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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

Celek Pharmaceuticals is addressing the need for new medicines to help patients suffering from cancers that are poorly served by current therapies. The company’s strategy is to enhance the value of in-licensed drug candidates by advancing them through proof-of-concept clinical trials. Formed as a Delaware LLC in 2009, Celek’s two founders, Graham Allaway, Ph.D., and Gary Robinson, Ph.D., are currently the sole employees. 

Technology Overview

Celek’s lead product, CEL-031, is a clinical-stage targeted anticancer drug that selectively induces apoptosis in tumor cells by inhibiting cyclic GMP phosphodiesterases, which are overexpressed in human tumors. Currently in preclinical development for non-muscle invasive bladder cancer (NMIBC), CEL-031’s mechanism of action involves the degradation of β-catenin, a cell signaling protein that plays a key role in bladder cancer tumorigenesis. In clinical studies against advanced cancers, orally-administered CEL-031 showed evidence of efficacy and a good safety profile. CEL-031 should have greater clinical efficacy against NMIBC, where it will be administered intravesically (i.e., instilled transurethrally), the standard drug delivery route for this indication. 

Market Potential

Bladder cancer is the fifth most common cancer in the U.S., with 70,000 new cases annually and 600,000 individuals living with the disease. Worldwide, there are approximately 400,000 new cases annually and the incidence is rising. 

About 70 percent of new bladder cancer diagnoses are made at the non-muscle invasive stage. Current NMIBC treatments involve transurethral resection (TUR), often followed by intravesical chemotherapy using non-specific cytotoxic drugs such as mitomycin C, or immunotherapy with Bacillus Calmette Guerin (BCG). These treatments often fail, with five-year recurrence and progression rates of 50-70 percent and 20-30 percent, respectively. Current drugs also cause adverse side-effects and are hazardous to health care workers.

Since NMIBC is a chronic disease requiring lifelong monitoring and treatment, the lifetime cost per patient of treating bladder cancer is the highest of all cancers.

Despite the pressing need, few new drugs are in development for NMIBC. Celek is developing CEL-031 for two NMIBC indications: (i) perioperative administration following TUR, and (ii) BCG-refractory NMIBC. CEL-031’s estimated peak annual sales in these indications range from $510 million to $660 million. 

Competitive Advantage

As the first targeted drug for NMIBC, CEL-031 represents a potential breakthrough in the treatment of patients with this disease. It should be possible to deliver CEL-031 safely at higher, more effective doses than current cytotoxic chemotherapies, resulting in dramatic reductions in rates of recurrence and progression. CEL-031’s favorable safety profile should also result in a substantial increase in the number of patients treated with CEL-031 compared to current drugs.

Financial Overview

Celek has raised more than $700,000 in funding, including investments by the principals and federal and state grants. The NCI awarded Celek a $176,000 Phase I SBIR contract supporting preclinical studies on CEL-031 for NMIBC. Celek is currently seeking to raise $3 million to support preclinical studies of CEL-031 in bladder cancer and acute myeloid leukemia (AML), and the initiation of a Phase I/II clinical trial in non-muscle invasive bladder cancer. 

Intellectual Property

Celek obtained exclusive rights to CEL-031 from OSI Pharmaceuticals. CEL-031 as a composition of matter and methods of treating cancer with CEL-031 are covered by four issued U.S. patents (plus foreign equivalents). Additional patents cover analogs, methods of identifying anticancer compounds and combination therapies. 

Commercialization Strategy

Celek plans to complete a proof-of-concept clinical trial of CEL-031 in NMIBC patients, then partner for later stage development/commercialization. Recent partnering deals in this therapeutic area have had attractive financial terms. Celek has already met with potential partners who indicated interest in the product. 

Pipeline Products

Celek is also developing CEL-031 to treat advanced cancers using novel formulation and delivery technologies to increase concentrations of the drug in the body, thereby maximizing efficacy. The company is focusing on: (i) advanced bladder cancer, and (ii) acute myeloid leukemia (AML). A recently published independent study reported that CEL-031 has potent activity against tumor cells from AML patients, including those resistant to current drugs, and recommended clinical testing of CEL-031 against AML. CEL-031 would be eligible for Orphan Drug status in this indication.

Management Team

Graham Allaway, Ph.D., President and C.E.O, has spent 22 years in the biotechnology industry. As founding CEO of Panacos Pharmaceuticals, he played a key role in building that company from a private venture-backed start-up to a public company, while raising more than $125 million in private and public equity financing. Dr. Allaway also led Panacos’ drug discovery and development programs. Prior to Panacos, Dr. Allaway was CEO of Manchester Biotech and he previously led therapeutic R&D at Progenics Pharmaceuticals. 

Gary Robinson, Ph.D., Chief Business Officer, has 20 years of experience in research, development, and commercialization of technologies and products in the physical and life sciences. Most recently, he was Senior Director of Business Development at Panacos Pharmaceuticals, where he led partnering, contracting, intellectual property and pre-launch marketing activities. Prior to Panacos, Dr. Robinson held business and corporate development positions at IGEN.

