Stem Cell Clinic

FINNCAP’S LIFE SCIENCES REPORT INDICATES CELL AND GENE THERAPY SECTOR IS DRIVING THE NEXT WAVE OF INNOVATION IN PHARMA – PharmiWeb.com

Breakthrough in delivery for cell and gene therapy products has led to a wave of M&A activity as big pharma aims not to miss out on the future of medicine

AIM healthcare index at the centre of innovation, has risen 6% YTD compared with the AIM all share, which has declined 7%

finnLife 50 index has also risen 6% in 2020 led by gains in Synairgen (+2,930%), Avacta (+654%), Omega Diagnostics (+322%) and Tiziana Life Sciences (+283%)

London 25 August 2020 Healthcare companies employing and developing cell and gene therapy (C>) are driving the next wave of innovation in the pharmaceutical industry, leading to increased M&A activity as big pharma aims not to miss out on the future of medicine. The AIM healthcare index has been at the centre of this innovation, rising 6% YTD compared with the AIM all share, which has declined 7%.

These are the findings of finnCaps new quarterly Life Sciences sector report, Rude Health.

Rather than just treating a disease and its symptoms, C> can target the underlying cause of a disease, with long-term benefits and curative potential. C> is now being realised on an applicable level, with many products already approved and the FDA expects to approve 10-20 products a year by 2025.

The financials of the sector are reflective of this rapid progress. In 2018, the market value of C> was $536 million - $1.07 billion; but by 2026 it is set to have a valuation of up to$35.4 billion. Given the high proportion of start-ups in the sector, M&A activity is on the rise, as evidenced by the $3 billion Astellas spent in January 2020 to acquire Audentes Therapeutics, specialists in genetics medicines.

In 2014/2015, M&A activity in the sector was $5 billion; by 2018/2019 it had surged 880% to $49 billion. Much of this is driven by big pharma firms not wanting to fall behind their smaller, more versatile competition, as they did with monoclonal antibody technology. Consequently, they have engaged with M&A to speed up and enhance their own R&D efforts.

The report notes that innovators in C> will be well placed to take part in the land grab that will follow as a result of continued advancements in the sector, and highlights now as a good time for investors and pharmaceutical companies to become involved as the sector is rapidly maturing past its high potential research and development stage with an established pipeline of therapies already being developed.

Some of the key reasons why the report considers the C> sector to be an attractive one for investment are:

Pharmas next wave of innovation. C>s can be potentially curative treatment options as they usually target the underlying cause of disease. In the long term, these therapies could become the backbone of treatment regimens, and solutions to various unmet needs.

Deals. Big Pharma had to play catch-up with monoclonal antibody technology and seems determined not to make the same mistake with C>, as reflected in the high deal activity and high deal values seen within this space.

Sector maturation. Advances in the sector mean that the C> sector is beginning to mature beyond the R&D stage and into commercialisation, with some products already approved, and with a very large future pipeline of therapies.

Revenue.Therapies in this space can command high prices, allowing for high revenue generation, even from rare diseases and limited patient populations.

Despite its vital role in the future of medicine, C> also comes with challenges. The report highlights that the manufacture of C>s is difficult given they are, by definition, personalised for the patient. This means they cannot be batch produced for distribution to multiple patients as more traditional medicines can. For example, Zolgensma, which treats those with motor neurone disease, is priced at $2.1 (1.6) million per therapy, making it the most expensive drug treatment ever.

The report also notes how the payment process for C> requires a reworking of reimbursement systems not used to outlaying so much money up front for a treatment with long-term benefits/curative potential versus continuous, and lower payments for ongoing medicine treatment.

The technologies the report shines a spotlight include CAR-T therapy, stem cell therapy, CRISPR, RNA therapies, among various others.

