Actinogen Medical (ASX:ACW) is an ASX-listed biotechnology company developing novel therapies for cognitive impairment associated with significant neurological and metabolic diseases, including Alzheimer’s disease (AD).
Actinogen's lead drug, Xanamem, has been specifically designed to reduce production of excess cortisol in the brain via antagonism of neuronally expressed 11β-HSD1. Chronically raised cortisol is a key risk factor for AD, and the association between raised cortisol and cognitive decline has been well documented in the scientific literature. Drugs that reduce cortisol in the brain offer a promising new approach to slowing, or even preventing, the cognitive decline associated with AD and a range of other neurological disorders. Actinogen recently announced the initial results for three clinical studies:
- XanADu, a Phase II clinical trial evaluating the safety and efficacy of Xanamem 10mg daily in patients with mild dementia due to AD. The trial demonstrated safety at this dose but it did not meet the primary endpoints.
- XanaHES, a Phase 1 clinical trial evaluating Xanamem 20mg daily in healthy elderly subjects. This trial demonstrated safety at this dose and expected pharmacodynamic effects, with a statistically significant cognitive enhancement and a large treatment effect. The trial reproduced results seen in earlier studies highlighting 20mg daily as a more optimal dose for future clinical studies of Xanamem.
- Target Occupancy studies investigating target engagement with neuronal 11β-HSD1 via PET imaging, demonstrating good brain penetrance and excellent target occupancy.
Actinogen is currently refining a clinical development strategy aimed at initiating multiple phase II studies in 2020; including in AD (patients with mild cognitive impairment), cognitive impairment in schizophrenia and/or bi-polar disorder, diabetes, and other indications.
Actinogen is proactively engaging with prospective biopharmaceutical partners globally that may be interested to collaborate with further development and commercialisation of Xanamem.
Acumen discovers and develops targeted therapies for the safe and effective treatment of Alzheimer’s and related neurodegenerative diseases. The company's founders pioneered seminal discoveries and developed methods to understand the role of toxic amyloid-beta oligomers (Aβo) in synaptic dysfunction and neurodegeneration. Acumen’s lead drug candidate, ACU193, is a humanized, affinity matured, IgG2m4 subclass monoclonal antibody which selectively targets toxic Aβo. ACU193 is positioned as a possible best-in-class Alzheimer’s immunotherapy based on its potential to provide meaningful clinical benefit by targeting toxic Aβo without inducing ARIA-related inflammation.
Acumen and Merck & Co. discovered and developed ACU193 through an eight-year research collaboration. Acumen currently holds exclusive rights to the program and lead candidate ACU193. ACU193 was developed using Aβo from both human Alzheimer's brain extracts and synthetic sources. In extensive non-clinical research testing, ACU193 demonstrates selectivity for Aβo over amyloid monomers and amyloid fibrils with consistent functional and biochemical efficacy and a favorable safety profile.
Acumen is nearing the completion of clinical-grade manufacturing of ACU193 and has initiated GLP safety toxicology testing. The company expects to file an Investigational New Drug Application (IND) for ACU193 in 2H2020 and initiate a phase 1 clinical trial in Alzheimer’s patients immediately after FDA acceptance of the IND.
In 2018, Acumen closed on a $15 million Series A-1 round co-led by PBM Capital Group and Sands Capital Ventures, with participation from previous and new private investors. A four-year, $3.6 million U01 grant from the National Institute of Aging is also supporting the pre-clinical and early clinical development of ACU193. The company intends to raise a Series B financing round in 1H2020.
The Allen Institute is dedicated to answering some of the biggest questions in bio-science and accelerating research worldwide. The Allen Institute for Brain Science continues to build out a comprehensive, multi-modal atlas of human brain cell types to advance our understanding of the structure and function of specific cell types as a crucial step toward understanding brain health and disease. https://alleninstitute.org/
Alzprotect is a French biotech company engaged in the development of small compound candidate drugs for the treatment of neurodegeneration.Alzprotect is developing AZP2006 a first-in-class NCE for the treatment of Neurodegenerative diseases that include Alzheimer's disease, Progressive Supranuclear Palsy (PSP) and Parkinson's diseases. AZP2006 is now in phase 2a for the treatment of PSP and aiming towards Alzheimer's disease.
