Feb. 3, 2020 08:48 UTC

CAMBRIDGE & WETHERBY, United Kingdom--(BUSINESS WIRE)-- Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is pleased to announce that it has signed a collaboration and license agreement with AffyXell Therapeutics (AffyXell), the recently established joint venture with Daewoong Pharmaceutical (Daewoong), to develop Affimer proteins to be used by AffyXell for the generation of new cell and gene therapies.

Avacta and AffyXell will now work together to develop Affimer proteins against a range of targets which, when produced by mesenchymal stem cells (MSCs), are intended to inhibit inflammatory and autoimmune pathways and improve the overall efficacy of MSCs, creating a next generation of stem cell therapies.

The initial focus for AffyXell will be on inflammatory and autoimmune diseases. In the longer term, there is potential for AffyXell to address oncology uses for these Affimer-enabled cell and gene therapies.

Under the terms of the collaboration and license agreement, Avactas research and development costs associated with generation of the Affimer proteins will be funded by AffyXell. In addition, Avacta will retain the rights to commercialise the Affimer proteins outside of the field of cell therapies.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: The potential for AffyXells new class of cell therapies, which can be applied to a wide range of inflammatory and autoimmune diseases, is enormous. We are therefore very excited by the opportunity to be part of this new venture and to demonstrate the power of Affimer proteins in the field of engineered cell therapies.

Our objective is for these cell therapies to finally fully address diseases, such as inflammatory bowel diseases and multiple sclerosis, as well as other autoimmune diseases, such as chronic obstructive pulmonary disease. The potential to make a difference in the quality of life for millions of patients continues to inspires us, as we know it does our colleagues at Daewoong as well.

From a commercial perspective, the global stem cell market is expected to be worth USD16bn [1] by 2025. AffyXell has a unique opportunity to combine two world-class technologies, Avactas Affimer antibody mimetic platform and Daewoongs proprietary technology for generating off-the-shelf allogeneic MSC therapies to create the next generation of stem cell therapies. We believe that this has the potential to create substantial value for stakeholders in the near future.

Seng-ho Jeon, CEO of Daewoong Pharmaceutical, commented: We are very excited to contract this Collaboration and License Agreement followed by the successful establishment of an innovative joint venture, AffyXell. Daewoong and Avacta will make every effort to AffyXells growth and its development of distinguished and innovative cell and gene therapy treatment.

As announced at the J.P. Morgan Healthcare Conference this January, Daewoong has been inspired to partner global biotechnology companies like Avacta to create the best and the most comprehensive technology in new drug development field. Starting from our very first cell and gene therapy specialised joint company, we reaffirm our belief that our contract can not only further establish AffyXell to thrive as an leader of cell and gene therapy, but also, allow us to enhance quality of lives to those who suffer from rare and intractable conditions.

[1] https://www.grandviewresearch.com/press-release/global-stem-cells-market

View source version on businesswire.com: https://www.businesswire.com/news/home/20200203005280/en/

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Avacta and Daewoong Agree Collaboration and License Agreement with AffyXell Therapeutics - BioSpace

When Bellicum Pharmaceuticals built the cell therapy plant in Houston, Texas, it planned to use the US site to support its early-phase chimeric antigen receptor (CAR)-T trials and late-phase development and commercialization of Rivo-cel (rivogenlecleucel), a drug designed to improve hematopoietic stem cell transplantation outcomes.

A registrational trial of Rivo-cel met its primary endpoint in July 2019, leading Bellicum to start looking for a partner for the asset. However, the search for a partner did not go as well as Bellicum hoped.

By November, Bellicum CEO Rick Fair was warning investors that it's unclear if an agreement [for Rivo-cel] will be reached. Bellicum responded to the uncertainty by pausing work in the area.

That decision about Rivo-cel had a knock-on effect on the viability of Bellicums manufacturing facility.

Fair said, Given our decisions on Rivo-cel, our facility is substantially underutilized with a significant fixed cost base. We are actively pursuing a partner for the facility with the goals of reducing operating costs while maintaining critical viral vector and cell therapy development capabilities and dedicated manufacturing capacity.

Bellicums pursuit of a partner led it to The University of Texas MD Anderson Cancer Center. In return for $15m (13.5m), MD Anderson is set to buy the 60,000-square-foot facility, giving it production capacity to support its own cell therapies and those of its strategic partners.

The deal features a master services agreement intended to ensure Bellicum can access cell therapy manufacturing capacity despite no longer having an in-house facility. MD Anderson will make CAR-Ts and other cell therapies for use in Bellicums clinical trials, plus potentially early commercial supply, from the Houston facility on a service basis.

