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Exam Code: 156-215-80 Practice exam 2022 by Killexams.com team
156-215-80 Check Point Certified Security Administrator (CCSA) R80 (156-215.80)

Exam ID : Check Point Certified Security Administrator (CCSA) R80
Exam Title : 156-215.80
Exam Duration : 90 mins
Number of Questions : 90
Passing Score : 70%
Exam Center : Pearson VUE
Practice Test Check Point 156-215.80 Certification Practice Test
1. Performance-based
Identify the basic functions of the Web UI.
Create and confirm admin users for the network.
Configure network messages.
Confirm existing network configuration settings.
Install and tour the GUI.
2. Knowledge-based
Describe the key elements of Check Points unified, 3-tiered architecture.
Interpret the concept of a firewall and understand the mechanisms used for controlling network traffic.
Recognize SmartConsole features, functions and tools.
Understand Check Point deployment options.
1. Performance-based
Create multiple administrators and apply different roles/permissions for concurrent administration.
Create and configure network, host and gateway objects.
Evaluate and manipulate rules in a unified Access Control security policy.
Apply policy layers and analyze how they affect traffic inspection.
Prepare and schedule backups for the gateway.
2. Knowledge-based
Describe the essential elements of a unified security policy.
Understand how traffic inspection takes place in a unified security policy.
Summarize how administration roles and permissions assist in managing policy.
Recall how to implement Check Point backup techniques.
1. Performance-based
Evaluate and manage different Check Point security solutions deployed for network access control.
Evaluate and manage Check Point security solutions for threat protection.
Examine how the Compliance blade monitors your Check Point security infrastructure.
Validate existing licenses for products installed on your network.
2. Knowledge-based
Recognize Check Point security solutions & products and the way they protect your network.
Understand licensing and contract requirements for Check Point security solutions.
1. Performance-based
Generate network traffic and use traffic visibility tools to monitor the data.
Compare and contrast various tools available for viewing traffic
2. Knowledge-based
Identify tools designed to monitor data, determine threats and recognize opportunities for performance improvements.
Identify tools designed to respond quickly and efficiently to changes in gateways, tunnels, remote users and traffic flow patterns or security activities.
1. Performance-based
Configure and deploy a site-to-site VPN.
Test the VPN connection and analyze the tunnel traffic.
2. Knowledge-based
Understand VPN deployments and Check Point Communities.
Understand how to analyze and interpret VPN tunnel traffic.
1. Performance-based
Create and define user access for a guest wireless user.
Test Identity Awareness connection.
2. Knowledge-based
Recognize how to define users and user groups for your environment.
Understand how to manage user access for internal users and guests.
1. Performance-based
Install and configure ClusterXL with a High Availability configuration.
2. Knowledge-based
Describe the basic concept of ClusterXL technology and its advantages.
1. Performance-based
Review rule-base performance for policy control.
2. Knowledge-based
Understand how to perform periodic administrator tasks as specified in Administrator job descriptions.
1. Performance-based
Generate reports that effectively summarize network activity.
2. Knowledge-based
Recognize how to effectively create, customize and generate network activity reports.

Check Point Certified Security Administrator (CCSA) R80 (156-215.80)
CheckPoint Administrator test
Killexams : CheckPoint Administrator test - BingNews https://killexams.com/pass4sure/exam-detail/156-215-80 Search results Killexams : CheckPoint Administrator test - BingNews https://killexams.com/pass4sure/exam-detail/156-215-80 https://killexams.com/exam_list/CheckPoint Killexams : LCCC getting piece of $3M grant to train veterans to become truck drivers

U.S. Transportation Secretary Pete Buttigieg came to the Lehigh Valley to see how federal money is being spent, but to also announce new money heading to the region.

Buttigieg started Tuesday at Lehigh Valley International Airport to see the new $29 million terminal connection and security checkpoint expansion. The airport staff recently learned they’ll receive $5 million from the federal government, part of $1 billion to Improve airport terminals across the country.

His visit to Lehigh Carbon Community College came with the announcement that the college will receive $193,000, part of $3.1 million in grants to community colleges and training institutes under the Commercial Motor Vehicle Operator Safety Training (CMVOST) program.

