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Oranoxis has a strong R&D team and we are enthusiastic in applying biomedical sciences. We actively pursue quick and accurate solutions for detections of small and big molecules in human body and environment, to help disease diagnosis, drug monitoring, personalized drug monitoring for efficient and safe dosing. We work hard to serve medical professionals, law enforcement, environment protection and personal care.

Orphagen focuses on orphan nuclear receptors for which pharmacological data is limited or non-existent and industry competition is minimal. Orphagen’s strengths lie in the validation of novel drug-like small molecule ligands in receptor assays and subsequent clarification of therapeutic utility in target cells and animal models. This "first-to-ligand" strategy attracts industry partners earlier in the drug development cycle than is possible in a more crowded area. By taking this approach, Orphagen signed a discovery and development partnership in autoimmune disease in 2008 with a mid-sized Japanese pharmaceutical company.

Orphagen Pharmaceuticals has been funded through partnership revenues and more than $5.5 million in external grant funding.

Orphagen's project pipeline:

1. Castration-resistant prostate cancer, Cushing's syndrome and adrenocortical cancer based on antagonists to steroidogenic factor-1 (SF-1).
2. Retinitis pigmentosa (novel target in retina) and the dry form of age-related macular degeneration
3. Mood disorders (novel target in CNS) based on modulation of circadian rhythm

TECHNOLOGY

Nuclear receptors are ligand-mediated transcription factors. As a drug class they have been very successful, but 23 of 48 remain unexplored (orphans).

Orphagen has performed the first small molecule validation for several of these orphan nuclear receptors and continues discovery on new targets.

Orphagen chooses targets based on key criteria:

1. Restricted expression (not ubiquitous)
2. Link between tissue distribution and knockout phenotype
3. Plausible therapeutic hypothesis
4. Evidence for ligand-binding pocket 

Company 

Qualiber, Inc. is a nanomedicine company with the mission to deliver innovative treatments for cancer and other life threatening diseases.  Utilizing nanotechnology it is creating medicines that have superior efficacy and safety profile. In addition, Qualiber is partnering with pharmaceutical/biotechnology companies to address delivery challenges of partner’s treatments.

The company has secured funding from the National Cancer Institute, UNC-CH, the North Carolina Biotechnology Center and pharmaceutical company partners.  The company is seeking $500K first tranche of $5M Series A funding to progress lead cancer product, NanoGTP™ (Nanomedicine delivering Gemcitabine Tri-Phosphate) towards human clinical trials.

1st Product: NanoGTP™, demonstrated superior efficacy & safety in animal models of human cancer 

Cancer (especially pancreatic and lung cancer) is a continuing leading cause of death and suffering in the US and the World. Though there are chemotherapeutic drugs on the market, most have limited effectiveness and cause serious side effects/toxicities. Qualiber is developing its first product NanoGTP for pancreatic and lung cancers. NanoGTP substantively improves the delivery of existing anticancer drug, gemcitabine, and enhances the potential for greater clinical benefit and expanded use.  In preclinical animal models of human cancer NanoGTP has demonstrated superior efficacy and safety than gemcitabine.  Company expects to complete scale-up manufacturing and preclinical toxicology studies by end-2013 followed by Investigational New Drug (IND) application filing to the FDA in 2014. The market for pancreatic cancer treatments is estimated to be $1.2Billion in 2015 and for lung cancer to be $9.5Billion in 2018.

Founders and Management Team

·        Dr. Anil K. Goyal, President & CEO. Over 20 years of leadership experience at venture-backed and public biotechnology companies. Managed and led exits: Optherion’s diagnostics division sale and Serenex >$300M sale to Pfizer.

·        Dr. Leaf Huang, CSO and Co-founder.  Distinguished Professor and Chair, Division of Molecular Pharmaceutics, UNC-Chapel Hill. More than 30 years research experience and world-renowned in development of liposome based drug and gene-delivery systems. Co-founder of four other companies.

Company Background

Michael Curley, Ph.D., and Patrick Hamilton, Ph.D., incorporated Thermedical in Delaware in 2008 to develop, manufacture, and sell thermal therapy devices. They have been collaborating since they met at the Massachusetts Institute of Technology’s Hyperthermia Center, and they have a unique and detailed understanding of biologic heat transfer. The company has seven employees.

