELI-01 and NATHALI-01 studies and therefore to stop enrollment and treatment of patients in the MELANI-01 study."

Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

Cellectis enters into warrant agreement with the European Investment Bank related to credit facility agreement and announces the drawdown of the first tranche of €20 million (GlobeNewswire) - "The Company plans to use the proceeds of Tranche A towards the development of its pipeline of allogeneic CAR T-cell product candidates: UCART22, UCART20x22, UCART123 and UCARTCS1."

Commercial • Oncology

Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01) (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Cellectis S.A. | Trial primary completion date: Dec 2023 ➔ Jun 2024

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Cellectis Announces Closing of Global Offering and Exercise of Underwriters’ Option to Purchase Additional Shares (GlobeNewswire) - "The Company plans to use (i) approximately $17.0 million (€15.6 million) of the net proceeds of the Global Offering to fund the continued clinical development of UCART 123, UCART22, UCART20x22, and UCARTCS1, and (ii) any remainder for working capital and other general corporate purposes."

Commercial • Oncology

Cellectis Announces Pricing of Follow-On Offering (Cellectis Press Release) - "Cellectis plans to use (i) approximately $17.0 million (€15.6 million) of the net proceeds of the Global Offering to fund the continued clinical development of UCART 123, UCART22, UCART20x22, and UCARTCS1, and (ii) any remainder for working capital and other general corporate purposes."

Commercial • Oncology

Cellectis secures a €40 million credit facility from the European Investment Bank to support its Research, Development and Innovation activities (GlobeNewswire) - "The credit facility will enable Cellectis to support the development of its UCART product candidates pipeline. The credit facility consists of three tranches of €20 million, €15 million, and €5 million respectively, each redeemable in fine in 6 years. The credit facility is part of the European Investment Bank’s strategy to support biotech companies developing a high-level of expertise in various therapeutic areas with significant unmet medical need. Cellectis...announced that it has entered into a €40 million credit facility agreement with the European Investment Bank ('EIB') (the 'Finance Contract'). The Company plans to use the facility toward the development of its pipeline in the field of allogeneic CAR T-cell product candidates, UCART22, UCART20x22, UCART123 and UCARTCS1."

Financing • Oncology

Cellectis Announces Positive Preliminary Clinical Data for UCART22 in ALL and UCART123 in AML (GlobeNewswire) - "Cellectis is enrolling patients at dose level 1 (1.0x106 cells/kg) with a fludarabine and cyclophosphamide (FC) lymphodepletion regimen in the MELANI-01 Phase 1 dose-escalation clinical study of UCARTCS1 for patients with relapsed or refractory multiple myeloma (MM)...On December 10, 2022, the Amsterdam University Medical Center (VUmc location), in collaboration with Cellectis, presented preclinical data in a poster session showcasing Cellectis’ UCARTCS1 product candidate. These initial preclinical data demonstrated anti-tumor activity in vitro and in vivo, supporting the potential benefit of Cellectis’ UCARTCS1 first in-human study MELANI-01. Collectively, the preclinical data demonstrated that UCARTCS1 has potent anti-MM activity against MM cell lines and primary MM cells, as well as in a MM xenograft model. These preclinical data support the ongoing Phase 1 clinical trial with UCARTCS1 in heavily pretreated multiple myeloma patients."

Preclinical • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Cellectis Provides Business Update and Reports Financial Results for Third Quarter and First Nine Months 2022 (GlobeNewswire) - "...Cellectis in collaboration with the Amsterdam University Medical Center (VUmc) announced the release of an abstract on product candidate UCARTCS1, which was accepted for poster presentation at the ASH 2022 Annual Meeting. The abstract includes preclinical data evaluating in vitro activity of UCARTCS1 against multiple myeloma (MM) cell lines and bone marrow samples from MM patients, as well as in vivo activity in a MM mouse model....The preclinical data that will be presented demonstrate anti-tumor activity in vitro and in vivo supporting the potential benefit of our UCARTCS1 first in-human study, MELANI-01....Presentation will occur on Saturday, December 10, 2022..."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01) (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Cellectis S.A. | Trial completion date: Nov 2022 ➔ Dec 2024 | Trial primary completion date: May 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Cellectis Provides Business Objectives for 2022 and Updates its Corporate Presentation (GlobeNewswire) - "Cellectis 2022 expected milestones: UCART Clinical Development Programs - (i) 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; (ii) 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; (iii) MELANI-01 (for UCARTCS1): Cellectis targets to enroll patients at Dose Level 1 (DL1) with Fludarabine and Cyclophosphamide (FC) preconditioning regimen."

