echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Biochemistry News > Biotechnology News > How "fire" is there in gene/cell therapy under the outbreak?

    How "fire" is there in gene/cell therapy under the outbreak?

    • Last Update: 2020-09-16
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Today, the Pharmaceutical Mingkang content team will share the highlights of this report with readers.
    The number of companies working to develop regenerative medicine therapies worldwide exceeded the 1,000 mark for the first time in the first half of 2020, with 415 companies entering clinical development, according to ARM.
    of these, 515 companies are committed to gene therapy, 632 are developing cell therapy, and 136 are developing tissue engineering/biomass technologies (some are also dedicated to the development of multiple technology areas).
    Photo Source: Supplied Silicon Valley Bank's investment and financing report for the first half of 2020 has pointed out that investment and financing in the healthcare sector is showing a "reverse-flow upward" trend under the new crown outbreak.
    the first half of 2020 in the field of regenerative medicine, which mainly develops gene and cell therapies.
    ,700 million U.S. dollars in the first half of the year, up 120 percent from the same period in 2019, according to the ARM report. Whether it's an early venture capital investment or a late IPO, regenerative medicine companies are doing at record levels.
    first half of this year, five gene and cell therapy companies, including Nanjing Legend, Passage Bio, Akouos, Generation Bio and Beam Therapeutics, made successful IPOs.
    30, 2020, 1,078 clinical trials are underway worldwide to test the effectiveness of different regenerative medicine therapies in treating hundreds of serious diseases.
    , 394 were phase 1 clinical trials, 587 phase 2 clinical trials and 97 phase 3 clinical trials.
    highest proportion of cell-based cancer immunotherapy (including CAR-T, TCR cell therapy, tumor immersion T-cell therapy, etc.) and 471 clinical trials are under way.
    Photo Source: Resources: In terms of adaptation, 665 clinical trials focused on oncology, accounting for 62% of the total number of clinical trials.
    other more clinical trials include musculoskeletal diseases (58), endocrine, metabolic and genetic diseases (55), central nervous system diseases (52), and cardiovascular diseases (45).
    first half of this year, several cell and gene therapies in the late stages of development reached important milestones.
    , for example, Kite Pharma's CAR-T therapy KTE-X19 and BMS's CAR-T therapy liso-cel are both eligible for FDA-granted priority reviews and are expected to be approved for listing this summer (KTEX-X19 was approved by the FDA on July 24).
    Ryoncil, a cell therapy developed by Mesoblast, is also eligible for FDA-granted priority review for graft anti-host disease.
    note that regenerative medicine development companies are also experimenting with cell therapy to treat COVID-19 patients as the new coronary disease sweeps the globe.
    arm statistics show that there are currently 11 clinical trials using regenerative medicine therapy to treat COVID-19, and another 25 research and development projects are in the preclinical development stage.
    many companies are using interstitial stem cells (MSCs) and other substring cells to treat ACUTE respiratory distress syndrome (ARDS) caused by COVID-19, including Mesoblast, Athersys, Pluris Therapeutics, and others.
    these allogeneic cell therapies can be frozen in advance and defrosted and infused to patients when needed.
    regulators continue to help develop innovative therapies, while the new crown outbreak is under heavy pressure from regulators around the world, both the FDA and the EUROPEAN EMA need to drain significant time and manpower to handle COVID-19-related regulatory applications.
    , the FDA and EMA have not slowed down in supporting regenerative therapies.
    according to ARM, in the first half of 2020, the FDA issued a total of seven Advanced Regenerative Medicine Therapies (RMAT) qualifications, and the EMA issued PRIME qualifications for one gene therapy and one cell therapy.
    recognition, which aims to accelerate the development and review process of research projects, reflects the efforts of the FDA and EMA to promote the development of regenerative therapies.
    , CRISPR Therapeutics and Vertex developed a gene-editing therapy for sickle cells and beta thalassemia, CTX001, which received RMAT in May this year.
    other treatments for RMAT include Novarma's CAR-T treatment Kymriah (treatment of filamentous lymphoma), Immunicum's cell therapy for renal cell carcinoma, tissueTech's tissue engineering therapy for spina bifida, and more.
    EMA has jointly developed gene therapy for Melia GTx and Janssen to treat X-series retinal pigmentation, and Viralym-M, a cell therapy developed by AlloVir to treat severe viral infections in immunodeficiency patients.
    conclusion arm pointed out that there is no denying that the new crown outbreak will affect the progress of a number of clinical trials, including regenerative therapy clinical trials.
    pressure on regulators from the outbreak could delay the review and launch of regenerative therapies in the future.
    face these challenges, ARM expects several regenerative medicines to be submitted for regulatory applications and approval in the second half of this year.
    they promise to change patients' lives in the long term.
    Resources: s1. Retrieved August 9, 2020, from.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Related Articles

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.