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First Data from Ongoing Phase 2 Study of Controlled IL-12 in Combination with Cemiplimab Demonstrate Promising Safety Profile in rGBM,and a Confirmed Partial Response

Updated Interim Data from Ongoing Phase 1 Study of Controlled IL-12 in Combination with Nivolumab Show a mOS of 16.9 Months in PatientsReceiving 10 mg Veledimex

First Data from Ongoing Phase 1/2 study of Controlled IL-12 Monotherapy Demonstrate Promising Safety Profile in Patient with DIPG

BOSTON, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (Ziopharm or the Company) (Nasdaq:ZIOP) today announced the presentation of new clinical data from three ongoing trials of Ad-RTS-hIL-12 plus veledimex (Controlled IL-12) for the treatment of recurrent glioblastoma (rGBM) and diffuse intrinsic pontine glioma (DIPG) at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting. Data highlights include the first discussion of interim data from the phase 2 study of Controlled IL-12 in combination with cemiplimab for the treatment of rGBM that has recently completed enrollment, updated interim data from the phase 1 study of Controlled IL-12 in combination with nivolumab for the treatment of rGBM and data from the first patient enrolled in the ongoing phase 1/2 study of Controlled IL-12 monotherapy for the treatment of DIPG.

Glioblastoma is a highly aggressive tumor and despite advances in oncology over the last few decades, median overall survival for patients with progressive GBM remains less than one year, said Rimas Lukas, M.D., Associate Professor of Neurology at Northwestern Memorial Hospital Malnati Brain Tumor Institute and investigator on the phase 2 trial of Controlled IL-12 in combination with cemiplimab. Here we report data for the first time from the ongoing phase 2 study of Controlled IL-12 in combination with PD-1 inhibitor cemiplimab, showing activation of the immune system across patients. These data are highly encouraging and underscore the potential of Controlled IL-12 to transform the treatment landscape of recurrent glioblastoma.

The updated data on combining Controlled IL-12 with nivolumab reveal a subset of patients with rGBM that demonstrate very encouraging survival at 16 months. This observation reveals that immune modulation with IL-12 and anti-PD-1 is well tolerated with an apparent survival benefit that will need further confirmation in upcoming more advanced clinical trials. These survival data in conjunction with previously reported MRIs showing partial responses is consistent with immune-mediated anti-tumor effects, noted E. Antonio Chiocca, M.D., Ph.D., study investigator, Chairman of Neurosurgery at Brigham and Women's Hospital, Professor of Neurosurgery at Harvard Medical School, and Surgical Director of the Center for Neuro-oncology at Dana-Farber Cancer Institute.

Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm, added, As we reflect on the growing body of evidence across our efforts utilizing our Controlled IL-12 platform, we are encouraged by the signs of efficacy we are seeing in these very hard-to-treat cancers. Not only are we observing cytokine production, increases in intra-tumoral T cells (cold tumors turning hot), and predictable safety after treatment with Controlled IL-12 as a monotherapy and in combination with PD-1 inhibitors, but we have reported at least one partial response in each rGBM trial we have conducted to date, for a total of six. These MRI data, along with IL-12-driven immune response complement our encouraging survival data and we look forward to future data read-outs in 2021. Further, the initial look at data from the first patient in our phase 1/2 pediatric glioma study supports Controlled IL-12s safety profile and continued development.

Controlled IL-12 in combination with PD-1 inhibitor cemiplimab is currently being examined in a phase 2 study for the treatment rGBM (NCT04006119). Preliminary data highlights shared in an on-demand presentation titled Phase 2 Trial of Controlled IL-12 in Combination with PD-1 Inhibitor in Adult Subjects with Recurrent Glioblastoma (Abstract #901183) and presented by Dr. Lukas, include:

Controlled IL-12 in combination with the PD-1 inhibitor nivolumab is currently being examined in a phase 1 study for the treatment of rGBM (NCT03636477). Interim data highlights shared in an oral on-demand presentation titled Combination of Controlled Interleukin-12 Gene Therapy with Immune Checkpoint Blockade in Recurrent Glioblastoma: Updated Results of a Multi-Institutional, Open Label Phase 1 Trial (Abstract #901050) and presented by Dr. Chiocca include:

As a follow up to our prior readout (ASCO 2020) for this combination which reported partial responses by MRI, the two patients had meaningful improvements in survival with one patient on 20 mg veledimex surviving 17.4 months (now deceased) and the other (10 mg veledimex) surviving 21.0 months (in follow up).

