Teva Pharmaceutical Industries spun 89bio off late last year, working with venture capital group OrbiMed to create a biotech that began life with $60m (€54m) and an early phase treatment for diseases, including nonalcoholic steatohepatitis diseases (NASH).
89bio filed for an initial public offering (IPO) to secure the funding for the next stage of its evolution earlier this year and went on to raise $85m before costs, around $15m more than it initially expected to reel in.
In its IPO paperwork, 89bio detailed plans to spend $5m to $10m on manufacturing and scale up for BIO89-100, a glycoPEGylated analog of fibroblast growth factor 21, that is in development for NASH and severe hypertriglyceridemia (SHTG).
Contract manufacturing organizations (CMOs) look set to be the beneficiaries of 89bio’s plans to spend some of the IPO money on manufacturing and scale up.
In its IPO filing, 89bio wrote, “We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates, and we lack the resources and the capabilities to do so. As a result, we currently rely, and expect to rely for the foreseeable future, on third-party manufacturers to supply us with BIO89-100 and any future product candidates.”
89bio currently has a sole source relationship with Northway BiotechPharma, a Lithuania-based CMO specialized in biologics, for the supply of BIO89-100. Teva supplies reagents used in the production of the drug under an agreement that runs until the end of 2022.
The spinout’s need for supplies of BIO89-100 and, by extension, production capacity is set to grow as the drug moves deeper into clinical development.
89bio began a Phase Ib/IIa clinical trial in NASH patients in July. Data from the study are due in the second half of next year, beyond which 89bio plans to use the remaining proceeds from the IPO to start a Phase IIb trial in the indication.
In parallel, 89bio is working to test BIO89-100 in SHTG. A Phase II trial in the indication is due to start in the first half of 2020 and deliver topline data around one year later. 89bio is working on the trials with contract research organizations (CROs).
89bio thinks SHTG could offer a shorter path to market than NASH. This prediction is based on R&D programs run by other companies and regulatory guidance, which suggest to 89bio that the trials needed to get BIO89-100 to market in SHTG will be shorter and smaller than those for NASH.