On January 6, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, updated its business outlook, strengthening its focus on its potentially transformational CAR T cell therapy candidate, AUTO1, which is being investigated in relapsed / refractory adult B-Acute Lymphoblastic Leukemia (ALL) (Press release, Autolus, JAN 6, 2021, View Source [SID1234573697]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are very excited about the unique characteristics of AUTO1 that we reported at ASH (Free ASH Whitepaper) 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 Dr. Christian Itin, chairman and chief executive officer of Autolus. "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."
Additional clinical data points in 2021 are expected from AUTO1/22, a novel dual targeting CAR T cell based therapy candidate based on AUTO1, with the first pediatric ALL patient dosed in December 2020, and AUTO4 in Peripheral T Cell Lymphoma (PTCL), which will continue in 2021 through a dose escalation phase. Furthermore, the company continues to progress its pipeline of next generation programs, including for solid tumor indications, in collaboration with its academic partners.
With the prioritization of the AUTO1 program, the company plans to seek a partner for the AUTO3 program, its CD19 and CD22 dual targeting CAR T product candidate being investigated in relapsed/refractory diffuse large B cell lymphoma (DLBCL), before progressing the program into the next phase of development. In addition, through Q1 2021, the company will adjust its workforce and infrastructure footprint, which will involve an overall reduction in headcount of approximately 20%. The company expects to realize cash savings, on an annualized basis, of approximately $15 million per annum once the operational changes are fully implemented. Additionally, the company announced a reorganization of its management team. David Brochu was promoted to Chief Technical Officer (CTO) with expanded responsibilities from Senior Vice President, Product Delivery. Senior Vice Presidents Dr. Adam Hacker and Dr. Nushmia Khokhar will be leaving the company in Q1 2021. A search for a new Chief Medical Officer is ongoing.
"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," said Dr. Christian Itin, chairman and chief executive officer of Autolus.