Arshad Ahad, Research Analyst, Life Sciences, at finnCap, commented:Few technologies in the life sciences sector hold as much promise as Cell and Gene Therapy, with its ability to provide long-term benefits and curative potential. These technologies have been seen as the future of medicine for many years, and now we are closer than ever to that future becoming a reality. If Cell and Gene therapy does become the backbone of treatment regimes in the future, similar to the rise of monoclonal antibodies, then the companies involved are developing expertise in a critical part of the life sciences industry, which should confer a significant competitive advantage as the sector matures further. Now is therefore a good time to invest in the future.

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FINNCAP'S LIFE SCIENCES REPORT INDICATES CELL AND GENE THERAPY SECTOR IS DRIVING THE NEXT WAVE OF INNOVATION IN PHARMA - PharmiWeb.com

Regulating advanced therapies: Q&A with patent lawyer David Silverstein – Pharmaceutical Technology

Axinn partner and patent attorney David Silverstein. Credit: Axinn. What challenges do cell and gene therapies pose to regulators? Credit: Shutterstock.

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Innovation is a key focus of the pharma industry. This has led to dramatic improvements in the treatment options available to at-need patients. Due to technological innovation and the development of cell and gene therapies, it is now possible to use CAR-T treatments to cure certain types of cancers and particular patient populations. in

Although these innovations drive medicine forward, they pose a significant challenge to regulators. These bodies need to stay abreast of the many new, emerging trends in the industry and figure out how best to assess these novel products for safety, efficacy and value.

Axinn partner and patent attorney with more than 15 years of experience looking at regulatory matters related to the pharma market David Silverstein discusses why cell and gene therapies are such an important development for the industry. However, he also notes how advanced therapies have challenged regulators, particularly linked to the rise in unlicensed clinics administering unapproved regenerative therapies.

Allie Nawrat: What makes cell and gene therapies such an exciting and important development for the pharma industry?

David Silverstein: If you had to analogise it as martial arts, there are traditional ways of treating diseases with small molecules, for example, and that is more like karate it is force against force, forcing the body to do something.

Whereas cell and gene therapies are more like judo, where you use the opponents momentum to your advantage.

To me, these therapies use the strength of the body; evolution has given us the fantastic cellular mechanisms, and cell and gene therapies tap into them.

Its just a much more targeted and efficient way to bring about the result youre after, rather than forcing some foreign small molecule into the cell, and triggering effect.

We are better off for small molecules, but the next step in the evolution of medicine is selling gene therapy.

AN: What challenges have cell and gene therapies created for regulators?

DS: It is a paradigm shift for regulators. Originally, regulators emerged out of the need to ensure that tonics being sold on roadside stands were safe and actually effective, so they are accustomed to dealing with that type of industry. Those products are much easier to describe, characterise and make, than these large, more complicated biological products.

The obvious challenges are around how do you categorise them? You cant just put them all in the same bucket; stem cells are different than gene therapy delivered by a virus. So [there are issues] with the agency just getting its head around that. What are the critical differences that need to be established so that we can evaluate these appropriately? So were not just painting with a broad brush and treating them all the same.

The other challenges [relate to] all the unapproved regenerative therapies. It is a significant [problem]. Studies have shown that [unqualified] people have been discovered administering unlicensed stem cell therapies. [This situation has arisen from] patients who either have exhausted traditional therapies and theyre just desperate to try anything to patients who dont trust what the government and regulators are telling them.

The FDA is struggling with enforcement actions against them; the lack of oversight and regulation on these can lead to fatal results.

AN: How have regulators, and particularly the FDA, responded to the emergence of cell and gene therapies?

DS: In the past several years, the FDA has gotten very motivated. In 2016 and 2017, key FDA guidances came out about the regulation of these products. The FDA had designated 2020 as the year of increased enforcement activity to get under control these unapproved labs that are administering unapproved and potentially dangerous preventative therapies but, unfortunately, Covid-19 has thrown a wrench in their gears.

Well see how priorities shift after this year currently Covid-19 is rightfully in the centre but I dont know if the FDA is going to lose interest or shift its priorities away from regulating these products and engaging in enforcement.