To smooth the transition, around 35 Bellicum employees based at the facility are set to start working for MD Anderson once the deal goes through. Bellicum expects to close the deal in the first quarter.

MD Anderson will use the capacity not taken up by Bellicums assets to support its own programs and those of its partners. The US cancer center has been at the forefront of efforts to develop and deploy cell therapies, creating a need for manufacturing capacity to support the work of its discovery division.

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Bellicum offloads cell therapy plant in switch to outsourced production - OutSourcing-Pharma.com

Hyperbaric oxygen therapy can improve heart functionality in healthy aging humans.This, according to a new study by the Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center in Beer Yaakov.In this new study, director of the Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Professor Shai Efrati and Dr. Marina Leitman, head of the Echocardiography Unit and Non-invasive Cardiology Service at Shamir Medical Center turned their attention to HBOTs impact on cardiac function.According to the center, the study of HBOT for cardiac function has been limited, mostly evaluating patients during and after short-term exposures. However, for the first time, the study was conducted in humans and it demonstrated that repetitive HBOT protocols have a sustained effect on heart function.Healthy patients receiving HBOT to improve cognitive function underwent a 60-session treatment course using the Sagol Centers regenerative HBOT protocols. Using a high-resolution echocardiography, patients were evaluated before HBOT was administered and three weeks after treatment concluded, to identify the sustained effect of the treatment. The study was conducted on 31 patients.Speaking to The Jerusalem Post, Efrati explained that hyperbaric oxygen therapy (HBOT) includes the inhalation of 100% oxygen at pressures exceeding one atmosphere absolute (ATA), which is the average atmospheric pressure exerted at sea level, in order to increase the amount of oxygen dissolved in the body tissues.Efrati, who has been pioneering new approaches for the application of HBOT treatments that specifically focus on HBOTs ability to trigger regeneration in the body, said that in the past HBOT has been applied worldwide mostly for chronic non-healing wounds. In recent years, there is growing evidence on the regenerative effects of HBOT, he said. We have now realized that the combined action of both hyperoxia (an excess of oxygen in the body) and hyperbaric pressure, leads to significant improvement in tissue oxygenation while targeting both oxygen and pressure sensitive genes, resulting in improved mitochondrial metabolism with anti-apoptotic (anti-cell death) and anti-inflammatory effects.According to Efrati, the newly developed protocols used in this study, which includes the intermittent increasing and decreasing of oxygen concentration, induces what is known as the Hyperoxic Hypoxic Paradox. This, he said induces stem cells proliferation and mobilization, leading to the generation of new blood vessels (angiogenesis) and tissue regeneration.Efrati said that during the first studies they conducted at the Sagol Center, they evaluated the beneficial effects of HBOT on brain injuries due to traumatic brain injury and stroke. However, in this study we evaluated for the first time the effect of these new regenerative HBOT protocols on the normal aging heart. For the first time in humans we have demonstrated that HBOT can improve cardiac function.Asked about what inspired the research, Efrati said that for over the last 12 years the team has developed an ongoing research program that investigates the regenerative effects of HBOT on different issues and degrees of damage. At the beginning we were focused on non-healing peripheral wounds, he said. Then, we turned our focus to certain types of brain injuries. However, once the researchers found that HBOT induced many of the essential elements crucial to repairing almost any mechanism, we initiated a complementary research program that targets other organs such as the heart and other elements related to expected age-related functional decline.Addressing the significance of this research, Efrati said that along with normal aging, there is typically a decrease in cardiac function particularly in the mitochondrial cells of the heart. The mitochondria are the powerhouse of the cell [and] this is where we create energy, he pointed out. HBOTs ability to improve mitochondrial function may explain the beneficial effects that we saw in the cardiac function of this normal aging population. By exposing the mitochondria to the fluctuations in oxygen by the use of HBOT, the team observed an improvement in contractility function of the heart meaning, the heart muscle contracted more efficiency over the course of the 60-session protocol. Efrati highlighted that the effect was particularly evident in the left ventricle, which is the chamber responsible for pumping oxygenated blood to the rest of the body. This is only the beginning of our understanding of the impact of HBOT on cardiac function in a normally aging population, and a larger and more diverse cohort will be required to further evaluate our initial findings, he said.Asked whether this treatment could also be used on people who are predisposed to heart conditions, Efrati said that the short answer is yes, but stressed that more research is needed.As far as we know, we are the first to identify HBOTs ability to improve cardiac function, he told the Post. Our study was on a group of 31 asymptomatic normal aging heart patients. We believe it is important to expand the scope of this study to a larger group, with both symptomatic and asymptomatic patients to understand the possibilities for HBOT as a treatment for patients with heart-related diseases, he emphasized.The Sagol Center has also been studying the impact of HBOT on a variety of cognitive conditions. We have also conducted studies which showed positive results for the treatment of post-concussion syndrome as a result of traumatic brain injury, post-stroke recovery, fibromyalgia, adding that today, medical professionals understand that fibromyalgia is linked to issues in the brain center responsible for pain interpretation. He made it clear that not every patient will benefit from HBOT, which is why patient selection should be done very carefully based on the damage seen in brain imaging assessments.For example, if someone has a stroke, some of the tissue at the core of the stroke will die we will not be able to recover this tissue, Efrati continued. But, other tissue that is damaged but not fully dead... is where HBOT can help. This damaged tissue, known as the metabolic dysfunction tissue (penumbra), is where we can have an impact and help recover lost function, he added.On the timeline as to when using HBOT protocols may be put into effect on healthy aging patients in Israel, Efrati said that these studies are already ongoing. I cant speak too much about this, as we are in the process of developing the results of the first study for publication, he said. However, we believe HBOT can positively impact both cognitive and physical performance in aging adults based on what we have seen at this point.Efrati said that they will continue pursuing this line of research as it has the ability to transform how we look at aging. Looking at 2020 and beyond, Efrati said that they have a number of research collaborations that are ongoing, including research on cognitive decline, fibromyalgia and PTSD. In addition, we have an ongoing research program on athletic performance both in professional and amateur level athletes, which looks at how HBOT may further improve performance, he said. Finally, we are studying the impact of HBOT on healthy aging adults to understand how HBOT may improve our health and cognitive performance as we age.Concluding, Efrati pointed out that when you look at aging as a disease that can be measured, then it can be treated, and this is a serious area of investigation for us.The study was led by Marina Leitman, MD; Shmuel Fuchs, MD; Amir Hadanny, MD; Zvi Vered, MD; and Efrati. It was published in The International Journal of Cardiovascular Imaging.

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Hyperbaric oxygen therapy improves heart function in healthy, aging people - The Jerusalem Post

Exosome Diagnostics Market Report analysis including industry Overview, Country Analysis, Key Trends, Key Retail Innovations, Competitive Landscape and Sector Analysis for upcoming years.

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Top Companies mentioned in this report are Capricor Therapeutics Inc, Evox Therapeutics Ltd, ReNeuron Group Plc, Stem Cell Medicine Ltd, Tavec Inc, Codiak Biosciences Inc, Therapeutic Solutions International Inc, ArunA Biomedical Inc, Ciloa 85.

This latest report is on Exosome Diagnostics Market Technologies which explores the application of exosome technologies within the pharmaceutical and healthcare industries. Exosomes are small cell-derived vesicles that are abundant in bodily fluids, including blood, urine and cerebrospinal fluid as well as in in vitro cell culture.

These vesicles are being used in a variety of therapeutic applications, including as therapeutic biomarkers, drug delivery systems and therapies in their own right. Research within this area remains in the nascent stages, although a number of clinical trials have been registered within the field.

Exosomes have several diverse therapeutic applications, largely centering on stem cell and gene therapy.

Exosomes have been identified as endogenous carriers of RNA within the body, allowing for the intracellular transportation of genetic material to target cells.

As such, developers have worked to engineer exosomes for the delivery of therapeutic miRNA and siRNA-based gene therapies. As RNA is highly unstable within the body, a number of different biological vector systems have been developed to enhance their transport within the circulation, including viruses and liposomes.

Similarly, exosomes derived from stem cells have also been identified for their therapeutic applications, particularly in the treatment of cancer and cardiovascular disease. Exosome technologies offer several advantages over existing biologic-based drug delivery systems.

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Develop a comprehensive understanding of exosome technologies and their potential for use within the healthcare sector, Analyze the pipeline landscape and gain insight into the key companies investing in exosomes technologies, Identify trends in interventional and observational clinical trials relevant to exosomes.

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Scope of this Report:

What are the features of the exosome lifecycle?,How are therapeutic exosomes prepared?,How do exosome therapies in development differ in terms of stage of development, molecule type and therapy area?,Which companies are investing in exosome technologies?,How many clinical trials investigate exosomes as biomarkers, therapeutics and vectors?

Table of contents for Exosome Diagnostics Market Technologies:

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 7

2 Exosomes in Healthcare 8

2.1 Overview of Exosomes 8

2.2 Drug Delivery Systems 9

2.2.1 Modified Release Drug Delivery Systems 9

2.2.2 Targeted Drug Delivery Systems 10

2.2.3 Liposomes 12

2.2.4 Viruses 14

2.2.5 Exosomes 17

2.3 The Exosome Lifecycle 18

2.4 Exosomes in Biology 18

2.5 Exosomes in Medicine 19

2.5.1 Biomarkers 19

2.5.2 Vaccines 20

2.6 Exosomes as a Therapeutic Target 20

2.7 Exosomes as Drug Delivery Vehicles 21

2.8 Therapeutic Preparation of Exosomes 21

2.8.1 Isolation and Purification 22

2.8.2 Drug Loading 22

2.8.3 Characterization 23

2.8.4 Bioengineering 23

2.8.5 Biodistribution and In Vivo Studies 23

2.8.6 Advantages of Exosome Therapies 24

2.8.7 Disadvantages of Exosome Therapies 24

2.9 Exosomes in Therapeutic Research 25

2.9.1 Exosome Gene Therapies 25

2.9.2 Exosome in Stem Cell Therapy 26

2.10 Exosomes in Oncology 27

2.10.1 Immunotherapy 27

2.10.2 Gene Therapy 28

2.10.3 Drug Delivery 29

2.10.4 Biomarkers 30

2.11 Exosomes in CNS Disease 30

2.11.1 Tackling the Blood-Brain Barrier 30

2.11.2 Exosomes in CNS Drug Delivery 31

2.11.3 Gene Therapy 32

2.12 Exosomes in Other Diseases 33

2.12.1 Cardiovascular Disease 33

2.12.2 Metabolic Disease 33

3 Assessment of Pipeline Product Innovation 36

3.1 Overview 36

3.2 Exosome Pipeline by Stage of Development and Molecule Type 36

3.3 Pipeline by Molecular Target 37

3.4 Pipeline by Therapy Area and Indication 38

3.5 Pipeline Product Profiles 38

3.5.1 AB-126 - ArunA Biomedical Inc. 38

3.5.2 ALX-029 and ALX-102 - Alxerion Biotech 39

3.5.3 Biologics for Autism - Stem Cell Medicine Ltd 39

3.5.4 Biologic for Breast Cancer - Exovita Biosciences Inc. 39

3.5.5 Biologics for Idiopathic Pulmonary Fibrosis and Non-alcoholic Steatohepatitis - Regenasome Pty 39

3.5.6 Biologic for Lysosomal Storage Disorder - Exerkine 39

3.5.7 Biologics for Prostate Cancer - Cells for Cells 40

3.5.8 CAP-2003 - Capricor Therapeutics Inc. 40

3.5.9 CAP-1002 - Capricor Therapeutics Inc. 41

3.5.10 CIL-15001 and CIL-15002 - Ciloa 42

3.5.11 ExoPr0 - ReNeuron Group Plc 42

3.5.12 MVAX-001 - MolecuVax Inc. 43

3.5.13 Oligonucleotides to Activate miR124 for Acute Ischemic Stroke - Isfahan University of Medical Sciences 44

3.5.14 Oligonucleotides to Inhibit KRAS for Pancreatic Cancer - Codiak BioSciences Inc. 44

3.5.15 Proteins for Neurology and Proteins for CNS Disorders and Oligonucleotides for Neurology - Evox Therapeutics Ltd 44

3.5.16 TVC-201 and TVC-300 - Tavec Inc. 45

4 Assessment of Clinical Trial Landscape 48

4.1 Interventional Clinical Trials 48

4.1.1 Clinical Trials by Therapy Type 48

4.1.2 Clinical Trials by Therapy Area 49

4.1.3 Clinical Trials by Stage of Development 50

4.1.4 Clinical Trials by Start Date and Status 50

4.2 Observational Clinical Trials 51

4.2.1 Clinical Trials by Therapy Type 51

4.2.2 Clinical Trials by Therapy Area 51

4.2.3 Clinical Trials by Stage of Development 52

4.2.4 Clinical Trials by Start Date and Status 53

4.2.5 List of All Clinical Trials 54

5 Company Analysis and Positioning 67

5.1 Company Profiles 67

5.1.1 Capricor Therapeutics Inc. 67

5.1.2 Evox Therapeutics Ltd 72

5.1.3 ReNeuron Group Plc 73

5.1.4 Stem Cell Medicine Ltd 77

5.1.5 Tavec Inc. 78

5.1.6 Codiak Biosciences Inc. 80

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Current research: 2020 Latest Report on Exosome Diagnostics Market Report Technologies, Analyze the Pipeline Landscape and Key Companies - WhaTech...

OBE: Original. Brilliant. Exceptional. You can conjure your own acronyms but the letters OBE are highly relevant to the current kudos of Cambridge life sciences gamechanger Mogrify and the senior management steering its roadmap to global growth.