Controlled IL-12 monotherapy is being studied in a phase 1/2 dose escalation study (NCT03330197) for the treatment of children with gliomas, including DIPG. Data highlights from the first patient in the study shared in a poster discussion titled Phase I/II Study of Controlled IL-12 as Immunotherapy for Diffuse Intrinsic Pontine Glioma (DIPG) (Abstract #901123) and presented by Stewart Goldman, M.D., Division Head Hematology-Oncology, Neuro-Oncology & Stem Cell Transplantation at Lurie Children's Hospital and investigator in the study, include:

It is important to note that these trials, including our previously disclosed monotherapy study now consist of over 125 patients with rGBM. These provide deep learning that is ongoing and is part of the efforts to develop Controlled IL-12 as a potential therapy for brain cancers. We will continue to monitor the data across both the monotherapy and checkpoint inhibitor combination studies in the coming months. We believe there are multiple potential paths to registration for our Controlled IL-12 program, either as a monotherapy therapy or in combination with other agents, concluded Dr. Cooper.

More information about Controlled IL-12 is available on the Companys website at https://ziopharm.com/controlled-il-12/. Additionally, the presentations presented at the SNO 2020 Virtual Meeting will be available on the Companys website in the Scientific and Medical Publications section.

AboutZiopharm Oncology, Inc.Ziopharm is developing non-viral and cytokine-driven cell and gene therapies that weaponize the bodys immune system to treat the millions of people globally diagnosed with a solid tumor each year. With its multiplatform approach, Ziopharm is at the forefront of immuno-oncology with a goal to treat any type of solid tumor. Ziopharms pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies based on its non-viralSleeping Beautygene transfer platform, a precisely controlled IL-12 gene therapy, and rapidly manufacturedSleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic partnerships with theNational Cancer Institute,The University of Texas MD Anderson Cancer Centerand others. For more information, please visitwww.ziopharm.com.

Forward-Looking Statements DisclaimerThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the Company's business and strategic plans and the progress and timing of the Company's research and development programs, including the anticipated dates for the readouts of its clinical trials and the Companys expectations regarding future enrollment in its clinical trials. Although Ziopharms management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Ziopharm, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in our operating plans that may impact our cash expenditures, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Ziopharms product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies and for which indication; the strength and enforceability of Ziopharms intellectual property rights; and competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Ziopharm, including those risks and uncertainties listed in Ziopharms Quarterly Report on Form 10-Q filed by Ziopharm with the Securities and Exchange Commission. We are providing this information as of the date of this press release, and Ziopharm does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

Investor Relations Contacts:Adam D. Levy, PhD, MBAEVP, Investor Relations and Corporate CommunicationsT: 508.552.9255E: alevy@ziopharm.com

Chris TaylorVP, IR and Corporate CommunicationsT: 617.502.1881E: ctaylor@ziopharm.com

Media Relations Contact:LifeSci Communications:Patrick BurseyT: 646.876.4932E: pbursey@lifescicomms.com

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Ziopharm Oncology Presents Encouraging Clinical Data for Controlled IL-12 for the Treatment of Glioblastoma and DIPG at the 2020 Society for...

Many media organizations have spent the past four years generally failing to adapt to a campaign, a president, a White House and an administration that is extremely online, said Stacy-Marie Ishmael, the editorial director of the nonprofit Texas Tribune. We are only, four years in, getting to grips with how to contend with rhetorical techniques, messaging and communications steeped in misinformation and propaganda.

Others predicted a deeper cultural shift from Stephen Colberts biting satire back to the sillier Jimmy Fallon, from politics back to entertainment, whenever the studios can get production running again. But some veterans of the business of politics doubt that news coverage can really calm down or that consumers can look away.

If Biden is elected, conservatives will be energized, not retreating, said Eric Nelson, the editorial director of Broadside Books, HarperCollinss conservative imprint. Trump will keep tweeting, and new scandals from his presidency will keep unfolding for well into 2022. By the time that all chaos and nonsense runs out, Trump could be running again for 2024.

You arent the only one just barely hanging on until Election Day. Most of the top leaders of many name-brand American news institutions will probably be gone soon, too. The executive editor of The Los Angeles Times, Norm Pearlstine, is looking to recruit a successor by the end of the year, he told me. Martin Baron, the executive editor of The Washington Post, just bought a house out of town and two Posties said they expected him to depart next year. He hasnt given notice, The Posts spokeswoman, Kristine Coratti Kelly, said. And the executive editor of The New York Times, Dean Baquet, is on track to retire by the time he turns 66 in 2022, two Times executives told me, dampening speculation that he might stay longer.

Over in big TV, Mr. Zucker, of CNN, has signaled that hes frustrated with WarnerMedia, and broadcast television is overflowing with speculation about how long the network news chiefs will stay on, though no executives have suggested imminent departures. Everyone is assuming theres going to be turnover everywhere, and everyone is absolutely terrified about who is going to come in, one television industry insider said.

