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Expert Rev Cardiovasc Ther. 2022 Jun 2. doi: 10.1080/14779072.2022.2085686. Online ahead of print.

ABSTRACT

INTRODUCTION: To date, the treatment option for tachyarrhythmia is classified into drug therapy, catheter ablation, and implantable device therapy. However, the efficacy of the antiarrhythmic drugs is limited. Although the indication of catheter ablation is expanding, several fatal tachyarrhythmias are still refractory to ablation. Implantable cardioverter-defibrillator increases survival, but it is not a curable treatment. Therefore, a novel therapy for tachyarrhythmias refractory to present treatments is desired. Gene therapy is being developed as a promising candidate for this purpose, and basic research and translational research have been accumulated in recent years.

AREAS COVERED: This paper reviews the current state of gene therapy for arrhythmias, including susceptible arrhythmias, the route of administration to the heart, and the type of vector to use. We also discuss the latest progress in the technology of gene delivery and genome editing.

EXPERT OPINION: Gene therapy is one of the most promising technologies for arrhythmia treatment. However, additional technological innovation to achieve safe, localized, homogeneous, and long-lasting gene transfer is required for its clinical application.

PMID:35655364 | DOI:10.1080/14779072.2022.2085686

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Gene therapy to terminate tachyarrhythmias - DocWire News

Dublin, May 30, 2022 (GLOBE NEWSWIRE) -- The "Cell and Gene Therapy Global Market Report 2022: By Product, By Application, By End-User" report has been added to ResearchAndMarkets.com's offering.

The global cell and gene therapy market is expected to grow from $6.58 billion in 2021 to $8.57 billion in 2022 at a compound annual growth rate (CAGR) of 30.2%.

The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges.

The market is expected to reach $21.33 billion in 2026 at a CAGR of 25.6%.

Major players in the cell and gene therapy market are Gilead Sciences, Bristol-Myers Squibb, Novartis AG, Amgen, Merck, Organogenesis Holdings, Dendreon, Vericel, Bluebird Bio and Fibrocell Science.

The cell and gene therapy market consist of sales of cell and gene therapies by entities (organizations, sole traders and partnerships) that develop cell and gene therapies. Cell therapy refers to the transfer of intact, live cells that are originated from autologous or allogenic sources and gene therapy refers to the introduction, removal, or change in the genome for treating diseases. The market consists of revenue generated by the companies developing cell and gene therapy products by the sales of these products.

The main types of products in cell and gene therapy are cell therapy and gene therapy. Gene therapy is a branch of medicine that focuses on modifying the genetic material of cells to achieve a therapeutic effect or to heal disease by repairing or reconstructing damaged genetic material. The different applications include oncology, dermatology, musculoskeletal, others and involves various sectors such as hospitals, ambulatory surgical centers, cancer care centers, wound care centers, others.

Steady investment and consolidation in cell and gene therapies contributed to the growth of the cell and gene therapy (CGT) market. After recognizing the potential of the CGT market, 16 out of the 20 largest biopharma companies by revenue, added CGT products to their portfolio.

For instance, Merck invested $109 million in viral vector and gene therapy manufacturing in April 2020. Moreover, 12% of industrial clinical pipeline products and at least 16% of preclinical pipeline products consist of CGT. Steady investment and consolidation in CGT production capacity led to an increase in production capacity and also contributed to the growth of the market.

Limited reimbursements preventing patients from receiving treatments are expected to limit the growth of cell and gene therapy (CGT market. In 2019, Trinity Life Sciences, a life sciences solution provider, researched national and large regional commercial health insurance plans in the US.

It found that the confluence of increasing price, patient volume and number of CGTs on the market is likely to change the reimbursement model for CGTs and impact payer budgets by 5-10%. Payers realize that financing needs to be generated for cost management due to the uncertainty surrounding reimbursement of ancillary costs. Limited reimbursements and uncertain insurance plans are preventing patients from receiving high-cost CGT, which is expected to limit market growth.

Chimeric antigen receptor (CAR) T-cell therapy is shaping the cell and gene therapy (CGT) market. (CAR) T-cell therapy is a combination of cell and gene therapy in which T cells are collected from the patient's blood and are genetically engineered to produce modified receptors at their surface, known as chimeric antigen receptors (CARs). These modified T cells with special structures (receptors) are reinfused into the patient.

