Release no 25/2010
New scientific findings: Affitech's lead drug candidate AT001/r84 potent on
tumours in mice studies with limited induction of side effects
Copenhagen and Oslo, 9th August, 2010
- Fully human antibody AT001/r84 binds human and mouse Vascular Endothelial
Growth
Factor (VEGF) and selectively blocks VEGF from interacting with VEGF receptor 2
- AT001/r84 has potent anti-tumour activity at least as comparable as
bevacizumab or sutent and shows no significant side effects after chronic high
dose therapy in mice
- AT001/r84's ability to block VEGF:VEGF receptor 2 binding provides a
valuable tool for characterisation of tumour progression driven by VEGF
receptor pathway and highlights the utility and potential safety of more
selective blockade of VEGF induced VEGF receptor 2 signalling in tumour
therapy
Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today
announced that the Company's lead drug candidate r84, which may have therapeutic
application against certain cancers, shows potent activity on tumours and does
not induce significant side effects in mice. This is the conclusion of a study
conducted by Rolf Brekken, University of Texas, Dallas, USA, a collaborator of
Affitech and a recognised expert in tumour angiogenesis. The study, ‘r84, a
novel therapeutic antibody against mouse and human VEGF with potent anti-tumour
activity and limited toxicity induction', was published on August 6th 2010 in
PLoS ONE.
The article is available at http://dx.plos.org/10.1371/journal.pone.0012031
The study compared human IgG anti-VEGF antibodies screened for specific VEGF
binding characteristics with other therapeutics targeting VEGF - among which was
bevacizumab (Avastin®/Roche).
New results:
- AT001/r84 was demonstrated to bind with equal affinity to both recombinant
human and mouse VEGF and was further established as an important tool in
evaluating
the contribution of both tumour cell- and host cell-derived VEGF in tumour
progression. The binding of AT001/r84 differed from other anti-VEGF antibodies
such as bevacizumab (Avastin®) that do not recognise mouse VEGF.
- AT001/r84 was demonstrated to selectively inhibit the VEGF: VEGF receptor 2
interaction by specifically blocking human and mouse VEGF-induced migration of
VEGF receptor 2 positive endothelial cells without interrupting VEGF receptor 1
signalling. This makes AT001/r84 a unique tool for assessing induction of
possible side effects.
- The efficacy of AT001/r84 as a cancer therapeutic was assessed in an animal
non-small cell lung cancer model. Compared to bevacizumab (Avastin®) the results
indicated that AT001/r84 may be even more effective in controlling tumour
implantation and growth, independent of dose.
- In this animal model, AT001/r84 significantly reduced tumour growth and
final tumour weight but did not produce any observable side effects.
Alexander Duncan, Chief Scientific Officer, Affitech A/S said:
“We recently announced that AT001/r84 had entered preclinical development and I
am very pleased that these results confirm our belief in the potential of
Affitech's lead antibody therapeutic AT001/r84 for therapy of certain cancers.
These pre-clinical results from Dr. Brekken's group show that our antibody-based
drug blocks both tumour and stromal derived VEGF. Furthermore, AT001/r84
demonstrates that selective blockade of VEGF:VEGF receptor 2 interaction without
interrupting the VEGF:VEGF receptor 1 signalling is potent and shows no
significant systemic side effects in mice. This is a good basis for further
preclinical and clinical development. We have now established a global
development team and are able to fulfil our goal of completing the preclinical
development of the drug candidate particularly enabling toxicology for
submission of a new drug application in Russia / CIS in 2011.”
In the spring of 2010 Affitech created a sound financial footing to add to its
clear strategic positioning in generating antibodies to biologically important
molecular targets. The investment by TransNova and the collaboration with NTS
Plus provided a solid platform for the Company's activities. For the rest of
2010 Affitech is focused on creating further shareholder value from the
development of r84 and building strong development links with its Russian
partner.
Affitech's updated outlook for 2010
- Initiate GMP manufacturing of AT001/r84 for the upcoming clinical trials
- Together with NTS Plus establish a product development team in Russia for
AT001/r84
- Conduct preclinical evaluation of AT008 (fully human anti-CCR4 antibody)
development candidate as a potential treatment targeted against certain
haematological and solid cancers
- Grow capabilities especially in preclinical development
- Evaluate further projects based on Affitech's leading antibody generating
technology
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| For more information please contact Affitech A/S: |
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| Martin Welschof, Managing Director | Randi Krogsgaard, |
| | Corporate Communications |
| Tel # +47 9512 8137 | Tel # +45 2320 1001 |
| | e-mail: ir@affitech.com |
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Disclaimer
This news release contains forward-looking statements and forecasts
based on uncertainty, since they relate to events and depend on circumstances
that will occur in the future and which, by their nature, will have an impact on
results of the financial condition and operations of Affitech A/S. There are
many factors that could cause actual results and developments to differ
materially from those expressed or implied by these forward-looking statements
and forecasts. These factors include, among other things, risks associated with
technological development, the risk that research & development will not yield
new products that achieve commercial success, the impact of competition, the
ability to transact viable and profitable commercial deals, the risk of
non-approval of patents not yet granted, and difficulties of obtaining relevant
governmental approvals for new products.
No expressed or implied representations or warranties are given concerning
Affitech A/S or the accuracy or completeness of the information provided herein,
and no claims shall be made by the recipient of this news release by virtue of
the information contained herein.
