The government set the maximum reimbursement price of the worlds first CAR-T cell therapy Kymriah (tisagenlecleucel), developed by Novartis, at 360,039,359 won ($296,138) per treatment.

It also newly established reimbursement for medical practices for cell collection, in vitro treatment, treatment preparation, and treatment injection that accompany CAR-T cell therapy.

On Thursday, the Ministry of Health and Welfare held a Health Insurance Policy Review Committee meeting and decided to revise the list of reimbursed drugs and the maximum reimbursement rates.

Kymriahs reimbursement will be valid from Friday.

Regarding the application of the risk-sharing system to Kymriah, the government decided to grant an increase in health insurance coverage for both two indications -- B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma.

To indicate diffuse large B-cell lymphoma, the government decided to apply a performance-based risk-sharing agreement (RSA) on a patient-by-patient basis. Therefore, patients without any treatment effect will have an additional refund.

On Thursday, the Korea Leukemia Patients Organization (KLPO) welcomed the news of Kymriah's reimbursement.

There is no better news than this for some 200 patients who are at risk of dying within three to six months if they did not receive Kymriah treatment, the patient group said.

The government authorities must thoroughly manage Kymriahs effects and side effects so that the refund-type RSA and expenditure cap RSA of 70.9 billion won per year, which are conditions for Kymriah's health insurance listing, but the performance-based RSA applicable only to lymphoma are properly implemented, it added.

KLPO said Kymriah, which was the nations first high-tech biological drug to win the license and health insurance coverage, will become the role model in reimbursement for ultra-expensive CAR-T therapies.

KLPO predicted that there would be more CAR-T therapies available in the market, including Zolgensma (onasemnogene abeparvovec), a CAR-T treatment for spinal muscular atrophy (SMA) seeking reimbursement, and Luxturna (voretigene neparvovec), gene therapy for inherited retinal disease.

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Reimbursement price of CAR-T cell therapy Kymriah set at $296138 - KBR

Olympus, a leadingmanufacturer of optical and digital precision technology, has announced a partnership with evorion biotechnologies, a pioneer in advanced single-cell analysis using unique microfluidic systems. By merging evorions3D hydrogel bead technology and Olympusmicroscope systems, the collaboration introduces a seamless and largely automated workflow solution to capture functional phenotypes of individual cells behaviour over time. This workflow enables researchers to reveal novel insights into thousands of cell-cell interactions in a 3D microenvironment, facilitating advanced single-cell research across applications such as adoptive cell therapy, cancer research and immunology.

The combination of OlympusIXploremicroscope systems and cellSenssoftware with evorions innovative CellCity system and CellCity Scout-AI software makes high-resolution live-cell analysis applications both easy and accessible. By encapsulating thousands of single cells or cell pairs into hydrogel beads and immobilising them on evorions CellCity Array Chip, researchers can monitor and image the functional phenotypes of cells in a physiologically relevant 3D microenvironment. High-resolution images of thousands of individual live cells are made possible by Olympus IXplore microscope systems, and the workflow can accommodate the IXplore Live, IXplore Spin or IXplore SpinSR system for exceptional 3D super-resolution imaging. Fast data analysis is facilitated by theCellCity Scout-AI software, which uses AI algorithms to automatically select positions of interest on the CellCity Array Chip and send the trackable coordinates to the IXplore system for further in-depth imaging.

A powerful aspect of the workflow is the ability to perform multi-modal analyses at single-cell resolution, enabling researchersfor the first timeto correlate time-resolved functional phenotypes with immunostaining, single-molecule RNA FISH analysis in a highly parallelised manner. Biomedical researchers can now obtain a more holistic understanding of dynamic cell behavior to drive advances in therapeutics.

Dr. Sebastian Bhren, CEO of evorion biotechnologies, commented, Early on we recognised theimpact that the CellCity platform could have on research fields like adoptive cell therapy, cancer immunotherapy and solid tumor treatment. We are excited to partner with Olympus, a renowned company with a global reach. Our partnership will allow us to bring our innovative platform to a wider audience and work together in advancing single-cell research by integrating the leadingimaging systems of Olympus into our innovative CellCity workflow.

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Partnership to advance cell therapy research - Scientist Live

Ontario says it will provide a $40-million loan to the Centre for Commercialization of Regenerative Medicine for its planned $580-million Hamilton facility where life-science companies can develop and commercialize cell and gene therapies.