Antisense Therapeutics (ASX:ANP & OTC:ATHJY) is an Australian publicly traded biopharmaceutical drug discovery and development company focused on development and commercialisation of novel antisense therapeutics for a variety of drug candidates including Duchenne Muscular Dystrophy (DMD), Multiple Sclerosis and Acromegaly. The products are in-licensed from Ionis Pharmaceuticals Inc. (NASDAQ:IONS), world leaders in antisense drug development and commercialisation. The Company is undertaking a clinical trial of ATL1102 in patients with DMD. The Company recently reported positive clinical results following completion of dosing of all patients in the trial.
Arviat Pharmaceuticals, Inc. is an emerging, Bay Area pharmaceutical company targeting neuroinflammation to treat Alzheimer’s and other adult neurodegenerative diseases. With most risk genes for Alzheimer’s disease originating from the microglia and its immune response, Arviat’s approach regulates a shared microglial inflammation pathway via oral small-molecule inhibitors, blocking downstream activation of the inflammasome. Arviat’s founder has a proven track record of rapid and successful drug advancement with 3 small molecules in the clinic for ALS, Parkinson’s and rare pediatric neurodegenerative diseases. Arviat Pharmaceuticals, Inc. is currently raising its seed round.
Bioasis Technologies Inc. is a biopharmaceutical company developing the xB3 ™ platform, a proprietary technology for the delivery of therapeutics across the blood brain barrier and the treatment of CNS disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases. The delivery of therapeutics across the blood brain barrier represents the final frontier in treating neurological disorders. The in-house development programs at Bioasis are designed to develop symptomatic and disease-modifying treatments for brain-related diseases and disorders. The Company maintains headquarters in Guilford, Conn., United States. Bioasis trades on the TSX Venture Exchange under the symbol “BTI” and on the OTCQB under the symbol “BIOAF.”
Bionic Vision Technologies, Pty., Ltd. (BVT) is a privately held Australian company developing the Bionic Eye System, a visual prothesis designed to restore functional vision to the blind suffering from inherited retinal diseases, such as Retinitis Pigmentosa (RP). To date, the Company has completed initial human testing in seven RP patients to demonstrate safety and initial efficacy with positive outcomes in patient mobility and device stability/durability. BVT intends to initiate a worldwide clinical trial in key markets, including Australia, USA and Europe, with commercialization anticipated soon after. BVT is collaborating with some of Australia’s leading research organizations, including The Centre for Eye Research Australia, The Bionics Institute, CSIRO’s Data61, The University of Melbourne and The Australian National University. http://www.bionicvis.com/
BIOS is developing a full stack neural interface platform, that is optimised to decode and encode the signals from the brain to the body, to treat chronic health conditions.
There are three parts to our technology: 1. Our hardware interface connects directly with the nerves to isolate the signals that travel between the brain and the body. 2. Our AI decodes and encodes this neural information from hundreds of thousands of individual neurons, tens of thousands of times per second, and sends corrected signals back into the body. 3. The BIOS software continuously updates, trains and enhances the treatment, via the cloud.
BIOS is positioned to be the platform on which a new generation of treatments can be built so that we can help millions of people suffering from chronic disease to improve their quality of life.
BrainScope Company, Inc. is revolutionizing the rapid and objective assessment of brain-related conditions, starting with mild traumatic brain injury and concussion, utilizing multiple integrated assessment capabilities, artificial intelligence (AI) and digitization, all covered by an intellectual property portfolio of >100 issued and pending patents globally. BrainScope has received 8 FDA clearances and ISO 13485:2016 Certification, and has 28 peer-reviewed publications on its technology. BrainScope® One is an objective, portable, point of care device that reliably, and without radiation, assesses the likelihood of a brain bleed in mild traumatic brain injury (mTBI) patients as well as the probability and severity of a concussion. The device also incorporates standard digitized assessment tools and neurocognitive performance tests, summarized as a panel of color-coded results, greatly facilitating triage and clinical assessment of head injuries. The company is a two-time winner of the GE-NFL Head Health Challenge and has received two nominations for the Prix Galien Best Medical Technology, regarded as the equivalent of the Nobel Prize for medical devices. BrainScope One is currently being used in health systems and hospitals, urgent care centers, military divisions and sports teams.
