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XBiotech |
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October 29, 2012 Issue |
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The Most Powerful Name In Corporate News and Information |
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With Several Indications using their True Human™ Antibody Platform targeting IL-1a in the Clinical Pipeline, including a Fast Track Designation from the FDA for a Pivotal Phase III Study for the Treatment of Cancer associated Cachexia, XBiotech is well Positioned for Growth over the Next Five Years |
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http://www.xbiotech.com/
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Austin, Texas 78744
512-386-2900 |
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Interview
conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published –October
29, 2012 Mr. Simard: XBiotech was founded in 2005 around the notion that we could improve therapeutic antibodies by deriving them directly from humans. Antibodies in the clinic and in the market remain derived from animals, and are ‘humanized’ or synthetically made in the laboratory. The opportunity to make a safer, more tolerable antibody was the motivating factor behind the launch of XBiotech. Along the way, we discovered a very remarkable target for an antibody, Interleukin 1 Alpha (IL-1α). We obtained a true human antibody to target IL-1α and that program has become a cornerstone of the company’s business. While we have a human antibody discovery pipeline, and have some interesting things in this pipeline, the potential and the diversity of diseases treatable by targeting IL-1α has taken on a life of its own.
CEOCFO: Why Have Others Not Pursued True Human Antibodies? Mr. Simard: There have been isolated attempts at cloning true human antibodies. However, the job at hand was onerous and time consuming, as well as technically quite difficult. With the desire to quickly launch into the market, and with the great potential for therapeutic antibodies, companies hastened to establish whatever means they could to get antibodies developed rapidly. The quickest way to get antibodies into the clinic and market was to generate them from mice that you could immunize, and worry about reducing the immunogenicity and the tolerability problems of these non-human antibodies later. Most of the technology in the industry thus focused around this ‘humanization’ and the in vitro steps of trying to manipulate animal antibodies to make them tolerable in humans. There were time pressures, which focused the industry on quicker approaches. We just entered from a slightly different perspective, where we focused on learning how to produce human antibodies more efficiently and to work directly on that approach.
CEOCFO: Would you explain what you have developed as well as the science behind it? Mr. Simard: We have developed a discovery platform capable of identifying true human antibodies from people that are therapeutically relevant, and learned how to move those therapeutic candidates into a manufacturing process where we can make a product. Our clinical platform is targeting IL-1α, which is a fascinating target. It is involved in destructive inflammation which occurs in virtually all diseases to a lesser or greater extent, and plays a key role in the progression of many chronic illnesses. By blocking IL-1α with an antibody, we can stop that part of the chronic disease process that is, in some cases, the only process we know to be involved in the disease progression.
CEOCFO: Where are you in the development process? Mr. Simard: We have several indications in our IL-1α clinical pipeline. We just received Fast Track Designation from the FDA for a pivotal Phase III study for the treatment of cancer associated cachexia based on some remarkable observations in a Phase I/II study. Results demonstrated dramatically improved survival in advanced cancer patients who were able to build new lean body or muscle tissue in response to treatment with the antibody. The chronic inflammation in cancer patients drives muscle wasting, and blocking that inflammation allows the body to normalize and re-establish muscle. This is our most advanced program. We also have a randomized controlled study in vascular disease looking at restenosis in the peripheral artery, the superficial femoral artery of the leg. We have positive interim data from this study thus far. Blocking IL-1α seems to be benefiting patients with severe vascular disease by helping their arteries stay open and helping reduce the risk of Major Adverse Cardiovascular Events entirely in these patients. We have another study in Type 2 diabetes that we have just completed. In that study we were looking to see if we could improve glycemic control. In diabetic patients we have observed that overall glucose levels in the blood have come down and patients appear to be more capable of regulating their blood sugar levels during treatment with the IL-1α antibody. We also have a study that just completed in psoriasis demonstrating a substantial reduction in inflammatory lesions on the skin quite rapidly, within a few weeks. We have yet another study in acne also showing improvement in inflammatory lesions in a short course of treatment. We will be pursing both of these skin indications further in randomized controlled studies.
CEOCFO: With the large number of targets and research going on how do you stay focused? Mr. Simard: The fascinating and fortunate thing is that we are treating all of these diseases with a single agent. Once you get your manufacturing process running and your clinical team going, moving from one indication to another is not such a logistically complex step. It’s quite manageable from that point of view. There are efficiencies for developing more than one indication using one drug. The initial development in quality and manufacturing systems and processes makes it very cost-effective to then evaluate multiple indications in the clinic to see how it works.
