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Mesoblast Limited is an Australian regenerative medicine company. It seeks to provide treatments for inflammatory ailments, cardiovascular disease, and back pain. The company is led by Silviu Itescu, who founded the company in 2004.[1]

History

In Mesoblast's annual report from August 2010, the company first announced positive results of preclinical trials showing radiographic and pathologic disc regeneration with MPC-06-ID. Mesoblast said they were in the process of completing an Investigational New Drug (IND) submission to the United States FDA to commence Phase 2 clinical trials.[2] In December 2010, Mesoblast entered into an agreement with US-based Cephalon to develop and commercialize novel adult Mesenchymal Precursor Stem Cell (MPC) therapeutics for degenerative conditions of the cardiovascular and central nervous systems.[3]

In September 2011, Mesoblast entered into an agreement with Swiss-based Lonza Group. Under the agreement, Lonza will manufacture the stem cells for Mesoblast's MPC cell products. Mesoblast will also have exclusive access to Lonza's Cell Therapy facilities in Singapore for the manufacture of allogeneic cell therapy.[4]

Osiris sold its MSC drug and patents to Mesoblast Ltd. in 2012.[5] In March 2014, Circulation Journal published the results of a clinical trial using MPCs as adjunctive therapy for patients with a Ventricular Assist Device.[6] In May 2014, Mesoblast announced it would receive incentives from the Singapore Economic Development Board (EDB) for activities in Singapore related to manufacturing operations, as well as product development and commercialization.[7]

On February 10, 2015, Mesoblast was granted a patent by the United States Patent and Trademark Office (USPTO) covering its proprietary Mesenchymal Precursor Cell (MPC) technology for use in the treatment of degenerated intervertebral discs.[8] On March 19, 2015, Mesoblast announced that it has been selected by the Japan External Trade Organization (JETRO) as the only regenerative medicine company worldwide to receive fast-track access to potential investment incentives across all levels of government in Japan[9] In June 2015, Mesoblast received $5.8 million from the Australian Government for Research and Development (R&D) activities conducted during the 2014 financial year. The funds were provided to Mesoblast under the Government's R&D Tax Incentive Program.[10]

In February 2016, Mesoblast's Licensee (JCR Pharmaceuticals Co., Ltd.) sold its first allogeneic cell product for the treatment of acute graft versus host disease (aGVHD) in children and adults in Japan. TEMCELL is the first allogeneic cell therapy to be fully approved in Japan.[11] In December 2016, Mesoblast and Mallinckrodt Pharmaceuticals entered into an agreement to exclusively negotiate a commercial and development partnership for MPC-06-ID in the treatment of chronic low back pain due to disc degeneration.[12]

Research

Mesenchymal lineage cells

Mesoblast products are largely derived from its proprietary mesenchymal lineage cells.[13] This includes Mesenchymal Precursor Cells (MPCs) and Mesenchymal Stem Cells (MSCs).

Focus areas

  • Back pain: Mesoblast's investigational product candidate MPC-06-ID is being developed.[8]
  • Rheumatoid Arthritis: On 24 March 2016 US patent 9,265,796 was granted for the use of Mesenchymal Precursor Cells (MPCs)for the treatment or prevention of rheumatic conditions, including rheumatoid arthritis, osteoarthritis, psoriatic arthritis, ankylosing spondylitis, sacroiliitis, enteric arthritis, and reactive arthritis.[14][15]
  • Crohn's disease: A trial was announced to evaluate Prochymal in moderate to severe Crohn's Disease.[16]
  • Graft versus host disease
  • Diabetic nephropathy: Mesoblast presented the results of a trial involving product candidate MPC-300-IV at the late-breaking scientific sessions of the 75th annual meeting of the American Diabetes Association.[17]
  • COVID-19 Acute Respiratory Distress Symptoms: In 2020, Ryoncil was tested on late-stage, ventilator-assisted COVID-19 patients with Acute Respiratory Distress Syndrome in the United States.[18][19]

Criticism

Mesoblast's solution for back pain came under heavy criticism from competitor Regenexx in August 2015. Dr. Chris Centeno said the trial results were "spit shined" with confusing and misleading language, press releases for phases 1 and 2 did not include images of MRIs to prove that discs were regenerated and expressed doubts about maintaining cell quality while mass-producing cells. He also said the host's immune system removes the injected stem cells.[20]

Financial performance

Mesoblast is listed as MSB on the Australian Securities Exchange (ASX), as MESO on the NASDAQ, and as MEOBF on the ATC Markets.

