NewLink Genetics Corporation announced today data from a Phase 1/2 study showing that patients with progressive advanced non-small cell lung cancer treated with its HyperAcute®-Lung cancer immunotherapy experienced favorable median survival. The data were presented at the 101st American Association for Cancer Research (AACR) Annual Meeting.
The study titled "Phase I/II study of antitumor vaccination using lung cancer cells expressing murine alpha(1,3)galactosyltransferase (alphaGT) in non-small cell lung cancer (NSCLC)" involved a unique treatment approach designed to trigger a powerful immune response to cancer cells similar to the hyperacute reactions that occur with xenotransplants (tissues from lower animals transplanted into old-world primates).
"This trial was the first to test this type of immunotherapy in patients, and we are quite encouraged by the findings," said lead investigator John C. Morris, M.D., Co-director of Clinical Trials, Metabolism Branch, National Cancer Institute, Bethesda, MD. "This study showed that HyperAcute-Lung cancer immunotherapy is feasible, safe, and associated with favorable survival in patients with previously-treated, advanced non-small cell lung cancer."
In transplants of human organs such as the kidneys or heart, recipients are at risk of rejecting donor organs because of immune system reactions directed against the foreign tissue. That immune response is dramatically stronger if non-primate organs, for example, pig hearts are transplanted into primates, largely because lower animals express sugar patterns on their cell surfaces that are not expressed in humans. The sugar epitopes, known as alpha(1,3)-galactosyl, or alpha-Gal residues, are powerful antigens that cause a rapid, hyperacute rejection response whenever foreign tissues bearing it are introduced into the human body. The response is strong enough to destroy transplanted cells and tissues within hours. NewLink's HyperAcute immunotherapy exploits this hyperacute antigen-antibody response to educate a patient's immune system to attack and destroy the patient's own unmodified cancer cells.
In this study, conducted at the National Cancer Institute, a total of 17 patients in the Phase 1 portion and 26 patients in Phase 2 portion were injected with an anti-tumor immunotherapy consisting of three types of viable, non-dividing, human lung cancer cells that had been genetically altered to express the mouse gene responsible for making alpha-Gal residues.
"Although cells making up naturally occurring NSCLC tumors in patients do not express alpha-Gal, they share other molecules with the genetically altered lung cancer cells introduced by the vaccine," Dr. Morris added. "Those similarities may allow the antibodies and immune cells targeting alpha-Gal to redirect their attack and destroy patients' own tumor cells."
Phase 1 results showed:
- Six of 16 evaluable patients experienced stabilization of disease for a median of 34.9 weeks.
- No dose-limiting toxicity or serious adverse events were attributed to the HyperAcute-Lung immunotherapy.
Phase 2 results showed: