Category Archives: Stem Cells

PRC Clinical to Provide Start-up CRO Services for BRTX-100 Phase 2 Clinical Trial

MELVILLE, N.Y., Nov. 19, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company" or BioRestorative) (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today announced that it has entered into a letter of intent with PRC Clinical, a CRO specializing in clinical trial management, with regard to PRC Clinical providing startup clinical project management activities for the Companys BRTX-100 Phase 2 clinical trial to treat chronic lumbar disc disease.

We are pleased to announce that we have entered into a letter of intent for PRC Clinical to provide startup activities for our Phase 2 study. PRC has extensive experience and expertise in managing clinical studies in the stem cell and regenerative medicine space. They also have the experienced and professional network of clinicians and study sites streamlining patient enrollment, site monitoring and management. Additionally, we have been working with and familiarizing ourselves with PRCs team and capabilities since 2019. We are thrilled to finally be in a position to begin the process of validating our technology through the FDA process, while keeping shareholders updated along the regulatory pathway, said Lance Alstodt, CEO of BioRestorative.

PRC Clinical has provided specialty CRO services for nearly 20 years. Their innovative approach to executing studies for biotech and pharmaceutical companies combines high-touch human elements and cutting-edge technology with extensive experience and deep therapeutic knowledge. PRC Clinical is an all inclusive CRO and has specialized expertise across regenerative medicine, CNS, ophthalmology, pulmonary and COVID-19, rare and orphan disease and more complex indications.

PRC Clinical is pleased to begin start-up CRO activities for BRTX-100. We look forward to being able to bring our stem cell experience to this trial. We are committed to supporting BioRestoratives development of BRTX-100 and its clinical application, said Curtis Head, CEO of PRC Clinical.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:

Email: ir@biorestorative.com

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BioRestorative Therapies Enters into Letter of Intent with PRC Clinical - BioSpace

TechFest events continue next week

In a series of online events as part of TechFests annual Festival of STEM, astounding scientific discoveries, theories and inventions from history will be investigated, opening up a world of thought-provoking research and possibilities.

Travelling back in time, the TechFest team has installed webcams in the 17th-century where audiences will have the chance to virtually meet one of Britains great geniuses, Sir Isaac Newton.

Using this modern-day technology, event attendees will be able to marvel at his amazing maths, gasp at gravity and feel moved by the forces of motion.

Taking place on Monday, November 22 at 7pm, Sir Isaac Zooms In! is presented by David Hall and suitable for ages eight and over.

This inspiring and interactive lecture will also explain how the seven colours of the rainbow were discovered by Newton himself, through his experiments with refraction of light.

Known for being the most complicated organ in the human body, the brain is highly researched with more discoveries and intelligence being made each day.

Digital festival goers can find out more about recent research, which shows how specific brain regions contain neural stem cells that can actually generate new neurons.

Join Dr Daniel Berg from the University of Aberdeen on Tuesday, November 23 at 7pm for How to Grow New Brain Cells, where he will discuss current knowledge on these stem cells and what we can to do activate them to renew.

Minds will be challenged on Thursday, November 25 at 7pm in Searching in the Dark.

Presented by Dr XinRan Liu from the University of Edinburgh, this highly engaging session questions if theres more than what can be seen, touch or felt.

Considering theories from the 19th-century, Dr XinRan Liu will discuss if there is more to the universe than what can be detected by powerful scientific tools.

Weaving in new evidence that strongly indicates a large percentage of the universe is in fact, dark matter, audiences interest will be piqued to explore more about a subject that scientists themselves are still unravelling.

Booking is now open for the events, which form part of TechFests 25 days of Live digital public programme.

Managing director of TechFest, Sarah Chew said: Each year, we try to include a variety of events that are thought provoking and inspirational to our audience.

Including scientific events which shows some of the initial discoveries that will forever go down in world history, as well as opening up conversations about research that is still going on in the field of dark matter, encourages individuals to be more actively involved in STEM and conduct their own research.

Science, technology, engineering and maths knowledge surrounds us every day whether thats understanding more about our internal organs, or the concept of daylight and rainbows, theres a subject matter to capture everyones interest.

The festival will wrap up on December 1 with Christmas content where audiences can then be directed to a STEM advent calendar for the remainder of the month.

TechFests festival of STEM is supported by joint principal sponsors, bp and Shell, with the public programme also being sponsored by Equinor.

Admission to all events is free.

For more information and to book, visit the TechFest website at http://www.techfestsetpoint.org.uk/

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TechFest zooms in on science through the ages - Grampian Online

It took just days for Pfizer and Moderna to design an effective mRNA vaccine against COVID-19 a breathtaking display of the power of this state-of-the-art mRNA technology.

By contrast it took years to design the first effective antiviral drugs against COVID-19, paxlovid and molnupiravir a dismal display of how very yesteryear drug development is.