BRAINStorm cell therapeutics, INC. [NASDAQ: BCLI]
Brainstorm Cell Therapeutics is a leader in the development of innovative, autologous stem cell therapies for ALS, progressive MS, and other highly debilitating neurodegenerative diseases such as Parkinson’s Disease, Huntington’s Disease and Autism. The company’s innovative cell therapy platform uses patient’s own bone-marrow derived mesenchymal stem cells and modifies the cells to deliver high levels of neuronal repair and immunomodulatory molecules directly into the neurodegenerative disease cellular environment to effectively modify known disease pathways. Brainstorm has fully enrolled a phase 3 clinical trial for ALS at 6 US sites in October 2019 and expects top line clinical trial data in October 2020. Brainstorm is also actively enrolling participants in a US phase 2 clinical trial in progressive MS.
CENNA Biosciences, Inc. is a privately-held biopharmaceutical company located in La Jolla, CA, focused on the discovery and development of novel drugs that inhibit the production of Aß for the prevention and treatment of Alzheimer’s Disease (AD). Cenna’s first-in-class proprietary patented drug candidates are small peptides and small molecules that reduce Aß by a novel mechanism that addresses the failures of others to date in this space.
Cerecin is a US-Singapore headquartered biopharmaceutical company focused on neurology and brain health. The lead compound, CER-001 (Tricaprilin), is entering a global Phase 3 for Alzheimer's disease which will be focused in China. CER-001 is a small molecule structure lipid that addresses the metabolic deficit in Alzheimer’s disease by providing an alternative energy substrate to neurons. Cerecin’s pipeline includes Parkinson's disease, Migraine and Epilepsy. The company is also in-licensing new development stage CNS assets for development globally and in Asia-Pacific. Cerecin’s experienced management team have strong global CNS drug development capabilities with particular strengths in the US and China. Cerecin is supported by two major shareholders, Nestle and Wilmar (Yihai Kerry) groups.
Clarigent Health has developed a system using artificial intelligence and machine learning technologies to study a person’s language and speech patterns to detect warning signs of distress, suicide ideation, and other types of mental health issues such as depression and anxiety.
Using a smartphone-based app and server-based algorithms, individuals may be identified with a simple six-minute interview.
With five issued patents and clinical data from decades of research, Clarigent has shown in four clinical trials the ability to classify patients with mental-health conditions, including suicide ideation, resulting in less expensive, more effective treatment.
A seasoned management team in medical, education, & informatics is commercializing this multi-billion dollar market. https://clarigenthealth.com/
Cognoptix is creating and developing a simple, innovative non-invasive eye scanning test for the early detection and diagnosis of Alzheimer’s Disease.
The key to effective preventive therapy and treatment of Alzheimer’s is the creation of an “early warning system” for the disease, before it progresses to the point where treatment options are limited. Cognoptix’s technology has demonstrated successful preclinical and clinical results as the company develops its diagnostic platform – which consists of a laser eye scanning device combined with an ophthalmic ointment which specifically identifies Alzheimer’s related proteins found in the lens of the eye.
Cognoptix’s goal is to provide clinicians with a reliable, inexpensive and widely available test that can be performed quickly and accurately by a general practitioner in an office setting, to enable swift intervention and ongoing monitoring of patients.
Cordance Medical is a seed stage startup developing a non-invasive focused ultrasound-based therapy delivery system for brain diseases such as Alzheimer’s, Parkinson’s and brain cancer. Our system is designed to open the blood-brain barrier safely and transiently. Our system is portable and broadly deployable in clinics and outpatient settings. Accomplishments to date include patent filings, construction of a bench-top prototype demonstrating our non-invasive method, conclusion of an initial preclinical study demonstrating our ability to open the BBB non-invasively. Cordance medical is led by an ultrasound expert and a seasoned medical device physician-entrepreneur. In addition, it is advised by a neurosurgeon and a neurologist.