Enrollment status • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01) (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Cellectis S.A.; Trial primary completion date: Nov 2022 ➔ May 2022

Clinical • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

FDA Lifts Clinical Hold on MELANI-01 Trial With CAR T Product UCARTCS1 in Myeloma (OncLive) - "The FDA has decided to lift the clinical hold placed on the phase 1 MELANI-01 trial (NCT04142619), which is examining the CAR T-cell therapy UCARTCS1 as a treatment for patients with relapsed/refractory multiple myeloma, according to Cellectis, the manufacturer of the product....The trial was initiated under the guidance of Krina K. Patel, MD, MSc...David Siegel, MD...is leading the effort at Hackensack Meridian..."

Regulatory

Cellectis Provides Business Update and Reports 4th Quarter and Full Year 2020 Financial Results (GlobeNewswire) - "Our MELANI-01 clinical study for patients with relapsed or refractory multiple myeloma (r/r MM) has restarted patient enrollment. We are planning to share selected updated interim data in 2021."

Enrollment status • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01) (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Cellectis S.A.; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

FDA Lifts Clinical Hold on MELANI-01 Study Evaluating Cellectis’ Product Candidate UCARTCS1 in Multiple Myeloma (GlobeNewswire) - "Cellectis...announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1 MELANI-01 trial evaluating the UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM). Cellectis worked closely with the FDA over the past months, to address the agency’s requests, which include adjustments to the MELANI-01 clinical protocol designed to enhance patient safety. Cellectis continues to work with the clinical site staff and investigators to efficiently obtain the required local approvals to reopen the trial and resume patient enrollment."

FDA event • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01) (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: Cellectis S.A.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

Second Cellectis CAR-T Therapy On Clinical Hold, Dosing Could Be Issue (Scripintelligence) - "A Phase I study for allogeneic therapy UCARTCS1A was put on clinical hold after a patient died. High dosing and double exposure to cyclophosphamide pre-conditioning may have played a role."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Cellectis Reports Clinical Hold Placed on MELANI-01 Study (GlobeNewswire) - "Cellectis...today announced that the MELANI-01 trial has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). This clinical hold which impacts one of the three Cellectis product candidates currently in clinical studies, was initiated following the submission of a safety report regarding one patient enrolled in the MELANI-01 study at dose level two (DL2), with relapsed and refractory multiple myeloma."

FDA event • Hematological Malignancies • Multiple Myeloma • Oncology

"Last time I heard about $CLLS UCARTCS1. Not sure how UCARTCS1A (now on US clinical hold) differs." (@JacobPlieth)

Clinical

Cellectis provides business update and reports financial results for first quarter 2020 (GlobeNewswire, Cellectis Inc.) - "During the first quarter of 2020, we continued to enroll patients in our three proprietary Phase 1 dose escalation trials, AMELI-01 evaluating UCART123 in relapsed/refractory (R/R) acute myeloid leukemia, BALLI-01 evaluating UCART22 in R/R B-cell acute lymphoblastic leukemia and MELANI-01 evaluating UCARTCS1 in R/R multiple myeloma. At the time of this update, all three clinical trials continue to progress through their respective dose levels...We plan to share preliminary data on our programs by the end of this year likely around the time of relevant scientific meetings, provided the enrollment of new patients and ability to conduct patient follow-up would not be significantly adversely impacted by the COVID-19 situation."

Enrollment status • P1 data • Infectious Disease • Oncology

Cellectis Provides business update and reports 4th quarter and full year 2019 financial results (Businesswire) - "Enrollment ongoing in Phase 1 dose-escalation trials AMELI-01 in r/r AML patients, BALLI-01 in r/r B-ALL patients and MELANI-01 in r/r MM patients...Cellectis is planning on filing a protocol amendment with the US FDA to evaluate the addition of alemtuzumab to the lymphodepletion regimen compared to the current regimen with UCART22 in B-ALL."

Clinical protocol • Enrollment status

Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01) (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Cellectis S.A.

Clinical • New P1 trial

Cellectis Reports financial results for third quarter and first nine months 2019 (Businesswire) - "First patient dosed with UCARTCS1 in MELANI-01 Phase 1 dose-escalation clinical trial for Relapsed/Refractory Multiple Myeloma; Patient screening ongoing with UCART22 in BALLI-01 Phase 1 dose-escalation clinical trial for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia; Grant of a new IND for UCART123 following a change in production process and site initiation ongoing for AMELI-01 Phase 1 dose-escalation clinical trial for Relapsed/Refractory Acute Myeloid Leukemia."

Enrollment open • IND • Trial status