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Technology Name: Reduction of Chemotherapy­Induced Myelosuppression (“Chemoprotection”)

Company Background

G1 Therapeutics (G1, or the Company) is a clinical-stage oncology company using a small molecule-based approach to attenuate multi-lineage bone marrow suppression due to chemotherapy. G1 was founded by Ned Sharpless, MD (Director, UNC Cancer Center), and Kwok-Kin Wong, MD, PhD (Director, Belfer Institute/DFCI/Harvard), to capitalize on their research into how certain cyclin-dependent kinases (CDKs) control the production of blood cells by hematopoietic stem and progenitor cells (HSPCs) in the bone marrow. The Company’s lead program, G1T28-1, is a highly potent and selective CDK4/6 inhibitor that is currently in Phase 1 clinical trials. G1 has assembled a team of accomplished drug discovery and development scientists with extensive experience in bringing innovative oncology drugs to market. The Company has 10 full-time employees and is based in Research Triangle Park, NC.

Technology Overview 

Bone marrow suppression (also known as myelosuppression) is a severe side effect of chemotherapy, resulting in the loss of red blood cells (anemia), white blood cells (neutropenia) and platelets (thrombocytopenia). Patients can experience fatigue due to anemia, infections due to neutropenia and bleeding due to thrombocytopenia. While oncologists expect chemotherapy to remain the standard treatment regimen for many kinds of tumors, the current treatments for myelosuppression have significant liabilities and shortcomings.

G1T28-1 induces a transient, reversible arrest of HSPCs, making them resistant to DNA damaging insults. Preclinical data has demonstrated that protecting the bone marrow from damage results in a quicker recovery of all blood lineages and mitigates bone marrow exhaustion. G1T28-1 has the potential to enhance anti-tumor efficacy by maintaining chemotherapy dose density and schedule, and to improve quality of life and to positively impact pharmacoeconomics by reducing transfusions, preventing hospital admissions due to infection, and attenuating the incidence of secondary hematological malignancies.

Market Potential

G1’s clinical candidate, G1T28-1, will enter the bone marrow supportive care market which includes growth factors (biologics) such as Neulasta, Epogen, Procrit, Neupogen, and Aranesp with combined 2013 sales of $8.4 billion in the United States alone. The Company has a target chemotherapy patient population of up to 300,000 per year in the US alone.

Competitive Advantage

G1's first-in-class chemoprotectant, G1T28-1, is differentiated from current treatments for myelosuppression because it protects all hematopoietic lineages: red cells, platelets, granulocytes and lymphocytes. While growth factors stimulate single-lineage bone marrow progenitor cells that have already been damaged by chemotherapy, G1T28-1 protects all hematopoietic stem and progenitor cells (HSPCs) before damage is done, potentially changing the treatment paradigm.

Financial Overview

Since inception, G1 has raised over $5 million from non-dilutive sources and closed a Series A financing of $12.5M in October 2013. The Company is currently seeking a $15M Series B for conducting a Phase 1b/2a trial to demonstrate reduction of chemotherapy-induced myelosuppression in cancer patients.

Intellectual Property

G1 has broad freedom to operate for its novel compounds and their methods of use. G1 has five issued composition-of-matter US patents covering compounds (including G1T28-1) related to the Company’s first proprietary scaffold. Additionally, G1 has multiple pending applications for composition-of-matter and methods-of-use on all three of its novel kinase inhibitor scaffolds.  

Commercialization Strategy

G1 is focused on developing G1T28-1, for chemoprotection. The Company plans to first demonstrate early proof of concept of bone marrow protection in a rapid and straightforward clinical trial in patients with small cell lung cancer.  Following this trial, G1 plans to conduct additional Phase 2 trials to demonstrate efficacy in other cancer types.

Additionally, there has been heightened interest in drugs that target CDK4/6 as antineoplastic agents. The Company is currently in active discussion with several potential partners for G1’s proprietary CDK4/6 inhibitors used as antineoplastics.

Pipeline Products

G1 Therapeutics is advancing a portfolio of proprietary drug candidates for both antineoplastic and chemoprotection indications.  The Company’s lead program, G1T28-1 is currently in Phase 1 clinical testing.  PK/PD data from this trial will inform dose and schedule for Phase 1b/2a trials in cancer patients that are planned for Q2 2015.  In addition, G1 has back-up/follow-on compounds for both chemoprotection (G1T30-1) and antineoplastic use (G1T38-1).