Company Background

Centrose is a biotechnology company formed in 2006 and is focused on developing a novel antibody-drug conjugation (ADC) technology that targets a wide variety of diseased cells. Centrose discovered the first-ever synergistic drug targeting system called the Extracellular Drug Conjugate System (EDC). 

Centrose has 10 employees and projects to grow to 25 staff. 

Technology Overview

Centrose is a preclinical stage company developing a novel ADC technology that targets a wide variety of diseased cells. Centrose discovered the first-ever synergistic drug targeting system called the EDC System. EDCs are like (ADCs), but are safer and more effective because they are not pro-drugs and only affect diseased cells. To modulate cell growth and activity, EDCs use antibodies (specific to diseased cells) attached to Centrose’s proprietary modulating drugs to work in concert together – the two must be attached to work. Currently, Centrose has four EDC lead drug candidates. As a platform, the EDC system allows for the construction and development of targeted drugs that can be developed for multiple indications including cancer, inflammation, and diabetes.

Market Potential 

Currently, Centrose has four lead programs that it anticipates moving into clinical trials in the next 24 months. The company’s lead program, EDC1, is focused on the lung and metastatic cancer markets; specifically non-small cell lung cancer (NSCLC) and pancreatic cancer. 

Competitive Advantage

There are limitations with regards to traditional antibody drug conjugates technologies:

• First, ADC cell internalization is inefficient and requires the use of very toxic drugs; 
• Second, to become activated, the drugs must be released from the antibody;
• Third, once released, the drugs can interact with normal surrounding tissue leading to toxicity concerns.

In combination, these requirements present formidable design challenges and seriously limit the power of traditional antibody drug conjugates.

To address these problems, Centrose discovered and developed a revolutionary new type of ADC, called EDC. The Centrose EDC system is composed of three parts: a binding component that specifically targets diseased cells, a proprietary drug, and a linker that connects them. This is similar to the ADC system except that the EDC never requires drug dissociation or cell internalization, negating the three major problems of the ADC system. 

Financial Overview

Centrose has raised $3.5 million from individuals and $1.5 million from government grants. The company is currently looking to raise $20 million under a Series A round to move Centrose’s lead compound into and through Phase I clinical trials.

Intellectual Property 

Centrose technology is the sole property of Centrose. Centrose has applied for multiple U.S. and worldwide patents covering EDC technology. Centrose also has the freedom-to-operate in the space. 

Commercialization Strategy 

Centrose’s business strategy is focused on producing the next generation of targeted therapies and to out-license these assets to select pharmaceutical companies. Strategic partnering is therefore critical to advance Centrose's novel therapeutics programs into clinical development and then to the market.

Pipeline Products 

In addition to EDC1, Centrose has four other EDC programs:

EDC2

The antibody target is CD147 and is highly expressed on cancer cells where it facilitates invasion and metastasis. CD147 is also a biomarker for wide range of cancers. As proof of efficacy, Centrose has tested EDC2 and with gemcitabine on pancreatic cell line and demonstrated that EDC2 shows picomolar activity on PANC1 cell line verses gemcitabine, which demonstrated only micromolar activity. Gemcitabine is approved for the treatment of pancreatic cancer.

EDC3

The antibody target is CD44v6 and is associated with tumor progression, metastasis, and specifically with NSCLC lymph node metastasis. Centrose studies show Na,K-ATPase-and CD44v6 complexes on certain cancer cells, yet EDC3 is not toxic to human skin cells in culture (warhead target is low on normal skin). 

EDC7

The antibody target for EDC7 is CD56 (aka NCAM-Neural Cell Adhesion Molecule). The mAB target, CD56, is also the target of ImmunoGen’s lead internal program: IMGN-901. CD56 is highly expressed on the following human tumors SCLC, multiple myeloma, ovarian, and other related indications such as leukemia and Wilms’ Tumor. Studies show Na,K-ATPase-and NCAM, form a complex on SCLC cells. EDC7 demonstrated low picomolar level activity when cancer cells express CD56; thus EDC7 may be an excellent candidate for SCLC.

Management Team 

Dr. James Prudent is the CEO and founder of Centrose and brings more than 20 years of biotechnology. Before Centrose, Dr. Prudent served as Chief Scientific Officer and on the Board of Directors at EraGen Biosciences (sold to Luminex). Dr. Prudent received his doctorate in chemistry from the University of California at Berkeley.

Steve Worsley is the Chief Business Officer and brings 25 years in the biotechnology industry to Centrose. Mr. Worsley has executed numerous transactions in the mAB market; most notably with the companies Abgenix and Raven Biotechnologies. Mr. Worsley out-licensed Vectibix®, the first fully human mAB specific to the EGFr (HER1). He received his MBA from the University of Washington.

The technical staff at Centrose includes two managers, Dave Marshall, Director of EDC Technologies,and Dr. Mohammed Shekhani, Director of Chemistry, who manage the biotechnology and chemistry groups respectively. 

