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Replies to post #178717 on Anavex Life Sciences Corp (AVXL)
MEI MEI HU, JD
Chief Executive Officer
Mei Mei Hu is one of our co-founders and a member of our Board of Directors. She serves as our Chief Executive Officer. She is a member of the executive committee of United Biomedical, Inc. and a member of its Board of Directors, and previously served as co-CEO. During that time, she oversaw the launch of one of the first endobody vaccines in the world and the successful spin-out of three companies. Mei Mei was formerly a consultant at McKinsey & Company where she advised pharmaceutical companies on strategic, operational and organizational issues. Prior to that, Mei Mei was in the Securities group at Cravath, Swaine and Moore. Mei Mei is also co-founder of an investment and advisory group with active investments in real estate, energy and life sciences. She holds a B.A. from University of Pennsylvania and her J.D. from Harvard Law School.
Senior Vice President, Clinical Development
Peter Powchik, MD, has been Senior Vice President, Clinical Development since October 2006. Prior to joining the company, Dr. Powchik served as Senior Vice President and Chief Medical Officer at Chugai Pharma USA, a position he held from May 2005 until October 2006. From April 2001 until May 2005, he held various senior clinical development positions at Novartis Pharmaceuticals Corporation, most recently as Vice President, U.S. Clinical Development and Medical Affairs. Dr. Powchik held various clinical development positions with Sepracor Inc. and Pfizer Inc. from October 1996 to April 2001. Dr. Powchik received his MD from New York University School of Medicine.
M.D, Executive Vice President of Research & Development
Dr. Ajay Verma Transitions to Senior Advisor
NEWS PROVIDED BY
United Neuroscience
Dec 21, 2018, 10:00 ET
DUBLIN, Dec. 21, 2018 /PRNewswire/ -- United Neuroscience (UNS), a clinical-stage biotech company pioneering a new class of medicine to treat and prevent brain disorders, today announced the appointment of Peter Powchik, M.D., to the newly created position of Executive Vice President of Research & Development effective Jan. 1, 2019.
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As Alz players stand United, new a-beta bids also to fall?
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By Randy Osborne
Staff Writer
United Neuroscience Inc.'s chief medical officer, Ajay Verma, told BioWorld that research into Alzheimer's disease (AD) has "positioned us now to finally test the hypothesis" that amyloid beta (a-beta) is the culprit, or at least a main one, in the scourge. "This may sound like punting a little bit, after 20 years of failures, [but] it took 15 years for cholesterol to even be accepted as a biomarker, let alone a therapeutic target," he said.
Verma noted that in genetic forms of AD, about 5 or 10 percent of the disease population, a-beta is "absolutely the target. In the sporadic population, it's likely that there are more than one target, but I don't think people are shying away from [a-beta] so much as a target as how do we address that target? When do we start to address it? When is it too late to address it? Who are the right people? How do we attack it? Some of that has been learned along the way, over the last decade."
As the elderly population grows and AD failures mount, research has picked up steam. "We're building an airplane while we're flying it," Verma said. "We have to, because of the urgency."
The clinical skies have not been friendly to AD, but Dublin-based United has hope for what the company calls an endobody approach – "an antibody that your body produces against an endogenous protein," CEO Mei Mei Hu said. United disclosed its analysis of phase I data with UB-311, a synthetic peptide vaccine targeting a-beta. Results showed that UB-311 was able to generate antibodies to specific a-beta oligomers and fibrils with no decrease in antibody levels in patients of advanced age. What's more, amyloid positron emission tomography (PET) imaging and genetic screening for APOE4 status in an ongoing phase II study demonstrated an efficient method to identify subjects with mild AD for disease modification trials in early to mild AD.
Results from the phase II trial are expected in the second half of next year. "Our goal is to get into a registration trial after the phase II readout," Hu said. "Very likely that will be a treatment trial," since a prevention study would take significantly longer. "Treatments are important, patients need them today," she said. "But can you imagine if, 10 years from now, you actually had a vaccine that you went in [and got] like a flu shot? Where you could prevent the disease in the first place? This is our vision. Obviously, there's a long road to get there."
Thanks to the company's platform, "we're able to target lots of other proteins," she said. "[A vaccine targeting] tau is a little farther behind" the a-beta candidate, and a combination vaccine is in the works. There's also a preclinical prospect that targets alpha-synuclein, plus two more that are undisclosed.
The platform technology was originally developed by United's parent company, United Biomedical Inc., of Hauppauge, N.Y. Key to the method is what's called the UBITh immunogen. Unlike with traditional vaccines that use keyhole limpet hemocyanin or a toxoid carrier so that the vast majority of response is directed at the toxoid, UBITh immunogens are "immunosilent," and the majority of response goes at the target B-cell epitope. "We want to train the body to fight these plaques in the brain," Hu said. "The trick is, can you do that safely and precisely."
Verma agreed about the long road, but pointed out that, for United, the trip "started a while ago. Our parent company has been at this for 20 years. They've learned a lot about the vaccine approach with endobodies in animal health. Along with the advancements in the technology itself, we're fortunate to be at a time when we're learning from other trials. I actually don't think the road is that long."
Regarding the value of an immunotherapy approach to a-beta or tau, "we will have a conclusive answer within the next three to five years," he said. "We're going to be part of the mix of companies that provide that answer."
Success in AD phase II studies has proved tough to follow with phase III wins. "Because of the size and logistics, you can't always do everything you want to in a phase III," Verma said. International trials have meant special complexities. "Even such a simple thing as [measuring] a cognitive skill, if you're doing it in Japanese vs. Korean vs. English," can muddy the data waters. "There's a lot of noise that gets built in, unfortunately."
A great help, he said, "has been the evolution of objective biomarkers" such as amyloid imaging. "When I was at Biogen, we were the first to absolutely require that as an inclusion criterion," he said. "It sounds simple now [but] it wasn't back then." PET imaging, peripheral biomarkers in the blood that report neurodegeneration, and "really nice ligands for tau that are developing will ensure much better success between phase II and phase III," he said.
