A New Immunotherapy/Immunoprevention for Triple Negative Breast Cancer


Vincent Tuohy, PhD
Justin Johnson
Ritiki Jaini, PhD


Contact Innovation Manager

Tony Giordano, PhD

What is it? What does it do?

a-Lactalbumin is a “retired” tissue specific protein that is found at high levels in the majority of triple negative breast cancer cells.  Vaccination of a mouse strain that develop breast cancer or in mice with transplanted breast tumors can prevent and inhibit tumor growth, respectively.  Since the targeted protein is only expressed in lactating women, there are no off-target activities and therefore no anticipated adverse events following vaccination.  This product can be used both as an immunotherapy to treat or prevent recurrence of existing tumors or as an immunopreventative in post-menopausal women.

Why is it better?

  • There are no current therapies for patients with triple negative breast cancer even though it represents 1 out of every 6 breast cancer cases and accounts for 40% of all breast cancer deaths.
  • The target of the immunotherapy is a breast-specific, differentiation protein expressed only in mammary epithelial cells during late pregnancy and early lactation.
  • a-Lactalbumin induces antigen-specific T cells that produce an interferon-g response confined to tumor tissues and sparing all normal tissues from inflammatory damage.
  • A proinflammatory immune responses to a-lactalbumin does occur in adult human T cells.

What is its current status?

A pre-IND meeting was held with the FDA and a protocol for Phase I clinical studies has been developed.  A GMP manufacturer of the vaccine is now being contracted with to produce the material for the clinical study.  A $5M+ Department of Defense grant was recently received to support the Phase I clinical program.

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