John Nobile
Tangen Biosciences is an early stage diagnostic instrument company that has developed a group of novel technologies that together enable rapid, portable, lab-free, and very low cost molecular diagnostics at the point of care.
The Tangen platform will amplify and detect specific nucleic acid sequences obtained from a variety of source samples, including clinical specimens such as blood, tissue and sputum, as well as environmental samples obtained from water, soil or food, for example. The first application of the Tangen platform is the detection and diagnosis of Tuberculosis using DNA extracted from sputum samples, using the Tangen Sputum Processing assay kit
Tangen Biosciences
President and CEODaniel O'Connell
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
Indication: |
Early Alzheimer’s dementia (Mild AD, aMCI) |
Therapy: |
Symptomatic + Disease Modifying |
Drug: |
ACU-193 |
Delivery Route: |
Intrathecal, Direct to Brain |
Device: |
FDA/CE Approved Implantable Infusion Pump and Intrathecal Catheter |
Refill Rate: |
Every 14-21 Days |
Duration: |
Life-Long (Chronic Delivery) |
Expected Effects: |
Improved Memory Decreased Soluble Aβ Toxicity Slow Disease Progression (Aβ and tau) |
Stage of Development: |
Pre-clinical – IND Enabling |
Development: |
ACU-193 is poised to reach clinical proof-of-concept (Phase 1b) with short (26 week) clinical studies based on improvements on memory and cognitive measures. |
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.
Inhibition of long-term potentiation |
Tau missorting in cell bodies and dendrites |
Disappearance of dendritic spines |
Tau hypo-phosphorylation |
Elevation of intracellular calcium |
Increased Tau targeting kinases |
Increased cytosolic calcium |
Decreased microtubules |
Increased missorted neurofilaments |
Decreased mitochondria density |
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.
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Humanized, affinity-matured, IgG2 monoclonal antibody with uniquely high selectivity for sAβo.
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Prevents binding of sAβo to neurons and sAβo toxic effects at synapses.
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Brain penetration, target engagement and robust biochemical and behavioral efficacy demonstrated in mouse models of Alzheimer’s.
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Excellent pharmacokinetics, bio-distribution and brain penetration demonstrated in 4 animal species.
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Excellent safety profile in exploratory studies in rhesus monkeys.
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GMP production cell lines and the necessary analytics established.
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Drug delivery collaboration with Medtronic for direct brain delivery.
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Companion diagnostic biomarker assay established.
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Composition of matter and use patent protection through 2030.
Acumen Pharmaceuticals
Senior Business and Corporate AdviserDaniel O'Mahony
Seroba Kernel is a venture capital firm based in Dublin, Ireland, with representatives in the United Kingdom. The firm has approximately €100M AUM and focuses solely on the life sciences. The firm has 2 funds and plans to raise a third fund in the near future. The firm typically allocates between €5-7M of equity over the life of the investment. The firm primarily invests in companies that are based in Ireland and Europe. Exceptional opportunities in North America will also be considered. The firm is actively seeking new investment opportunities.
Seroba Kernel Life Sciences
PartnerWalter Olesiak
Remiges Ventures is a US-based cross-border venture capital firm with close connections to the Japanese pharmaceutical industry and its strong focus on drug discovery and development.
Remiges Ventures
PartnerMr David Olson
IMS Health Capital (IMSHC) is a niche life-science focused investment bank which manages financing transactions, and advises on M&A and licensing/partnering transactions.
IMS Health Capital (IMSHC) is a fully owned subsidiary of IMS Health, Inc. (www.imshealth.com) and affiliated with IMS Consulting Group (www.imscg.com).
IMSHC has privileged access to a vast array of IMS Health’s resources and connections and can help prepare a compelling value proposition and put you in touch with the right interested parties. Our team has extensive life-science industry experience and can provide support at any and all stages of the transaction process. Unlike most investment banks or business development consultants, IMSHC has immense strategic partnering capabilities and can work with companies on both partnering and financing efforts. Given our unique positioning and access to a vast array of information and relationships, we see a high volume of opportunities.
IMSHC is a SEC/FINRA licensed broker dealer and a wholly owned subsidiary of IMS Health, Inc. IMS Health Inc. is publicly traded on the NYSE under the ticker “IMS”, and is the world’s leading information, services and technology company in the Life Sciences sector. Customers of IMS Health’s data and consulting services include most of the top names in pharmaceutical, medical device and consumer health manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community (www.imshealth.com).
Nandan Padukone
Joslin Diabetes Center is a foundation based in Boston, Massachusetts that was founded in 1898, and is the world's largest diabetes and clinical care organization.