Category Archives: Stem Cell Medicine

BioMed Realty fully leases flagship life sciences development at Babraham Research Campus within 12 months as first occupier moves in – Cambridge…

Bit Bio, a world leader in synthetic biology, has agreed to take 25,000 sq. ft. of space on a 10-year lease at the BioMed@Babraham development. The fast-growing company joins the likes of drug discovery and development platformsMission Therapeutics andRxCelerate,as well as liquid biopsy specialistsInivata, with nearly two-thirds of tenants moving from existing facilities on the campus to larger scale-up labs to remain closely connected to the robust on-campus science and research community.

All 100,000 sq. ft. of mixed laboratory and office space at BioMed@Babraham has been leased within 12 months - ahead of schedule. The first business to take up occupancy isPetMedix, a fast-growing biotherapeutics firm.

Launched in 2017,BioMed@Babrahamwas developed by BioMed Realty and is operated in collaboration with Babraham Research Campus, one of the UKs leading campuses to support early stage bioscience enterprises. BioMed@Babraham offers 100,000 sq. ft. of flexible and fully-fitted premium lab and work space, allowing fast-growing businesses to move in and focus solely on science and research.

The research space at BioMed@Babraham has been highly specified to support scale-up companies with pre-installed lab benches, fume hoods, vacuum and gas lines and Trespa shelving.

BioMed is a world leader in providing real estate solutions to the life science and technology communities with more than 13.6 million sq. ft. of space under occupation and development. The company owns and operates approximately 1 million sq. ft. of laboratory space across Cambridge - approximately a quarter of total space in the market.

Since entering the UK market in 2012, BioMed has been dedicated to developing Grade-A lab and office space for the life sciences sector. Many of its global occupiers - including firms such as AstraZeneca and Gilead - are now leading the fight against COVID-19.

Cheffins advised BioMed Realty.

Matt Smith, Director, U.K. Market, BioMed Realty said: The life sciences industry makes a huge contribution to the UK economy, supporting thousands of highly skilled jobs. With the right investment in facilities to help nurture innovation, it will provide the industry a path for growth and compete globally with knowledge clusters across the US, Europe and Asia. Weve seen unprecedented demand for high quality research space and full credit must be given to Derek Jones and the Babraham Research Campus for being one of the first organisations in Britain to recognise the huge value of offering turnkey facilities to spin-outs and scale-ups.

Derek Jones, CEO of Babraham Bioscience Technologies, which develops and manages the Babraham Research Campus, said: We are delighted Bit Bio and PetMedix have chosen to make the Campus their home. They will benefit from being part of the wider Campus community of 60 innovative commercial organisations, as well as co-location with world leading research at the Babraham Institute. Our supportive and highly networked community shares a common objective; to make a positive contribution to the worlds health and we welcome both companies presence and contribution to that aim.

Dr Tom Weaver, PetMedix CEO, said: Were delighted to have new, state-of-the-art premises within such a fantastic community that will benefit our staff both professionally and socially. As our company scales, it will be from this site that PetMedix will continue to innovate and develop novel antibody therapeutics for the companion animal market. The Babraham Research Campus has shown great foresight in creating facilities which we believe can play a key role in helping other spin-outs quickly scale up. We are a science-led company, but it is our people that make us who we are. We have some ambitious plans and this move will help us maintain our trajectory of strong growth.

Bit Bio, founded in 2016 by leading neurosurgeon Dr Mark Kotter, has developed a unique technology to edit the code of stem cells to create specialised cells like neurons and muscle tissue that can then be used for academic and medical research. Bit Bios current projects include cell therapy for cancer patients and finding cures for diseases affecting the central nervous and immune systems. The company closed on a $41.5 million Series A investment last month, bringing the companys total funding to $50 million.

The firm will be joining PetMedix, a fast-growing biotherapeutics company focused on therapeutic antibody research and development for dogs and cats. Antibody therapeutics have been transformative in human medicine, treating a wide range of diseases including cancers and autoimmune diseases, and are just starting to be developed for veterinary applications. The business, which raised 8 million of series A funding last year, has already taken occupancy and recently secured equity investment from Cambridge Innovation Capital.

As part of PetMedixs move, laboratory equipment not required at the new site has been donated to the NHS for use in COVID-19 research, including four laminar flow cabinets suitable for tissue culture.

Cambridge life sciences real estate market

Cambridge is a high growth location at the core of the Oxford-Cambridge Arc - a world-leading hub of pharmaceutical, biomedical and biotechnology companies that is estimated to have contributed over 111 billion to the UK economy in 2019 alone. However, acute demand-supply imbalances threaten to undermine the regions long-term growth and ability to play a leading role in the UKs economic recovery post-coronavirus.

Healthy demand and a lack of suitable lab space has seen rents increase in Cambridge over the last year. In 2019, rents in the sector rose by 12 percent to an historic high of 46.50 per sq ft, according to Bidwells, a Cambridge-based property consultancy. Occupiers are also continuing to focus on Grade-A space, accounting for 64 percent of total take up in last year.

