Arix Bioscience plc Autolus presents additional AUTO3 data in DLBCL

 
TIDMARIX 
 
Arix Bioscience plc 
 
                Autolus presents additional AUTO3 data in DLBCL 
 
LONDON, 29 May 2020: Arix Bioscience plc (LSE:ARIX) ("Arix"), a global venture 
capital company focused on investing in and building breakthrough biotech 
companies, notes that its portfolio company Autolus Therapeutics plc 
("Autolus") (Nasdaq: AUTL), today announced new data highlighting progress on 
AUTO3, the Autolus CAR T cell therapy being investigated in a Phase 1/2 study 
in relapsed/refractory diffuse large B cell lymphoma (DLBCL), during the Annual 
Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program beginning 
May 29. 
 
The announcement can be accessed on Autolus' investor website at https:// 
www.autolus.com/investor-relations and full text of the announcement from 
Autolus is contained below. Management will host a conference call and webcast 
at 8:30 am EDT/1:30 pm BST on 1st June 2020 to discuss the ASCO data. To listen 
to the webcast and view the accompanying slide deck, please go to: https:// 
www.autolus.com/investor-relations/news-and-events/events 
 
[ENDS] 
 
Enquiries 
For more information on Arix, please contact: 
 
Arix Bioscience plc 
Charlotte Parry, Head of Investor Relations 
[phone] 
[e-mail] 
 
Optimum Strategic Communications 
Mary Clark, Supriya Mathur, Shabnam Bashir 
[phone] 
[e-mail] 
 
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 to help accelerate their ideas into 
important new treatmentsfor patients. As a listed company, we are able to bring 
this exciting growth phase of our industry to a broader range of investors. 
 
Arix Bioscience plc is listed on the Main Market of the London Stock Exchange. 
For further information, please visit www.arixbioscience.com 
 
  Autolus Therapeutics presents additional data on AUTO3 in DLBCL during the 
                       ASCO20 Virtual Scientific Program 
 
   - Data continue to show encouraging clinical activity alongside tolerable 
    safety to deliver a potentially highly differentiated product profile - 
 
Conference call and webcast to be held Monday, June 1, 2020 at 8:30 am EDT / 1: 
30 pm BST 
 
LONDON, May 29, 2020 -- Autolus Therapeutics plc (Nasdaq: AUTL), a 
clinical-stage biopharmaceutical company developing next-generation programmed 
T cell therapies, today announced new data highlighting progress on AUTO3, the 
company's CAR T cell therapy being investigated in the ALEXANDER study, a Phase 
1/2 study in relapsed/refractory diffuse large B cell lymphoma (DLBCL), during 
the Annual Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific 
Program beginning May 29. 
 
"Data from the ALEXANDER trial of AUTO3, a CD19/CD22 dual-targeting CAR T 
product candidate in DLBCL have shown a complete response rate of 63% at the 
recommended Phase 2 dose range with an excellent safety profile," said Dr. 
Aravind Ramakrishnan, Medical Director, Bone Marrow Transplant and Cellular 
Therapy Program, Sarah Cannon Blood Cancer Center at St. David's South Austin 
Medical Center. "We are encouraged by the current study results and have begun 
enrollment in an outpatient cohort to assess how this approach may benefit a 
greater population of DLBCL patients." 
 
As of the data cut-off date of April 27, 2020, 23 patients in the ALEXANDER 
Phase 1/2 clinical trial of AUTO3 were evaluable for safety and efficacy with a 
minimum of 28-days follow-up.  AUTO3 was well tolerated, with no patients 
experiencing dose limiting toxicity, and there were no treatment-related 
deaths. At a dose of ? 150 x 106 cells across the 2 dosing regimens for 
pembrolizumab, a single dose of pembrolizumab on day minus 1 (D-1) or three 
doses of pembrolizumab starting on day 14 (D14), no patient experienced Grade 3 
or higher Cytokine Release Syndrome (CRS) and no patient experienced 
neurotoxicity of any grade. At these doses, 11 out of 16 patients achieved a 
complete or partial response (ORR=69%), and 9 out of 16 achieved a complete 
response (CRR=56%) with all 9 complete responses ongoing at a median follow-up 
of 3 months (range 1-12 months). Additionally, at the recommended Phase 2 dose 
range of 150 - 450 x 106 cells with pembrolizumab D-1, 6 out of 8 patients 
achieved a complete response or partial response (ORR=75%), and 5 out of 8 
patients achieved a complete response (CRR=63%). 
 
"We are very pleased with the progression of AUTO3 in DLBCL, combining a high 
level of complete remissions with a safety profile supportive of outpatient 
use. We have not seen early relapses from complete remissions and are in the 
process of confirming the profile at the recommended Phase 2 regimen. Our 20 
patient outpatient cohort has started, and the results are expected for the 
second half of 2020 and will further inform the design of the Phase 2 study," 
said Dr. Christian Itin, chairman and chief executive officer of Autolus. 
 
Investor call on Monday June 1, 2020 
 
Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST 
to discuss the ASCO data. To listen to the webcast and view the accompanying 
slide presentation, please go to:  https://www.autolus.com/investor-relations/ 
news-and-events/events. 
 
The call may also be accessed by dialing [phone] for U.S. and Canada 
callers or [phone] for international callers. Please reference 
conference ID 4880556. After the conference call, a replay will be available 
for one week. To access the replay, please dial [phone] for U.S. and 
Canada callers or [phone] for international callers. Please reference 
conference ID 4880556. 
 
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. For more information please visit www.autolus.com. 
 
About AUTO3 
 
AUTO3 is a programmed T cell therapy containing two independent chimeric 
antigen receptors targeting CD19 and CD22 that have each been independently 
optimized for single target activity. By simultaneously targeting two B cell 
antigens, AUTO3 is designed to minimize relapse due to single antigen loss in 
patients with B cell malignancies. AUTO3 is currently being tested in diffuse 
large B cell lymphoma in the ALEXANDER clinical trial, with a 20-patient cohort 
that was initiated in Q2 2020 to assess feasibility of treatment in an 
outpatient setting. 
 
Forward-Looking Statements 
 
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 Autolus' financial condition and 
results of operations, including its expected cash runway; the development of 
Autolus' product candidates, including statements regarding the timing of 
initiation, completion and the outcome of pre-clinical studies or clinical 
trials and related preparatory work, and the periods during which the results 
of the studies and trials will become available; Autolus' plans to research, 
develop, manufacture and commercialize its product candidates; the potential 
for Autolus' product candidates to be alternatives in the therapeutic areas 
investigated; and Autolus' manufacturing capabilities and strategy. 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 with the 
Securities and Exchange Commission on March 3, 2020 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. 
 
Contact: 
 
Lucinda Crabtree, PhD 
Vice President, Investor Relations and Corporate Communications 
[phone] 
[e-mail] 
 
Julia Wilson 
[phone] 
 [e-mail] 
 
Susan A. Noonan 
S.A. Noonan Communications 
[phone] 
[e-mail] 
 
 
 
END 
 

(END) Dow Jones Newswires

May 29, 2020 08:06 ET (12:06 GMT)