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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.

Company Background 

CellSight Technologies is a privately held company with six employees located at the UCSF QB3 incubator in San Francisco.  The company started operations in 2010 on the principle of providing innovative new PET imaging technologies to accelerate therapy development and to leverage these imaging tools to personalize patient treatments.

Technology Overview

CellSight is developing a PET probe, [18F]FAraG, for imaging anti-tumor immune response. [18F]FAraG is a fluorine-18 labeled analog of the lymphoblastic leukemia drug AraG, a guanosine analog. Since [18F]FAraG accumulates specifically in activated T cells, which is a major factor in anti-tumor immune response, detection of activated T-cells should enable early prediction of therapeutic efficacy, optimization of immunotherapeutic regimens, and personalization of immunotherapy.  Cellsight has other PET probes in various stages of development targeted at immunotherapy and cell therapy.  In addition CellSight has reporter gene technology to determine trafficking of therapeutic cells in living subjects, including humans.

Market Potential

Immunotherapy is a rapidly expanding market segment due to demonstrated success in various hard to treat cancers such as melanoma and glioma. ClinicalTrials.gov shows that there are currently 90 industry-sponsored, cancer specific cell-based immunotherapy trials actively recruiting, of which 60 trials are in the U.S. According to a June 2014 report by Citigroup, the immunotherapy market could exceed $35 billion by 2023. There is currently no imaging technology on the market that is focused on imaging immune activation in humans. An imaging tool that can help predict a patient’s response to an immunotherapy early could enable patients to find effective therapies and reduce unnecessary medical costs.

Competitive Advantage

There are no commercially available imaging technologies that help visualize the biodistribution of activated T-cells. As immunotherapies gain traction based on their clinical success, there will be increased demand for a companion test to determine if an immunotherapy agent is effective with a particular patient.  A scan that can be used to visualize immune cell activation post infusion or after treatment with immune modulating agents would provide invaluable information to guide future treatment options. 

Financial Overview

CellSight has received over $3 million in grants from NCI. The annual revenue from grants, product sales, and service contracts totaled $377,045 in 2011, $430,864 in 2012, and $669,707 in 2013 our estimate for 2014 is $ 1.1M.

CellSight is seeking a minimum of $7 million in external funding beyond the nondilutive grant funding. The company plans to obtain $10 million in grants and private funding in order to conduct a Phase I/II clinical trial for the [18F]FAraG imaging probe. CellSight will also continue to provide selective fee-based imaging services that have contributed about $200,000 per year.

Intellectual Property

CellSight has exclusively licensed the [18F]FAraG PET probe from Stanford and has two other patents focused on reporter gene technology.  The patent from Stanford includes claims on the composition of matter, methods of synthesis, and methods of use.  Also CellSight personnel are sponsors for an FDA IND for [18F]FHBG PET reporter imaging probe, which is used to image patients undergoing HSV1-tk gene therapy.  In addition, the company founder is inventor of several other immunotherapy/cell therapy focused PET probes and has expressed a strong desire to commercialize them through CellSight given the right opportunity and financial conditions.

Commercialization Strategy

CellSight is in the process of applying to the FDA for an IND approval for [18F]FAraG and expects approval by December 2014. The company’s initial focus is the oncology market where we hope to fully partner with immunotherapy companies and offer the probe as a companion-imaging tool. We are in the early stages of partnering with two large pharma companies and are actively seeking additional partnerships.  CellSight plans to expand the probe’s use to other markets such as rheumatoid arthritis and diabetes mellitus where immunotherapy is in early stages.

Pipeline Products

CellSight intends to expand the probe for use in the rheumatoid arthritis and diabetes mellitus markets as the immunotherapy models for these applications mature and our company’s capacity expands.  In addition we will exclusively license two additional PET probes that our founder has developed for immunotherapy and cell therapy.  The additional PET probes are specific to receptors on immune cells and could be used to image and monitor other processes affected by immunotherapies beyond T cell activation.

Management Team

• Founder Sam Gambhir is Chair of Radiology at Stanford and is a world-renowned pioneer in the field of molecular imaging.
• CEO Aruna Gambhir has over 25 years of broad experience in startups, R&D, sales, marketing, and operations.
• CSO Shahriar Yaghoubi has over 18 years of experience in molecular imaging, including pre-clinical and clinical assessment of novel PET probes and FDA experience with IND.
• COO Sam Quezada has over 30 years of experience in marketing, business development, and operations.

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.

CPC Scientific is a world-leading peptide CMO. With headquarters in the San Francisco Bay Area, CPC has the world-largest >200,000 sq ft cGMP peptide facility. This cGMP peptide facility passed multiple inspections from FDA without any Form 483 observations, is certified by ISO9001:2000 and ISO13485, and has capacity of hundreds of kg/cGMP product. Under leadership from many peptide industry veterans, CPC has been an ideal "partner", beyond just being a "supplier", offering our global clients, including all the top 10 global pharmaceutical companies, with extensive technical expertise, the highest quality, fast delivery, local access, and cost-effective solutions.