AN: What are the special intellectual property considerations around these advanced therapies?

DS: The challenges are that as these are products of nature you have to be careful and make sure the products different enough so you dont fall afoul of the Supreme Courts case law on patentable subject matter.

Another challenge is the importance of trade secrets. A lot of people when they think about how do you protect these products and manufacture these products, they jump right to patents. But with these kind of products, its important for a stakeholder to take into account trade secret protection. It is an alternative to patent protection. It, of course, complements patent portfolio; but you can protect things with trade secrets that you couldnt protect with patents.

Often I advise clients to segment their manufacturing workflow, so that there isnt one single group or individual who knows every step of the manufacturing process. This is a highly competitive industry and theres a lot of mobility with people changing jobs. Even without getting to malfeasance of people trying to steal trade secrets, you need to think about what knowledge is in peoples heads. You can control it by breaking up your work group so that theyre collaborating together, but no one group knows every step of the process.

AN: What impact has the regulators reactions had on advancing cell and gene therapy innovation?

DS: In the last 10 years, [there has been] an uptick in industry emphasis on them and innovation. This is in part because the regulatory landscape is becoming clearer. If companies know what rules they need to play by, then they can properly assess the risks and rewards of investing in research projects.

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Regulating advanced therapies: Q&A with patent lawyer David Silverstein - Pharmaceutical Technology

The Road To Scale: Challenges Facing the Implementation of Animal-Free Recombinant Proteins Into Stem Cell Supply Chains – Technology Networks

Protein engineering techniques can be used to produce more potent animal-free growth factors as highlighted by the higher level of Nanog expression in iPSCs cultured with an optimized form of the key growth factor TGF-1 (RHS), when compared with cells cultured with the mammalian-cell expressed protein (LHS). Credit: Stemnovate

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Most industries today are under pressure to switch to more ethical and sustainable animal-free alternatives, and now the trend is coming to stem cell labs. As stem cell applications accelerate towards the clinic, novel drug discovery platforms are rapidly scaled, and new transformative stem cell-based technologies such as cultured meat arise, there is a drive to switch to animal-free cell culture media. This move is essential to facilitate future regulatory approval for advanced therapies, and enable pharma and biotech companies to ethically, reproducibly and cost-effectively scale stem cell-based innovations. Most stem cell scientists today use recombinant growth factor and cytokine proteins in their chemically-defined media to supply their cultures with the necessary biological signals required for maintenance of pluripotency, cell proliferation and differentiation into specific cell lineages. However, the fundamental biochemistry and manufacturing processes of these protein messengers can often be overlooked. But as scientists are trying to establish new animal-free systems to support the scale-up of their stem cell applications, the properties and challenges inherent in these proteins are becoming more prominent and frankly a headache for many.

Highlighted here are three key challenges facing pharma and biotech companies as they embark on the path to implementing animal-free systems, from the perspective of two protein scientists. 1.Why batch consistency is kingAs stem cell therapies gear up to make the leap from bench to clinic and the promise of stem cell biology in drug discovery and other industrial applications is realized, more subtle and still largely inexplicable challenges in optimizing growth factor and cytokine supply chains for defined media are being identified why when you change from one supplier or even batch of a recombinant protein do stem cells need weaning onto that protein, or dont tolerate the change? Is this a fundamental lack of batch consistency across the supply chain or is there an underlying biological basis?

At the minute, there is simply not enough data to answer this definitively. While we are starting to tease apart these questions, it highlights the need for greater innovation within the recombinant protein supply chain to bring best practice and innovation from other areas to improve the robustness of the global supply chain and encourage great openness and scrutiny of fundamental biochemical quality early in process development.

Questions we should ask include: are we seeing heterogeneity in post-translational modifications, which is well documented in monoclonal antibody manufacturing? Can synthetic biology or protein engineering be used to optimize proteins and engineer out features contributing to this variation?