The technical group is provided consultation by Dr. Homer Pearce who developed gemcitabine (Gemzar) and has numerous years of experience in oncology while at Eli Lilly and numerous other technical advisors.

Company Background

Firefly is introducing a universal technology platform for biomarker detection with a broad range of applications in life sciences, agriculture, veterinary medicine, and human diagnostics. Firefly BioWorks is a spin-out of the Chemical Engineering Department at the Massachusetts Institute of Technology (MIT), where the founders developed a novel method for high-throughput production of complex microparticles. The company began operations in 2010 and grew to seven full-time employees through a combination of SBIR awards and angel funding. The company is focused on developing multiplexed assays for biomarker detection that scale from discovery to clinical diagnostics. The company has adopted a lean startup approach. The first minimum viable product is being launched and operations will be scaled according to demand.

Technology Overview

Firefly develops and manufactures next-generation microparticles for biomolecule detection. The company’s first product, a kit for detecting microRNA aimed at the research market, has just been launched commercially. Firefly’s core technology, Optical Liquid Stamping, was developed by combining photolithography (typically used in microchip production) with microfluidics. This method allows fabrication of microparticles with virtually any shape, chemistry, and biofunctionality. Using Optical Liquid Stamping, Firefly developed a barcoded particle architecture that enables multiplexed biomarker detection on standard laboratory instrumentation. Through the support of the NCI SBIR Program, Firefly developed a particle-based assay for high-throughput profiling of microRNAs, a class of molecules with enormous potential for early diagnosis of cancer. 

Market Potential 

Firefly operates in the global market for biotechnology tools, a market that generates approximately $70 billion in worldwide sales. Firefly developed its first product for microRNA profiling, a market currently estimated at approximately $100 million and expected to grow very rapidly. Several market surveys indicate that bead-based assays for high-throughput/mid-multiplexing profiling are expected to address a critical need in the industry and grow at the fastest rate, especially in the area of microRNA.

Competitive Advantage

The Firefly platform enables detection of clinically relevant biomolecules with an unprecedented combination of performance, flexibility, throughput, and cost. Additionally, the assay developed by Firefly allows direct detection of miRNA in clinical samples without purification. This eliminates protocol discrepancies in RNA purification and will likely lead to more reliable diagnostics.

Beyond microRNA, Firefly’s platform has been used for the detection of disease-related proteins, mRNAs, and genomic DNA. The technology naturally lends itself to simple bedside or handheld devices that can be used in routine screens for early disease detection or point-of-care diagnostics.

Financial Overview

Initial funding was provided by two Phase I SBIR awards, for a total of about $500,000, followed by a seed round of $1 million from angel investors. In August 2011, Firefly was awarded a $2 million NCI SBIR Phase II award that catalyzed a $2 million second round of angel funding used for commercial development in the research market. Firefly seeks an industry partner to adopt the company’s technology and estimates additional funding in the $10 to $20 million range is required to expand its diagnostics capabilities.

Intellectual Property

Firefly has obtained an exclusive license from MIT for use of its technology in any research or clinical diagnostics application. The company’s current IP portfolio comprises four issued patents and 16 pending applications, covering the entire value chain of Firefly products from particle fabrication, encoding and bio-functionalization, to custom microRNA assays and readout in standard instrumentation.

Commercialization Strategy

Firefly’s long-term goal is to become a trusted provider of reliable and cost-effective solutions for clinical diagnostics. The company plans to first establish a presence in the research market and eventually enter the diagnostics field. Firefly intends to grow the company in three phases:

• Selling initial products to leading academic laboratories.
• Partnering with flow cytometry manufacturers for co-marketing of products.
• Expanding the product offering to include diagnostic applications by partnering with content developers in the cancer space.

Pipeline Products

Firefly’s first product is a custom 25-plex microRNA profiling kit that can be used on standard benchtop cytometers. The next generation of products will offer expanded multiplexing, a larger set of supported cytometers, and sensitivity that rivals polymerase chain reaction (PCR). Once the company has proven the technology in the field of microRNA, it will enter the protein market, with a set of companion products with relevance in both research and diagnostics.

Management Team

Firefly has built a team of executives and business advisors with deep expertise in molecular assays, microfluidics, materials, computer science, flow cytometery, and protein science, with roots in both start-ups and large life-science corporations. The team includes:

Operational Team:

Davide M. Marini, Ph.D., Co-founder, Chief Executive Officer

Daniel C. Pregibon, Ph.D., Co-founder, Chief Technology Officer

Andreas Windemuth, Ph.D., Chief Information Officer

Isaac B. Stoner, Vice President of Product Development

Andrea K. Bryan, Ph.D., Director of Engineering

Directors: 

Roger Dowd and Rick Ryan

Business Advisory Board: 

Joseph Gentile, Martin Madaus, Ph.D., Paul B. Manning, Ian Ratcliffe, and Michael P. Rubin, M.D., Ph.D.

Scientific Advisory Board: 

David P. Bartel, Ph.D., and Patrick S. Doyle, Ph.D.

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.