The CCRM, a non-profit industry group, said Thursday that the facility will be run by a new subsidiary called OmniaBio Inc., which will operate what it hopes to become the largest contract development and manufacturing facility for these therapies in Canada. Up to 2,000 people could be employed at the planned 400,000-square-foot facility by 2026, and it is expected to it take on life-sciences companies of all sizes as clients.

The Alliance for Regenerative Medicine, an international advocacy group for the sector, said in 2021 that there are nearly 1,200 cell- and gene-therapy developers worldwide with more than 1,300 continuing clinical trials. This growing field of therapies treats or prevents diseases with technologies that alter genes or cells in the human body.

CCRM said the new facility would help improve the supply of cells and other biological tools for these therapies and trials in a market where demand for them is five times greater than whats currently available.

Michael May, the chief executive officer of CCRM, said in an interview that his organization has been working toward such a facility since launching nearly a decade ago. From Day 1, we understood that to drive commercialization and create companies that stay in Ontario, we needed to build manufacturing capability and capacity, he said.

The organization has built that capacity gradually, including through a partnership with the MaRS Discovery District entrepreneurship centre and the University Health Network to manufacture therapeutics for use in clinical trials. CCRM has been working over the past three years on developing the Hamilton facility, which was first announced in 2020. There is already a pipeline of potential customers, added Mr. May, who is also OmniaBios chair.

Of the $580-million costs, he said that $480-million would come from the private sector for real estate and construction at the McMaster Innovation Park. The remaining $100-million would be directed toward OmniaBios operations, and includes the $40-million loan from the province and a further $60-million from the private sector.

Economic Development Minister Vic Fedeli said that OmniaBio was the first-ever client for the provinces new Invest Ontario agency, which has earmarked $400-million to encourage businesses to set up in the province over the next four years. He told The Globe and Mail that he hoped the loan would be a signal to other businesses that his government wants to establish Ontario as a biomanufacturing hub.

It tells all of the vaccine and medical manufacturers that were open for business, he said. But it also tells the Ontario patients that theyre going to be able to have access to breakthrough technology, innovative medicines, right here with a with a made-in-Ontario stamp on it.

The provincial Progressive Conservatives used the Thursday OmniaBio news to announce they would make efforts to encourage life-sciences companies to set up in Ontario, establishing a council of medical experts and private-sector leaders to guide its work. The government said it plans to bring more vaccine, medicine, personal-protective-equipment and medical-supply manufacturing to the province.

The province also said it would work to encourage more Ontario businesses to commercialize their research, and to more easily allow locally made innovations to be used in the health care system removing roadblocks that Mr. Fedeli acknowledged in March could be a problem for innovators in the province.

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New gene- and cell-therapy manufacturing facility to launch in Hamilton with $580-million commitment - The Globe and Mail

DUBLIN, April 4, 2022 /PRNewswire/ --The "Global CAR-T Cell Therapy Market, By Product Type, By Tumor Type, By Indication, By Treatment Type, By Targeted Antigen, By End User, By Region, Competition, Forecast and Opportunities, 2017-2027" report has been added to ResearchAndMarkets.com's offering.

The Global CAR-T Cell Therapy Market value in the year 2021 was valued at USD1709 million that is anticipated to grow with CAGR of 64.66% during the forecast period, 2023-2027 to achieve market value of USD33153.30 million by 2027F.

Increasing instances of cancer among the world population and thus increasing death rate due to cancer is driving the growth of the Global CAR-T Cell Therapy Market in the upcoming five years. Rapidly growing clinical trial activities, proliferative M & A activities, and lucrative IPOs are majorly responsible for the growth of the Global CAR-T Cell Therapy Market in the next five years.

Consistent researches on cancer and its treatment along with the advancement in the therapeutics are further substantiating the growth of the Global CAR-T Cell Therapy Market in the future five years. Increasing demand for the effective cancer treatment for the growing number of people suffering from cancer along with the flourishing pharmaceutical industry producing products and therapies for the cancer are also responsible for the growth of the Global CAR-T Cell Therapy Market in the forecast years through 2027.

Although side-effects of the CAR-T cells therapy and high cost of treatment making it unaffordable to the financially challenged population may restrain the growth of the market. Government schemes, tax incentives, along with insurance policies for the treatment and increasing number of NGOs working for providing in-expensive treatment to the patients lacking financial support may aid the growth of the Global CAR-T Cell Therapy Market in the forecast period.

