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Crestone, Inc. is an early stage drug discovery and development company focused on developing novel treatments for serious bacterial infections.  The company currently has two main programs that address areas of significant and growing unmet medical need, both with novel mechanism of action agents.

1.         Novel treatment for Clostridium difficile infections.  CRS3123 is currently in clinical development for the treatment of C. difficile infection (CDI), and is nearing completion of Phase 1.  CDI occurs when toxin-producing bacteria colonize the gastrointestinal tract.  The infection spreads rapidly via spores which contaminate hospitals and nursing homes, and recurrence is a major clinical issue.  Due to the emergence of hyper-virulent drug resistant strains, mortality from CDI has increased over 700% since 1999.  In preclinical studies, CRS3123 shows much lower recurrence compared to vancomycin, a key attribute for improved therapy of CDI.  We seek funding for Phase 2 clinical studies to demonstrate clinical proof-of-concept.

2.         Novel oral agents for Gram-positive infections.  We are developing a novel class of DNA replication inhibitors, currently in advanced preclinical research.  These compounds selectively inhibit an essential component of the replicative DNA polymerase complex and are potent, orally available, and effective against all clinically-relevant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), penicillin-resistant Streptococcus pneumoniae (PRSP) and Bacillus anthracis (anthrax).  We anticipate development of a drug similar to Zyvox in spectrum, but with key advantages such as rapid bacterial killing and improved safety.  This grant-supported program is expected to produce a clinical candidate in 2015.   

Crestone will develop these programs through key value inflection points in early clinical development, and then share the risk and expense of late-stage trials with a partner.  We have a talented core team in place, and have a plan for strategic hiring to ensure that we can accomplish critical milestones.  We have identified potential candidates to fill a number of key positions, while outsourcing activities that benefit from economies of scale/expertise, including large-scale chemical synthesis, animal testing, clinical trial execution and regulatory affairs.  We have demonstrated the ability to leverage non-dilutive financing to meet critical early milestones, maintaining a semi-virtual structure and low burn rate. 

Cynvenio has developed a new LiquidBiopsy technology to sequence the DNA of tumor cells isolated from peripheral blood. Key applications include longitudinal patient monitoring throughout the cancer care cycle, the detection of resistance mutations, and providing physicians with accurate molecular evidence to select the best targeted therapy for a given patient.

Cynvenio's technology can be accessed as a CLIA lab service, or  can be installed and operated inside hospital labs and cancer research centers. Cynvenio's lab has been CLIA certified since 2013 and LiquidBiopsy system deployments began in the second half of 2014.

EIP Pharma, LLC is a private company based in Cambridge, MA.  The company has licensed-in and is developing a phase 2 clinical-stage oral small molecule that targets neuroinflammation and dysfunction of microglia, the major immune-cell in the brain.

Human genetic and other biologic data strongly indicate inflammation & microglial dysfunction are one of the major drivers of late-onset Alzheimer’s disease (AD), and likely the major driver in patients with symptomatic disease.

VX-745 (the licensed compound) specifically inhibits intra-cellular enzyme p38 mitogen activated protein kinase alpha (MAPKa).  In the brain, p38 MAPKa is a major regulator of inflammation through effects on microglia. P38 MAPKa is also expressed in neurons, where it is directly involved in memory formation and synaptic plasticity. 

VX-745 readily enters the brain, with brain concentrations in pre-clinical studies being approximately two-fold higher than in peripheral blood.  VX-745 had previously been clinically evaluated in non-CNS disorders, where already has demonstrated anti-inflammatory activity in patients. The combination of blood-brain-barrier penetration and previous clinical experience with demonstrated anti-inflammatory activity uniquely positions VX-745 to target inflammation to treat Alzheimer’s and other CNS disorders in which inflammation plays a role.

EIP Pharma licensed VX-745 from the originator company, Vertex Pharmaceuticals, and conducted animal studies to re-position the compound towards disease of the brain, including AD.  Vertex had previously completed a full chronic toxicology program and had demonstrated significant clinical and anti-inflammatory activity in a phase 2a 12-week treatment study of VX-745 in rheumatoid arthritis (RA).  An Investigational New Drug (IND) application remains open at FDA.

The animal studies conducted by EIP Pharma have demonstrated pro-cognitive effects, anti-inflammatory and other pharmacologic effects of VX-745 in the brain.  These data combined with dose response data in prior animal and clinical studies, have been utilized to identify doses that are highly likely to have positive activity in human brain.  The predicted doses are 2- to 5- fold lower than the dose that demonstrated anti-inflammatory activity and was well tolerated in RA, consistent with VX-745 preferentially distributing to the brain in animals.  Importantly, these dose levels should minimize risks of systemic toxicity that otherwise have hampered development of p38 MAPK inhibitors for peripheral disorders.  The animal studies have also generated new intellectual property (IP), including issuance of a US patent on 15 April 2014 (#8,697,627) for the use of VX-745 to lower brain amyloid plaque load.  This IP, along with additional IP that has been filed will support commercially the development of VX-745 beyond the primary composition of matter patent expiring in 2017.

Start-up activities (IRB submissions, CRO contracting, etc.) are underway for two phase 2a clinical studies in patients with AD; both studies are anticipated to be underway in early 2015.  Combined, the studies are designed to demonstrate anti-inflammatory and microglial modulatory activity in the brain.  Once demonstrated, VX-745 should have ability to demonstrate clinical proof-of-concept in AD and/or other disease indications in which neuroinflammation plays a role in disease pathogenesis.

