BIOFEST INVEST APPLICANT
Carocell Bio, Inc
Legal Entity Type: C-Corp
Company Type: Biotechnology
Company Stage: Development
No. of Employees: 7
Desired Financial Amount: $3 million over the next 12 months (2023) to gain pre-IND and a pre-clinical scar prevention study; $7 million in year 2 (2024) to do everything else to gain IND approval. $20-30 million over final two years (2025-2026) to gain clinical proof of concept in over 100 patients.
Carocell Bio are developing novel peptides, using nanoparticle delivery, to more safely treat inflammatory diseases. The anti-inflammatory peptides were developed by AstraZenenca and licensed and patented by my previous company, Blueberry Therapeutics. Blueberry changed direction and so I formed Carocell Bio to license and develop these important peptides. Carocell Bio was incorporated in 2017.
Dr Mike Davies MD, FRCPSG, FRCSEd FRCSEngl. is the founder and CEO of Carocell Bio. He graduated from Edinburgh University Medical School in 1985 and has over 20 years of pharma experience in large, medium and small BioPharma in EU and US. Mike worked for 5 years at Pfizer where he led the early clinical development in Tissue Repair and Cardiovascular projects. He then moved to help start-up the biotech Renovo in Manchester Incubator where he led the clinical development in anti-scarring and wound healing compounds. Mike then moved into consultancy and worked for dermatology companies in US and EU and spent 12 months as Medical Director at AstraZeneca. From 2005, Mike worked as Vice President of Global Clinical Development at Shire Pharmaceuticals for 4 years where he led the late phase development and EU registration of Dynepo™, Fosrenol®, and Lialda™/Mezavant® for IBD. Mike was also Vice President of the Global Strategic Drug Development Unit at Quintiles Transnational (now IQVIA). Mike left his position at Quintiles in October 2011 to start Blueberry Therapeutics where he aided investment and took the lead compound (nanoparticle formulation of terbinafine for onychomycosis and tinea pedis) into clinical development. In October 2017 he agreed the exclusive worldwide licences to the peptides and nanoparticle delivery technology and so started Carocell Bio. Graham Coombe, BScBusiness Development Director.BSc (Hons), University College London. 23 years developing marketing and branding strategies for biotech companies. Immersive industry presence matches talent to opportunity. Founder and Chief Connector, BioSell Professor Antony Sedgwick, PhDExperienced biotech executive with over 40 years of experience in the sector. Trusted advisor roles for CEOs and heads of R&D. Chairman positions at several companies including Plastid AS (2008-2011), ThioLogics (2011-2013) and Cotton Mouton Diagnostics (2017-2019). Priya Kalia, BSc, PhD Director of Communications. Molecular Genetics and Molecular Biology, University of Toronto. Regenerative Medicine, UCL. Managing Director at sciTribe. Chair of the London Materials Society
Board of directors
John Nicholson – Chairman – has international experience in pharma and chemical industries from start-ups to £200m businesses. He has run AIM listing of a pharma services company and separately the sale of a chemical business for £50m. John is well networked for raising new monies for pharma business in UK and USA. He has raised new capital for several start-ups and led the management team of a VC backed analytical services business. He sits on the Advisory Board of North West Business Fund (£155m). John was latterly Chairman and CEO of Gentronix Ltd until his retirement in 2019 Dr Mike Davies is the founder and CEO of Carocell Bio. See Management team. Ann Mackey – BA, CPABA, Vanderbilt University. Chief Financial Officer – Debt and capital raised for companies from startup to IPO on NYSE. Adept at corporate structuring and working with private equity. Experience as FD, CFO and CEO since leaving public accounting. All companies grown >25%
Product / Service
disease area / application
The target is upregulated in every inflammatory disease! Our target is to prevent the formation of a scar after cancer resection surgery and atopic dermatitis (eczema)
product / Service
