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Medly Therapeutics (Medly) is a digital health company transforming care for cardiac and chronic disease patients. Developed based on technology invented at the University Health Network in concert with its Peter Munk Cardiac Centre (PMCC) and Centre for Digital Therapeutics as well as the Ted Rogers Centre for Heart Research, the Medly program is a first of its kind in Canada. The program uses the Medly management algorithm developed by heart failure clinicians to rapidly assess and triage patients, and includes access to a digital health team for patients. Medly demonstrates unrivaled clinical validation with a 50% reduction in heart failure related hospitalizations and a 6-fold increase in patient capacity, as well as validation for its platform technology via 27 peer-reviewed publications.

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UNMET NEED

50% of  heart failure patients are re-hospitalized within 6 months of admission, leading to significant health system costs. There is a current shortage of health care staff specializing in cardiac care, e.g.(nurses, cardiologists and primary care physicians who are trained in heart failure management. Consequently, clinicians are forced to manage care by events instead of outcomes, a costly approach.

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INNOVATION
Medly Therapeutics (Medly) combines gold standard protocols integrated with a clinician developed expert system, directing the patient through an automated front (e.g. smart phone app or digital portal) that transforms event-based care to proactively managing patients to their baseline. Medly demonstrates unrivaled clinical validation with a 50% reduction in heart failure related hospitalizations and a 6-fold increase in patient capacity. Medly's platform has gained validation in over 27 peer-reviewed publications.

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‍APPLICATION/UTILITIES

The Medly platform is being prescribed by Canadian clinicians to manage their heart failure patients on a daily basis and boasts an 80% adherence rate in patients over 70 years of age. Medly is changing the face of chronic disease management with additional applications including co-morbidities such as diabetes, COPD and mental health/depression.

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‍INVESTMENT & OBJECTIVES

$3M USD Series Seed; $10M pre-money valuation with $2.4M committed.

Investment would be targeted to:

·   Port the platform to the cloud for commercial scale

·  Continue with FDA application (breakthrough designation received 11/22)

·  Execute2-3 US pilots (pilot sites in discussion

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‍COMPETITIVE ADVANTAGE

1)   Evidence-based (27 peer reviewed publications; competition has only 1)

2)  (Validated) trade-secret data and algorithms - usually takes years take years to validate

3)  Successful early adoption in Canada

4) Breakthrough designation from FDA

5) Health Canada approval for medical device

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‍MARKET SIZE

US and Canada TAM $22B

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‍IP PORTFOLIO

Extensive trade secret portfolio; additional patents being filed on remote medication titration and multiple chronic condition management

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‍CURRENT MANAGEMENT TEAM

Tracey Dodenhoff, CEO

With a personal mission to “Help Good People do Great Things with Innovation”, Tracey is an impact-focused entrepreneur dedicated to high value solutions. Tracey’s background encompasses technology entrepreneurship, innovation leadership and venture investing. Over her career, Tracey has launched and invested in over two dozen startups, as well as partnering with ventures to accelerate the growth of new product initiatives across medical, consumer, software and industrial verticals. Tracey specializes in integrating innovative programming with technology, resulting in game-changing collaborations across geographies and disciplines. She holds an MBA from Babson College, an MID from Pratt Institute and a BSc from Rhode Island College. She is also the holder of several patents in medical device and software. She advises and mentors early stage ventures across medtech, advanced materials and data science.

The company also includes a VP of Engineering, Clinical Director, CTO, CFO, and VP of Operations.

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‍CURRENT READINESS LEVEL

TRL 8 – Porting to the commercial cloud platform (completion by Q3 2023 this year).

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‍‍SCIENTIFIC FOUNDER(S)

Dr. Heather Ross - Head Division of Cardiology at the Peter Munk Cardiac Centre, Professor of Medicine, University of Toronto, Site Lead Ted Rogers Centre for Heart Research

Dr. Joseph Cafazzo - ‍Executive Director, Biomedical Engineering, the Centre for Digital Therapeutics, and Healthcare Human Factors (HHF) at UHN, and Wolfond Chair in Digital Health

Nearly half of all patients receiving treatment for cancer will receive radiation treatment. The radiation treatment process takes clinicians hours, sometimes days, to complete. Curait Medical has a patent-protected platform providing automated, quantitative quality review enabling the radiation team to make more informed clinical decisions for each radiation treatment with reduced costs, increased quality, higher patient throughput, and fewer treatment errors. Curait's medical platform is Software as a Service (SaaS) based, enabling users access to machine learning of clinical practice and the ability to build models based on their clinical expertise. In addition, the platform facilitates more objective and consistent clinical practices across cancer centers, making it a valuable tool for healthcare managers.

