NEW YORK, NY--(Marketwire - May 29, 2012) - LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Ablynx, NV (EURONEXT BRUSSELS: ABLX), a biopharmaceutical company engaged in the discovery and development of a novel class of protein-based therapeutics called Nanobodies. The Company is conducting several clinical trials of Nanobody products to treat various disorders. Ablynx also maintains multiple development partnerships with major pharmaceutical companies, which strengthen the sustainability of the business and the Company's cash generation potential.
Ablynx expects clinical trial data from the TITAN Phase II trial for the ALX-0081/ALX-0681 Nanobody as a treatment for thrombotic thrompocytopenia purpura (TTP) in the second half of 2013. There are no drugs currently approved for treating TTP; the standard of care is plasma exchange (PE). The proposed treatment is a combination of an intravenous (ALX-0081) and subcutaneous (ALX-0681) dosing of the therapeutic Nanobody targeting vWF. TTP is a rare blood-clotting disease in which clots form in a patient's blood vessels, causing damage to red blood cells and eventually to the heart, brain and kidneys. The anti-vWF Nanobody treatment for TTP received Orphan Drug designation from the FDA and EMA in May 2009, providing a period of market exclusivity upon approval. Because of the level of unmet need, it may be possible for Ablynx to file for marketing approval based on positive Phase II data. If that is the case, a marketing authorization application (MAA) in Europe may be filed after the primary endpoint has been achieved in the trial. This could then be the first Nanobody on the market.
Before the end of 2012, Ablynx expects potential proof-of-concept for the anti-IL-6R Nanobody, ALX-0061, in patients with rheumatoid arthritis, and Phase I data for the Nanobody targeting respiratory syncytial virus, ALX-0171, the first Nanobody in the clinic that is administered through inhalation rather than injection.
"Ablynx' Nanobody biologic therapeutic development platform has the potential to successfully introduce effective, targeted therapies for difficult targets," said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. "Importantly, the Company's extensive development agreements with Boehringer Ingelheim, Merck Serono, and Novartis, as well as considerable early clinical success, offer important validation of the potential of the Nanobody technology platform to deliver unique biological treatments for multiple diseases."
In a 50-page Initiation Report by LifeSci Advisors, we explain the scientific basis and commercial prospects for the novel compounds produced from Ablynx's proprietary drug discovery program. Nanobodies are a novel class of therapeutic proteins based on single-domain antibody fragments. Ablynx has established a series of collaborations with large pharmaceutical partners who provide non-dilutive funding for the ongoing development of Nanobody therapeutics. Ablynx has received more than $208 million (EUR 160 million) and selected 18 Nanobody candidates with Merck Serono, Novartis, and Boehringer Ingelheim. In March 2012, Ablynx announced that the research funding stage of the strategic alliance with BI has been extended through September of 2014. Phase I testing is expected to begin in 2012 for a Novartis-partnered Nanobody program and for the Alzheimer's program with Boehringer Ingelheim. Ablynx is partnering with large pharmaceutical partners to develop Nanobodies targeting both blockbuster and niche applications. The Company has used the proceeds of these collaborations to fund clinical programs in indications such as thrombotic thrombocytopenic purpura (TTP), treatment of respiratory syncytial virus (RSV) infections, and rheumatoid arthritis (RA).
Nanobodies, also known as single-domain antibodies, can be thought of as scaled-down versions of the increasingly important class of biological drugs called monoclonal antibodies (mAbs). Like antibodies, Nanobodies can be developed to go after any target antigen. However, Nanobodies have many advantages over mAbs, including the ability to format and go after multiple targets. Nanobodies can be monovalent or may contain multiple functional domains, allowing these therapeutic molecules to specifically target complex biological targets. It is also possible to control the half-life of Nanobodies using serum albumin binding domains or pegylation. Nanobodies are easier to handle and store than mAbs, and many do not require cold storage. Their small size and robustness allows for alternative routes of administration such as inhalation. While mAbs are exclusively manufactured using mammalian cells, Nanobodies can be manufactured using yeast or E. coli, which is easier and cheaper. These factors lead to lower cost of goods for Nanobodies than for mAbs. Finally, Nanobodies' small size may allow them to penetrate tissues or bind targets that may be inaccessible to the larger mAbs. Clinical proof of concept for Nanobodies has been achieved, as detailed in our Initiation Report.
Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.
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