CEO Dr Darrin Disley received his OBE from Prince William a short while ago while Mogrify chair Dr Jane Osbourn was made OBE in January for her contribution to UK science.

Incredibly Janes sister, who works at plant science innovation hub, the John Innes Centre in Norwich, also received an OBE on the same day and the sisters in science are thought to be planning a novel joint venture.

We can chart a number of likely developments for Mogrify following an exclusive interview at the start of 2020 with Dr Disley.

The path to the Palace for both the CEO and chair person in recent times adds a crowning glory to Mogrify which has developed a proprietary direct cellular conversion technology, which makes it possible to transform (transmogrify) any mature human cell type into any other without going through a pluripotent stem cell- or progenitor cell-state.

Leveraging data from next-generation sequencing and regulatory networks (DNA-protein & protein-protein), the platform takes a systematic big-data approach to identify the transcription factors (in vitro) or small molecules (in vivo), needed to convert, maintain and culture a target cell phenotype.

Mogrify can perform cell conversions from any starting cell type giving it the best opportunity to address challenges associated with efficacy, safety and scalability that currently mean cell therapy is underperforming its undoubted potential.

Mogrify is applying its patented technology through therapeutic development as well as licensing of proprietary cell conversions that will power the development and manufacture of new cell therapies across every therapeutic area.

The combination of Darrin Disley and Jane Osbourn is incredibly powerful. Jane has this week stepped down as chair of the UK BioIndustry Association although she will stay on the board for a further year and has done wonders in building relationships with key China organisations.

She is also now CSO of a new antibody company called Alchemab, which has been under the radar for a while but is now emerging. Alchemab has a presence in London and will have labs in Oxford and Cambridge.

Formerly with the now defunct MedImmune arm of AstraZeneca in Cambridge, Dr Osbourn is now free to weave her own brand of magic into the Mogrify tech tapestry.

Business Weekly has a 30-year reputation for backing winners and the minute Dr Disley walked through their door convinced us that Mogrify was the only play that he would risk his rock-solid reputation on promoting.

Members of the Mogrify leadership team in Cambridge. Photograph by Phil Mynott.

Mogrify is gearing towardsa stellar 2020 and will be able to dictate the pace and compass of future growth, we confidently predict.

It has already ticked one crucial box by positioning itself as a leading innovator and partner of choice to organisations developing life saving cell therapies across a range of diseases and medical conditions.

Global demand for collaborations is already notable with potential partners and clients from around the world jostling to form an orderly queue.

As it continues to build world-class scientific, operational and commercial credentials, Mogrify will double headcount in short order to around 65 or so at its 12,000 sq ft state-of-the-art office and laboratory headquarters at TusPark UKs Bio-Innovation Centre at Cambridge Science Park.

Mogrifys mission is to progress internal cell therapy programs in autoimmune, cancer immunotherapy, cardiovascular, muskskoskeletal and ocular disease indications. It has already rolled out initial key programmes in selected areas.

You can expect to see Mogrify close multiple new partnerships with biotechnology and Big Pharma and the nature of its technology suggests that the company could excel in securing significant additional grant funding for its lead programs.

The next natural move would be for the business to expand the IP footprint of the direct cell conversion platform and, in that regard, global engagement already secured will facilitate that strategy.

Jane Osbourn OBE

Business Weekly understands that Mogrify is considering further strategic funding options which will excite investors around the world; from what we have seen from the best life sciences businesses in this world-leading cluster, it would be logical for Mogrify to push through a second close to its $16 million Series A funding round announced in October.

We reported then that the funding was led by existing investor Ahren Innovation Capital.

Mogrify launched in February 2019 with $3.7m seed funding from Ahren, 24Haymarket and Dr Disley and went on to secure grants from Innovate UK and SBRI Healthcare.

Parkwalk, the largest EIS growth fund manager, backing businesses with IP-protected innovations creating solutions to real-world challenges, 24Haymarket, an early investor in Mogrify and a prolific early-stage investment syndicate in deep technology and the life sciences, and the University of Bristol Enterprise Fund III, also contributed to the Series A raise.

It is informative when mapping the future potential of Mogrify to re-echo the words of Alice Newcombe-Ellis, founder and managing partner of Ahren Innovation Capital, at Octobers Series A announcement.

She said: Mogrifys technology is well positioned to disrupt the global cell therapy market. The company has grown rapidly since February, appointing a world-class management team and delivering strongly against its business plans. We look forward to supporting Mogrify as it continues to go from strength to strength.

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Mogrify a right Royal success in the realm of cell therapy innovation - Business Weekly