After a brief stumble with UCART123 that resulted in a clinical hold last year, Cellectis is moving on with its study.
Andre Choulika is excited about the future of CAR-T therapies and where his company Cellectis fits into the space.
During the week of the recent J.P. Morgan Healthcare Conference, Choulika said the excitement that he is feeling was shared by so many, particularly given the recent approval of Novartis’ and Kite Pharma’s CAR-T treatments. Additionally, Choulika said the rumors of Celgene’s interest in acquiring its partner Juno Therapeutics (which has since become official) added fuel to the fire.
“That shows there’s great interest from large companies over CAR-T technology,” Choulika said in an exclusive interview with BioSpace. “But, that shouldn’t be surprising. It’s not surprising. It’s one of the most important paradigm shifts in the field of medicine in the past 20 years. Using a cell as a cancer-killing machine inside the body is something that’s a real paradigm shift.”
What’s going on with immuno-oncology is something he believes will provide momentum for Cellectis throughout 2018 as it looks to move its off-the-shelf CAR-T products toward regulatory approval. Choulika said the 2017 CAR-T approvals “pave the way for other strategies in the CAR-T space.” He hopes that Cellectis’ UCART123 and UCART19, which is being developed with Servier and Pfizer, will become one of those future strategies.
During the American Society of Hematology meeting in December 2017, Cellectis presented preliminary results from two Phase I studies of UCART19 in adult and pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). Data showed patients on UCART19 achieved an 83 percent complete remission rate.
“That was very striking data,” Choulika said.
Choulika said he expects additional data on UCART19 later this year. Another milestone Choulika hopes to see this year is with UCART123, a product solely owned by Cellectis.
After a brief stumble with UCART123 that resulted in a clinical hold last year, Cellectis is moving on with its study. In November, the U.S. Food and Drug Administration released its hold on two Phase I trials. Cellectis is exploring its use as a treatment for acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA clinical hold came after the death of the first patient in the BPDCN study died. The patient died after he experienced a grade 2 cytokine release syndrome (CRS) and a grade 3 lung infection.
Cellectis was allowed to continue the trial after agreeing to lower the dose of UCART123, Choulika said. He said they will have to learn if they can re-escalate the dosage, but added that the fact the FDA lifted the hold indicates there is promise the drug that it can move forward in the clinic.
In addition to advances in UCART123 and UCART19, Choulika said the company anticipates filing an Investigational New Drug Application for UCART22 for non-Hodgkin’s lymphoma later this year. The company has hopes this CART will be able to treat patients who have relapsed. Choulika said the belief is UCART22 will provide a second chance for patients who have not previously responded to CART treatments. They expect a trial to begin in the second half of the year, Choulika said.
By 2019, Cellectis hopes to have a fourth CART in the clinic. UCARTCS1 will be developed for multiple myeloma.
Not only is Cellectis moving forward with its pipeline, the company closed out 2017 by shoring up its leadership. In December, Cellectis tapped Elsy Boglioli as executive vice president in charge of strategy and corporate development, and Stéphane Depil to serve as chief medical officer to helm the company’s research and development division. Choulika said he believes they now have “the keys in place” to carry the company forward. Regarding the hiring of Depil, Choulika said bringing him on board will “change the power” of the company when it comes to designing sophisticated clinical trials and speeding up patient enrollment in future trials.
“Both of the hires are young and dynamic people who will change the shape of the company. I think they’re inspiring people. I like to work with inspiring people and they have a lot of things that I don’t have,” Choulika said.
As Cellectis moves into 2018, Choulika said each of the company’s teams is “laser focused” on its priorities. The clinical team is focusing all attention on UCART123 to bring the product to the patient and the regulatory team is focused on filing the IND for UCART22.
“Each team has one singular focus for the transformation of the company. The goal at the end is to grow the size of the company. We have to remain focused in order to meet those goals,” Choulika said.