The company reported its financial results in November 2020.[21] As of September 30, 2020:

  • Cash on hand was $108.1 million
  • Net loss before tax $25.3 million
  • Cash outflows for Q1 FY21 were $24.5 million.

References

  1. ^ "BRW Rich 200 list 2014: 136. Silviu Itescu". BRW. Retrieved 13 June 2015.
  2. ^ http://ir.mesoblast.com/DocumentDownload.ashx?item=WH9llnmHhUKiM63h75M58w
  3. ^ Cephalon, Inc.; Mesoblast Limited (7 December 2010). "Cephalon and Mesoblast Enter Into Strategic Alliance to Develop... -- FRAZER, Pa. and MELBOURNE, Australia, Dec. 7, 2010 /PRNewswire-FirstCall/ --" (Press release).
  4. ^ "Mesoblast and Lonza partner to mass-produce stem cells".
  5. ^ Waltz, Emily (December 1, 2013). "Mesoblast acquires Osiris' stem cell business". Nature Biotechnology. 31 (12): 1061. doi:10.1038/nbt1213-1061. ISSN 1546-1696. S2CID 32036070.
  6. ^ Ascheim, D.D. (2014). "Mesenchymal Precursor Cells as Adjunctive Therapy in Recipients of Contemporary LVADs". Circulation. 129 (22): 1–52. doi:10.1161/CIRCULATIONAHA.113.007412. PMC 4243683. PMID 24682346.
  7. ^ Mesoblast (28 May 2014). "Mesoblast Accelerates Plans For Commercialization Manufacturing Operations In Singapore". GlobeNewswire News Room (Press release).
  8. ^ a b "News Announcements". Mesoblast.
  9. ^ Christine Bennett. "Home - Mesoblast Ltd". Mesoblast. Retrieved 13 June 2015.
  10. ^ http://ir.mesoblast.com/DownloadFile.axd?file=/Report/ComNews/20150605/01631222.pdf [bare URL PDF]
  11. ^ http://investorsmedia.mesoblast.com/phoenix.zhtml?c=187006&p=irol-news&nyo=0 [dead link]
  12. ^ http://investorsmedia.mesoblast.com/phoenix.zhtml?c=187006&p=irol-asxnews&nyo=0
  13. ^ "Ondek, Mesoblast and Sirtex investors roll the biotech dice | the Australian". Archived from the original on 2015-01-17. Retrieved 2014-11-07.
  14. ^ ASX. "KEY UNITED STATES PATENT GRANTED FOR CELL-BASED TREATMENT OF RHEUMATOID ARTHRITIS AND OTHER RHEUMATIC CONDITIONS" (PDF). Retrieved 24 Mar 2016.
  15. ^ US Patent 9265796, Peter Ghosh & Silviu Itescu, "Methods of treating or preventing rheumatic disease", published 2014-09-18, assigned to MESOBLAST, INC. 
  16. ^ Mesoblast. "Crohn's Disease". Mesoblast.
  17. ^ http://ir.mesoblast.com/DownloadFile.axd?file=/Report/ComNews/20150609/01631584.pdf [bare URL PDF]
  18. ^ Sheikh, Knvul; Thomas, Katie (May 8, 2020). "More Coronavirus Vaccines and Treatments Move Toward Human Trials". The New York Times. ISSN 0362-4331. Retrieved 2020-08-13.
  19. ^ Knapp, Alex (May 2, 2020). "Clinical Trials Of Mesoblast's Stem Cell Treatment For COVID-19 Set To Begin Soon". Forbes. Retrieved 2020-08-13.
  20. ^ "Did the Mesoblast Stem Cell Disc Trial Succeed or Fail? -Regenexx®". 5 August 2015.
  21. ^ http://investorsmedia.mesoblast.com/static-files/dcb7d445-8492-4f68-b8fb-f0cbb3c87685
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