Gentibio Inc. has raised $157 million to develop its engineered regulatory T cells (Tregs), setting itself a target to cure type 1 diabetes and treat other diseases caused by the immune system. Boston-based Gentibio launched in August last year with $20 million seed funding from Orbimed, Novartis Venture Fund and RA Capital. Those investors stayed on into the next round, which was led by Matrix Capital Management with participation by Avidity Partners and JDRF T1D Fund.
There’s a lot of competition in the regulatory T cells (Tregs) space and that’s a sign that something good is happening. Sonoma Biotherapeutics Inc. CEO Jeff Bluestone likened it to a typical drive leading to an everyday observation.
LONDON – Topas Therapeutics GmbH announced the close of a series B round at €40 million (US$47.5 million), to take forward its two lead immune tolerizing programs. The first, TPM-203, is in clinical development for the treatment of the rare, severe autoimmune skin disorder pemphigus vulgaris, while the second, TPM-502, is due to enter the clinic in celiac disease before the end of the year.
Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 May 27 that the benefits of Provention Bio Inc.’s teplizumab outweighed its risks, but the vote was not a ringing endorsement of the anti-CD3 monoclonal antibody biologic that could be the first disease-modifying treatment for people at risk of developing type 1 diabetes (T1D).
Provention Bio Inc.’s diabetes candidate, teplizumab, is heading into a May 27 advisory committee meeting with a skinnier label than originally planned, which could signal a smoother path to approval. The positive briefing document the FDA put out Tuesday also suggested an approval path for what could be the first disease-modifying treatment available for type 1 diabetes (T1D).
If the FDA follows the advice of its Cellular, Tissue and Gene Therapies Advisory Committee, the U.S. could soon see its first approved islet transplant therapy, but few expect it to be broadly used. The adcom voted 14-9 April 15, with one abstention, that Celltrans Inc.’s donislecel, or cadaveric allogenic pancreatic islet cells, has an overall favorable risk-benefit profile for some patients with type 1 diabetes.
If the FDA follows the advice of its Cellular, Tissue and Gene Therapies Advisory Committee, the U.S. could soon see its first approved islet transplant therapy, but few expect it to be broadly used. The adcom voted 14-9 April 15, with one abstention, that Celltrans Inc.’s donislecel, or cadaveric allogenic pancreatic islet cells, has an overall favorable risk-benefit profile for some patients with type 1 diabetes.
The FDA told Provention Bio Inc. that its BLA under priority review for teplizumab needs some work but the May 27 advisory committee meeting to discuss the application in full is still on the calendar.
“We’re launching at the right time,” said Frank Sanders, president of Zealand Pharma A/S’s business in the U.S., in the wake of clearance granted by the FDA for the Copenhagen, Denmark-based firm’s glucagon analogue Zegalogue (dasiglucagon) in severe hypoglycemia.
