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Company Background

Omniox is a biotechnology company commercializing a breakthrough oxygen delivery technology called H-NOX for a broad range of peripheral hypoxia diseases including cancer, acute cardiovascular ischemia, wounds, and trauma. The H-NOX technology directly overcomes key reasons for the failure of prior efforts in this area. The technology was originally developed in the laboratory of Michael Marletta, currently President and CEO of The Scripps Research Institute. Omniox currently employs seven full-time scientists and has laboratory operations in Mission Bay, San Francisco, and Sunnyvale, Calif. 

Technology Overview

Omniox is a preclinical/IND-stage company initially focused on developing an H-NOX product that sensitizes hypoxic tumors to radiation and chemotherapy. Preclinical data with the lead H-NOX candidate demonstrate substantial re-oxygenation of hypoxic tumors. When combined with radiation, there is a significant delay in tumor growth and enhanced survival in relevant mouse models of human cancer including glioblastoma, with a promising safety profile.

The University of California, San Francisco Neuro-Oncology Clinical Site Committee has approved H-NOX for parallel Phase IB clinical trials in recurrent and newly diagnosed glioblastoma. A real-time pharmacodynamic biomarker for hypoxia has been validated in the clinic and will be used to identify appropriate patients and measure the biological effects of H-NOX in reducing tumor hypoxia. 

Market Potential

Radiation therapy is the most common non-surgical treatment for cancer patients (more than chemotherapy and targeted therapies combined). Needham & Company estimates that an oxygen-delivery therapy to improve chemo-radiation would command $4,000 to $20,000 per round of chemo-radiation treatment and may represent a market of $3 to $5 billion per year. The competitive, regulatory, clinical, and reimbursement landscapes for this indication are compelling.

Competitive Advantage 

Omniox’s H-NOX oxygen carriers are designed to penetrate deep into the tumor tissue, beyond the reach of red blood cells. This approach is a major improvement over prior clinical efforts relying on manipulating red blood cells: this only succeeded in hyper-oxygenating normoxic tissues with minimal effects on hypoxic tumors. H-NOX is an entirely new approach to re-oxygenating hypoxic tumors to enhance chemo/radiosensitiation.

Financial Overview 

Omniox has secured more than $4 million in NIH SBIR funding since 2009. We are actively seeking equity financing to match the NCI Phase IIB $3 million Bridge Award to advance a lead candidate through Phase IB clinical trials. This clinical milestone will create a significant value inflection for investors joining at this stage of development.

Omniox has received firm commitments for $1 million from high net worth investors, and is seeking a minimum of $2 million in additional investments to match the NCI Bridge award. 

Intellectual Property 

In 2006, UC Berkeley filed broad patent claims to protect the core technologies, and Omniox continues to file for further protection of specific applications. Omniox holds an exclusive option to negotiate (with capped financials) for an exclusive worldwide license for all therapeutic and industrial uses of these technologies. The company has retained the law firm of Morrison & Foerster to oversee IP matters and the firm of Latham & Watkins for corporate affairs. More details on the current status of national filing phases of the core patents are available upon further request.

Commercialization Strategy 

Omniox expects to partner with or be acquired by a pharmaceutical company to successfully commercialize H-NOX for peripheral oxygen delivery. All major pharmaceutical companies are currently conducting clinical trials with chemotherapeutics or targeted therapies in combination with radiation, with the goal of enhancing the efficacy of radiation. 

The lead H-NOX product will be best utilized by medical oncologists who oversee patient treatment plans as part of a team of oncology professionals, including a radiation oncologist. More than 90 percent of radiation oncologists practice within two blocks of medical oncology clinics, therefore, radiosensitizers can be infused at the medical oncology office prior to transport of the patient for radiation treatment.

Pipeline Products 

H-NOX oxygen carriers have the potential to reduce tissue loss during myocardial infarctions and stroke, as well as in acute and chronic wound settings, a range of transplant surgeries, and ultimately may function as part of a resuscitation fluid in emergent situations. There is tremendous life cycle potential for H-NOX proteins beyond their utility in oncology.

Management Team 

Omniox is led by CEO and co-founder Stephen Cary, formerly in Research and Development/Market Strategy at Genentech. 

The Chair of the Scientific Advisory Board is co-founder, Michael Marletta, currently President/CEO of The Scripps Research Institute, member of the SAB of HHMI, and member of NAS and IOM. He has extensive experience in advising pharmaceutical companies in drug development. 

The business co-founder is Ajit Shah, who has a combined 24 years of experience as an entrepreneur, operating executive, and venture capitalist. He is active in Silicon Valley as an outstanding scientific and strategic advisor to start-ups. 

The IND Core Team is made up of experienced drug development veterans from Genentech, Quintiles, and Baxter Healthcare. 

Company Background

NovoMedix LLC specializes in the development of small molecule inhibitors of multiple biological pathways that are critical drivers of disease and are relatively inactive in normal tissues and housekeeping processes, with an initial focus on cancer. NovoMedix targets underserved markets with unmet clinical needs, including triple negative breast cancer (TNBC), high risk B-cell acute lymphoblastic leukemia (B-ALL), and melanoma.

