Shares of Cellectis S.A. (NASDAQ: CLLS) saw a handy gain early on Wednesday after the firm announced preliminary data from its two Phase 1 studies in conjunction with Pfizer Inc. (NYSE: PFE) for adult and pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). This update came as part of a presentation at the American Society of Hematology (ASH) Annual meeting.
Ultimately, these first-in-human data demonstrated the safety and tolerability of UCART19, resulting in an 83% complete remission rate across the adult and pediatric patient population.
In terms of the breakdown, five out of seven patients treated achieved molecular remission at Day 28 post UCART19. Molecular remission is defined by negative minimal residual disease (MRD) and is a measurement of the number of residual leukemic cells that remain after treatment.
Reuben Benjamin, principal investigator of the CALM Study and Consultant Hematologist at King’s College Hospital, United Kingdom, commented:
These early results for UCART19 are very encouraging both in terms of manageable safety and the impressive complete molecular remission rate in these hard-to-treat adult patients with R/R B-ALL. This first cohort explored a lower dose of UCART19 that is approximately one tenth of that used in most autologous CAR-T trials. These results support additional evaluation of UCART19 at varying doses.
Separately, results from the PALL (Pediatric Acute Lymphoblastic Leukemia) study showed all five children achieved MRD negativity, enabling them to proceed to allogeneic stem cell transplant.
Excluding Wednesday’s move, Cellectis had outperformed the broad markets, with its stock up roughly 42% year to date. Over the past 52 weeks, the stock was up closer to 36%.
Shares of Cellectis were last seen up about 17% at $28.14, with a consensus analyst price target of $39.00 and a 52-week trading range of $16.32 to $35.07.
Pfizer traded at $36.74 a share. The stock has a 52-week range of $30.90 to $36.82 and a consensus price target of $38.24.