Our Pipeline & Clinical Trials
Clinical Development of Ii-Key Immunotherapeutic Vaccines
The company’s most advanced immunotherapeutic product is AE37, an Ii-Key-HER2 vaccine that contains the HER2/neu antigenic peptide linked to the Ii-Key to enhance immune stimulation against HER2, which is expressed in numerous cancers.
Immuno-Oncology Development Rationale:
- CPIs Need Immune Activators to Optimize Effectiveness
- Ii-Key Immunotherapeutic Peptide Vaccines Activate CD4 & CD8 T-Cell Responses
- Study Design: Usual Care with CPIs +/- Ii-Key Vaccines
- Front-line Opportunity
Phase I Breast Cancer
In Phase I studies, AE37 has demonstrated a clean safety profile and generated T-cell immune responses in patients with breast cancer.
Phase II Breast Cancer
The final results of the Phase IIb clinical trial of AE37 vaccine for the prevention of recurrence of breast cancer have been published in the peer-reviewed journal, Breast Cancer Research & Treatment. In the AE37 arm of this trial, patients with advanced stage, HER2 under-expression, and TNBC showed benefit from AE37 vaccination, and those with both advanced stage and HER2 under expression have a significant clinical benefit to AE37 vaccination, demonstrating improved disease-free survival for up to ten years of follow-up. Brown et al. Breast Cancer Research & Treatment;
Phase II Triple Negative Breast Cancer: AE37 +/- pembrolizumab (Merck’s Keytruda®)
Based on the promising results from this trial, NuGenerex has entered into a collaborative agreement with Merck Sharpe & Dohme Corp. (Merck) and the National Surgical Adjuvant Breast and Bowel Program (NSABP) to conduct a Phase II trial to evaluate the safety and efficacy of AE37 in combination KEYTRUDA (pembrolizumab) in patients with metastatic triple‐negative breast cancer. The trial is ongoing.
We conducted a phase I/IIa trial of AE37 with recombinant granulocyte macrophage colony-stimulating factor as adjuvant in patients with HER-2/neu+ prostate cancer. The primary end points of the study were to evaluate toxicity and monitor patients’ immune responses to the vaccine. The trial demonstrated safety and strong immunological response (both CD4+ and CD8+ T-cell responses) to AE37 in prostate cancer patients, with T-Cell memory responses lasting for 3 years. The investigators concluded that AE37 vaccine is safe and can induce HER-2/neu–specific cellular immune responses in patients with castrate-sensitive and castrate-resistant prostate cancer, thus emphasizing the potential of AE37 to target HER-2/neu for the immunotherapy of prostate cancer.
Ii-Key-HA Avian Influenza Vaccine Phase I
Phase I Human Clinical Trial:
- 110 healthy subjects vaccinated
- Twelve (10) li-Key-HA hybrid peptides to H5N1 synthesized
- Ii-Key-HA peptides (500 μg) administered IM
- 21-day booster (500 μg)
- Safe & well tolerated