Technology Overview 

NovoMedix has developed two new classes of small molecule translation initiation inhibitors with unique mechanisms of action as targeted therapies for high risk TNBC (estrogen and progesterone receptor, and HER2/neu-negative breast cancer). Lead compounds are currently in the preclinical stage and have been tested in an animal model of TNBC in which they significantly reduced tumor growth (better than paclitaxel) with no apparent toxicity. These novel compounds are promising clinical candidates and represent first-in-class small molecule therapeutics aimed at reducing recurrence and increasing survival rates for TNBC. Since these drug candidates are small molecules, they will be less expensive and easier to administer than biologics and should fit easily within the current treatment regimen.

Market Potential 

Breast, prostate, and colorectal cancer account for more than half of cancer patients in the United States. One in eight women in the U.S. will develop breast cancer during her lifetime. Although the overall survival rate for early stage breast cancer is high, triple negative breast cancers are particularly aggressive and are more likely to recur than other subtypes, resulting in a significantly increased risk of death. Currently, no targeted therapies exist for TNBC. Since more than 60 percent of triple negative breast tumors overexpress eIF4E (a critical factor in translation initiation), and high levels of eIF4E are correlated with recurrence and death, inhibitors of protein translation initiation should prove to be a viable targeted therapy for TNBC with high eIF4E.

Competitive Advantage

NovoMedix’s most advanced drug candidates for the treatment of TNBC represent two new classes of translation initiation inhibitors with unique mechanisms of action. Besides the anti-viral drug, ribavirin, there are no viable drug-like inhibitors of translation initiation have been reported to date. More importantly, there are virtually no novel therapies in clinical trials for TNBC. Most ongoing trials for TNBC are on various combinations of existing chemotherapy drugs. Recent data suggests that at least one of these “first-in-class” compounds has the potential to enter into a Phase I clinical trial for TNBC.

Financial Overview 

NovoMedix LLC was established as a partnership in 2001 and converted to an LLC in 2010 in anticipation of angel or VC funding and/or corporate partnerships. NovoMedix is currently privately owned and has no venture capital investment. NovoMedix has raised $1.75 million in equity, government grant, and tax credit revenue. SBIR funding has allowed the company to increase its value without dilution. NovoMedix is seeking a strategic investment of $5 million to complete preclinical studies and file an IND for TNBC within 24 months. NovoMedix would then partner with a larger pharmaceutical company for clinical development and commercialization of a novel therapy for TNBC.

Intellectual Property 

NovoMedix has filed a composition of matter patent application (PCT/US2011/039377) for the NM043 series of compounds for the treatment, prevention, and/or amelioration of various disorders, including cancer. In addition, NovoMedix is in the process of filing provisional patents on several other lead series.

Commercialization Strategy 

NovoMedix’s commercialization strategy is to design and execute an IND-enabling nonclinical safety program to support a Phase I clinical trial in patients with advanced metastatic disease and enter into partnerships with pharmaceutical companies for the clinical development and ultimate commercialization of novel small molecule drugs. NovoMedix plans to license its compounds in exchange for licensing fees, milestone payments, and royalties.

Pipeline Products 

The NovoMedix pipeline contains several novel compounds in various stages of development. Most relevant to this project are follow-up studies that are planned to determine the efficacy of previously identified lead compounds for the treatment of metastatic breast cancer. In addition, several different novel lead compounds are currently under development for the treatment of high risk pediatric B-ALL. These compounds have demonstrated in vitro safety and efficacy and preliminary safety in animals. In vivo studies in mouse models of high risk B-ALL are the subject of a recently submitted Phase I SBIR proposal.

Management Team 

Cathy Swindlehurst, Ph.D., Founder and CEO, has 22 years of experience in biotechnology. Former V.P. at PanCel, MagneSensors, and NovaDx.

Leah Fung, Ph.D., Founder and Exec. Director, Drug Discovery, has 20 years of experience in medicinal chemistry. Management positions at Structural Genomics, Structural Bioinformatics, and Celgene.

Sabine Ottilie, Ph.D., Director, Molecular Oncology, has 20 years of molecular oncology research experience in academia and biotechnology.

Company Background

BioMarker Strategies was founded in 2006 by Dr. Douglas Clark, a Professor of Pathology at Johns Hopkins, to improve the treatment of cancer by developing first-in-class, live-tumor-cell-based predictive tests to guide targeted drug therapy selection. Today the company is based at the Johns Hopkins Science + Technology Park and employs 10 people. BioMarker Strategies has successfully developed the SnapPath™ testing platform, and is engaged in pre-clinical and clinical studies with two major academic medical centers. 

