Utilizing Academic Labs
Yaupon Therapeutics(www.yaupontherapeutics.com) seeks out small molecule drugs developed in academic laboratories, "which are untapped repositories for drug candidates," says Robert Alonso, president and CEO of the Radnor-based company.
Yaupon is an American Indian name for tree leaves, and two of the company's four lead candidates are derived from plants. The lead candidate, Lobeline, obtained from the leaves of lobelia plants, treats metamphetamine addiction by modulating dopamine in the central nervous system to prevent the dopaminergic high induced by metamphetamine. Lobeline is moving into a multidosing Phase Ib trial.
Another plant product, nornicotine, comes from tobacco plants and is in preclinical evaluation as a treatment for smoking cessation. The company also will begin Phase II/III trials of Clearazide, a topical drug for cutaneous T-cell lymphoma with Orphan Drug Status.
Han Cao, Ph.D., founder of BioNanomatrix (www.bionanomatrix. com), in Philadelphia, knows first hand that necessity is the mother of invention. As a molecular biologist working with embryonic stem cells, he needed to accumulate samples for two months in order to perform microarray experiments.
"I wanted a technology to look at single cells," says Dr. Cao. So he joined a nanotechnology group at Princeton University to learn about nanomaterials used in the semiconductor industry. He designed a nanoarray with parallel channels to look at large populations of molecules at the resolution of a single molecule.
"You can look at hundreds to thousands of molecules in parallel simultaneously, yet every molecule is in its own channel," he says. Dr. Cao foresees nanoarrays enabling researchers to look at a stream of genomic DNA in its native state with all the biological information intact.
In contrast, all current methods, like Northern blots, require that samples be broken up, then reassembled, and provide indirect data. BioNanomatrix plans to provide instruments, nanochips, and consumables to help clinical researchers zoom in on parts of chromosomes related to diseases.
"The world of protein therapeutics is exploding," says David King, CEO of BioRexis Pharmaceutical (www.biorexis.com) in King of Prussia. However, many biophamaceuticals have short half-lifes and are expensive to manufacture.
"We have a technology to solve these problems," says King. The proprietary platform fuses transferrin to protein and peptide therapeutics, thereby extending their half-life from minutes or hours to weeks. Consequently, patients may require just a weekly injection rather than daily injections.
"Transferrin is the second most abundant protein in blood that carries iron," says Rick Jones, M.D., director of business development at Biorexis. Transferrin not only protects the attached peptides, but also is "very bioavailable and reaches all the cells in the body," says Dr. Jones.
In addition, Biorexis manufactures its transferrin fusion proteins in yeast. The yeast process can be scaled up to produce large quantities of biotherapeutics, so "our cost of goods is much less than other biopharmaceuticals," says Dr. Jones.
Biorexis will file its first IND in the summer of 2005 to evaluate its formulation for glucagon-like peptide 1 (GLP-1) for type 2 diabetes.
In May 2005, the FDA approved Byetta (exenatide), the first commercial product based on GLP-1, made by Amylin Pharmaceuticals and Eli Lilly & Co.