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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. 

Company Background 

Cynvenio is a commercial-stage diagnostics company providing a comprehensive, non-invasive blood test to match cancer patients with the best targeted therapy for their tumor. The company has developed and patented unique technology to detect cancer cells circulating in the bloodstream. These invasive cells are responsible for the spread of disease in patients – or the metastatic process – which is the primary cause of death. Cynvenio’s ability to capture these tumor cells in blood provides doctors the molecular evidence to characterize their patients’ cancers, administer tumor-specific drugs, and to measure response to treatment over time.

Technology Overview

Cynvenio’s LiquidBiopsy® technology provides reliable access to rare populations of cancer cells in whole blood, with the ability to detect mutations in as few as one target cell per mL. LiquidBiopsy is capable of concurrently sampling DNA or RNA from circulating tumor cells as well as cell-free DNA (cfDNA) from a normal blood draw. This technology enables faster, cheaper, and safer molecular analysis than traditional tissue biopsy approaches.

Market Potential

The rapid adoption of personalized medicine protocols is being fueled by the availability of new targeted therapies designed to fight cancer mutations that vary over time and from patient-to-patient. This has created a large unmet need for providing physicians with the patient-and-tumor specific mutational information that forms the underpinning of evidence-based medical decisions. There are 235K new cases of breast cancer every year resulting in over 40K deaths. This presents a target of 3 million breast cancer patients and survivors in the United States. Cynvenio believes this is a $350 million revenue opportunity that will validate the LiquidBiopsy approach and benefit large cohorts of patients.

Competitive Advantage

Cynvenio is the only company that offers a commercial test that allows sequence analysis of tumor cells recovered from blood. Legacy circulating tumor cell tests are all based on enumeration, a read out with prognostic value but no predictive molecular information. Cynvenio’s LiquidBiopsy® and ClearID™ blood tests can be used to complement traditional tissue biopsy analysis, or as standalone tests to find therapies for patients in which tissue biopsy is deemed difficult or too risky to harvest.

Financial Overview

Cynvenio has been privately funded since its inception in 2008. The company has raised $14.5 million in equity capital and has generated approximately $7 million in revenue.

Intellectual Property

Cynvenio has issued patents protecting the core technology. There are being pursued internationally and have been issued in Japan. Cynvenio has also pursued IP development around the platform and enabling consumables.

Commercialization Strategy

Cynvenio is seeking $15 million in equity financing to fund the commercialization of its LiquidBiopsy system and the ClearID blood test for the genomic analysis of breast cancer.

Pipeline Products

Cynvenio’s lead indication for LiquidBiopsy and ClearID is breast cancer because it has well-defined genetic alterations, the availability of multiple targeted drugs, and a large addressable patient population. The company will scale into other solid tumor indications including colorectal, prostate, and lung cancer.

Management Team

• CEO André de Fusco has 28 years of experience in high-tech development and financing as well as domestic and international experience in public companies and venture-backed startups.
• CSO Paul Dempsey, PhD has 25 years of experience in immunology and biomedical research and was an assistant researcher professor at UCLA.
• CFO Maureen Cullum has more than 20 years of financial leadership positions specializing in medical device and pharmaceutical startup companies.
• Vice president of operations and CLIA lab services Andreas Bakker, PhD has over 25 years of experience in laboratory, pharmaceutical, and biotechnology senior leadership positions.
• Vice president of sales and marketing Leila Colgan has over 20 years of sales and marketing leadership positions in the pharmaceutical, biotechnology, and oncology/diagnostic industries and specializes in strategy development for multichannel regional, national, and global marketing and sales plans.