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Company Background

StemMed is a pre-clinical stage drug discovery, development, and testing company that is developing C188-9, a first-in-class, oral inhibitor of signal transducer and activator of transcription (Stat) 3, for treatment of ER-, PR-, HER2- (triple negative) breast cancer (TNBC). StemMed also provides state-of-the-art pre-clinical drug testing services using a panel of 44 breast cancer patient-derived xenograft (PDX) models developed from a diverse patient population, which includes 23 PDX models derived from patients with TNBC; 4 pancreatic cancer PDX models also are available.

Technology Overview 

Stat3 plays a central role in breast cancer stem cell development and has been validated as a drug target in these cells, as well as in the treatment of TNBC, for which no targeted therapy exists. StemMed used computer-based docking to screen 920,000 compounds and identified three small-molecule probes that targeted the phosphotyrosyl peptide-binding pocket within the Src homology 2 domain of Stat3. The most active probe, C188, reduced TNBC PDX tumor volumes and improved tumor-free survival of engrafted mice 4-fold when used in combination with standard chemotherapy. StemMed performed 2-D similarity screening, 3-D pharmacophore analysis, and 3-rounds of structure-activity relationship (SAR)-directed medicinal chemistry to identify C188-9, its lead, first-in-class drug for targeted treatment of TNBC.

Market Potential

The first patients that will be targeted to receive C188-9 will be those patients with locally invasive, metastatic, or treatment-refractory TNBC. An estimated 230,480 new cases of invasive breast cancer were diagnosed in the United States in 2011. Of these, ~40,000 will suffer breast cancer recurrence including 50% of those with TNBC. Unfortunately, standard therapies cannot eradicate the disease and these patients succumb to metastatic disease with a median survival of 2 years. The size of the U.S. market for C188-9 for metastatic/refractory TNBC on a yearly basis is ~20,000 cases for 7 cycles, or a total of 140,000 cycles. C188-9 will be administered orally once daily in the interval between cycles of first-line chemotherapy. Using a conservative figure of $2,000 per cycle, the income generated from 140,000 cycles of C188-9 would be $280 million.

Competitive Advantage

There are two orally bioavailable, small-molecule competitors of C188-9 in development, BP-1-102 and HJC0123. BP-1-102’s modest potency coupled with its low MTD will make it challenging to establish a safe and effective dose of BP-1-102 in humans. HJC0123’s mechanism of action has not been established and the mouse toxicity data presented in the original report was very limited. Other oral agents under development have mechanisms of action that are not understood, substantial toxicity, and did not demonstrate an efficacy signal in Phase I studies.

Financial Overview

StemMed’s drug testing revenue since 2010 totals $913,000. Revenue from STTR grant awards totals $417,000. StemMed also received $100,000 from PDX licensing and $213,000 from partner contributions.

StemMed needs $1 million in external funds for IND-enabling safety and PK studies and for IND filing.

Intellectual Property

StemMed has an exclusive license to ten patents issued to, or filed by, BCM and ownership of composition for C188-9. StemMed also has an exclusive license to use all 48 PDX models for drug testing services, as well as sublicensing to other companies for their in-house use.

Commercialization Strategy

StemMed’s objectives for the next two years are to continue developing its lead product candidate C188-9 by taking it through various studies. StemMed is also in discussions with Atara Biotherapeutics regarding licensing C188-9 for use in cachexia in chronic kidney disease.

Pipeline Products

StemMed has compelling pre-clinical results in cancer cell line xenograft models that also support the use of C188-9 either alone or with radiation therapy in patients with non-small cell lung cancer and head and neck squamous cell cancer. In addition, results from mouse pre-clinical models support its use in patients with cachexia secondary to chronic kidney disease or cancer, and in patients with idiopathic pulmonary fibrosis, scleroderma, inflammatory bowel disease, asthma, and immediate-type hypersensitivity reactions.

Management Team

• President, CEO, and director of drug discovery and development, David Tweardy, MD, discovered key molecular and cellular features of Stat3 during his 28-year research career supported by NIH and other extramural funding totaling over $16 million as PI.
• Vice president and director of drug testing, Michael Lewis, PhD, is an expert in breast cancer biology and developer of 48 breast and pancreatic cancer PDX models whose 15 year research career has been supported by NIH and other extramural funding totaling over $11 million as PI.
• Consultant and vice president of Texas BioAlliance, Jeffrey Larson, PhD, is a drug developer with extensive experience in pharmaceutical, biotechnology, and contract research industries, as well as a record of successful early- and late-stage regulatory meetings with the FDA.
• Consultant and Principal of Soller Regulatory & Research Services, R. William Soller, PhD, has extensive regulatory experience including serving as team leader and lead presenter for over 60 FDA or advisory committee meetings on drug development or postmarketing issues.

Surgisense Corporation is a privately held C-corporation founded in 2006 with the mission of improving surgical care through intra-operative assessment of a patient’s risk for surgical complications. The company is developing a new category of surgical instruments that integrate a novel oxygen sensing technology which directly measures tissue oxygenation. This enables surgeons to identify patients at risk of surgical complication due to alterations in blood flow and oxygenation through real-time assessment of tissue viability, and propensity to heal.

