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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

A&G Pharmaceutical (A&G), founded in 2000, is a privately held company based in Columbia, Md. A&G uses proprietary technology for rapid development of monoclonal antibodies (mAB) to unique cancer-specific theranostic targets, to develop novel therapy/diagnostic combination products that address a broad range of cancers. A&G holds a proprietary position on the detection and treatment of diseases related to the growth factor GP88 (progranulin). The company is currently developing a therapeutic mAB to treat lung and breast cancer. A&G has also developed clinically validated proprietary companion diagnostic products to identify and monitor patients treated with mAB. The company employs 22 people.

Technology Overview

Several peer reviewed studies have demonstrated that glycoprotein GP88 has a critical role in the proliferation and survival of cancer cells. A&G has developed a recombinant therapeutic anti-GP88 to treat cancers overexpressing GP88. Direct validation of GP88, as a novel therapeutic target, was provided by inhibition of GP88 expression and function in breast carcinoma cells resulting in both reduced proliferation in vitro and reduced malignancy in vivo. Xenograft data demonstrates that anti-GP88 is useful for the treatment of breast and lung cancers as a single agent. When used in combination with Tamoxifen in Tamoxifen-resistant tumors, anti-GP88 restores Tamoxifen sensitivity, leading to significant tumor reduction. Restored sensitivity to Tamoxifen and other anti-estrogen therapies is a major breakthrough, more than 50 percent of all patients on anti-estrogen develop resistance de novo or during treatment. Similar results were obtained with chemo resistant lung cancers. A&Gs pre-clinical candidate is ready to enter IND-enabling acute and repeat dose toxicology studies in primates.

Market Potential

GP88 therapy can address two leading cancers in the U.S., including: breast (220,000 new cases; 40,000 deaths annually) and lung (200,000 cases;160,000 deaths) cancers. More than 50 percent of lung cancer patients die within 5 years. There is an unmet need for targeted lung cancer therapies, especially among cancers that are chemo resistant. In the case of breast cancer even for Tamoxifen, a leading drug used to treat breast cancer, 40-50 percent of patients do not respond to initial treatment, while the majority of those patients that do respond can have the cancer become resistant during treatment. A&G has developed diagnostic kits to identify patients who are de novo resistant or who are becoming resistant and thus identify patients that are suitable for anti-GP88 therapy.

Competitive Advantage

• GP88 is uniquely placed as a novel biological target for development of products for oncology:
• GP88 is a critical biological player in development, proliferation and survival, and drug resistance for several cancers
• GP88 expression in tumor tissue has been statistically shown to be a prognostic indicator of poor patient outcome (disease-free and overall survival)
• GP88 is secreted by cancer cells and detectable in blood, making it an important target for therapeutic and diagnostic product development
• Inhibiting GP88 with mAB reduces tumor growth and reverses resistance to hormone therapy in breast cancer
• 2 GP88 Diagnostic tests have been clinically evaluated: (1) Tumor levels are prognostic, (2) Blood levels are linked to tumor growth and can be used to monitor treatment

Herceptin remains the last major combination therapeutic and companion diagnostic co-development in oncology. GP88 is positioned to be the next major theranostic product.

Financial Overview

A&G Pharmaceutical’s financial overview includes:

• Seed capitalization of $1.5 million in 2002
• Closed a Series A round of $2 million in 2005
• Raised a total of $6.4 million in 2006 in form of strategic investment. As part of license agreement with Celltrion they agreed to provide cash and candidate development including initial manufacturing process development and materials for toxicology.
• Completed Series B prime financing of $4 million 2008.
• Profits from sales of custom monoclonal antibodies (www.precisionantibody.com); anticipated revenues for 2012 are more than $2.8 million.
• Seeking a $5.0 million investment to fund toxicology and first-in-human clinical studies.

Intellectual Property

Fifty patent applications and 49 patents (15 U.S. patents) granted worldwide covering therapy and diagnostic use of GP88.

Commercialization Strategy

A&G will enter safety/efficacy clinical studies of anti-GP88 in lung/breast cancer. During early clinical trials, A&G will pursue agreement(s) with key player (s) in the pharmaceutical/biotech industry active in the field of oncology. Such agreement(s) will dictate the commercialization strategy for anti-GP88.

Pipeline Products

GP88 has been implicated in several cancers and as such A&G is interested in developing its proprietary theranostic pipeline for use in cancers of the GI, prostate, and brain. Using A&G’s proprietary antibody development technology the company is researching other cancer biomarkers for development along the theranostic pathway.

Management Team

A&G’s CEO, Ginette Serrero, Ph.D., has 25 years of experience in cancer research and 10 years in biotech management and has been instrumental in directing A&G’s vision and assembling the management team.

VP of Drug Discovery, Randy Barton, Ph.D., was previously the director of drug discovery, Boehringer Ingelheim, and has 20 years of experience validating small-molecule and biological drug candidates.