The only reason these drugs appeared in the clinic within two years of the COVID-19 outbreak rather than ten was because they were salvaged from existing pipelines: paxlovid from a compound targeted against the SARS virus of 2002 and molnupiravir from a compound to target influenza. The normal timeframe of drug development is usually greater than ten years.

Its slow because it involves screening libraries for promising compounds and tweaking their chemistry to turn them into well-behaved drugs years of work before they can even begin to be tested in clinical trials.

Now, by taking a leaf from the mRNA vaccine playbook, that first phase of antiviral drug development the design might become lightning fast.

Last July Mohammed Fareh, a cancer researcher at Melbournes Peter MacCallum Cancer Institute (the Peter Mac) and Sharon Lewin, director of the Peter Doherty Institute, delivered a proof of concept. They made an RNA-based drug that killed SARS-CoV-2 in the culture dish all within a few weeks.

It could be a gamechanger, believes Lewin.

The big question is how to turn it into a treatment, says Melanie Ott, director of the Gladstone Institute of Virology in San Francisco, who was not involved in the research. Nevertheless, she shares the excitement. There is no shortcut when it comes to classical drug chemistry, so this is an opportunity to rethink our approach.

If the vision pans out, this could mark the dawn of an era where we beat viruses at their own evolutionary game. Designer drugs could be deployed within weeks to demolish new SARS-CoV-2 variants and other emerging viruses.

Prior to the pandemic, Farehs day job didnt revolve around shifty viruses but shifty cancers. Some cancer patients show an initial response to a drug. But within months the cancer cells evolve survival strategies, such as learning how to spit out toxic drugs, and resume their unbridled growth.

A diverse arsenal of weapons is needed to tackle these evaders.

In 2017, Feng Zhang at the Broad Institute in Massachusetts found such an arsenal: CRISPR-Cas13. Like CRISPR-Cas9, it is a customisable weapons system that bacteria use to defend themselves from even tinier invaders: the virus-like bacteriophage.

Because it can selectively snip DNA, scientists adapted CRISPR-Cas9 to edit the DNA of plants, animals and even people. Jennifer Doudna and Emmanuelle Charpentier won the 2020 Nobel Prize in Chemistry for those efforts, but Zhang was also a pioneer. Returning to fossick around the bacterial arsenal, he found another tool, CRISPR-Cas13, lurking in a species called Leptotrichia wadei.

But while Cas9 targets DNA, Cas13 targets RNA.

That opened up a new universe of possibilities. You wouldnt use Cas9 as a drug because you dont want to be messing with human DNA, except for the rare case of trying to correct a genetic illness like cystic fibrosis. On the other hand, Cas13 could be the basis of a powerful new class of drugs that target RNA, particularly the type known as messenger RNA (mRNA), which is crucial to executing the business of the cell.

If DNA is the leather-bound manual containing all the instructions for how to operate a cell, mRNA is a flimsy photocopy of just the page that is needed at any one time on the factory floor.

Messenger RNA is a highly strategic target if you want to interfere with what a cancer cell is doing. For Fareh and his lab head Joe Trapani, Cas13 offered the chance to target the instructions that were helping cancer cells escape drug treatments.

Thats because Cas13 operates like scissors that snip away at the photocopied page of instructions represented by mRNA. Just which page is snipped is determined by a smart guide: a small, customisable piece of RNA that is able to seek out matching mRNA and is attached to the scissors. For every new page of mRNA instructions, a new guide could be quickly designed and attached.

In early tests, Cas13 was able to selectively destroy mRNA produced by the cancer cell lines. Buoyed by their success, Fareh and Trapani were embarking on a collaboration with the Childrens Cancer Institute in Sydney when COVID-19 struck. Like many researchers who were not mobilised to the COVID offensive, they had to down tools.

Until they realised: Cas13 could easily be adapted to fight SARS-CoV-2.

All that was needed was the genome sequence of the virus. Fareh had that by 10 January 2020, when the data was released by Chinese researchers led by Yong-Zhen Zhang at Fudan University, China who had isolated and fully sequenced the virus. (This was also the moment Moderna and Pfizer started designing their vaccines.)

What Fareh didnt have was a way to test the Cas13 scissors on the virus. But the Peter Mac is in striking distance of the Doherty Institute, the major nerve centre of Australias COVID response. So in May 2020 Fareh and Trapani walked across the road to chat with Doherty head, Sharon Lewin.

Within a week, Fareh and his lab had decked out the Cas13 scissors with a guide that could seek out the SARS-CoV-2 mRNA instructions for manufacturing the spike protein. This is the bit that gives the virus access to cells. Because the virus can mutate its spike, Farehs team used a computer to predict the least-changeable part of the spike mRNA instructions as their target.

Working with Lewins team, they tested the tool on SARS-CoV-2 growing in green monkey kidney cells and human lung cells in culture dishes.

Cas13 obliterated the spike protein message and stopped the virus from proliferating.