Technology Overview

The SnapPath biomarker testing system is an automated live-tumor-cell processing platform that enables next-generation, ex vivo biomarker tests to guide targeted drug therapy selection. A small portion of a patient’s live tumor (from a biopsy or surgical excision) is placed into a disposable cartridge and inserted into the SnapPath instrument. The SnapPath uses onboard robotics and fluid handling systems to expose a patient’s live tumor cells to drugs and/or growth factors to evoke a phosphoprotein-based Functional Signaling Profile (FSP) of the signal transduction network that is not possible using static biomarkers from dead, fixed tissue. These FSPs generated by the SnapPath device can be utilized by oncologists to guide targeted therapy for cancer patients. To date, the company completed proof-of-mechanism studies with human melanoma samples using a prototype device, produced and verified several SnapPath alpha units, and placed two of alpha units at academic medical centers for clinical research studies.

Market Potential 

With approximately 1.5 million solid tumor cancer patients in the U.S., the total addressable market for live-tissue testing exceeds $5 billion, assuming value-based reimbursement. Within this population, the initial target markets include: 

• Melanoma (BRAF V600E)
• Lung carcinoma (EGFR wt)
• Colorectal carcinoma (KRAS wt)
• Breast (Triple Negative) 
• Renal cell carcinoma 

Competitive Advantage 

Most current molecular profiling strategies rely on the analysis of static DNA or protein-based biomarkers, but this tells little about the actual functioning of the complex signal transduction network within tumor cells. By interrogating living solid tumor cells from cancer patients using the SnapPath testing platform, the resultant predictive tests will contain novel information content — such as pathway bypass mechanisms and feedback loops — that will enable oncologists to select better targeted therapies, including drug combinations, for their patients. 

Financial Overview 

To date, BioMarker Strategies has obtained the following funding:

• $9 million from private investors 
• $2.3 million SBIR Fast Track Phase I/II contract for SnapPath instrumentation development
• $200,000 Phase I SBIR contract for companion diagnostic development 
• Additional funding from the Federal Therapeutic Discovery Tax Credit Program, MD TEDCO, and Johnson & Johnson

BioMarker Strategies is currently seeking investors for an initial institutional investment round of $7 million to achieve the early-stage commercialization goals outlined below.

Intellectual Property 

BioMarker Strategies is using a combination of patent filings, trade secrets, and trademarks to protect its proprietary interest in the SnapPath testing system. To date, the company has filed three patent applications that focus on the platform, the process of ex vivo stimulation, and the resultant ex vivo test content. 

Commercialization Strategy 

The company’s long-term commercialization strategy is focused on developing SnapPath-deployed predictive tests to guide therapy for solid-tumor cancer patients in the U.S., Europe, and Asia. BioMarker Strategies will use the following steps to bring its products to market: 

• Early-stage commercialization
• Place first-generation SnapPath units at comprehensive cancer centers 
• Achieve 510(k) approval for the platform
• Expand academic and pharma collaborations 

Later-stage commercialization 

• Increase SnapPath placements at additional cancer centers
• Expand sales and marketing infrastructure
• Validate and clinically qualify tests
• Establish Clinical Laboratory Improvement Amendments (CLIA) lab and launch Laboratory Developed Tests (LDTs)
• Transition LDTs to pre-market approval (PMA) 

Pipeline Products 

BioMarker Strategies’ proof-of-concept studies have focused on characterizing resistance to BRAF inhibitors in advanced melanoma. This will be followed by the development and launch of tests to guide targeted drug use in larger markets such as non-small-cell lung, colorectal, breast, and renal cell carcinomas. Given the ability to test specific drugs in the device, SnapPath also has the potential to become a platform to improve early drug development, provide more effective clinical trial design through patient stratification, and enable companion diagnostics. To this end, the company was awarded a SBIR grant in September 2011, to support the development of a pathway-based companion diagnostic test to use in conjunction with the SnapPath platform. 

Management Team 

Douglas Clark, M.D., Chief Medical Officer/Acting CEO, is an entrepreneur and a Professor of Pathology at The Johns Hopkins Medical Institutions, who brings over 20 years of experience in diagnostic pathology, laboratory management, and biomarker discovery. 

Scott Allocco, co-founder, brings 15 years of business development, pharmaceutical drug management, and public-sector reimbursement experience to the company, having most recently served as the Vice President of State Government Affairs and Business Development for Coventry Health Care. 

Adam Schayowitz Ph.D., MB A, Senior Director of Operations and Business Development, brings nearly a decade of experience in tumor cell biology with a focus in targeted cancer therapeutics, preclinical, and early clinical drug development, and leads the company’s strategic partnerships and collaborations with external collaborators.

Board of Directors: Glenn Miller, Ph.D., Chairman, VP/Head of Personalized Medicine at AstraZeneca; Dr. Samuel Broder, former Director of the National Cancer Institute; Dr. Paul Beresford, VP of Business Development at Biodesix and former VP of Translational Diagnostics at Ventana Medical Systems; Skip Klein, Managing Member at Gauss Capital Advisory and founder of the T. Rowe Price Health Sciences Fund; and Christy Wyskiel, former Managing Director at Maverick Capital and Life Sciences Equity Analyst at T. Rowe Price.

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.