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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: 3D Cell-based Cancer Diagnostic

Company Background

KIYATEC is a privately held company that has developed a platform to enable accurate ex vivo prediction of cancer patients’ response to drug treatment.  Incorporated in 2010 by co-founders David Orr and Matt Gevaert, the company has created novel 3D cell-based models for drug response profiling that can generate information relevant to preclinical testing, clinical trials, and clinical diagnostics applications. By accurately predicting patient drug response without exposing patients to drugs, KIYATEC will enable informed drug selection that minimizes clinical trial failures and maximizes patient outcomes.

KIYATEC is located in Greenville, SC and is based in the Greenville Health System’s Institute for Translational Oncology Research (ITOR) which conducts phase I clinical trials and is a life science incubator for companies pursuing translational cancer therapeutics and/or diagnostics. KIYATEC currently has 9 employees.

Technology Overview 

KIYATEC’s  3DKUBE™is a technology platform that uses human clinical samples to generate 3D microtumors to accurately predict human response to cancer drugs ex vivo. The 3DKUBE™ is a 3D perfusion bioreactor that allows for co-culture of the different cell types found in tumors, and incorporates optimized 3D scaffolds and media conditions. In addition to many cell lines, KIYATEC has tested clinically annotated, patient derived primary ovarian and breast cancer cells in its drug response profiling and is expanding into primary Glioblastomas (GBMs).  KIYATEC’s 3D microtumors can be used in preclinical drug evaluation, as a co-clinical trial patient selection tool, and as an ex vivo diagnostic for real time clinical decision making.

Market Potential            

The global cancer/tumor profiling market was valued at $13.3 billion in 2012 while the global market for cell-based assays for drug discovery was valued at $6.2 billion in 2010. The US total available market opportunity for cell-based ovarian cancer, breast cancer, and GBM cancer diagnostics is approximately $1 billion. KIYATEC’s live cell cancer diagnostics will enable response based drug selection and will be offered via a laboratory service model.

Competitive Advantage

KIYATEC’s drug response profiling platform uses a 3D microenvironment to culture cells, enabling better prediction of clinical outcomes than 2D microenvironments. In KIYATEC’s Phase I contract, cells cultured in an actively perfused microenvironment had increased cell viability, richer paracrine interactions, and increased cell functionality compared to static cultures. The 3D cultures are maintained as closed systems without manipulations, saving time and cost, decreasing contamination risk, and increasing scalability. KIYATEC’s demonstrated ability to choose and utilize the best scaffold for a given cell type maximizes the number and type of tissues that can be effectively modeled and maximizes the potential for multi-cell interaction for better cell function. KIYATEC’s exceptional clinical connectivity results in more effective procedures with the clinical partner and more successful translation of laboratory results back into the clinic, aspects not possible for competitors relying on third party primary tissue sourcing.

Financial Overview

KIYATEC has secured over $5.1 million in committed capital since 2008 ($2.6 million in investment; $2.5 million non-dilutive funding including a recently awarded NCI Phase II contract) and is currently working to raise a series B round of $12.5 million, with an initial tranche of $7 million to support company milestones. 

Intellectual Property

KIYATEC’s IP portfolio consists of an exclusive license to issued utility patents (product and method claims).  The company has assignment of issued design patents and pending utility filings associated with the core technology for applications in drug screening, cancer diagnostics, and 3D cell-based assays.

Commercialization Strategy

KIYATEC is currently generating revenue from late stage preclinical 3D cell-based assay services for pharma, biotech and CRO clients with potential to expand quickly into co-clinical trials.  Future ex vivo cancer diagnostics that enable response based drug selection will be offered as a CLIA lab based service offering either as an LDT or as an FDA regulated diagnostic as required.

Pipeline Products

KIYATEC’s first generation platform (3DKUBE™) has been tested with patient derived ovarian and breast cancer cells / tissues; GBM studies will begin in Q4, 2014.  A second generation, higher throughput platform is under development.  KIYATEC’s platforms can be further expanded into additional solid tumor types (e.g. lung, colon, pancreas, and liver).

Management Team

• CEO Matt Gevaert, Ph.D., has IP commercialization/technology startup experience as commercialization officer at Clemson University and has experience with Merck and 3M.
• COO David Orr, Ph.D., MBA, inventor of KIYATEC technology, has biomedical, industrial operations and financial management experience at Cook Medical, Ingersoll-Rand, and Dwyer Instruments.
• Chief Medical Officer Hal Crosswell, M.D., is a practicing oncologist and the lead investigator for more than 40 industry and NCI-sponsored clinical research studies.
• Sr. Director of Business Development Bryce Chaney, MBA, has business development and technical experience at Cirrus Pharmaceuticals, Azopharma, Scynexis and BD Technologies.
• Chairman of the board Robert Silverman is a diagnostics industry veteran whose last company was acquired by Roche for $270 million. 

Vaxiion Therapeutics is dedicated to the further development of VAX-IP, a promising investigational bacterial-minicell based biologic product initially intended for the topical intravesical treatment of Non-muscle Invasive Bladder Cancer (NMIBC).  VAX-IP exerts rapid selective tumoricidal effects against human urothelial carcinomas in addition to synergistic secondary immunotherapeutic effects, a combination unlike that of any other product under development or on the market in the NMIBC space. With compelling pre-clinical efficacy data in several clinically relevant variations of the gold standard mouse model of NMIBC, Vaxiion is now committed to the commercial and clinical development of VAX-IP for initial use as an intravesical agent for the treatment of NMIBC.   Currently, Vaxiion is initiating IND-enabling studies with the intention of filing an IND application with the FDA in Q1 of 2016.  Clinical trials would focus on serving as a salvage therapy for BCG-refractory and BCG-intolerant NMIBC patients, and if successful,  quickly be expanded to other areas of unmet need within the NMIBC treatment algorithm.