Management Team

·   CEO Mark Velleca MD, PhD was instrumental in founding, building, and leading CGI Pharmaceuticals. He forged a major drug discovery/development collaboration with Genentech and an acquisition of the company by Gilead.

·   CMO Raj Malik MD is an oncologist with more than 20 years of drug development experience in academics (University of Virginia), large pharma (BMS), and small biotech (Agennix).

·   CBO Greg Mossinghoff, MBA has extensive operational, financial, and deal-making experience in small biotech and big pharma. As President of Inspire (from inception through IPO), he established significant corporate partnerships.

·   CSO Jay Strum PhD brings more than 20 years of drug discovery experience to G1. He was a key leader of programs in cancer and metabolic diseases at GSK that led to marketed therapeutics such as Tykerb.

Developing the medical applications of bubble technologies, and seeking the advantages of Contrast-enhanced Ultrasound Imaging (CEUS). We serve with the advanced ultrasound contrast agents for research purposes. Currently under clinical developments of our microbubble product. The target indications would be focal liver lesion detection, breast cancer detection, and CAD perfusion imaging. Furthermore, we aim to develop the ultrasound-triggered release system and make it available in clinical practices.

Technology Name: Image-guided therapy with magnetic nanoparticles 

Company Background

Weinberg Medical Physics LLC, founded in 2008, is a privately-held company based in Bethesda, Maryland. WMP has special competence in medical imaging and image-guided therapy. Its mission is to introduce disruptive technologies that address compelling clinical indications. The company works closely with investigators at University of Maryland. Company currently has 8 employees and 4 university subcontracts.

Technology Overview

We have developed a new image-guided therapy system. The system has two properties that have never before been realized in therapeutics:

• It can deliver any drug to any location in the body non-invasively

• It can image any location in the body with cellular resolution (20 microns)

The system consists of two components: (1) an MRI-like set of electromagnetic (EM) coils and drivers that can steer magnetic particles and rapidly image tissues, and (2) proprietary magnetic particles that can carry any drug or molecule, and can ablate tissues through rotational motion. The proprietary EM drivers are enabled through novel and energy-efficient application of pulsed power technology, which has been shown to have less bio-effects than conventional methods.  The EM drivers alternately propel and image magnetizable particles as they are moved into and within solid organs (e.g., brain).

The company’s particles are built with proprietary scalable nano-engineering processes to have specific magnetic and drug-eluting properties. These particles can deliver concentrated boluses of drugs or gene products to specific locations and can rotate rapidly in order to disrupt bio- films or ablate solid tumors. The system does not require liquid helium, and thus can be used portably and in sites without extensive infrastructures. The size of the body part to be targeted impacts product cost, and so we have selected diseases of the head/brain as first targets.

Market Potential

The system will be comparable in function to advanced radiation therapy and minimally-invasive devices, but with the advantage of being able to deliver molecular therapy non-invasively. The image-guidance component of the systems will be priced in the million-dollar range, lower than devices (e.g., robotic surgery, proton therapy) with similar therapeutic missions. We have selected chronic refractory sinusitis as the first clinical indication for FDA pre-market approval, because of the high prevalence of the disease (10M patients in USA), lack of attractive surgical options, and likely device status of the application. Subsequent drug-device versions of the system will serve as minimally invasive alternatives to surgery for treatment of brain and head/neck tumors. Including renewable revenues from supplied unit-dose particle formulations, total revenues are expected to be several hundred million dollars per year within 5 years of FDA approval.

Competitive Advantages

Unlike prior systems for directing nanoparticles that could not concentrate assemblies of the particles at desired locations, our proprietary systems use pulsed fields to alternatively align, propel, and focus the particles. These fast and strong magnetic fields, which are interposed with imaging pulse sequences, have been proven to be well-tolerated by patients in clinical trials, and can realize spatial resolution at cellular levels. The particles used in the system have been shown to evade the blood-brain barrier by traveling in the interstitial spaces, and are made of biodegradable and biocompatible materials. Unlike other particle drug-delivery systems, the drugs in our system are not linked chemically to the particles, but are contained in an inner chamber that releases the drug to the body through an aperture. As a result, the elution time of drugs carried by the particles can be adjusted in the nano-manufacturing process, with is massively scalable. Additionally, there is no constraint to the type of drug, for example whether it is a biologic, chemical compound, siRNA molecule, or a viral vector.