About BioMed Realty

Founded in 2004, and a Blackstone portfolio company since 2016, BioMed Realty owns, operates and develops high quality life science real estate comprising 13.6 million square feet, including 2.5 million square feet of Class A properties in active development to meet the growing demand of the life science industry. BioMed Realtys portfolio is located in the leading innovation markets throughout the United States and United Kingdom, led by Boston-Cambridge, San Francisco, San Diego, Seattle, New York and Cambridge, U.K. With over 200 tenant partners, BioMed Realty provides real estate solutions for global enterprises, established biotechnology and innovation companies, leading universities and premier research institutions. To learn more about BioMed Realty, visitbiomedrealty.com, and please follow us on Twitter @biomedrealty.

About Bit Bio

Bit Bio is a human synthetic biology company based in Cambridge, UK. The Companys mission is the application of computational principles to biology. The team includes world leaders in stem cell biology, cellular reprogramming and cell therapy who are harnessing the power of synthetic biology to tackle the problem of inconsistency in the production of human cells.

Bit Bios current focus is to develop a scalable technology platform capable of producing consistent and functional batches of every human cell. Access to high-quality human cells will allow enhanced research outcomes and drug discovery efficiency, enabling a new generation of cell and tissue therapies.

To find out more, please visitwww.bit.bio

About PetMedix

PetMedix is a Cambridge, UK based research and development stage biopharmaceutical company developing antibody-based therapeutics for companion animals. The growing team have over 30 years experience building platforms that can develop species-specific therapeutic antibodies. Driven by the core value of improving the health and welfare of animals, PetMedix is taking the cutting edge of human medicine and using it to develop innovative new veterinary treatments against a wide range of clinical indications for dogs and for cats.

To find out more, please visithttps://www.petmedix.co.uk

About the Babraham Research Campus

Babraham Bioscience Technologies Ltd (BBT) is responsible for the management and commercial development of the Babraham Research Campus.

The Babraham Research Campus is distinct in its colocation of 60 bioscience companies with the Babraham Institute, a worldrenowned research organisation which receives strategic funding from the Biotechnology and Biological Sciences Research Council (BBSRC).

The aim of the campus is to support U.K. bioscience through academic research, but also with facilities and capabilities for early-stage and growing commercial organizations. The campus provides companies laboratory and office space, networking and collaboration opportunities, together with access to outstanding scientific facilities in an ideal geographical location at the core of the Cambridge cluster.

The campus is managed and developed by BBT on behalf of the BBT shareholders, BBSRC and the Babraham Institute.

For more information please visit:www.babraham.com

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BioMed Realty fully leases flagship life sciences development at Babraham Research Campus within 12 months as first occupier moves in - Cambridge...

Global Stem Cells Group has Announced an Agreement with Rokit Healthcare – PRUnderground

The Global Stem Cells Group (GSCG) a world leader in Regenerative Medicine Technologies has signed an agreement with South Korean-based Rokit Healthcare, an esteemed bioprinter manufacturer that is committed to advancing the field of regenerative medicine and bettering the quality of life of people around the world.

The field of bioprinting is an extremely new one, but it shows great promise. Simply, it is the automated, computer aided deposition of bio-materials (which are cells, growth factors, and biocompatible polymers) for the manufacturing of functional human tissues or organs. Growth factors are harvested and used with a proprietary printing technology to create or regenerative damaged or diseased organs. Rokit Healthcare does this primarily through the proliferation of a machine that they dub an organ regenerator it looks like a 3D printer, but instead of using plastics to create things, they use cells and materials that will be safe to implant within the human body.

The process of 3D bioprinting human tissues and organs is a revolutionary technology in the field of tissue engineering. One of the major challenges in regenerative medicine research and tissue engineering is mimicking the micro and macro environment of human tissues. In response to this challenge, advances in additive manufacturing have inspired scientists in Korea to develop novel bioprinting technology, for human tissues and organs.

With the advancements of 3D printing and regenerative medicine working together, the potential is seemingly limitless for the spreading of bioprinting technology, a process that is known as 4D Printing and Global Stem Cells Group, in an effort make this revolutionary technology available to patients, has forged an agreement with Rokit Healthcare to promote, and distribute the companys technology in Latin America-

The Invivo 4D Printer is Rokit Healthcares flagship product, and it is one that revolutionizes the application of regenerative medicine and growth factor-based therapies. creating a solution for personalized and improved patient care. By leveraging a combination of 3D and bioprinting technologies, it can better distribute a patients autologous tissues and cells, making it an invaluable tool for those that are looking to improve the efficacy of their results, especially for certain dermatological conditions including scarring.

Were extremely excited about this new opportunity and look forward to working with Rokit, Says Benito Novas, CEO of the Global Stem Cells Group, The Invivo 4D Printer is in a position to turn the practice of regenerative medicine onto its head, and we are planning on creating a training center in Cancun, Mexico exclusively to showcase and instruct other physicians in this cutting-edge technology,

About Global Stem Cells Group

Global Stem Cells Group (GSCG) is a worldwide network that combines seven major medical corporations, each focused on furthering scientific and technological advancements to lead cutting-edge stem cell development, treatments, and training. The united efforts of GSCGs affiliate companies provide medical practitioners with a one-stop hub for regenerative medicine solutions that adhere to the highest medical standards.

About ROKIT :

ROKIT Healthcare is a global healthcare company that is committed to providing an effective and autologous organ regeneration platform. In order to undertake this daunting task, the company uses proprietary biofabrication technologies that show promise in treating several types of diseases in the field of regenerative medicine. Through the proliferation of 4D bioprinting technology, autologous stem cell technologies, ROKIT Healthcare believes that supplying an avenue for organ regeneration will drastically change the way that everyday people trust and manage their own body.

