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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.

Technology Name: Closed-System Drug Transfer Device (CSTD)
Company Background
OSHA and NIOSH confirm that over 5.5 million workers are exposed annually to chemotherapy and other hazardous pharmaceuticals during drug preparation and delivery, which studies have shown causes cancers, organ failures, reproductive toxicity, and genetic mutations. Corvida Medical is an emerging device company developing a disposable, Closed-System Drug Transfer Device (CSTD) that provides greater safety and significantly improved usability, enabling healthcare providers to safely deliver the highest quality care to patients. Corvida is led by a management team with experience leading multiple prior medical device companies from start-up to successful exit. Corvida has scheduled the inaugural product unveiling to the public at a hospital pharmacy conference later this year and is on track for FDA 510(k) submittal of its initial CSTD product by end of 2014 and commercialization in 2015.
Technology Overview
Corvida’s 2nd generation CSTD products have new features that optimize containment effectiveness, simplify system configuration, and improve ergonomics. Preliminary data from Corvida’s NCI-funded Phase II Small Business Innovation Research (SBIR) project shows the CSTD meets design and production quality criteria for product performance and has been validated against industry test standards.
Competitive Advantages
Corvida’s innovative CSTD system consists of a set of proprietary disposable components incorporating key differentiators over existing technology that significantly improve safety, effectiveness, and usability.
Market Potential
The global CSTD market is valued at an estimated at $1B total available market, growing ∼20% annually as cancer rates and use of chemotherapy continue to rise. The US hospital segment includes 1,500 leading cancer centers that treat the most patient and are driving the adoption of CSTD technology. Sixty-eight (68) of these facilities achieved an NCI Comprehensive Cancer Center or Cancer Center designation. Given both their high patient volume and prestige, these national Cancer Centers will be targets for Corvida’s initial marketing and sales efforts, and many of these leading cancer centers have committed to collaborating with Corvida Medical on the NCI SBIR Phase II and Phase IIB projects. Beneficiaries of CTSD technology advances include pharmacists, pharmacy technicians, and nurses who prepare and/or administer chemotherapy, other workers who may be inadvertently exposed, and the patients who receive the drugs as well as their family/visitors.
Pipeline Products
Corvida has plans to introduce additional offerings to their CSTD product line. The company pipeline includes further feature development of the CSTD products as well as additional systems that can utilize the CSTD devices. Additional features of the CSTD will address drug administration (nursing) needs, alternate site needs, continued ergonomic improvements, and expansion to a wider category of hazardous drugs. The company is actively developing these pipeline products in tandem with the primary CSTD product offering scheduled to launch later this year.
Financial Overview
Corvida has raised multiple millions of dollars since the company was founded in 2008. The company completed a multi-million Series A Financing in 2011 for R&D, IP development, and initial production. The company is currently raising a
Series B Financing for 510(k) clearance and initial commercialization. Management has secured a lead investor and closed over half of this round of funding to date. Management is working to close the Series B by end of 2014. Management also plans to raise a Series C round to scale operations/manufacturing, which is planned for 2015.
Intellectual Property
Corvida maintains seven (7) issued/allowed utility patents domestically and in foreign jurisdictions, and has 15 PCT utility applications pending. The company also has multiple trademarks, protecting both the company and product brand. Additionally, Corvida has secured a clear freedom-to-operate analysis.
Commercialization Strategy
Corvida is in discussions with several potential strategic partners to distribute their CSTD product once it receives FDA 510(k) clearance. A partner will maximize sales penetration via use of their established sales and marketing organizations. Corvida will initially pursue direct sales and support, starting with pre-market launch Q4 2014 at the major pharmacy conference drawing over 20,000 hospital pharmacists, with a focus on a limited set of prestigious cancer centers. The early launch goal will provide an opportunity to establish reference accounts which will broaden the opportunity to sell to a wider audience. Corvida is collaborating with over 20 leading cancer centers that are participating in the Corvida NCI SBIR Phase II study and are likely to become customers upon completion of the study and receipt of FDA 510(k) clearance.
Management Team
• CEO and President Kent Smith has 30 years of successful global medical device commercialization and business leadership experience, and 10 years of experience in startups. He helped lead a medical device startup from $0 to $30 million with a $310 million acquisition.
• Vice President of Manufacturing Dana Schramm has 20 years of experience in medical device manufacturing, working at companies ranging from $1 million to over $1 billion in sales, and was successful in developing and launching over 50 medical devices.
• Vice President of Research Prasad Sunkara has 35 years of corporate, financing, research, development, and management experience in corporate and startup environments. He has been an officer and/or founder in multiple life science companies, several of which were acquired.
• Co-Founder & CFO John Slump has a BBA in Finance and a background in corporate accounting, fundraising, financial modeling, and capital formation.
• Co-Founder & CTO Jared Garfield has a BBA in Management Information Systems and a background in information technology, engineering, and business management experience.