Cortexyme is a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what we believe to be a key underlying cause of Alzheimer’s and other degenerative diseases. Cortexyme is targeting a specific pathogen found in the brain of Alzheimer’s patients that causes neurodegeneration and other pathology in animal models. Cortexyme’s lead small molecule, COR388, has advanced through preclinical and Phase Ib testing and is currently the subject of a Phase 2/3 GAIN clinical trial in mild to moderate Alzheimer’s disease patients. https://www.cortexyme.com/
eip pharma, inc.
EIP Pharma is a leading CNS therapeutics-directed clinical stage pharmaceutical company with a scientific focus on the critical pathogenic drivers of early-stage neurodegenerative disease. We are developing neflamapimod, a potent first-in-class oral ATP-competitive inhibitor of p38α kinase, that is ready for late-stage development in Alzheimer’s disease (AD). Mechanistic studies have demonstrated that inhibition of p38α kinase activity targets a critical convergence point within neurons that mediates the toxicity of the major pathogenic drivers (amyloid-beta, tau, neuroinflammation) of AD and related dementias. Preclinical data has shown positive effects of neflamapimod on both functional (cognitive) and neurodegenerative outcomes. The company presented phase 2b clinical trial data at the Clinical Trials in Alzheimer's Disease (CTAD) meeting in December 2019 that demonstrated target engagement and proof-of-mechanism for neflamapimod treatment through a positive, statistically significant reduction relative to placebo in CSF markers of neurodegeneration and synaptic dysfunction. Phase 2 studies in Huntington’s disease (HD) and Dementia of Lewy bodies (DLB) are currently enrolling patients and are due to read-out in Q3'2020. Neflamapimod was licensed in 2014 from Vertex Pharmaceuticals, who had developed neflamapimod through to early phase 2 clinical trials in non-CNS disease indications and had completed a full chronic toxicology program. EIP Pharma is led by a top-tier management team that has a track record in developing major, innovative medicines and with that success build and grow companies. The founders, the executive chair and CEO, previously had executive management roles at major biopharmaceutical companies (Biogen, Vertex, Shire). https://www.eippharma.com/
GeNeuro SA [EPA: GNRO]
GeNeuro’s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases such as multiple sclerosis (MS) and type 1 diabetes (T1D) by neutralizing potential causal factors expressed by human endogenous retroviruses (HERV), which represent 8% of the human DNA. This new approach focused on HERVs is based on more than 25 years of R&D, including 15 within Institut Mérieux and INSERM before the creation of GeNeuro in 2006. GeNeuro's lead drug candidate, temelimab, is a humanized monoclonal antibody targeting the pathogenic protein HERV-W Env to block key neurodegenerative mechanisms of multiple sclerosis, through reducing microglial activation and through the rescue of the myelin repair process, independently of the immune pathways used by existing drugs. GeNeuro’s recent Phase IIb and its extension have shown its impact on key neuroprotection markers known to be linked to disease progression. These results confirm the potential of temelimab to act against disease progression, the largest unmet medical need in MS. This is also the first time that the benefit of a treatment targeting endogenous retrovirus protein has been observed in a clinical trial, opening a field led by GeNeuro to tackle other areas of unmet medical needs such as T1D or amyotrophic lateral sclerosis.
Gismo Therapeutics Inc. is a preclinical-stage biopharmaceutical company targeting fundamental biochemical processes that are at the root cause of neurodegenerative diseases. The company has been awarded several prestigious research grants to further develop its industry-leading technology, GISMO, which is associated with a new hypothesis of the etiology of neurodegenerative amyloid diseases. Gismo Therapeutics Inc. is developing first-in-class, disease modifying oral therapeutics for the treatment of Alzheimer’s and Parkinson's Disease. GTC-3309 and GTC-3295, the lead products in preclinical development, have shown robust data and proof of principle in animal studies together with very good safety profile. http://gismotherapeutics.com/
Global kinetics corporation ltd.