Then, the modified receptors of T cell help in targeting the surface antigen of the cancer cell that ultimately results in the killing of tumor cells in patients. In 2020, the US-FDA approved Bristol-Myers Squibb's two CAR-T cell therapies to treat lymphoma and multiple myeloma and is set to be launched.

Currently, FDA approved CAR-T cell therapy treatments like Tisagenlecleucel for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in children and Axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Key Topics Covered:

1. Executive Summary

2. Cell and Gene Therapy Market Characteristics

3. Cell and Gene Therapy Market Trends And Strategies

4. Impact Of COVID-19 On Cell and Gene Therapy

5. Cell and Gene Therapy Market Size And Growth5.1. Global Cell and Gene Therapy Historic Market, 2016-2021, $ Billion 5.1.1. Drivers Of The Market 5.1.2. Restraints On The Market 5.2. Global Cell and Gene Therapy Forecast Market, 2021-2026F, 2031F, $ Billion 5.2.1. Drivers Of The Market 5.2.2. Restraints On the Market

6. Cell and Gene Therapy Market Segmentation6.1. Global Cell and Gene Therapy Market, Segmentation By Product, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

6.2. Global Cell and Gene Therapy Market, Segmentation By Application, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

6.3. Global Cell and Gene Therapy Market, Segmentation By End User, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

7. Cell and Gene Therapy Market Regional And Country Analysis7.1. Global Cell and Gene Therapy Market, Split By Region, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion 7.2. Global Cell and Gene Therapy Market, Split By Country, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/1mm93h

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Global Cell and Gene Therapy Markets, Analysis & Forecasts, 2016-2021, 2021-2026F, 2031F - Benzinga - Benzinga

Dive Brief:

Treatment of SMA has transformed over the six years since Biogen first gained approval for Spinraza. The disease was previously considered fatal for many babies born with the mutation that causes it. Even for those with less severe forms of the disorder, there were lifelong disabilities that often required use of a wheelchair or mechanical ventilation.

Until Evrysdi's latest approval, Spinraza was the only drug approved for all patients. Novartis' Zolgensma, which replaces the defective genes to stimulate production of an important muscle protein, is approved for children younger than 2 years old. The company has faced setbacks in trying to complete the clinical studies necessary to win approval in patients older than that.

With SMA's incidence estimated as once per every 10,000 births, the three drugmakers are all targeting a small group of patients with their treatments. While oral and therefore more convenient, Evrysdi must be taken every day. Spinraza, by comparison, is administered once every four months after a two-month loading period through the more invasive intrathecal injection. Zolgensma is intended to be a one-time treatment, although with the long-term safety of gene therapy still unclear, some parents could be more cautious about using it for their babies.

Spinraza is the biggest seller, with $473 million in sales in the first quarter of 2022, compared to $363 million for Zolgensma and about $236 million for Evrysdi. When the two Swiss drugmakers reported earnings, Novartis disclosed that Zolgensma had been used in about 2,000 patients worldwide and Roche said Evrysdi had been used in more than 5,000. (Roche's number includes those treated in clinical trials and compassionate use, however.)

Sales of both Zolgensma and Evrysdi are growing, at the apparent expense of Spinraza, sales of which shrank by 9% in the first quarter compared to the same period last year.

With all three drugs now approved for use in the youngest infants and two of the three available more widely, a new question is how these treatments might be used in sequence. All three, however, are costly: Zolgensma's one-dose list price is around $2 million, while Spinraza's list price is $375,000 a year at the maintenance dose and Evrysdicosts $340,000 annually.

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Roche SMA drug approved in youngest infants, challenging Novartis and Biogen - BioPharma Dive

New Jersey, United States TheGene Therapy Cell Culture Media Marketreport is the result of extensive and expert research into theGene Therapy Cell Culture Mediaindustry. TheGene Therapy Cell Culture MediaMarketreport explains what the market is all about, the market prognosis, several segmentations, and everything that falls under the markets umbrella. It also looks at major and secondary market drivers, market share, potential sales volume, regional analysis, and the markets key segments. The research also includes key variables that contribute to the markets growth as well as elements that might stifle the markets growth. The professionals at VM Reports applied precise research techniques and other analyses.

