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Company Background

Bexion Pharmaceuticals, LLC is a clinical-stage company developing SapC-DOPS proteolipid nanovesicles (BXQ-350) as a therapy for glioblastoma multiforme. The company was founded in 2006 with technology licensed from Cincinnati Children’s Hospital Medical Center. The distinctive tumor-targeting property of SapC-DOPS was discovered during Bexion’s research on the function of saposin C, a lysosomal protein involved in sphingolipid catabolism, which is essential for tumor-targeting of nanovesicles.

Technology Overview 

Bexion is developing a new molecular entity with a novel mechanism of action for targeting and eliminating glioblastoma multiforme. The SapC-DOPS proteolipid nanovesicles specifically target and kill tumor cells in orthotopic xenograft models of glioma and have a high affinity for aberrant phosphatidylserine (PS)-rich membrane domains that occur on the surfaces of tumor cells and cells of tumor neovasculature, but not normal cells. The prolongation of life of tumor-bearing mice following BXQ-350 treatment was dramatic and statistically significant.

Market Potential

Glioblastoma multiforme is the most common and lethal primary brain tumor. The median survival time is still limited to less than 15 months under the standard treatment, comprised of surgery, radiation, and chemotherapy. Because of the high unmet need for a treatment for malignant GBM, the market for an efficacious drug is very significant with estimates for year one as much as half a billion dollars.

Competitive Advantage 

BXQ-350 nanovesicles offer a new approach for targeting and killing cancer cells, potentially without harming normal cells and tissues. Current radio- and chemotherapies have low therapeutic indices, incur severe side effects, and in the case of brain tumors, also display neurotoxicity. BXQ-350 is expected to avoid the most debilitating side effects because its mechanism of action is significantly different. The efficient targeting of brain tumors by BXQ-350 was confirmed in a recent MRI study in which brain tumors were visualized using paramagnetic Gd-DTPA-BSA/SapC-DOPS vesicles. Multiple lines of evidence suggest that PS is potentially a universal tumor target, to which BXQ-350 is targeted. Alternative PS-targeted therapeutics have been proposed but none have the ability to bypass the blood brain barrier (BBB).

Financial Overview

Bexion’s projects have been supported over the last five years by almost $6 million in SBIR grants (Phase I, Phase II + Kentucky Match Program, Phase IIb Bridge) and over $15 million from combined founding equity, Series A financing, and private investments.

Intellectual Property

Bexion’s technology is protected by two issued US patents, several other pending applications, and trade secrets. Issued patents are for composition of matter and combinations. Recent filings by Bexion and its collaborators are focused on protecting additional new anti-cancer technologies, including novel chemistries, methods, and compositions. In conjunction with Bexion’s overall business plan, the company plans to in-license complementary technologies as needed.

Commercialization Strategy

Bexion will explore additional funding options through acquisition, partnering, or licensing by major pharmaceutical companies who will carry on Phase III clinical development, product launch, and sales & marketing; or through an IPO. Potentially and importantly, with further clinical studies, BXQ-350 could target the antineoplastics market for other types of cancers, both as the primary or adjuvant therapy.

Pipeline Products

Bexion’s pipeline includes novel formulations and combination therapies for targeting a range of aggressive and lethal cancers, including pancreatic cancer; compositions to enable the imaging of invasive and hidden cancer cells’ and very exciting methods to enhance the delivery of drugs across the BBB for targeting CNS diseases.

Management Team

• CEO, president, and co-founder Ray Takigiku, PhD is a former member of the leadership team at Procter & Gamble Pharmaceuticals that developed and marketed the blockbuster osteoporosis drug Actonel, and the market leader for ulcerative colitis, Asacol.
• Senior vice president Ellen Monson, PhD has extensive knowledge of large molecule drug development experience from Eli Lilly and was formerly Director of Intellectual Property and Technology Transfer at the University of Cincinnati.
• Vice president and co-founder Kevin Xu, MD, PhD, MBA has been a PI on multiple SBIR grants and received in PhD training in tumor biology from the Mayo Graduate School.
• Vice president Tom Wei, PhD is the former Associate Director of the Research and Development and Quality Control labs at Coldstream Laboratories.
• Vice president of business development Margaret van Gilse, MBA has over 25 years of business development, strategic planning, governmental relations, communications, and fundraising experience with entrepreneurial companies in multiple healthcare segments.
• The medical advisor Olivier Rixe, MD, PhD is associate director for clinical research at the University of New Mexico Cancer Center.

Blaze Bioscience, Inc. is a privately held biotechnology company focused on the development of guided cancer therapies. Blaze was founded in 2010 and is working to develop Tumor Paint™ products and Optide-based guided cancer therapeutics. Tumor Paint products are designed to provide real-time, high-resolution visualization of cancer cells during surgery, enabling better detection and more complete and precise surgical removal of cancer--while sparing surrounding normal tissue.  Precise illumination of cancer cells has been demonstrated in brain, lung, breast, prostate, colorectal, head and neck cancers and in sarcomas.  The first clinical candidate from the Tumor Paint platform--BLZ-100—is an intravenously (IV) delivered drug that is a combination of a cancer targeting peptide and a fluorescent beacon. The company’s first Phase I clinical study of BLZ-100 is ongoing and initiation of a Phase 1b in brain cancer is anticipated in Q4 2014.   Blaze has an ongoing collaboration with the Fred Hutchinson Cancer Research Center focused on the discovery and development of Optide-based products for use as guided therapeutics.

Blaze has licensed patents and patent applications to the Tumor Paint and Optides platforms from the Fred Hutchinson Cancer Research Center and has filed additional patent applications related to Tumor Paint technology and BLZ-100.

The company has raised over $20M since 2012 and anticipates initiating a Series C fundraising round in late 2014/early 2015 to support Phase II clinical development of BLZ-100, device development, research Optides guided therapeutics, and other general corporate needs.