Arix Bioscience PLC (ARIX)
Arix Bioscience plc
Autolus Therapeutics presents positive obe-cel data at the American Society of Hematology (ASH) Annual Meeting 2021
LONDON, UK, 13 December 2021: Arix Bioscience plc ("Arix", LSE:ARIX), a global venture capital company focused on investing in and building breakthrough biotech companies, notes that its portfolio company, Autolus Therapeutics plc (Nasdaq: AUTL), today announced the presentation of new data on obe-cel (AUTO1) and AUTO1/22 at the American Society of Hematology (ASH) Annual Meeting, being held between December 11-14, 2021.
At the meeting, Autolus reported the following:
Autolus management held a conference call and webcast earlier today at 8:00 am ET/1:00 pm GMT to discuss the ASH data. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus' website https://www.autolus.com/
Full text of the announcement from Autolus is contained below and can also be accessed on Autolus' website.
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Arix Bioscience plc
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About Arix Bioscience plc
Arix Bioscience plc is a global venture capital company focused on investing in and building breakthrough biotech companies around cutting-edge advances in life sciences.
We collaborate with exceptional entrepreneurs and provide the capital, expertise and global networks o help accelerate their ideas into important new treatments for patients. As a listed company, we are able to bring this exciting growth phase of our industry to a broader range of investors. www.arixbioscience.com
AUTOLUS PRESS RELEASE
Autolus Therapeutics presents positive obe-cel data at the 63rd ASH Annual Meeting & Exposition
Conference Call and Webcast to be held Monday, Dec 13, 2021 at 8:00 am ET / 1:00 pm GMT
LONDON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, presented further progress on obecabtagene autoleucel (obe-cel) in an oral presentation [Abstract 477] entitled "Industrialization of an Academic Miltenyi Prodigy-Based CAR T Process" at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, being held between December 11-14, 2021. The Company also presented an update of obe-cel in relapsed/refractory aggressive and indolent B-Cell Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic Leukaemia (CLL) patients from the ALLCAR19 extension study, as well as preclinical and initial engraftment data with AUTO1/22 in Pediatric ALL in two separate poster presentations [Abstracts 3823 and 1710, respectively].
"We continue to observe sustained responses with obe-cel, with an EFS of 46% at 24 months and patients approaching up to 42 months of durability in the ALLCAR-19 study, supporting the curative potential of obe-cel as a standalone therapy in r/r B-ALL patients. Furthermore, we were encouraged to observe comparable safety and high complete response data between patients treated in the academic ALLCAR19 study and those in the Phase 1b portion of the Autolus sponsored FELIX study," said Dr. Christian Itin, chief executive officer of Autolus. "In addition, we are excited to observe further positive data for obe-cel in r/r B-NHL and B-CLL patients, as well as compelling initial data for AUTO1/22, pointing to the potential for indication expansion and life cycle management opportunities longer term."
Obe-cel in Adult Acute Lymphoblastic Leukemia patients (FELIX study)
Initial experience in the phase 1b portion of the FELIX 1b/2 study (NCT04404660) resulted comparable results as seen in the Phase 1 ALLCAR19 study. As of the cut-off date of 13 September, 16 patients in the Phase 1b part of the FELIX study had received obe-cel. Patient characteristics in the FELIX 1b portion were broadly comparable to those observed in the ALLCAR19 study in r/r adult B-ALL.
The company expects to present data from the Phase 2 portion of the FELIX study in 2022.
1 Roddie et al. "Durable responses and low toxicity after fast off-rate CD19 CAR-T therapy in adults with relapsed/ refractory B-ALL." DOI: 10.1200/JCO.21.00917 Journal of Clinical Oncology - published online before print August 31, 2021
Obe-cel (AUTO1) in Adult Acute Lymphoblastic Leukemia patients (ALLCAR study)
As of the data cut-off date of October 15, 2021, 15 r/r B-NHL and 1 B-CLL patient had received obe-cel with 14 patients evaluable for response.
The company expects to present further data from more B-NHL and CLL patients in H1 2022.
AUTO1/22 in Pediatric Acute Lymphoblastic Leukemia patients (CARPALL)
Obe-cel had previously been tested in r/r pediatric B-ALL2 in the CARPALL Study. Whilst obe-cel was safe and effective, similar to other studies in pediatric B-ALL, antigen escape was a common cause of treatment failure. AUTO1/22 has been designed to address antigen escape by the co-expression of a CD22 CAR with the CD19 CAR in obe-cel. Pre-clinical data demonstrated a high level of in vitro and in vivo activity of AUTO1/22 against leukemia cells. AUTO1/22 was shown to control leukemia in a mouse model of CD19 negative escape. AUTO1/22 is currently being tested in a study of r/r pediatric B-ALL. As of the cut-off date of October 21, 2021, 6 patients had received AUTO1/22. All patients showed engraftment of single and double CAR positive populations, pointing to early CAR T cell persistence. We expect to present clinical data from the full cohort of patients in H1 2022.
2 Ghorashian et al. "Enhanced CAR T cell expansion and prolonged persistence in pediatric patients with ALL treated with a low-affinity CD19 CAR." Nature Medicine volume 25, pages1408-1414(2019) (Sept 25, 2019)
Investor call details
The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 9036269. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 9036269.
About Autolus Therapeutics plc
About obe-cel (AUTO1)
About obe-cel FELIX clinical trial
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