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Key Players Mentioned in the Gene Therapy Cell Culture Media Market Research Report:

Fujifilm Holdings Corporation, HiMedia Laboratories Pvt., Ltd, Lonza Group Ltd, Sartorius AG, Thermo Fisher Scientific Inc., Merck KGaA, Danaher Corporation, Takara Holdings Inc., Novartis International AG, Bio-Techne Corporation.

Gene Therapy Cell Culture MediaMarket Segmentation:

Gene Therapy Cell Culture Media Market, By Media Type

Serum-containing Media Serum-free Media Stem Cell Media Specialty Media Chemically Defined Media

Gene Therapy Cell Culture Media Market, By End User

Biotechnology & Pharmaceutical Industry Academic Institute Research Laboratory

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Gene Therapy Cell Culture Media Market Report Scope

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Gene Therapy Cell Culture Media Market Size, Scope and Forecast | Fujifilm Holdings Corporation, HiMedia Laboratories Pvt., Ltd, Lonza Group Ltd,...

AMSTERDAM--(BUSINESS WIRE)--VectorY, a biotech company focusing on the development of innovative gene therapy approaches for the treatment of neurodegenerative and muscular disorders through vectorized antibodies, today announced new data at the 2022 ENCALS meeting in Edinburgh.

The poster, which was presented on 1 June in McEwan Hall, d114, was titled Reduction of oxidized phospholipids or misfolded protein aggregates by AAV-VecTabs in ALS pre-clinical models (Sogorb-Gonzalez, M. et al). The new data demonstrate the therapeutic potential and versatility of VectorYs VecTab platform technology, enabling development of secreted or intracellular antibody fragments that are AAV-vectorized and delivered to neurons and/or astrocytes, in vitro and in vivo.

TAR-DNA binding protein-43 (TDP-43) is necessary for the correct processing and transport of multiple mRNAs that are essential for neuronal survival. Cytoplasmic mis-localized, misfolded or aggregated TDP-43 has been implicated in the pathogenesis of >97% of ALS patients. VectorY has confirmed that iPS-derived ALS motor neurons exhibit TDP-43 pathology. The Company has developed a library of single-chain variable fragments (scFv), named VecTabs, which are designed to exclusively bind to the misfolded, toxic TDP-43, while leaving the native TDP-43 functional. Todays new data show that TDP-43-targeting intracellular VecTabs can effectively clear (large) TDP-43 aggregates from U2OS cells. In addition, iPS-derived ALS motor neurons were efficiently transduced with AAV to express TDP-43 VecTabs in a dose-dependent manner.

TDP-43 pathology and mitochondrial dysfunction are closely linked to formation of oxidized phospholipid (oxPL) species, which are highly toxic to motor neurons. Recent in vivo and ex vivo data indicate a pivotal role for oxPL in axonal damage and motor neuron death in ALS.

VectorY has developed AAV-expressed secreted VecTabs that specifically bind and neutralize oxPL, thereby protecting iPS-derived motor neurons from oxPL-mediated cell death. The biodistribution and expression of VecTabs in the central nervous system were investigated in mice and pigs. The results presented today demonstrated transduction of the target spinal cord and cortical motor neurons and expression of the therapeutic scFv antibodies. Multiple humanized and optimized constructs were generated, leading to the selection of VTx-001 and VTx-002 for further development in ALS.

For more information or to meet the VectorY team at ENCALS, please contact info@vectorytx.com.

Notes to Editors

About VectorY

VectorY combines the therapeutic potential of antibodies and gene therapy to develop long-lasting therapeutic solutions for neurodegenerative and -muscular diseases with high unmet medical need. Founded in October 2020 and based in the Amsterdam Science Park, VectorY is a fully integrated gene therapy company focused on the development of innovative therapeutics based on a novel AAV gene therapy platform, antibody-based targeted protein degradation technologies and proprietary manufacturing technology. While focusing initially on neurodegenerative and -muscular diseases, VectorY's synergistic technologies may be applied across a wide range of indications. VectorYs manufacturing capabilities will include a state-of-the-art multi-product GMP facility in the Netherlands.

For more information, see http://www.vectorytx.com.

