TIDMHEMO
RNS Number : 2930M
Hemogenyx Pharmaceuticals PLC
07 January 2019
Hemogenyx Pharmaceuticals plc
("Hemogenyx" or the "Company")
Operations Update
Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to provide
the following update on its development activities. The Directors
believe that, taken together, the recent progress made across the
full range of its activities represents a significant step forward
for the Company considerably broadening the scope of its
development activities.
Highlights
CDX Antibodies
-- In February 2018, the Company announced its CDX Antibodies
can attack and eliminate the blood cancer Acute Myelogenous
Leukemia ("AML") in vitro
-- Development Agreement with global pharmaceutical company
(announced May 2018) progressing well, discussion regarding
licensing deal expected to commence in early 2019
-- Expanded use of CDX antibodies to improve the efficacy of
already approved drugs as well as those still in clinical trials
for AML
-- Progress continues toward the submission of an Investigational New Drug ("IND") application
Advanced Hematopoietic Chimeras ("AHC")
-- Originally developed to improve the testing of the Company's
own products in vivo, AHC, or humanized mice, is evoking much wider
interest across the bio-pharmaceutical industry
-- Potential application of these mice in disease modelling and
drug discovery as AHC possess a seemingly fully functional human
immune system
-- Announced collaborations with Janssen Research &
Development, LLC, and Orgenesis, Inc., to advance opportunities
presented by AHC with an initial $1 million invested into the
project by convertible loan at a project valuation of $8
million
Hu-PHEC products
-- Steps taken to bring forward Human Postnatal Hemogenic
Endothelial Cell ("Hu-PHEC") based suite of product candidates
-- Hemogenyx-Cell SA, a Belgian registered subsidiary
wholly-owned by the Company has entered into a collaboration
agreement with Orgenesis, Inc., to further develop and
commercialise the Hu-PHEC technology with an initial $1 million
invested into the project by convertible loan at a project
valuation of $12 million
-- Hemogenyx-Cell will engage in preclinical development of the
Hu-PHEC technology, and will be eligible for significant financial
support from the Belgian government in the form of non-dilutive
matching grants
Appointments
-- In March 2018, H. Michael Shepard, Ph.D., a pioneer in modern
cancer research, was appointed to the Scientific Advisory Board
-- In April 2018, Sir Marc Feldmann, AC, FRS, a pre-eminent
medically trained immunologist at the University of Oxford, was
appointed Executive Chairman of the Board
CDX Antibodies
Progress continues toward the submission of an Investigational
New Drug ("IND") application to the US Food and Drug Administration
or to a UK or European regulatory agency for the Company's lead
product candidate, CDX antibodies, and pre-clinical evaluations of
additional clones of CDX antibodies to use in combination with
other blood cancer treatments are now completed.
In February 2018, the Company announced that its CDX antibodies
attacked and eliminated the blood cancer Acute Myelogenous Leukemia
("AML") in vitro (test tube experiments) (https://goo.gl/fa7u45).
Since then, the Company has established a new in vivo model of
human AML in its AHC mice that will be used to test CDX antibodies
for their potential ability to eliminate AML in vivo. If these
tests are successful, the Company will most likely be able to use
CDX antibodies not only to condition patients for bone marrow
transplantation, but also to eliminate refractory and/or relapsed
AML in patients who might otherwise qualify for bone marrow
transplantation. The AML market across seven developed countries
(US, France, Germany, Italy, Spain, the UK, and Japan) is projected
to increase to $1.5B by 2026. The Directors consider the expansion
of the use of CDX antibodies to treat AML to be a significant
opportunity for the Company that may allow it to potentially double
revenues from the CDX antibodies when approved for sale and, of
equal importance, save more lives.
In May 2018, the Company announced a Development Agreement
("Agreement") with a global biopharmaceutical company for the
development of the Company's CDX antibodies
(https://goo.gl/6hWaUS). The Company is pleased to report that the
development of CDX antibodies under the Agreement is progressing
well, and hence the Company is planning to initiate preliminary
discussions with the partner in January 2019 regarding a potential
licensing deal.
