News
Company News: Anergis Reaches Important Milestones with Second Product Candidate AllerR
– US Regulatory path for new vaccine against ragweed pollen allergies established –
Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it has reached several preclinical development milestones with AllerR, a novel allergy vaccine candidate for the treatment of patients with allergies to ragweed pollen. In addition, the company received positive feedback from the FDA on its AllerR development program.
In the development of AllerR, its second allergy vaccine candidate, Anergis reached essential preclinical milestones and held its first meeting with the US FDA in preparation for the first clinical trial of AllerR in patients allergic to ragweed pollen.
In preclinical experiments carried out by Anergis, binding of the AllerR peptides to IgE antibodies of allergic patients remained consistently undetectable in all conditions tested. In mice pre-sensitized to ragweed pollen, AllerR, unlike natural ragweed allergens, did not elicit an anaphylaxis-like response. And, importantly, AllerR was found to elicit antibody responses in mice, in which the antibodies recognized the natural ragweed allergens. Following collection of these data, Anergis held a pre-IND meeting with the U.S. FDA during which the regulatory path was clearly established until and including the clinical Phase I trial protocol.
akampion Meets… Martin Austin, Founder & Managing Director of TransformRx and Director of Alma Bio Therapeutics
akampion: When we first met, you were with Paul Capital Partners and very actively scouting the European biotech scene for potential deals. Since then, you have founded TransformRx and now you are also a Director at Alma Bio Therapeutics – how did that come about?
Martin Austin: I left Paul Capital because in my view, the market for royalty funds was beginning to narrow and only companies with sufficient revenues could really fit into the investment model. At the same time, the market trend moved more towards development and R&D. So I was wondering how to address these developments, and so I eventually acquired the Swiss subsidiary of Paul Capital and founded TransformRx GmbH.
Since I know operations in the pharma and the investment industries very well, the idea was to offer financial intermediation services. How can a biotech get money? How to invest in biotech?
akampion: We definitely believe there must have been a market for financial intermediation in the biotech sector – there still is!
Martin Austin: Indeed. But in addition, I also had clients calling up to get support in business development and commercialization, since I have been working in that space for a long time. So I took on these projects and had a request to develop a my commercial BD course with CELforPharma in Brussels into a format for a business development course at the University of Basel. It is part of a Master´s program at the European Center of Pharmaceutical Medicine ECPM which offers a range of training courses in the field of drug development, including leadership and biobusiness development. And then I had an invitation to run a course in China, which I have been running annually since 2007.
akampion: So one project led to another…
Martin Austin: Yes – and it continues! I received similar requests from France and elsewhere which led to my first book on Business Development in the Pharmaceutical Industry being published.The next book is out this year, by the way, and will focus on commercializing IP in healthcare. Just to give you some background, I have also been advising various technology transfer offices for a several years and this sparked the idea for the second book.
akampion: And now you´re also with Alma Bio Therapeutics, a company developing novel antiinflammatory drugs to treat Crohn´s disease and Ulcerative Colitis.
Martin Austin: Right. The CEO is a former “student” of mine. She contacted me because in Israel, the conditions for biotech companies are not very favorable, so the idea was to transfer IP and the company from Israel to Europe. Alma, for example, has a product licensed from the Weizmann Institute. The company is now situated at the Basel incubator and is looking for further funding from angel investors and VCs. The lead product is a synthetic gene sequence encouraging the body to produce a protein called HSP70. HSP70 acts as a transient signal to T-regulatory cells in the immune system which re-harmonises the body’s responses to inflammation. The initial mouse experiments have yielded very good results, so we have a mammalian proof-of-principle – and the manufacturing is already in place as well. I am very glad to be part of the company´s team because I believe that Alma as a start-up company is very well set. So we are ready for investment!
akampion: Thank you, Martin! We will keep our fingers crossed for Alma´s financing and hope to be able to read your new book soon.
Food for Thought: How to (Not?) Create a Buzz With Your Corporate Press Release
This week, NYC-based Immune Response BioPharma, Inc. announced that the company has terminated partnering discussions on its multiple sclerosis vaccine NeuroVax with GlaxoSmithKline. The news per se may not trigger a lot of interest – but the company has managed to create a significant buzz around its announcement, with CEO David Buswell stating that (quote from corporate press release):
“GSK is a joke and seems very ignorant on how multiple sclerosis drugs work and how to develop one, we gave them a chance to develop NeuroVax but their management appears to be very poor. We have decided to terminate any collaboration or development with GSK. GSK is a loser in the MS market and will continue to be a loser.”
When we first saw this press release, we immediately did some research to verify if it was a joke or not. However, it was posted on the company’s website on May 24. While the CEO certainly has shut the door for any further discussions with GSK, the PR has generated a lot of attention in the industry and everyone will be out following the company and the further fate of its compound. Still, we believe that the impact on Immune Response BioPharma´s corporate reputation will not be as positive as the buzz suggests.
What was your first thought when you read this statement?[poll id=”5″]
Company News: InDex Pharmaceuticals Appoints Stig Løkke Pedersen as Board Member
– Former Lundbeck Executive Brings Strong Commercial Experience and Extensive Pharmaceutical Industry Network –
InDex Pharmaceuticals today announced that Stig Løkke Pedersen has been appointed as a new member of the Board of Directors. Mr. Pedersen brings to InDex Pharmaceuticals over 25 years of longstanding life sciences industry experience in commercial operations and leadership.
Mr. Pedersen previously served as Executive Vice President of Commercial Operations at H. Lundbeck A/S. He joined Lundbeck in January 1992, being responsible for the company’s business development activities. Following a period as Managing Director of Lundbeck Netherlands, he became part of the corporate senior management in 1998. Mr. Pedersen was appointed Executive Vice President in April 2003 and held the position as EVP for Commercial Operations from 2007 until June 2011, when he resigned from his position at Lundbeck. Mr. Pedersen is a Partner at Executive Capital A/S and serves as the Chairman of the Board of Directors at Chemometec A/S and Nuevolution A/S. He is a member of the Board of Directors at MSI Methylation Sciences Inc. and a member of the Advisory Board of Atrium Partners A/S and JSB-Partners, as well as an advisor to the Lundbeck Foundation.