Global Kinetics, headquartered in Melbourne, Australia and Minneapolis, Minnesota, is the market leader in digital health and clinical algorithms for people with Parkinson’s Disease with the Personal Kinetigraph® (PKG®) . The PKG System provides objective, real-life symptom data to enhance clinical decision making for people with Parkinson’s. PKG elements include a wrist-worn PKG Watch, a clinician portal, and our proprietary algorithms and PKG Report. Our innovative report provides clinicians with novel insights into movement symptoms during the course of everyday living, allowing clinicians to optimize clinical decision-making. Better information in the clinical discussion leads to more informed treatment decisions, an improved quality of life, and improved healthcare economics. PKG is the world’s only FDA and CE cleared continuous, objective, ambulatory assessment and interpretation of the disabling symptoms of Parkinson’s.
Global Kinetics’ Mission:
Our mission is to help individuals lead their best possible lives by delivering novel insights into Parkinson’s Disease
Enhancing clinical decision making for people with Parkinson’s:
The PKG platform enhances the clinical discussion in Parkinson’s by providing actionable, objective data. We are on a trajectory to revolutionize the management of Parkinson’s disease by enabling informed treatment decisions which are based on continuous and objective measurement of patients’ key movement symptoms in everyday environments.
Ischemix, Inc. is developing novel, proprietary cytoprotective compounds for the treatment of serious neurological diseases and conditions. Our lead compound, CMX-2043, is in preclinical development for the treatment of traumatic brain (TBI) and for ischemic stroke. CMX-2043 has produced the strongest preclinical data of any compound in development for TBI, as demonstrated by significant findings in controlled rat and pig studies of sensorimotor activity, cognition, memory, contusion volume and hyperactive behavior, as well as by biochemical assays. With respect to ischemic stroke, the Company’s collaborator has recently reported significance in a study of the ability of CMX-2043 to improve mitochondrial respiration in a pig model of global ischemia. Ischemix had previously shown favorable results in a preliminary study of CMX-2043 in a rat model of regional ischemic stroke (MCAO). Because the etiology of TBI and stroke are similar, Ischemix believes this combination of results is very encouraging. We also plan to study our compound as a prophylactic for TBI. Further, there is reason to believe that our compound could be a therapeutic candidate to slow the progression of Alzheimer's disease.
Keystone Bio is a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic/preventive approach to treat and eliminate the key underlying infectious cause of a spectrum of chronic, clinically silent inflammatory diseases of the heart brain axis.
Keystone Bio has identified a "one of a kind Inflammapath ", the keystone pathogen of chronic inflammation that initiates and advances vascular bed type diseases such as Atherosclerosis, Heart disease, neuro-vascular cognitive decline/dementias, fronto-temporal dementia and Alzheimer's disease. Over half of individuals in the general population will acquire the infection at various ages and Keystone Bio has the only biologic that we are aware (PrevEvent) that can eliminate it for an extended period of time (at least 1 year), thus reversing and preventing a large catalogue of our most deadly diseases.
Our target, Porphyromonas gingivalis, is being referred to as the keystone pathogen of inflammatory disease. The lead molecule, PREVEVENT, has completed preclinical and Phase I proof of concept testing.
Lachesis Biosciences is a development company focused on nasal spray and nasal absorption technology. Lachesis Biosciences clinical-stage, Rivastigmine Nasal Spray product candidate is for the treatment of dementia symptoms associated with Alzheimer's and Parkinson's diseases.
Metys Pharmaceuticals is developing MP-101 to prevent chemotherapy-induced peripheral neuropathy, an uncomfortable and troubling side effect of several important cancer treatments; and to treat painful diabetic peripheral neuropathy. We seek Series A investors to participate in a $20 million Series A round to finance our planned Phase 2 clinical trials.
