Aug 25 Advaxis Inc on Monday said it
will test an experimental immuno-oncology drug in combination
with a high-profile immunotherapy from Merck & Co Inc as
a treatment for patients with advanced prostate cancer.
The tiny U.S. biotechnology company, in its second cancer
collaboration with a large drugmaker in the past month, said it
would evaluate the use of its ADXS-PSA as a standalone treatment
and also study it in combination with Merck's pembrolizumab in
the Phase I/Phase II trial.
Merck's drug is a member of an exciting new class of
medicines called "PD-1 inhibitors" that work by blocking the
PD-1 protein, thereby taking the brakes off immune system cells
and prodding them to attack tumors.
The Advaxis drug consists of a modified form of the Listeria
bacterium fused to a protein called PSA that is shed by prostate
tumors. It is meant to spur creation of immune system soldiers,
called T-cells, that are primed to recognize and kill prostate
By using different approaches, the drugmakers hope the two
drugs have a better chance of knocking down the prostate cancer
than either could achieve on its own.
"If the combination of drugs shows an added effect, the
companies would likely continue their collaboration," perhaps
under a licensing deal, said Daniel O'Connor, chief executive
officer of Advaxis.
Prostate cancer is the most common cancer among men, other
than skin cancer. One man in six will get prostate cancer
during his lifetime, and about 3 percent of men die from the
disease, according to Advaxis.
O'Connor, in an interview, said his company will bear most
costs of the study, which is slated to begin in early 2015 and
probably be conducted by a contract research organization. Merck
will provide the pembrolizumab, an injectable monoclonal
antibody, to be used in the trial.
PD-1 inhibitors and other immuno-oncology drugs have already
shown promise against other types of cancer, including melanoma,
but have not yet been tested to any great extent against
prostate cancer, according to David Mauro, executive director of
oncology at Merck.
"We think this combination gives us the opportunity to do
early exploration in prostate cancer and bring immuno-oncology
into this space," Mauro said in an interview.
Merck previously announced collaborations with several other
drugmakers on combined uses of pembrolizumab with their
medicines, including British drugmaker GlaxoSmithKline,
Pfizer Inc, Amgen Inc and Incyte Corp.
Advaxis last month announced a collaboration with British
drugmaker AstraZeneca to test immunotherapy drugs from
both companies in combination.
Under that deal, AstraZeneca's drug MEDI4736 will be
evaluated in a Phase I/II clinical study together with the U.S.
company's cancer vaccine ADXS-HPV. The AstraZeneca drug blocks
PD-L1, a protein similar to PD-1.
The combination will be tested in patients with cervical
cancer and head and neck cancer, tumors that are closely linked
to infection with the human papillomavirus.
(Reporting by Ransdell Pierson; Editing by Leslie Adler)