About Global Stem Cells Group

Global Stem Cells Group (GSCG) is a worldwide network that combines seven major medical corporations, each focused on furthering scientific and technological advancements to lead cutting-edge stem cell development, treatments, and training. The united efforts of GSCGs affiliate companies provide medical practitioners with a one-stop hub for stem cell solutions that adhere to the highest medical standards.

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Global Stem Cells Group has Announced an Agreement with Rokit Healthcare - PRUnderground

An intriguingbut far from provenHIV cure in the ‘So Paulo Patient’ – Science Magazine

HIV, shown here budding from cell, remains stubbornly resistant to cure strategies because its DNA can lie silently in host chromosomes for years.

By Jon CohenJul. 7, 2020 , 9:00 AM

A 36-year-old man in Brazil has seemingly cleared an HIV infectionmaking him the proof of principle in humans of a novel drug strategy designed to flush the AIDS virus out of all of its reservoirs in the body. After receiving an especially aggressive combination of antiretroviral (ARV) drugs and nicotinamide (vitamin B3), the man, who asks to be referred to as the So Paulo Patient to protect his privacy, went off all HIV treatment in March 2019 and has not had the virus return to his blood.

The patients story is remarkable, says Steven Deeks, an HIV/AIDS clinician at the University of California, San Franciscowho was not involved with this study. But he and others, including the study leaders, caution that the success hasnt been long or definitive enough to label it a cure. Interesting anecdotes have long driven the HIV cure field, and they should be considered largely as hypothesis-generating observations that can simulate new areas of investigation, says Deeks, who also conducts HIV cure research.

Most people who suppress HIV with ARVs and later stop treatment see it come racing back to high levels within weeks. Not only did the So Paulo Patient not experience a rebound, but his HIV antibodies also dropped to extremely low levels, hinting at the possibility he may have cleared infected cells in the lymph nodes and gut.

Ricardo Diaz of the Federal University of So Paulo, the clinical investigator running the study, says he doesnt know whether the patient is cured. He has very little antigen, Diaz says, referring to HIV proteins that trigger the production of antibodies and other immune responses. But he notes his team has not sampled the mans lymph nodes or gut for the virus since he stopped treatment. Diaz discussed the patient today at a press conference for AIDS 2020, the 23rd International AIDS Conference taking place virtually this week, and he plans to present the study in full tomorrow.

Only two people are known to have been cured of their HIV infections:Timothy Ray Brown and a man who has asked to be referred to as the London Patient; both received bone marrow transplants as part of a treatment for cancers. The transplants cleared their infections and gave them new immune systems that resist infection with the virus. But bone marrow transplants are expensive, complicated interventions that can have serious side effects, making them an impractical cure for the 38 million people now living with the AIDS virus.

Other potential HIV cure cases have received intense media attention only to see the virus return after prolonged absences. Most soberingly, a baby in Mississippi who started ARVs shortly after birth stopped treatment at 18 months and was thought to be cured until the virus suddenly resurfaced more than 2 years later. Several adults who had bone marrow transplants and appeared to have been cured were not.

HIV has proven particularly difficult to eliminate because the virus weaves its genetic material into human chromosomes, where it can lie dormant, escaping the immune surveillance that typically eliminates foreign invaders. These silently infected cells may persist, perhaps indefinitely, because they have stem cell-like properties and can make clones of themselves. Researchers have come up with several strategies to flush reservoirs of cells that harbor latent HIV infections, but none have provedeffective.

To compare different reservoir-clearing strategies, Diaz and colleagues in 2015 recruited the So Paulo Patient and other individuals who had controlled their HIV infections with ARVs. The most aggressive approach, used in this man and four others, added two ARVs to the three they were already taking, in the hopethis would rout out any HIV that might have dodged the standard treatment. On top of this intensification, the study group received nicotinamide, which can, in theory, prod infected cells to wake up the latent virus. When those cells make new HIV, they either self-destruct or are vulnerable to immune attack.

After 48 weeks on this intensified schedule, the five trial participants returned to their regular three-drug regimen for 3 years, after which they stopped all treatment. Four saw the virus quickly return, but the So Paulo Patient has now gone 66 weeks without signs of being infected. Sensitive tests that detect viral genetic material did not find HIV in his blood. An even more sensitive test, which mixed his blood with cells that are susceptible to HIV infection, produced no newly infected cells.

Intriguingly, during the intensification period with nicotinamide, this man was the only one of the five who twice had the virus detected on standard blood tests. To Diaz, this suggests that latently infected cells had been roused, leading to blips of viral production. Im always trying to be a little bit the devils advocate, but in this case, Im optimistic, Diaz says. Maybe this strategy is not good for everybody because it only worked in one out of five here. But maybe it did get rid of virus. I dont know. I think this is a possibility.

Deeks says he does not know of any report, other than the two people cured by bone marrow transplants, of decreases in HIV antibody levels after stopping treatment. One large, outstanding question, he says, is whether the man indeed stopped taking his ARVs. I have not taken any HIV medication since March 30, 2019, the So Paulo Patient says. Diaz plans to confirm this by examining the mans blood for ARVs.

