Syncona upbeat on latest data from Autolus Therapeutics

Syncona shares were just above the waterline on Monday morning, after two updates from its portfolio company Autolus Therapeutics, in which it announced new data at the American Society of Hematology (ASH) annual meeting in Orlando, Florida.

The FTSE 250 company said that in the first Autolus announced new data highlighting progress on its next-generation programmed T cell therapies to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and pediatric acute lymphoblastic leukemia (ALL).

"DLBCL is an aggressive and rapidly progressing cancer, and early response is critical to ensuring positive outcomes for these patients,” said Autolus chairman and chief executive officer Christian Itin.

“The data from the AMELIA trial of AUTO3 in pediatric ALL has informed us on the encouraging role of dual antigen targeting in reducing target-negative relapses and delivering high levels of complete molecular remission with well-tolerated safety.

“We look forward to advancing AUTO3 to a decision point in relapsed/refractory DLBCL by the mid-point of next year.”

Autolus said in the study, AUTO3 was well-tolerated, with no patients experiencing more than grade 3 cytokine release syndrome (CRS) with primary infusion and one of 14 experiencing grade 3 neurotoxicity that resolved swiftly with steroids.

It said there were no pembrolizumab immune-related toxicities, and the majority of grade 3 or higher adverse events were hematological.

Low levels of serum cytokines were said to be consistent with the observed low levels of CRS and neurotoxicity.

Across all tested doses, five patients achieved a complete response, with four of five complete responses ongoing - the longest at 18 months.

All complete responses were achieved without the need for steroid or tocilizumab-based management of the patients or intensive care unit-level care.

In the second update, Autolus Therapeutics said the data presented formed the basis for the advancement of the AUTO1 programme into a pivotal clinical trial in adult ALL, with initiation of the pivotal programme targeted for the first half of 2020.

“The data on AUTO1 presented at this year's ASH meeting demonstrate the favorable safety profile and high level of clinical activity of AUTO1 in both adults and pediatric patients with ALL, and we look forward to initiation of the pivotal program in adult ALL in the first half of 2020," said Dr Christian Itin.

Autolus said as of the data cut-off date of 25 November, 16 patients had received at least one dose of AUTO1.

AUTO1 was said to have been well tolerated, with no patients experiencing more than grade 3 cytokine release syndrome, and three of 16 patients who had high leukemia burden experiencing grade 3 neurotoxicity, which resolved “swiftly” with steroids.

Of 15 patients evaluable for efficacy, 13 achieved MRD negative complete response at one month, and all patients had ongoing CAR T cell persistence at last follow up.

CD19-negative relapse occurred in 22%, or two of 15, patients.

In the patients dosed with AUTO1 manufactured in the closed process, nine of nine achieved MRD negative complete response at one month and six months event free survival, and overall survival in that cohort was 100%.

At 0913 GMT, shares in Syncona were up 0.92% at 220p.