‍UNMET NEED

There is a significant shortage of clinically trained experts in radiation oncology able to deliver radiation treatment to cancer  patients. In short, we will not be able to train enough professionals to meet  the increasing clinical demands associated with treatment delivery.

The radiation treatment process requires tremendous clinical expertise, is highly time consuming and expensive. Radiation treatments are planned (i.e. simulated) using specialized software and are subject to rigorous review by the entire radiation treatment team, before any radiation is approved and delivered to the patient. The radiation treatment plan is customized for each patient and specifies how the radiation treatment machine will deliver the radiation, and the radiation expected to reach the targeted tumour and any healthy organs.

RT treatment planning involves collaborating with a multidisciplinary team through repeated touchpoints. Curait’s patented SaaS uses machine learning to aid the team in evaluating and reviewing thousands of characteristics for each treatment plan in minutes. Whereas the total treatment planning process can take many hours to days to complete, with Curait, that time can be reduced by 30%, typically saving 3-6 hours per patient. This is because the Curait platform is designed to perform on-demand consultation, helping technicians complete treatment plans quickly, as well as expedite the mandatory treatment plan reviews for medical physicists and radiation oncologists. Curait’s SaaS improves workflow and eliminates expensive process bottlenecks resulting from handoffs within the radiation treatment team, thereby helping patients get their treatment faster.

The platform is vendor-agnostic, scalable, and can readily be integrated into the clinical workflow of any cancer center. It increases both the quality of and access to radiation treatment, while  providing immediate savings. The increased capacity realized using the Curait platform will positively impact revenues.

‍INNOVATION

Curait’s SaaS learns the characteristics of high quality treatment plans to build machine learning “models”.  It has been developed based on a comprehensive database from one of the world’s top 5 cancer centres,the Princess Margaret Cancer Centre. Curait’s SaaS also connects the radiation treatment team to a constantly expanding database of models.

Curait’s SaaS creates a personalized approach for reviewing each patient’s care by drawing on thousands of relevant historical cases and it can automatically access the most applicable patient data without relying on hard-coded metrics being entered by the user, as is common practice.

Curait also provides the team with understandable reasoning behind the evaluation of each component of the radiation treatment plan to aid in both identifying specific issues/errors, saving the radiation oncologist from having to complete multiple intermediary reviews, and in providing direct insights for making necessary adjustments to improve the radiation treatment plan quality.

For more information: https://curaitmedical.com/

‍APPLICATION/UTILITIES

‍Curait’s QA solution is applicable to all cancer patients requiring radiation treatment.  The technology can be easily integrated into any healthcare application that leverages a treatment plan.

‍INVESTMENT & OBJECTIVES

‍Investment Raise: $2 Million

Investment would be targeted to:

·  Product Development (45%) 

·  Sales-Marketing Commercialization (30%)

·  General Administration (25%)

‍COMPETITIVE ADVANTAGE
Patent pending with priority date in the U.S.; AI training using patient datasets from one of the world’s top 5 cancer centres; automatically learned clinical practice metrics.

‍MARKET SIZE
RT addressable market:  >US$500M

‍IP PORTFOLIO
The company's IP portfolio includes a patent pending for  automated quality assurance in radiation therapy.

US patent 201180211725A1: https://patents.google.com/patent/US20180211725A1/  

‍CURRENT MANAGEMENT TEAM
Curait's management team is experienced and has a track record of successfully navigating early-stage companies to commercial success.

‍CURRENT READINESS LEVEL

‍Curait’s platform (“Thor”) contains the following products:

Thor Data; completed – ready for sale.

Thor Audit; completion and sale readiness Q4 2023 (assuming financing)

Thor On-Demand; requires 510K for regulatory approval – completion  and sale readiness in 2024

Note: a NON-AI version of Thor Audit and On-Demand is  being used clinically (>9,000 patients) – the products are not fully  commercial-ready, but functional.

