A major step towards developing a cure for cancer was taken during
the week with a success recorded in the production of DNA-based vaccines
by a United States company.
US-based Inovio Pharmaceuticals Inc announced, on Thursday,
preliminary data showing that its INO-3112 DNA-based immunotherapy
generated strong CD8+ T cell responses in three of four patients with
head and neck cancer associated with human papillomavirus (HPV) types 16
and 18. The data, which are T cell measurements from the first four
treated patients of this phase I/IIa study, were on Thursday, presented
at the World Vaccine Congress 2015 by Inovio’s Chief Operating Officer
(COO), Dr. Niranjan Y. Sardesai.
These positive results represent the first study and first report of
T-cell immune responses generated in cancer patients after treatment
with an Inovio DNA immunotherapy. The magnitude and characteristics of
these interim immune response data mirror immune responses previously
observed in human studies of VGX-3100 for HPV-associated cervical
dysplasia; in a placebo-controlled phase II study, strong T cell immune
responses were positively correlated with achievement of primary and
secondary efficacy endpoints.
Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer
(CEO), said, “This initial data set from Inovio’s first cancer study
provides encouraging evidence that we are on an important path to better
optimised immunotherapy products. Regardless of whether it is an
infectious disease, a precancer, or a cancer, the immune system uses the
same mechanism to eliminate infected or mutated cells. In
immune-oncology, it’s all about the T-cells. Here, we show in cancer
patients that we can generate antigen-specific CD8+ killer T-cell
responses, which are essential to an effective immunotherapy.
“We look forward to completing our currently enrolling studies for
HPV-associated head and neck and cervical cancers, completing the
preparations for our planned phase III study for cervical precancer, and
launching new studies for hepatitis B and prostate cancer that all rely
on the same targeted T-cell-based killing activity.”
This open-label study of HPV-caused head and neck cancer is intended
to assess the safety, tolerability, and immunogenicity of up to 20
adults with HPV-positive head and neck squamous cell carcinoma. The
study includes patients who are being treated with the drug before and
after resection of their tumor as well as patients being treated with
the drug after completion of chemotherapy and radiation therapy.
The company recently won a $45 million grant from the Defense
Advanced Research Projects Agency (DARPA) to lead a collaborative team
to develop products and a DNA-based vaccine against Ebola.
Inovio is the prime contractor on the DARPA program. Other
collaborators are MedImmune, the global biologics R&D arm of
AstraZeneca; GeneOne Life Sciences and its manufacturing subsidiary,
VGLI; and Professor David B. Weiner, Ph.D., professor of pathology and
laboratory medicine at UPenn, Emory and Vanderbilt.
Plans are to dose the first patient with Inovio’s vaccine during the
second quarter of this year. In preclinical testing the vaccine
protected 100 per cent of vaccinated animals from death and sickness
after being exposed to a lethal dose of the Ebola virus.
“We are advancing against this virus on all fronts,” said Dr. Kim, in
a statement thanking DARPA. The contract represents the largest single
grant ever awarded to Inovio, which has previously won two grants
totaling $28 million from the National Institutes of Health in 2015.
Fourteen years ago, Dr. Kim left a job developing vaccines for Merck
to launch a new company with his former PhD. advisor. Today, Inovio is
considered leader in the vaccine market for its drive to produce DNA
vaccines: synthetic, gene-based medicines that train the body’s immune
system to attack cancers, influenza, Ebola, even HIV/AIDS.
“In many ways, the immune system is like an iPhone without any
software or apps,” he said. “By delivering small snippets of DNA that
tell the immune system to recognise a cancer cell or flu virus as the
enemy, we can more effectively train the immune system to destroy them.”
If his company is successful in bringing an Ebola and other DNA
vaccines to market, it could change the way we think about disease—to
say nothing of vaccines themselves. By attacking the disease at a DNA
level, an Ebola vaccine could both prevent and treat the illness.
Cancers could be cured or prevented with a single, risk-free shot.
Public health crises ranging from flu season to Africa’s AIDS disaster
could be brought under control. Fear-mongering over vaccines and their
supposed side effects could be eased. And the financial rewards for
Inovio and its investors—the value of the flu vaccine alone is estimated
at $4 billion—could be astronomical.
Inovio is just one of several pharmaceutical companies chasing an
Ebola vaccine, including Merck, Johnson & Johnson and
GlaxoSmithKline. Though several ebola vaccines have been fast-tracked in
the wake of the epidemic in West Africa, it’s still unclear when any
will come to market.
Sources: CSBN and streetinsider.com