Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of April 2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
FDA TO REVIEW MOXETUMOMAB FOR HAIRY CELL
LEUKAEMIA
3 April 2018 07:00 GMT
US FDA ACCEPTS BIOLOGICS LICENSE APPLICATION
FOR MOXETUMOMAB PASUDOTOX IN HAIRY CELL
LEUKAEMIA
Moxetumomab pasudotox BLA granted Priority Review
AstraZeneca and MedImmune, its global biologics research and
development arm, today announced that the US Food and Drug
Administration (FDA) has accepted the Biologics License Application
(BLA) for moxetumomab pasudotox, an investigational anti-CD22
recombinant immunotoxin and a potential new medicine for the
treatment of adult patients with hairy cell leukaemia (HCL) who
have received at least two prior lines of therapy. The FDA has
granted the moxetumomab pasudotox BLA Priority Review status with a
Prescription Drug User Fee Act date set for the third quarter of
2018.
The Phase III ('1053') moxetumomab pasudotox clinical trial
met its
primary endpoint of durable
complete response in adult patients with relapsed or refractory
HCL, for which there is currently no established standard of care
and few treatments available.[1],[2]
Results from the 1053 Phase III trial
will be presented at a forthcoming medical
meeting.
Priority Review is granted by the FDA to applications for medicines
that, if approved, would offer a significant improvement in the
safety or effectiveness of the treatment, diagnosis, or prevention
of serious conditions.[3]
About Moxetumomab Pasudotox
Moxetumomab pasudotox (formerly CAT-8015 or HA22) is an
investigational anti-CD22 recombinant immunotoxin and a potential
new medicine with the opportunity to be a first-in-class treatment
in the US for patients with relapsed or refractory HCL who have
received at least two prior lines of therapy. Immunotoxins are a
class of anticancer agents that combine the selectivity of
antibodies to target drug delivery and the potency of toxins to
kill target cancer cells.[4]
Moxetumomab pasudotox is composed of a
binding portion of an anti-CD22 antibody fused to a toxin. CD22 is
a B-lymphocyte restricted transmembrane protein with a higher
receptor density in HCL cells relative to normal B cells, making it
an attractive therapeutic target for the treatment of this
cancer.[5]
After binding to CD22, the molecule is
internalised, processed and releases its modified protein toxin
that inhibits protein translation, leading to apoptotic cell death.
Moxetumomab pasudotox has been granted Orphan Drug Designation by
the FDA for the treatment of HCL.
About Hairy Cell Leukaemia
HCL is a rare, incurable slow-growing leukaemia in which the bone
marrow overproduces abnormal B cells or
lymphocytes.[6]
HCL can result in serious and
life-threatening conditions, including infections, bleeding and
anaemia.[7]
Approximately 1,000 people are
diagnosed with HCL in the US each year.[8],[9],[10]
While many patients initially respond
to treatment, up to 40% will relapse.[11]
With no established standard of care
and very few treatments available, there remains significant unmet
medical need for people with relapsed or refractory
HCL.1,2
About the '1053' Phase III Trial
The '1053' trial is a single-arm, multicentre Phase III clinical
trial assessing the efficacy, safety, immunogenicity and
pharmacokinetics of moxetumomab pasudotox monotherapy in patients
with relapsed or refractory HCL who have received at least two
prior therapies. The trial is being conducted in 80 patients across
34 sites in 14 countries.[12]
About AstraZeneca in Haematology
Leveraging its collective heritage in oncology, AstraZeneca has
established haematology as one of four key oncology disease areas
of focus, and is accelerating development of a broad portfolio of
potential blood cancer treatments. AstraZeneca and Acerta Pharma,
its haematology research and development centre of excellence,
recently received US FDA approval for Calquence (acalabrutinib), the first medicine in this
franchise.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a
quickly-growing portfolio of new medicines that have the potential
to transform patients' lives and the Company's future. With at
least six new medicines aimed to be launched between 2014 and 2020
and a broad pipeline of small molecules and biologics in
development, we are committed to advance New Oncology as one of
AstraZeneca's five Growth Platforms focused on lung, ovarian,
breast and blood cancers. In addition to our core capabilities, we
actively pursue innovative partnerships and investments that
accelerate the delivery of our strategy as illustrated by our
investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and one day eliminate cancer as a cause
of death.
About MedImmune
MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and
Infection and Vaccines. The MedImmune headquarters is located in
Gaithersburg, MD, one of AstraZeneca's three global R&D
centres, with additional sites in Cambridge, UK, and Mountain View,
CA. For more information, please visit www.medimmune.com.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. The Company also is selectively active
in the areas of autoimmunity, neuroscience and infection.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com
and follow us on Twitter
@AstraZeneca.
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Adrian Kemp
Company Secretary, AstraZeneca PLC
[1] López-Rubio, M.,
& Garcia-Marco, J. A. (2015). Current and emerging treatment
options for hairy cell leukemia. OncoTargets and Therapy, 8,
2147-2156. http://doi.org/10.2147/OTT.S70316.
Accessed 3 January 2018.
[2] National Institutes of
Health. Hairy Cell Leukemia. Accessed 7 December 2017.
https://rarediseases.info.nih.gov/diseases/6560/hairy-cell-leukemia.
[3] US Food and Drug
Administration. Priority Review. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm
Accessed December
2017
[4] G Aruna. Immunotoxins: A
review of their use in cancer treatment. J Stem Cells Regn Med.
2006; 1(1): 31-36. Published online 2006 Dec 26. Accessed 7
December 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3907961/
[5] Park JH, Ross LL. Targeted
Immunotherapyu for Hairy cell leukemia. Journ Clin Onc
2012; 30: 1888-1890. Accessed 24
October 2017.
http://ascopubs.org/doi/abs/10.1200/JCO.2011.39.8313.
[6] National Institutes
of Health. Hairy Cell Leukemia. Accessed 7 December 2017.
https://rarediseases.info.nih.gov/diseases/6560/hairy-cell-leukemia.
[7] Hairy Cell Leukemia
Foundation. Complications. Accessed 7 December 2017.
https://www.hairycellleukemia.org/about-hcl/complications/.
[8] Troussard X, Cornet E.
Hairy cell leukemia 2018: Update on diagnosis,
risk‐stratification,
and treatment. Am J Hematol. 2017; 92(12): 1382-1390. Published
online 2017 Nov 7. Accessed 20 March
2018.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698705/
..
[9] Teras L, DeSantis C, et
al. 2016 US Lymphoid Malignancy Statistics by World Health
Organization Subtypes. Ca Cancer J Clin. 2016; 66: 443-459.
Accessed 20 March 2018. https://onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21357.
[10] Grever M, Blachly J,
Andritsos L. Hairy cell leukemia: Update on molecular profiling and
therapeutic advances. Blood. 2014; 28(5): 197-203.
https://www.sciencedirect.com/science/article/pii/S0268960X14000514.
Accessed 20 March 2018.
[11] Hairy Cell Leukemia
Foundation. Treatment. Accessed 7 December 2017.
https://www.hairycellleukemia.org/about-hcl/treatment/.
[12] ClinicalTrials.gov.
Moxetumomab pasudotox for Advanced Hairy Cell Leukemia.
https://clinicaltrials.gov/ct2/show/study/NCT01829711?term=moxetumomab&rank=4&show_locs=Y#locn.
Accessed 7 December 2017.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
03 April
2018
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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