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Actinobac Biomed is conducting IND-enabling studies for their primary drug candidate, Leukothera®, a highly effective therapeutic for the treatment of hematological malignancies including B-cell lymphoma. Leukothera™ is a naturally derived biologic that specifically targets the subset of white blood cells (WBCs) expressing activated leukocyte function antigen-1 (LFA-1). Since LFA-1 is only present on WBCs and its activated form is uniquely expressed on cancerous and hyper-inflammatory WBCs, other cells and tissues are not affected, minimizing negative side effects.

Actinobac has exclusively licensed the patent portfolio established by Rutgers University covering the use of Leukothera® for the treatment of multiple medical conditions including cancer, autoimmune/inflammatory diseases, and HIV infection. The company has raised $960,855 since 2009 and is presently seeking funds to support the GMP production and formulation ($700,000) of their drug candidate. This high quality material will be used to complete preclinical research and development activities ($900k), stability and storage testing ($500k), the assembly and filing of regulatory documentation and an IND application ($1 million), and perform safety and preliminary efficacy clinical studies ($1.5 million). Actinobac is presently in discussions with a number of major pharmaceutical companies and investment groups to provide scientific support and financing for these activities.

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.

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. 

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.

DreamCatcher Ventures:

Dream Catcher Ventures was founded to address the inefficiencies in the marketplace and to align the goals and aspirations of entrepreneurs with investors. It is focused on creating and building disruptive biotech/healthcare companies that are positioned to excel in global markets.

Currently working with BioHealth Innovation to raise a $50M “Gap Fund” to invest in early stage healthcare businesses, primarily in therapeutics, diagnostics, medtech and healthcare IT.

Founder Profile:

Broad and in-depth experience in both science and business: Over fifteen years of experience in the life sciences and over 10 years of venture investing experience in biotech/ life sciences/healthcare and healthcare delivery with Burrill & Company, a $1.5B life sciences fund.

 Previously on Boards of Adlyfe , a CNS diagnostics company, Strand (A bioinformatics/ genomic data analysis company), White Glove Health, healthcare delivery company (Board observer), Bioimagene, a digital pathology company (Board observer, exited via a  $100M sale to Roche) and the Advisory Board (Finance) for Express Pharma. On the Editorial Board of the "Interdisciplinary Journal of Applied & Biomedical Sciences. Also managed India as a region of investment interest for the firm. Sourced, diligenced and led cross-border investment opportunities in both US and India. Strongly networked to venture capitalists, investment banks, pharma and biotech companies both nationally and internationally.

Mentoring entrepreneurs: Course instructor at UCSF "An idea to IPO and beyond". Involved with business plan evaluations and competitions at Berkeley, UC Davis, LARTA and previously WTC

Prof. Suzie Chen and her colleagues at Rutgers University have recently discovered that the metabotropic glutamate receptor 1 (GRM1, mGluR1) plays a significant role in the development and growth of melanoma tumors.  They found that riluzole, the only drug approved by the U.S. FDA for the treatment of amyotrophic lateral sclerosis (ALS), which also blocks glutamate release from GRM1 cells, inhibits melanoma growth and proliferation both in vitro, in mouse xenograft models, and in limited human clinical trials in melanoma patients.  However, the clinical use of riluzole for ALS, and potentially for melanoma, is severely limited by variable CYP1A2-mediated first pass metabolism.  Fox Chase Chemical Diversity Center, Inc. has developed novel and innovative prodrug derivatives of riluzole which avoid CYP1A2 in vitro metabolism and are expected to provide more regular pharmacokinetics and exposure in patients, with a longer half-life, allowing for once daily oral dosing versus the current twice daily dosing that is required, and potentially greater patient compliance.  

The company has filed several PCT provisional U.S. patent applications on riluzole prodrugs, with additional composition of matter patent filings anticipated. Other than riluzole, there are no compounds that target the glutamate pathway for treatment of metastatic melanoma.  The company has raised more than $2.2 million specifically for this program since 2010, and is looking to raise an additional $3 million by the third quarter of 2015, in order to perform the required IND-enabling studies for an IND application and enter Phase I clinical trials at the Cancer Center of New Jersey

Galen Biotechnologies is an early-stage biotech company developing small molecule drugs to disrupt protein-protein interactions. Using genetically encoded-chemical fragment libraries we are rapidly advancing small molecules targeting Ras and Bcl-2 pathways in oncology. Our platform technology combines the strengths of encoded biologically relevant diversity with chemical evolution of pharmacophore structures to drive drug design with unparalleled efficiency against difficult protein-protein interaction targets.

Galen Biotechnologies was founded in 2013 and is located in the University of California, Santa Cruz QB3 incubator. The privately held company has raised $1M in nondilutive funding from research collaborations and SBIR grants and contracts (NIH-GMS, NCI, and DoD) in support of its platform. We anticipate a Series A fundraising in mid-2015 to accelerate our platform validation with the aim of progressing a lead molecule to full IND-enabling studies as well as exploring new targets in inflammation.

