Mesoblast

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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]

Contents

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 Food and Drug Administration to commence Phase 2 clinical trials. [2] In December 2010, Mesoblast entered into an agreement with U.S.-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 therapies. [4] In May 2014, Mesoblast announced it would receive incentives from the Singapore Economic Development Board (EDB) for activities in Singapore related to manufacturing operations, product development, and commercialization. [5] [6]

Osiris Therapeutics, a pharmaceutical company, sold its stem cell business and its related patents to Mesoblast in 2013. [7] [8] In March 2014, Circulation Journal published the results of a clinical trial using MPCs as adjunctive therapy for patients with a Ventricular Assist Device. [9]

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. [10] 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. [11]

In February 2016, Mesoblast's licensee, JCR Pharmaceuticals Co., Ltd., began marketing its MSC drug, Ryoncil, under the trade name TEMCELL. The company sold it as an 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. [12] [13] [14] [15] 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. [16] In June 2024, the company resubmitted a Biologics License Application with the FDA Ryoncil (TEMCELL) to treat children with steroid-refractory acute graft-versus-host disease (SR-aGVHD); in July of the same year, the government agency accepted the application. [17] A Phase III clinical trial began enrollment on July 22, 2024, of rexlemestrocel-L for patients with chronic low back pain caused by inflammatory degenerative disc disease. [18]

In December 2024, Mesoblast received regenerative medicine advanced therapy designation (RMAT) from the FDA for its drug Revascor (Rexlemestrocel-L) to treat children with regenerative heart disease. [19] [20]

Research

Mesenchymal lineage cells

Mesoblast products are largely derived from its proprietary mesenchymal lineage cells. [21] This includes Mesenchymal Precursor Cells (MPCs) and Mesenchymal Stem Cells (MSCs).

Focus areas

Criticism

Mesoblast's solution for back pain was criticized by competitor Regenexx in August 2015. Dr. Chris Centeno said the trial results contained confusing and misleading language, press releases for phases 1 and 2 did not include images of MRIs to prove that discs were regenerated and Centeno expressed doubts about mass producing cell quality. He also stated that the host's immune system removes the injected stem cells. [30]

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 June 2024. [31]

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References

  1. ↑ "BRW Rich 200 list 2014: 136. Silviu Itescu". BRW. Archived from the original on 10 May 2015. Retrieved 13 June 2015.
  2. ↑ "Mesoblast document". Archived from the original on 27 January 2014. Retrieved 27 September 2015.
  3. ↑ "Cephalon and Mesoblast Enter Into Strategic Alliance to Develop... -- FRAZER, Pa. and MELBOURNE, Australia, Dec. 7, 2010 /PRNewswire-FirstCall/ --" (Press release). Mesoblast Limited. 7 December 2010.
  4. ↑ "Mesoblast and Lonza partner to mass-produce stem cells". www.labonline.com.au. Retrieved 28 March 2024.
  5. ↑ Mesoblast (28 May 2014). "Mesoblast Accelerates Plans For Commercialization Manufacturing Operations In Singapore". GlobeNewswire News Room (Press release).
  6. ↑ “Mesoblast Limited SEC Filing.” Form 20-F, 31 Aug. 2021.
  7. ↑ Waltz, Emily (1 December 2013). "Mesoblast acquires Osiris' stem cell business". Nature Biotechnology. 31 (12): 1061. doi: 10.1038/nbt1213-1061 . ISSN   1546-1696. S2CID   32036070.
  8. ↑ Carroll, John (11 October 2013). "Osiris exits stem cell business, sells unit to Mesoblast in $100M deal | Fierce Biotech". www.fiercebiotech.com. Retrieved 11 December 2024.
  9. ↑ 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.
  10. ↑ "News Announcements". Mesoblast. Archived from the original on 15 February 2015. Retrieved 15 February 2015.
  11. ↑ Report mesoblast.com [ dead link ]
  12. ↑ “First Allogeneic Cell Therapy Product Launched in Japan by Mesoblast Licensee.” GlobeNewswire News Room, Mesoblast Limited, 24 Feb. 2016.
  13. ↑ “Mesoblast Limited Partner JCR Pharmaceuticals Files for Marketing Approval of the First Allogeneic Stem Cell Product in Japan.” BioSpace, 1 Oct. 2014.
  14. ↑ “Mesoblast Limited SEC Filing.” Form 6-K EX-99.2, 25 Mar. 2019.
  15. ↑ “Mesoblast Faces FDA Pushback over Cell Therapy Manufacturing, Clinical Data: Documents.” Journal for Clinical Studies, 13 Aug. 2020.
  16. ↑ "ASX Announcements | Mesoblast". Archived from the original on 9 November 2018. Retrieved 28 March 2024.
  17. ↑ "FDA accepts remestemcel-L BLA to treat steroid-refractory acute graft versus host disease". Contemporary Pediatrics. 24 July 2024. Retrieved 12 December 2024.
  18. ↑ Priyan, Vishnu (22 July 2024). "Mesoblast begins subject enrolment in Phase III back pain treatment trial". Clinical Trials Arena. Retrieved 12 December 2024.
  19. ↑ Tan, Adrian (5 December 2024). "Mesoblast's Revascor gets FDA nod, but shares dip". Finance News Network. Retrieved 12 December 2024.
  20. ↑ Barrie, Robert (11 March 2024). "Mesoblast eyes accelerated approval filing for heart failure cell therapy". Clinical Trials Arena. Retrieved 12 December 2024.
  21. ↑ "Ondek, Mesoblast and Sirtex investors roll the biotech dice | the Australian". Archived from the original on 17 January 2015. Retrieved 7 November 2014.
  22. ↑ "Graft vs. Host Disease (GvHD)". Cleveland Clinic. Archived from the original on 26 November 2024. Retrieved 13 December 2024.
  23. ↑ "Will Mesoblast's Heart Failure & Chronic Low Back Pain Trial Data Readouts Be Heartening Or Painful?". RTTNews. Retrieved 13 December 2024.
  24. ↑ ASX. "KEY UNITED STATES PATENT GRANTED FOR CELL-BASED TREATMENT OF RHEUMATOID ARTHRITIS AND OTHER RHEUMATIC CONDITIONS" (PDF). Retrieved 24 March 2016.
  25. ↑ USPatent 9265796,Peter Ghosh&Silviu Itescu,"Methods of treating or preventing rheumatic disease",published 2014-09-18, assigned to MESOBLAST, INC.
  26. ↑ Vosough, Massoud, et al. “Mesenchymal Stromal Cell Therapy Improves Refractory Perianal Fistula in Crohn’s Disease: Case Series Clinical Interventional Study.” Cell Journal, U.S. National Library of Medicine, Feb. 2022.
  27. ↑ Reportmesoblast.com Archived 14 June 2015 at the Wayback Machine
  28. ↑ Sheikh, Knvul; Thomas, Katie (8 May 2020). "More Coronavirus Vaccines and Treatments Move Toward Human Trials". The New York Times. ISSN   0362-4331 . Retrieved 13 August 2020.
  29. ↑ Knapp, Alex (2 May 2020). "Clinical Trials Of Mesoblast's Stem Cell Treatment For COVID-19 Set To Begin Soon". Forbes. Retrieved 13 August 2020.
  30. ↑ "Did the Mesoblast Stem Cell Disc Trial Succeed or Fail? -Regenexx®". 5 August 2015.
  31. ↑ “Mesoblast Limited SEC Filing.” Form 6-K EX-99.1, 18 Aug. 2024.
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