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VectorY presents new pre-clinical data at the European Network for the Cure of ALS (ENCALS) - Business Wire

BOSTON--(BUSINESS WIRE)--BDOs BioProcess Technology Group (BPTG), the world leader in providing strategic, technical, regulatory, and business consulting services to the biopharmaceutical industry, will be presenting at the upcoming 2022 BIO International Convention, June 13-16, 2022 in San Diego. The annual convention, hosted by Biotechnology Innovation Organization (BIO), is the worlds largest industry gathering and has returned live and in person for the first time since the start of the COVID-19 pandemic.

Patti Seymour, managing director in BDOs BioProcess Technology Group, will chair the panel about cell and gene therapy development, on Tuesday, June 14, from 12:00 PM to 12:45 PM at the Emerging Therapies Track within the BPI Theater. Her discussion will focus on factors impacting the decision to develop one therapy type over another.

Nick Vrolijk, Ph.D., managing director in BDOs BioProcess Technology Group, will chair a panel about business and manufacturing strategies for therapeutic cell and gene therapy modalities, on Wednesday, June 15, at the Emerging Therapies Track, within the BPI Theater from 12:00 PM to 12:45 PM. The roundtable discussion will cover new technologies to compress timelines, increase capacity and reduce costs for cell and gene therapy development.

BPTG has presented at this conference in 2019, and for several years prior, before being acquired by BDO. The four-day convention presents an opportunity for BPTG to demonstrate its expertise in bioprocess manufacturing to senior biotech executives, business development leaders and investors.

BDOs BioProcess Technology Group is proud to exhibit and speak alongside biotech and pharmaceutical organizations showcasing groundbreaking development at this years BIO Convention, said Patti Seymour, Managing Director of BDOs BioProcess Technology Group. These organizations are on the frontiers of medical breakthroughs, and were excited to show how we can partner to help them solve their greatest challenges including CMC product development, quality, regulatory and compliance, and manufacturing strategy and operations.

To learn more about BDOs Life Sciences practice and our services, connect with BPTG professionals at booth 1414 and Biodefense professionals at booth 5113.

Visit our website for a complete overview of BDOs presence at BIO 2022.

About BDOs BioProcess Technology Group

BPTG is the recognized worldwide leader in biologics CMC consulting, providing a full range of technical, regulatory, and strategic assistance to pharmaceutical and biotechnology companies in the development and commercialization of biopharmaceutical products. The company works with clients globally to find and apply solutions to the challenges of biopharmaceutical product development from clone to commercial. BPTG helps develop manufacturing processes and strategies that enhance the overall value of client companies, de-risk biopharmaceutical development, and accelerate the advancement of new products from clone to clinic. BPTG also helps investors, service providers, and companies make informed decisions by providing technical due diligence services and business evaluations of new products as well as technologies for product discovery, development, or commercialization. Learn more about BPTG and our services here. Follow us on Twitter.

About BDO USA

BDO is the brand name for BDO USA, LLP, a U.S. professional services firm providing assurance, tax, and advisory services to a wide range of publicly traded and privately held companies. For more than 100 years, BDO has provided quality service through the active involvement of skilled and committed professionals. The firm serves clients through more than 65 offices and over 740 independent alliance firm locations nationwide. As an independent Member Firm of BDO International Limited, BDO serves multi-national clients through a global network of more than 91,000 people working out of over 1,600 offices across 167 countries.

BDO USA, LLP, a Delaware limited liability partnership, is the U.S. member of BDO International Limited, a UK company limited by guarantee, and forms part of the international BDO network of independent member firms. BDO is the brand name for the BDO network and for each of the BDO Member Firms. For more information please visit: http://www.bdo.com and follow us on LinkedIn.

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BDO's BioProcess Technology Group to Present at the 2022 BIO International Convention - Business Wire

PARIS--(BUSINESS WIRE)--Regulatory News:

Lysogene (Paris:LYS) (FR0013233475 LYS), a phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, provided updated clinical data from the ongoing AAVance phase 2/3 clinical trial with the investigational gene therapy LYS-SAF302 for the treatment of MPS IIIA (NCT03612869) during the 25th Annual Meeting of the ASGCT (American Society for Gene & Cell Therapy) in Washington, DC.

