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Replimune Presents Late-Breaking Abstract Featuring Data from IGNYTE Clinical Trial of RP1 Combined with Nivolumab in Anti-PD1 Failed Melanoma at the 39th Annual Meeting of the Society for Immunothera

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Oral presentation highlighting IGNYTE primary analysis data shows anti-tumor activity across all subgroups with injected and non-injected lesions responding with similar frequency, depth, duration, and kinetics

Initial biomarker data shows increase in tumor CD8+ T cell and PD-L1 expression after dosing along with an increase in gene signatures associated with CD8+ T cells and inflammatory cytokines, highlighting the potential of RP1 plus nivolumab to generate a potent anti-tumor immune response

WOBURN, Mass., Nov. 09, 2024 (GLOBE NEWSWIRE) — Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the primary analysis data from the IGNYTE clinical trial, including initial biomarker analyses, was presented as a late-breaking abstract during an oral session at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024) in Houston, Texas. In addition, data from the ARTACUS clinical trial evaluating RP1 monotherapy in solid organ transplant patients with advanced cutaneous malignancies was also shared in an encore poster presentation during the meeting.

The initial biomarker analyses included in the SITC presentation which demonstrate increases in tumor CD8+ T cell infiltration and PD-L1 expression along with the induction of an immune inflammatory gene signature after treatment, further support the intended mechanism of RP1 in combination with nivolumab, including its ability to induce a systemic response after progression on prior anti-PD1 therapy, said Kostas Xynos, MD, PhD, MBA, Chief Medical (TASE:) Officer of Replimune. We believe that the systemic activity of RP1 and nivolumab is in particular demonstrated by the similar level of responses seen in both injected and non-injected lesions, including hard to treat visceral lesions, and by the durability of the responses seen.

IGNYTE Clinical Trial Data at SITC
The IGNYTE clinical trial cohort in anti-PD-1 failed melanoma included 140 patients who received RP1 plus nivolumab after confirmed progression while being treated for at least 8 weeks with anti-PD-1 based therapy, with or without anti-CTLA-4. The primary analysis by blinded independent central review was triggered once all patients had been followed for at least 12 months. The median follow-up at the time of the primary analysis was 15.4 months (0.5-47.6 months).

Data from the IGNYTE trial presented at SITC 2024 show:

  • One-third of patients experienced a confirmed response, with an overall response rate (ORR) of 33.6% by modified RECIST (mRECIST) v1.1 criteria, the primary endpoint in the trial protocol, and 32.9% by RECIST v1.1 criteria, an additional analysis requested by the FDA. The complete response (CR) rate by mRECIST v1.1 was 15%. In patients who had prior anti-PD1 and anti-CTLA-4, the ORR was 27.7% and for those who had primary resistance to anti-PD1, the ORR was 35.9% by mRECIST v1.1.
  • The median duration of response from response initiation was 21.6 months.
  • Most injected and non-injected lesions (85%) in responders had a 30% or greater reduction in size. RP1 plus nivolumab induced deep responses in non-injected lesions in visceral organs, including those distant from the injection site.
  • Median overall survival for the trial has not been reached, however, one-, two-, and three-year survival rates were 75.3%, 63.3%, and 54.8%, respectively. 12-month progression free survival (PFS) was 32.8% and median PFS was 3.7 months.

Initial biomarker data included in the SITC presentation show:

  • Tumor inflammation signature (TIS) and nano string analysis revealed an increase in the expression of genes associated with CD8+ T cells and inflammatory cytokines. These markers highlight the potential of RP1 plus nivolumab to generate a potent anti-tumor immune response. TIS is an investigational use only assay consisting of 18 genes that assesses the presence of an adaptive immune response, and which is associated with responsiveness to anti-PD1 therapy1.
  • Immunohistochemistry (IHC) images demonstrate that RP1 plus nivolumab may stimulate tumors to a more immune inflamed state, further highlighting the potential of RP1 plus nivolumab to reverse mechanisms of resistance to anti-PD1 therapy.

