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HemoShear is a privately held biotechnology company that is changing the way drugs are discovered and developed, departing from traditional and often misleading scientific methods and animal studies in favor of translational tissue systems that accurately replicate human disease biology.  Its proprietary platform integrates best-in-class human disease systems, a comprehensive biorepository, interdisciplinary molecular and clinical disease expertise, and cutting-edge computational biology, together providing a unique and powerful lens to interpret biological mechanisms and human disease at a level not possible until now.  HemoShear’s drug discovery collaborations uncover new targets, elucidate previously unknown mechanisms, differentiate drug candidates, and predict efficacy and safety of drugs before entering the clinic.  HemoShear is collaborating to discover and develop new drugs with major pharmaceutical and biotechnology companies, five divisions of NIH and leading academic research institutions across several therapeutic areas, including oncology.

In November 2013, HemoShear announced a collaboration with NCI to initiate work to recreate the human tumor microenvironment in a physiologically relevant context that replicates human disease.  HemoShear has successfully completed the first stage of the NCI contract to create a tumor system that incorporates three essential cell-types, restores molecular signaling pathways and responds to three cancer treatments at human concentrations.  We know of no other systems that can assess drugs at human concentrations.   HemoShear is seeking $10 million from investors and/or pharmaceutical partners to engage in drug discovery collaborations and expand development of a wide range of tumor types and therapeutic approaches.

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.

Vasculox is a biotechnology company dedicated to developing CD47-targeting drugs for the treatment of cancer. CD47 is a checkpoint for the innate immune system, and tumor cells in numerous types of cancer up-regulate CD47 in order to ward off the anti-tumor activities of macrophages. Vasculox’s lead compounds are monoclonal antibodies (mAbs) against CD47 that not only promote phagocytosis of tumor cells but also have direct tumor-cell killing activity. Vasculox plans to develop one or more anti-CD47 antibody therapies through Phase II trials.

Although CD47 is recognized as a promising immuno-oncology target, no anti-CD47 products are currently on the market. Several entities are pursuing CD47 as a target preclinically or in early-stage clinical trials, but these competitors’ compounds appear to lack the direct anti-tumor activity that provides the Vasculox mAbs with a competitive advantage. In animal models of lymphoma and pancreatic cancer, the Vasculox dual-function mAbs demonstrate superior efficacy compared to single-function mAbs, a distinction which has the potential to translate into improved efficacy in the clinic.

Vasculox’s IP estate includes two U.S. patent filings and one PCT covering compositions of matter and uses of humanized anti-CD47 mAbs. The company has raised $4.4 million since 2009 and is currently raising a Series A of $8 million. Vasculox aims to achieve an exit by acquisition of at least $300 million no later than 2019.

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

Company Background 

Accelerated Medical Diagnostics, Inc. (AMD) was founded in 2008 and is enabling personalized chemotherapy for cancer patients through the development of PlatinDx, a test for predicting response to platinum-based chemotherapeutics. The test works by directly measuring in vivo the patient’s individual tumor susceptibility to platinum agents. We are presently conducting a multisite clinical feasibility study of PlatinDX for carboplatin/cisplatin in lung and bladder cancers, and a single site feasibility study oxaliplatin for advanced, metastatic breast cancer.

Technology Overview

The PlatinDx assay is a drug-device combination product that depends upon accelerator mass spectrometry (AMS) to analyze biopsy samples after patients are given microdoses of radiolabeled carboplatin or oxaliplatin. AMS is capable of detecting as little as one 14C atom per human cell, which enables administering humans with extremely low “microdoses” of labeled drugs for diagnostics purposes. Microdosing creates very low levels of a transient, radiolabeled biomarker that allows the in vivo measurement of the pharmacodynamic effect of this drug via the formation of drug-target complexes (adducts). The measurement of this label by AMS forms the basis for the ability of the PlatinDx test to predict response to subsequent full dose platinum-based therapy. The assay will identify those potential responders who have relatively high drug-DNA adducts and are likely to respond to platinum-based chemotherapy

Market Potential

The addressable market for PlatinDx is $500 million for the United States lung cancer market, $250 million each for the U.S. bladder and breast cancer markets, and $3-$5 billion globally for multiple cancers and drugs.

Competitive Advantage

PlatinDx directly measures in vivo the patient’s individual tumor susceptibility to specific chemotherapeutic agents, which will improve survival for one group and reduce acquired drug resistance caused by needless exposure of non-responders to platinum-based therapy. PlatinDx does not require patient or tumor genotype information or culturing of tumor cells. Other tests rely on quantitation of a single or a few gene mutations or expression levels, which is inadequate for prediction of platinum-based drug efficacy. FDA approval will lower barriers to reimbursement.

Financial Overview

AMD has been primarily funded through NIH/NCI contracts to develop PlatinDx for bladder and lung cancer. The company has raised over $2 million since 2011. Currently accruing patients for feasibility trials, AMD has funding for operations through early 2015. The company will be raising $32 million in additional capital over the next five years to complete the pivotal trials, establish the clinical and sales teams, develop the reimbursement and manufacturing processes, obtain CLIA certification, and gain FDA approval. Product launch is set for 2019.

Intellectual Property

AMD is presently refining and reducing to practice specific diagnostic methods for platinum-based chemotherapeutics through clinical evaluations. The company is pursuing protection of the PlatinDx platform via a series of patent filings for the global market, the first of which is a U.S. patent expected to be filed in November 2014. Microdose-based diagnostic applications to be covered include specifics of the microdose-based assay used for human studies, including useful drug concentrations, formulations, and specific activities, the resulting useful drug-DNA adduct frequencies in patients induced by microdosing, and sample processing methods optimized for AMS analysis. When issued, patent protection should extend until at least 2034. In addition to patent protection, FDA approval of the drug component as a “similar drug” will result in a period of market exclusivity for the drug component.

Commercialization Strategy

AMD is seeking regulatory approval for its diagnostic assays. AMD has key opinion leaders participating in the clinical trials and expects them to be early adopters upon launch. AMD plans to do a health economic study to justify reimbursement. AMD plans to develop regional laboratories that will serve U.S. and international markets. As an FDA approved test, AMD can license to large diagnostics companies.

Pipeline Products

The PlatinDX assays under development predict patient response for the three approved platinum chemotherapy agents (cisplatin, carboplatin and oxaliplatin) in the lung, bladder and breast cancer areas. The platform technology will be applied to other cancer drugs and tumor types.

Management Team

• CEO and founder Paul Henderson, PhD is a UC Davis faculty member with 15 years of experience in designing and implementing experiments to assess drug resistance, mostly with respect to accelerator mass spectrometry analysis.
• Vice president of development George Cimino, PhD is the co-founder and former vice president of development for Cerus Corporation and has over 30 years of research experience with small molecules that interact with DNA and 25 years of experience in bringing regulated drug/device combination products to market, including CE Mark and FDA approvals.
• Founder Chong-xian Pan, MD, PhD is a UC Davis faculty member and practicing medical oncologist who led the clinical implementation of two trials for PlatinDx.

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.