MP-101 is an orally-active modulator of glutamate signalling in spine and brain. Glutamate signalling has long been a sought-after target for the development of new central nervous system drug candidates. MP-101 is a particularly well-suited candidate, with outstanding pharmaceutic properties; it is a small molecule, obtained by a straight-forward chemical manufacturing process. It is also orally active in a wide range of rodent models of central nervous system disorders, such as depression, cognition, or neuropathic pain.
MP-101 is a patented non-racemic mixture of the left-handed and right-handed versions (the "enantiomers") of dimiracetam. It is not a one-to-one mixture (a "racemate"), but a ratio that has been chosen because it is - unexpectedly - considerably more potent pharmacologically than the racemate. While the one-to-one mixture has long been known to be superior to either of the two single-handed enantiomers alone, Metys Pharmaceuticals has discovered that certain mixtures of dimiracetam enantiomers are far more potent still.
Metys Pharmaceuticals has licensed the world-wide exclusive rights to racemic dimiracetam from Neurotune AG, including the entire dossier of regulatory studies supporting clinical trials of racemic dimiracetam. Metys Pharmaceuticals has obtained FDA's written consent to use these pharmacological, toxicological and clinical data obtained with racemic dimiracetam to support the future clinical trials of MP-101, without any further toxicological or clinical bridging studies.
Minoryx Therapeutics S.L is a late clinical stage biotech company focused on the development of new therapies for X-ALD, Friedreich's Ataxia and other orphan CNS diseases. The company’s lead program, a differentiated and brain penetrating PPAR gamma agonist (leriglitazone; MIN-102) is now in a phase 2/3 trial for adult X-ALD patients (AMN) and phase 2 for Friedreich's Ataxia, both fully recruited and with a read out by the end of 2020. Additionally a phase 2 study is now being launched in pediatric X-ALD patients with cerebral form (cALD).
Mitokinin is late-preclinical stage biotechnology company developing PINK1-targeted small molecule therapeutics. PINK1 is a master regulator of mitochondrial quality control genetically linked to Parkinson’s disease. By selectively amplifying active-form PINK1 activity, Mitokinin believes it can address the cellular pathologies underlying Parkinson’s disease and ultimately slow or halt the progression of the disease.
Neuroelectrics® is a digital brain health company that innovates at the intersection of neuroscience, physics, machine learning, and wearable tech. We have developed wireless, portable devices that are able to be personalized for every individual. Our brains are different so the treatment should change from person to person. Our objective is to enhance brain health through targeted and individualized care.
Neuroscience Trials Australia is a niche, full service, CNS-focused CRO committed to ensuring the highest quality conduct of clinical studies in accordance with Good Practices (GxP). We connect our clients to world-leading clinical experts and sites through our ongoing affiliations with several Clinical Trial Networks. This unique aspect of our business allows us to keep the capabilities databases, assist with feasibility and co-bid for projects in conjunction with the trial networks. Our staff has global project management expertise in all phases of clinical research, including studies by the pharmaceutical/device/biotechnology industry, granting bodies (NIH or Australian equivalent NHMRC), collaborative groups, institutions and Investigators. Quality is the role of every NTA employee and integral to all stages of our clinical development process. Our team is trained in GCP Principles and we work according to global regulatory standards, including projects under FDA IND application. We meet or exceed our client expectations to ensure the successful execution of projects in a timely and cost-effective manner. Our services and core capabilities can also be tailored according to the individual needs of the client.
Neurothera is a medical device company built on strong intellectual property using Photobiomodulation (PBM) treatment for brain health. Applications include major depressive depression (MDD), Alzheimer’s disease, Parkinson’s disease, cognitive enhancement, and traumatic brain injury. Based in Newark, Delaware, Neurothera has over 23 issued patents based on treating the brain with light to treat many devastating brain injuries and disease. Photobiomodulation is a rapidly growing medical field where light in the form of lasers and/or LED (light emitting diodes) is used to stimulate cellular activity to help healing. There have been several thousand scientific studies published on the mechanism of action as well as clinical studies showing positive results. Neurothera's team is composed of several scientific and business leaders in the field of photobiomodulation. Many years and over 150 million dollars have been spent determining how to safely get light to areas of the brain in order to effectively apply photobiomodulation. Neurothera has acquired and/or developed this knowledge and intellectual property in order to commercialize medical devices to treat brain disorders. The first devices will be used to apply photobiomodulation to the brain for the treatment of MDD. There have been several animal and human studies showing positive effects for Photobiomodulation on models for depression, Stoke, trauma brain injury (TBI) and Alzheimer’s disease. Neurothera is now expanding these results into human clinical trails in order to commercialize medical devices. The company has been conducting a clinical trail for the treatment of MDD. The study is a dual site, double –blinded, placebo controlled using very well verified and validated outcome measures. A parallel study on cerebral blood flow has been completed.