Surgisense’s efforts initially target colorectal cancer for which surgical resection remains the mainstay of treatment. After removal of the tumor, the free ends of bowel are surgically joined to form an anastomosis. Surgisense's Stapled Anastomosis Viability Evaluation (SAVE) System strives to reduce the most dreaded complication: the anastomotic leak; a condition in which fecal material leaks into the abdominal cavity from the surgical junction. The technology integrates into the surgical workflow by replacing the anvil of commercially available, circular staplers with a sensing anvil that wirelessly transmits actionable data to the operative team. The System aims to reduce patient suffering while saving $2 billion annually in excess healthcare costs.

Surgisense’s core technology is protected in the largest medical device markets, and is extensible into many clinical applications. The company has been funded through a combination of federal grants and commercial revenue totaling $2.3 million and is looking to raise $6 million in Series A financing to support first-in-human clinical trials, U.S. and E.U. regulatory approval, and product launch.

Synergys Biotherapeutics is a privately held antibody therapeutics company developing multifunctional anti-vasculogenic antibody therapeutics for cancer and other angiogenesis-related diseases of significant unmet medical needs. The Company focuses on in-licensing early stage candidates from external sources for additional development in-house as well as through building collaboration and partnering with larger pharma and biotech organizations. The Company’s current preclinical programs include Anti-EGFR-ATAP, an antibody fusion molecule being developed for Triple Negative Breast Cancer and other EGFR+ malignancies, as well as a bi-targeted, bifunctional “first-in-class” fully human Anti-Ang-1/2 antibody for various cancers.   Synergys’ management and the members of its scientific and business advisory boards are veterans of biotech business having more than 20 years of average expertise and experience in cancer drug development.  

Developing the medical applications of bubble technologies, and seeking the advantages of Contrast-enhanced Ultrasound Imaging (CEUS). We serve with the advanced ultrasound contrast agents for research purposes. Currently under clinical developments of our microbubble product. The target indications would be focal liver lesion detection, breast cancer detection, and CAD perfusion imaging. Furthermore, we aim to develop the ultrasound-triggered release system and make it available in clinical practices.

Vala Sciences, Inc. is a life sciences company that develops and markets pathology diagnostics, in vitro alternatives to animal cardiac and neurological assays for early drug discovery, and related technologies to academia, pharmaceutical, and biotechnology companies. The company’s multiplexed breast cancer assay includes quantitative fluorescent labels on a single slide for ER, PR, HER2/neu, and cytokeratin, and is read with an automated microscope that measures expression of all four biomarkers at the single cell level. Multiplexing speeds the pathologists’ workflow over classical reading of one biomarker/slide and by converting the current subjective scoring to an analytical test, Vala will eliminate the 15-25% error rates reported with the current standard of practice.

Vala holds a dozen issued patents and a total of 26 patents and patent applications encompassing the underlying enabling technological approaches and the key aspects of analytical biomarker testing and workflow optimization critical for this new diagnostic approach.  This digital analytical pathology diagnostic approach can be adapted to pharmaceutical research, companion diagnostics and all cancer diagnostic tests that utilize biomarkers in tissue sections – the histopathology market – a global market that will surpass $3 billion annually in 2015. Vala has raised $26.7 million since 2004 and is seeking $10 million to create a suite of related pharmaceutical biomarker assays, carry out validation studies with CLIA-approved diagnostic laboratories, introduce a laboratory-developed test (LDT), obtain FDA 510(k) approval, and ramp marketing and sales.

Vasculox is a biotechnology company dedicated to developing CD47-targeting drugs for the treatment of cancer. CD47 is a checkpoint for the innate immune system, and tumor cells in numerous types of cancer up-regulate CD47 in order to ward off the anti-tumor activities of macrophages. Vasculox’s lead compounds are monoclonal antibodies (mAbs) against CD47 that not only promote phagocytosis of tumor cells but also have direct tumor-cell killing activity. Vasculox plans to develop one or more anti-CD47 antibody therapies through Phase II trials.

Although CD47 is recognized as a promising immuno-oncology target, no anti-CD47 products are currently on the market. Several entities are pursuing CD47 as a target preclinically or in early-stage clinical trials, but these competitors’ compounds appear to lack the direct anti-tumor activity that provides the Vasculox mAbs with a competitive advantage. In animal models of lymphoma and pancreatic cancer, the Vasculox dual-function mAbs demonstrate superior efficacy compared to single-function mAbs, a distinction which has the potential to translate into improved efficacy in the clinic.

Vasculox’s IP estate includes two U.S. patent filings and one PCT covering compositions of matter and uses of humanized anti-CD47 mAbs. The company has raised $4.4 million since 2009 and is currently raising a Series A of $8 million. Vasculox aims to achieve an exit by acquisition of at least $300 million no later than 2019.