NewLink Genetics Presents Positive Phase1/2 Data on HyperAcute(R)-Lung Cancer Immunotherapy
Poster Data Presented at the American Association for Cancer Research Annual Meeting
WASHINGTON, April 19 /PRNewswire/ -- 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:
-- Median progression-free survival for the entire group was 15.5 weeks
and for patients with stable disease was 28.1 weeks.
-- Median overall survival was 52.1 weeks.
-- Overall survival correlated with the persistence of anti-alphaGal
immunoglobulin (IgG) antibody titers.
-- Longer overall survival was associated with increased gamma-interferon
(IFNg) secretion by peripheral blood mononuclear cells (PBMC's)
post-vaccination in an ELISPOT assay in those patients in which the
assay was performed.
"NewLink has a broad and growing platform of tumor-specific
immunotherapies based on our HyperAcute technology," said Charles
Link, M.D., chairman and chief executive officer of NewLink
Genetics Corporation. "In addition to this promising new lung
cancer data, we have started screening patients for a pivotal Phase
3 trial of HyperAcute-Pancreas immunotherapy in patients with
pancreatic cancer."
NewLink is currently advancing four product candidates in human
clinical trials. Its HyperAcute immunotherapy for pancreatic cancer
will enroll about 700 previously untreated patients with resected
pancreatic cancer. This Phase 3 trial will randomly assign patients
to receive either the current standard of care or the current
standard of care plus the NewLink HyperAcute pancreatic cancer
immunotherapy. The HyperAcute product for melanoma is showing early
promise in a small, investigator-sponsored Phase 2 study. Data from
Phase 2 studies of the NewLink pancreatic cancer and melanoma
immunotherapies will be presented at ASCO in June 2010. NewLink is
also developing a first-in-class, small-molecule inhibitor of the
indoleamine 2,3 dioxygenase (IDO) pathway, which is presently
undergoing Phase 1 safety testing and which the company plans to
move into Phase 2 studies later this year.
The company's HyperAcute products are composed of irradiated,
allogeneic (off the shelf), whole cancer cells that have been
genetically modified to add alpha-Gal residues to cell-surface
lipids and proteins. The alpha-Gal epitopes function as a molecular
adjuvant, effectively harnessing this xenotransplant rejection
mechanism.
About Lung Cancer
Lung cancer is the leading cause of cancer-related death in the
United States. An estimated 159,390 Americans died of the disease
in 2009, accounting for approximately 28 percent of all cancer
deaths. Lung cancer is most often diagnosed at advanced stages when
it is difficult to treat. About 85 to 90 percent of lung cancers
are classified as non-small cell lung cancer (NSCLC). The remainder
is called small cell lung cancer. About 80 percent of NSCLC cases
are detected when they have progressed to stages III or IV.
About NewLink Genetics Corporation
NewLink Genetics Corporation is a biopharmaceutical company
applying innovative technologies to create new therapeutic agents
for patients with cancer and infectious diseases. Its products are
designed to enhance the patient's immune system, enabling the
body's immune cells to target pathogens and diseased tissues.
Contact NewLink Genetics Corporation Gordon Link, CFO, 515-598-2925
Source: NewLink Genetics Corporation
CONTACT: Gordon Link, CFO of NewLink Genetics Corporation,
+1-515-598-2925
Web Site: http://www.linkp.com/
Posted: April 2010