Company was founded and is led by experienced biotech/pharma R&D executive (John Alam; former head of Alzheimer’s R&D at Sanofi, ex-Chief Medical Officer at Vertex Pharmaceuticals, led clinical development of AvonexÒ for Multiple Sclerosis) with extensive translational and drug development experience & expertise in both inflammation and CNS disorders.

Formula Pharmaceuticals is a US-based oncology focused biotech company, developing Chimeric Antigen Receptor (CAR) based therapies using a proprietary platform.

Formula's CAR therapies involve allogeneic immune effector cells and a NON-viral transfection method for highly efficient cell expansion and differentiation. Additionally, Formula's target effector cells primarily involve Cytokine Induced Killer cells, instead of T-cells or Natural Killer cells. These various characteristics offer distinct practical, clinical, regulatory and commercial benefits over other CAR approaches that involve autologous cells and viral transfection methods. Although not yet in clinical stage development, Formula believes that its CAR based development program will catch up with competing clinical-stage development programs, based on the significant CMC and regulatory advantages that Formula's CAR approach offers.

Formula is interested in meeting with investors and prospective pharmaceutical/biotech partners. Near-term value driving milestones (including clinical trial results) are expected within the next 2-3 years.

Significant industry and investor interest in CAR based therapies have been established over the past 12 months, with 4 leading industry players (Pfizer; Novartis; Celgene and Juno Therapeutics). Formula's CAR therapy is distinctive, and is believed to offer significant advantages of the aforementioned CAR technologies. CARs represent a new and important paradigm for cancer therapy, with the leading pharmaceutical players expected to acquire and develop their own position into this space.

Fusion Genomics Corp (FG) is a molecular diagnostic test  development company that is introducing diagnostic kits with companion analysis software that offer superior clinical information, faster turn-around-times and ease of use for hospitals and clinical laboratories. Fusion is the first of two companies in the world to bring a validated Next Generation Sequencing (NGS) diagnostic test complete with highly secure cloud based analytical service for childhood cancers (ChildSeq-RNA SRCT) into the clinic. This test was validated in the renowned medical testing facility at the Texas Children Hospital, Baylor College of Medicine.

FG is completing development of kits for facilitating absolute diagnosis of pediatric and adult blood cancers. In addition, FG has partnered with the Royal Tropical Institute (Dutch: Koninklijk Instituut voor de Tropen; KIT) a World Health Organization reference diagnostic laboratory for infectious diseases to design the next generation of assays for the detection of infectious diseases including drug-resistant forms of tuberculosis, influenza, hepatitis and hemorrhagic fevers including Ebola.

Fusion Pharmaceuticals is a clinical stage company committed to developing next generation precision radiopharmaceuticals for the diagnosis and treatment of human cancers with unmet medical needs.  The Company’s lead product, FPX-01, combines an alpha radionuclide with the precise targeting of an antibody to cause selective cytotoxicity of tumor cells.  FPX-01 will be entering Phase 2 clinical development in H2, 2015.

Gordian Biotechnologies addressing the urgent unmet medical existing within antibiotic resistance by developing first-in-class reversible b-lactamase inhibitors that allow existing antibiotics to be effective against otherwise resistant pathogens. By combining an FDA approved antibiotic with our novel b-lactamase inhibitors, Gordian Biotechnologies  disarms the bacteria’s resistance mechanism, allowing the antibiotic to defeat the pathogen. 

The HudsonAlpha Institute for Biotechnology

The HudsonAlpha Institute for Biotechnology is a Genomic focused Institute located on a 152-acre bio-medical research campus in Huntsville, Alabama whose mission is to translate scientific breakthroughs in the laboratory into real-world benefits that have a profound impact on people’s lives.

HudsonAlpha BioVentures Philanthropic Fund

•       Specific Philanthropic Fund - part of the HudsonAlpha Foundation a tax-exempt, 501(c) 3 non-profit organization.

•       All investments to the Fund are tax-deductible

•       Fund goal is $50 million

•       Targeted toward donors seeking to make a long-term impact in human health and make a difference for thousands, even millions, of people suffering from serious disease.

Option 1

HudsonAlpha Foundation invests funds in new or established companies and scientific discoveries. Foundation will have an equity stake and receive a ROI, as companies are successful. The return is reinvested into other companies and HudsonAlpha to further its mission and goals – the multiplier effect.

Option 2

HudsonAlpha Foundation will fund promising intellectual property emanating from HudsonAlpha laboratories.

Option 3

HudsonAlpha Foundation provides grant funding to companies who are relocating to or expanding on the HudsonAlpha campus.

All investors/donors will have an opportunity to invest in the future in any and all companies and will be informed regularly on the progress of these companies

Humabs BioMed is a profitable Swiss biotech company that is discovering and developing nature-selected human monoclonal antibodies using proprietary platforms. 

Humabs is currently focusing on the development of human antibodies to fight infectious diseases. Additional indications are being targeted at the discovery research stage.

Humabs has already achieved four major licensing deals with Pharmaceutical companies generating significant revenues in the form of near term revenues, as well as a stream of longer term milestones and royalties. Two of these programs are in clinical development phases.

Humabs is seeking additional investments to allow the company to bring selected programs into clinical research on its own, thus significantly increasing the added value.

Immunimed Inc is a clinical-stage Biopharmaceutical company developing innovative egg-derived, oral potclonal antibody therapy to treat gastro-enteric infections/diseases. Our lead product IMM-001 targets super bug, Clostridium difficile, leading cause of hospital-acquired infections.

Currently is Phase II ready with remarkable clinical response in Proof on Concept multi-center clinical studies.  Phase II clinical study is planned for Q2 2015.