Autolus Aligns Pipeline Around Promising CAR T Cell Therapy Candidate
Autolus Therapeutics is going all-in on finding a viable treatment for Acute Lymphoblastic Leukemia (ALL), announcing on Wednesday that it will align its workforce and infrastructure around the development of its potentially transformational CAR T cell therapy candidate, AUTO1.
Based in London, England, Autolus is developing precisely targeted, highly active T cell therapies for the treatment of hematological cancers and solid tumors with unmet needs.
The company announced hopeful data from its ALLCAR Phase I trial of AUTO1 in relapsed/refractory adult B- Acute Lymphocytic Leukemia (ALL) at the American Society of Hematology (ASH) Annual Meeting and Exposition in December.
“We are very excited about the unique characteristics of AUTO1 that we reported at ASH in December 2020, with some patients continuing in molecular complete remission at 24 months without a subsequent transplant, an event-free survival of 52% at 12 months and a well-tolerated safety profile. Taking into consideration the high unmet need in adult ALL and the commercial opportunity this represents, we are prioritizing this program with potential pivotal data expected in 2022,” said Autolus Chairman and Chief Executive Officer, Dr. Christian Itin. “We also plan to capitalize on the differentiated profile of AUTO1 by exploring activity in additional B-cell malignancies, including Primary CNS Lymphoma (PCNSL) where no adequate standard of care currently exists. We expect to see first data from these additional indications in 2021.”
AUTO1, a CD19 CAR T cell investigational therapy designed to overcome safety limitations inherent in current treatments of its kind while maintaining similar efficacy levels, also has potential in pediatric ALL. Autolus has expanded the program with AUTO1/22 for this population and dosed the first patient in December 2020. Additional clinical data points are expected this year.
With the decision to rally resources around the AUTO1 program, Autolus will seek a partner for its AUTO3 program, a CD19 and CD22 dual targeting CAR T product candidate being investigated in relapsed/refractory diffuse large B cell lymphoma (DLBCL). The program is currently in phase I/II and Autolus will wait for a partnership before moving it further forward.
“Building on its differentiated clinical profile, we believe AUTO1 is well-positioned to deliver fundamental value for patients and shareholders. Our organizational focus will position us well to realize the potential of AUTO1 and lay the foundation for the next opportunities in our pipeline with several clinical proof of concepts targeted during 2021 and 2022,”Itin said.
The recalibration will also have workforce implications, including an overall workforce reduction of approximately 20 percent during Q1, 2021. When these operational changes are complete, Autolus hopes to achieve an annualized cash savings of around $15 million.
Changes have also been implemented at the executive level, as senior vice presidents, Dr. Adam Hacker and Dr. Nushmia Khokhar will leave the company during Q1, 2021. Former Senior Vice President of Product Delivery, David Brochu, will step up into the position of Chief Technical Officer with increased responsibilities. Autolus continues to search for a new Chief Medical Officer to take the AUTO1 program into the end zone.