Carocell Bio is revolutionising the treatment of inflammatory disease with its peptide-based, next-generation approach to promoting healthier healing and skin. Its pipeline of products, meant for topical application to the skin, is designed to interrupt the inflammatory cascade – potentially providing safer and novel therapeutic options for patients. This includes preventing traumatic scarring following tumour resection as part of cancer treatment, the treatment of burns, and AD (eczema). Cancer – tumour resection Over half of cancer patients will need surgery as a part of their treatment. Cancer surgery often involves tumour resection, where the tumour and its surrounding tissues are removed from the body to treat the patient. This means that almost all patients who have surgery will have a scar. As surgery involves damaging the skin, the scars from tumour resection can have uncomfortable or even painful side effects. They can also act as constant, unwanted reminders of a patient’s cancer treatment. Significant psychological impact has also been reported for patients with scarring and burns, in addition to the existing physical injury and trauma. Currently, nothing prevents the formation of a scar, and current treatments vary in their effectiveness and can have side effects. Scars don’t only have consequences related to their cosmetic appearance. They can cause pulling and pain and can impact movement or function – for example decreased flexibility around a joint like a knee or elbow. Additional surgery might also be required if they negatively impact a patient’s quality of life. Burns Burns that take over 21 days to heal will result in a scar. The inflammation related to burn wounds contributes to the issue by delaying healing. Unfortunately, burn tissue only has 80% of the (tensile) strength of healthy, normal tissue and has a different visual, structural and physical properties. It is therefore weaker, more inflexible, more vulnerable. Pathological scars might result from constant inflammation, which can be bulky and aesthetically unsightly, causing disfigurement. In joint areas, such scarring can cause mobility issues. A burn is a type of injury to the skin caused by heat, electricity, chemicals, friction, or radiation. The depth of burn is important in determining its management and current treatment depends on the severity of the burn. Burn tissue, when healed, forms a ‘bird’s nest’ of collagen, in contrast to healthy skin which forms sheets of collagen which has mobility and allows for normal function. The disordered collagen found in scars resulting from burns does not have the same function. Current scar prevention therapies use of non-invasive scar management strategies such as silicone-based products, hypoallergenic microporous tapes, pressure garments and manual or mechanical scar massage. Semi-invasive scar management techniques can include microneedling and dermarolling, shockwave therapy, intralesional corticosteroid injections and laser resurfacing. Invasive scar surgery offers operative reconstruction for most severe and restrictive scarring. Eczema (atopic dermatitis) Atopic dermatitis (AD), also known as eczema, is a disease of unknown origin that usually starts in early infancy and can cause itching, lesions, dry skin as well as ‘lichenification’ of the skin, which involves thickening and an increase in skin marking. This can cause psychological trauma to patients, in addition to constant discomfort and pain, especially where AD affects the face. AD is the most common skin disease in children, affecting approximately 15% – 20% of children and 1% – 3% of adults (Nutten S, 2015; Eichenfield LF et al, 2014). The onset of the disease is often by 5 years of age, with the highest incidence occurring between the ages of 3 and 6 months although it can occur at any age (Eichenfield LF et al, 2014, Hanifin JM et al, 2007). Early diagnosis and treatment are essential to avoid complications of AD and improve quality of life (Eichenfield LF et al, 2014). The current treatments for AD carry significant safety risks, which limit their application to mainly moderate-to-severe patients.
technology / ip
Carocell Bio is revolutionising the treatment of inflammatory disease with its peptide-based, next-generation approach to promoting healthier healing and skin. Its pipeline of products, meant for topical application to the skin, is designed to interrupt the inflammatory cascade – potentially providing safer and novel therapeutic options for patients. This includes preventing traumatic scarring following tumour resection as part of cancer treatment, the treatment of burns, and AD (eczema). The five peptides were developed by AstraZeneca but never developed. Initial IP, developed in my previous company, Blueberry Therapeutics, has been licensed by Carocell Bio. This IP has been granted in US, EU and Japan. Carocell Bio has also submitted its own IP and is currently writing new IP to build upon the granted IP.
Carocell Bio are a biotechnology company. We plan to develop the lead compound to clinical proof of concept over the next 4 years and then sell/license the lead to large phrma who will take it through Phase 3 and onto the market. Of course, other deals may become appropriate as we develop. Any potential deal may be taken after discussion with our investors.