Vaxiion estimates the market size for an effective and reimbursable bladder cancer product addressing this admixed disease niche to be ~$937 - ~$1.87 billion depending on the number of approved indications. The company feels that it will take ~$7-10M and 3.5-4 years to complete two Phase 2a efficacy studies and demonstrate human proof-of-concept. Vaxiion has raised ~$5 million for this effort to date, and is looking for $3-$4 million in addition to proceeds from a pending SBIR Phase II award to advance the program through this inflection point.

Technology Name: Small molecule CDK8/19 inhibitor

Company Background

The mission of Senex Biotechnology is to develop novel therapeutics for the treatment of cancer and other major diseases by targeting key disease-promoting pathways induced by cellular damage and aging, and by identifying and attacking novel cancer-specific molecular targets. Founded by Dr. Igor Roninson, on the basis of discoveries in his laboratory in 2002, the company is located in Columbia, SC, and currently supports three scientists.  Senex has won a series of grants, including two Phase II SBIR grants, and concluded a strategic licensing agreement with a foreign pharmaceutical company in 2014. Senex has identified several novel targets and generated first-in-class small molecules against three of these targets. The drug for the most advanced program is about a year from clinical trials.

Technology Overview 

Senex’s most advanced program targets CDK8/19, a transcription-regulating oncogenic kinase. CDK8/19 inhibition has multiple anti-cancer effects at the molecular level, including the inhibition of oncogenic transcription factors, as well as stimulating immune surveillance by NK cells. The lead molecule, Senexin B, is fully optimized and exceptionally selective for CDK8/19. It is orally available, non-toxic, and extremely potent in numerous in vivo studies: Senexin B directly suppresses prostate and breast tumor growth, exhibits strong synergistic effects with several widely used drugs, and has anti-metastatic activity in several cancer types.

Market Potential

Senex will initially develop Senexin B for treatment of metastatic castration-resistant prostate cancer (mCRPC), the second leading cause of cancer related death in the United States. Over 29,000 people die from prostate cancer every year; 1 out of every 36 men will die from prostate cancer.  Median survival for mCRPC is less than 2 years.  Although several new drugs have recently been approved, resistance to these drugs develops within several months so there is a large unmet need.  Senexin B acts against those cancers that do not respond to any class of androgen receptor inhibitors, including cancers that are resistant to the newly approved drugs Xtandi and Zytiga.

Competitive Advantage

CDK8/19, Senex’s primary target, belongs to the CDK family, but unlike better-known CDKs, CDK8/19 does not mediate cell cycle progression, and is not required by normal cells under homeostatic conditions. As a consequence Senexin B is extremely well tolerated. Senex is the only company to describe selective CDK8/19 inhibitors in a peer-reviewed article. Based on the known poster presentations and published patent applications, CDK8/19 inhibitors have been recently developed by Selvita (Poland), Bayer Pharma, and CNIO (Spain). Based on the available information, none of the competitors’ compounds appear to be as selective as Senex’s CDK8/19 inhibitors, and no comparable in vivo studies have been reported.

Financial Overview

Senex has received over $2.8 million in NIH funding and over $3.5 million from other sources, including angel investors, licensees, charitable foundations and the DOD. Senex is seeking $10 million to fund additional pre-clinical and clinical studies through proof-of-concept in castration-resistant prostate cancer.  The plans for this study have been developed with a NCI-designated cancer center.

Intellectual Property

The key issued patents for Senex’s CDK8/19-related IP are US patents 8,598,344 protecting the composition-of-matter of its CDK8/19 inhibitors and 8,592,147 protecting the general screening method for identifying inhibitors of transcriptional pathways including those regulated by CDK8/19. Senex also has several pending utility patent applications protecting other novel applications of CDK8/19 inhibitors that Senex and its collaborators have discovered.

Commercialization Strategy

Senexin B has been licensed to a foreign pharmaceutical company for minor markets. Marketing rights for all major markets are retained by Senex. The licensee will provide Senex with GMP manufactured Senexin B, the results of FDA acceptable preclinical safety studies, and clinical trials that will be conducted to international GCP standards. Senex will receive milestone payments and royalties from sales of drugs in the licensee’s minor markets. These results will enable Senex to partner with a major pharmaceutical company to perform additional clinical trials and to market the drug.  Anticipated milestone payments will fund other programs in Senex’s pipeline.

Pipeline Products

Senex also has programs targeting CDK3 and COPZ1. Senex has identified CDK3 as a cancer-specific target and is optimizing the first CDK3-selective small molecule inhibitors. COPZ1 is a component of the vesicle-coating complex and Senex has discovered the first COPZ1-targeting small molecules. COPZ1 inhibition should kill most types of tumor cells, including dormant cells and cancer stem cells, which are resistant to conventional therapy.

Management Team

• President and CSO Igor Roninson is the founder of Senex and the inventor on 41 issued US patents.
• CEO Lawrence Friedhoff has a long history of successful and rapid FDA approval of new drugs, including two blockbusters, one of which is Aricept, the main drug used to treat Alzheimer’s disease.
• Karthik Gopalakrishnan brings several years of experience in business development and negotiation skills to Senex.  He has successfully concluded business transactions with several pharmaceutical companies.