Another unknown is how soon the man started ARVs after becoming infected with HIV. Studies have shown that a small percentage of people who begin ARV treatment shortly after becoming infected have a better chance of controlling the virus for prolonged periods if they cease the drugs, presumably because they never built large reservoirs of infected cells. The So Paulo Patient started treatment 2 months after being diagnosed in October 2012. As with most people who become infected with HIV, he cannot say for certain when transmission occurred, but he suspects it was in June 2012. The only certainty is that he tested negative in 2010.

Its also unclear how nicotinamide would awaken silent infected cells. HIV DNA remains latent when it tightly spools around chromosome proteins known as histones. To make viral copies, it must unspool, and Diaz points to evidence that nicotinamide can trigger this unspooling in different ways.

Sharon Lewin, an HIV cure researcher who directs the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia, finds the antibody response intriguing. But she underscores it is not a convincing, controlled experiment. We need to move beyond case reports of HIV remission, Lewin says. I would be super excited to see long term remission in multiple participants in a clinical trial. This is what the field needs to really advance.

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An intriguingbut far from provenHIV cure in the 'So Paulo Patient' - Science Magazine

Researchers uncover a critical early step of the visual process – Newswise

Newswise The key components of electrical connections between light receptors in the eye and the impact of these connections on the early steps of visual signal processing have been identified for the first time, according to research published today in Science Advances by The University of Texas Health Science Center at Houston (UTHealth).

To understand fully how the light receptors, called photoreceptors, impact the early stages of the process of vision, researchers have traditionally focused their attention on how two key sensory cells rods and cones convert elementary particles of light into electrical signals and how these signals are relayed to the brain through devoted circuits. Rods are used for night vision and cones are used for daytime and color vision. While it has been known for some time that electrical signals can spread between photoreceptors through cell connectors called gap junctions, the nature and function have remained poorly understood.

This research will lead to a better understanding of how the retina processes signals from the rods and the cones in the eyes, in particular under ambient lighting conditions when both photoreceptor types are active, such as at dawn and dusk. This knowledge is currently missing and may have to be taken into consideration when designing photoreceptor or retinal implants to restore vision, said Christophe P. Ribelayga, PhD, co-lead author of the study and associate professor and Bernice Weingarten Chair in the Ruiz Department of Ophthalmology & Visual Science at McGovern Medical School at UTHealth.

Co-lead author Steve Massey, PhD, is professor, Elizabeth Morford Chair, and research director in the Ruiz Department of Ophthalmology & Visual Science at McGovern Medical School at UTHealth.

The coupling or communication between rods and cones in the retina is critical for understanding how the visual signaling process works.

What the researchers discovered, to their surprise, is that rods do not directly communicate with other rods and cones seldom communicate directly with other cones. Instead, the majority of signaling happens through communication between rods and cones. Researchers identified a specific protein called connexin36 (Cx36) as the main component of rod/cone gap junctions.

We noted that every single rod has electrical access to a cone and that cone/cone gap junctions are very rare, Massey said. We estimated that more than 95% of all gap junctions between photoreceptors are rod/cone gap junctions; they have the largest volume and the largest conductance. So, rod/cone gap junctions dominate the network of photoreceptors both in size and number.

To help researchers better understand how the photoreceptor network is organized, they developed genetic mouse strains for the work that were bred to eliminate gap junctions in either rods or cones.

Our study has important implications, said Ribelayga. Our data position rod/cone gap junctions as the keystone of the photoreceptor network. The rod/cone gap junction is the entry of a rod pathway through which signals of rod origin can travel across the retina. We have thus generated mice that are essentially deficient for the entry of this pathway. In future experiments, we will use these animals to determine the functional importance of the rod/cone pathway in the retinal processing of rod signals and for vision.

In 2018, researchers in the Ruiz Department of Ophthalmology & Visual Science received more than $4 million in grants from the National Institutes of Healths National Eye Institute to study photoreceptor development, function, and electrical interactions. Ribelayga and Massey led the effort to lay out the architecture of the network of electrically coupled receptors, a critical step toward a better understanding of how photoreceptors encode light signals and how the retina processes these signals.

Additional UTHealth authors include Nange Jin, PhD; Zhijing Zhang, PhD; Joyce Keung, PhD; Munenori Ishibashi, PhD; Lian-Ming Tian; Iris Fahrenfort, PhD; Takae Kiyama, PhD; Chai-An Mao, PhD; David W. Marshak, PhD; Jiaqian Wu, PhD; Haichao Wei, PhD; and Yanan You, PhD. Marshak is with McGovern Medical Schools Department of Neurobiology and Anatomy; and Wu, Wei, and You are with the UTHealth Center for Stem Cell and Regenerative Medicine at the Brown Foundation Institute of Molecular Medicine.

Other authors include Sean B. Youn with Rice University; Eduardo Solessio, PhD; and Yumiko Umino, PhD, with the Center for Vision Research and SUNY Eye Institute at SUNY Upstate Medical University; and Friso Postma, PhD; and David L. Paul, PhD, with Harvard University.

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Researchers uncover a critical early step of the visual process - Newswise

Business impacts of COVID-19 on Regenerative Medicine Market. Strategies of Major Industry Competitors – Cole of Duty

The increasing incidence of genetic disorders and chronic diseases is one of the biggest factors responsible for the burgeoning sales of regenerative medicine throughout the globe. The rising adoption of sedentary lifestyles and unhealthy dietary habits of the people all around the world are the main reasons causing the high prevalence of chronic diseases across the world. According to the World Health Organization (WHO), almost 17.9 million deaths are recorded every year because of cardiovascular diseases. Moreover, the cardiovascular diseases account for nearly 31% of the total deaths occurring across the world every year.