‍‍SCIENTIFIC FOUNDER(S)
Dr. Thomas Purdie, Medical Physicist, Princess Margaret Cancer Centre; Associate Professor, University of Toronto.

Dr. Purdie is a staff medical physicist/clinician scientist and is the recipient of academic awards from NSERC and CIHR. Dr. Purdie’s research lab focuses on developing and deploying machine learning algorithms and methods for automating clinical radiation oncology workflow processes, including radiation treatment planning, quality assurance, and decision support.

‍Dr. Chris McIntosh, Toronto General Hospital Research Institute

Dr. McIntosh is the recipient of academic awards from NSERC, CIHR, and the Michael Smith Foundation for Health Research. His lab is focused on the theory and clinical application of AI in medicine for improving patient care including transfer learning, meta learning, computer vision, and explainable AI. Applications include deep learning for automated diagnosis, segmentation, quality assurance, and treatment planning.

Our novel drug candidate blocks the cis-interaction between Repulsive Guidance Molecule A (RGMa) and Neogenin and disrupts Neogenin incorporation in lipid rafts. This candidate’s therapeutic interaction promotes cell survival and axonal regeneration in severe medical conditions including retinitis pigmentosa, multiple sclerosis, ischemia (e.g., stroke), and spinal cord injury. The ideal strategy to ameliorate CNS damage is through promoting both survival and axonal regeneration.

UNMET NEED
4IG targets the neuronal regeneration pathway that has not yet been drugged. Multiple disease indications are implicated including Retinitis Pigmentosa, Stroke, Spinal Cord Injury, and Multiple Sclerosis.

INNOVATION
Biologic therapeutic comprised of ~400 amino acid, soluble Ig extracellular domain of Neogenin

Dual mechanism of action by:
1.binding (Repulsive Guidance Molecule a (RGMa) and
2. inhibiting Neogenin incorporation in lipid rafts

Potential therapeutic for preventing neuronal death in multiple human indication through direct effect at neurons and indirect effect through reducing permeability of Blood Brain Barrier

APPLICATION/UTILITIES
Biologic therapeutic targeting diseases involving neurodegeneration; multi-disease potential (one product).

INVESTMENT & OBJECTIVES
 $5-7M for IND enabling studies.

COMPETITIVE ADVANTAGE
Closest competitors are elezanumab and unasnemab, which are under development from AbbVie Inc and Mitsubushi Tanabe Pharma Corp, respectively.   Both elezanumab and unasnemab  are intravenously administered, α-RGMa monoclonal antibodies. Elezanumab is under Phase II development for the treatment of relapsing-remitting multiple sclerosis, acute ischemic stroke, primary and secondary progressive multiple sclerosis and spinal cord injury. Unasnemab is under Phase II development for the treatment of spinal cord injury and Phase I development for the treatment of Tropical Spastic Paraparesis.

Whereas elezanumab and unasnemab have a single mechanism action, 4Ig both binds RGMa and inhibits the incorporation of Neogenin in lipid rafts.

‍MARKET SIZE
·   Global stroke therapy market expected to grow to over $US10B by 2027

·   Global Multiple Sclerosis therapy market expected to grow to over US$29B by 2030

·   Global Retinitis Pigmentosa therapy market expected to exceed US$2B by 2030

·   Global spinal cord injury treatment market expected to reach almost US$3B by 2027

IP PORTFOLIO
Two patent families describing methods, with 6 issued patents and 1 issued patent.

CURRENT MANAGEMENT TEAM
‍n/a

CURRENT READINESS LEVEL
Proof of concept/pre-clinical.‍

EIR STATUS
‍Recruitment in progress.

‍SCIENTIFIC FOUNDER(S)
Dr. Philippe Monnier, Senior Scientist, Krembil Research Institute, an accomplished researcher focused on uncovering the role of extracellular proteins in the developing and regenerating CNS.

Porphysomes are a platform technology based on lipid molecules that form porphysome nanoparticles, with versatile applications including cancer imaging, phototherapy, and drug delivery. Porphysome nanoparticles have the unique ability to be loaded with drugs, such as chemotherapeutics or immunotherapy agents, and have properties that make them ideal for both targeted photothermal therapy (PTT) and photodynamic therapy(PDT), Porphysomes are capable of fluorescence, which enables more accurate tumor diagnosis. They also selectively accumulate in cancer tissue and release photoenergy when a specific laser light is directed at the tumor, which means they can selectively ablate malignant tissue. Additionally, porphysomes can be modified with heavy metals to facilitate PET imaging.

