Arix Bioscience PLC: Autolus presents additional AUTO3 data in DLBCL (1133459)

 
 Arix Bioscience PLC (ARIX) 
Arix Bioscience PLC: Autolus presents additional AUTO3 data in DLBCL 
 
18-Sep-2020 / 08:57 GMT/BST 
Dissemination of a Regulatory Announcement, transmitted by EQS Group. 
The issuer is solely responsible for the content of this announcement. 
 
                            Arix Bioscience plc 
 
              Autolus presents additional AUTO3 data in DLBCL 
 
LONDON, 18 September 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), announced new data highlighting progress on 
   AUTO3, the company's CAR T cell therapy being investigated in a Phase 1/2 
clinical trial in relapsed/refractory diffuse large B cell lymphoma (DLBCL), 
    during the European Society for Medical Oncology (ESMO) Virtual Congress 
                                               2020, beginning 18 September. 
 
            The announcement can be accessed on Autolus' investor website at 
         https://www.autolus.com/investor-relations [1] and full text of the 
announcement from Autolus is contained below. Autolus management will host a 
 conference call and webcast today at 8:00 am EDT/1:00 pm BST to discuss the 
         ESMO 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 [2]. 
 
[S] 
 
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 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. 
 
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 
                       ESMO Virtual Congress 2020 [3] 
 
? AUTO3 shows promise of a highly differentiated product profile 
 
Conference call and webcast to be held Friday, September 18, 2020 at 8:00 am 
                             EDT / 1:00 pm BST 
 
    LONDON, September 18, 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 clinical trial in relapsed/refractory diffuse 
      large B cell lymphoma (DLBCL), during the European Society for Medical 
              Oncology (ESMO) Virtual Congress 2020, beginning 18 September. 
 
  "Today we presented data from our recommended Phase 2 dose cohort from the 
      ALEXANDER trial of AUTO3, a CD19 and CD22 dual targeting CAR T product 
    candidate in DLBCL. The data support a best in class profile with a high 
 level of complete remissions and a well tolerated safety profile," said Dr. 
            Christian Itin, chairman and chief executive officer of Autolus. 
 
 "AUTO3 has a tolerable and very favorable safety profile when compared with 
       approved CD19 CAR T therapies," said Dr Craig Moskowitz, Professor of 
   Medicine at Miller School of Medicine, University of Miami Health System. 
   "It has a promising complete response rate of 64%, as demonstrated in the 
completed cohorts at the recommended Phase 2 dose range and, thus far, these 
      complete remissions also appear durable. Among all dose cohorts with a 
   median follow up of 6 months, 93% of the patients who achieved a complete 
                                                  response did not relapse." 
 
 As of the data cut-off date of August 3, 2020, 35 patients in the ALEXANDER 
  Phase 1/2 clinical trial of AUTO3 have been treated and were evaluable for 
safety. AUTO3 was well tolerated, with no Grade 3 or higher cytokine release 
   syndrome (CRS) with primary infusion and low rates of neurotoxicity (NT). 
 Across all 35 patients, only three cases of NT have been reported, with two 
  having >= Grade 3. Among the 20 patients treated at a dose of >= 150 x 106 
cells with pre-conditioning pembrolizumab on day minus 1 (D-1), which is the 
 declared recommended Phase 2 dose (RP2D), one patient experienced >=Grade 3 
NT (patient died due to disease progression and multiorgan failure). None of 
  the patients achieving a complete response (CR) experienced any NT and all 
cases of NT reported have been atypical in nature and seen in a setting with 
                                disease progression and confounding factors. 
 
    In terms of efficacy data, of the 35 patients dosed to date, 30 patients 
were evaluable within their completed cohort. The cohort receiving a dose of 
 >= 150 x 106 cells and pre-conditioning pembrolizumab D-1 (the RP2D) had an 
objective response rate (ORR) of 71% and CR rate of 64%. For all patients on 
    study across all dose levels that were evaluable, the ORR was 68% and CR 
                                                                rate of 54%. 
 
                                  Investor call on Friday September 18, 2020 
 
Management will host a conference call and webcast today at 8:00 am EDT/1:00 
      pm BST to discuss the ESMO 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 [4]. The 
     call may also be accessed by dialing [phone] for U.S. and Canada 
callers or [phone] for International callers. Please ask to be joined 
into the Autolus Therapeutics call. After the conference call, a replay will 
                              be available for one year on Autolus' website. 
 
                                              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 the efficacy, safety 
   and therapeutic potential of AUTO3 and the future clinical development of 
 AUTO3 including progress, expectations as to the reporting of data, conduct 
and timing. 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. These risks and uncertainties 
     include, but are not limited to, the risks that Autolus' preclinical or 
 clinical programs do not advance or result in approved products on a timely 
 or cost effective basis or at all; the results of early clinical trials are 
 not always being predictive of future results; the cost, timing and results 
     of clinical trials; that many product candidates do not become approved 
  drugs on a timely or cost effective basis or at all; the ability to enroll 
 patients in clinical trials; possible safety and efficacy concerns; and the 
         impact of the ongoing COVID-19 pandemic on Autolus' business. For a 
   discussion of other risks and uncertainties, and other important factors, 
       any of which could cause Autolus' 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 amended, as well as discussions 
  of potential risks, uncertainties, and other important factors in Autolus' 
         subsequent filings with the Securities and Exchange Commission. 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] 
 
                                   # # # 
 
ISIN:          GB00BD045071 
Category Code: MSCH 
TIDM:          ARIX 
LEI Code:      213800OVT3AHQCXNIX43 
Sequence No.:  84398 
EQS News ID:   1133459 
 
End of Announcement EQS News Service 
 
 
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(END) Dow Jones Newswires

September 18, 2020 03:57 ET (07:57 GMT)