The program offers two solutions at once, said Buttigieg, a Navy Reserves veteran. It connects veterans with great opportunities that they are qualified for with additional training, and helps meet an enormous need for America’s supply chains.

The grants to LCCC and LVIA are part of President Joe Biden’s $1 trillion infrastructure law, which includes the proposed Allentown-NYC passenger rail line, millions for local road and bridge projects.

“That is happening because members of Congress like Susan Wild stepped up and said, ‘No more talk, time for action, we’re going to support this bi-partisan infrastructure deal and work with the President to get it done,’” Buttigieg said.

For this round of grant funding, the U.S. Department of Transportation’s Federal Motor Carrier Safety Administration allowed a broader range of institutions to apply for the grants and did not require applicants to propose local grant match funding.

The training program seeks to help members of the armed forces, veterans and their spouses earn a commercial driver’s license (CDL) and get training behind the wheel.

LCCC offers a four-week CDL training and testing course and the new grant will cover tuition for 30 military veterans and five individuals from underserved communities.

They will learn at the community college how to drive a truck, get their CDL license, and then receive help getting trucking jobs after the program.

The announcement was close to U.S. Rep. Susan Wild’s heart. Her father served in the Air Force and the family moved every two years until they moved to the Lehigh Valley.

The region’s proximity to New York and Philadelphia makes it a prime transportation and logistics hub, Wild said, which is why the CDL programs at the local community colleges are so incredibly important.

The programs are also important to help combat the growing truck driver shortage. Last October, the American Trucking Associations said the driver shortage had worsened to a worst-ever 80,000 drivers. The figure was based on the difference between the number of drivers in the market and the optimal number of drivers based on freight demand.

Many drivers are retiring. There aren’t enough women drivers or drivers passing drug tests. There aren’t enough 21-year-old applicants. That’s the federally mandated minimum age to drive commercially across state lines, the ATA said.

Jabree Williams, Tamaqua, was part of a small group of LCCC students currently in the CDL training program that were on the training lot and met Buttigieg. They did not envy the student trying to back up a tractor-trailer while Buttigieg and a small crowd watched.

Williams said he chose LCCC because it was close to him and it is a four-week program.

“I talked to a couple of people, and they said they were very efficient with their training, they were very in tune with you, and they help you, Williams said.

The training includes a written portion, 40 hours in a classroom and then the written test. And then students train on the range for all the driving maneuvers before the driving test.

The current students will be taking the driving test soon. Asked about the job market, Williams said he was looking at long-haul driving for Walmart or Dollar General.

Other students have spoken about joining UPS or FedEx, but Williams said those were local jobs with 12- to 14-hour days. As a long-haul driver, Williams said he liked that he would be gone during the week but home during the weekend.

Russell Lande, is a Coast Guard veteran and a retired police officer, who used the grant to go through LCCC’s program and now works for FedEx.

Lande, who lives in Salisbury Township, was part of a local convoy who traveled to Dulles International Airport in Virginia to transport a shipment of baby formula to the Nestlé distribution facility in Upper Macungie Township, part of “Operation Fly Formula.”

“What your program does doesn’t just affect someone like me, it affects everybody...that grant is not just about the veterans, it affects so many others,” he said.

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Sarah Cassi may be reached at scassi@lehighvalleylive.com.

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Tue, 02 Aug 2022 07:18:00 -0500 en text/html https://www.lehighvalleylive.com/business/2022/08/lccc-getting-piece-of-3m-grant-to-train-veterans-to-become-truck-drivers.html
Killexams : Groundbreaking CAP Guideline Clarifies Biomarker Testing, Impacts Multiple Cancer Types

A new College of American Pathologists (CAP) evidence-based guideline is among the first to address testing based less on the cancer type or tumor origin and more on the methodology and status of a biomarker—in this case, microsatellite testing and deficient mismatch repair process assessment.

The "Mismatch Repair (MMR) and Microsatellite Instability (MSI) Testing for Immune Checkpoint Inhibitor Therapy" guideline provides clarity for pathologists and oncologists to Improve the evaluation of patients with colorectal, endometrial, gastroesophageal, small bowel, and certain other cancers who may be eligible for immunotherapies known as immune checkpoint inhibitors.

Published today in an early online release in Archives of Pathology & Laboratory Medicine, the guideline also breaks new ground with recommendations on the role of tumor mutational burden in MMR testing and the evaluation for Lynch Syndrome, a hereditary cancer syndrome that may be unexpectedly detected in the work-up of these patients with advanced cancers. The CAP developed the guideline in collaboration with experts from the Association for Molecular Pathology (AMP), the American Society of Clinical Oncology (ASCO), and the patient advocacy group Fight Colorectal Cancer (Fight CRC).

"We've seen that patients whose cancers had high levels of MSI or defective MMR can respond well to immune checkpoint inhibitor therapy, and now we have objective guidance to assess that status across a range of cancer types," explains pathologist Russell Broaddus, MD, PhD, FCAP, who led the expert panel to develop the guideline.

Dr. Broaddus noted that when the FDA approved immunotherapy treatment for patients with MSI-high or MMR-deficient tumor status, regardless of cancer type, it did not detail how to test for that status. The new CAP guideline helps to fill that gap, providing oncologists, pathologists, and laboratories of all sizes with objective, evidence-based recommendations to efficiently deploy specific assays and accurately identify patients eligible for treatment.

With six recommendations and three good practice statements, the guideline provides data and details regarding the efficacy and utility of specific testing modalities across applicable cancer types, including MMR by immunohistochemistry, MSI by polymerase chain reaction, and MSI by next generation sequencing, for patients being treated with immune checkpoint inhibitors. In addition, the guideline identifies gaps in our current knowledge base, which, when addressed, may represent opportunities to help Improve the methodological approach for identifying the patients with advanced cancers who are most likely to respond to this therapeutic approach.

To ensure patients receive more effective testing with consistent, high-quality results, and expert interpretations, the CAP provides free, open access tools and resources with each evidence-based guideline to help clinical and laboratory teams adopt the recommendations. MMR-MSI guideline resources are downloadable on cap.org.

About the College of American Pathologists

As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, READ THE CAP ANNUAL REPORT at CAP.ORG.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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Wed, 03 Aug 2022 08:18:00 -0500 text/html https://www.benzinga.com/pressreleases/22/08/b28341149/groundbreaking-cap-guideline-clarifies-biomarker-testing-impacts-multiple-cancer-types
Killexams : SJC to take up breath test issue in Salem case

Aug. 1—SALEM — Nearly a decade after her arrest at a state police sobriety checkpoint, Lindsay Hallinan still deals with the fallout.

In October 2013, when a device called the Draeger Alcotest 9510 registered her blood alcohol level at .23, Hallinan figured she had no option but to admit to sufficient facts in the case the following month.

Because it was a second offense, she spent two years on probation, lost her license for the same length of time, and when it was reinstated, she struggled with a malfunctioning ignition interlock device that triggered new license suspensions, her lawyer, Murat Erkan, said.

Hallinan is among approximately 27,000 people who since have been notified that the state lab that oversees all alcohol test devices used by police in Massachusetts tried to cover up issues with the Draeger Alcotest. Inasmuch, the former Danvers woman potentially has the option of getting a new trial.

The problem: Because Hallinan — like the vast majority of drunken driving defendants in Massachusetts courts — resolved the case through an admission to facts rather than a trial, prosecutors are opposing her request. They point to decades of legal precedent that give significant weight to a person's admission of guilt or responsibility when considering whether to grant a new trial. And, they say, there was plenty of other strong evidence that Hallinan was drunk behind the wheel, including the odor of alcohol, her red, glassy eyes, and her failure of field sobriety tests.

But Hallinan's lawyers say that the conduct of the state lab — which was found to have intentionally withheld evidence about the devices — was so egregious that she's entitled to a do-over.

Last month, the Supreme Judicial Court announced that it would take up Hallinan's appeal in order to address what could be thousands of similar requests. It has also asked for "friend of the court" briefs on the issue.

"She feels motivated to stand up against unfairness and for due process of law," said Erkan, whose practice is in Andover. He reached out to Joseph Bernard, the Springfield attorney who led most of the litigation over the controversial breath-test machines over the past seven years. Bernard is now also representing Hallinan.