‍UNMET NEED/COMPETITIVE ADVANTAGE
‍The FDA approved the only photosensitizer agent available in the US for internal solid tumors in 1995.  While this agent has been proven to be effective in both early and late-stage cancers, the major limitations are severe skin photosensitivity that can last >30 days and the inability to fluoresce cancer cells. Porphysomes represent an advanced generation of photosensitizers with minimal expected side effects and additional capabilities, such as enhanced tumor detection and visualization via fluorescence.  

‍INNOVATION
Porphysomes are a patented porphyrin-lipid technology. The porphyrin component of a porphysome delivers the photosensitizing property while the lipid component provides additional functional capabilities. These multi-functional characteristics provide the opportunity to design agents for a variety of applications.

‍APPLICATION/UTILITIES
The initial target applications of Porphysomes will be pre-cancerous skin conditions and oropharyngeal cancer where significant unmet needs exist with the currently available treatment options.  The development pipeline also includes pancreatic cancer and non-small cell lung cancer where porphysomes represents a major advancement in targeted therapy.

‍INVESTMENT & OBJECTIVES
$20M USD, for the purpose of: 

-        CMC, GMP and regulatory planning for humantrials       

-        Initiation of first-in-human phase-I studiesin the initial target indications

‍MARKET SIZE
Estimatedmarket value of photodynamic therapy is US $3-5B. CAGR is estimated at 3-5%.

IP PORTFOLIO
Three patents cover the composition ofporphysomes, usage in photothermal therapies and photoacoustic imaging as wellas different porphysomes with alternative lipid conjugates. Several patentfilings are in progress covering porphysome modifications that enhance uptakeinto cancer cells and enhance ability to carry chemotherapeutic agents (e.g.paclitaxel), as well as patents focused on proprietary potency testing devicesand methods.

‍CURRENT READINESS LEVEL
‍RegulatoryIND/CTA filings followed by the initiation of first in human trials

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MANAGEMENT TEAM
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Glenn Kutschera, CEO 

Glenn is an experienced industry executive with recent experience as president of a U.S. photodynamic therapy company.

Dr. Gang Zheng - Senior Scientist and Associate Research Director, Princess Margaret Cancer Centre & Scientific Co-Founder

Porphysomes are based on ground-breaking research by Dr. Gang Zheng, a world-renowned expert in nanomedicine and Associate Research Director at the Princess Margaret Cancer Centre. Named contributor to the “top 10 cancer breakthroughs of 2011” by the Canadian Cancer Society for his work on harnessing porphysome nanotechnology in the fight against cancer, Dr. Zheng’s nanotechnology platform is the foundation for this new venture. For more information: http://zhenglab.utoronto.ca/

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Dr. Brian Wilson - Senior Scientist, Princess Margaret Cancer Center; Professor, University of Toronto

Dr. Wilson's work lies in the development and commercialization of novel technologies and methods that can be translated to cancer patients and that are based on light and nanoparticles. The applications include cancer detection/diagnosis (using different forms of optical spectroscopy and imaging), cancer treatment (using light-activated drugs), and image-guided cancer interventions (surgery guided by fluorescence imaging).

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Dr. Michael Valic, Scientist, Princess Margaret Cancer Centre

Despite significant progress in CPR methods in recent decades, survival following sudden cardiac arrest due to Ventricular Fibrillation (VF) and subsequent advanced life support has not dramatically improved. The on-market, off-patent drug Dantrolene has been safely used in clinical practice with few side effects for many years. Research at UHN has shown that Dantrolene decreases the number of refibrillations required and substantially improves cardiac contractility and Return of Spontaneous Circulation (ROSC) following defibrillation. Dantrolene administration thus has significant potential to improve survival following VF arrest. This technology also has potential applications in the treatment of chronic heart failure and chemotherapy-induced cardiotoxicity.