The Global CAR-T Cell Therapy Market is segmented by product type, tumor type, indication, treatment type, targeted antigen, end-user, regional distribution, and competition landscape. Based on treatment type, the market is further segmented into single treatment and combination treatment.

Single treatment is anticipated to hold the largest revenue shares of the market and dominate the market segment in the upcoming five years on grounds of increasing cases of cancer among the population. Increasing awareness about the cancer diagnostics and early recognition of the tests are responsible for the patients opting for single treatment.

Cancer in early stages can be treated with single treatments. The combination treatments are recent developments where multiple therapies are involved together to stop the cancer tumor development, to remove the lumps, and even alter the genetic information.

Objective of the Study:

Report Scope:

Years considered for this report:

CAR-T Cell Therapy, By Product Type:

CAR-T Cell Therapy Market, By Tumor Type:

CAR-T Cell Therapy Market, By Indication:

CAR-T Cell Therapy Market, By Treatment Type:

CAR-T Cell Therapy Market, By Targeted Antigen

CAR-T Cell Therapy Market, By End-User:

CAR-T Cell Therapy Market, By Region:

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global CAR-T Cell Therapy Market.

For more information about this report visit https://www.researchandmarkets.com/r/sesih9

Media Contact:

Research and Markets

Laura Wood, Senior Manager

press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470

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View original content:https://www.prnewswire.com/news-releases/global-car-t-cell-therapy-markets-competition-forecast-and-opportunities-2027---rapidly-growing-clinical-trial-activities-proliferative-ma-activities-and-lucrative-ipos-301516604.html

SOURCE Research and Markets

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Global CAR-T Cell Therapy Markets, Competition, Forecast and Opportunities, 2027 - Rapidly Growing Clinical Trial Activities, Proliferative M&A...

Dublin, April 05, 2022 (GLOBE NEWSWIRE) -- The "Global CAR-T Cell Therapy Market, By Product Type, By Tumor Type, By Indication, By Treatment Type, By Targeted Antigen, By End User, By Region, Competition, Forecast and Opportunities, 2017-2027" report has been added to ResearchAndMarkets.com's offering.

The Global CAR-T Cell Therapy Market value in the year 2021 was valued at USD1709 million that is anticipated to grow with CAGR of 64.66% during the forecast period, 2023-2027 to achieve market value of USD33153.30 million by 2027F.

Increasing instances of cancer among the world population and thus increasing death rate due to cancer is driving the growth of the Global CAR-T Cell Therapy Market in the upcoming five years. Rapidly growing clinical trial activities, proliferative M & A activities, and lucrative IPOs are majorly responsible for the growth of the Global CAR-T Cell Therapy Market in the next five years.

Consistent researches on cancer and its treatment along with the advancement in the therapeutics are further substantiating the growth of the Global CAR-T Cell Therapy Market in the future five years. Increasing demand for the effective cancer treatment for the growing number of people suffering from cancer along with the flourishing pharmaceutical industry producing products and therapies for the cancer are also responsible for the growth of the Global CAR-T Cell Therapy Market in the forecast years through 2027.

Although side-effects of the CAR-T cells therapy and high cost of treatment making it unaffordable to the financially challenged population may restrain the growth of the market. Government schemes, tax incentives, along with insurance policies for the treatment and increasing number of NGOs working for providing in-expensive treatment to the patients lacking financial support may aid the growth of the Global CAR-T Cell Therapy Market in the forecast period.

The Global CAR-T Cell Therapy Market is segmented by product type, tumor type, indication, treatment type, targeted antigen, end-user, regional distribution, and competition landscape. Based on treatment type, the market is further segmented into single treatment and combination treatment.

Single treatment is anticipated to hold the largest revenue shares of the market and dominate the market segment in the upcoming five years on grounds of increasing cases of cancer among the population. Increasing awareness about the cancer diagnostics and early recognition of the tests are responsible for the patients opting for single treatment.

Cancer in early stages can be treated with single treatments. The combination treatments are recent developments where multiple therapies are involved together to stop the cancer tumor development, to remove the lumps, and even alter the genetic information.