VP of R&D Jun Hayashi, Ph.D., is an immunologist and inventor of A&G’s proprietary mAB technology.

COO Michael Keefe, MBA, is seasoned in raising capital and managing the growth of start-ups.

VP of Product Management, David Hicks, has more than 20 years of experience with diagnostic products and clinical development.

Company Background Gamma Medica, Inc., (GMI) is a revenue-stage company that develops and utilizes advanced solid-state digital detectors in health care imaging systems with leading-edge technology. CEO Bradley Patt, Ph.D., co-founded GMI in 2001. GMI acquired in 2005 IDEAS of Oslo, Norway, and in 2006 Advanced Molecular Imaging of Sherbrooke, Quebec. GMI and GE Healthcare entered a joint venture in preclinical imaging in 2008, and then Gamma Medica acquired the entire business in 2011. GMI has 60 employees and leverages contract engineers, contract manufacturers, and distributors. Projected 2012 sales will be $24.7 million, comprising 75 percent preclinical, 20 percent clinical, and 5 percent industrial electronics.  Technology Overview  GMI’s FDA-approved Molecular Breast Imaging (MBI) device is installed in 20 clinical sites and uses mild immobilization of the breast between two digital, solid-state gamma photon detectors that image cancer lesions regardless of breast density. The patient is injected intravenously with a tracer amount of Tc-99m-sestamibi, avid for tumor cells, and imaging begins within five minutes. The company has lowered radiation dose to equal screening digital mammography.  Market Potential  Clinical revenues were $1.8 million in 2010, $1.9 million in 2011, $4.9 million projected in 2012, and growing to $50 million in 2015. GMI recalibrated several market analyses using actual equipment sales and constructed Rogers/Bass diffusion models to predict market potential. The company divided the market for breast cancer imaging into three segments: general screening, high-risk screening (dense breasts, BRCA genes, family history), and secondary diagnosis. The primary application for MBI will be screening of radiographically dense breasts (40 percent of European and American population; 70 percent of Asian population). The Mayo Clinic and GMI predict that MBI utilization will grow to 10.5 million high-risk screening and 5 million secondary diagnostic procedures per year.  Competitive Advantage  Women with radiographically dense breasts carry a sixfold increased risk for breast cancer. However, mammography fails to detect most cancers in these women. In a Mayo Clinic 1,700-patient dense-breast screening trial, digital mammography detected only 2 of 20 tumors, while MBI found 18 of 20.  MBI has a clear advantage in specificity over competing technologies: a Mayo Clinic 1,000-patient study demonstrated 91 percent sensitivity and 93 percent specificity in dense-breasted women, much better than mammography and with similar sensitivity to MRI but better specificity (fewer negative biopsies). The GMI LumaGEM® system is 1.5 to 2.0 times more efficient than competing MBI systems, which results in the lowest dose. Financial Overview  Gamma Medica has been supported by $13.2 million in grants, including NCI STTR and SBIR Bridge grants, $82.4 million in product sales, $18.2 million in venture capital, and $16.3 million in debt financing. GMI is seeking $15 to $20 million to grow its Clinical Division by developing a mobile gantry, to conduct dense-breast MBI screening trials required for PMA, to develop international distribution capabilities, and to promote reimbursement, accreditation, and ACR/SBI clinical use guidelines.  Intellectual Property  The GMI technology is protected by eight patents for electronic detector readout and MBI with mild breast compression. In addition, GMI has licensed exclusively all Mayo Clinic patents and know-how related to MBI. Commercialization Strategy  GMI has developed a commercially successful (19 installations) MBI system (LumaGEM®) for breast cancer secondary diagnosis. The company is expanding usage of MBI for breast cancer screening, treatment monitoring, and guidance of biopsy and surgery.  The cost of the MBI system hardware and procedure is less than one-third that of MRI. Average reimbursement is $450 (plus professional component and radiotracer cost) and most payors have positive reimbursement policies or approve MBI with prior authorization.  Pipeline Products  GMI is developing an MBI-guided biopsy procedure (2012 commercial release). The company expects to introduce a mobile gantry in 2013, and plans to combine ultrasound with MBI in 2014-15. The same detector technology can be applied to prostate, brain, and other small organ cancer imaging. Management Team  The seasoned management team has a combined 150 years of professional experience with 110 years in management, 100 years in health care, and 60 years focused on women’s health.  Bradley Patt, Ph.D., CEO, President, Co-founder of GMI & Radiant Detectors (sold to Seiko in 2005), Director of Photon Imaging, DxRay, & TheraCell. James Hugg, Ph.D., VP R&D, CTO: GE Healthcare and Global Research, Henry Ford Health, University of Alabama - Birmingham, British Petroleum, Shell. Debbie Thomas, VP Marketing: Aurora Imaging Technology, WebMD, SAP America. Sharon Smith, VP Sales: Aurora Imaging, Naviscan, Hologic, Procter & Gamble. Deborah Matthew, VP Operations: Paragon Business Systems, Delphi Information Systems.

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.