As previously reported, RP1  combined with nivolumab continues to be well-tolerated. Treatment-related adverse events associated with  RP1  in combination with nivolumab were predominantly Grade 1-2 constitutional type events (> 5% of patients), including fatigue, chills, pyrexia, nausea, influenza-like illness, injection-site pain, diarrhea, vomiting, headache, pruritis, asthenia, arthralgia, myalgia, decreased appetite, and rash, with a low incidence (12.8% of patients) of Grade 3-4 events, which were predominantly Grade 3. Grade 4 events were one each of lipase increased, cytokine release syndrome, myocarditis, hepatic cytolysis, and splenic rupture. There were no Grade 5 events.

The presentation is available on the Company website under  Events and Presentations.

The IGNYTE-3 confirmatory phase 3 trial evaluating RP1 plus nivolumab versus physician’s choice in patients with advanced melanoma who have progressed on anti-PD1 and anti-CTLA-4 or who are not candidates for anti-CTLA-4 therapy is currently recruiting. For additional information, visit https://replimune.com/clinical-trials/ignyte-3/.

About  Replimune  
Replimune Group, Inc., headquartered in  Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit  www.replimune.com.

Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as could, expects, intends, may, plans, potential, should, will, would, or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the  Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

Investor Inquiries
Chris Brinzey
ICR Westwicke
339.970.2843
chris.brinzey@westwicke.com

Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com

Source: Replimune Group Inc (NASDAQ:)

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It’s Utility Scam Awareness Day and FirstEnergy Urges Customers to Stay On Guard Through the Winter Months

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AKRON, Ohio, Nov. 20, 2024 /PRNewswire/ — In recognition of Utility Scam Awareness Day on Wednesday, Nov. 20, FirstEnergy Corp. (NYSE: NYSE:) is offering tips to prevent the public from falling for common utility scams, especially as the cold winter months are fast approaching.

Scammers often prey on the fears of vulnerable customers to steal their personal information and trick them into paying “unpaid bills” to avoid service disconnection. To date in 2024, FirstEnergy has received more than 3,400 reports of scams from customers. The actual number of scam attempts is even higher since many go unreported to the company or law enforcement officials.

Michelle Henry, Senior Vice President of Customer Experience at FirstEnergy: “Education is key when it comes to helping our customers avoid common utility scams. While we take significant measures to ensure the safety and security of our customer account information, we urge you to be on guard against impostors who claim to be associated with our company.”

Read about known utility scams and how to avoid them on our website.

Utility Scam Awareness Day is organized by Utilities United Against Scams, a group of more than 150 electric companies and related organizations working together to educate customers on how they can prevent becoming victims of utility impostors.

Scammers work year-round, but they tend to be more active during colder months because they know customers rely on electricity to stay safe and warm and are more likely to comply due to fear of disconnection.

Stop Utility Impostors in Their Tracks

Scammers continue to implement sophisticated tactics to impersonate utility companies. It is important that customers can distinguish between legitimate contacts from their utility and attempts used by utility impostors. Here are some tips to help:

  • Well in advance of the disconnection date, FirstEnergy utility customers who are behind on their accounts will be sent written notice of their account status with instructions on how to avoid disconnection of service.
  • Utility impostors often require that you use unusual payment methods like digital payment apps, cryptocurrencies or money transfers. Only send payments to your FirstEnergy operating company using our established payment methods.
  • FirstEnergy field collectors working in New Jersey, Maryland and Ohio may offer customers with past-due accounts the opportunity to pay their bill in person before disconnecting service. All employees carry company-issued photo identification.
  • Some scammers go door-to-door posing as representatives of FirstEnergy and offer “special deals” to customers who provide their personal information. FirstEnergy employees and authorized contractors do not solicit door-to-door and will never ask you to provide a copy of your electric bill.
  • Scammers often use Caller ID spoofing software to misrepresent the source of a phone call to further mislead and confuse their targets. When in doubt, hang up and dial the phone number on your FirstEnergy bill. Never dial the phone number provided by the scammer or the Caller ID.
  • Bad actors frequently pretend to offer bill assistance through programs that do not exist in order to steal sensitive customer information. Customers in need of assistance should view our list of authorized bill assistance programs.
  • Utility imposters have spoofed employment listings on legitimate job-search websites to trick jobseekers into providing personal data. You can verify the authenticity of the posting by visiting www.firstenergycorp.com/careers or contacting FirstEnergy’s Human Resources department at FirstEnergyHR@firstenergycorp.com.
  • Cyber criminals may also try to steal your private information using malware delivered through texts and emails. Avoid clicking on any links or downloading attachments from suspicious emails or texts.