Alcotest problems

Issues with the Draeger Alcotest 9510 first came to public attention in 2015, when The Salem News reported that the machines were returning results outside of the acceptable margin of error under Massachusetts regulations — something state officials initially blamed on "operator error," but also acknowledged they were addressing through a software patch and recalibration.

Later, in the course of litigation led by Bernard, it emerged that the Office of Alcohol Testing had withheld reports of significant problems in attempting to calibrate the machines, which had never been scientifically vetted for use in the state's courts. It was discovered that at least one in five machines had failed calibration attempts — information that the lab did not turn over to the court.

Eventually, the use of results between 2011, when the state first purchased the machines, and 2019 was barred. And the 27,000 defendants whose cases rested at least in part on those results were notified.

But was the lab's conduct so egregious that it should create an automatic presumption that a defendant is entitled to a new trial? Erkan and Bernard believe it does — and they're joined by defense lawyers all over the state, including the Massachusetts Association of Criminal Defense Lawyers and the state public defender agency, the Committee for Public Counsel Services.

"For years, (the Office of Alcohol Testing) hid evidence that its testing failed to meet minimum scientific standards, rendering its results inadmissible," the lawyers wrote. "Thousands of individuals were convicted based on these false assurances."

'Tests led to pleas'

Judge Robert Brennan, the former presiding judge at Salem District Court, heard the legal challenge to the machines. He's also the judge who heard Hallinan's motion for a new trial, since the judge who originally sentenced Hallinan died.

Brennan, who was named to the state Appeals Court earlier this year, stopped short of granting Hallinan a new trial, however, saying he does not believe he has the legal authority to conclude that the lab's conduct was "egregious" enough to automatically create a right to a new trial — but that a higher court does.

The case has some similarities to the scandals at two state drug labs, where chemists were found to be falsifying test results. Courts later held that the there was no way to specifically identify which cases were tainted by misconduct by the chemists and eventually ordered the dismissal of thousands of drug convictions as a result.

That's not the case here — at least not yet, Erkan said. The drug cases in the Annie Dookhan and Sonja Farak scandals required proof that the evidence really was an illegal substance, as opposed to a breath test being just one piece of evidence to consider in a drunken driving case.

Defendants seeking new trials, like Hallinan, would also have to show that but for the breath test result they would have been found not guilty.

Essex County prosecutors say the sentence imposed on Hallinan by the judge in 2013, a continuation without a finding on a second-offense drunken driving case less than 10 years after her first drunken driving conviction, was so favorable it may have been a significant inducement to admit to sufficient facts in the case, in addition to the other evidence available.

State troopers noted Hallinan's appearance, an odor of alcohol, her failure on field sobriety tests and her admission to having had three drinks as other evidence against her in the case.

"Here ... notwithstanding the Alcotest 9510 breath test, the case against the defendant was strong," a prosecutor wrote in opposing a new trial for Hallinan.

But Erkan and Bernard say it was the breath test result that convinced Hallinan to admit to the offense. They say prosecutors "induced her to forego trial by presenting her guilt as a scientific fact — a fact conclusively proved by a breath test result which it held out as unimpeachable," her lawyers argue. "It is not a stretch to infer that, of the total number of individuals who took a breath test, a great many did so because they believed they were not impaired and thus not guilty."

Simply put, people like Hallinan were induced to admit guilt by faulty machine readings, the lawyers argue.

If granted a new trial, Hallinan, now 39 and living in upstate New York, and her lawyer would be able to ask a judge to suppress the breath test result from the evidence against her, leaving officers' now-nearly decade-old observations as evidence in the case.

The Essex District Attorney's office has until Sept. 23 to file its response with the SJC and the court is also expecting briefs from the state public defender's agency and a group of private defense attorneys. After that they will schedule a hearing.

