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Company Background

DEKK-TEC, Inc. was founded in 1983 and specializes in the research and development of novel anticancer and hormonal technologies to improve the management of cancer and allied diseases. DEKK-TEC was presented the 2000 National Tibbett’s Award in recognition for its contributions to cancer research development in the SBIR program. The company is located in New Orleans, LA.

Technology Overview

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridine cholesteryloxycarbonate, which is being evaluated in Phase II clinical trials in patients with advanced lung, breast, melanoma and primary cancers involving the brain/CNS (IND 68,876).

DM-CHOC-PEN is an active and stable member of a larger series of carbonates and carbamates that has completed a Phase I clinical trial involving 26-patients with advanced cancer. Eleven of the latter patients had cancers involving the CNS, of which six (6) demonstrated objective responses/PFS – 1-breast, 2-melanoma, 1-sarcoma, 1-lung and 1-glioblastoma multiforme (GBM) cancers. Four of these patients had responses 1.3-3.5+ years in duration. These observations are supported by objective responses observed in pre-clinical studies with intracranial (IC) implanted human xenografts in mouse models – U251 and D54 GBM and MX-1 breast cancer [% long-term survival >52 days (%LTS) and complete response (%CR): +29/25 and +20/17, respectively, and in B-16 melanoma (%LTS/CR): 100/100%.

The drug is currently in a Phase II clinical trial – “Use of DM-CHOC-PEN as treatment for primary and metastatic cancers (lung, breast, melanoma) involving the CNS”. Objective responses are being verified in patients with lung cancer involving the brain. All trials support DEKK-TEC’s goal to include DM-CHOC-PEN in the treatment of CNS cancers. 

DM-CHOC-PEN’s MOA is via alkylation of DNA at N7- guanine and cellular senescence which means it could be added to O6 - guanine alkylators - BCNU, temozolamide (TMZ), etc. Thus, combination therapy is a possibility.

To date, the product has only demonstrated reversible hepatic toxicity in patients with prior liver disease/metastases. No hematologic, renal toxicities or neuro/psycho-performance abnormalities were noted in Phase I or in animal studies. Complete chemistry (incl. lipid profiles) and hematological lipid profiles are closely monitored. RECIST 1.1 was used to monitor responses.

Market Potential

Primary brain cancer (glioblastoma multiforme, GBM) is a dreaded cancer occurring in ~18,000 new patients annually in the US. In addition, approximately 20% of patients with all types of cancer will develop intracranial metastases. Approximately 150,000 patients will develop CNS metastastatic cancers from primary – lung, breast and melanoma in 2014. The latter are the most common primary cancers responsible for brain metastases and generally correlate with the distribution of the neoplasia in the population.

The survival for advanced GBM remains less than one year. For anaplastic astrocytoma and low-grade glioblastomas, it varies from 18 months to five years. Thus there are a sufficient number of patients available to treat with the drug. For metastatic CNS cancer, survival is 4-6 months. There are just under 200,000 patients annually in the US that are potential candidates for such a drug.

Competitive Advantage

In general, patients are living longer with cancer and have an increased incidence of developing CNS metastases - a 'safe haven' from systemic chemotherapy. Most drugs do not penetrate into the brain tissue. Thus a product to manage primary and metastatic CNS cancers has increasing demand. The prevalence of patients with these types of cancer presentations and the estimated markets make such a product worth developing.

DEKK-TEC’s product delivers across the BBB into CNS cancer sites, potentially reverses hepatic toxicity in patients with hepatic disease, and can be used with other drugs. 

Financial Overview

DEKK-TEC has raised almost $5 million in NIH grants, $2.2 million in licenses & milestone payments, & 1.8 million in Morgan personal funds, and half a million in LA State Tax Credits.

Intellectual Property

To date, DEKK-TEC’s commitment has been issued eight patents in the US; fifteen issued worldwide patents and four worldwide patents pending. The patents cover DEKK-TEC’s interest in penclomedine analogs, hormone delivery, phosphoramide mustards, phenylhydrazones and radiation devices.

Commercialization Strategy

In 2010, DEKK-TEC developed a c-GMP manufacturing facility (DEKK Pharmaceuticals, Inc.) to formulate and prepare unique and difficult delivery systems for Phase I drugs.

