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Tuesday, 08/10/2010 11:35:04 AM

Tuesday, August 10, 2010 11:35:04 AM

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8-10-10: Affitech Aims for R84 (Fhu2C3) clinical trial in Russia…

Recall, the Peregrine/Affitech AntiVEGF-2C3 deal (incl. fully-human 2C3, aka R84=AT001), announced 7-22-09, called for $250k upfront ($100k/immed + $150k/6mos), $1,000,000 to Peregrine upon “delivery of a pre-clinical dev. package” to Affitech, up to $16.5mm in milestones, royalties on future sales, and addl. payments if Affitech sub-licenses “Ocular Field” indications. [See 7-31-09 10Q, pg.15: http://tinyurl.com/mfppjh & 7-22-09 PR: http://tinyurl.com/n67v57 ].

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8-10-10: “Affitech Aims for a Clinical Trial Application for AT001/r84 in Russia in 2011”
Copenhagen & Oslo: Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today announced that the news release no. 25 of August 9th 2010 by mistake gave the impression that Affitech aims for a New Drug Application in Russia and CIS for AT001/r84 in 2011 based on the announced preclinical results with this drug candidate. The right information is that the company aims for a Clinical Trial Application for AT001/r84 in Russia and CIS in 2011.

8-9-10: ”Affitech Announces New Scientific Findings”
• Affitech's lead drug candidate AT001/r84 potent on tumors in mice studies with limited induction of side effects
Copenhagen & Oslo:
• 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-tumor activity at least as comparable as bevacizumab [Avastin] or Sutent [Pfizer]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 characterization of tumor progression driven by VEGF receptor pathway and highlights the utility and potential safety of more selective blockade of VEGF induced VEGF receptor 2 signaling in tumor 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 tumors and does not induce significant side effects in mice. This is the conclusion of a study conducted by Rolf Brekken [PPHM SRB, co-inventor of 2C3 with Dr. Thorpe], University of Texas, Dallas, USA, a collaborator of Affitech and a recognized expert in tumor angiogenesis. The study, “r84, a novel therapeutic antibody against mouse and human VEGF with potent anti-tumor 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
[ also, http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0007669 ]

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 tumor cell- and host cell-derived VEGF in tumor 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 tumor implantation and growth, independent of dose.
• In this animal model, AT001/r84 significantly reduced tumor growth and final tumor 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 tumor 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 & 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 [4-21-10: http://tinyurl.com/29tzen9 ] 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 dev. team in Russia for AT001/r84
• Conduct preclinical evaluation of AT008 (fully human anti-CCR4 antibody) dev. candidate as a potential treatment targeted against certain haematological & solid cancers
• Grow capabilities especially in preclinical development
• Evaluate further projects based on Affitech's leading antibody generating technology

http://www.affitech.com
http://www.affitech.com/investors-news/press-releases-english

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6-30-10: “Affitech Commences Pre-clinical Dev. of 2 Novel Antibody Medicines with Initial Clinical Dev. to be Conducted in Partnership with NTS Plus”
Clinical trials with AT001/r84 (anti-VEGF) and AT008 (anti-CCR4) to be conducted in Russia
• First step in building a clinical development pipeline of innovative new antibody products
• Rapid value creation through unique access to Russian and CIS markets
• Generation of lead antibodies to 5 addl. chemokine receptor targets (G-Protein Coupled Receptors)
• Transition continues from technology company to intl. biopharmaceutical dev. business
http://www.evaluatepharma.com/Universal/View.aspx?type=Story&id=217339

Copenhagen & Oslo, June 30, 2010: Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today announced that the Company has commenced preclinical development of two novel proprietary biopharmaceutical products, AT001/r84 - a highly selective human antibody to VEGF, and AT008 - a human antibody antagonist of CCR4. Both products are being developed as new potential treatments for cancer. As part of Affitech's recent strategic partnership with NTS Plus, initial clinical trials will be conducted in Russia. If successful, Affitech plans to bring both products rapidly to market in Russia and the CIS territories through its alliance with NTS Plus and Pharmstandard. Affitech will also look to commercialize the products in other territories subject to successful clinical results and further funding.

Managing Director Martin Welschof said, “Our goal is to build Affitech into an innovative, world class antibody biopharmaceutical company operating internationally. Our new partnership with NTS Plus, with its proven access to Russia and the CIS markets, enables us to initiate human clinical trials in Russia rapidly and generate cost effective but high quality clinical data within a time frame that would not be possible elsewhere. Along with other BRIC nations, the Russian pharmaceutical environment is one of the fastest growing and dynamically emerging pharmaceutical markets. Our strong relationship with NTS Plus and its experienced Russian development expertise is likely to benefit Affitech in early revenue generation, patient safety data, and clinical proof of concept results, substantially reducing the costs and risks involved before initiating trials in other pharmaceutical markets such as the EU or US.”