Under the Agreement, Hemogenyx will receive on a cost-free
basis: technical support access to advanced methods of discovering,
developing and engineering antibodies; and certain intellectual
property which is expected to assist the successful preclinical
development of the Hemogenyx's lead candidate bi-specific CDX
antibodies. This will complement the Company's own development work
currently being undertaken.
Also, Hemogenyx will grant the global pharmaceutical company a
research license for anything jointly developed under the
Agreement, as well as an option for an exclusive worldwide license
to commercially exploit CDX antibodies or any variants, which will
be jointly developed. If such option is not exercised by the global
pharmaceutical company, the Company has the option to license the
jointly developed CDX antibodies or any variants.
Hemogenyx is already benefitting from the Agreement as its
partner has produced good bi-specific antibodies which appear to be
clinical grade, and discussions in 2019 will clarify their
intentions. Either way, Hemogenyx benefits considerably.
The Company is expanding the use of its CDX antibodies to
improve the efficacy of already approved drugs as well as those
still in clinical trials for AML. Hemogenyx's goal is to
significantly improve the outcomes of treatments using these drugs
without a risk of compromising the standard of care. The Directors
believe that the ability to use CDX antibodies to improve the
performance of existing drugs without any risk of a negative impact
on treatment outcomes will be very attractive to major
pharmaceutical companies. Consequently, the Company has filed a
provisional patent application covering the composition matter of
additional clones of CDX antibodies and their combination with a
wide class of novel compounds that are currently undergoing
clinical development by a number of other companies. The purpose is
to create a new paradigm of combination treatment for patients with
AML and possibly other types of blood cancers. The Company is in
exploratory talks with a number of potential pharmaceutical
partners about these opportunities.
The consequences of these developments in the CDX project are
extensive. Hemogenyx may no longer need to spend money and use
staff resources to make its own antibodies, because the preferred
strategy now is to work with its partner which has already made a
suitable antibody. With the availability of a new patented
combination therapy strategy, it is likely that this or potentially
other biopharmaceutical companies will decide to in-license
CDX.
Advanced Hematopoietic Chimeras
The Company continues to be encouraged by the interest generated
by its new type of humanized mice - Advanced Hematopoietic Chimeras
or "AHC" - and the potential application of these mice in disease
modelling and drug discovery. AHC possess a seemingly fully
functional human immune system. This is a crucial advantage that
the Directors believe makes AHC unique among other types of
humanized mice currently available.
The Company initially developed AHC in order to have an improved
means of testing its own products in vivo, but has now found that
the AHC platform is evoking much wider interest across the
bio-pharmaceutical industry and beginning to provide significant
immediate levels of revenue for the Company. To fully exploit this
newly created opportunity, the Company is forming strategic
collaborations with major bio-pharmaceutical companies to expand
the use of AHC and to open new venues to increase its own product
portfolio.
To take full advantage of opportunities presented by AHC, the
Company established a wholly owned subsidiary, Immugenyx, LLC
("Immugenyx"), which is dedicated to the development and
commercialization of AHC as an in vivo platform for disease
modelling and drug development and testing. In addition, Immugenyx
itself is leveraging the unique properties of AHC to discover and
develop novel treatments for autoimmune diseases.
The value of AHC as an in vivo platform for disease modelling
and drug development, as well as a source of revenue for the
Company, has been evidenced not only by two previously announced
ongoing collaborations with major biopharmaceutical companies, but
also by the interest shown by a number of other biopharmaceutical
companies that are currently in talks with the Company about
entering into collaborations. The Company will be able to update
shareholders as these talks progress.
The first announced collaboration with a major US biotechnology
company to use the Company's AHC as a tool for drug development and
testing has progressed well and is expected to generate up to
US$377,000 in revenue at the conclusion of the current phase of
collaboration (https://goo.gl/M1oKAP). Although confidentiality
restrictions prevent Hemogenyx from disclosing the results of the
collaboration, the Company is confident that it has been successful
to date and that there is the potential to extend it and to
generate additional revenue.
