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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.

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. 

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.

Technology Name:  Cytomegalovirus Therapeutic Vaccine – Glioblastoma and other cancers 

Company Background

Annias Immunotherapeutics, Inc., is a biopharmaceutical company focused on the development of novel immunotherapeutic approaches to treat cancer.  The company was founded in 2009 by Senior Investigators at the Duke Medical Center and is led by CEO Reiner Laus, MD. It is based on a patented and proprietary immunotherapeutic platform, discovered by John Sampson and Duane Mitchell at Duke University that targets human Cytomegalovirus (CMV). CMV is over-expressed in a variety of human cancers including significant and homogeneous expression in almost all glioblastoma (GBM) but not in normal brain tissue.  Annias Immunotherapeutics is focused on this promising opportunity to utilize CMV proteins as tumor-specific targets.  Additionally, the company has developed superior methods to immunize humans against cancer, and has already tested this approach in human clinical trials. This novel immunotherapeutic platform has shown extraordinary promise in eradicating GBM with virtually no toxicity experienced in the treated patients.

Technology Overview

Annias has exclusive rights to the next generation of proprietary immunotherapeutic platforms for peptide-based and dendritic cell approaches developed at Duke by Senior Investigators in the Preston Robert Tisch Brain Tumor Center who have completed two consecutive clinical trials using CMV pp65 loaded dendritic cells (DCs) in patients with GBM. The first of these trials was randomized and blinded and demonstrated the induction of CMV-specific immunologic responses along with remarkable progression-free (PFS) exceeding 36.6 months vs. 10.8 months for the control group and a median overall survival (OS) exceeding 36.6 months vs. 18.5 months for the control group.  The CMV vaccine is currently being reformulated into a cutting-edge rationally designed multi-epitope peptide conjugate, PEP-CMV. This proprietary technology platform combining chemotherapy and vaccination will be used to clinically evaluate the efficacy and immunologic effects of PEP-CMV vaccines in patients with newly diagnosed GBM. The poor prognosis for patients with GBM will enable Annias to obtain efficacy data from a randomized, controlled trial within two years of trial initiation. Product candidates based on this platform can be rapidly advanced in breast cancer, prostate cancer, and colorectal cancer.

Market Potential

Despite aggressive treatment, GBM remains uniformly lethal with median survival rates for patients with GBM being less than 15 months from the time of diagnosis. Thus, there is a large and urgent need for improved therapies for GBM. World-wide sales of the chemotherapeutic temozolomide (Temodar®) for GBM have reached one billion dollars in spite of its very limited efficacy. The markets for the products in the Annias pipeline for treatment of breast, colorectal, and prostate cancer present multi-billion dollar opportunities.

Competitive Advantage

The recent discovery and confirmation by five independent laboratories, that CMV propagates within a high proportion of GBMs, without infecting surrounding normal brain tissue provides an unparalleled opportunity to utilize the highly immunogenic antigens from CMV as tumor-specific targets. A distinct advantage of immunotherapeutic targeting of viral antigens is that the immune system is better equipped to target viral antigens compared to autoantigens. The frequency of CMV-specific T-cells is several orders of magnitude higher than what can be achieved with approaches targeting autoantigens.

Financial Overview

Annias secured $246,000 in NCI Phase I SBIR funding in 2012 and has recently submitted a Phase II application for $1.9 million. Through the Duke University Medical Center, several million dollars were secured in grant funding for CMV-targeted vaccine research.  The company expects that taking PEP-CMV through a randomized Phase II program, developing its pipeline products, and operating the company over the next four years will require significant incremental investment.

Intellectual Property

The company has exclusive rights to the Duke University portfolio of Immunotherapy patents. This portfolio includes both issued and pending patents, as well as published and as of yet unpublished patent applications. The issued patent includes claims that cover Annias approach both broadly (immunotherapy of cancer by targeting CMV) and narrowly (composition of PEP-CMV therapeutic).

Commercialization Strategy

Annias plans to start the next clinical trial for PEP-CMV this year. The initial capitalization of the company will serve to conduct and collect data from a large-scale, randomized controlled clinical trial for PEP-CMV. This trial will position the company well for product registration, partnering, and further development of its pipeline in additional diseases.

Pipeline Products

The company is developing PEP-CMV with GBM as the lead indication. Follow-on indications that can be targeted with the same product include the four leading cancers: prostate, breast, lung, and colorectal cancer.

Management Team

• CEO and President Reiner Laus, MD. Dr. Laus has worked on developing cancer immunotherapeutics for over 20 years. He was most recently CEO of BN Immunotherapeutics and prior to that he was VP of R&D at Dendreon, where he was a co-inventor of Provenge.
• Chief Scientific Collaborator and Founder, John Sampson, MD, PhD, is leader of the Neuro-Oncology Program at Duke University and head of the Brian Tumor Immunotherapy Program there. He has published extensively on CMV as a tumor-specific antigen and immunotherapy approaches. His laboratory at Duke developed the EGFRvIII-targeted vaccine which is now completing worldwide Phase III trials in patients with GBM.
• Vice president and corporate secretary James Sheldon was founder of Embrex, Inc. (acquired by Pfizer) and EnSys, Inc. (merged into SDOI).

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.