Helicure AB develops novel vaccines to protect against
Helicobacter pylori-induced gastric cancer
Introduction
Helicure ABis a biotech company with focus on developing
vaccines for prevention of gastric cancer caused by
Helicobacter pylori, through active immunisation in
infected patients with persistent dyspepsia. The company was
started in 2005, as a spin-off from Umeå University in Sweden and
is based in Umeå. The founders of Helicure, Professors
Thomas Borén and Lennart Hammarström, are world-renowned and among
the leading in research regarding Helicobacter pylori and
immunotherapy research.
Helicure - Innovative H. pylori vaccines
Helicure AB is developing and commercializing therapeutic
vaccines to protect against gastric cancer, caused by
Helicobacter pylori. The vaccines are utilizing
proprietary attachment proteins from Helicobacter pylori
as immunization agents, combined with an immune stimulating
adjuvant. The vaccine will be administered nasally or orally.
Project highlights
- A candidate drug, consisting of a mixture of proprietary
recombinant H. pylori adhesion proteins, has been
selected
- Efficacy of the multi-component vaccine has been confirmed in
H pylori infected animals
- The selected vaccine candidate represents a novel approach for
protection against H.pylori-induced gastric cancer.
- The multi-component vaccine candidate is a first-in-class
active immunotherapeutic with the potential of becoming a
blockbuster product addressing a >USD 1 bn market
- A collaboration agreement has been signed with Eurocine AB
regarding a novel and efficient adjuvant/delivery system for nasal
delivery
Therapeutic Concept
Up to 50 % of the population in western countries is infected
with H. pylori, and the great majority in developing
countries. One out of hundred infected people (1%) will develop
gastric cancer which comes to one million new cases a year and,
this figure is expected to double within the next decades. This is
most alarming in perspective of gastric cancer being recognized as
the 2nd most fatal form of cancer in the world. Of particular
relevance, there is a causative relationship between H.
pylori and gastric cancer and a H. pylori vaccine
would fill a large medical need.
Product Description and Mechanism of Action
The vaccine development project started up as a research project
by Thomas Borén at Umeå University and Lennart Hammarström
Karolinska Institute, and this pioneer work constituted the basis
for the biotech spin-off company Helicure. Today Helicure holds its
own premises and laboratory facilities in the Umeå Biotech
Incubator (UBI). The vaccine candidate involves three novel and
distinct antigens. These structures are unique to H.
pylori and have dual identities also as functional attachment
proteins used by H. pylori during life-long infection for
firm adhesion of the bacteria to the cells lining the stomach. The
vaccine products will use proprietary recombinant versions of the
adhesion proteins as the active components, in combination with an
efficient adjuvant, for oral or nasal delivery. A major series of
animal studies have shown that this novel vaccine composition is
most effective.
Development Plan
The project development work is carried out in Helicures
facilities at UBI. Helicure plans to further develop the project
where the selected vaccine composition will be produced and
evaluated in several pharmacological and pharmacokinetic models.
During the same time period Helicure will develop stable
recombinant cell lines to be used for future large scale
production. The biochemical properties of the composition will be
evaluated. This work aims at evaluating the vaccine in humans
within 3 years. The following mile stones apply:
- Milestone 1. Efficacy of CD candidate confirmed, December
2009
- Milestone 2. Efficacy study optimized protocol, Q1 2011
- Milestone 3. GMP batch 1, Q2 2012
- Milestone 4. GLP tox finalized, Q3 2012
- Milestone 5. Start phase I/IIa, Q4 2012
Commercial Potential
In EU an estimated 15 million patients with symptoms of
dyspepsia visit primary care each year. Up to 50 % of these
patients or 7,5 million could potentially be offered the treatment.
Based on an assumption that the average frequency of health care
visits for these patients is similar in the entire area, this
corresponds to an estimated 25 million target patient group for the
area US, Europe (based on all 25 EU countries and additional
countries in Eastern Europe), Japan and Russia (the total
population in the area is 1,2 bn).