The second announced collaboration with Janssen Research &
Development, LLC ("Janssen"), one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, is centred on the development
of a model of systemic lupus erythematosus ("SLE", also known as
Lupus) using AHC. Lupus is a systemic autoimmune disease wherein
patients' immune systems attack their own organs including the
skin, kidneys, blood cells, brain, heart and lungs. Lupus is often
a life-long disease that currently has no cure. Establishing a
human Lupus model is very important for understanding the emergence
and development of the disease. In addition, if successful, the
Lupus model will provide the opportunity not only to test
therapeutics that are currently under development, but also
potentially to discover fundamentally new therapeutic approaches
for treatment of the disease. For a more detailed description of
the terms of the collaboration please see the full announcement
(https://goo.gl/rsoqKS)
The Company has also announced that its wholly owned subsidiary
Immugenyx has entered into a collaboration agreement with
Orgenesis, Inc ("Orgenesis") to further develop and commercialize
its AHC. Orgenesis will advance to Immugenyx a convertible note in
an amount of not less than US$1,000,000 that can be converted into
shares of Immugenyx at a price per share based on a pre-money
valuation of US$8,000,000 with an option to increase the
convertible note by up to an additional $1,000,000. For a more
detailed description of the terms of the transaction please see the
full announcement (https://goo.gl/RKoTpf). This collaboration
represents additional validation of the potential value of the AHC
platform. The Directors believe that the participation of Orgenesis
in the business development and commercialization of AHC may
significantly expand and speed up the platform's adoption as a
standard tool for drug discovery, testing, and disease modeling by
a wide variety of pharmaceutical and biotechnology companies around
the world as well as providing access to Orgenesis' marketing
resources
The research collaboration with Rockefeller University, which
focuses on auto-immune disease modelling to develop new treatments
for diseases such as Lupus, is still in its early stages and
continues to progress in line with the Company's expectations.
The collaborations above and the broad interest currently being
shown by other potential collaborators reinforces the additional
value that AHC can potentially unlock.
Hu-PHEC products
The Company has in recent months focused its attention on the
CDX Antibodies product candidate but has also taken clear steps to
bring forward its Human Postnatal Hemogenic Endothelial Cell
("Hu-PHEC") based suite of product candidates.
To that end, because the technical requirements are different
and costly the Company is in the process of establishing a wholly
owned subsidiary, Hemogenyx-Cell SA ("Hemogenyx-Cell"), and has
entered into a collaboration agreement with Orgenesis to further
develop and commercialise its Hu-PHEC technology. Hemogenyx-Cell
will engage in preclinical development of the Hu-PHEC technology,
and as a Belgian company will be eligible for significant financial
support from the Belgian government in the form of non-dilutive
matching grants.
Hu-PHEC is a cell replacement product candidate that is being
developed by the Company to generate cancer-free, patient-matched
blood stem cells after transplantation into the patient. Orgenesis
will advance to Hemogenyx-Cell a convertible note in an amount of
not less than US$1,000,000 that can be converted into shares of
Hemogenyx-Cell at a price per share based on a pre-money valuation
of US$12,000,000 with an option to increase the convertible note by
up to an additional US$1,000,000. For a more detailed description
of the terms of the transaction please see the full announcement
(https://goo.gl/xgCQQY). The Directors believe that this
collaboration is especially important for the Company as it has the
potential to drastically speed up development of its Hu-PHEC
product candidate without reducing progress on other projects.
Appointments
The Company has made two significant appointments to its
leadership and advisory team. In March 2018, the Company appointed
H. Michael Shepard, Ph.D. to its Scientific Advisory Board
(https://goo.gl/jfQ37L). Dr. Shepard is a pioneer in modern cancer
research. His work has led to the discovery and development of many
successful cancer treatments, most notably leading the development
of Herceptin/trastuzumab, an antibody used to treat breast cancer
patients. Sales of Herceptin and its biosimilars currently exceed
$6.5 billion worldwide. In his Advisory Board role, Dr. Shepard
draws on his many years of experience advancing antibody-based
therapeutics from the development phase, through clinical studies
and FDA approval, to commercial launch.
