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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.  

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. 

Technology Name: Intraoperative cancer imaging system

Company Background

The Lumicell Imaging System combines a hand-held, single-cell detection imaging device and a cancer-specific molecular imaging agent (LUM015) for real-time identification of residual cancer in the patient’s tumor bed. The system provides surgeons with visual information to perform a thorough removal of residual cancer cells, thus eliminating the need for repeat surgeries due to positive margins or local recurrence.

Technology Overview

The Lumicell Imaging System is a clinical-stage intraoperative technology for detecting and guiding the removal of all residual cancer during the initial surgery. After the initial breast cancer surgery over 35% of patients undergo a second surgery due to residual cancer.  LUM015, which is injected several hours prior to surgery, emits a fluorescence signal having been activated by cancer enzymes in and around the tumor cells. Lumicell’s imaging head is a hand-held device designed for maneuverability in the tumor bed providing seamless operation within the existing surgical workflow. The system uses Lumicell’s proprietary detection algorithm to highlight regions containing residual cancer in a computer display.

Market Potential

Lumicell addresses the unmet need for locating microscopic residual cancer and guiding its removal during the initial surgery. Lumicell is in human clinical trials for breast cancer and sarcoma and have IRB approval to begin trials in esophageal and colon cancers. The U.S. market for Lumicell is a combined $1.43 billion for breast, lung, prostate, colon, esophageal, ovarian, and brain cancers and sarcoma. Most large cancer practices are at risk for the cost of the second surgery and view Lumicell’s product as an immediate financial benefit. The cost savings to the hospitals together with expected additional reimbursement for the guided surgery procedure ensures attractive revenues to Lumicell.

Competitive Advantage

A number of devices attempting to detect cancer without an imaging agent have shown poor sensitivity (below 60%) and specificity (below 40%) and struggled to be adopted. Other competitors are developing comparable technology using an imaging agent and device, but Lumicell is far along in the development process having successfully completed a Phase I clinical trial that demonstrates safety and preliminary efficacy (91% sensitivity and 86% specificity). In contrast with competitors’ imaging agents, LUM015 is also specific to cells at the tumor margin, which reduces the dose requirement and increases the signal to background ratio. Unlike the same-day injection of LUM015, some competitors attempting to use antibody-based agents, which take days for clearance, require an extra visit to the clinic by the patient in advance of the surgery. The handheld device, which is insensitive to surgeon’s and patient’s motion, has unprecedented detection of sub-millimeter residual cancer in a large field of view.

Financial Overview

Lumicell is very capital efficient and has raised $6.7 million in Series A and B venture capital funding. Through NSF and NCI SBIR programs, Lumicell has been awarded $2.4 million. The company has also received a $1 million Massachusetts Life Sciences Accelerator Loan, and our academic and clinical collaborators have received about $1.6 million in funding to support pre-clinical and clinical studies with the Lumicell system.

Intellectual Property

Lumicell has obtained an exclusive license from MIT for the use and commercialization of the imaging device. The company also has an expansive IP portfolio (U.S. and international) including specific architectures of imaging agents, methods for labeling the tumor margin, and a novel laser ablation technology for instantaneous and precise removal of residual cancer.

Commercialization Strategy

Lumicell has secured funds to finance operations through the pivotal trial (2015) and expects to raise $10 million upon FDA product marketing approval (PMA) in late 2015 for product launch.

Regulatory strategy and Pipeline Products

Lumicell’s LUM015, combined with our first device, has completed a Phase 1 safety study at Duke University Medical Center. Lumicell’s combination product has been assigned to the device group (CDRH) of the FDA. Lumicell has completed a pre-IDE meeting with the FDA to discuss upcoming trials in breast cancer.  Lumicell aims for FDA approval under a PMA in breast cancer by late 2015. In parallel, Lumicell has developed a laser ablation module to perform precision surgeries required in brain and ovarian cancers. Lumicell has a pipeline of imaging agents offering further benefits including higher signal-to-background ratios, higher specificity for certain types of cancers and at lower doses.

Management Team

• David Lee, CEO and co-Founder, has 25 years of demonstrated success in product development at Arthur D. Little and has experience running R&D groups and early commercialization of products. He is a co-Founder and the founding CEO of T2 Biosystems, Inc. (NASDAQ:  TTOO) which is about to enter the market.
• Jorge Ferrer, Ph.D., Director of R&D, developed the original imaging system and LUM015. He has 8 years of experience in research, development, and project management.
• David Strasfeld, Ph.D., Senior Scientist, trained in physical chemistry, instrument design, and experimentation, leads the device development efforts.

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