Courts reporter Julie Manganis can be reached at 978-338-2521, by email at jmanganis@salemnews.com or on Twitter at @SNJulieManganis

Courts reporter Julie Manganis can be reached at 978-338-2521, by email at jmanganis@salemnews.com or on Twitter at @SNJulieManganis

Mon, 01 Aug 2022 02:09:00 -0500 en-US text/html https://www.yahoo.com/news/sjc-breath-test-issue-salem-135500997.html
Killexams : 'Smuggler' ferrying five migrants shot dead after his driver blew past police checkpoint in southern Mexico

'Smuggler' ferrying five migrants shot dead after his driver blew past police checkpoint in southern Mexico

  • Alleged migrant smuggler identified as Fernando was shot dead by cops in San Cristóbal de las Casas, Mexico, on Monday 
  • The Chiapas State Attorney General's Office said Fernando was in a pickup truck transporting five migrants when the driver failed to stop at a checkpoint
  • A man identified as Marcelino told the prosecutor's office that they encountered gun fire from the cops before Fernando was killed
  • Authorities said that someone in the vehicle shot at the police, who then responded with fire 

An alleged smuggler was shot dead by cops moments after the driver of the pickup truck they were ferrying migrants in failed to stop for a revision near Mexico's border with Guatemala.

At least five migrants were in the vehicle with the driver and the man who was shot early Monday, the Chiapas State Attorney General's Office said in a statement.

The driver, identified only as Marcelino, told investigators with the state prosecutor's office that he and the smuggler, Fernando, had picked up the migrants in the Mexican border town of Comitán de Domínguez.

A pickup truck from the police department in the southern Mexican city of San Cristóbal de las Casas lies burned in a street after residents protested the killing of an alleged migrant smuggler who was shot dead by cops Monday

A police vehicle burns in the middle of a street in San Cristóbal de las Casas, Mexico, on Monday after an alleged migrant smuggler was shot by the police after his driver refused to stop at a checkpoint

They were headed north when they encountered municipal police from San Cristobal de las Casas around 12:06 a.m. local time.

"They were shot at on different occasions, and Fernando, who was traveling in the back seat, was wounded and killed," the Chiapas State Attorney General's Office said.

Someone in the truck opened fire on police, who then responded by shooting at the truck, according to an official in the state prosecutor's office who was not authorized to speak about the case.

Fernando's sparked protests in San Cristobal de las Casas as friends and family sought answers. 

A police pickup truck was torched in the middle of a street near the state prosecutor's building around 3:00 a.m.

While receiving less attention than other migratory routes in southern Mexico, smugglers frequently use the sparsely-populated mountains in San Cristobal de las Casas to move people north from Central America.

The town is located almost 270 miles from the border city of Tapachula, where thousands are United States-bound migrants find themselves waiting on the Mexican government to approve special 30-day permits that allow them to move freely through the country while they wait for the their immigration process to play out.

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Mon, 01 Aug 2022 05:08:00 -0500 text/html https://www.dailymail.co.uk/news/article-11069935/Police-kill-alleged-smuggler-southern-Mexico.html
Killexams : MAIA Biotechnology Doses First Patient With THIO in Phase 2 Trial (THIO-101) for Non-Small Cell Lung Cancer

CHICAGO--(BUSINESS WIRE)--Jul 18, 2022--

MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs (“MAIA”), announced today that the first patient has been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating the administration of THIO, in sequence with cemiplimab, in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

The THIO-101 Phase 2 trial is designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of the checkpoint inhibitor cemiplimab (developed by Regeneron), allowing for immune activation and PD-1 sensitivity to take effect. The primary objectives of the trial are to evaluate the safety and tolerability of THIO administered as a direct anticancer and priming immune system agent prior to cemiplimab administration, as well as the clinical efficacy of THIO in patients with advanced NSCLC who either progressed or relapsed through treatment with an immune-check point inhibitor alone or in combination with chemotherapy. The first patient in THIO-101 was dosed in Australia in July 2022 after the Company’s application received regulatory approval in March 2022. The Company also plans to submit a similar application in the second quarter of 2022, to conduct the same Phase 2 study in Europe.

“Dosing our first patient in this Phase 2 trial with THIO is an important milestone for MAIA, marking the continued development of our telomere-targeting approach,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Despite the advancements made in the field with checkpoint inhibitors, monoclonal antibodies and newer immunotherapies, very limited treatment options exist for patients that have progressed beyond the standard-of-care regimens. We believe THIO has the potential to hold a significant place in the NSCLC treatment paradigm.”