‍UNMET NEED
Ventricular Tachycardia (VT) is a common cause of sudden cardiac death. Implantable devices to monitor and correct the irregular heart rhythm can save lives, but this strategy is invasive and costly, and it does not cure the lethal condition. Radiofrequency ablation is an alternative treatment, but it has a high failure rate. Treatment with doxorubicin although very useful in many cancers, can lead to heart damage that reduces the quality and quantity of life that a cancer survivor can expect.

INNOVATION
Dantrolene is traditionally prescribed as a muscle relaxant and has been in clinical use for decades. Research at UHN has demonstrated that Dantrolene can also suppress life-threatening irregular heartbeats. Analysis of clinical data has indicated that long-term use of Dantrolene as a muscle relaxant is safe and does not exert negative influences on the heart.  Further, the use of dantrolene during chemotherapy with doxorubicin can reduce the possibility of future cardiomyopathy. 

APPLICATION/UTILITIES
·        Acute treatment of Ventricular Tachycardia (VT)

·        Treatment of treatment of chronic heart failure  

·        Prophylaxis of chemotherapy induced cardiotoxicity

‍INVESTMENT & OBJECTIVES
$5M - $15M required to: 

·        Develop a rapid administration formulation of Dantrolene. 

·        Assess the pharmacokinetics (PK) of rapid administration Dantrolene formulation in a large animal model. 

·        Assess human PK of reformulated Dantrolene in a FDA-approved centre. 

·        Demonstrate the effects of reformulated Dantrolene on the frequency of PVCs of patients suffering from idiopathic PVCs.

COMPETITIVE ADVANTAGE
First-line therapies, such as β-antagonists and Ca2+ channel blockers, are often ineffective for the treatment of VT.[JA6]  While Flecainide is effective, its concurrent blockade of sodium channels can also promote ventricular arrhythmia. Though effective in inactivating arrhythmogenic tissues, cardiac ablation is an invasive procedure with a high failure rate.  

‍MARKET SIZE
The global market for ventricular tachycardia [JA7] diagnosis and treatment was valued at US $12.5 Bn. in 2021 and . is expected to grow at a CAGR of 5.26 % to US$17 B. by 2027. Doxorubicin currently sells US$1.3B annually and its use is increasing despite substantial risk of cardiotoxicity. The success of an abatement for cardiotoxicity as well as potentially selling as much as doxorubicin may increase the demand for doxorubicin-based chemotherapy.

IP PORTFOLIO
Two patent families, including issued patents in EU and US, covering multiple applications of the technology.

‍CURRENT READINESS LEVEL
Pre-clinical technology, requires demonstration in clinical trial. 

EIR
Nigel deGruyther

Nigel deGruyther is a pharmacist and entrepreneur with experience in drug repositioning efforts and venture capital and the former Head of Business Development at Cynapsus Therapeutics.

‍SCIENTIFIC FOUNDER(S)
Dr. Kumaraswamy Nanthakumar is a clinical cardiologist and cardiac electrophysiologist at UHN and a Senior Scientist at the Toronto General Hospital Research Institute, with a focus in cardiac arrhythmia modulation and stabilization of RyR2. He is also Professor of Medicine at the University of Toronto.

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Gliachem is developing a small molecule therapeutic whose first clinical opportunity will be Rett Syndrome, a rare, pediatric disease with limited treatment options.

‍UNMET NEED

Rett Syndrome is a rare, X-linked genetic neurological and developmental disorder that affects the way the brain develops. With approximately 350,000 patients worldwide, it manifests primarily in young girls, presenting with a wide range of disabilities and often misdiagnosed as general autism, cerebral palsy, or other conditions of pervasive developmental delay. Limited treatment options exist for these patients, most of which are off-label treatments for symptom management & occupational therapy. There is one approved drug (Trofinitide, Acadia Pharmaceuticals; approved 2023) which has a small effect size and tolerability issues, leaving significant room for improvement.

Rett Syndrome is caused by mutations of the MECP2 gene. In Rett patients, the brain fails to properly mature, remains under-developed throughout life, and functions inefficiently.  While the errant function of many systems contributes to these neural impairments, the hypoactivity of mTOR represents a key convergence point of pathogenic processes. Strategies to improve mTOR activity represent potential treatments for Rett Syndrome. The Transient Receptor Potential Cation Channel Subfamily M Member 2 (TRPM2) is one system that negatively regulates mTOR, and is over-expressed in the Rett Syndrome brain. We have developed new molecules that block TRPM2. These small molecules display high affinity and selectivity for TRPM2, and represent a first-in-class approach to engage TRPM2 for translational development in Rett Syndrome.  