For now, and until we have answers, its a good idea to source proteins from reputable suppliers that have rigorous standards for batch quality testing and meticulously scrutinize all biochemical and bioactivity data provided. 2.Cost of goods as a barrier to scaleTo bring innovative stem cell applications to market, pharma and biotech companies need to be able to seamlessly scale their cultures, meet regulatory requirements and achieve a sensible and sustainable process cost. Where recombinant proteins are needed in cell culture media, they are usually the greatest contributor to cost of goods.

Well-defined industry challenges catalyze change and the stem cell field is seeing renewed focus on much needed innovation in complex bioactive protein production to meet the needs for animal-free, highly reproducible proteins. Protein engineering technology, enhanced cell-based and cell-free expression systems, such as bacteria, yeast and even plants, coupled with improvements to downstream processing systems are just some of the latest innovations in this space. Previously, there have been concerns over the ability of simpler systems to form correctly folded and bioactive recombinant proteins. However, it is clear that many of these barriers can be overcome to produce highly pure growth factors and cytokines at scale. Others are striping back chemically-defined media protocols to determine the essential growth factors and cytokines needed for their cell type. For example, homebrews of key growth factors to reduce costs - Paul Burridge and his team at Northwestern University Feinberg School of Medicine have pioneered a cost-effective B8 chemically-defined media for weekend-free hiPSC culture at just 3% of the price of commercially available media. Now the challenge is to take the learnings from academic studies such as these and translate them into industrial processes. Meating the price of lab-grown steaksYou cannot discuss the cost of growth factors without mentioning the daunting step-change and barrier facing the fast-evolving cultured meat market. Here, highly optimized animal-free growth factor production systems will be required to provide the economies of scale needed to deliver kilogram-ton quantities at a fraction of the price in order to bring these lab-grown meat alternatives to consumers. After all, it just isnt viable for companies to be spending hundreds of dollars on each liter of culture media - instead, this needs to be reduced to ~$1/liter. 3.Animal-free or ADCF? Now that is the questionDespite animal-free/animal-derived component free (ADCF) growth factors and cytokines becoming increasing important, there are no standard definitions for these terms across the industry, with many protein manufacturers supporting the sector by defining their own internal standards. For the clinical space, the United States Pharmacopeia and International Organization for Standardization have published a framework for classifying raw materials used in cell therapy manufactureinto four different tiers based on their risk. Under this classification, ancillary materials used in the manufacture of cell-based therapies and tissue-engineered products, such as recombinant growth factors and cytokines, are considered low risk so fall into tiers 1 and 2 with an ADCF level of manufacturing defined as all components, sub-components and consumables do not contain materials derived from animals. To support the wider sector, not just those at the transition to the clinic, clarity over definitions and transparency from manufacturers will help to define and overcome the challenges faced and allow the promise of stem-cell derived innovations to be delivered.

Article Authors:

Beata Blaszczyk, Senior Scientist, Qkine

Dr Catherine Elton, CEO and Founder, Qkine

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The Road To Scale: Challenges Facing the Implementation of Animal-Free Recombinant Proteins Into Stem Cell Supply Chains - Technology Networks

3D Cell Culture Systems in Cancer Organoids Reveal Drug Efficacy that is Undetectable in Traditional 2D Monolayer Systems – b3c newswire

Wednesday, 26 August 2020 09:00 Hits: 523

CARDIFF, UK, August 26, 2020 / B3C newswire / -- A new paper exploring the application of patient-derived organoids (PDOs) in the study of novel inhibitors of stem cell activity has recently been published in the journal PLOS ONE (Badder et al., 2020).

The study utilised 3D image-based morphometric analysis to quantify over 600 different features from individual organoids following treatment with inhibitors of the tankyrase protein (TNKSi). While the morphometric analysis approach mirrored the trend seen in traditional biochemical assays, importantly this more sophisticated method was able to detect subtle alterations in growth and morphology in response to TNKSi with much greater accuracy. This leads to the conclusion that whilst traditional biochemical assays still have value in detecting compounds that merit further investigation in early stage drug discovery, combining these with 3D morphological analysis could be the key to unlocking the full potential of organoids in predictive drug testing at a much larger scale.

