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20/20 GeneSystems is a revenue stage diagnostics company that markets a blood test for the early detection of lung cancer.  Several marketing partnerships entered in late 2014 should permit a nationwide expansion in 2015.  A JV with a multi-billion dollar Chinese company is expected to lead to commercialization of the lung cancer test in China in the near term.   20/20 also is developing companion tests to targeted cancer therapies.   

In 2014 we raised $1.2 million from our existing shareholders and members of the Keiretsu Forum, the nation's largest network of Angel investors.   A Term Sheet and Due Diligence package has been prepared by Keiretsu Forum members with expertise in healthcare investing and molecular diagnostics.  

5AM Ventures is an early-stage venture capital firm focused on building next-generation life science companies. The firm has offices in Menlo Park, CA and Waltham, MA. Formed by successful industry executives and experienced venture capitalists, the 5AM team takes a focused, hands-on approach to company building.  In addition to leading investments and contributing as board members of its portfolio companies, 5AM is directly involved in company strategy, management recruiting, business development and fundraising and often takes on short-term operating roles.

The 5AM portfolio, built on advanced life science technologies, is diversified by two key categories: sector & type.  In the sector category, companies are diversified by innovative platform technologies, corporate spin-offs, and products with shorter development cycles.  In the type category, companies are diversified by product discovery, drug development, and medical technologies.

Acumen Pharmaceuticals, Inc.

Direct to Brain Soluble Aβ Oligomer Selective Immunotherapy

First/Best in Class Therapy for Alzheimer’s Disease

Right Target - Right Patients - Right Delivery.  ACU-193 is Acumen’s monoclonal antibody drug candidate that targets soluble amyloid-beta oligomers (sAβo) with high affinity and selectivity.  Acumen is developing ACU-193 for direct intrathecal delivery to the brain via a device collaboration designed to increase the probability of early clinical success and enhance long term commercial potential.

The Only Alzheimer’s Immunotherapy Specifically Targeting Toxic sAβo Using Direct Brain Delivery.  ACU-193 is a late-preclinical, fully humanized monoclonal antibody that selectively targets sAβo, the primary pathologic agent in Alzheimer’s.  Composition of matter and use patents for ACU-193 run through 2030; and further IP protection is available.

Acumen is establishing an exclusive collaboration for access to FDA/CE approved chronic infusion pump systems for direct to brain drug delivery.  ACU-193 and direct brain delivery positions the program as a scientifically and clinically differentiated approach to Alzheimer’s with attractive long-term commercial and therapeutic potential.

Program Profile & Positioning

Scientific Background & Program History.  SAβo are widely recognized as the primary neurotoxins responsible for the acute cognitive deficits and progressive neurodegeneration in Alzheimer’s disease.  SAβo are non-fibrillic assemblies of Aβ peptides, and are distinct from protofibrils, fibrillar Aβ, and β-amyloid plaques.  Brain levels of sAβo are 3-8 orders of magnitude lower than levels of β-amyloid plaques or monomeric Aβ.  They are elevated in the Alzheimer’s brain, and studies suggest a correlation between levels of sAβo and cognitive deficits in Alzheimer’s.  SAβo bind with high affinity to mature synapses, most likely to a small number of highly selective neuronal receptors.  Binding to these receptors interferes with normal neuronal function leading to memory loss and neurodegeneration.  Because sAβo are present at concentrations that are 3-8 orders of magnitude lower than non-toxic monomeric and fibrillar Aβ, they are an optimal immunotherapeutic target.  However, because only approximately 0.1-0.2% of peripherally administered antibodies cross the blood-brain-barrier and reach the brain, brain exposure of peripherally administered antibodies may limit their therapeutic efficacy.  Acumen is pursuing intrathecal delivery of ACU-193 to ensure therapeutic levels of the drug candidate reach the brain and achieve effects.

Effects of sAβo.

Acumen pioneered research on sAβo.  The company’s anti-sAβo antibody program was licensed to Merck & Co. in 2003 for significant upfront and milestone payments.  ACU-193 is a third generation product of the ~8 year/~$70M partnership with Merck.  Merck advanced the program to a late preclinical development stage.  In November 2011, as part of Merck’s restructuring following its merger with Schering Plough, Acumen reacquired all rights to the program including ACU-193, backup molecules, and substantial IP with no financial or take-back rights obligations to Merck.

ACU-193 Details.  

• Humanized, affinity-matured, IgG2 monoclonal antibody with uniquely high selectivity for sAβo.

• Prevents binding of sAβo to neurons and sAβo toxic effects at synapses.

• Brain penetration, target engagement and robust biochemical and behavioral efficacy demonstrated in mouse models of Alzheimer’s.

• Excellent pharmacokinetics, bio-distribution and brain penetration demonstrated in 4 animal species.

• Excellent safety profile in exploratory studies in rhesus monkeys.

• GMP production cell lines and the necessary analytics established.