Better yet, the shifty virus could not easily evade Cas13. When Farehs team mutated the virus by introducing single letter changes, Cas13 with its attached RNA guide continued to seek and destroy them. The tipping point was when the virus accrued three mutations.

But vanquishing a virus in culture dishes is just the first step.

The next step is to test Cas13 in mice that have been bred to be susceptible to COVID-19. It will also be tested in infected human cells washed from the nose, and in infected lung organoids: mini organs grown from human stem cells.

A crucial issue is how to turn Cas13 into a drug. Cas13 itself is a protein, but its all-important guide is made of flimsy RNA.

This is where the Melbourne team plan to leverage off the global RNA revolution. Thirty years ago, the idea that RNA could be used as a drug was laughable. Its fragility was only the beginning researchers also knew that injecting large amounts of it could trigger dangerous immune reactions.

But dogged pioneers engineered workarounds, substituting the RNA code letter uridine for pseudouridine, an alternative naturally-occurring code letter, which calmed the stormy immune response. And to protect the RNA, they packaged it in fatty capsules known as lipid nanoparticles.

These are the steps the Melbourne team will not have to reinvent. But still, the question remains: how can Cas13 be delivered into the body?

A nasal spray, says Lewin.

Used early in the infection or as a preventive treatment, the spray could stop the virus gaining a foothold in nasal cells before it invades the lungs, where the real damage is done.

Lewins group already has years of experience packaging drugs in lipid nanoparticles, as part of a strategy to target drugs to reach the HIV virus hiding deep inside some cells. The team aims to use this technology to deliver Cas13, says Lewin.

Despite borrowing from the RNA revolution, theres no doubt that developing the Cas13 delivery technology will take years.

But more funding will speed its passage. To that end, Lewin has wasted no time, weaving together a collaboration of several Australian groups as well as those in Israel, the US and Denmark to submit a proposal to a US$3 billion fund for COVID antivirals announced by the Biden administration on 17 June 2021.

It may well take years for the first Cas13 antiviral nasal spray to run the gauntlet of development pipelines and prove itself in the clinic.

But it will take weeks for the second.

Well be ready for the next pandemic, says Fareh.

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Learning from vaccines: the race to make antiviral drugs - Cosmos

LIBERTY, Mo., Oct. 26, 2021 /PRNewswire/ -- Vitti Labs (www.vittilabs.com), an AATB Accredited Tissue Bank focused on Life Science Research, Development and Manufacturing, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to conduct Phase II Clinical Trials using a combination of Umbilical Cord Mesenchymal Stem Cell and Umbilical Cord Mesenchymal Stem Cell Exosomes for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with the Novel Corona Virus (COVID-19). This marks the very first time the FDA has approved an IND that uses both of these components together and so first of its kind therapy.

This therapy is designed to suppress the pro-inflammatory processes in the pulmonary system that occurs in COVID patients, while simultaneously alleviating pulmonary distress, such as acute lung injury and inflammation as seen in ARDS (Acute Respiratory Distress Syndrome). In addition to its anti-inflammatory and anti-fibrotic properties, the combination therapy aims to reduce oxidative stress. This Phase II study will evaluate the utility of intravenous umbilical cord mesenchymal stem cells and exosomes in mitigating the pulmonary consequences of COVID-19. As this treatment has already shown tremendous promise in the treatment for ARDS associated with COVID-19, the completion of this Phase II Clinical Trial is expected to conclude in Q1 of 2022.

Philipp Vitti, Chief Scientist of Vitti Labs, stated, "We are very excited to be the first FDA Approved IND to have Umbilical Cord Mesenchymal Stem Cells and their Exosomes being utilized together as a multi-dose combination therapy for IV use. The preliminary trials have been overwhelmingly successful. Mesenchymal Stem Cells and their exosomes have unique therapeutic benefits, and together they create advanced therapeutic properties. This application approval is a great advancement in the ongoing progress to utilize Umbilical Cord Mesenchymal Stem Cells and Exosomes for different disease models, and Vitti Labs is excited and proud to contribute their resources to finding effective treatment options for the worldwide pandemic."

Story continues

About Vitti Labs

Vitti Labs is a cGMP certified, AATB accredited Tissue bank in Liberty, Missouri. They harvest biomaterials from the umbilical cord and placenta to utilize their properties to activate and support the repair of the body. Vitti Labs has a commercial division which focuses on human cellular tissue products. Vitti Labs' research and development division focuses on understanding various disease models and utilizing umbilical cord and placental derived Mesenchymal Stem Cells and Exosomes for therapies of those diseases.

For any media requests/inquiries: Miriam McKinney, 816-200-7959, 322286@email4pr.com

http://www.vittilabs.com

Cision

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SOURCE Vitti Labs

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Vitti Labs Announces FDA Approval of IND Application for Phase II Clinical Trial of Combination Mesenchymal Stem Cell and Exosome Treatment of Novel...

