Autolus is advancing its lead program, AUTO1 in relapsed/refractory adult acute lymphoblastic leukemia (ALL) patients, into a potential pivotal trial in the United Kingdom and the United States. During the year, the company also expects to report further clinical data across several programs at key medical conferences, including AUTO1 in adult ALL, AUTO1 in pediatric ALL, AUTO3 in diffuse large B cell lymphoma (DLBCL) and AUTO4 in Peripheral T cell lymphoma (PTCL). Additionally, Autolus expects to commence a Phase 1 clinical trial of AUTO1NG in pediatric ALL in the first half of 2020, plans for a go/no-go decision on Phase 2 initiation of AUTO3 in DLBCL in the middle of 2020, and expects to initiate two new Phase 1 clinical trials with next generation programs, AUTO6NG across certain solid tumor settings and AUTO8 in multiple myeloma, both in the second half of 2020.
Autolus will continue in 2020 to progress additional next generation programs through pre-clinical development and expand its suite of cell programming technologies to include programming modules designed for allogeneic applications. A first novel allogeneic application is expected to enter the clinic in the fourth quarter of 2020.
“2020 promises to be an exciting year for Autolus. We believe our lead program, AUTO1, has the potential to be the best-in-class CD19 CAR T in ALL and we are focused on advancing this program into a potential pivotal study,” said Dr. Christian Itin, chairman and chief executive officer of Autolus. “With AUTO3, based on preliminary data in DLBCL we reported at ASH last month, durable CRs were achieved with a good safety profile and are looking forward to completing the dose ranging phase of the trial. Additionally, we expect to report data from multiple clinical and pre-clinical programs.”
About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the anticipated development of Autolus’ product candidates, including its intentions regarding the timing for providing further updates on the development of its product candidates. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed on November 23, 2018 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' future filings with the Securities and Exchange Commission from time to time. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.
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Susan A. Noonan
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