R.J Steffens

Genentech and Generex: New HER2/neu Research

"The small life science company is a fully owned subsidiary of Generex (GNBT) Biotechnology, and AE37 is currently in a large scale Phase II efficacy study."

Results of the Phase II are not expected for some time, but I just found an early indication that appears in an upcoming peer review from the CVDP. It is part of the final paragraph in this 8 page article:.

Expert Opin Biol Ther. 2009 Jan ;9

CD4(+) T cells in antitumor immunity: utility of an Ii-Key HER2/neu hybrid peptide vaccine (AE37).

"Based on early observations of patients enrolled in our Phase II AE37 trial, we are confident that this Ii-Key hybrid peptide will effectively stimulate an HER2/neu-specific immune response and will be an important component as we move forward with our plans to develop a multiepitope vaccine."

lib.bioinfo.pl/auth:Pe...

Generex Biotechnology and the USMCI: Armed with Antigens in the War Against Breast Cancer

I notice that Antigen Express, the life science company that is developing AE37 with the USMCI, has now entered into a collaboration with the prestigous Mayo Clinic in a new trial of AE37 for a melanoma vaccine:

www.primenewswire.com/...

I feel this validates the technology platform of Ii-Key hybirds and reinforces my view that these peptide vaccines may represent aviable therapuetic option in the near future.

Genentech: Britain's National Health Won't Pay for Avastin

"The biotechnology industry counters that they must be paid huge sums for small innovations to promote expensive research. Progress is in slow and steady steps, with very few dramatic breakthroughs. The industry claims that traditional cost-benefits should not apply."

Interesting article, thanks. In a somewhat related note, I wrote an article about two promising peptide based BC vaccines that are in development in collaboration with the United States Military Cancer Institute:

seekingalpha.com/artic...

The peptide vacines mentioned would cost much less than Herceptin or Avastin. E75 has shown survival benefit in a subgroup of a completed Phase II, and AE37 is now in a large efficacy Phase II trial and last week AE37 was also announced that it is to be trialed at the Mayo Clinic for a melanoma vaccine. AE37 is already in a prostate cancer vaccine trial at prestigous St Savas.

Continued success for Col Peoples and these vaccines would be great news, and give her2 expressing cancer patients MUCH less expensive treatment options for safe and effective treatment. These peptide vaccines have had no safety concerns and in the case of AE37, it was the first ever to have a robust immuno response without an adjuvant.

Hence, the "dramatic breakthroughs" may come from the smallest of companies, whose research is attracting the greatest of collaborators. If approved, they would shake up the entire vaccine and oncology field. With much lower projected costs, it should be a new treatment the British National Health Service and our own insurance companies would support.

Generex Biotechnology and the USMCI: Armed with Antigens in the War Against Breast Cancer

My quote: "Antigen Express entered into a Clinical Trial Agreement with HJF"

4th item down: www.hjf.org/research/u...

www.usmci.org/generex....

My quote: "data from researchers at the USMCI also appear to show the potential linking of E75 to a li-Key/HER2/neu MHC class II peptide which brings us to the subject of the other promising therpauetic vaccine in the USMCI's arsenal."

Here is some JUNE 2008 data showing potential E75 and Ii-Key binding: www.ncbi.nlm.nih.gov/p...

My quote: "Earlier this month at ASCO, Generex and the USMCI presented final Phase I data for AE37 in breast cancer / the investigators at the USMCI concluded that "AE37 is the first peptide vaccine derived from a tumor-associated antigen that elicits a robust immunologic response in cancer patients without the use of an immunoadjuvant.""

The ASCO abstract:
www.ascocancerfoundati...

I would bet that Genentech and Glasko pay close attention to the peptide vaccine initiative of Col. Peoples and the USMCI. Antigen Express and Generex are entered into an impressive collaboration.

www.medicalnewstoday.c...

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?