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The other major factors propelling the demand for regenerative medicine are the soaring investments being made by the governments of many countries in research and development activities in the domain of regenerative medicine, surging number of regenerative medicine companies throughout the world, and rapid technological developments in tissue engineering areas and stem cell research. Due to these factors, the global regenerative medicine market is expected to exhibit huge expansion over the coming years.

Across the globe, the regenerative medicine market is predicted to record the fastest growth in the Asia-Pacific (APAC) region in the upcoming years. This is mainly credited to the improving healthcare facilities and infrastructure in the region and the subsequent rise in stem cell research in the developing nations of APAC. For instance, the Chinese government has recently approved R&D activities pertaining to the human embryonic stem cells, which has in turn, encouraged more research on the clinical potential of the stem cells in the country.

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Business impacts of COVID-19 on Regenerative Medicine Market. Strategies of Major Industry Competitors - Cole of Duty

Oncologie Expands and Strengthens Management Team with Key Appointments and Promotions – BioSpace

WALTHAM, Mass., July 09, 2020 (GLOBE NEWSWIRE) -- Oncologie, Inc., a precision medicine company using an innovative RNA-based biomarker platform to develop novel, targeted oncology therapies, today announced an expansion of its management team with the appointments of Matthew Osborne as Chief Financial Officer, Hagop Youssoufian, M.D., as Interim Chief Medical Officer, Bill McDonald, Ph.D., as Vice President of Chemistry, Manufacturing and Controls (CMC), as well as the promotion of Kerry Culm-Merdek, Ph.D., to Vice President of Clinical Development.

We are pleased to expand Oncologies management team with the additions of Matt, Hagop and Bill, and the promotion of Kerry, and look forward to their contributions, said Laura Benjamin, Ph.D., Founder and CEO of Oncologie. Their collective experience and leadership will be critical as we further develop and deploy our RNA-based biomarker platform to advance the state of the art of precision medicine to identify the right patients for our clinical stage programs, Navicixizumab and Bavituximab.

Mr. Osborne brings to Oncologie more than 20 years of leadership, financial and industry experience, gleaned from years on Wall Street and through professional roles with small to large cap biotechnology companies. In these roles, he successfully led multiple equity financings, applying his expertise across disciplines spanning scientific, financial, strategic planning, investor relations and corporate communications functions. Before joining the company in 2020, Mr. Osborne served as Chief Financial Officer at Unum Therapeutics, Inc. Prior to joining Unum Therapeutics, Mr. Osborne served as Head of Corporate Affairs, Communications and Investor Relations at Voyager Therapeutics, Inc., and through similar roles at Shire, Plc (acquired by Takeda Pharmaceutical Company in 2019), Synageva BioPharma Corp. (acquired by Alexion Pharmaceuticals, Inc. in 2015) and Vertex Pharmaceuticals Incorporated. Mr. Osbornes Wall Street experience includes serving as a sell-side analyst at Lazard Capital Markets and Leerink Swann (now SVB Leerink), where he covered small to large cap biotechnology companies, analyzed drug launches and launched several initial public offerings. He received a B.S. in Biology from Syracuse University and an M.B.A. from the DAmore-McKim School of Business at Northeastern University.

Dr. Youssoufian is a physician-scientist with more than 25 years of experience in drug development working with seed-stage ventures to multi-national biotech and pharmaceutical corporations. After a successful academic career as a clinician, teacher and NIH-funded investigator, he held increasingly senior roles in clinical and translational science including Head of Experimental Medicine at Bristol-Myers Squibb Company, Distinguished Scientist at Sanofi Aventis, Chief Medical Officer at ImClone Systems Incorporated, President of Research and Development and Chief Medical Officer at Ziopharm Oncology, Inc., Executive Vice President of Research and Development at Progenics Pharmaceuticals, Inc., and Chief Medical Officer at BIND Therapeutics, Inc. He supported or led the development and approval of a number of medicines including Sprycel, Taxotere, Erbitux, Cyramza, Lartruvo and Copiktra. He is an elected member of the American Society for Clinical Investigation, the recipient of many national and international awards, and the author of more than 100 publications. He received a B.S. in biology from Boston College and M.Sc./M.D. from University of Massachusetts Medical School, followed by fellowships at Johns Hopkins University, Harvard University and the Massachusetts Institute of Technology.

William Bill McDonald, Ph.D., brings more than 20 years of experience in process development and the manufacturing of antibodies, recombinant enzymes, antigens, antibody targets, viral vectors and vaccines. Prior to joining Oncologie, Bill served as Vice President, CMC at Contrafect Corporation where he was responsible for all CMC activities for Contrafects novel biologics platform of anti-microbial therapies. Previously, Bill served as Executive Director and Manufacturing Site Head at Celldex Therapeutics, Inc., where he oversaw the Fall River GMP manufacturing facility and was responsible for internal manufacturing of all early clinical stage biologics. Bill also held roles of increasing responsibility at Synageva BioPharma Corp. (acquired by Alexion Pharmaceuticals, Inc. in 2015), including Senior Director of Process Development. He also previously served as Head of Process Science at Pfizer, Inc., Director of Antigen Production at Genocea Biosciences Inc. and Director of Biochemistry at VaxInnate Corporation. Within the scope of technical operations, he has supported the development and manufacture of several approved biologics including Kanuma, Soliris and Strensiq. Bill received a B.S. in Microbiology from the University of Florida and received a Ph.D. in Molecular Biology at Cornell University.

