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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.

Diagnostic Photonics (DxP) is a medtech company commercializing a handheld, high-resolution imaging system for cancer surgery. The Foresee (4C) Imaging System provides new, crucial information and insight on the extent of disease at the microscopic level.  Surgeons can act on that information during surgery - no longer waiting days for final pathology - and avoid costly repeat procedures and poor clinical outcomes.  In the company's 50-patient, multi-center trial in breast cancer surgery, 62% of repeated surgeries could have been avoided.  The Foresee system recently received CE-marking and initial FDA 510(k) clearance, and the company established new CPT coding (Cat III) to provide additional reimbursement for surgeons and healthcare facilities.

The company’s initial focus is on breast cancer lumpectomy surgery, where the repeat surgery rate from positive margins exceeds 25%. Lumpectomy surgery is performed on 1.6 million patients each year and represents an opportunity in excess of $1 billion annually. The company has five issued patents and multiple patents pending. The company has established new CPT coding (Cat III) for breast imaging and successfully conducted a 50-patient, multi-center trial with excellent results. The company is working with leading academic medical centers to conduct a 460-patient multi-center pivotal clinical trial. Diagnostic Photonics has raised $6.2 million to date and has a $6 million Series B round pending to conduct the pivotal trial and generate initial commercial sales at leading medical centers in Canada, Europe, and the U.S.

Robin Medical, Inc., has developed and commercialized a wide range of medical devices since its formation in 1997. The ultimate goal of its newest cryopreservation technology is to collect biopsy tissue samples that retain the cells’ viability, the in-vivo biochemical profile, and the tissue ultrastructure by using differential freezing profile that keeps part of the sample frozen (for biomarker analysis) and part unfrozen (for histology analysis). The cryogenic apparatus is either built into a cryobiopsy needle (CyroBx™)  to enable in-situ freezing of the tissue, or in a disposable sample holder (the CryoTray™) that maintains differential cryo temperature profile of samples acquired by any biopsy device.

The CryoBx™ will initially address the market of breast vacuum-assisted biopsy (VAB), estimated at $300 million, as a competitive VAB device with tissue cryopreservation. We then plan to address the much larger market of biopsy devices for internal organs that require thinner biopsy needles. In parallel, the company plans to complete the development of the CryoTray™tissue holder, to conduct clinical studies and to release it to market for use in any biopsy procedure.  A pending U.S. patent application for the cryogenic biopsy device and method awaits USPTO Office Action; a provision patent application covering the innovation of the CryoTray™ has been recently filed. Robin Medical has raised $15 million since its formation in 1997. The company looks for phase I investment of $1.5 million and intends to to apply for an SBIR Phase IIB (bridge) grant. The raised funds will be used to continue the development and clinical testing of the devices and to commercialize the biopsy cryopreservation line of products.