Technology Name: Closed-System Drug Transfer Device (CSTD)
Company Background
OSHA and NIOSH confirm that over 5.5 million workers are exposed annually to chemotherapy and other hazardous pharmaceuticals during drug preparation and delivery, which studies have shown causes cancers, organ failures, reproductive toxicity, and genetic mutations. Corvida Medical is an emerging device company developing a disposable, Closed-System Drug Transfer Device (CSTD) that provides greater safety and significantly improved usability, enabling healthcare providers to safely deliver the highest quality care to patients. Corvida is led by a management team with experience leading multiple prior medical device companies from start-up to successful exit. Corvida has scheduled the inaugural product unveiling to the public at a hospital pharmacy conference later this year and is on track for FDA 510(k) submittal of its initial CSTD product by end of 2014 and commercialization in 2015.
Technology Overview
Corvida’s 2nd generation CSTD products have new features that optimize containment effectiveness, simplify system configuration, and improve ergonomics. Preliminary data from Corvida’s NCI-funded Phase II Small Business Innovation Research (SBIR) project shows the CSTD meets design and production quality criteria for product performance and has been validated against industry test standards.
Competitive Advantages
Corvida’s innovative CSTD system consists of a set of proprietary disposable components incorporating key differentiators over existing technology that significantly improve safety, effectiveness, and usability.
Market Potential
The global CSTD market is valued at an estimated at $1B total available market, growing ∼20% annually as cancer rates and use of chemotherapy continue to rise. The US hospital segment includes 1,500 leading cancer centers that treat the most patient and are driving the adoption of CSTD technology. Sixty-eight (68) of these facilities achieved an NCI Comprehensive Cancer Center or Cancer Center designation. Given both their high patient volume and prestige, these national Cancer Centers will be targets for Corvida’s initial marketing and sales efforts, and many of these leading cancer centers have committed to collaborating with Corvida Medical on the NCI SBIR Phase II and Phase IIB projects. Beneficiaries of CTSD technology advances include pharmacists, pharmacy technicians, and nurses who prepare and/or administer chemotherapy, other workers who may be inadvertently exposed, and the patients who receive the drugs as well as their family/visitors.
Pipeline Products
Corvida has plans to introduce additional offerings to their CSTD product line. The company pipeline includes further feature development of the CSTD products as well as additional systems that can utilize the CSTD devices. Additional features of the CSTD will address drug administration (nursing) needs, alternate site needs, continued ergonomic improvements, and expansion to a wider category of hazardous drugs. The company is actively developing these pipeline products in tandem with the primary CSTD product offering scheduled to launch later this year.
Financial Overview
Corvida has raised multiple millions of dollars since the company was founded in 2008. The company completed a multi-million Series A Financing in 2011 for R&D, IP development, and initial production. The company is currently raising a
Series B Financing for 510(k) clearance and initial commercialization. Management has secured a lead investor and closed over half of this round of funding to date. Management is working to close the Series B by end of 2014. Management also plans to raise a Series C round to scale operations/manufacturing, which is planned for 2015.
Intellectual Property
Corvida maintains seven (7) issued/allowed utility patents domestically and in foreign jurisdictions, and has 15 PCT utility applications pending. The company also has multiple trademarks, protecting both the company and product brand. Additionally, Corvida has secured a clear freedom-to-operate analysis.
Commercialization Strategy
Corvida is in discussions with several potential strategic partners to distribute their CSTD product once it receives FDA 510(k) clearance. A partner will maximize sales penetration via use of their established sales and marketing organizations. Corvida will initially pursue direct sales and support, starting with pre-market launch Q4 2014 at the major pharmacy conference drawing over 20,000 hospital pharmacists, with a focus on a limited set of prestigious cancer centers. The early launch goal will provide an opportunity to establish reference accounts which will broaden the opportunity to sell to a wider audience. Corvida is collaborating with over 20 leading cancer centers that are participating in the Corvida NCI SBIR Phase II study and are likely to become customers upon completion of the study and receipt of FDA 510(k) clearance.
Management Team
• CEO and President Kent Smith has 30 years of successful global medical device commercialization and business leadership experience, and 10 years of experience in startups. He helped lead a medical device startup from $0 to $30 million with a $310 million acquisition.
• Vice President of Manufacturing Dana Schramm has 20 years of experience in medical device manufacturing, working at companies ranging from $1 million to over $1 billion in sales, and was successful in developing and launching over 50 medical devices.
• Vice President of Research Prasad Sunkara has 35 years of corporate, financing, research, development, and management experience in corporate and startup environments. He has been an officer and/or founder in multiple life science companies, several of which were acquired.
• Co-Founder & CFO John Slump has a BBA in Finance and a background in corporate accounting, fundraising, financial modeling, and capital formation.
• Co-Founder & CTO Jared Garfield has a BBA in Management Information Systems and a background in information technology, engineering, and business management experience.