Halozyme ($HALO) has numerous collaborations with biopharma bigwigs centered on its Enhanze drug delivery platform for moving from infusion-based to subcutaneous injectable-based formulations.
Now the company is focusing on deploying the delivery technology to its internal pipeline. It just announced the commencement of the Phase III trial of its previously untreated metastatic pancreatic cancer candidate, saying dosing of the medication has been initiated.
The key to Enhanze is its ability to degrade a chain of natural sugars known as hyaluronan, or HA. Doing so enables subcutaneous delivery for Roche's ($RHHBY) Herceptin and MabThera and Baxalta's ($BXLT) Hyqvia, and possibly for other candidates from partners such as Pfizer ($PFE) and AbbVie ($ABBV) as well.
Pancreatic cancer accumulates a high level of hyaluronan, contributing to a tumor microenvironment that acts as a physical barrier to drug delivery, the company says. Degrading hyaluronan to open constricted vessels could improve the ability of co-administered therapies to access the tumor.
Dr. Margaret Tempero
"High levels of HA have been associated with a worse prognosis in certain cancers, notably pancreas cancer," said principal investigator Dr. Margaret Tempero, director of the Pancreas Center at the University of California, San Francisco, in a statement. "We have assembled a team of expert investigators at nearly 200 global sites to further study this potential link with the hope of bringing new treatment options to an area of high unmet need."
The intravenous candidate is being tested in conjunction with Celgene's ($CELG) Abraxane and gemcitabine. The 420-patient trial aims to improve progression-free survival in those who use the candidate in combination with the two meds, compared to those who use the two meds plus a placebo.
Halozyme has said that 35% to 40% of metastatic pancreatic cancer patients have tumors with a high level of hyaluronan. Those patients will be identified using a companion diagnostic developed by Roche's Ventana Medical Systems. Halozyme said the FDA has approved the diagnostic's Investigational Device Exemption, enabling its usage in the ongoing Phase III clinical trial.
The candidate is also being developed as a treatment for lung, gastric and breast cancer.
- read the release