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Generex Biotechnology Receives IND Approval from FDA for Phase II Combination Study using AE37 plus Keytruda® (pembrolizumab) for the Treatment of Triple Negative Breast Cancer

Generex Biotechnology Corporation (OTCQB:GNBT) today announced that the
FDA had reviewed the companya??s investigational new drug (IND)
application and given notification that the study can proceed. The
study: A Phase II Clinical Trial of Pembrolizumab (KeytrudaA®) in
Combination with the AE37 Peptide Vaccine in Patients with Metastatic
Triple Negative Breast Cancer
, is sponsored by Generex and conducted
under a collaboration agreement with Merck and a clinical trial
agreement with the NSABP Foundation, Inc. (NSABP).


The combination study builds on previous clinical studies of both AE37
and KeytrudaA®. AE37, a cancer vaccine, was the subject of a 300 patient
prospective, randomized and single-blinded Phase II study in patients
with breast cancer. That study showed a strong trend toward reduced
relapses,particularly in patients with triple negative breast cancer.
KeytrudaA® also has shown encouraging results in patients with triple
negative breast cancer when used as monotherapy. The complementary
mechanisms of action of the two drugs suggest the combination may have
the potential to be better than either alone.


AE37 is unique among therapeutic cancer vaccines in that it ensures
specific activation of CD4+ T helper cells, which are critical in
generating an effective immune response.A Its improved immunological
potency, along with an excellent safety profile, offers particular
advantages for combination studies. In addition to the Phase II study in
breast cancer patients, AE37 also has been tested in a Phase I study in
prostate cancer patients.A AE37 treated patients have consistently
displayed a robust, long-lasting and specific response to the vaccine.


Liesha Emens, M.D., Ph.D., Principal Investigator for the study and
Professor of Medicine at the University of Pittsburgh Medical Center
commented: "So far, metastatic triple negative breast cancer patients
treated upfront with immunotherapy benefit clinically from immune
checkpoint immunotherapy only if their tumors contain PDL1+ cells.
Increasing the number of patients with immune-activated tumors should
bring the benefit of immunotherapy to even more patients. This Phase II
trial will test whether the AE37 vaccine may trigger immunity in triple
negative breast cancer patients, priming them for clinical benefit from
immune checkpoint blockade.a??


Eric von Hofe, President of NuGenerex-ImmunoOncology commented: "We are
gratified to see this important trial moving forward. While we have
tested AE37 in breast and prostate cancer patients, there is good
rationale for inclusion of AE37 in the treatment regimen of a variety of
additional cancer types of high unmet need. Gastric, colon, ovarian and
bladder cancers all express the same tumor target expressed in breast
and prostate cancer that AE37 activates the immune system to recognize.a??
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