Newronika is the spin-off company of two of the world leading research institutions in the field of Neurology (the Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Hospital and the University of Milan. Newronika has developped the first close loop system for Deep Brain Stimulation, allowing to record in real time the brain's reaction and adapt the stimulation accordingly. Newronika restores brain and body functions with its innovative technology, translating their deep knowledge on bioelectrical signal decoding into clinical practice with the aim of developing new treatments and improve existing ones. Newronika is made by a multidisciplinary team involving neurophysiology, neurology, biomedical engineering, neuropsychology, bioinformatics and biotechnologies.
Oryzon is a public clinical stage biopharmaceutical company listed on the Madrid stock exchange and a European leader in the development of epigenetics-based therapies. Oryzon has programs in clinical phase: CNS - Vafidemstat (ORY-2001), a dual LSD1-MAOB inhibitor, currently in three Phase IIA: • "ETHERAL": in mild to moderate AD • "REIMAGINE": aggression in adult population with Alzheimer’s Disease (AD), Adult attention deficit hyperactivity disorder (ADHD), Borderline Personality Disorder (BPD), and Autism Spectrum Disorder (ASD) • "SATEEN": in relapse-remitting and secondary progressive forms of MS. Oncology – Iadademstat (ORY-1001), a selective LSD1 inhibitor, currently in two Phase IIA: • "ALICE": in AML • "CLEPSIDRA": in SCLC A third epigenetic compound (ORY-3001), also against LSD1, has completed the preclinical development, for a yet undisclosed non-oncological indication.
Paradromics is bringing to market the first high data rate brain computer interface. We envision a future where data is exchanged seamlessly between brains and computers. Conditions such as blindness, paralysis, and mental illness, which today are considered untreatable, can be reframed as data problems with technological solutions. Our first product is planned to act as an assistive communication device, restoring conversation capability to people with severe paralysis who have lost the ability to speak or type. Brain computer Interfaces are Investigational devices in the United States. https://paradromics.com/
ProMIS™ Neurosciences, Inc.
ProMIS™ Neurosciences, Inc., headquartered in Toronto Ontario, and with offices in Cambridge Massachusetts, is publicly traded on the Toronto Stock Exchange (ticker symbol: PMN.TO) and OTCQB (ticker symbol: ARFXF).ProMIS is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD).
ProNeurogen is a neuroinflammation company that is developing a platform of novel, proprietary drug candidates to treat: cognitive impairment due to vascular dementia, mixed dementia and traumatic brain injury; and chronic and neuropathic pain.
Vascular cognitive impairment (VCI) and vascular dementia are the second most common causes of dementia and are involved in more than 50% of all other dementia cases. Market is expected double every 20 years with a market size ~$20B, 8% CAGR.
Increased brain inflammation and decreased brain blood flow accelerate the progression of VCI and vascular dementia. To date the FDA has not approved any drugs specifically to treat vascular dementia.
ProNeurogen drugs are designed to decrease brain inflammation and improve brain blood flow to protect brain function. ProNeurogen’s lead compounds, PNA1, PNA5 and PNA6, are rationally-designed Angiotensin-(1-7) Mas receptor agonists that have enhanced BBB penetration, half-life and are designed to inhibit chronic inflammatory pathways in both the brain and the cerebrovasculature endothelium. These pathways are involved in vascular dementia and and neuropathic pain.