Umbilical cord blood or cord blood refers to the blood that stays inside the placenta and umbilical cord after delivery. Toward the end of term, maternal-fetal cell transfer takes place to better the immune system of both baby and mother, thereby preparing both for labor. Umbilical cord blood becomes a very rich source of stem cells. It also contains cells of the immune system. Umbilical cord blood refers to the process of collection of this cord blood, which is then extracted from the source and cryogenically frozen in its stem cells or other immune system cells. It is then stored for potential use for medical purposes in future.

Cord Blood America, Inc, Cryo-Cell International, Inc, Cordlife Group Limited, Cord Blood Registry Systems, Vita 34 International, and StemCyte Inc are few renowned companies in the globalumbilical cord blood banking market.

Transparency Market Research (TMR) has prepared a comprehensive study on the global umbilical cord blood banking market, for the period 2017 to 2025. The market is prophesized to rise at a promising growth rate of 11.4% CAGR during the period of review.

Request Brochure of Report - https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=19922

Rise in the Awareness to Fuel Growth of the Market in Asia Pacific

Considering geography, North America is likely to take lead in the global umbilical cord blood banking market. The regional dominance of North America in the market is attributed to increasing demand for umbilical cord blood for stem cell research. There are other factors as well that favor the growth of the market in years to come. Augmented investment by the various pharmaceutical companies coupled with improvement in the research and development infrastructure is likely to boost the global umbilical cord blood banking market.

The Asia Pacific region is likely to emerge as a rapidly growing region in the global umbilical cord blood banking market. With the presence of a huge untapped market in Asia Pacific and immense potential for growth is estimated offer fuel growth of the regional market. In addition, augmented awareness about the benefits of umbilical cord banking in the region, particularly in China and India, is forecasted support rise of the global umbilical cord blood banking market toward prominence.

TOC of Report - https://www.transparencymarketresearch.com/report-toc/19922

Rapid Technological Advancement Favor Growth of the Market in Forthcoming Years

The global umbilical cord blood banking market is likely to gather momentum mainly from the increasing awareness about its benefits across the globe. Blood forming stem cells find ample use in the treatment of several blood-related disorders. Apart from that, there is immense scope for the application of umbilical cord blood in the treatment of disorders that require cell-based therapies. Such preference for umbilical cord blood is owing to its capability of harvesting hematopoietic stem cells. Later on, these cells find use as an instant medical solution for many malignant as well as non-malignant blood diseases. Certain types of cancer, leukemia, few metabolic disorders, and sickle-cell anemia are some of the diseases that could be cured utilizing umbilical cord blood.

Buy Umbilical Cord Blood Banking Market Report at - https://www.transparencymarketresearch.com/checkout.php?rep_id=19922&ltype=S

The information shared in this review is based on a TMR report, bearing the title, Umbilical Cord Blood Banking market (Storage - Public Cord Blood Banks and Private Cord Blood Banks; Application - Cancers, Blood Disorders, Metabolic Disorders, Immune Disorders, and Osteoporosis; End User - Hospitals, Pharmaceutical Research, and Research Institutes) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2017 to 2025

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Umbilical Cord Blood Banking Market Size to Expand Significantly by the End of 2025 - BioSpace

Published: Oct. 27, 2021 at 4:30 AM EDT|Updated: 22 hours ago

FRANKFURT, Germany, Oct. 27, 2021 /PRNewswire/ European Wellness Academy (EWA), the educational arm of European Wellness Biomedical Group (EWG), has signed an agreement to carry out joint scientific research on the efficacy of peptides, cell therapy, exosomes and cell reprogramming for rejuvenation in premature murine aging models.

EWA was represented by its Group Chairman, Prof. Dr. Mike Chan, while Heidelberg University was represented by its Commercial Managing Director, Katrin Erk and its Head of Institute of Anatomy and Cell Biology III, Prof. Dr. Thomas Skutella.

The cutting-edge therapeutics used for the studies include precursor (progenitor) stem cells (PSC), precursor cells (Frozen Organo Crygenics (FOC)), Mito Organelle (MO), Nano Organo Peptides (NOP) and exosomes.

Their studies include in vitro experiments concentrating on the effects of the products on the aging of somatic cells and cellular senescence, which is known to contribute to disease onset and progression. Investigated exosomes include neuronal stem cells (NSCs), mesenchymal stem cells (MSCs), cardiomyocytes, kidney progenitors and hepatocytes.

EWA and Heidelberg University will also conduct in vivo experiments to demonstrate both safety and efficacy of the therapeutics, whereby the proof of effectivity will be recorded in the life span, histopathological and molecular criteria of neurodegeneration including Alzheimer/dementia, and system degeneration disorders including those affecting the immune system, skin, cardio, lung, kidney, liver, stomach/intestine/gut, eye, and muscular dystrophy.

