R.J Steffens

Oncology Conference Countdown: What Will Pharma and Biotech Companies Report?

Hi Mike, great article and idea for investors of biotech and pharma oncology stocks. We know big pharma has been looking at small biotechs with promising cancer vaccines. Looks like this one of a Phase I study I found from ASCO 2008 is not only safe (no grade 3 toxicity cases), but is the first peptide vaccine to exhibit such positive immuno responses even WITHOUT an adjuvant:

Results of the first phase I clinical trial of the novel Ii-key hybrid preventive HER2/neu peptide (AE37) vaccine: United States Military Cancer Institute Clinical Trials Group Study I-03.
Sub-category: Vaccines
Category: Developmental Therapeutics: Immunotherapy
Meeting: 2008 ASCO Annual Meeting

"Results: All 15 patients completed the trial with no grade 3-5 local or systemic toxicities. Dose reductions occurred in 47% of patients for local reactions >100mm or grade 2 systemic toxicities. The second group (peptide=500mcg, GM-CSF=250mcg) all required dose reductions prompting peptide-only inoculations in the third group (peptide=1,000mcg, GM-CSF=0mcg). AE37, with and without GM-CSF, elicited dose-dependent immunologic responses in vitro and in vivo to both AE37 and AE36 albeit AE37 responses were more robust. Assessing both toxicities and immunologic responses, the hypothesized optimal biologic dose was determined as peptide=500mcg, GM-CSF=62.5mcg, in 6 monthly injections. Conclusions: The hybrid AE37 vaccine appears safe and well tolerated with minimal local or systemic toxicity if properly dosed. AE37 is capable of eliciting HER2/neu-specific immune responses, even without the use of an adjuvant.

This trial represents the first human experience with the Ii-Key modification, and to our knowledge, AE37 is the first peptide-based cancer vaccine to show potency in the absence of an immunoadjuvant."

www.abstract.asco.org/...

AE37 vaccine is from Antigen Express- a wholly owned subsidary of (GNBT) Generex. This is now in a large Phase II with the USMCI. What do you think?