Kerry Culm-Merdek, Ph.D., brings over 15 years of clinical drug development expertise and experience in small molecule and therapeutic protein development in rare disease and oncology indications including her role as Head of Clinical Pharmacology and Quantitative Bioanalytics at ImmunoGen Inc., where she was responsible for clinical pharmacology strategy for global clinical and preclinical development of oncology therapies. Prior to joining ImmunoGen, Kerry spent 13 years at Sanofi Genzyme, most recently serving as a Global Project Head, where she led the therapy project teams for Fabry disease, Gaucher disease type 3 and multiple gangliosidosis/galatosialidosis indications. Kerry received a B.S. in Biochemical Pharmacology from the State University of New York at Buffalo. She received a Ph.D. in Pharmacology and Experimental Therapeutics at Tufts University School of Medicine.

About Bavituximab

Bavituximab is an investigational chimeric monoclonal antibody that targets the activity of phosphatidylserine (PS). Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors, as well as by sending an alternate immune activating signal. PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Oncologie is conducting a Phase 2 trial of bavituximab plus pembrolizumab as a second-line treatment in patients with advanced gastric or gastroesophageal cancer. Using its biomarker platform, Oncologie is analyzing patient tissue samples from this on-going trial with results expected later this year to inform future clinical development for this program.

About Navicixizumab

Navicixizumab is an anti-DLL4/VEGF bispecific antibody designed to inhibit both Delta-like ligand 4 (DLL4) in the Notch cancer stem cell pathway as well as vascular endothelial growth factor (VEGF) and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities. In preclinical studies, navicixizumab demonstrated robust in vivo anti-tumor activity across a range of solid tumor xenografts, including colon, ovarian, lung and pancreatic cancers, among others. In a Phase 1a trial of 66 patients with various types of refractory solid tumors, treatment with single agent navicixizumab generated an overall response in three of 12 (25%) patients with ovarian cancer. In a Phase 1b trial in platinum-resistant ovarian cancer patients who had failed more than two prior therapies including bevacizumab, treatment with navicixizumab plus paclitaxel generated an interim overall response in 10 of 30 (33%) patients. Treatment-related adverse events in the Phase 1b trial were manageable and included hypertension (58%), headache (29%), fatigue (26%) and pulmonary hypertension (18%). Using its RNA-based biomarker platform, Oncologie is analyzing patient tissue samples from all navicixizumab trials with results expected later this year to inform future clinical development with this program. The FDA granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with bevacizumab.

About Oncologies RNA-based Biomarker Platform

Predictive biomarkers historically worked on single-driver mutations yet only approximately 10% of cancer patients have known driver mutations with available targeted therapies. Using its proprietary biomarker platform, Oncologie is advancing a new paradigm of precision oncology with an RNA-based approach to identify the dominant biology in the tumor microenvironment. This could improve clinical outcomes by matching patients to therapies with a mechanism of action that targets that specific biology and expand precision medicine to those therapies whose potential remains unrealized. Oncologie is further optimizing the biomarker platforms tumor microenvironment panel through multiple research collaborations, including a collaboration with Moffitt Cancer Center.

About Oncologie, Inc.

Oncologie, Inc. aims to advance the state of the art of precision medicine to dramatically improve the lives of people with cancer. Leveraging a deep understanding of the evolving biology of cancer, Oncologie is developing unique RNA-based biomarker panels to match patients to novel, targeted therapies that modulate the bodys tumor immune system and angiogenesis pathways. Oncologie, Inc., based in Waltham, Massachusetts, and Oncologie Shanghai Co., Ltd., based in Shanghai, China, are subsidiaries of Oncologie, Ltd., and are working with global partners to acquire and further develop innovative drugs for cancer patients around the world. For more information on Oncologie, Inc., please visit https://oncologie.com/.

Investor and Media Contact:

Ashley R. Robinson LifeSci Partners, LLC arr@lifesciadvisors.com

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Oncologie Expands and Strengthens Management Team with Key Appointments and Promotions - BioSpace

The first cell therapy for COVID-19 reduces mortality in critically ill patients – Explica

Pioneering research by Spanish researchers has proven to be efficient for the clinical improvement of critical cases of COVID-19. The work, the largest so far, has been published in the journal The Lancet EClinicalMedicine, after demonstrating that an advanced treatment based on cell therapy, tested in 13 patients intubated in mechanical ventilation, reduces the mortality of critically ill coronavirus patients from 85% to 15%, that is, 70%.

This is the first results of the BALMYS-19 project, co-led by a professor at the Miguel Hernndez University (UMH) in Elche and researcher at the Alicante Institute of Health Research (ISABIAL) Bernat Soriatogether with the teacher Damin Garca-Olmo from the Jimnez Daz Foundation (Autonomous University of Madrid). In addition, six other Spanish universities and six hospitals have participated in the study.