Company Background 

Founded in 2007, Insight Genetics is a full service precision medicine company. The company has a portfolio of proprietary Companion Diagnostic (CDx) assays that detect specific cancer biomarkers. The assays have potential to become new standards of care in the lung, breast, ovarian, and leukemia cancer markets. Together with its CLIA certified laboratory, Insight Molecular Labs, the company also develops custom clinical trial assays and provides clinical trial testing services for the pharmaceutical industry, contract research organizations, and academic research institutions.                                                                                      

Insight Genetics lead product Insight ALK Screen™ was developed in collaboration with NCI to address an unmet need in the diagnosis of non-small cell lung cancer (NSCLC). The assay is exclusively licensed, manufactured, and distributed globally by commercial partner QIAGEN N.V. as an RUO kit (QIAGEN ALK RGQ RT-PCR™). The company and QIAGEN continue to co-develop the assay as a CE marked and FDA approved CDx for ALK inhibitors such as Pfizer’s Xalkori®.

Technology Overview

Despite anti-tumor response to targeted cancer drugs such as Xalkori, most lung cancer patients eventually experience disease progression due to mechanisms that induce resistance to the inhibitor. In response, Insight Genetics has developed two resistance products: Insight ALK Resistance™, a qPCR test for ALK inhibitor resistance; and Insight Resistance ID™, a panel on both NGS and multiplex-qPCR platforms that comprehensively detects multiple mechanisms of targeted inhibitor resistance including EGFR and KRAS. As additional targeted therapies enter the lung cancer market, physicians will require these tests for patient monitoring to determine drug efficacy and combination therapies tailored to a patient’s real time genetic data. The next phase of development for these two products is non-invasive methodologies (from blood).

Market Potential

Insight ALK Resistance and Insight Resistance ID have potential to be the standard of care for diagnosing and characterizing therapeutic resistance in NSCLC patients (1.3 million annual incidence globally). As a CDx and patient monitoring tool, the global addressable market for the two products exceeds $500 million. The addressable market for the company’s complete product pipeline is estimated at over $1 billion. Primary target customers include pharmaceutical companies, oncologists, pathologists, and academic research institutions.

Commercialization Strategy 

Insight ALK Resistance and Insight Resistance ID are currently available to pharmaceutical companies and clinical researchers as CLIA validated tests for (1) selection of patients for clinical trials, and (2) detection and monitoring of molecular-driven drug resistance in patients being treated with specific cancer therapies. The next step is to develop the assays in a non-invasive format with select multiplex-qPCR and NGS IVD platform companies, and together commercialize the assays as CLIA tests, RUO/CE marked kits, and FDA approved IVDs. Insight Genetics revenue sources include: government contracts and grants; licensing, royalty and milestone payments; fees for custom assay development and clinical trial services, and clinical laboratory reference testing.

Competitive Advantage 

In addition to a strong proprietary IP position, Insight Genetics will have first-to-market advantage. Patented platforms on which the assays will be offered ensure the best combination of performance, ease of use, and cost for resistance detection and monitoring. Insight Genetics competitive position will be strengthened through its commercial alliances with industry partners.

Intellectual Property

Insight Genetics growing IP estate includes one awarded patent (ALK resistance mutations) and ten patents pending. The IP estate is filed and prosecuted globally.

Pipeline products

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Financial Overview 

Insight Genetics has raised more than $11.1 million since 2007 including $5.3 million in NCI contracts. To fund growth, the company is seeking $10 million from a combination of sources. 

Use of Proceeds:

• $3 million for further development and commercialization of lead product Insight ALK Screen.
• $4.5 million to support the full development, regulatory approval, and commercialization of the resistance assays.
• $2.5 million for working capital to further build and commercialize the company’s total portfolio of novel assays.

Management Team

• Chairman and CEO Eric Dahlhauser, CPA has more than 20 years of clinical diagnostic laboratory experience and was previously the founder, Chairman, and CEO of Genetic Assays, Inc.
• President and COO Christopher Callaghan, DPA, MBA co-founded Insight Genetics and has more than 20 years of senior management experience in startup and turnaround ventures.
• Vice President of R&D David Hout, PhD has extensive experience in the field of molecular diagnostics and served as a senior research microbiologist at Biomune.
• Scientific Founder and CSO Stephan Morris, MD is an internationally recognized physician-scientist most known for the discovery of ALK.
• Chief Technology Officer Robert Seitz previously served as Senior Vice President of Clarient, Inc., after Clarient acquired Applied Genomics, Inc. (AGI). He served as AGI’s Co-founder and CEO from 2000 to 2009.
• Managing Director of Pharmaceutical Partnerships, Pia Gargiulo, PhD previously lead teams in the development and delivery of Companion Diagnostic Programs for the pharmaceutical industry. She has worked on eight PMA submissions resulting in three pivotal CDx offerings to breast, colorectal, and lung cancer patients.  

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. 

Magnetic Insight seeks to introduce a ground breaking imaging technology addressing today's clinical and translational research challenges called magnetic particle imaging. 

Magnetic Particle Imaging (MPI) is a new imaging technology unique from any other technology on the market. It is a functional imaging modality similar to PET, SPECT and optical where real time biological events can be monitored verses anatomical imaging such as computed tomography (CT) or magnetic resonance imaging (MRI). MPI offers the ability to target biomarkers, cell tracking and real-time blood flow and vascular architecture all with direct quantitation. Harnessing the magnetic properties of iron oxide (rust) nanoparticles, visualization and quantitation is specific, direct and unobstructed by tissue depth at exquisite sensitivity and with elegant resolution