CEOCFO: You have been in the industry for quite a while; what have you learned along the way which aids in your development with XBiotech? Mr. Simard: There are some simple principles in this business that remain true, and one is not to give up. We have been through some tough times in the macroeconomics of the world over the last several years and it makes it all that more difficult for a pre-revenue company. You have to stay focused on your technology and keep creating value, building and moving ahead with your crucial programs.
CEOCFO: Would you tell us about the new manufacturing facility? Mr. Simard: We acquired a 48-acre parcel of land near the city of Austin and we have designed a manufacturing complex along with some supporting operations that we intend to build on that property. To date, we have cleared the land and we have completed site preparation. From the date we lay our first brick, we expect it to be about eighteen months before the facility becomes operational. The facility is designed to provide capacity for the first few years of sales in the market, with the intention of providing infrastructure for the foreseeable future in the domestic market.
CEOCFO: You have a grand plan! Mr. Simard: Yes we do! The beauty of the manufacturing process that we have is that it is very simple. The plant and equipment infrastructure is scaled down compared to what’s in the industry today. The infrastructure we are building is actually very low cost and very manageable from a capital expenditure point of view. Ultimately, the facility itself will enable a great deal of flexibility and scalability in the manufacturing program. Unlike the conventional reactors today, which are large stainless steel reactors, we have relatively small units, so that if we sell drug faster, we can expand production by just bringing more units on the floor. Conversely, if production does not demand as much earlier on, we can begin operations with fewer units. This scalable, flexible, and low cost process we believe provides us with significant advantages in terms of a path to commercialization.
CEOCFO: Are you ahead of the curve in realizing the potential more efficiently? Mr. Simard: Disposable bioreactor technology was pioneered by a company back in the nineties and eventually the technology itself, the wave reactor, was purchased and pursued by GE. The use of disposable systems to date has been as small-scale ancillary production units within big pharma. They have been used in the seed train or for making small product batches, but never as a commercial platform. We are the pioneers in using this technology on a commercial scale. Currently, our manufacturing operation is up and running in our Austin facility. We think it makes tremendous sense and it will be a very good commercial platform from which to work.
CEOCFO: Have the medical and investment communities been paying attention? Mr. Simard: The medical community certainly has. We have had overwhelmingly positive and enthusiastic support from hospitals and clinicians. We are in a number of different leading centers in the country. For example, our Phase III study in cancer associated cachexia is launching with the lead center at the Mayo clinic. Our previous Phase I/II study in oncology was led by researchers at MD Anderson and our trials in other indications have been conducted by thought leaders in various fields. We have had great support from clinicians who are encouraged by the results they see for their patients. On the financial side, the markets have been so desperate over the last several years that there has been little opportunity for fundraising in the public markets. It is a very surprising situation on the investment banking side.
CEOCFO: How far will your current funding take you? Mr. Simard: Our current funding does not take us through to market, but we are constantly building our financial strength through equity placements and we are entertaining partnership opportunities.
CEOCFO: Why should the business and investment community pay attention to XBiotech?
Mr. Simard:
We have an extraordinary lead product and a clear commercialization path
both from a regulatory point of view and a manufacturing and product
development point of view. I do not think there is a biotech company in the
world, positioned to grow over the next five years as much as XBiotech. In
that respect, I think we are a unique investment opportunity. |
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We have an extraordinary lead product and a clear commercialization path both from a regulatory point of view and a manufacturing and product development point of view. I do not think there is a biotech company in the world, positioned to grow over the next five years as much as XBiotech. In that respect, I think we are a unique investment opportunity. –John Simard |
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Drug Development Companies, XBiotech, CEO Interviews 2012, True Human Antibody Platform, targeting IL-1a, Treatment of Cancer associated Cachexia, Recent CEO Interviews, Drug Development Stock, Healthcare Stocks, therapies that improve the safety and efficacy of antibody therapeutics, therapies that inhibit chronic sterile inflammation by targeting IL-1α, a master regulator of inflammation, drugs that address acne, psoriasis, cachexia, cancer, type 2 diabetes and cardiovascular disease, XBiotech Press Releases, News, Companies looking for venture capital, Angel Investors, private companies looking for investors, healthcare companies seeking investors, drug development companies needing investment capital |
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