Regeneus gets green light to move personalized cancer vaccine into PhI

Australian biotech Regeneus is set to become the latest company to brave moving a personalized cancer vaccine into the clinic. The company picked up clearance from an ethics committee this week, clearing the last remaining obstacle between it and the start of an early-phase study.

Sydney, Australia-based Regeneus has promising early data from tests in dogs--71% of the 21 treated exceeded the forecast survival time--but is yet to trial its autologous tumor cell vaccine, RGSH4K, in humans. That will change imminently when the biotech begins a single-center, open-label Phase I dose-escalation study, in which it will process stored tumor samples to create vaccines designed to trigger an immune response when given to patients. Regeneus is looking to get a few things out of the small trial.

"We hope the trials will show that this personalized treatment is relevant to primary and secondary tumours and will reduce the risk of tumour recurrence. We're also hoping it will prove to be generally applicable and that, eventually, we can create a large number of vaccines from a single tumour sample," principal investigator Professor Stephen Clarke said in a statement. Clarke, along with fellow University of Sydney researcher Associate Professor Nick Pavlakis, is overseeing the trial at the Northern Cancer Institute in St Leonards.

Many biotechs have entered the clinic with such hopes--and more--only to find cancer vaccines are a particularly tough class of product to bring to market. Regeneus thinks its technology--which it licensed from Northern Sydney Local Health District (NSLHD)--can succeed where others have failed. RGSH4K is made by solubilizing the sample and mixing the then-exposed tumor-associated antigens with a bacterial protein. This mix is precipitated into microparticles, combined with Freund's incomplete adjuvant and administered intradermally to the patient.

Regeneus predicts the approach will induce immune memory and in doing so help patients to fight back against the recurrence of tumors. And, if RGSH4K overcomes the long odds and makes it to market, Regeneus expects its relatively-simple manufacturing process will insulate it from the cost of goods sold problems that contributed to Dendreon's downfall.

- read Regeneus' statement
- here's NSLHD's release
- and ProactiveInvestors' take