The therapy tested is based on stem cells with regenerative, anti-inflammatory and immunoregulatory properties and it is the first cell therapy for COVID-19, developed and produced entirely in Spain. During the pilot study, critical coronavirus patients who did not respond to conventional treatments were treated with the cellular medicine, made up of allogeneic stromal mesenchymal cells at doses of 1 million cells per kilogram of weight in one or more doses.

The results of its application in coronavirus patients admitted to ICUs were compared with the clinical evolution and mortality of similar cases. Cell treatment does not produce adverse reactions, but it does lead to generalized clinical and radiological improvement. Patient mortality decreased from 70-85% to 15% (2 patients). Most of the people treated with the cellular medicine were disinfected during the data collection period. Their markers of inflammation (C-reactive protein and ferritin), coagulation (D-dimer) and tissue damage (lactic dehydrogenase) decreased. In addition, it was found that the drug does not decrease the lymphocyte count. In fact, the results suggest that the new treatment increases the presence of T lymphocytes (which directly attack the virus) and B lymphocytes (which synthesize the antibodies).

The study authors explain that cellular medications, unlike other treatments, they are live drugs and must be used by qualified medical personnel and produced by units accredited by the Spanish Agency for Medicines and Health Products. Knowledge of the biological scientific foundations of these treatments, as well as the physiology of the interaction between the drug and the host, are essential for their correct handling.

July 10, 2020

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The first cell therapy for COVID-19 reduces mortality in critically ill patients - Explica

Cell Expansion Market Worth $30.1 billion by 2025 – Exclusive Report by MarketsandMarkets – PRNewswire

CHICAGO, July 6, 2020 /PRNewswire/ -- According to the new market research report "Cell Expansion Marketby Product (Reagent, Media, Flow Cytometer, Centrifuge, Bioreactor), Cell Type (Human, Animal), Application (Regenerative Medicine & Stem Cell Research, Cancer & Cell-based Research), End-User, and Region - Global Forecast to 2025", published by MarketsandMarkets,the Cell Expansion Marketis estimated to be USD 14.9 billion in 2020 and projected to reach USD 30.1 billion by 2025, at a CAGR of 15.1%.

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Growth in this market is primarily driven by the increasing incidence of chronic diseases, government investments for cell-based research, growing focus on personalized medicine, increasing focus on R&D for cell-based therapies, and increasing GMP certifications for cell therapy production facilities.

The media segment accounted for the largest share of the consumables segment in the Cell Expansion Market

Based on product type, consumables are segmented into media, reagents, sera, and disposables. The media segment accounted for the largest share of the consumables segment in the market. The large share of this segment can be attributed to its high requirement during the production of pharmaceutical products and rising R&D investments on cell-based therapies.

Browsein-depth TOC on"Cell Expansion Market"

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Biotechnology & biopharmaceutical companies accounted for the fastest-growing end user segment of the market

Based on end-users, the market has been segmented into research institutes, biotechnology & biopharmaceutical companies, cell banks, and other end users (includes hospitals, diagnostic centers, and laboratories). In 2019, biotechnology & biopharmaceutical companies were the largest end-users in the Cell Expansion Market, and the trend is the same throughout the forecast period. Increasing production of regenerative medicine and rising awareness regarding advanced treatment methods such as personalized medicines and other cell-based therapies are the major driving factors for this segment.

North America accounted for the largest share of the market

North America accounted for the largest share of the market. The large share of this segment can primarily be attributed to the rising incidence of cancer, increasing government funding, rising research activates on stem cell therapies, growing awareness regarding advanced treatment methods, increasing geriatric population, and the strong presence of industry players in the region.

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Some of the leading players in the Cell Expansion Market include Thermo Fisher Scientific, Inc. (US), Danaher (US), Becton, Dickinson and Company (US), Lonza (Switzerland), Corning, Inc. (US), Merck KGaA (Germany), Sartorius Stedim Biotech (France), Getinge AB (Sweden) Terumo Corporation (Japan), and Miltenyi Biotec (Germany)

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Cell Expansion Market Worth $30.1 billion by 2025 - Exclusive Report by MarketsandMarkets - PRNewswire

As Segway Retires, Its Inventor Gears Up to Grow Organs – Smithsonian Magazine

Dean Kamen, inventor of the Segway, rode the self-balancing personal transportation device outside his home in 2002.

Over the past 20 years the Segway has become ubiquitous on city streets and industrial campuses, in malls and even on wooded trails. The electrically charged, stand-and-ride personal transporter, an oft-parodied icon of the Silicon Valley tech world, quickly gained popularity among law enforcement and security agencies, as well as recreational tour operators around the world.

But the time for the original self-balancing standing scooter has come to a close. According to All Things Considered, Ninebot, the company that now owns Segway, will retire the device on July 15. But its creator, Dean Kamen, has bold new plans.

Kamen made a name for himself as an inventor of medical devices, including the insulin pump. Initially, the Segway grew out of his work on a self-balancing wheelchair. When the Segway launched in December 2001, Kamen believed the new device would transform cities, replacing cars and their pollution with residents gliding down green streets, each one on a segway, writes Liz Brody for OneZero. He told Time magazine it would be to the car what the car was to the horse and buggy.

Despite their widespread use, Segways never became the mobility machines of the future that Kamen dreamed, and in fact, have been criticized for being the cause of countless accidental injuries and deaths. But these incidents did not deter Kamen who, Brody writes, is still busy inventing. Kamen currently holds more than 440 patents in the United States and internationally. And, if successful, his next bright idea, unlike the Segway, might actually have a positive impact on human health: Kamen is now in the market to mass-produce human organs.

