Takashi Noaki

Santen Pharmaceutical Co., Ltd.
Coordinator, Scientific Affairs, Licensing 

John Nobile United States

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

Year Founded
2012
Biotech Subsector
Indication
Biotech Phase of Development
Current Financing Needs

Additional $0.5-1M to close seed round

Tangen Biosciences
President and CEO 

Daniel O'Connell United States

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.  

  • 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.

Year Founded
1996
Biotech Subsector
Biotech Phase of Development
Technology Overview

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.  

  • 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.

Current Financing Needs

Investment of $8M brings ACU-193 to IND in ~18 months; incremental investment of $22M brings ACU-193 through clinical proof of concept in Alzheimer’s by 2018.

Acumen seeks potential partners and investors to accelerate development of ACU-193 and an associated companion diagnostic for Alzheimer’s.

Current Timeline

18 months to IND, 20 months to completion of Phase 1A/B clinical trials; 24 months to completion of Phase 2A Proof-of-Concept clinial trails.  ACU-193 is expected to deliver acute behavioral benefits and chronic disease modification benefits:

  • ACU-193 is expected to show behavior benefits within 3 months

  • POC for acute clinical benefits via Aricept/Memantine like clinical trials

Current Investors

Investors.

  • Biotechnology Value Fund

  • NeuroVentures Fund

  • Individuals

IP Status

Composition of matter and use patents for ACU-193 and backup antibodies run through 2030; and further IP protection is available.

Recent Milestones

Acumen’s soluble Aβ oligomer selective antibody shows more robust behavioral and biochemical efficacy in transgenic mouse models of Alzheimer’s disease than that reported for any Aβ immunotherapy in clinical testing.

Management Team Highlights

Acumen Pharmaceuticals
Senior Business and Corporate Adviser 

Daniel O'Mahony Ireland

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.

Year Founded
2001
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Seroba Kernel Life Sciences
Partner 

Walter 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
Partner 

Mr David Olson United States

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).

Website:
www.imscg.com
Service Provider Type
Unique Capabilities
Life-Science focused and IMS Health resources
Mr David Olson
IMS Health Capital, Inc.
LinkedIn logo COO & CCO 

Nandan Padukone United States

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.

Joslin Diabetes Center
Vice President, Office of Commercialization & Ventures 

Paul Papi

Freedom Investors Corporation
Director, Investment Banking 

Art Pappas

Chiesi Ventures is a Venture Capital firm formed by a partnership between the Italian Pharmaceutical company Chiesi and US based VC firm Pappas Ventures. The firm is currently looking to make seed and venture stage investments into companies ranging anywhere from $2K to $5 million initially and up to $8 million over the life of the investment. The firm is actively seeking investment opportunities throughout the United States and Europe and could make as many as 2-4 new investments over the next year.
Chiesi Ventures
Partner 

Alejandra Paradones

BSI Capital is a Single Family Office based in Mexico City Mexico. The firm is looking to make growth stage investments into healthcare companies generally in series C and D rounds or later. Due to the structure of the firm BSI has a highly variable investment size that will depend of the financial needs of the company. The firm is currently looking for new opportunities throughout the United States Mexico and Canada. The firm has no set number of investment in plans to make over the next 6-9 months.
BSI Capital Group
CEO & Founder