Sergei Gryaznov, Ph.D., Chief Scientific Officer of MAIA, added, “Lung cancer is the second most diagnosed cancer worldwide and NSCLC is the most common form of lung cancer, accounting for more than eighty percent of all lung cancer diagnoses. This represents a significant unmet medical need across the globe, and we remain enthusiastic about THIO’s observed mechanism of action.”

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of the checkpoint inhibitor cemiplimab (developed by Regeneron), potentially allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety of THIO administered as an anticancer agent and a priming immune system agent prior to cemiplimab administration and (2) to assess the clinical efficacy of THIO followed by cemiplimab using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed for patients with NSCLC that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully Improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in development for the treatment of patients with telomerase-positive cancers. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s real results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to Improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause real results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

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Killexams : Valo Therapeutics Advancing Plans for Oncolytic Virus Treatments With Tailored Immunogenic Peptides

NEW YORK – Valo Therapeutics has reimagined oncolytic virus treatments by adding an exterior coating of tumor-specific peptides designed to stimulate an immune response against the tumor.

This enhancement, according the company, has opened development pathways for personalized therapy based on its PeptiCRAd technology.

PeptiCRAd uses electrostatic interactions to attach immunogenic peptides with a positively charged lysine tail to the negatively charged outside surface of a virus or bacteria. It was developed at the University of Helsinki, which spun out Valo in 2016.

The Finnish firm's lead product, PeptiCRAd-1, is an engineered adenovirus coated with NY-ESO-1 and MAGE-A3 tumor antigens genetically modified for increased tumor cell infection, high viral replication within the tumor, and increased immunogenicity. It also carries two co-stimulatory molecules as transgenes. One encodes a CD40 ligand to drive CD8+ T-cell responses. Another encodes an OX40 ligand for increased clonal expansion and survival of CD8+ T cells, and formation of a larger pool of memory T cells.

In nature, oncolytic viruses infect and kill cancer cells. Their potential as therapeutics has been harnessed through engineering of oncolytic viruses to have specific cancer-fighting properties. The US Food and Drug Administration approved Amgen's Imlygic (talimogene laherparepvec) for melanoma as the first oncolytic viral immunotherapy in 2015, and a number of others are in clinical trials, including some that use biomarker strategies and others in which oncolytic viruses are being combined with autologous CAR T-cell treatments.

Examples include a Phase I trial of the oncolytic virus Vaxinia (CF33-hNIS) and Merck's Keytruda (pembrolizumab) in metastatic solid tumors started by Imugene and City of Hope in May; and Phase I and Phase II trials by Vyriad of an attenuated measles virus and vesicular stomatitis virus alone and in combination with checkpoint inhibitors. The biomarker of interest in the City of Hope/Imugene and Vyriad trials is PD-L1 expression. Meanwhile, Mustang Bio is testing out an oncolytic virus with an autologous CAR T-cell therapy in brain cancer patients.

According to Valo CEO Paul Higham, what differentiates Valo's approach from others is the peptide coating, which gives the virus additional vaccine-like properties on top of the oncolytic effect of the virus. Because the peptides are attached weakly to the virus exterior by electrostatic charge rather than chemical bonds, they are released in the tumor environment, stimulating an immune response.

"Oncolytic viruses in the past stimulated a strong immune response. But most of that has been directed against the virus itself, not against the tumor," said Higham. "We're really shifting the focus of the immune system away from the virus and onto the tumor."

In preclinical research, the Helsinki-based company has shown that a PeptiCRAd virus targeting MAGE-A1 eradicated tumors in humanized mice with melanomas and increased the population of MAGE-A1-specific CD8+ T cells. "We've seen in our preclinical work, we have something close to a 90 percent response rate in the mice that we've treated," said Higham, adding that the effect is increased when a PeptiCRAd therapy is combined with checkpoint inhibitors.

Higham said Valo has also conducted experiments in which two identical tumors are grafted onto a mouse, one on the right side and one on the left, and PeptiCRAd therapy is injected into one of the tumors. Researchers observed an expected effect in the PeptiCRAd-injected tumor, but they also saw a "really strong effect" on the untreated tumor on the other side of the body.

