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Company Background

AcuityBio is a preclinical stage company focused on the commercialization of the company’s unique biocompatible, biodegradable drug delivery platform technology to prevent post-surgical locoregional tumor recurrence in early-stage lung cancer patients. AcuityBio’s formation in 2010 stemmed from a collaboration between lung cancer thoracic surgeon Dr. Yolonda Colson (Brigham and Women’s Hospital) and Professor of Chemistry/Biomedical engineering Mark Grinstaff (Boston University). Together with Drs. Grinstaff and Colson, AcuityBio was co-founded in 2010 with CEO Jay Schwartz, Ph.D., and co-inventor of the technology and Director of Research, Jesse Wolinsky, Ph.D. AcuityBio currently has two full-time employees.

Technology Overview

AcuityBio has developed chemotherapy-eluting ABC Mesh™ based on their proprietary slow-release, biodegradable ABC Polymer™ for the prevention of locoregional lung cancer recurrence. It functions by delivering paclitaxel locally at a slow and predictable rate directly at the resection site following lung cancer tumor removal surgery. This maintains a localized high level of drug while minimizing side effects without affecting healing, which will result in better patient outcomes. AcuityBio is currently evaluating applying ABC MeshTM to select soft tissue orphan oncology indications that have a high recurrence rate. This will allow a shortened time through a first-in-human trial as an “orphan” indication and accelerated FDA approval. AcuityBio has developed ABC Mesh to the preclinical stage, focusing on Chemistry Manufacturing and Control, engineering, and securing key manufacturing and supplier CMO/CRO vendor relationships. 

Market Potential

Lung cancer is responsible for more deaths annually in the U.S. than breast, colorectal, and prostate cancers combined. Surgical removal of the tumor (resection) is the standard of care for early-stage lung cancer patients, yet lethal, locoregional tumor recurrence continues to afflict about half of the 50,000 patients per year who receive surgical treatment with curative intent. 

Each year in the U.S., 221,000 new lung cancer cases are reported. Roughly one-quarter of these patients (about 50,000/year in the U.S.) will be considered candidates for surgical resection (the standard of care). The cost to the health care system resulting from the 50 percent endemic cancer treatment failure in the U.S. alone is a staggering $1 to $2 billion per year. Other early stage cancers also suffer from high locoregional recurrence rates, including stage II colorectal cancer (50,000 patients) and breast cancer lumpectomy patients (71,000). Several soft tissue “orphan” oncology indications more than 50,000 patients per year.

Competitive Advantage

Existing drug-eluting polymer products on the market do not possess the properties that are required for the development of an ideal soft tissue compliant, biocompatible, biodegradable drug-eluting implant with tunable drug release. ABC Mesh has all these features. ABC Mesh is an easy-to-manufacture, widely applicable drug delivery platform, which can predictably and locally deliver insoluble and water-sensitive drugs to soft tissue for more than 50 days. The implant has already been proven to be biocompatible (ISO10993), biodegradable, and physically compliant and capable of slow, controlled drug delivery.

Financial Overview

AcuityBio has received almost $3 million in non-dilutive capital through NIH, SBIR Phase I and II, government and Coulter Foundation grants, which will be sufficient to advance their ABC MeshTM program to a first IND. The company seeks $3.5 million to help propel its first product through preclinical and to Phase I safety trials for early-stage non-small-cell lung cancer and to support the clinical development of its orphan drug first-in-human trials

Intellectual Property

AcuityBio has negotiated with Boston University and Brigham and Woman’s Hospital-Harvard/Partners to obtain exclusive world-wide rights to issued patent (U.S. 7,671,095) and three pending patents covering compositions and methods of use. The company has determined it will have a freedom to operate clear of prior art.

Commercialization Strategy

The value proposition of ABC Mesh is that it combines clinical differentiation, ease of use, and positive patient impact at lower overall cost per patient. Thoracic surgeons, hospital purchasing agents, group purchasing organizations will be the company’s main customers. Customers will be compelled to choose ABC Mesh because of its compelling clinical data, key opinion leader, and contract sales channels. 

Pipeline Products

ABC Mesh is a platform technology that has been specialized to deliver water-insoluble or water-sensitive drugs that are traditionally difficult to formulate for administration. The company can tune the drug release rate and the implant’s degradation rate depending on the application. AcuityBio is actively pursuing other clinical indications including orphan indication that would benefit from their localized delivery technology. 

Management Team

John ‘Jay’ Schwartz, Ph.D., Co-Founder, CEO, and Chairman, has more than 20 years in life sciences technology development. He was research faulty at MIT working on drug delivery, is experienced in private equity fundraising, and has succeeded in securing multiple U.S. government grants. He co-founded the venture-backed engeneOS, bought by ADNEXUS, which was acquired by Bristol-Myers Squibb in 2007. Jay received his Ph.D. in Biochemistry and Molecular Biology from New York Medical College and pursued postdoctoral work at Harvard and MIT in drug delivery, protein engineering, and cardiovascular medicine.

Jesse Wolinsky, Ph.D., Co-Founder and Director of Research, is a co-inventor of the ABC Mesh. He holds a doctorate in Biomedical Engineering from Boston University and a Bachelor of Science in Materials Science and Engineering from the University of Florida where he specialized in Polymer Chemistry. 

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

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.