The preliminary results from the AAVance study evaluating LYS-SAF302 in patients with Sanfilippo syndrome type A (MPS IIIA) who have been followed for at least two years demonstrated improvement, stabilization, or slowing down of decline in cognitive developmental age (DA) in about half of the patients. Notably, in all 6 patients enrolled under the age of 30 months, a persistent increase or stabilization of the cognitive, language and motor domains of the BSID-III was observed in the 24 months period post-treatment. Two (2) of these 6 patients, including 1 patient over 4 years of age, have already exceeded by several months the highest cognitive DA (35 months) observed in the natural history cohort. The 2 patients reached 41 and 42 months of cognitive DA in the 24 months period post-treatment with an increase of 25 and 17 months compared to their baseline, respectively.

These results, which suggest that younger patients are more responsive to the gene therapy treatment, need to be corroborated and confirmed by the final statistical analyses. They will also include secondary behavioral and imaging endpoints as well as data from the observational study in children treated with LYS-SAF302, using video and parent interviewing (also called the Patient Reported Outcome Videos [PROVide] study). Full results will be available in Q3 2022.

Considering these promising efficacy signals and the observed general trend towards stabilization and/or decrease of the total white matter lesional volume at injection sites, from 12 months post-treatment onwards, with no apparent clinically significant consequences, the company will plan further discussions with regulatory authorities to determine next steps.

Karen Aiach, Founder and CEO of Lysogene said: "We are pleased to share these promising efficacy data in patients treated with LYS-SAF302, after a 2-year follow-up period. The data show encouraging signals of efficacy on cognitive, language and motor development in young patients. We look forward to confirming and supporting these observations by analyzing all the data collected since the beginning of the study, including secondary behavioral and imaging endpoints and real-life behaviors assessed through the video study. Following this full analysis expected in Q3 this year, we will have all the necessary elements to discuss the path forward with the regulatory authorities. Karen Aiach added: "These promising data will support our effort to raise funds, which remains Lysogenes top priority. In a context of challenging market conditions for innovative life sciences companies, Lysogene is reviewing on an ongoing basis all options available to extend its cash runway.

AAVance is an open-label single-arm multicenter trial aimed at evaluating the effectiveness of a one-time intracerebral delivery of a recombinant adeno-associated virus vector rh.10 carrying the N-sulfoglucosamine sulfohydrolase (SGSH) gene (LYS-SAF302, olenasufligene relduparvovec) in children with MPS IIIA. MPS IIIA is caused by mutations in the SGSH gene, which produces an enzyme involved in the catabolism of heparan sulfate. LYS-SAF302 is intended to deliver a functional copy of the SGSH gene and allow the brain to secrete the missing enzyme.

About Lysogene

Lysogene is a gene therapy Company focused on the treatment of orphan diseases of the central nervous system (CNS). The Company has built a unique capability to enable delivery of gene therapies to the CNS to treat lysosomal diseases and other disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA is ongoing. An adaptive clinical trial in GM1 gangliosidosis is also ongoing. Lysogene is also developing an innovative AAV gene therapy approach for the treatment of Fragile X syndrome, a genetic disease related to autism. The Company also entered into an exclusive worldwide license agreement with Yeda, the commercial arm of the Weizmann Institute of Science, for a novel gene therapy candidate for neuronopathic Gaucher disease and Parkinson disease with GBA1 mutations. http://www.lysogene.com.

Forward Looking Statement

This press release may contain certain forward-looking statements, especially on the Companys progress of its clinical trials and cash runway. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice, (ii) factors beyond the Companys control, (iii) clinical trial results, (iv) increased manufacturing costs, (v) potential claims on its products. These statements may include, without limitation, any statements preceded by, followed by or including words such as target, believe, expect, aim, intend, may, anticipate, estimate, plan, objective, project, will, can have, likely, should, would, could and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Companys control that could cause the Companys actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. A further list and description of these risks, uncertainties and other risks can be found in the Companys regulatory filings with the French Autorit des Marchs Financiers, including in the 2021 universal registration document, registered with the French Markets Authorities on April 19, 2022, and future filings and reports by the Company. Furthermore, these forward-looking statements are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. If the Company updates one or more forward-looking statements, no inference should be drawn that it will or will not make additional updates with respect to those or other forward-looking statements.

This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.

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Lysogene Provides Clinical Update on AAVance Phase 2/3 Clinical Trial with Gene Therapy LYS-SAF302 for the Treatment of MPS IIIA at the 25th Annual...