Financial Overview

WMP has received more than $10 million in Federal and State funding to develop the strong magnetic drivers that are at the heart of the system, and is currently licensing some of its technology in fields unrelated to this application. Company is seeking additional $7 million from investors and/or foundations (to be partially matched by Federal funds) in order to build a human-head-sized prototype that could be used in clinical trials, establish particle safety, submit an IDE to the FDA, and conduct the clinical trial.

Intellectual Property

USA and foreign patents have been granted for the use of strong magnetic fields without bio-effects. As a result of this innovation, magnetic gradients can be used in vivo, that are orders of magnitude stronger and faster than in conventional MRI systems. Other foreign patents and patents of additional innovations are pending. Company has out-licensed the application of its high-field low bio-effect magnetic technology for dental diagnostic imaging, a field with no overlap to the proposed interventional application that is the basis of this presentation.

Commercialization Strategy

To date, WMP has taken a licensing approach in order to further develop its core technology. Those licenses relate to niche diagnostic applications of strong/fast MRI (e.g., dentistry). Our preference would be to work with selected investors and/or strategic partners in order to develop and validate the therapeutic system. To this end, we will work with selected luminary sites to validate the safety and efficacy of the magnetic delivery technology in a breakthrough clinical device indication with existing high reimbursements for competitive technologies (e.g., chronic sinusitis). Upon FDA premarket approval of this first indication, we will either sell the company to a major medical device company, license the particle technology to a drug company, or raise financing necessary for commercialization through an IPO.  Because of the large potential scope of the innovation, our preference would be to eventually go public.

Pipeline Products

The company has already demonstrated transport of drug-laden particles in rat brain, and will develop oncology and neurology products based on these particles. WMP’s proprietary particle designs could be adapted to deliver most drug and/or gene products. Considering that the current roles for gene and RNA therapy have historically been delivery-limited, we anticipate that the new interventional system could play a role in advancing applications of these products.

Management Team

·         President Irving Weinberg has been a serial medical device entrepreneur for 15 years. His designs that have helped over one million people with suspected or confirmed breast cancer, and have recently been acknowledged by manufacturers of medical imaging systems as addressing critical issues in the development of new high-field MRI systems. Dr. Weinberg is an experimental physicist and practicing radiologist who has worked at the Johns Hopkins Hospital, UCLA, and the National Institutes of Health. He has founded companies that have raised over $50 million, and initiated multi-center clinical trials. He will continue to lead the technical team, and assist in coordinating clinical trials.

·         Chief Physicist Pavel Stepanov MS has been responsible for instrumentation design and implementation for the 4 FDA-approved products introduced by Dr. Weinberg. He will supervise quality and design control for the project, and assist in preparation of the premarket approval application to the FDA.

·         Lead bioengineer Alek Nacev PhD has a doctorate in magnetic control, and has been key in demonstrating the capability to concentrate particles magnetically. He will manage the development of the coil, driver, and software.

·         Bioengineer Lamar Mair PhD has a doctorate and post-doctoral NIST work in nanoparticle fabrication, and is the designer of our nano-engineering processes. He will manage particle development and transfer of the technology to a GMP-qualified supplier.

·         Senior Biologist Mika Shimoji PhD has implemented preclinical studies of magnetic nanoparticles with GLP rigor. She will manage GLP-level animal studies.

Company Background 

CellSight Technologies is a privately held company with six employees located at the UCSF QB3 incubator in San Francisco.  The company started operations in 2010 on the principle of providing innovative new PET imaging technologies to accelerate therapy development and to leverage these imaging tools to personalize patient treatments.

Technology Overview

CellSight is developing a PET probe, [18F]FAraG, for imaging anti-tumor immune response. [18F]FAraG is a fluorine-18 labeled analog of the lymphoblastic leukemia drug AraG, a guanosine analog. Since [18F]FAraG accumulates specifically in activated T cells, which is a major factor in anti-tumor immune response, detection of activated T-cells should enable early prediction of therapeutic efficacy, optimization of immunotherapeutic regimens, and personalization of immunotherapy.  Cellsight has other PET probes in various stages of development targeted at immunotherapy and cell therapy.  In addition CellSight has reporter gene technology to determine trafficking of therapeutic cells in living subjects, including humans.

Market Potential

Immunotherapy is a rapidly expanding market segment due to demonstrated success in various hard to treat cancers such as melanoma and glioma. ClinicalTrials.gov shows that there are currently 90 industry-sponsored, cancer specific cell-based immunotherapy trials actively recruiting, of which 60 trials are in the U.S. According to a June 2014 report by Citigroup, the immunotherapy market could exceed $35 billion by 2023. There is currently no imaging technology on the market that is focused on imaging immune activation in humans. An imaging tool that can help predict a patient’s response to an immunotherapy early could enable patients to find effective therapies and reduce unnecessary medical costs.