THE FIRST TWO PRODUCTS IN AFFITECH’S CLINICAL DEVELOPMENT PIPELINE:
I. AT001/r84
AT001/r84 is a novel, proprietary human therapeutic antibody to vascular endothelial growth factor (VEGF) which has recently been shown to have intriguing effects on immune cells in preclinical models. Anti- VEGF antibody therapy is a clinically validated approach to cancer treatment with the currently marketed product (Avastin®) having ‘blockbuster' status and sales in 2008 of $4.6 billion. Avastin® is projected to be the leading pharma product by 2014 with $ 9 billion in sales. Avastin® is, however, not a fully human antibody and has various well documented side effects (e.g. GI perforation, haemorrhage and wound healing complications; hypertension, thromboembolic events and proteinuria). AT001/r84 differs from Avastin® in a number of ways, including being a fully human antibody and binding to VEGF in a more selective fashion. These properties provide potential for improvement over Avastin® and in particular, Affitech's AT001/r84 may have a better side effect profile. Data from the first clinical trials in Russia will allow us to assess the potential of r84 in additional territories.
II. AT008/CCR4 is a novel, proprietary therapeutic antibody directed against CCR4, an important G-protein coupled receptor (GPCR). . . *snip*
OUTLOOK FOR 2010. . . *snip*

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ANTI-ANGIOGENESIS AGENT ’2C3’ [Fhu: R84=AT001] ANTI-VEGF MAB:
8-6-10/PLoS: PPHM-Brekken/UTSW/Affitech article on pre-clin. R84=AT001 (Fhu 2C3): http://tinyurl.com/2unp4j3
…”Extended r84 therapy controls tumor growth without induction of toxicity”
6-30-10: NTS-Plus to run 2C3/R84 clinical trial(s) in Russia: http://tinyurl.com/26hhln4
4-21-10: Affitech sub-licenses Anti-VEGF mabs (incl. R84) to Russian partner NTS-Plus: http://tinyurl.com/29tzen9
11-3-09/PLoS: R.Brekken (PPHM SRB) on R84, increases “immune cell infiltration” in Breast Cancer: http://tinyurl.com/y8ooxah
7-22-09: Peregrine Licenses Anti-VEGF mabs (incl. R84) to Affitech: http://tinyurl.com/n67v57
6-30-09: R.Brekken article in Mol-Cancer-Ther on 2C3/R84+Avastin vs. Breast Cancer: http://tinyurl.com/mqv5ol
12-11-08: Dr. Brekken (PPHM SRB) presents F.H. 2C3 (R84/PGN311) at TX Breast-Cancer Conf. http://tinyurl.com/63utya
11-3-07: Dr. Brekken presents ‘R84’ (F.H. 2C3, aka PGN311) data at IBC-Conf: http://tinyurl.com/yp459d
4-16-07 AACR2007: Brekken [PPHM SRB] presents fully-human 2C3 (‘R3’) http://tinyurl.com/2udkgr
”The anti-tumor activity of 2C3, which only blocks VEGFR2 compared favorably to that of Avastin, which blocks both VEGFR1+2”
2-14-05: Humanized 2C3 Pre-Clin. data presented at "Anti-Angio. Symposium": http://tinyurl.com/85qy3
2-10-05: VEGF Pioneer Dr. Donald Senger joins PPHM’s SRB to assist with 2C3 pgm: http://tinyurl.com/yul72w
5-20-03: PPHM compares 2C3 vs. Genentech’s AVASTIN: http://tinyurl.com/37k2nl

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AFFITECH-PPHM Collab: Fully-Human Mabs, Anti-PS & Anti-VEGF/2C3 http://tinyurl.com/bxyfjk
• AT001 is Fully-Human 2C3 = R84 = PGN311.
• AT004 is Fully-Human BAVI=PGN635=1N11, and AT005 is the Duke-PPHM-HIV candidate PGN632=11.31.
...4-21-10: Affitech sub-licenses Anti-VEGF mabs (incl. R84) to Russian partner NTS-Plus: http://tinyurl.com/29tzen9
...7-22-09: Peregrine Licenses Anti-VEGF mabs (incl. R84) to Affitech: http://tinyurl.com/n67v57
...4-28-09 Affitech comments on PGN635 & PGN632 presented at AACR'09 http://tinyurl.com/cxkcb4
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