Arix Bioscience plc Autolus presents initial AUTO3 clinical data at ASH

 
TIDMARIX 
 
Arix Bioscience plc 
 
              Autolus presents initial AUTO3 clinical data at ASH 
 
LONDON, 3 December 2018: Arix Bioscience plc (LSE:ARIX) ("Arix"), a global 
healthcare and life science company supporting medical innovation notes that 
its portfolio company, Autolus Therapeutics plc (NASDAQ: AUTL) ("Autolus"), 
announced updated results from its ongoing AUTO3 Phase 1/2 clinical trials in 
paediatric acute lymphoblastic leukemia (AMELIA trial) and diffuse large B cell 
lymphoma (ALEXANDER trial), presented at the 60th American Society of 
Hematology (ASH) Annual Meeting, San Diego, CA. 
 
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. 
 
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 
 
[phone] 
 
[e-mail] 
 
Burns McClellan (US Media & IR Enquiries) 
 
Bill Slattery Jr., Nancie Steinberg 
 
[phone] 
 
[e-mail] 
 
About Arix Bioscience plc 
 
Arix Bioscience plc is a global healthcare and life science company supporting 
medical innovation. Headquartered in London and with an office in New York, 
Arix Bioscience sources, finances and builds world class healthcare and life 
science businesses addressing medical innovation at all stages of development. 
Operations are supported by privileged access to breakthrough academic science 
and strategic relationships with leading research accelerators and global 
pharmaceutical companies. 
 
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 Initial AUTO3 Clinical Data from Phase 1/2 
     Clinical Trials in B cell Malignancies at the 60th ASH Annual Meeting 
 
  - Initial results were presented from ongoing Phase 1/2 trials in pediatric 
    acute lymphoblastic leukemia (AMELIA trial) and diffuse B cell lymphoma 
                              (ALEXANDER trial) - 
 
LONDON, December 2, 2018 -- Autolus Therapeutics plc (Nasdaq: AUTL), a 
clinical-stage biopharmaceutical company developing next-generation programmed 
T cell therapies, today highlighted updated results from its ongoing Phase 1/2 
AMELIA clinical trial of AUTO3 in patients with relapsed/refractory pediatric 
acute lymphoblastic leukemia (pALL) and its ongoing Phase 1/2 ALEXANDER 
clinical trial in patients with relapsed/refractory diffuse large B cell 
lymphoma (DLBCL) presented at the 60th American Society of Hematology (ASH) 
Annual Meeting, San Diego, California. AUTO3 is a dual-targeted therapy 
incorporating two separate chimeric antigen receptors (CARs).  Observations 
from preclinical studies indicate that AUTO3 independently targets CD19 and 
CD22. AUTO3 is designed to reduce relapse driven by antigen loss, a key defense 
mechanism used by the tumor cells and the primary cause of relapse in pALL. 
 
"The preliminary results of the AMELIA trial indicate that AUTO3, the first 
dual targeting CD19 and CD22 CAR T cell therapy under development for pediatric 
ALL, appears to have a manageable safety profile, with the potential to 
overcome target-negative relapse, a major limitation of current CD19-targeted 
therapies," said Professor Persis Amrolia, lead investigator and Consultant in 
Bone Marrow Transplant at Great Ormond Street Hospital (GOSH) and NIHR Research 
Professor of Transplantation Immunology at UCL Great Ormond Street Institute of 
Child Health (ICH). 
 
"In the ALEXANDER trial, preliminary results indicate that AUTO3 followed by 
consolidation with a limited duration of anti-PD1 therapy appears to have a 
manageable safety profile at the doses evaluated. This is the first therapy 
that aims to address two emerging resistance mechanisms for non-Hodgkin 
lymphoma, target-negative relapse and checkpoint upregulation," said Dr. Anas 
Younes, Chief, Lymphoma Service at Memorial Sloan Kettering Cancer Center. 
 
Simultaneous Targeting of CD19 and CD22: Phase 1 Trial of AUTO3, a Bicistronic 
Chimeric Antigen Receptor (CAR) T-cell Therapy, in Pediatric Patients with 
Relapse/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL): AMELIA 
Trial (Abstract Number 279, oral presentation at 8:00AM on Sunday, December 2, 
2018) 
 
Dr. Amrolia reported on 10 patients with relapsed or refractory ALL who 
received an AUTO3 infusion as a single dose or split dose dependent on their 
tumor burden. Key inclusion criteria included age 1-24 years old with relapsed 
or refractory B-lineage ALL at high risk in first relapse or in second or 
greater relapse. Prior targeted therapies to CD19 and CD22 were not excluded. 
The average age of the 10 evaluable patients was 8.5 years, the median number 
of prior lines of therapy was 3. Product was successfully manufactured for all 
patients.  AUTO3 was generally well tolerated with no ? Grade 3 CRS, no ICU 
admission, and no pressors or critical care support for CRS required. One case 
of Grade 3 neurotoxicity was observed which was considered unlikely related to 
AUTO3 and primarily attributed to prior intrathecal chemotherapy. Grade 3 or 
higher cytopenias lasting at least 30 days were noted in 4 out of 10 patients. 
Among the 10 evaluable patients at all dose levels, 8 out of 10 achieved MRD 
negative CR and higher response rates were observed at doses ?3 x106/kg dose 
levels with all patients achieving MRD-negative remission. In the higher dose 
group, 4 out of 6 (67%) patients have an ongoing molecular CR and importantly, 
no loss of CD19 or CD22 was noted among relapsed patients. Initial data 
indicates response rates and persistence are dose dependant. Dose escalation is 
ongoing. 
 