‍APPLICATION/UTILITIES
The first clinical indication for our small molecule will be Rett Syndrome. However, TRPM2 has been implicated in other indications beyond Rett. We will look to validate additional clinical indications once we have the compounds to build the pipeline.

‍INVESTMENT & OBJECTIVES

‍We are currently looking to raise a $2.9M seed round, which will enable us to complete our hit to lead activities and select our lead candidate in ~12-18 months. This includes proof of concept in a mouse model and a comparison study of our lead vs. Trofinitide. A follow-on round of ~$5M will support Lead Optimization and a Series A of ~$5M will advance us through IND-enabling studies.

‍MARKET SIZE
350,000 patients worldwide, including major markets of EU (13k), USA(11k), Canada (4k) & Japan (1k). With only one approved drug (Trofinitide)which has a small effect size and tolerability issues, there is an opportunity to capture a significant segment of this market.

‍IP PORTFOLIO
Composition patent applications pending (NCEs).

CURRENT READINESS LEVEL
‍Hit to lead

‍MANAGEMENT TEAM

Vanessa Williamson – Entrepreneur-in-Residence/CEO

Vanessa’s career has focused on helping life sciences companies grow, including leadership roles in industry and innovation intermediary organizations. She began her career as a development scientist with NPS Pharmaceuticals, where she successfully scaled up and transferred clinical and commercial manufacturing processes for small molecule therapeutics. Most recently, she held VP roles with scaling molecular diagnostics companies, responsible for M&A, in-licensing, strategic partnerships and financing.

‍SCIENTIFIC FOUNDER(S)
This new initiative is a collaboration among distinguished researchers at the Krembil Brain  Institute:

- Dr. Mark Reed, expertise in medicinal chemistry, chemical biology & CNS drug discovery, and leads UHN’s Centre for Medicinal Chemistry and Drug Discovery

- Dr. James Eubanks, epigenetic and mitochrondrial diseases expert, and a Rett Syndrome KOL.

DNT Therapeutics offers an allogeneic double negative T cell therapy platform that is a viable ‘off-the-shelf’ T cell based therapeutic.

UNMET NEED
Autologous Cancer Antigen T cell therapy (CAR T) has generated substantial excitement and has been shown to eradicate advanced leukemias and lymphomas. However, autologous use has limited their utility and a substantial fraction of treated patients are unresponsive or relapse or ineligible for treatment. CAR based allogeneic therapeutics would address the limitations of current CAR Ts and impact tumor eradication in patients that are not treatable by  current autologous CAR Ts.

INNOVATION
A novel subset of mature double negative T cells (DNTs) that are CD3+, CD4- and CD8- double negative cells. They have off-the-shelf T cell therapy attributes and are suitable for CAR engineered T cell therapy. DNTs have demonstrated a significant differentiation from competitor allogeneic cell therapy platforms in the areas of safety, suppression of GvHD, persistence and promising efficacy.

APPLICATION/UTILITIES
The therapy targets relapsed/refractory and relapsed allo-transplanted AML patients. Engineered DNTs will be pursued as a platform technology focused on creating a pipeline to address high unmet medical need and provide a competitive advantage in the treatment of various cancers including solid tumors.

INVESTMENT & OBJECTIVES
‍Capital raise of $10-15M will enable completion of an investigator-initiated Phase 1 AML clinical trial at Princess Margaret Cancer Centre and help to build an engineered allogeneic T cell cancer therapy portfolio of two to four assets.

COMPETITIVE ADVANTAGE
Clinically de-risked – demonstrating safety, a defined starting dose and dose frequency. A moderate clinical response in AML was observed. The key competitive differentiation is a true allogeneic T cell platform that has a simplified CMC process and is more efficiently scalable. DNTs also demonstrate superiority to competitor allogeneic platforms (e.g., gamma delta T cells and NK cells) with regards to tumor efficacy, persistence, and safety in preclinical animal models.

‍MARKET SIZE
The global T cell therapy market is expected to grow to over US$25.6 Billion by 2027.

