AlloVir, a portfolio company of ElevateBio, became the latest company to announce it has received an RMAT designation from the U.S. FDA with its June 11, 2019 announcement. AlloVir’s lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, Viralym-M (ALVR105), received the designation.
Viralym-M is being developed to treat BK virus-associated hemorrhagic cystitis after hematopoietic stem cell transplantation (HSCT). It is a “ready-to-administer” single T-cell product that can treat six different viral infections at the same time.
According to the company, “Following positive Phase 2 clinical data published in the Journal of Clinical Oncology (Tzannou, JCO, 2017), AlloVir is in the process of planning Phase 3 registrational studies of Viralym-M.”
Who is AlloVir, an ElevateBio Company?
Founded in 2013, AlloVir is late-clinical stage allogeneic T-cell therapy company, that became a portfolio company of ElevateBio, a cell and gene therapy holding company, in May 2019. At the same time, AlloVir announced a $120 million Series B financing led by Fidelity Management and Research Company and joined by seven other investors (Gilead Sciences, F2 Ventures, Redmile Group, Invus, EcoR1 Capital, Samsara, BioCapital, Leerink Partners Co- investment Fund, LLC).
AlloVir also raised substantial funds in previous rounds, to include:
- AlloVir raised $120M (Series B Investors) – May 23, 2019
- AlloVir raised $30M (Series A Investors) – Sept 17, 2018
- AlloVir raised $8.99M with a Grant from Cancer Prevention and Research Institute of Texas – Aug 18, 2017
Allovir’s RMAT Designation
RMAT stands for “Regenerative Medicine Advanced Therapy” designation. Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
Introduced in December 2016 as part of the 21st Century Cures Act, an RMAT designation can shorten time to market for innovative medicines.
Products eligible for an RMAT designation include:
- Cell therapies
- Gene therapies
- Therapeutic tissue engineering products
- Human cell and tissue products
- Combination products using such therapies or products
To date, 28 RMAT designations have been announced, with Allovir being the latest to announce its designation on June 11, 2019. Clearly, Allovir has the financial strength to pursue this promising “off-the-shelf” T-cell therapy through clinical trials and toward commercialization.
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