Other criteria included are cartilage/joint/bone regeneration including knees/joints/hips, cervical, thoracic, lumbar, pelvic and musculoskeletal disorder, as well as endocrine disorders like endocrinal dysfunction due to over and underproduction of hormones and other activity pattern under the sleep wake cycle.

The ongoing specially designed studies are coordinated and designed by Prof. Dr. Thomas Skutella of Heidelberg University, a world-renowned research university and one of Germany's Top 3, Prof. Dr.Mike Chan and scientists of EWG.

European Wellness Academy

Located in Germany, Switzerland, Greece and Malaysia, EWA is a UK CPD authorised body with a premium training and development wing that revolves around cutting-edge Bio-Regenerative Medicine modalities for practitioners and researchers. The Academy has extensive years of combined clinical experience and a core academic team comprising of qualified clinicians and scientists with multiple international affiliations and accreditations.

https://ewacademy.euhttps://european-wellness.eu/

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SOURCE European Wellness Biomedical Group

The above press release was provided courtesy of PRNewswire. The views, opinions and statements in the press release are not endorsed by Gray Media Group nor do they necessarily state or reflect those of Gray Media Group, Inc.

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European Wellness Collaborates with Heidelberg University Germany to Conduct Efficacy Studies of Peptides and Cell Therapy Research -...

SEATTLE & SEOUL, South Korea--(BUSINESS WIRE)--Curi Bio, a global leader in development of human stem cell-based platforms for disease modeling and drug discovery, and NEXEL, a leader in induced pluripotent stem cell (iPSC) technology, today announced the formation of Celogics, a joint venture company focused on the development and commercialization of human iPSC-derived cell products for drug discovery, drug safety testing, and biological research. Celogics iPSC production and distribution headquarters will be located in Seattle, WA.

The US accounts for nearly 50% of the global stem cell market, and the Celogics joint venture partnership with market leader Curi Bio will represent a major strategic entry for Nexel into the US. Celogics will provide Nexels iPSC-derived cell products, including Cardiosight-S cardiomyocytes, to US and global markets, and will launch a Seattle-based iPSC production facility to support rapid growth and iPSC contract development and manufacturing services. Celogics will also develop and commercialize next-generation iPSC-derived cell products.

Curi Bio is a global leader in developing cardiac, skeletal muscle, and neuromuscular in vitro disease models, and provides market-leading products and services for modeling of human tissues for drug discovery. Curis 3D engineered tissue platform (Mantarray) can be used in combination with iPSC-derived cell models to develop advanced 3D heart and muscle tissue models for phenotypic screening. Curi Bio has previously been awarded more than $7M in grant funding by the US National Institutes of Health to support development of core technologies, including a proprietary approach for advanced functional maturation of iPSC-derived cardiomyocytes (ComboMat). By providing leading global pharmaceutical companies access to human-relevant models during preclinical drug development, Curi Bio helps leading pharmaceutical companies develop safer and more effective therapeutics in less time, at lower cost. NEXEL was the first Korean company to in-license iPSC technology and has advanced the in vitro toxicity field through successful commercialization of iPSC-derived cells that better mimic human cellular function.

Human iPSC-derived cells are rapidly becoming a vital tool in the drug development industry for the discovery, preclinical efficacy testing, and safety profiling of new medicines. iPSCs can be differentiated into a wide variety of human cell types, including cardiomyocytes, neurons, hepatocytes, and many others, and can be created from healthy individuals or patients who have specific diseases through a process called cellular reprogramming. iPSC-derived disease models serve as platforms for discovery of next-generation therapeutics.

Researchers in the pharmaceutical industry are increasingly relying on gene editing technologies such as CRISPR to create genetically-engineered iPSC-derived cellular models of human diseases, including cardiomyopathies and muscular dystrophies. Following major collaborative initiatives between US regulatory agencies and companies in the iPSC industry, human iPSC-derived cardiomyocytes are increasingly being used by leading global pharmaceutical companies in cardiac safety screening.

As a joint venture partnership between Curi Bio and Nexel, Celogics will be extremely well-positioned to meet the large and rapidly growing market need for high-quality human iPSC-derived cell products, said Curi Bio CEO Michael Cho. We look forward to helping cutting-edge researchers and pharmaceutical companies accelerate the discovery and development of next-generation therapies."

"Celogics is leading the global market with stem cell-derived somatic cell products for toxicity evaluation and drug discovery, said Nexel CEO Choong-seong Han. We are committed to developing and producing exceptional iPSCs that pharmaceutical quality control standards demand.

About Curi Bio

Curi Bios preclinical discovery platform combines human stem cells, systems, and data to accelerate the discovery of new medicines. The Curi Engine is a seamless, bioengineered platform that integrates human iPSC-derived cell models, tissue-specific biosystems, and AI/ML-enabled phenotypic screening data. Curis suite of human stem cell-based products and services enable scientists to build more mature and predictive human iPSC-derived tissueswith a focus on cardiac, musculoskeletal, and neuromuscular modelsfor the discovery, safety testing, and efficacy testing of new drugs in development. By offering drug developers an integrated preclinical platform comprising highly predictive human stem cell models to generate clinically-relevant data, Curi is closing the gap between preclinical data and human results, accelerating the discovery and development of safer, more effective medicines.