For more information about this trial and the inclusion criteria, visit 
www.ClinicalTrials.gov (NCT03289455). 
 
Trial of AUTO3, the First Bicistronic Chimeric Antigen Receptor (CAR) Targeting 
CD19 and CD22, Followed By Anti-PD1 Consolidation in Patients with Relapsed/ 
Refractory (r/r) Diffuse Large B Cell Lymphoma (DLBCL): Alexander Trial 
(Abstract Number 1679, poster presentation from 6:15 PM - 8:15PM on Saturday, 
December 1, 2018) 
 
Dr. Kirit Ardeshna, principal investigator at University College London, UK, 
reported preliminary clinical data on safety and efficacy from this open-label, 
multi?center trial in patients with DLBCL treated with a single dose of AUTO3 
followed by consolidation with anti-PD-1 antibody (pembrolizumab). Key 
inclusion criteria included histologically confirmed DLBCL, 
chemotherapy-refractory disease or relapse after at least two lines of therapy 
or after ASCT, and no prior allogeneic stem cell transplant. There were 7 
patients evaluable for safety with at least 28 day follow up post-treatment. 
The median number of prior lines of therapy in these 7 evaluable patients was 3 
(range was 2 to 4). All patients were treated at the starting dose of 50x106 
transformed CAR T cells. Three patients received a consolidation with 
pembrolizumab, and 4 patients did not receive treatment with pembrolizumab. 
None of the treated patients developed CRS grade 3 or higher and one patient 
had neurotoxicity grade 3, considered possibly related to AUTO3. No dose 
limiting toxicities were observed and dose escalation continues. Six patients 
were evaluable for response, two achieved a CR and two a PR; two patients did 
not respond. The two CRs were ongoing at six and three months, respectively. 
 
For more information about this trial and the inclusion criteria, visit 
www.ClinicalTrials.gov (NCT03287817). 
 
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 two 
clinical trials, referred to as the AMELIA and ALEXANDER trials. 
 
The AMELIA trial is a single-arm, open label, multi-center Phase 1/2 clinical 
trial of AUTO3 in patients up to 24 years of age with high-risk relapsed or 
refractory B-lineage. The trial also is enrolling patients who previously 
received CD19 or CD22 targeting therapies including other CAR T cell therapy. 
The primary objective for Phase 1 is to assess the safety and tolerability of 
AUTO 3 administration as well as to identify the Phase 2 dose and schedule. 
The purpose of this trial is to test the safety and efficacy, including the 
complete remission rate or minimal residual disease (MRD) negative response, of 
AUTO3. Autolus expects to enroll up to 54 patients in this trial. 
 
The ALEXANDER trial is a single-arm, open label, multi-center Phase 1/2 
clinical trial of AUTO3 in patients with relapsed or refractory diffuse large B 
cell lymphoma (DLBCL).  The primary objective for the Phase 1 portion is to 
assess the safety and tolerability of AUTO3 administration as well as to 
identify the recommended Phase 2 dose and maximum tolerated dose (MTD) of 
AUTO3. The purpose of this trial is to test the safety and efficacy, including 
the overall response rate as per Lugano criteria, of AUTO3 followed by limited 
duration of consolidation with anti-PD1 antibody. Autolus expects to enroll 
approximately 100 patients in this trial. 
 
For more information about these trials and the inclusion criteria, visit 
www.ClinicalTrials.gov. 
 
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. 
 
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 progress, timing and results 
of the company's clinical trials and the anticipated clinical development of 
the company's 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 the company's Annual 
Report on Form 20-F filed on November 23, 2018 as well as discussions of 
potential risks, uncertainties, and other important factors in the company's 
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. 
 
                                     # # # 
 
Investor contact: 
 
S.A. Noonan Communications 
 
Susan A. Noonan 
 
[phone] 
 
[e-mail] 
 
International Media Contact: 
 
JW Communications 
 
Julia Wilson 
[phone] 
 
[e-mail] 
 
U.S. Media Contact: 
 
Rx Communications Group, LLC 
 
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+ 1-917-322-2571 
 
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END 
 

(END) Dow Jones Newswires

December 03, 2018 02:00 ET (07:00 GMT)