Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, announces publication of AUTO6 (1RG-CAR T) Phase 1
data in Science Translational Medicine. AUTO6 is a second
generation GD2-targeting CAR T candidate, developed in
collaboration with UCL, and the trial was sponsored and run by
Cancer Research UK’s Centre for Drug Development.
These new results highlight that AUTO6 can
induce rapid regression of bulky disease in a solid tumor setting
without inducing on-target off-tumor toxicity, despite dose
dependent CAR T expansion. CAR T cell expansion was observed in all
six patients treated at the higher cell dose cohorts in this Phase
1 study. Three of these six patients demonstrated evidence of
transient CAR T cell activity, including cytokine release syndrome,
and regression of soft tissue and bone marrow disease activity. The
GD2 binder used in AUTO6 has been designed to minimize on-target
off-tumor neurotoxicity associated with GD2 expression at low
levels in pain fibers and the brain. Despite the presence of clear
CAR T cell activity, no neurotoxicity was observed. The publication
also suggests that, whilst AUTO6 is a valid and safe strategy for
targeting neuroblastoma, further modifications are required to
promote CAR T cell persistence and induce deeper and more durable
responses for these patients.
“We are encouraged by the anti-tumor activity in
neuroblastoma, a disease where there are limited therapeutic
options for children with relapsed or refractory disease,” said Dr
Karin Straathof, Consultant Paediatric Oncologist and research
group leader at UCL Great Ormond Street Institute for Child Health.
“This is of particular importance as this activity was observed in
the absence of neurotoxicity which occurs with antibody-based
approaches that target GD2.”
Nigel Blackburn, director of drug development at
Cancer Research UK, said, “Children who have hard to treat, or
relapsed cancer have limited treatment options open to them, and
early results of AUTO6 are encouraging. We look forward to seeing
the next steps in the development of AUTO6NG, and if the treatment
has durable effects in neuroblastoma.”
“This is amongst the clearest data which
demonstrate that CAR T cells can be highly active against advanced
solid cancers,” said Dr Martin Pule, CSO and founder of Autolus and
director of the UCL CAR T programme. “It is encouraging that highly
active CAR T cells do not cause on-target off-tumor neurotoxicity
and the findings represent an important step in our ongoing efforts
to develop CAR T cell therapies for solid cancers.”
These data support Autolus’ continued
development of AUTO6NG, which builds on this approach utilizing the
same GD2 CAR alongside additional programming modules designed to
enhance efficacy and persistence. Earlier this year at the American
Association for Cancer Research (AACR) meeting, Autolus announced a
preclinical data update demonstrating the validity of GD2 as a CAR
T target in small cell lung cancer (SCLC) and the ability of
Autolus’ efficacy-enhancing modules to drive in vivo efficacy in an
SCLC mouse model. The data also suggested AUTO6NG can overcome the
immune suppressive mechanisms in the tumor microenvironment.
Autolus plans to test AUTO6NG in a Phase 1 study in 2021.
About Autolus Therapeutics
plcAutolus 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 defence mechanisms and eliminate these cells. Autolus has a
pipeline of product candidates in development for the treatment of
haematological malignancies and solid tumors. For more information
please visit www.autolus.com.
About UCL Business PLCUCL
Business PLC (UCLB) is a leading technology transfer company that
supports and commercialises research and innovations arising from
UCL, one of the UK’s top research-led universities. UCLB has a
successful track record and a strong reputation for identifying and
protecting promising new technologies and innovations from UCL
academics. UCLB has a strong track record in commercialising
medical technologies and provides technology transfer services to
UCL’s associated hospitals; University College London Hospitals,
Moorfields Eye Hospital, Great Ormond Street Hospital for Children
and the Royal Free London Hospital. It invests directly in
development projects to maximise the potential of the research and
manages the commercialisation process of technologies from
laboratory to market. For further information, please
visit: www.uclb.com Twitter: @UCL_Business
About Cancer Research UK
- Cancer Research UK is the world’s leading cancer charity
dedicated to saving lives through research.
- Cancer Research UK’s pioneering work into the prevention,
diagnosis and treatment of cancer has helped save millions of
lives.
- Cancer Research UK has been at the heart of the progress that
has already seen survival in the UK double in the last 40
years.
- Today, 2 in 4 people survive their cancer for at least 10
years. Cancer Research UK’s ambition is to accelerate progress so
that by 2034, 3 in 4 people will survive their cancer for at least
10 years.
- Cancer Research UK supports research into all aspects of cancer
through the work of over 4,000 scientists, doctors and nurses.
- Together with its partners and supporters, Cancer Research UK's
vision is to bring forward the day when all cancers are cured.
For further information about Cancer Research
UK's work or to find out how to support the charity, please call
0300 123 1022 or visit www.cancerresearchuk.org. Follow us
on Twitter and Facebook.
About
NeuroblastomaNeuroblastoma is the
most common solid tumor in children that occurs outside of the
brain and makes up 8% of the total number of children’s cancers.
The site of origin is either in one of the two adrenal glands
situated in the abdomen or in nerve tissue that runs alongside the
spinal cord, in the neck, chest, abdomen or pelvis. The adrenal
glands normally release hormones to maintain blood pressure and
enable the body to respond to stress. In up to half of patients
diagnosed with neuroblastoma, the tumor has spread to tissues
beyond the original site such as the bone marrow, bone, lymph
nodes, liver, and skin. As with most cancers, the cause of
neuroblastoma is not known. When the lesion is localised, it is
generally curable. However, long-term survival for children with
advanced disease older than 18 months of age is poor despite
aggressive multimodal therapy.
About AUTO6NGAUTO6NG is a next
generation programmed T cell product candidate in pre-clinical
development. AUTO6NG builds on preliminary proof of concept
data from AUTO6, a CAR targeting GD2-expression cancer cell
currently in clinical development for the treatment of
neuroblastoma. AUTO6NG incorporates additional cell programming
modules to overcome immune suppressive defence mechanisms in the
tumor microenvironment, in addition to endowing the CAR T cells
with extended persistence capacity. AUTO6NG is currently in
preclinical development for the potential treatment of both
neuroblastoma and other GD2-expressing solid tumors, including
osteosarcoma, soft tissue sarcoma, small cell lung cancer, and
melanoma.
Forward-Looking StatementsThis
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, PhDVice President, Investor
Relations and Corporate Communications+44 (0) 7587 372
619l.crabtree@autolus.com
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.com
Susan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
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