The study was led by Cellesce founding director Professor Trevor Dales Cardiff University-based academic research group working together with Cellesce and other partners. It describes the derivation of a novel set of colorectal cancer PDOs. The PDO models are then used as a platform to test the response of colorectal cancer to Wnt pathway modulation using small molecule TNKSi. The work utilises a range of analysis techniques and highlights 3D quantitative image analysis in particular as having the potential to greatly enhance the high throughput prediction of compound efficacy in pre-clinical testing.

In recent years, there has been a shift within the drug discovery industry to focus on the development of compounds targeting cancer stem cell populations within tumours. Historically, conventional chemotherapeutics have aimed to target the tumour bulk, to kill as many tumour cells as possible; the effects of which are usually to drive tumour regression in the short-term, albeit with greater side-effects - and a high chance of patient relapse. It is now widely understood that, in order to permanently prevent tumour growth, the initiating cancer stem cell population must be removed or inhibited. In the patient, this might have a relatively small impact initially on overall tumour size, but a longer term more effective treatment caused not by killing the cells, but by a more subtle change in the behaviour of the cells within the tumour.

The study of such targeted compounds has led to demand for better predictive model systems. While historical drug discovery has relied heavily on the predictive power of 2D cancer cell lines, their lack of cellular heterogeneity and relevant phenotypic behaviour leaves them largely unsuited for the study of cancer stem cell inhibitors, and far from ideally placed for anti-cancer drug development in general.

PDOs which retain intra-tumoral complexity and, crucially, stem cell function - are now gaining increasing momentum as predictive in vitro models in the drug discovery field, with the potential to reduce compound attrition rates and development costs, ultimately increasing the number of successful compounds available for use in the clinic. A more complex model, the study argues, demands a more comprehensive method of analysis that is capable of capturing the complete range of changes that may occur in response to treatment.

The paper can be accessed here: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0235319

Notes to editors

The organoid lines generated for this study are licensed for sale by Cellesce in large scale validated batches produced using Cellesces patented bioprocess. Cellesce PDOs:

About Cellesce Cellesce is a biotechnology company that has developed a patented bioprocessing technology for the propagation of organoids in culture. Cellesce is focused on the supply of standardised and well-characterised cancer organoids for large-scale applications such as compound screening, where significant quantities of reproducible batches are required.

PDOs are three-dimensional (3D) cell cultures that can self-organise intoex vivo'mini-organs. They facilitate the study of tumour pathology to enable cancer drug discovery. Organoids more faithfully replicate in vivo tumours compared to conventional 2D cell line cultures and can provide more relevant pharmacological responses to therapeutic agents. By using organoids in drug discovery screening assays, scientists can identify active compounds for further progression earlier in the drug discovery process and weed out less attractive compounds before incurring higher downstream costs.

The Cellesce team is based in state-of-the-art laboratory space in the Cardiff Medicentre. Cellesce operates according to the highest ethical standards to ensure appropriate confidentiality and regulatory requirements.

Twitter: @Cellesce

Contacts

Cellesce Paul Jenkins, Chief Executive This email address is being protected from spambots. You need JavaScript enabled to view it. or Victoria Marsh Durban, Lead Scientist This email address is being protected from spambots. You need JavaScript enabled to view it.or William Allbrook,Marketing Director This email address is being protected from spambots. You need JavaScript enabled to view it.