Technology Overview

Thermedical’s first product, SERF Ablation therapy for liver cancer, has a 510(k) application pending with the FDA. Thermedical is taking a revolutionary approach to tumor thermal ablation by altering the physics of heat transfer in tissue. SERF Ablation transports thermal energy deep into tissue using convection of warm saline, which carries the heat through the extracellular space. The tissue is transformed from having the insulating properties of wood to conducting heat as efficiently as bronze. Radiofrequency (RF) energy then heats the transformed tissue, and can thereby treat 100 times the volume of tissue that conventional RF can heat. Thermedical has demonstrated that SERF Ablation can treat an 8-cm diameter liver tumor in five minutes.

Market Potential

SERF Ablation for Liver Cancer will extend a treatment therapy for small tumors—RF Ablation—to the 80 percent of patients with tumors larger than 3 cm. The 1.3 million patients annually diagnosed with these large tumors have no cure available to them and live less than one year. This market is significant, with $1.8 billion spent annually on palliative therapies for these patients.

The markets for follow-on products are even more substantial. SERF Ablation will be curative for Ventricular Tachycardia (VT), and will be a disruptive technology for the $7 billion Implantable Cardioverter Defibrillator market. SERF Ablation for fibroids is an alternative to hysterectomy and may restore fertility in the 300,000 women who present with fibroids annually in the U.S. 

Competitive Advantage

Thermedical’s competitive advantage is their expertise on biologic heat transfer and their techniques for increasing heat transfer in tissue. Tissue does not conduct heat well, so existing ablation systems overheat tissue near the energy applicators. These products create hot-spots, islands of therapy in a sea of untreated tissue. SERF Ablation addresses the source of the problem. Warm saline transport increases the heat transfer capacity of tissue by a factor of more than 20, and can quickly and uniformly heat very large volumes of tissue — up to 8 cm diameter — using a single RF applicator. SERF Ablation is uniquely capable of treating conditions that require ablation of large volumes of tissue.

Financial Overview

Thermedical has been funded through NCI and NHLBI grants ($9.0 million) and a grant from the Massachusetts Life Sciences Center ($500,000). With these funds the company has brought SERF Ablation to a 510(k) application. Thermedical has just received its Series A investment from Dr. Samuel H. Maslak, the founder and former CEO of Acuson, the pioneering developer of modern ultrasound imaging systems, acquired by Siemens in 2001. These funds will be used for expanded regulatory clearances. Thermedical seeks funds for human clinical trials of their liver cancer ablation system.

Intellectual Property

Thermedical’s technique is protected by U.S. Patent #6,328,735. The company has filed four additional patents and two trademarks.

Commercialization Strategy

Thermedical will sell direct in the U.S., building a strong training program to ensure that physicians understand the technology. The company will use this approach in Europe for product introduction, but will shift to distributors once the product is established. Thermedical plans to use distributors in the rest of the world. 

Pipeline Products

New SERF Ablation therapies will be built around the company’s SERF Ablation system, which can be used to treat a variety of conditions using therapy-specific applicators. The SERF Ablation system and needle for treating liver cancer are undergoing FDA 510(k) review. The company has also completed a preclinical prototype of their VT ablation catheter, which is undergoing successful preclinical testing. The gynecological application for treating fibroids is in design development. Clinical collaborators for all three applications are enthusiastic about bringing these new tools into the clinic.

Management Team

Michael Curley, Ph.D., President, is the inventor of SERF Ablation Therapy. Dr. Curley previously founded Acuson’s Interventional Devices Business Unit and was its Vice President and General Manager with full profit and loss responsibility. He invented the AcuNav™ Diagnostic Ultrasound Catheter and led its successful introduction to the electrophysiology and interventional cardiology markets; the AcuNav has accumulated more than $1.0 billion in sales to date. His graduate research focused on thermal therapy for cancer. He holds S.B., S.M, and Ph.D. degrees from MIT.

Katharine M. Stohlman, Chief Operating Officer and VP Regulatory and Clinical Affairs was VP of QA and Regulatory Affairs for Viacor, Inc., from 2002 to 2011 and held operational management positions with HP Medical Products Group from 1983 to 2002, with direct reports of more than 200 employees. She holds an S.B. from MIT and an MBA from Harvard Business School.

Patrick S. Hamilton, Ph.D., Founder and VP Engineering, has considerable experience designing and implementing hardware and software for diagnostic and therapeutic medical systems. Dr. Hamilton holds an S.B. from MIT and M.S. and Ph.D. degrees from the University of Wisconsin.