Competitive Advantage

There are no commercially available imaging technologies that help visualize the biodistribution of activated T-cells. As immunotherapies gain traction based on their clinical success, there will be increased demand for a companion test to determine if an immunotherapy agent is effective with a particular patient.  A scan that can be used to visualize immune cell activation post infusion or after treatment with immune modulating agents would provide invaluable information to guide future treatment options. 

Financial Overview

CellSight has received over $3 million in grants from NCI. The annual revenue from grants, product sales, and service contracts totaled $377,045 in 2011, $430,864 in 2012, and $669,707 in 2013 our estimate for 2014 is $ 1.1M.

CellSight is seeking a minimum of $7 million in external funding beyond the nondilutive grant funding. The company plans to obtain $10 million in grants and private funding in order to conduct a Phase I/II clinical trial for the [18F]FAraG imaging probe. CellSight will also continue to provide selective fee-based imaging services that have contributed about $200,000 per year.

Intellectual Property

CellSight has exclusively licensed the [18F]FAraG PET probe from Stanford and has two other patents focused on reporter gene technology.  The patent from Stanford includes claims on the composition of matter, methods of synthesis, and methods of use.  Also CellSight personnel are sponsors for an FDA IND for [18F]FHBG PET reporter imaging probe, which is used to image patients undergoing HSV1-tk gene therapy.  In addition, the company founder is inventor of several other immunotherapy/cell therapy focused PET probes and has expressed a strong desire to commercialize them through CellSight given the right opportunity and financial conditions.

Commercialization Strategy

CellSight is in the process of applying to the FDA for an IND approval for [18F]FAraG and expects approval by December 2014. The company’s initial focus is the oncology market where we hope to fully partner with immunotherapy companies and offer the probe as a companion-imaging tool. We are in the early stages of partnering with two large pharma companies and are actively seeking additional partnerships.  CellSight plans to expand the probe’s use to other markets such as rheumatoid arthritis and diabetes mellitus where immunotherapy is in early stages.

Pipeline Products

CellSight intends to expand the probe for use in the rheumatoid arthritis and diabetes mellitus markets as the immunotherapy models for these applications mature and our company’s capacity expands.  In addition we will exclusively license two additional PET probes that our founder has developed for immunotherapy and cell therapy.  The additional PET probes are specific to receptors on immune cells and could be used to image and monitor other processes affected by immunotherapies beyond T cell activation.

Management Team

• Founder Sam Gambhir is Chair of Radiology at Stanford and is a world-renowned pioneer in the field of molecular imaging.
• CEO Aruna Gambhir has over 25 years of broad experience in startups, R&D, sales, marketing, and operations.
• CSO Shahriar Yaghoubi has over 18 years of experience in molecular imaging, including pre-clinical and clinical assessment of novel PET probes and FDA experience with IND.
• COO Sam Quezada has over 30 years of experience in marketing, business development, and operations.

Surgisense Corporation is a privately held C-corporation founded in 2006 with the mission of improving surgical care through intra-operative assessment of a patient’s risk for surgical complications. The company is developing a new category of surgical instruments that integrate a novel oxygen sensing technology which directly measures tissue oxygenation. This enables surgeons to identify patients at risk of surgical complication due to alterations in blood flow and oxygenation through real-time assessment of tissue viability, and propensity to heal.

Surgisense’s efforts initially target colorectal cancer for which surgical resection remains the mainstay of treatment. After removal of the tumor, the free ends of bowel are surgically joined to form an anastomosis. Surgisense's Stapled Anastomosis Viability Evaluation (SAVE) System strives to reduce the most dreaded complication: the anastomotic leak; a condition in which fecal material leaks into the abdominal cavity from the surgical junction. The technology integrates into the surgical workflow by replacing the anvil of commercially available, circular staplers with a sensing anvil that wirelessly transmits actionable data to the operative team. The System aims to reduce patient suffering while saving $2 billion annually in excess healthcare costs.

Surgisense’s core technology is protected in the largest medical device markets, and is extensible into many clinical applications. The company has been funded through a combination of federal grants and commercial revenue totaling $2.3 million and is looking to raise $6 million in Series A financing to support first-in-human clinical trials, U.S. and E.U. regulatory approval, and product launch.