This isnt just the usual revolving door. Newsroom leaders face strong pulls in conflicting directions. Outlets all along the spectrum, from the staid BBC to the radical Intercept, have been moving to reassert final editorial control over their journalists. But newsroom employees like a generation of workers across many industries are arriving with heightened demands to be given more of a say in running their companies than in years past. New leaders may find opportunities to resolve some of the heated newsroom battles of the last year, or they may walk into firestorms.

Mr. Pearlstine, the only one talking openly of his departure, told me that the new metrics for success might be different as well issues such as inclusiveness, such as being anti-racist, such as really commanding some new platform, be it podcasts or video or newsletters, in addition to having journalistic credentials.

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Its the End of an Era for the Media, No Matter Who Wins the Election - The New York Times

This week the seemingly interminable 2020 presidential campaign will (hopefully) be at an end. While it is too soon to predict whether Trump or Biden will prevail on November 3, it is almost certain thatsocialmediawill be declared the undisputed loser.

If Biden wins, the Republicans will likely allegeunfair treatment onsocialmediaas a contributing factor in their loss. In the months leading up to the election,socialmediaplatforms including Facebook and Twitter have repeatedly flagged, fact-checked, or removed a number ofTrumps posts. They will blamesocialmediafor not doing more to bepolitically neutral.

If Trump wins, the Democrats will likely allege insufficientcontrol of misinformationonsocialmediaas a primary cause.False informationabout coronavirus, candidates, and conspiracies spread faster thansocialmediasites can take it down. Thus, the Democrats will blamesocialmediafor not doing more to address misinformation.

Regardless of the outcome, the losing side will be primed to blamesocialmediafor their loss and try to punish them for it over the next four years. Meanwhile, the winning side will likely say they won in spite of a brokensocialmediaenvironment and try to fix the rules to their advantage for the next election cycle.

This hostility will set the stage for Congress and the next administration to come out guns blazing to try to set new rules forsocialmedia, and such proposals may find bipartisan appeal. Some will call to break up Big Tech based on the mistaken belief that having more and smaller platforms will lead to better national dialogues. Others will demand thatsocialmediacompanies be stripped of theirliability protectionfor third-party content, unless they adhere to new rules on content moderationrules that would differ by the party in power.

Overall, the impact of such rules would be a major setback for Americans. Whensocialmediaplatforms are turned into political punching bags, they are forced to prioritize the demands of the prevailing political winds rather than the need of their users. In this case, they would likely be forced to significantly limit what the average user posts online to avoid potential violations.

While this might indeed reduce misinformation and punish those perceived as insufficiently politically neutral, it would come at the expense of the vibrancy that makes these platforms attractive to users in the first place. Moreover, it would undermine long-held values on both sides. Conservatives would be turning on their commitments to free markets and individual liberty in favor of increased regulation and government control. And by placing greater restrictions onsocialmediaplatforms, liberals would be curtailing free speech online, which would be unfortunate because, as the ACLUs national legal director David Coleexplains, the targets of censorship are typically dissidents, outsiders, the marginalized.

Win or lose, both parties are likely to targetsocialmediafollowing the 2020elections. Reactionary policies to right perceived wrongs will ultimately hurt major U.S. tech companies, reduce U.S. competitiveness, and hurt U.S. consumers. The questions about fairly and transparently moderating online content that have emerged throughout this election cycle should continue after the votes are counted, but with an eye toward improving consumer welfare, not just the next election.

This article was originally published onInformation Technology & Innovation Foundation's website.Governing's opinion columns reflect the views of their authors and not necessarily those of Governing editors or management.

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No Matter Who Wins the Election, Social Media Will Lose - Governing

2016 electoral map | Wikimedia Commons

Former Vice President and 2020 Democratic presidential nominee Joe Biden is not only benefiting from a favorable electoral map, but also from favorable, biased coverage by the mainstream media.

This May, Biden angrily told a prominent Black radio host, If you have a problem figuring out whether youre for me or Trump, then you aint Black! In August 2019, he told a group of Iowa voters that poor kids are just as bright as white kids. As a senator from Delaware, he voted for a controversial crime bill, The Violent Crime Control and Law Enforcement Act of 1994, which the American Civil Liberties Union criticized as a key contributor to the perpetuation of mass incarceration. Biden also voted for the U.S. invasion of Iraq in 2003, a conflict that has lasted for 17 years and one that a 2018 Gallup poll found only 43% of Americans approve of. Bidens campaign platform also promises to consider implementing unprecedented national restrictions to combat the coronavirus, as well as limiting fracking by banning new oil and gas permitting on public lands and waters.

While Trumps antics and his own controversial actions have led to well-deserved media criticism, it is obvious that Biden, a U.S. Senator of 36 years and a vice president of eight years, has a huge public record that ought to be scrutinized and debated as he runs for president.

2020 was never about Biden or the Democratic party. It is about Trump, the pandemic, and his response to it. Sadly, the consequence of this focus has resulted in the Biden-Harris campaign rarely facing questions on the solvency or constitutionality of their policies.

