Following the FDA’s April 2010 landmark approval of Dendreon’s (NASDAQ:DNDN) Provenge as the first active vaccine for cancer, enthusiasm runs high for other immunotherapy companies to find similar success. But Miller appropriately urges caution.
In his May 12 article Finding the Next Dendreon, Miller employs his considerable industry experience to elucidate factors one should consider before investing in any cancer vaccine company.
By Miller’s criteria, Biovest, Accentia Biopharmaceuticals’ (OTC:ABPIQ) majority-owned subsidiary, has what it takes to become “the next Dendreon” by gaining conditional FDA approval for its lymphoma vaccine, BiovaxID.
Let’s examine Biovest under Miller’s standard for achieving success as a cancer vaccine company.
Miller notes that vaccine production failures are important:
The manufacturing success rate for Provenge is above 95%. If there is a manufacturing failure, it takes a few days to fix. This is one of two key advantages of Provenge compared to other active immunotherapies, and one almost nobody talks about. . .
So, the first question you ask of your prospective next Dendreon is, “What’s your manufacturing success rate and is there any peer-reviewed literature documenting it?” Anything under 90% should cause you to move to the next company.
BiovaxID handily meets this requirement, with a manufacturing success rate of 95% to 98%.
The National Cancer Institute’s Larry Kwak, MD, PhD, lead investigator in BiovaxID’s phase 3 clinical trial, discussed this issue in his plenary presentation at the 2009 American Society of Clinical Oncology. Dr. Kwak and his colleagues revealed in their ASCO abstract that only four manufacturing failures occurred.
Out of the 177 patients randomized in the trial, that’s a failure rate of 2.3%. Or, out of the 117 patients who actually received either vaccine or control, it’s a failure rate of 3.4%. And even if you count only the 76 patients who received the vaccine, it’s a failure rate of 5.3%. No matter how the peer reviewer will slice it in Dr. Kwak's forthcoming academic article on the trial, that’s an admirably low rate.
Angelos Stergiou, MD, Biovest's vice president of product development, stated after Dr. Kwak’s ASCO presentation that the BiovaxID manufacturing failure rate was only 2%: “The success rate in the BV301 study was actually 98 percent,” he said. “[That was the rate at which] we were able to successfully manufacture the vaccine.” His comment is at 32:50 in Dr. Kwak’s ASCO presentation video here.
Question number two is, “How fast can you manufacture the drug?” If the answer is longer than 14 days, look elsewhere.
This is true for Provenge and other treatments administered independently of chemotherapy, when time can be of the essence to arrest a cancer’s spread.
It’s not true for the BiovaxID vaccine, which is administered after immunosuppressive chemotherapy has induced remission of a patient’s lymphoma, and after the physician has waited at least another six months for the patient’s immune system to recover. In this setting, the vaccine need only take less time to manufacture than the waiting period for immune reconstitution. Currently, BiovaxID takes three months to manufacture, according to Dr. Stergiou (at 33:15 in the video above), well under the time it takes for a patient’s T-cell counts to recover enough to receive the vaccine.
In Part 2, we'll look at cancer vaccine technology and more.
Disclosure: Long BVTI.PK, ABPIQ.PK, and DNDN at time of writing. No company affiliation.