More than 110,000 people in the U.S. alone are in need of an organ transplant, and each day 20 people die waiting for a replacement organ. Those who do receive transplants can be at high risk of their body rejecting the organ. For those suffering from failing organs, some hope sprang in the 1990s when scientists began engineering human tissues.

Significant progress has been made in the field since the 90s, and just last year researchers from Tel Aviv University announced they were the first to bioprint a human heart, reports FreeThinks Kristen Houser. Using methods similar to those employed when 3-D printing solid objects from digital models, bioprinting uses living cells to create computer-generated tissue grafts.

Mass availability of lab-grown organs may seem far off to some, but Kamen is poised to spearhead production when the time comes. In 2016, Kamen teamed up with Martine Rothblatt, the head of biotech company United Therapeutics, who was, at the time, working on growing artificial lungs. According to OneZero, the two had already begun collaborating when they heard about a U.S. Department of Defense (DOD) grant opportunity for a scalable process of manufacturing human organs. Kamen and his collaborators won the $80 million DOD grant to manufacture replacement tissue and organs on-demand.

"We need to essentially make the printing press for the world of regenerative medicine, said Kamen at the time.

The grant kickstarted the formation of Advanced Regenerative Manufacturing Institute (ARMI), a nonprofit consortium of around 170 companies, institutions and organizations from across the country, which works hand-in-hand with Kamens BioFabUSA. With a staff and board of directors boasting FDA, Microsoft and Boston Scientific alumni, the group has continued to contribute and raise additional funds, and set up shop in a New Hampshire millyard.

This collaboration is what could enable Kamen to have the world-transformative impact hes hoped for. While other endeavors in the field have been siloedwith policy, robotics, organ and stem-cell research, and biotech engineering all operating more or less independentlynone have yet achieved the printing press factory model that Kamen described.

When youre in this industry and youre thinking about scale, you cant go to Home Depot, Michael Lehmicke, director of science and industry affairs at the Alliance for Regenerative Medicine, told OneZero. Whats unique about ARMI, is theyre thinking of how you would actually scale the system when it is fully commercialized.

Of course, while some have been critical, or at the very least skeptical of Kamens work in the past, Gizmodos Joanna Nelius, for one, is intrigued by the latest prospect.

I had knee surgery to replace my torn ACL over 10 years ago, but the cadaver tendon used to replace it disintegrated inside my joint, so Ive been living without that connective tissue for a decade, she writes. All thats left are two screws that once held it in place, one burrowed into my tibia and the other in my femur. If Kamens vision comes true, then perhaps in the future Ill have my own printed tissue put in its place.

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As Segway Retires, Its Inventor Gears Up to Grow Organs - Smithsonian Magazine

Hitachi and ThinkCyte to Develop an AI-driven Cell Analysis | ARC Advisory – ARC Viewpoints

Hitachi, Ltd and ThinkCyte, Inc. announced that they have entered into a collaboration focused on developing an artificial intelligence (AI)-driven cell analysis and sorting system. Hitachi and ThinkCyte are promoting collaboration with pharmaceutical companies and research institutes working in the field of regenerative medicine and cell therapy to expedite the development of the system toward commercialization.

Founded in 2016 and headquartered in Tokyo, Japan, ThinkCyte, is a biotechnology company that develops life science research, diagnostics, and treatments using integrated multidisciplinary technologies. It has been performing research and development focused on high-throughput single cell analysis and sorting technology to precisely analyze and isolate target cells. ThinkCyte has developed the Ghost Cytometry technology to achieve high-throughput and high-content single cell sorting and has been conducting collaborative research projects with multiple pharmaceutical companies and research institutes to utilize this technology in life science and medical fields.

Hitachi has been providing large-scale automated induced pluripotent stem (iPS) cell culture equipment, cell processing facilities (CPFs), manufacturing execution systems(MES), and biosafety cabinets among other products to pharmaceutical companies and research institutes, and has developed a value chain to meet a variety of customer needs in the regenerative medicine and cell therapy industry. Hitachi has also been carrying out collaborative research projects with universities, research institutes, and other companies to develop core technologies for pharmaceutical manufacturing instruments and in vitro diagnostic medical devices, prototyping for mass production, and working on manufacturing cost reduction and the development of stable and reliable instruments.

Hitachi and ThinkCyte have initiated a joint development of the AI-driven cell analysis and sorting system based on their respective technologies, expertise, and know-how. By combining ThinkCyte's high-throughput and high-content label-free single cell sorting technology and Hitachi's know-how and capability to producing stably operative instruments on a large scale, the two companies will together develop a novel reliable system to enable high-speed label-free cell isolation with high accuracy, which has been difficult to achieve with the existing cell sorting techniques, and to realize stable, low-cost and large-scale production of cells for regenerative medicine and cell therapy.

Hitachi and ThinkCyte will further advance partnerships with pharmaceutical companies and research institutes that have been developing and manufacturing regenerative medicines and cell therapy products in Japan and other countries where demand is expected to be significant, such as North America, in order to make this technology a platform for the production of regenerative medicines and cell therapy products.

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Hitachi and ThinkCyte to Develop an AI-driven Cell Analysis | ARC Advisory - ARC Viewpoints