Phase I Anixa Vaccine Trial Shows Promise for Preventing Triple-Negative Breast Cancer

 At the San Antonio Breast Cancer Symposium (SABCS), investigators reported final phase I results of an alpha-lactalbumin (aLA) vaccine designed to help prevent triple-negative breast cancer (TNBC), particularly among women at elevated genetic risk.

In this exclusive video, Justin Johnson, PhD, of the Cleveland Clinic in Ohio, discusses the study and next steps toward phase II testing.

Following is a transcript of his remarks:

So, my mentor, Dr. Vincent Tuohy, who I trained under and worked for for 30 years originally conceived of this idea of a preventative breast cancer vaccine based on alpha-lactalbumin, which is a normal lactation protein made by healthy breasts during nursing. And when you're not nursing, that protein completely goes away. It shouldn't be there.

But what Dr. Tuohy discovered is that certain tumors, especially triple-negative, or TNBC tumors, often most of the time actually express alpha-lactalbumin, and that makes them a potential target for this vaccine while sparing normal healthy tissue. So the idea is we immunize with alpha-lactalbumin and then a woman is protected from getting this type of cancer.

When we originally published these findings in Nature Medicine in 2010, Dr. Tuohy was determined to launch a phase I clinical trial to help develop this vaccine, ensure that it's safe, and bring it to the women who need it. So, actually, the findings we presented today represent the fruits of those labors, 15 years of work, getting the vaccine through our preclinical studies, and then a clinical phase I study that we conducted at Cleveland Clinic.

So, a phase I study is only looking at safety and determining what dose works best. Those are the primary endpoints that we want to address for a phase I. And the good news that we presented today is that we met all study primary endpoints. So, we found a safe and effective dose that we hope will demonstrate efficacy and protection against TNBC breast cancer.

So, the results of phase I will inform the design of phase II, which is being conducted as a partnership between Cleveland Clinic and a biotech company called Anixa Biosciences. And in phase II, we hope to determine the efficacy of this vaccine in breast cancer.

We hope that it continues to be safe and show efficacy and get through phase II and phase III, so we have a road ahead. But if successful, this vaccine will not only help prevent breast cancer in women especially at risk for triple-negative breast cancer -- so, if they carry genetic markers such as BRCA1 or 2, or PALB2, they would want to get vaccinated after menopause and before the time when these breast cancers most likely occur.

And so, not only could we potentially prevent these breast cancers in these women, but the design of this vaccine could be applied to other types of breast cancer and other types of cancer in general. So, we're already working on an ovarian cancer vaccine that's based along the same principles.

https://www.medpagetoday.com/meetingcoverage/sabcs-vp-earlybrca/118929