|Halozyme CEO Helen Torley|
A month after Genmab and Johnson & Johnson's ($JNJ) Janssen released successful mid-stage data for its multiple myeloma antibody daratumumab, Halozyme ($HALO) has jumped on board, planning a Phase I trial with its subcutaneous delivery technology.
The candidate marks San Diego-based Halozyme's first in its collaboration with Janssen, inked in December last year. That agreement--worth an initial $15 million for Halozyme and up to $566 million in milestones--gave Janssen access to the delivery company's Enhanze technology, which uses a human enzyme found in the extracellular matrix to aid in the dispersion and absorption of injected drugs.
In early February this year, Genmab and J&J had analysts humming about a fast-track approval down the road for daratumumab, the CD38 monoclonal antibody the companies hope to bring to market in the first half of 2016. The 124-patient Phase II trial from Janssen achieved an overall response rate of 29.2% for a median of 7.4 months in 124 patients who had already received at least three different lines of treatment.
The antibody is the first of up to 5 targets Janssen can develop using Enhanze under the current agreement. And for Halozyme, this is just one of several Big Pharma partnerships with Enhanze as the main focal point. Roche ($RHHBY), Pfizer ($PFE) and Baxter ($BAX) are also looking to make use of the subcutaneous biologics and small molecule enhancer. Baxter's Halozyme-partnered immunodeficiency treatment HyQvia won FDA approval last year.
Halozyme is, however, coming off an unexpected flop from 2013, in which ViroPharma cut short its Cinryze trial mid-stage, leaving partner Halozyme flapping in the wind. But the other products in the works then figured more heavily into analysts' expectations than Cinryze ever did, Halozyme's then-CEO Gregory Frost said at the time. Helen Torley has since stepped into the CEO role.
Daratumumab picked up an FDA breakthrough designation in 2013, and while the current results limit it to a salvage therapy, Janssen is hoping to expand upon its label. Late-phase trials as a first-line treatment in combination with other multiple myeloma drugs such as Celgene's ($CELG) Revlimid and Takeda's Velcade are underway.
- here's the release