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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.  

Synergys Biotherapeutics is a privately held antibody therapeutics company developing multifunctional anti-vasculogenic antibody therapeutics for cancer and other angiogenesis-related diseases of significant unmet medical needs. The Company focuses on in-licensing early stage candidates from external sources for additional development in-house as well as through building collaboration and partnering with larger pharma and biotech organizations. The Company’s current preclinical programs include Anti-EGFR-ATAP, an antibody fusion molecule being developed for Triple Negative Breast Cancer and other EGFR+ malignancies, as well as a bi-targeted, bifunctional “first-in-class” fully human Anti-Ang-1/2 antibody for various cancers.   Synergys’ management and the members of its scientific and business advisory boards are veterans of biotech business having more than 20 years of average expertise and experience in cancer drug development.  

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.

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.