For more information, please visit http://www.curibio.com.

About NEXEL

NEXEL, Co., Ltd. is a bio-company that was incorporated in 2012 with proprietary stem cell technologies. Their philosophy is to make a better place by supporting innovative research around the globe by providing high quality stem cell-derived cell products. NEXEL, Co., Ltd. launched the Cardiosight-S in 2018 which has since been validated on multiple platforms as a pure and functional population of hiPSC-derived cardiomyocytes. Other product lines include the Hepatosight-S (iPS-derived hepatocytes) and the Neurosight-S (iPS-derived neurons).

For more information, please visit: http://www.nexel.co.kr

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Curi Bio and NEXEL Announce Celogics, Joint Venture to Develop Leading iPSC-derived Cell Products - Business Wire

-- Biohaven initiates a clinical trial of the novel antibody recruiting molecule BHV-1100 to assess safety, tolerability, and exploratory clinical activity in Multiple Myeloma

Published: Oct. 27, 2021 at 5:30 AM MDT|Updated: 19 hours ago

NEW HAVEN, Conn., Oct. 27, 2021 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), announced the enrollment of the first patient in a Phase 1a/1b trial in Multiple Myeloma using the ARM, BHV-1100, in combination with autologous cytokine induced memory-like (CIML) natural killer (NK) cells and immunoglobulin (Ig) to target and kill multiple myeloma cells expressing the cell surface protein CD38 (Figure 1). BHV-1100 is the lead clinical asset from Biohaven's ARM Platform, developed from a strategic alliance with PeptiDream Inc. This clinical trial will assess the safety and tolerability, as well as exploratory efficacy endpoints, in newly diagnosed multiple myeloma patients who have tested positive for minimal residual disease (MRD+) in first remission prior to autologous stem cell transplant (ASCT).

NK cells are part of the innate immune system, which is designed to recognize and destroy "non-self" or diseased cells in the body. However, tumor cells can evade detection by immune effector cells, allowing the tumor to advance. BHV-1100 targets a cell-surface protein, CD38, that is heavily overexpressed on multiple myeloma and binds to it, recruiting primed autologous cytokine induced memory-like (CIML) natural killer (NK) cells to destroy the tumor.

Charlie Conway, Ph.D., Chief Scientific Officer at Biohaven commented, "While many recent advances have been made to benefit multiple myeloma patients, most patients will unfortunately still relapse. We are excited to investigate BHV-1100 for its ability to recruit autologous CIML NK cells to the site of the tumor. Based on preclinical data from Biohaven Labs, we anticipate that our CD38 targeting ARM-enabled NK cells will kill CD38-positive multiple myeloma cells, and recruit other immune effector cells to assist in reducing the tumor burden."

Biohaven has initiated enrollment in the clinical trial and plans to enroll 25 patients for this single-center, open-label study (ClinicalTrials.gov Identifier: NCT04634435; https://clinicaltrials.gov/ct2/show/NCT04634435). The study will enroll newly diagnosed multiple myeloma patients who have minimal residual disease (MRD+) in first remission prior to an autologous stem cell transplant (ASCT).

David Spiegel M.D., PhD, inventor of the ARM technology and Professor of Chemistry and Pharmacology at Yale University, commented, "This is an important milestone in the development of the ARM therapeutic platform taking a novel technology from 'benchtop to bedside'. It also highlights Biohaven's commitment to benefit patients in need."

About ARMs: Antibody Recruiting Molecules

ARMs,antibody recruiting molecules, are engineered with modular components that are readily interchangeable, giving the platform tremendous flexibility and rapid development timelines. ARM compounds are being developed at Biohaven Labs to redirect a patient's own antibodies for therapeutic effect with multiple benefits over traditional monoclonal antibody therapies, including the potential for oral dosing. For BHV

1100, the ARM platform is being used to provide antigen targeting to NK cell-based therapies without genetic engineering. This NK cell targeting approach is also being investigated with allogeneic, or 'off-the-shelf', immune cell-based therapies.

About Multiple Myeloma Multiple myeloma is a type of blood cancer of the plasma cell that develops in the bone marrow, the soft tissue inside our bones. Healthy plasma cells produce antibodies, which are critical for the immune system's ability to recognize disease-causing entities, such as bacteria, viruses and tumor cells. In multiple myeloma, however, genetic abnormalities in a single plasma cell cause it to divide uncontrollably. This leads to the over-production of a single (monoclonal) antibody protein, referred to as an "M protein". Also, these cancerous cells divide to the point of crowding out normal, healthy cells that reside in the bone marrow. Many patients are diagnosed due to symptoms such as bone pain or fractures, kidney failure (thirst, dehydration, confusion), nerve pain, fever, and weakness. The American Cancer Society estimates that approximately 34,920 new cases will be diagnosed, and 12,410 deaths will occur in 2021 from multiple myeloma.

About BiohavenBiohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders and areas of unmet need. Biohaven's neuro-innovation portfolio includes FDA-approved NURTEC ODT (rimegepant) for the acute and preventive treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral sclerosis. More information about Biohaven is available atwww.biohavenpharma.com.

About PeptiDream PeptiDream Inc. is a public(Tokyo Stock Exchange 1st Section 4587) biopharmaceutical company founded in 2006 employing their proprietary Peptide Discovery Platform System (PDPS), a state-of-the-art highly versatile discovery platform which enables the production of highly diverse (trillions) non-standard peptide libraries with high efficiency, for the identification of highly potent and selective hit candidates, which then can be developed into peptide-based, small molecule-based, or peptide-drug-conjugate-based therapeutics. PeptiDream aspires to be a world leader in drug discovery and development to address unmet medical needs and improve the quality of life of patients worldwide. Further information regarding PeptiDream can be found at: http://www.peptidream.com.

Forward-looking Statement This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about BHV-1100 as a treatment for multiple myeloma. Forward-looking statements include those related to: Biohaven's ability to effectively develop and commercialize BHV-1100, delays or problems in the supply or manufacture of BHV-1100, complying with applicableU.S.regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be firstin class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission onMarch 1, 2021, and Biohaven's subsequent filings with the Securities and Exchange Commission. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC.Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

ARM is a trademark of Kleo Pharmaceuticals, Inc.

Biohaven ContactDr. Vlad CoricChief Executive OfficerVlad.Coric@biohavenpharma.com

Media ContactMike BeyerSam Brown Inc.mikebeyer@sambrown.com312-961-2502

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SOURCE Biohaven Pharmaceutical Holding Company Ltd.

The above press release was provided courtesy of PRNewswire. The views, opinions and statements in the press release are not endorsed by Gray Media Group nor do they necessarily state or reflect those of Gray Media Group, Inc.

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Biohaven Enrolls Phase 1a/1b Clinical Trial of BHV-1100, Lead Asset from its ARM (Antibody Recruiting Molecule) Platform, in Combination with NK Cell...

Harvard University and National Resilience, Inc. (Resilience), a manufacturing and technology company, have established a five-year R&D alliance with a $30 million commitment from Resilience directed toward the development of complex medicines, including biologics, vaccines, nucleic acids, and cell and gene therapies.

Under the alliance agreement coordinated by Harvards Office of Technology Development (OTD), Resilience will fund faculty-initiated research focused on certain novel therapeutic and biomanufacturing technologies pioneered in University labs. The alliance also anticipates that these Harvard innovations may be commercially advanced by new companies formed by Resilience expressly to drive these technologies into clinical development and commercialization.

An initial technology platform has already been identified for incubation under the alliance, with promising applications in skeletal muscle disorders. In the Harvard lab of Lee Rubin, professor of Stem Cell and Regenerative Biology, researchers have developed a means to culture millions of cells in vitro that behave like skeletal muscle stem cells (satellite cells), retaining their regenerative potential, for use in possible cell therapies. Resilience is now funding the labs continuing work on the platform, aiming to further validate it, in a project led by staff scientist Feodor Price.

Meanwhile, Resilience has formed an entity called Circle Therapeutics, anticipating that Circle may carry the technology forward under license.

For six decades since the discovery of the satellite cell, it has not been possible to expand therapeutic numbers of satellite cells in vitro, until we made real headway on it at Harvard, said Rubin. Were truly excited for the possible therapeutic impact of our innovations.

Our mission at Resilience is to make a new generation of complex medicines, such as curative gene therapies, life-saving vaccines and immune-system-boosting cell therapies, more accessible to people in need, said Rahul Singhvi, chief executive officer of Resilience. Current biomanufacturing processes pose significant hurdles to making these medicines quickly, and at scale, which is why we are excited to work with researchers at Harvard to identify and develop the technologies needed to make this future a reality.

The Rubin Labs platform to expand and maintain in vitro-derived satellite cells could lead to transformative cell therapies, said Vivian Berlin, executive director, HMS, at Harvard OTD, who leads OTDs Corporate Alliances team. With prior support from the Blavatnik Biomedical Accelerator, the team has compellingly demonstrated the clinical relevance of this work. Now with Resiliences focused funding and experience in the development of complex medicines, we hope to set it on a clear path toward benefiting patients.

Going forward, Resilience and Harvard will jointly issue a call for proposals to identify additional research projects to be funded at Harvard. Under the terms of the alliance, Resilience will receive an option to license technologies arising from funded projects.

