Generex Biotechnology Corp. (fka GNBTQ)

[WeeZuhl]

Old but good: REPOST 5/14/15


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=113680277

Generex Provides Data Update from AE37 Phase II Breast Cancer Trial One Year Post Completion of Enrollment
9:30 AM ET, 05/14/2015 - PR Newswire

A prior interim analysis conducted in 2011, as well as a primary efficacy analysis conducted in 2013, pointed to a benefit of the AE37 vaccine in patients not receiving Herceptin and, in particular, patients with triple negative breast cancer. This latter group represents a patient population of high unmet need. The present study continues to show a trend in this population, with a 35% reduction in the relative risk of recurrence in patients receiving the AE37 vaccine.

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Congratulations to the Antigen team. This shows there is great promise for AE37, especially for this tough to manage population with triple-negative breast cancer. Nothing else has shown anything near this effective for this group. No way this can be let alone. I think we can expect to hear more soon. I suspect the next step will be a combination trial with at least one other peptide. I suspect it will be with Dr. Mittendorf as primary investigator.

Question: Will the new peptide(s) be hybrid vaccine with Ii-key moeity? I would think so.

"Soon" turned out to be three years, but there finally is an AE37 combination trial for triple negative breast cancer. I was also a little off in my prediction of the combo agent, which turned out to be Keytruda, a therapeutic antibody, instead of another peptide with Ii-key. The addition of Keytruda is really smart. AE37 is a vaccine which results in an immune reaction against a specific target protein expressed on breast cancer cells. Keytruda is an antibody which blocks a cell receptor on cancer cells so they cannot hide from AE37's immune reaction. That's what we call synergy, my friends, and it is enough to make a molecular biology nerd feel all tingly.


Another important point about AE37 and triple negative breast cancer: the 35% reduction in risk of recurrence cited above from is from ASCO 2015 meeting, and it was an interim analysis at 25 months. In 2017, there was a 55 month analysis in which the triple negative numbers looked even more compelling. Check this number:


http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.3088

Subgroup efficacy evaluation of the AE37 HER2 vaccine in breast cancer patients in the adjuvant setting.

Results: There were no clinicopathologic differences between groups in the 298 enrolled pts (VG = 153, CG = 145). The vaccine is safe and well tolerated. After a median f/u of 55 mo, there was a trend toward improved DFS in the VG among stage IIB/III pts (VG, n = 73, DFS 82% vs CG, n = 61, 67%, HR = 0.48, p = 0.06) and those with low HER2 expression (HER2 LE, VG, n = 68, 89% vs CG, n = 66, 51%, HR = 0.47, p = 0.1). Improved DFS in the VG was documented in patients with both stage IIB/III disease and HER2 LE (VG, n = 39, 90% vs CG, n = 38, 32%, HR 0.3, p = 0.02) and triple negative (TNBC) pts (VG, n = 21, 89% vs CG, n = 21, 0%, HR 0.26, p = 0.05).

If you know anything about triple negative breast cancer and the sparsity of options available to this subgroup, this number should make your jaw drop to the floor. 89% disease-free survival at 55 months in the AE37 vaccine group compared with 0% in the control group. Now add Keytruda. Both of these therapies are very well tolerated by patients, and in my opinion, if the company can prosecute these expensive trials in an efficient fashion then AE37 + Keytruda will be standard of care for TNBC within the next few years.