LONDON, December 3, 2018 /PRNewswire/ --
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
+44(0)20-7290-1072
charlotte@arixbioscience.com
Optimum Strategic Communications
Mary Clark, Supriya Mathur
+44(0)203-714-1787
optimum.arix@optimumcomms.com
Burns McClellan (US Media & IR Enquiries)
Bill Slattery Jr., Nancie Steinberg
+1-212-213-0006
arix@burnsmc.com
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
http://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) -
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 paediatric 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 Paediatric 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
x10[6]/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 http://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
50x10[6] 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 http://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 http://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
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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,
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