DEKK-TEC plans to raise $5 to $7 million to finish the Phase II trial and conduct the orphan drug trial. FDA funds are also a possible source of additional funding, though limited. The NCI Bridge Award is a possibility, but DEKK-TEC strives for a partner or financial associate.

Pipeline Products

DEKK-TEC is also developing 4-hydroperoxyifosfamide (HOOI) (pre-IND 381,783, US Pat 1,805,192) for use in the treatment of CNS cancers. The drug has a definite MOA (O6 –guanine alkylation); also active in pre-clinical studies against IC xenograft brain human tumors; Phase I trial studies are pending.

Management Team

• CEO and Medical Officer Lee Roy Morgan, MD, PhD is the founder who designed and synthesized DM-CHOC-PEN.
• Director of Research Andrew Rodgers, PhD developed the PK program.
• Director of Clinical Research Lisa Stokes, BSRN is a nurse oncologist and has worked with DEKK-TEC since 1986.
• Scientist Edmund Benes, BS works in the area of pharmaceutical and cell technology and has worked with DEKK-TEC since 1983.
• Clinical Pharmacologist Gerard Bastian, PhD collaborated with Dr. Rodgers to develop the PK program.
• Pharmacologist and biochemist David Adams, PhD is a consultant who has worked in collaboration with DEKK-TEC since 2006.

Technology Name:  Ultrasound Tomography for Breast Imaging

Company Background  

Delphinus Medical Technologies, Inc. is a privately held medical technology company headquartered in Plymouth, Michigan and was founded in 2010 as a spin-off of the Barbara Ann Karmanos Cancer Institute (KCI). Delphinus has succeeded in creating an innovative whole breast ultrasound imaging device called SoftVue  that characterizes suspicious lesions for diagnostic applications using a safe (non-ionizing), comfortable (non-compressing), and reliable (operator independent) patented technology.

Technology Overview 

The SoftVue system, designed and manufactured by Delphinus, utilizes ring transducer technology to transmit and receive ultrasound signals, and represents a first-ever innovation in automated whole breast ultrasound.  The unique approach uses a dynamic new design to capture reflection echoes from all directions around the breast and leverages sophisticated algorithms to gather transmitted signals coming through the breast, and image a volumetric map with a single scan…..something no other ultrasound system, currently available, can do. The end result of this approach is enhanced tissue characterization designed to deliver best in class specificity, improved sensitivity and a gentle patient experience.  SoftVue has received 510(k) clearance from the FDA for diagnostic ultrasound imaging and is not a replacement for screening mammography.

Market Potential[ND(3] 

Analysis from Frost & Sullivan in February 2013 reported the global breast imaging market is poised to grow at a CAGR of 15.37% from 2012 reaching approximately $5 billion by 2017. The United States breast imaging systems market research finds that the market earned revenues of $1 billion in 2011 and expects it to reach $1.4 billion by 2016 at a compound annual growth rate of 5.8%. Due to growing legislation and advocacy around the issue of dense breasts and the ineffectiveness of mammography, whole breast ultrasound is gaining traction.  SoftVue represents an innovative new technology and compelling alternative to improve women’s health. The Delphinus business model includes SoftVue systems, consumables and service contracts to hospitals and imaging centers throughout the United States and the rest of the world.

Competitive Advantage

Delphinus is committed to creating improved imaging methods that assist medical professionals better define and diagnose breast disease, while establishing a better patient experience that can be available for all women, regardless of age, and without concern of radiation or discomfort.  SoftVue’s innovative transducer design, with its novel ring configuration, allows through transmission imaging of the whole breast which allows tissue characterization over the entire breast. Furthermore, SoftVue scans the breast quickly (in 1 to 2 minutes) with no additional views required, unlike the other whole breast systems which often require multiple positionings and up to 30-40 minutes per exam. Another competitive advantage is SoftVue’s modular design, which allows the product to be configured easily for different markets and cost level and allows it to grow and evolve in performance by incorporating rapidly improving electronics and computing components.

Financial Overview

Delphinus has raised $22.5 million since its inception in 2010 and is launching a process to raise a $35 million series C round to cover the costs of the multi-center clinical trial to support a screening indication, and to support production and commercialization.   Delphinus has no revenue to date.   Potential sources of funding include venture capital firms and/or strategic partners.