Intellectual Property
For methods of production, uses and specific compositions
comprising the BabA adhesin protein sequence, the corresponding
gene, antibodies, immunoglobulins, vaccines and diagnostic kits,
Helicure holds issued Patents in the US, Japan, New Zealand,
Australia, Europe and pending patent application in Canada.
According to the invention the compositions are useful for treating
and/or preventing H. pylori infections in humans e.g via
immunization therapies.
Helicure also has two other patent families: one related to
methods for production, isolation and use of a new immunoglobulin
Abba3 against H. pylori; and a second one related to
methods of treatment of H. pylori with sialic acid binding
adhesin SabA and SabA genes, both are pending and being protected
by PCT- and US patent applications.
Synergon AB is managing Helicure AB's patent portfolio.
Current Ownership
Current owners of Helicure AB are Thomas Borén (24%), Lennart
Hammarström (24%), Ackra Invest AB (11%), Uminova Invest AB (11%),
Innovationsbron i Umeå AB (8%), Stiftelsen JC Kempes Minne
(22%).
Key Management and Board
Dr. Claes Lundberg, CEO, has 20 years of
experience in pre-clinical drug development within the
biotech/pharmaceutical industry and regulatory authorities as both
line and project manager.
Prof. Thomas Borén, CSO and
Director of the board, is professor at Umeå
University with a long-standing interest in molecular genetics and,
in particular, pathogenesis of Helicobacter pylori. He is
the main inventor of the original H. pylori patent
applications.
Mr. Thomas Almesjö, Chairman of the board, has
a Bachelor of Science (BSc) in Business Administration and
Economics. He has a strong background and track record from life
science industry including pharmaceutical, biotech and medical
technology.
Prof. Lennart Hammarström, MD, PhD, Director of the
board, is Professor at the Karolinska Institute. He
scientific interest includes immunodeficiency, immunogenetics,
regulation of antibody production as well as immunotherapy.
Mr. Per-Olof Gunnesson, Director of the board,
has a Business School degree and has almost 40 years experience in
biotech/pharmaceutical industry, including the ASTRA group.
Dr. Jacob Odeberg, MD, PhD, M.Sci. Chem.
Engineer, Director of the board, is
Associate Professor in Molecular Biotechnology at the Royal
Institute of Technology and affiliated with the Department of
Medicine, Karolinska Institute.
Scientific Advisors
Prof. Jay Solnick, Center for Comparative
Medicine, UC Davis, USA. Prof. Solnick has performed ground
breaking research in the field of regulation of H. pylori
attachment proteins and has in addition worked on both immunology
as well as microbiology of H. pylori in Rhesus
macaques, which is also a focus of Dr Solnick's research center,
the Center for Comparative Medicine.
Prof. Pierre Michetti,
Division of Gastroenterology and Hepatology at the Centre
Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Prof.
Michetti is most respected for his pioneer work on
identification of a protective antigen of H. pylori, and
the phase I and phase II clinical trials he conducted with vaccine
candidates.
Prof. Olof Nyrén, Department of Medical
Epidemiology and Biostatistics, Karolinska Institute, Sweden. Prof
Nyrén has worldwide reputation as expert in cancer epidemiology and
H. pylori infections in relation to gastric cancer
Intended Transaction
Helicure is seeking financing from VC and collaboration with
pharma companies to carry through the development plan with a
Proof-of-Concept in humans within 3 years.
References
Aspholm-Hurtig M et al.
Functional adaptation of BabA, the H. pylori ABO blood
group antigen binding adhesin. Science. 2004 Jul
23;305(5683):519-22.
Mahdavi J et al.
Helicobacter pylori SabA adhesin in persistent infection
and chronic inflammation. Science. 2002 Jul
26;297(5581):573-8.
Ilver D et al.
Helicobacter pylori adhesin binding fucosylated
histo-blood group antigens revealed by retagging.
Science. 1998 Jan 16;279(5349):373-7.
Borén T et al.
Attachment of Helicobacter pylori to human gastric
epithelium mediated by blood group antigens. Science.
1993 Dec 17;262(5141):1892-5.
October 2009
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