Objective of the Study:

Report Scope:

Years considered for this report:

CAR-T Cell Therapy, By Product Type:

CAR-T Cell Therapy Market, By Tumor Type:

CAR-T Cell Therapy Market, By Indication:

CAR-T Cell Therapy Market, By Treatment Type:

CAR-T Cell Therapy Market, By Targeted Antigen

CAR-T Cell Therapy Market, By End-User:

CAR-T Cell Therapy Market, By Region:

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global CAR-T Cell Therapy Market.

For more information about this report visit https://www.researchandmarkets.com/r/bg6oxl

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Global $33+ Billion CAR-T Cell Therapy Markets, 2017-2021 & 2022-2027: Focus on Yescarta, Kymriah, Tecartus, Breyanzi, Abecma - GlobeNewswire

Neurona Therapeutics

SAN FRANCISCO, April 01, 2022 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, announced the presentation of preclinical data from its lead inhibitory neuron cell therapy candidate, NRTX-1001. NRTX-1001 is being evaluated in a Phase 1/2 clinical trial in people with drug-resistant mesial temporal lobe epilepsy. The data are being presented at the annual meeting of the American Academy of Neurology (AAN) held April 2-7, 2022 in Seattle, WA.

These studies were part of an important body of work that supported the design of our first-in-human clinical trial and provided important insight into potential biomarkers using magnetic resonance spectroscopy (MRS) to correlate neurometabolic changes with seizure reduction following NRTX-1001 administration, said Cory R. Nicholas, Ph.D., Neuronas president and chief executive officer. We are excited to have begun recruiting for the clinical trial and to evaluate the safety and efficacy of NRTX-1001, which has the potential to improve quality of life for people living with drug-resistant focal epilepsy.

The data, generated from a single targeted administration in a preclinical model of chronic mesial temporal lobe epilepsy, demonstrate that the NRTX-1001 inhibitory neurons persisted in the epileptic hippocampus for the duration of the 7-month study, were well-tolerated, and resulted in significant seizure suppression. The activity of NRTX-1001 was not perturbed by co-administration of the common anti-seizure drugs levetiracetam or diazepam. Moreover, the NRTX-1001-treated group exhibited significantly less mortality and reduced hippocampal sclerotic pathology compared to controls. Of translational relevance as a potential biomarker of seizure reduction, non-invasive 1H MRS analysis revealed a metabolic signature of the epileptic hippocampus that was corrected to normal, non-epileptic levels following NRTX-1001 administration.

About Neuronas Clinical Trial of NRTX-1001 for MTLENeuronas multi-center, Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of a single administration of NRTX-1001 for drug-resistant mesial temporal lobe epilepsy (MTLE). The first stage of the trial is an open-label dose-escalation study in up to 10 people with MTLE. The second stage will consist of a randomized, blinded investigation of NRTX-1001 compared to a control group to determine safety and efficacy in up to 30 people with MTLE. Patient recruitment is underway at epilepsy centers across the United States. For more information, please visit http://www.clinicaltrials.gov (NCT05135091).

Story continues

About NRTX-1001NRTX-1001 is a regenerative neural cell therapy derived from human pluripotent stem cells. The fully-differentiated neural cells, called interneurons, secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Delivered as a one-time dose, the human interneurons are intended to integrate and innervate on-target, providing long-term GABAergic inhibition to repair hyperexcitable neural networks that underlie epilepsy, as well as other disorders of the nervous system.

About Mesial Temporal Lobe Epilepsy (MTLE)MTLE primarily affects the internal structures of the temporal lobe, where seizures often begin in a structure called the hippocampus. MTLE is the most common type of focal epilepsy. For some people with seizures that are resistant to drugs, epilepsy surgery, where the damaged temporal lobe is surgically removed or ablated by laser, can be an option. However, the current surgical options are not available or effective for all, are tissue-destructive, and can have significant adverse effects.

About NeuronaNeuronas regenerative neural cell therapies have single-dose curative potential. Based on a novel neural cell lineage developed by the companys scientific founders, Neurona has built a robust regenerative platform and is developing off-the-shelf, allogeneic neuronal, glial, and gene-edited cell therapy candidates that provide long-term integration and repair of dysfunctional neural networks for multiple neurological disorders. For more information about Neurona, visit http://www.neuronatherapeutics.com

Neurona TherapeuticsInvestor and Media Contacts:

Sylvia WheelerWheelhouse LSAswheeler@wheelhouselsa.com

Elizabeth Wolffe, Ph.D.Wheelhouse LSAlwolffe@wheelhouselsa.com

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Neurona Therapeutics Presents Preclinical Data at the American Academy of Neurology (AAN) Annual Meeting from Lead Cell Therapy Candidate, NRTX-1001,...