Keywords: Drug Discovery; Tankyrases; Wnt Signaling Pathway; Organoids; Antineoplastic Agents; Neoplastic Stem Cells; Colorectal Neoplasms; Cell Line; Cancer Stem Cells Inhibitors;

Published by B3C newswire

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3D Cell Culture Systems in Cancer Organoids Reveal Drug Efficacy that is Undetectable in Traditional 2D Monolayer Systems - b3c newswire

Demand for Myelofibrosis Treatment Market to Witness Rapid Surge During the Period 2016 2022 – Scientect

Myelofibrosis or osteomyelofibrosis is a myeloproliferative disorder which is characterized by proliferation of abnormal clone of hematopoietic stem cells. Myelofibrosis is a rare type of chronic leukemia which affects the blood forming function of the bone marrow tissue. National Institute of Health (NIH) has listed it as a rare disease as the prevalence of myelofibrosis in UK is as low as 0.5 cases per 100,000 population. The cause of myelofibrosis is the genetic mutation in bone marrow stem cells. The disorder is found to occur mainly in the people of age 50 or more and shows no symptoms at an early stage. The common symptoms associated with myelofibrosis include weakness, fatigue, anemia, splenomegaly (spleen enlargement) and gout. However, the disease progresses very slowly and 10% of the patients eventually develop acute myeloid leukemia. Treatment options for myelofibrosis are mainly to prevent the complications associated with low blood count and splenomegaly.

The global market for myelofibrosis treatment is expected to grow moderately due to low incidence of a disease. However, increasing incidence of genetic disorders, lifestyle up-gradation and rise in smoking population are the factors which can boost the growth of global myelofibrosis treatment market. The high cost of therapy will the growth of global myelofibrosis treatment market.

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The global market for myelofibrosis treatment is segmented on basis of treatment type, end user and geography:

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As myelofibrosis is considered as non-curable disease treatment options mainly depend on visible symptoms of a disease. Primary stages of the myelofibrosis are treated with supportive therapies such as chemotherapy and radiation therapy. However, there are serious unmet needs in myelofibrosis treatment market due to lack of disease modifying agents. Approval of JAK1/JAK2 inhibitor Ruxolitinib in 2011 is considered as a breakthrough in myelofibrosis treatment. Stem cell transplantation for the treatment of myelofibrosis also holds tremendous potential for market growth but high cost of therapy is foreseen to limits the growth of the segment.

On the basis of treatment type, the global myelofibrosis treatment market has been segmented into blood transfusion, chemotherapy, androgen therapy and stem cell or bone marrow transplantation. Chemotherapy segment is expected to contribute major share due to easy availability of chemotherapeutic agents. Ruxolitinib is the only chemotherapeutic agent approved by the USFDA specifically for the treatment of myelofibrosis, which will drive the global myelofibrosis treatment market over the forecast period.

Geographically, global myelofibrosis treatment market is segmented into five regions viz. North America, Latin America, Europe, Asia Pacific and Middle East & Africa. Northe America is anticipated to lead the global myelofibrosis treatment market due to comparatively high prevalence of the disease in the region.

Some of the key market players in the global myelofibrosis treatment market are Incyte Corporation, Novartis AG, Celgene Corporation, Mylan Pharmaceuticals Ulc., Bristol-Myers Squibb Company, Eli Lilly and Company, Taro Pharmaceuticals Inc., AllCells LLC, Lonza Group Ltd., ATCC Inc. and others.

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Demand for Myelofibrosis Treatment Market to Witness Rapid Surge During the Period 2016 2022 - Scientect

Autologous Cell Therapy Market Along With Covid-19 Impact Analysis and Business Opportunities Outlook 2027 – Scientect

Transparency Market Research (TMR)has published a new report titled, Autologous cell therapy Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027. According to the report, the globalautologous cell therapy marketwas valued atUS$ 7.5 Bnin2018and is projected to expand at a CAGR of18.1%from2019to2027.

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Overview

Rise in Prevalence of Neurological Disorders & Cancer and Others to Drive Market

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Bone Marrow Segment to Dominate Market

Neurology Segment to be Highly Lucrative Segment

Hospitals Segment to be Highly Lucrative Segment

North America to Dominate Global Market

Competitive Landscape

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The global autologous cell therapy market has been segmented as follows:

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Autologous Cell Therapy Market Along With Covid-19 Impact Analysis and Business Opportunities Outlook 2027 - Scientect