According to an October 2020 article by The Hill, at least 119 newspaper editorials endorsed Biden, while only 6 endorsed Trump. While being a left-leaning publication does not disqualify a publication from providing objective media coverage, it means that the American media establishment has essentially become an extension of the Biden-Harris campaign. If a media outlet endorses a campaign, then that outlet should not be trusted to report objectively, because it is in its interest to promote the candidate it endorses. When The New York Times and Washington Post endorsed the Biden-Harris campaign, they revealed themselves to be partisan advocates, not fair informants. The same article from The Hill cited Purdue University Communications Professor Jennifer Hoewe, who said, Research has shown that newspaper endorsements are impactful, particularly if they come from an unexpected source.

An August 2020 Gallup poll found 86% of Americans believe there is a fair amount of bias in news coverage. This conclusion is hardly surprising, as the media routinely derides positions it disagrees with. Glance at any major news outlets opinion sectionor even newsand you find predictions that a Trump victory will crush democratic government, a claim that Trumps America is hopelessly racist, a long analysis of a controversial Trump tweet, or a fact-check that claims the latest Biden gaffe is being taken out of context.

The language used by commentators in the mainstream media also suggests that the issues at hand are dogmatic moral positions, rather than debatable policies. This willful ignorance of the other side is reminiscent of the prisoners in Platos Allegory of the Cave. In this allegory, chained prisoners were only able to see cave-fire illuminated shadows of objects. Only when a prisoner was able to leave behind his chains could he see the real object illuminated by the sun.

The mainstream media is the personification of the chains in Platos cave. The grand spectrum of politics is boiled down into two candidates who are clearly portrayed as representatives of good, Biden and the Democratic party, versus evilTrump. Complicated issues are simplified as moral goods versus the tyrannical evils, actively anti-racist or complicit in racism, forced redistribution of income or against the poor and healthcare. The medias simplistic framing of these issues, rather than courageously engaging in their complexities, creates a false image of moral and political goods. Regardless of where one stands on these issues, policy proposals and political philosophies of the candidates deserve to be debated on their merits, not accepted or dismissed because they do not fit a narrative.

The motto of the Washington Post is Democracy Dies in Darkness. Its words ring truer than ever because the Post, like many other outlets, appeals to the darkness of partisanship and a hypocritical application of righteousness against the rights faults, while dismissing the faults of the left. Instead of educating people to arrive at their own decisions, the mainstream media and its keyboard crusaders mislead and imprison people in their own ignorance, fear, and biases.

The medias coverage of the 2020 election bears a lot of the blame for our divisive politics, eroding liberties, and the shocking ignorance of the citizenry. Let us hope 2024 is different.

Thomas Curro is a sophomore studying politics.

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Media bias undermined the 2020 election - Hillsdale Collegian

The likely November 3 outcome that worries observers is this scenario: The voting boxes and machines might very likely reveal an early Trump lead, but as the postal ballots keep getting counted that lead will start whittling away. This will be keenly watched in currently borderline states like Pennsylvania, Michigan, Wisconsin, Texas, Georgia, and Florida, states that favoured Trump in 2016. Trump operatives are expected to scrutinise each and every postal ballot and challenge many. It is estimated that close to 1.3% of postal ballots are rejected on various technicalities. This suggests close to 110,000 rejected postal ballots. Remember in Florida in 2000 just 537 votes decided the outcome by requiring the Florida electoral votes to go to George W Bush. This time around hundreds of Trump lawyer operatives have fanned out and the electoral process can expect to get slowed down by the sheer weight of challenges. Trump has been quite blatantly signalling to his troops to hobble the postal ballot counting. He has now openly said it.

Postal ballots will have plenty of flaws for the Trump lawyers to seize upon. For instance, if a voter gives a different address, or a different version of his name such as Joe for Joseph or Richie for Richard, or if there is a variation in the signature, any one of them can become a ground for dispute. Now here comes the catch. The states are required to finalise the appointment of the 538 members of the Electoral College by December 8. The Electoral College will have to formally meet by December 14 to elect the President. The big question now is what next?

The USA and even the world are accustomed to choosing the Electoral College by popular vote, but nothing in the US Constitution says it has to be that way. Article II, section 1 states: Each State shall appoint, in such Manner as the Legislature thereof may direct, a Number of Electors, equal to the whole Number of Senators and Representatives to which the State may be entitled in the Congress.

The Republicans control the governorships and state legislatures many of the decisive states. Thus, these states can, in the absence of a popular vote, appoint the Electors.

If that happens, given the predicted red states voting for him, Donald Trump might very well be deemed to have been elected or decide he is still the elected President of the United States. The matter will almost certainly have to be resolved by the US Supreme Court. But its tendencies are well understood.

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Biden might win, but Trump could still be President - National Herald