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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.

Vaxiion Therapeutics is dedicated to the further development of VAX-IP, a promising investigational bacterial-minicell based biologic product initially intended for the topical intravesical treatment of Non-muscle Invasive Bladder Cancer (NMIBC).  VAX-IP exerts rapid selective tumoricidal effects against human urothelial carcinomas in addition to synergistic secondary immunotherapeutic effects, a combination unlike that of any other product under development or on the market in the NMIBC space. With compelling pre-clinical efficacy data in several clinically relevant variations of the gold standard mouse model of NMIBC, Vaxiion is now committed to the commercial and clinical development of VAX-IP for initial use as an intravesical agent for the treatment of NMIBC.   Currently, Vaxiion is initiating IND-enabling studies with the intention of filing an IND application with the FDA in Q1 of 2016.  Clinical trials would focus on serving as a salvage therapy for BCG-refractory and BCG-intolerant NMIBC patients, and if successful,  quickly be expanded to other areas of unmet need within the NMIBC treatment algorithm.

Vaxiion estimates the market size for an effective and reimbursable bladder cancer product addressing this admixed disease niche to be ~$937 - ~$1.87 billion depending on the number of approved indications. The company feels that it will take ~$7-10M and 3.5-4 years to complete two Phase 2a efficacy studies and demonstrate human proof-of-concept. Vaxiion has raised ~$5 million for this effort to date, and is looking for $3-$4 million in addition to proceeds from a pending SBIR Phase II award to advance the program through this inflection point.