• Drug delivery collaboration with Medtronic for direct brain delivery.

• Companion diagnostic biomarker assay established.

• Composition of matter and use patent protection through 2030.

The Addario Lung Cancer Medical Institute (ALCMI), founded in 2008 as a 501c(3) non-profit organization, is a patient-centric, international research consortium driving research otherwise not possible, evidenced by ALCMI's current clinical studies CASTLE, INHERIT EGFR T790M, Genomics of Young Lung Cancer and others. ALCMI overcomes barriers to collaboration via a world-class team of investigators from 21+ institutions in the U.S., France, Italy, Spain and U.K., supported by dedicated research infrastructures such as centralized project management, tissue banks and data systems. ALCMI directly facilitates research by combining scientific expertise found at leading academic institutions with patient access through our network of community cancer centers – accelerating novel research advancements to lung cancer patients. 

The Advanced Medical Technology Association (AdvaMed), is a trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world. AdvaMed represents 80 percent of medical technology firms in the United States and acts as the common voice for companies producing medical devices, diagnostic products and health information systems. AdvaMed members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 40 percent purchased annually around the world. AdvaMed's member companies range from the largest to the smallest medical technology innovators and companies.

AdvaMed 2015 - October 5-7, San Diego - is the leading MedTech Conference in North America, bringing more than 1,000 companies together in a uniquely multifaceted environment for business development, capital formation, innovative technology showcasing, world-class educational opportunities and networking. An event rich in international flavor and featuring a deep, diverse attendee list that includes influential policy-makers, business executives and media, AdvaMed 2015 seeks to advance industry discussion from key perspectives through detailed panel sessions, executive forums and more. It is a “must-attend” event for any MedTech company.

AdVax is an inter/multi-disciplinary team of individuals who have developed major paradigm-shifting science, research, technology and new clinical data sets demonstrating previously unidentified bacterial infections are able to translocate to the brain and be linked to the induction of Alzheimer’s disease.

We have developed novel and proprietary real time molecular diagnostics to identify these non-culturable bacteria and then apply novel immune refocusing technologies to create both monoclonal antibodies that could be used in treatments and a first of its kind vaccine for the prevention of both cardiovascular and Alzheimer’s disease.

Our program is well on its way to identifying the major disease-inducing bacteria, which are then ready to be put into the immune refocusing technology for the derivation of human monoclonal antibodies and vaccines.

Allurion Technologies was founded in 2009 to develop an intragastric balloon for weight loss that can be administered without surgery, endoscopy, or anesthesia. Obesity is a worldwide epidemic, yet only 2% of patients who qualify for bariatric surgery go on to be treated. Several endoscopic weight loss techniques are under development for the overweight and obese population, but they are restricted to the gastroenterologist call point and more expensive due to the costs associated with endoscopy and anesthesia.

Allurion's Elipse intragastric balloon is swallowed and excreted and can be delivered without endoscopy or anesthesia, thereby making it accessible to non-endoscopists and to consumers at a lower price point.

Allurion is currently a clinical-stage company seeking funds for further clinical work and OUS commercialization.

Altravax is a privately held biopharmaceutical company focused on developing first-in-class biological products to fight infectious diseases or treat other indications. The Company has a robust pipeline of candidates at various preclinical stages of development including a therapeutic vaccine against chronic hepatitis B infection. Altravax seeks investment opportunities to develop these lead candidates for clinical testing.

Amorphex Therapeutics is an early clinical stage company that was founded to develop products for sustained ophthalmic drug delivery using patented TODDD™ technology. Topical ophthalmic pharmaceuticals are a $5+Billion market, but inaccurate and inefficient delivery systems, poor compliance and excessive side effects undermine their clinical benefits and true sales potential. TODDD™ is a soft, non-invasive device that is completely concealed under the eyelid and continuously delivers therapeutic levels of drug 24/7 over several months. While TODDD™ is soft and flexible, unlike soft contact lenses, it doesn’t contain appreciable water and avoids the surface drying and resulting deposits that irritate and deter many contact lens wearers. In recognition of the potential benefits and their developmental progress, the company’s founders have been awarded three National Institutes of Health (NIH-SBIR) grants for the TODDD™ technology totaling $2.5 million.

TODDD™ has issued patents in major markets and has been successfully tested in safety studies, animal trials with drugs and without drug in humans.

Amorphex is seeking to fund small, 30 - 40 subject, human clinical trials of TODDD™ delivering timolol, prostaglandin and both drugs simultaneously. This funding will also support pre-clinical development of TODDD™ for ocular allergy and inflammation applications.  These milestones will drive dramatic increases in valuation and corporate partner interest.

Antibody Solutions is a premier developer of therapeutic, diagnostic and critical reagent antibodies. Our platforms include human antibodies from transgenic OmniRats™, Hybridoma Libraries™, and high-throughput flow-cytometry screening of cell-associated targets. We provide full technical support and project management with all services performed in the USA.