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ImmuneXcite is a privately held biotech company developing the next generation of immune-activating therapies for cancer and infectious diseases utilizing a novel immunotherapy platform technology. ImmuneXcite’s platform technology, mAbXcite, creates novel monoclonal antibody constructs that trigger a potent immune cell response selectively against disease targets. The mAbXcite technology is based on a unique polysaccharide that signals infection to the immune system. By linking this polysaccharide to monoclonal antibodies (or other targeting moieties like bi-specific mAbs, aptamers, peptides), a recruitment and activation of neutrophils/immune cells against the bound target is triggered, leading to its destruction. The mAbXcite constructs have demonstrated superior efficacy in resistant tumor xenograft models when compared to monoclonal antibodies. The company is currently developing lead therapeutic mAbXcite constructs for high unmet medical needs and breakthrough indications. IND-enabling studies have started and the company has developed an imaging assay that validates the mechanism of action and which can potentially be used as a pharmacodynamic marker for anti-tumor activity in Phase I clinical studies.

ImmuneXcite has a strong patent portfolio and has raised $8 million from angel/private investors and non-dilutive sources (Massachusetts Life Science Center and a SBIR grant from NCI). The company is seeking to raise $14-16 million in its next  financing in the 4th quarter 2014 to support development of its lead compound through completion of Phase I clinical trials. ImmuneXcite’s business development strategy is to establish partnerships/collaborations to maximize the therapeutic potential of its platform technology, and to build its internal pipeline through in-licensing. Active partnering discussions are ongoing.

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.