Saturday, January 20, 2018

OncoSec Provides Encouraging Clinical Observations Related To Triple Negative Breast Cancer Study - with findings related to younger women, African Americans and Hispanics



OncoSec Medical Incorporated ("OncoSec" or the "Company") (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, today announced preliminary clinical observations related to its pilot biomarker OMS-I140 clinical trial of ImmunoPulse® IL-12 in patients with metastatic Triple Negative Breast Cancer (TNBC). The study is designed to assess whether a single cycle of ImmunoPulse IL-12 increases TNBC tumor immunogenicity by driving a pro-inflammatory cascade of events including activation of cytotoxic tumor-infiltrating lymphocytes (TILs).   

To date, five patients with TNBC have been treated with a single cycle of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation). Two of these five patients were subsequently treated with single agent nivolumab (Opdivo®) - an anti-PD-1 checkpoint inhibitor treatment - as their immediate next therapy. Both of these patients, who were heavily pretreated metastatic TNBC patients with chemotherapy refractory disease, experienced robust objective responses in both ImmunoPulse IL-12 treated and untreated lesions. These clinical observations have prompted the Company to further commit to a more definitive evaluation of the combined therapies.
"Metastatic TNBC is a heterogeneous cancer with a poor prognosis where less than five percent of pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint treatments," explained Sharron Gargosky, Chief Clinical and Regulatory Officer of OncoSec. "The marked synergy shown in these patients strongly suggests that IL-12 may have primed the tumor microenvironment, impacting the clinical result. The combination of ImmunoPulse IL-12 and checkpoint inhibition represents a highly promising new therapeutic approach for TNBC and warrants a formal evaluation given the extremely low response rate in women who have failed multiple prior therapies."
Previous studies have demonstrated that breast cancer patients whose tumors are associated with markers of inflammation, such as the presence of TILs, achieve better clinical outcomes. In addition, the density of TILs is a key requirement for the anti-tumor activity of immune checkpoint inhibitors like anti-PD-1/PD-L1 antibodies. By augmenting the expansion of CD8+ tumor infilatrating T cells, ImmunoPulse IL-12 may be an ideal candidate to combine with checkpoint inhibitors, which has demonstrated low and variable activity as a monotherapy in TNBC.
Immunological examination of samples from all patients are currently being analyzed. These data, along with the full information regarding clinical observations and safety data, will be submitted for presentation at an upcoming medical meeting in 2018.
To learn more about the trial, visit www.oncosec.com. Additional details can also be found atwww.clinicaltrials.gov via NCT02531425.
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company.
ImmunoPulse® is a registered trademark of OncoSec Medical Incorporated, San Diego, CA, USA.
About Triple Negative Breast Cancer (TNBC)
Breast cancer cells that test negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-) means the cancer is triple negative.1 Approximately 15-20 percent of US breast cancer cases are triple negative breast cancer (TNBC),2 which disproportionately affects younger women as well as African-American women, followed by Hispanic women.3
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Monday, December 4, 2017

Black Conservatives: Obamacare Individual Mandate Repeal: House of Representatives Should Follow Senate Lead

Health Care Expert Says Congress Can Fix Gross Violation of Individual Liberty

Mandate to Buy Insurance Failed to Make Obamacare Exchanges Function Properly

 
With the Senate version of tax reform containing a repeal of Obamacare's individual mandate, a health care expert with the National Center for Public Policy Research says the House of Representatives would be wise to embrace this restoration of individual liberty as the chambers conference on a final version of the bill to be sent to the White House.

"If Congress can't repeal Obamacare all at once, then repealing it piece by piece is the next best thing. That's what the Senate did Friday when it rolled back the individual mandate," notes David Hogberg, Ph.D., a National Center adjunct fellow specializing in health care policy.

In a new National Center commentary published by the American Spectator, Dr. Hogberg suggests that the House of Representatives "now follow the Senate's lead" in its own version of tax reform by adding a repeal of the penalty that compels Americans to buy health insurance, so that it is included in the final version sent to President Donald Trump.

"The Senate struck a blow for freedom," adds Dr. Hogberg, the author of the book Medicare's Victims: How the U.S. Government's Largest Health Care Program Harms Patients and Impairs Physicians. "The House should do the same. This was never anything more than a gross encroachment on liberty. Nowhere in the Constitution or in constitutional law is there any justification for letting the government force people to buy health insurance. Chief Justice John Roberts erred greatly when he sided with the Supreme Court's liberals in letting the mandate stand."

In the commentary, Dr. Hogberg refutes Obamacare supporters who argue that the Obamacare exchanges will fall apart without the individual mandate. "The individual mandate has never worked as advertised," he says. "It was supposed to keep premiums low and keep insurance companies in the exchanges. It has done neither."

Also noted in the commentary:
  • The lowest-cost plan for a 27-year-old has risen 77 percent in cost since the exchanges started operating in 2014. The second lowest-cost silver plan has risen a whopping 88 percent in cost since that time.
  • Exchanges had over 250 insurance companies participating in 2014. In 2018 that number will fall to under 170, a drop of over one-third.
  • In 2014, 76 percent of exchange enrollees had at least three insurers to choose from. Only six percent had just one. Due to so many insurers leaving the exchanges, the percentage of enrollees with a choice of only one insurer will rise to 26 percent in 2018, while those with three or more insurers will fall to 48 percent.
"In short, the individual mandate does not now, nor will it ever, work as Obamacare supporters claimed it would," writes Dr. Hogberg. "Considering that the mandate is also a gross encroachment on individual freedom, there is no reason why Congress shouldn't repeal it in the name of tax reform."

To book an interview with Dr. Hogberg, contact Judy Kent at (703) 759-7476.

 

The National Center for Public Policy Research, founded in 1982, is a non-partisan, free-market, independent conservative think-tank.  Ninety-four percent of its support comes from individuals, less than four percent from foundations and less than two percent from corporations.  It receives over 350,000 individual contributions a year from over 60,000 active recent contributors.  Sign up for email updates here.  Follow us on Twitter at @NationalCenter for general announcements.  To be alerted to upcoming media appearances by National Center staff, follow our media appearances Twitter account at @NCPPRMedia.