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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.

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.

Galen Biotechnologies is an early-stage biotech company developing small molecule drugs to disrupt protein-protein interactions. Using genetically encoded-chemical fragment libraries we are rapidly advancing small molecules targeting Ras and Bcl-2 pathways in oncology. Our platform technology combines the strengths of encoded biologically relevant diversity with chemical evolution of pharmacophore structures to drive drug design with unparalleled efficiency against difficult protein-protein interaction targets.

Galen Biotechnologies was founded in 2013 and is located in the University of California, Santa Cruz QB3 incubator. The privately held company has raised $1M in nondilutive funding from research collaborations and SBIR grants and contracts (NIH-GMS, NCI, and DoD) in support of its platform. We anticipate a Series A fundraising in mid-2015 to accelerate our platform validation with the aim of progressing a lead molecule to full IND-enabling studies as well as exploring new targets in inflammation.