TVAX Biomedical

Human kidney cancers (renal cell carcinomas) are highly immunogenic, which means that patients’ cancers are susceptible to TVAX Immunotherapy.  When patients are vaccinated with their own attenuated cancer cells and a powerful immunological adjuvant such as GM-CSF, kidney cancer patients routinely develop immune responses against their own cancers.

Phase IIa kidney cancer trial data demonstrated that TVAX Immunotherapy could be a more effective treatment for advanced metastatic kidney cancers than any currently available kidney cancer treatment and is considerably less toxic than any of them.  TVAX Immunotherapy has already caused several treated patients’ cancers to regress and generated many long-term survivors among treated patients.  One of those phase IIa studies using an earlier, less potent, more toxic version of TVAX Immunotherapy was published in the prestigious Journal of Clinical Oncology¹.  The results of that study can be summarized as follows.  Thirty-four renal cell carcinoma patients received a complete course of treatment during the phase IIa study.  The phase IIa study documented a twenty-six percent response rate (five partial and four complete responses) and, most importantly, highly significant (p < 0.0001) prolongation of survival of responders compared to non-responders.  The durations of the complete responders were >48, 45, >35 and 12 months.  The durations of the partial responses were >63, 48, 15, 12 and 4 months.  At the time of publication of the study, eight of the nine (89%) responders were alive >2 years following treatment.

A second group of investigators has performed a similar, but smaller phase IIa clinical trial of a less toxic, but more powerful version of TVAX Immunotherapy.  In that study, eight out of ten treated patients had significantly prolonged survival.  One of those is described below as case report one.

Additional clinical trials will have to be performed to determine exactly how effective the current version could be.  However, the outcomes that already have been produced likely will be improved upon in upcoming trials.  Earlier outcomes were produced with treatment versions that were less potent than the treatment version that will be tested in the future.

Patients who have metastatic kidney cancers that have progressed after being treated with a drug could be eligible for treatment in a TVAX clinical trial.  Patients who have recently diagnosed metastatic kidney cancers also could be eligible for treatment in a TVAX clinical trial.  The conclusion that was drawn from those studies was that the treatment had a significant inhibitory effect on the progression of some renal cell carcinoma patients’ cancers and that those observations merited further study.

¹Chang AE, Jiang Gl Sayre DM, Braun TM, Redman BG. Phase II trial of autologous tumor vaccination, anti-CD3-activated vaccine-primed lymphocytes, and interleukin-2 in stage IV renal cell cancer. Journal of Clinical Oncology. 21:884-90 (2003)

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