"The only way you can really explain that is that we've stimulated the immune system in the right way and the relevant immune cells – mainly T cells – have gone throughout the mouse's body, identified that there's a tumor on the other side, and attacked that tumor," Higham said. Those results from mouse studies suggest that in humans this therapy could be active against metastases via a systemic immune reaction, even when only the primary tumor is treated.

Valo is hoping to see this effect in an upcoming Phase I clinical trial, in which it is combining PeptiCRAd-1 with Keytruda in 15 patients with melanoma, triple-negative breast cancer, and non-small cell lung cancer. Higham said patients in the study will receive four injections of PeptiCRAD-1 into their tumors followed by checkpoint inhibitor therapy "to take down any barrier there may be to T cells getting in and killing tumor cells." Researchers will measure changes in immune cells throughout the body indicating they are recognizing tumor antigens as well as patients' responses to therapy.

Valo, which is currently raising money for the study, has started recruiting patients at sites in Germany and expects to begin dosing patients before year end. The trial will report data before the end of 2023. "Within less than 18 months from now, we hope to have the full results of the study available," Higham said.

The company's acquisition of the PeptiCHIP platform from the University of Helsinki last month adds personalization capability to its development plans for its pipeline of PeptiCRAd therapies. PeptiCHIP combines microfluidic chip technology with a software algorithm to identify antigens from a tumor. Valo plans to develop individualized, n-of-1 therapies by using PeptiCHIP to test a patient's tumor for antigens and treating the patient with a PeptiCRAd therapy targeted to those antigens specifically.

That could happen in one of two ways. First, the company could create a bespoke therapy based on the patient's tumor antigen profile. A second option, Higham said, might be to create a library of the most common peptide antigens patients with a specific tumor type tend to have and cross-match an individual's PeptiCHIP analysis with that library to find an off-the-shelf PeptiCRAd therapy.

While a similar analysis using conventional methods might take two or three days, Higham said that Valo hopes to develop a method that will complete the tumor antigen analysis in two to three hours.

Toward that end, Higham said Valo's Phase I study would serve as proof of concept to show that the PeptiCRAd platform works. Once that's established, the company will expand into personalization strategies. That would put the start of clinical trials at least two years out, Highman estimated.

Another possibility being explored by Valo is repeating the antigen screening periodically during treatment and in follow-up in order to adapt the therapy to changes in the tumor, which often leads to loss of effectiveness of immunotherapies over time. "The targets we initially choose may not, six months or a year down the line, be the most relevant targets," said Higham. "We may have the adaptability to flex with the tumor as it changes."

While Valo is able to go after a variety of cancers with PeptiCRAd therapies, one limitation is that the tumor must be accessible to inject with a needle. Higham said that liver cancer and bladder cancer could be future areas of study for the company, but that with personalized therapy, the type of cancer "becomes a little bit irrelevant because we're treating individual tumors in a particular patient. If we can get biopsy sample from them, we can create a therapy."

Comparing a personalized PeptiCRAd therapy to autologous CAR T cell-therapy, which is also an n-of-1 treatment, Higham noted that adapting the therapy to changes in the tumor would require starting over, which would be expensive and time-consuming. "CAR T therapies can cost up to $400,000," Higham said. "Our therapy would be well below $100,000 because we're using a simpler, off-the-shelf oncolytic virus. That doesn't change. We just change the antigens."

In terms of regulation, Higham said the pathway for its Phase I PeptiCRAd product is "fairly straightforward." The company has permission from the German Regulatory Agency to proceed with its Phase I trial, and oncolytic viruses are an established mode of therapy. "The trickier thing is the adaptability we want to build in regarding the personalized therapy, and there may be a number of ways of doing that," Higham said.

That's where the use of a library may be helpful. "What we'd aim to do is have the peptides in the library approved by the regulatory authority so we're then free to select down from that library at any time and not have to seek individual regulatory approval for each patient or each therapy."