This research alliance with Resilience will help support biomedical innovation at Harvard, said Isaac Kohlberg, Harvards chief technology development officer and senior associate provost. Collaborating to both advance Harvard science and place arising technologies with dedicated new ventures, we can provide yet another valuable source of support and industry expertise to translational biomedical researchers across Harvards Schools as they seek to impact human health for the better.

Link:
Harvard's R&D alliance with Resilience to advance manufacture of complex medicines - Harvard Gazette

Imagine youre about to go on a cross-country trip, stopping at spots along the way to admire local attractions. Youd probably want to have a road atlas handy, containing maps at different scales, covering both the major highways and the roads of smaller cities and towns or at least a GPS that can access a digital atlas with this information.

Until recently, cancer researchers have been like cross-country travelers with only a few maps of a few popular cities. And because of how fast some cancers grow, the maps quickly go out of date. This situation has hindered doctors ability to understand whats really going on inside tumors and develop effective treatments.

The Human Tumor Atlas Network (HTAN) was created to change that. It aims to develop high-resolution maps of many kinds of cancer so that doctors could have a more-complete view of the textured terrain of tumors including how they change over time to become more deadly. HTAN is funded by the National Cancer Institute and involves a consortium of cancer centers across the United States.

After several years of painstaking research, the first such atlas from investigators at Memorial Sloan Kettering Cancer Center for small cell lung cancer is now ready for viewing, and its full of new insights.

The most exciting thing we found is a rare population of stem-like cells within these tumors that is closely correlated with patient outcomes, explains Charles Rudin, a physician-scientist at MSK who co-led the lung cancer project. The more enriched they are in the tumor, the worse the prognosis.

Not only that, but these stem-like cells have metastatic properties meaning theyre prone to spread and researchers found them across many SCLC tumors that otherwise were very different.

That was a massive surprise, says Dana Peer, a computational biologist at MSK who is a principal investigator of the HTAN and co-led the lung cancer atlas project. It raises the possibility that this tiny fraction of cells could be driving metastatic behavior across tumors.

Small cell lung cancer is one of the deadliest cancers. It tends to spread early and aggressively; two-thirds of cases are already metastatic at diagnosis. Chemotherapy is not very effective. The researchers hope their new atlas, which was published October 14, 2021, in the journal Cancer Cell, will lead to improvements in care for people with the disease.

Building the atlas required years of collaborative work from two groups with very different areas of expertise: clinicians like Dr. Rudin with disease-specific expertise in small cell lung cancer and computational biologists like Dr. Peer and her team.

Dr. Rudin points to the fact that there are four co-first authors on the paper an unusual occurrence as evidence of the diversity of skillsets needed to complete a study like this. The co-first authors are Joseph Chan, lvaro Quintanal-Villalonga, Vianne Ran Gao, and Yubin Xie.

Dr. Peer, Chair of the Computational and Systems Biology Program at the Sloan Kettering Institute, took the lead on the computational side of things. She is an expert in single-cell RNA seq (scRNAseq), a technique that allows scientists to get a detailed picture of which genes are turned on in many hundreds of cells at the same time.

By applying scRNAseq to SCLC tumor specimens obtained from patients at MSK, Dr. Peer and her team were able to find this rare population of stem cell-like cells lurking amidst the cells of the surrounding tumor, like locating a needle in a haystack.

We would never have been able spot these cells with bulk sequencing. We really needed single cell analysis to find them.

We would never have been able spot these cells with bulk sequencing, she says. We really needed single cell analysis to find them. (Bulk sequencing is what researchers would do before scRNAseq was available essentially putting the tumor in a blender and sequencing all the RNA that fell out.)

The single cell technique also allowed the team to go further. Within the cells making up this tiny population, one gene stood out: PLCG2. This gene makes a protein that acts as a second messenger it relays signals from one protein to another.

PLCG2 did not initially strike me as the sort of gene that would be involved in regulating stem cell populations, Dr. Rudin says. It seems like more of a worker bee.

But indeed, PLCG2 does seem to be playing an important role. The gene is most highly expressed in this stem cell-like population, the scientists found. And when they experimentally increased or lowered its activity in cancer cell lines, it altered the ability of the cancer cells to metastasize.

They researchers think that these PLCG2-high cells could be part of the explanation for SCLCs aggressiveness. If so, it could open up new possibilities for treatment.

The thought is that if we can develop strategies to selectively target this cell population, we might be able to suppress metastasis and ultimately improve outcomes for patients with small cell lung cancer, Dr. Rudin says.

What we really want to do is try to stop metastasis in its tracks, Dr. Peer adds. But to do that, we need to better understand these rare cell populations that seem to be driving it. Thats the goal of this atlas.

Key Takeaways

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Molecular Atlas of Small Cell Lung Cancer Reveals Unusual Cell Type That Could Explain Why Its So Aggressive - On Cancer - Memorial Sloan Kettering