Intellectual Property

Delphinus holds or has exclusive license to 14  patents covering broad aspects of its technology. In addition, the company has 12 additional patents pending including narrower aspects of the technology. As a result, Delphinus has broad coverage of the field of use while also covering specific aspects of core technology.

Commercialization Strategy 

The Delphinus business model includes sales of SoftVue systems, consumables and service contracts to hospitals and imaging centers throughout the United States and the rest of the world. The company plans to use a combination of direct and channel sales in the U.S.  For the rest of the world, Delphinus will partner with large distributors and imaging Original Equipment Manufacturers looking for entry into the breast cancer imaging market. Delphinus will produce the devices through subcontracted manufacturing. Final assembly, testing, and quality assurance of the product has been contracted to an FDA and ISO 13485 certified manufacturer located close to the facility in Michigan.

Pipeline Products

Delphinus secured its first 510(k) market clearance from the FDA in December 2013 for Softvue, indicated for use as a B-mode ultrasonic imaging system. The system is not intended to be used as a replacement for screening mammography but it is fully commercially developed for the diagnostic market. The initial clearance established a foundation for future submissions incorporating sound speed and attenuation measurements. Current technical development is aimed at integrating color maps of stiffness tissue with the current imaging capabilities to expand the utility of SoftVue in the diagnostic market.  Plans include additional 510(k) submissions over the next year, initial commercialization outside of the US, and a multi center trial to gain an indication for screening, followed by global commercialization of a system with diagnostic and screening indications.

Management  Team

·         President & CEO, Mark J. Forchette is an accomplished medical technology executive with more than 30 years of demonstrated success driving breakthrough medical technologies to market leadership with companies such as Abbott, OptiMedica, Alcon and Grieshaber.

·         CTO and co-founder, Neb Duric has over 30 years of experience in imaging and is a key inventor of the SoftVue technology.

·         CMO and co-founder, Peter Littrup is a key inventor of the SoftVue technology and a renowned radiologist who has significant experience in breast imaging and has been instrumental in the conduct of ultrasound clinical studies.

·         VP of Engineering, Chris Sanders has over 20 years of global innovation expertise in medical ultrasound and has driven advancements in matrix array transducer design and led collaborative partnerships at companies such as Toshiba and Siemens.

·         VP of Finance, Shawn O’Brien has broad based financial operations experience and has served in senior financial leadership positions at Cyto-Pherex, Kux and Advanced Material Process Corporation.

·         Vice president of Sales and Marketing, Debra Saunders has over 20 years of marketing and sales experience in women’s healthcare with market changing breast cancer detection technologies and has been instrumental in advancing previous medical imaging companies including R2 Technologies, NaviScan, and Lorad.

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.

DreamCatcher Ventures:

Dream Catcher Ventures was founded to address the inefficiencies in the marketplace and to align the goals and aspirations of entrepreneurs with investors. It is focused on creating and building disruptive biotech/healthcare companies that are positioned to excel in global markets.

Currently working with BioHealth Innovation to raise a $50M “Gap Fund” to invest in early stage healthcare businesses, primarily in therapeutics, diagnostics, medtech and healthcare IT.

Founder Profile:

Broad and in-depth experience in both science and business: Over fifteen years of experience in the life sciences and over 10 years of venture investing experience in biotech/ life sciences/healthcare and healthcare delivery with Burrill & Company, a $1.5B life sciences fund.

 Previously on Boards of Adlyfe , a CNS diagnostics company, Strand (A bioinformatics/ genomic data analysis company), White Glove Health, healthcare delivery company (Board observer), Bioimagene, a digital pathology company (Board observer, exited via a  $100M sale to Roche) and the Advisory Board (Finance) for Express Pharma. On the Editorial Board of the "Interdisciplinary Journal of Applied & Biomedical Sciences. Also managed India as a region of investment interest for the firm. Sourced, diligenced and led cross-border investment opportunities in both US and India. Strongly networked to venture capitalists, investment banks, pharma and biotech companies both nationally and internationally.

Mentoring entrepreneurs: Course instructor at UCSF "An idea to IPO and beyond". Involved with business plan evaluations and competitions at Berkeley, UC Davis, LARTA and previously WTC