DESCRIPTION OF IP PORTFOLIO
Mature portfolio comprised of two families, covering a breadth of applications and utilities. Second family encompasses 8 patents including engineered DNTs.

CURRENT READINESS LEVEL
The lead un-engineered DNTs are poised to initiate Phase 1 studies in a Health Canada approved Phase 1 clinical trial. Three CAR-DNTs have demonstrated preclinical proof-of-concept and poised to generate a differentiated CAR-DNT pipeline

CURRENT MANAGEMENT TEAM
Kuldeep Neote – CEO
A former senior executive with Eli Lilly and Johnson & Johnson, Dr. Neote began his career as a discovery scientist, initiating the chemokine receptor drug discovery platform that led to the discovery and further development of several clinical candidates at Pfizer Inc. He spent the latter part of his pharma career on external innovation, NewCo value creation and start-ups, JLABS incubator companies and venture initiatives.
‍Jongbok (JB) Lee – Interim CSO

SCIENTIFIC FOUNDER(S)
Li Zhang , Senior Scientist, Toronto General Hospital Research Institute (TGHRI)
‍Jongbok (JB) Lee, Senior Scientific Associate at UHN, Immunologist

Immunotherapies are showing promise for the treatment of cancer, including approaches that target cancer cell antigens. However, despite the presence of these antigens, tumors are not readily recognized and eliminated by the host—resulting in cancer development and progression. Interleukin-12 (IL-12) forms the platform for Vela. IL-12 is a cytokine that has powerful effects on the immune system. Direct injections of IL-12 as a leukemia therapy have illustrated the potential of this approach in clinical trials, although outcomes were modest and toxicity was evident at required levels. Research at UHN has demonstrated that IL-12 delivered via transduced cancer cells has a marked anti-cancer effect while dramatically reducing IL-12 dosage required for therapeutic impact, potentially with reduced toxicology.

UNMET NEED
IL-12 has long been recognized as one of the most potent cytokines in mediating antitumor activity in the immune system.  However, the application of this agent to cancer treatment has met with great difficulty.  Systemic and some targeted delivery of IL-12 failed to show sustained antitumor responses and were associated with significant toxic side effects. 
VELA has developed a lentivirus-based IL-12 cell therapy that minimizes undesirable side effects while providing sustained therapeutic effect to the target. Acute myelogenous leukemia (5 year survival rate of 26%) and ovarian cancer (5 year survival rate of 45%), which have low survival rates, are being targeted by VELA.

INNOVATION
VELA has invented a lentivirus cell therapy that delivers IL-12.  By transforming patient-derived cancer cells with IL-12 and then delivering back to the patient, VELA is able to precisely calibrate the amount of IL-12 to use and train the immune system to provide a sustained treatment effect.

APPLICATION/UTILITIES
IL-12 mediates antitumor response in a variety of cancers. Potential applications include both liquid and solid tumors. Lead applications under development for Autologous Acute Myeloid Leukemia (AML) and ovarian cancer.

INVESTMENT & OBJECTIVES
$20 Million USD to be used for:

·        Completion of Phase I Trial in AML 

·        Conduct Phase I Trial in Ovarian cancer

·        Complete pre-clinical development of dual cytokine therapy

·        Develop off-the-shelf therapeutic product

COMPETITIVE ADVANTAGE
The Vela approach allows the generation of high local concentrations near cancer cells, with very low, non-toxic systemic levels of IL-12.  This method also generates ‘memory’ in the immune system and provides a sustained effect.  In addition to IL-12, other cytokines or biological agents can also be co-administered to complement additional therapeutic modality.

‍MARKET SIZE
·   The Acute Myeloid Leukemia (AML) market is projected to reach US $976M by 2026 with a CAGR of 12.6%.

·   The ovarian cancer market is projected to reach US $3.5 billion by 2025 with a CGAR of 19%.

IP PORTFOLIO
Two patent families including issued patents covering multiple applications of the technology

CURRENT READINESS LEVEL
Clinical stage technology (Phase I trial in AML underway)‍

EIR STATUS
‍Actively recruiting

‍SCIENTIFIC FOUNDER(S)
Dr. Christopher Paige is a Senior Scientist at Princess Margaret Cancer Centre of UHN. Additionally he is a scientific founder and board member of the NASDAQ listed AvroBio Inc. and former Vice President, Research (1997 to 2016)

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