Planned Phase 2 Trial to Test Vaccine in Triple-negative Breast Cancer Patients, Generex Says

Planned Phase 2 Trial to Test Vaccine in Triple-negative Breast Cancer Patients, Generex Says
Generex Biotechnology has entered into an agreement with the NSABP Foundation to manage a possible Phase 2 clinical trial testing an anti-cancer vaccine in patients with metastatic triple negative breast cancer. Sponsored by Generex and conducted in collaboration with Merck, the trial will evaluate the safety and anti-cancer activity of the company's AE37 peptide vaccine in combination with Keytruda (pembrolizumab), an immunotherapy marketed by Merck. An investigational new drug application (IND) has been filed with the U.S. Food and Drug Administration, and plans for this trial are under FDA review. If accepted, patient enrollment is expected to start in early 2019. “We are very pleased to be working with the NSABP Foundation on this important trial combining AE37 and Keytruda in triple-negative breast cancer patients,” Eric von Hofe, president of Generex’s wholly owned subsidiary Antigen Express, said in a press release. “The extensive expertise of the NSABP Foundation and their network of sites and investigators will be a great asset in this development effort.” Up to 80% of breast cancers have some level of HER2. But available therapies targeting this protein are only recommended for patients with the highest HER2 levels, amounting to abo
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One comment

  1. Carrie Fisher says:

    I am a TNBC patient first time was 4/10/2009 Stage 2, used chemo and radiation and was clear until 2016 and was diagnosed TNBC Stage 4 with mets to lung and liver. Spot on lung continues to grow currently at .9cm. If you feel I would be a candidate for the trial program I would be happy to do that.

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