ProNeurogen’s drug candidates are based on technology developed at the University of Arizona. ProNeurogen, founded in 2013, is the exclusive licensee of this technology. IND-enabling studies and GMP manufacturing efforts are underway and supported by a $5.6 million grant from NIH. PNA1, as a proof of concept study, is in FDA-approved, phase 2a pilot clinical trials for vascular dementia cardiac disease patients. Phase 1 clinical trials for PNA5 and PNA6 are planned for 2021.
ProNeurogen’s technology includes both composition of matter and methods patents with protection through at least 2035. Currently 6 patents have issued and an additional 5 are expected 2020.
ProNeurogen is seeking $20M for a Series A round. This investment will be used to accelerate the IND process, P1 safety studies and begin P2 efficacy studies in vascular dementia.
Seneca Biopharma, Inc., is a clinical-stage biopharmaceutical company developing novel treatments for diseases of unmet medical need. Seneca is in the process of finding and acquiring new assets, promising sciences and technologies that will provide meaningful therapies for patients. https://senecabio.com/
STALICLA is a Biotech Company developing a first-in-class precision medicine platform to accelerate drug development for patients with Neurodevelopmental Disorders (NDDs). STALICLA is using computational systems biology tools to characterize correlations between NDD phenotypes, gene expression in relevant molecular pathways and treatment response. First focus of development has been Autism Spectrum Disorder (ASD). Today, patients diagnosed with ASD account for 1-1.5% of the world population. The condition remains a high unmet medical need. In its Geneva and Barcelona units, STALICLA has assembled a world-class team of drug developers and computational biologists. The Company is recognized as a disruptive player, using its DEPIv3 innovative AI platform. DEPIv3 integrates domain specific large-scale genetic, molecular, pharmacological and clinical data to define patient subgroups and to identify personalized treatments. It is the first time that such technologies have been utilized within for NDDs with the potential to change the direction of the specialty. DEPIv3 has already proven successful in expediting and de-risking drug development for a first subgroup of patients with Autism and identifying two additional subgroups. STALICLA’s first therapeutic package - STP1 - addresses this first distinct subgroup of ASD patients - ASD Phenotype 1- estimated to 1.5 - 2M people in the EU and North America. Clinical entry for STP1 is planned in Q1 2020. ASD Phenotype 1 patient cells have been characterized at molecular level, revealing a ‘fingerprint’ specific to this subgroup of patients with ASD and allowing the development of a Companion Diagnostic tool.
To support its platform and pipeline development, STALICLA has developed a network of top-tier research and clinical partners in the US. This has enabled STALICLA to gather one of the largest Autism patients Electronic Health Records database to date. STALICLA is currently scaling up DEPIv3 to advance new pipelines for additional groups of patients with NDDs. http://stalicla.com/
vincere biosciences, inc.
Vincere is focused on developing small molecules to stop/slow progressive neurodegeneration in Parkinson's disease by restoring the deficits in mitochondrial pathways/function. These distinct molecular targets and pathways are informed by the proprietary computational platform of our parent company, Neuroinitiative, LLC, which integrates human genetics, genomics and other biomarker data to identify and rank-order pathogenic mechanisms.
A Milan- and Berlin-based biomedical company developing a genuinely new generation of implantable leads for Neuromodulation and Neuromonitoring .
WISE’s electrodes are highly biocompatible, foldable, stretchable and minimally invasive compared to existing products and will overcome the major limitations of today’s technology. They will allow to improve the treatment of patients that are already profiting from Neuromodulation, while at the same time expanding the use of Neuromodulation to fields and clinical indications in which the complex technical demands cannot be met by the current technology.
The electrodes are produced through a proprietary innovative technology: the Supersonic Cluster Beam Implantation (SCBI), which allows the metallization of stretchable polymers. SCBI consists in embedding metal nanoparticles inside a preformed polymer base in order to form a conductive metal-polymer skin on its surface. The SCBI technology has been protected by patents in Europe, USA, Israel, Canada, India, Japan and Korea. Alongside the IP, WISE holds a strong know-how on the technology and its implementation.