Many treatments aim to soften and reduce existing scars, a current market of $37-billion. However, at present, no treatment prevents the formation of scars; there is a need for innovation. This market is large, surgical scar prevention currently represents an untapped opportunity. More broadly, the total worldwide inflammation market is expected to reach $119-billion by 2027. At this time, surgical scar prevention is the sole focus of Carocell Bio’s research and development activities. However, there are other potential applications for its patented peptides including atopic dermatitis ($19-billion market) and other conditions triggered by inflammation. Atopic drmatitis is a chronic, relapsing skin disease affecting between 15 and 20% of infants and young children, 1-3% of adults and with a lifetime prevalence of 7%. The global atopic dermatitis market is poised for significant growth of approximately 24.1% CAGR during the projection period (2020-2027), (Globe Newswire, April 06, 2020). Millions of people continue to be affected by debilitating skin ailments which in turn escalates the development of new pharmaceutical drugs. The current lead treatment for AD are emollients. More serious disease is addressed using corticosteroids and calcineurin inhibitors but these are toxic and treatments have to be stopped after 30 days. There is a clear gap in the market for a new, safe and effective treatment for mild to moderate AD to replace topical emollients, topical steroids and topical calcineurin inhibitors, which all have medical limitations. The atopic dermatitis market is large and is expected to exceed US$19 billion by 2027 end. We also see a potential market for JEL0305 or a modified form of it within the cosmetic market with senescence/ageing of the skin. An inflammatory response is one of the hallmarks of cellular senescence (ageing). Inflammation serves to propagate the senescence/ageing process and the senescence–inflammatory response may in extremis support tumour proliferation and invasion. Blocking the response is potentially therapeutic in cancer and ageing-related diseases. Continued treatment with JEL0305 (allowed because of its safety profile) could lead, with time, to a slowing in the ageing process of the skin where it is applied. The global longevity and anti-senescence therapy market is predicted to grow from US$329.8 million in 2018 to US$644.4 million by 2023 with a compound annual growth rate (CAGR) of 14.3% during 2018-2023 (PR Newswire, June 5th, 2019).
Nothing is currently available that prevents the formation of a scar. Products are in development that are antibodies and small molecules that target the collagen. These will have cost issues (antibodies), systemic side effects (small molecules) and it has been shown before that collagen targets have not worked. Atopic dermatitis (AD, eczema) is a competitive field: we have identified over 40 clinical and preclinical R&D programs in large, medium and small sized pharmaceutical companies. These companies are all developing novel or reformulated small molecule approaches which, whether applied topically or delivered systemically, will result in systemic exposure and very likely cause side effects. Our benefits include that we peptides, and will be safe; our data shows that we not only switch off inflammation we also prevent the activation of inflammation and so can be used long term to treat the flare, prevent the recurrance and, long term, delay the aging of the skin.
Desired financial amount
$3 million over the next 12 months (2023) to gain pre-IND and a pre-clinical scar prevention study; $7 million in year 2 (2024) to do everything else to gain IND approval. $20-30 million over final two years (2025-2026) to gain clinical proof of concept in over 100 patients.
Friends and family started Carcoell Bio. I have personally invested over £500,000 ($600,500). In 2020-21 we gained two Innovate UK grants totalling £393,000 ($470,000) to look into burns In 2021-22 we recieved £650,284 ($781,000) Seed investment from Deepbridge Capital
Currently we have a burn rate of $20,000 per month. We have enough in the bank to keep us going for 6 months. We have support from Deepbridge Capital who will support us until the next raise.
$3 million overthe first 12 months (2023) will enable formulation development, a pre-clinical efficacy study and a pre-IND meeting. $7 million over 2024 will complete everything else we need for full IND approval 4Q24. Including toxicology, GMP manufacturing and regulatory approval. $20-30 million over 2025-6 will enable clincal proof of concept in about 100 patients.
Carocell Bio does not have revenue at the moment, we are purley an R&D company.
End 2024 – regulatory approval for clincal trials, could be our first exit point End 2026 – clinical proof of concept will be our prefered and largest exit.