Granting Resolution an Option to a Commercial License to panCELLa's FailSafe and iACT StealthCells Technology

London and Toronto, 5 April, 2022 - Resolution Therapeutics Limited ("Resolution"), a biopharmaceutical company developing macrophage cell therapy to treat advanced liver disease, and panCELLa Inc, ("panCELLa") a private biotechnology company which makes cell lines incorporating therapeutic cell-focused Platform Technologies that are widely available for the treatment of degenerative, infectious and malignant diseases, today announced a research collaboration to develop iPSC-derived macrophage cell therapies. Under the agreement, panCELLa is providing its hypo-immunogenic engineered iPSC technology to Resolution. Resolution is using its proprietary macrophage engineering and manufacturing technology to develop "off-the-shelf" macrophage cell therapies. As part of this agreement Resolution has an option to obtain commercial rights to use the panCELLa technology in the field of macrophage biology.

panCELLa, a specialist in developing cell-based therapies for a broad range of diseases, provides safe therapeutic cell products. Under the terms of the collaboration, Resolution will have access to two of panCELLa's platforms, FailSafeTM and induced Allogeneic Cell Tolerance (iACT Stealth CellsTM), which paves the way for Resolution to progress the development of its allogeneic macrophage programme, expanding the Company's pipeline with iPSC-derived macrophages. This technology has the potential to guarantee long term engraftment of cells, which, in turn, could enable an unprecedented level of safety. Specifically, the iACT Stealth CellsTM protect the implanted cells from the patient's immune system offering long-term allogeneic-tolerance without the need for immune suppression. FailSafeTM is a superior safety switch. Unlike others, it will not be lost or silenced as it is precisely linked to cell division. Any time that cells deregulate or "go rogue" they can be eliminated while still allowing the therapeutic non-dividing cells to continue to do their work.

"We are thrilled to partner with panCELLA, a pioneer in the development of safe iPSC-derived cell therapies," said Edward Hodgkin, Chairman and CEO of Resolution. "We believe panCELLa's technology has the potential to overcome the dual challenge of preventing host immune rejection of allogeneic cell therapy, while adding to their safety, which will be key to delivering durable patient benefit."

"Resolution technology and innovation are impressive and we believe in their plan for the development of macrophage cell therapy for advanced liver disease," said Mahendra Rao, Chairman of panCELLa." Resolution is well-positioned to develop off-the-shelf products that maintain optimal macrophage function with prevention of immune rejection, which are critical for persistent engraftment of cells and clinical benefit."

Resolution is developing macrophage cell therapies to repair inflammatory organ damage, with a focus on treatment of end-stage chronic liver disease. Macrophages are cells of the innate immune system which orchestrate the body's defence against infection and injury; the company is built upon more than a decade of work in the Founders' laboratories characterising the role of macrophages in organ repair, including the liver, both in the pre-clinical and clinical settings.

panCELLa aims to make its therapeutics cell focused Platform Technologies widely available for the treatment of degenerative, infectious and malignant diseases. panCELLa continues its internal R&D efforts to develop additional novel uses of its platform technologies in areas such as bio-production, cancer vaccination and tolerization.

The terms of the collaboration have not been disclosed.

- Ends -

Further information:

JW Communications

Julia Wilson

+44 (0)7818 430877

juliawilsonuk@gmail.com

Notes for Editors:

About Resolution

Resolution Therapeutics is a biotechnology company developing macrophage cell therapies to treat advanced liver disease. The Company is built upon more than a decade of work in the Founders' laboratories characterising the role of macrophages in organ repair, including the liver, both in the pre-clinical and clinical settings. Resolution will discover, develop, and take to market macrophage cell therapies based on its proprietary platform of macrophage biology, cell engineering and manufacturing processes. http://www.resolution-tx.com

About panCELLa

Founded in 2015, panCELLa is a privately-held early-stage biotechnology firm based on the innovative technology developed in Dr. Andras Nagy's lab at the Sinai Health System (SHS). panCELLa has created platforms that allow for the development of safe, universal, "off-the-shelf" cell lines. To learn more, visit https://pancella.com

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Syncona : Resolution Therapeutics and panCELLa Inc announce a Research Evaluation & Option Agreement to develop iPSC-derived macrophage cell...