Copenhagen and Oslo, 26th May, 2011, 2011-05-26 15:03 CEST (GLOBE NEWSWIRE) --
- Net loss for the quarter DKK 22.6 million as expected
- Maintains expectation of net loss for 2011 (DKK 50‐60 million)
- Cash reserves of DKK 50.5 million as per 31st March 2011
- Anti-angiogenesis antibody AT001/r84 completed preclinical toxicology
- Clinical trial material manufactured for AT001/r84
- Anti-cancer antibody AT008/CCR4 drug candidates identified and production cell line being developed
- European patent granted for CBASTM technology platform
- US patent granted for multivalent multiple antigen binding antibodies
- Exclusive license agreement with Cancer Research UK for the use of anti-CCR4 antibodies in treatment of solid tumors and diagnostic tests
- Sponsored research agreement with University of Texas Southwestern to further understand the mechanism and potential differentiation of lead antibody drug candidate AT001/r84 as an anti-angiogenic compound
Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today announced that in the first quarter of 2011 its two most advanced research and development programs had both made strong progress and that the Company generated a loss for the period of DKK 22.6 million. Affitech had cash of DKK 50.5 million as of 31st March 2011 and maintains its expectation of a net loss for 2011 in the range of DKK 50‐60 million.
Martin Welschof, Managing Director of Affitech A/S commented on the interim report:
“I am pleased to report that in the first part of 2011 the Company continued to make significant progress. We achieved the goals in our development programs as planned. AT001/r84 is now close to completion of the pre-clinical program and a CTA (Cinical Trial Application) is currently in preparation such that clinical trials can be started in Russia later this year. Preclinical research with our AT008/CCR4 cancer program is also progressing well, and we will soon be selecting a drug development candidate. Meanwhile, material revenues from license fees and milestone payments from the cooperation with NauchTekhStroy Plus are expected over the remaining quarters of 2011.”
Highlights of the first quarter 2011
-
Fully human antibody AT001/r84, an anti‐angiogenesis development compound, is in late pre-clinical testing with initial clinical trials planned for this year
- Preclinical GLP toxicity studies of AT001/r84 have been successfully completed at high doses with no significant safety issues reported
- A Clinical Trial Application for phase I clinical trials with AT001/r84 is in preparation
- GMP manufacturing of AT001/r84 material to be used in clinical trials has been completed
-
Affitech’s first anti-GPCR antibody program AT008, designed to block the binding of chemokine ligands to its cell surface receptor CCR4, is in preclinical pharmacology testing. The program includes several different antibodies with a multiple potential mechanism of action targeting hematological cancers, solid tumors, metastatic lesions and regulatory T cells (in stroma and circulation)
- Preliminary proof of concept completed
- Potential development candidates to be confirmed
- Development of an AT008/CCR4 manufacturing cell line initiated
- Six other chemokine receptor programs are being profiled in pharmacology
-
Technology patents
- Affitech’s proprietary Cell Based Antibody Selection – CBASTM technology was granted European patent in January 2011. This significantly strengthens Affitech’s intellectual proprietary position. CBASTM technology is used to generate antibodies to highly complex antigens on cell surfaces
- In January, 2011 Affitech announced a granted US patent for multivalent multispecific antibodies that covers a specific format of recombinant antibody and antibody fragments. This format enables the construction of next generation designer antibodies which allows new approaches for treatment of cancer and other diseases
Outlook for 2011
During the remainder of 2011, Affitech expects to continue its research and development programs in line with its objectives of building a pipeline of novel antibody products in development. At the same time the Company anticipates receiving significant revenues from its Russian development partnership and expects the net loss for 2011 to be in the range of DKK 50‐60 million (as announced in the Company’s Annual Report for 2010).
During 2011, Affitech expects to make the following progress in its R&D programs:
- Complete pre‐clinical development of AT001/r84
- File a Clinical Trial Application in Russia and commence the first human clinical trial for AT001/r84
- Complete pharmacological testing of potential drug candidates in the AT008 program targeting CCR4, to confirm a development candidate and commence preclinical toxicology testing
- Continue optimization of the proprietary CBASTM technology platform through investments in quality control and new equipment and to continue the process of making new antibody libraries
- Identify the next target program likely to result in the Company’s third pipeline product candidate
Subsequent Events after the end of the reporting period 31st March, 2011
On 27th April 2011 Affitech announced two collaboration agreements:
- A license agreement with Cancer Research Technology (CRT), the commercial arm of Cancer Research UK that grants Affitech exclusive rights to a CRT patent application and relevant know how to develop and use therapeutic antibodies that recognize and block the function of CCR4, a protein found on certain tumors, in therapeutic and diagnostic applications
- A sponsored research agreement with Dr. Rolf Brekken at the University of Texas Southwestern to further understand the mechanism and potential differentiation of Affitech’s lead antibody drug candidate AT001/r84 as an anti-angiogenic compound
The hearing in the court case where a certain group of minority shareholders have sued the company was completed on 25th March, 2011. The decision of the Eastern High Court was scheduled to be published on 25th May, 2011 but has been postponed to 7th June, 2011.
About Affitech
Affitech AS is a publicly traded (NASDAQ OMX Copenhagen) human therapeutic antibody company based in Copenhagen, Denmark with R&D facilities in Oslo, Norway. The company utilizes a range of proprietary antibody technologies for the discovery of fully human antibodies for application in oncology, inflammation and other disease areas. CBAS™ (Cell Based Antibody Selection) is Affitech’s premier discovery engine for the isolation of lead antibodies to cell surface molecules. Affitech co-develops its two lead antibody drug candidates AT001/r84 and AT008/CCR4 with Russian partner NauchTekhStroy Plus. The Company’s initial focus is on rapid and cost effective development by partnering clinical trials in emerging markets. Further information is available at www.affitech.com.
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.
Contact:
Randi Krogsgaard, Director IR & Corporate Communications
Tel # +45 2320 1001, e-mail: ir@affitech.com