Because the peptide-coating technology is applicable to any oncolytic virus, Higham said that Valo is talking with other oncolytic virus companies about potential partnerships to apply the PeptiCRAd technology to their viruses. "It's a way our technology platform can [move] forward into Phase II and III studies very quickly, because we'd simply be enhancing what's already there," Higham said.

The firm is eyeing opportunities to work with companies developing checkpoint inhibitors or cell-based therapies, as PeptiCRAd therapies can potentially be combined with those, as well as with companies in need of a platform for validating neoantigens.

Thu, 04 Aug 2022 07:42:00 -0500 en text/html https://www.precisiononcologynews.com/cancer/valo-therapeutics-advancing-plans-oncolytic-virus-treatments-tailored-immunogenic-peptides
Killexams : Groundbreaking CAP Guideline Clarifies Biomarker Testing, Impacts Multiple Cancer Types

NORTHFIELD, Ill.--(BUSINESS WIRE)--Aug 3, 2022--

A new College of American Pathologists (CAP) evidence-based guideline is among the first to address testing based less on the cancer type or tumor origin and more on the methodology and status of a biomarker—in this case, microsatellite testing and deficient mismatch repair process assessment.

The “Mismatch Repair (MMR) and Microsatellite Instability (MSI) Testing for Immune Checkpoint Inhibitor Therapy” guideline provides clarity for pathologists and oncologists to Improve the evaluation of patients with colorectal, endometrial, gastroesophageal, small bowel, and certain other cancers who may be eligible for immunotherapies known as immune checkpoint inhibitors.

Published today in an early online release in Archives of Pathology & Laboratory Medicine, the guideline also breaks new ground with recommendations on the role of tumor mutational burden in MMR testing and the evaluation for Lynch Syndrome, a hereditary cancer syndrome that may be unexpectedly detected in the work-up of these patients with advanced cancers. The CAP developed the guideline in collaboration with experts from the Association for Molecular Pathology (AMP), the American Society of Clinical Oncology (ASCO), and the patient advocacy group Fight Colorectal Cancer (Fight CRC).

“We’ve seen that patients whose cancers had high levels of MSI or defective MMR can respond well to immune checkpoint inhibitor therapy, and now we have objective guidance to assess that status across a range of cancer types,” explains pathologist Russell Broaddus, MD, PhD, FCAP, who led the expert panel to develop the guideline.

Dr. Broaddus noted that when the FDA approved immunotherapy treatment for patients with MSI-high or MMR-deficient tumor status, regardless of cancer type, it did not detail how to test for that status. The new CAP guideline helps to fill that gap, providing oncologists, pathologists, and laboratories of all sizes with objective, evidence-based recommendations to efficiently deploy specific assays and accurately identify patients eligible for treatment.

With six recommendations and three good practice statements, the guideline provides data and details regarding the efficacy and utility of specific testing modalities across applicable cancer types, including MMR by immunohistochemistry, MSI by polymerase chain reaction, and MSI by next generation sequencing, for patients being treated with immune checkpoint inhibitors. In addition, the guideline identifies gaps in our current knowledge base, which, when addressed, may represent opportunities to help Improve the methodological approach for identifying the patients with advanced cancers who are most likely to respond to this therapeutic approach.

To ensure patients receive more effective testing with consistent, high-quality results, and expert interpretations, the CAP provides free, open access tools and resources with each evidence-based guideline to help clinical and laboratory teams adopt the recommendations. MMR-MSI guideline resources are downloadable on cap.org.

About the College of American Pathologists

As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, READ THE CAP ANNUAL REPORT at CAP.ORG.

View source version on businesswire.com:https://www.businesswire.com/news/home/20220803005040/en/

CONTACT: Kerry Lydon

800-323-4040, ext. 7844

Email:media@cap.org

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SOURCE: College of American Pathologists

Copyright Business Wire 2022.

PUB: 08/03/2022 04:18 PM/DISC: 08/03/2022 04:18 PM

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Copyright Business Wire 2022.

Wed, 03 Aug 2022 08:47:00 -0500 en text/html https://www.joplinglobe.com/region/national_business/groundbreaking-cap-guideline-clarifies-biomarker-testing-impacts-multiple-cancer-types/article_1465d9f0-5d99-581a-bfe6-b3997f5bc893.html
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