In April 2018 Sir Marc Feldmann, AC, FRS, a pre-eminent
medically trained immunologist at the University of Oxford, was
appointed Chairman of the Board (https://goo.gl/Qo49qJ). Sir Marc
was the Head of the Kennedy Institute of Rheumatology until 2014
and is now an Emeritus Professor. Sir Marc shares the academic
credit for inventing and developing anti-TNF therapy for rheumatoid
arthritis, the first major use of monoclonal antibodies in a common
disease. Centocor, Inc licensed Sir Marc's key patent, and
developed Infliximab, ultimately branded as Remicade. Remicade was
the main driver of the $4.9 billion acquisition of Centocor by
Johnson and Johnson in 1999 and is still J&J's best-selling
drug. Since 2012 Anti-TNF therapy has become the world's largest
drug class with sales in 2016 exceeding US$36 billion, all based on
Feldmann's research. Sir Marc has broad experience in drug
development , having worked through all stages from developing new
concepts of how diseases emerge, through testing ideas and early
clinical development, leading clinical trials, approval,
registration and commercial execution.
Conclusion
The Company has made significant progress in widening its suite
of products (e.g., its collaborations pertaining to AHC) and their
potential applications (e.g., the application of CDX antibodies to
treat AML) and providing important partnerships and finance for all
of its product suites. The Directors believe that investment in the
diversification of the Company's product suites and their
application to additional disease markets de-risks the business and
maximizes overall potential shareholder value.
Overall the Board is very pleased with the progress being made,
in particular the unlocking of opportunities for CDX antibodies, as
well as the potential value that can be created through the
Company's new type of humanized mice.
Enquiries:
Hemogenyx Pharmaceuticals Plc www.hemogenyx.com
Dr Vladislav Sandler, Chief Executive Officer Via Walbrook PR
& Co-Founder
Sir Marc Feldmann, Executive Chairman
Northland Capital Partners Limited Tel: +44 (0)20 3861 6625
Matthew Johnson, Vadim Alexandre, Dugald J
Carlean
Peterhouse Corporate Finance Limited Tel: +44 (0)20 7469 0930
Lucy Williams, Duncan Vasey
Walbrook PR (UK Media & Investor Tel: +44 (0)20 7933 8780 or hemogenyx@walbrookpr.com
Relations)
Paul McManus Mob: +44 (0)7980 541 893
US Media enquiries
Lowell Goodman Tel: +1 (323) 646-3249 or lowell@corbomitecomms.com
About Hemogenyx Pharmaceuticals plc
Hemogenyx Pharmaceuticals plc is a publicly traded company (LSE:
HEMO) headquartered in London, with its wholly owned US operating
subsidiary, Hemogenyx LLC, located in New York City at its
state-of-the-art research facility ("Hemogenyx").
Hemogenyx is a pre-clinical stage biopharmaceutical group
developing new medicines and treatments to bring the curative power
of bone marrow transplantation to a greater number of patients
suffering from otherwise incurable life-threatening diseases.
Hemogenyx is developing two distinct and complementary products, as
well as a platform technology that it uses as an engine for novel
product development.
For more than 50 years, bone marrow transplantation has been
used to save the lives of patients suffering from blood diseases.
The risks of toxicity and death that are associated with bone
marrow transplantation, however, have meant that the procedure is
restricted to use only as a last resort. Hemogenyx's technology has
the potential to enable many more patients suffering from
devastating blood diseases such as leukemia and lymphoma, as well
as severe autoimmune diseases such as multiple sclerosis, aplastic
anemia and systemic lupus erythematosus (Lupus), to benefit from
bone marrow transplantation.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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