Please share this information with friends and family to continue raising awareness of these crimes. You can also follow FirstEnergy electric companies on Facebook (NASDAQ:) and X as well as visit Utilities United Against Scams’ website for regular scam safety tips.

FirstEnergy is dedicated to integrity, safety, reliability and operational excellence. Its electric distribution companies form one of the nation’s largest investor-owned electric systems, serving more than six million customers in Ohio, Pennsylvania, New Jersey, West Virginia, Maryland and New York. The company’s transmission subsidiaries operate more than 24,000 miles of transmission lines that connect the Midwest and Mid-Atlantic regions. Follow FirstEnergy online at www.firstenergycorp.com and on X @FirstEnergyCorp.

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ENLV stock touches 52-week low at $0.99 amid market challenges

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In a challenging market environment, Enlivex Therapeutics Ltd. (NASDAQ:) stock has reached its 52-week low, trading at $0.99. This price level reflects a significant downturn for the company, which has experienced a 1-year change with a decline of -41.95%. Investors are closely monitoring ENLV as it navigates through the pressures that have led to this low point, considering both the company’s strategic responses and the broader market conditions that have contributed to this decline. The 52-week low serves as a critical indicator for the company’s performance over the past year and sets a new benchmark for its potential recovery.

In other recent news, Enlivex Therapeutics has made significant strides in its clinical trials for treating knee osteoarthritis. The company received authorization from the Danish Medicines Agency to commence the Phase 2 stage of its trial, following a positive endorsement from the independent Data and Safety Monitoring Board. The advancement of this trial could potentially strengthen Enlivex’s position in the development of osteoarthritis treatments.

In financial news, Enlivex reported a robust position for Q2 2024, with $25.9 million in cash and short-term deposits, and secured $5 million in a direct offering. Analyst firms H.C. Wainwright and EF Hutton have both maintained a Buy rating on Enlivex, reflecting confidence in the company’s clinical development strategy.

The company has also scheduled its Annual General Meeting of Shareholders for late October, with standard corporate matters on the agenda. These recent developments highlight the progress Enlivex Therapeutics is making in its clinical trials and its financial stability, which are crucial for investors to note.

InvestingPro Insights

Enlivex Therapeutics Ltd. (ENLV) is facing significant challenges, as reflected in its recent stock performance. InvestingPro data shows that the company’s market capitalization has dwindled to $21.41 million, with the stock price experiencing a sharp 32.24% decline over the past month. This aligns with the article’s mention of ENLV reaching its 52-week low.

InvestingPro Tips highlight that ENLV’s stock is currently in oversold territory according to the RSI indicator, which could potentially signal a buying opportunity for contrarian investors. However, it’s crucial to note that the company is quickly burning through cash and is not profitable over the last twelve months, with a negative EBITDA of -$17.89 million for the same period.

On a positive note, ENLV holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. This financial cushion may provide some stability as the company works through its current challenges.

For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for ENLV, which could provide valuable insights into the company’s future prospects and potential turnaround strategies.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Factbox-What Trump 2.0 could mean for trade, migrants, climate change and electric cars

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By James Oliphant

WASHINGTON (Reuters) -Donald Trump’s second presidential term could have huge implications for U.S. trade policy, climate change, the war in Ukraine, electric vehicles, Americans’ taxes and illegal immigration.

While some of his campaign proposals would require congressional approval, here is a summary of the policies he has said he will pursue when he takes office in January: 

MORE TARIFFS

Trump has floated the idea of a 10% or more tariff on all goods imported into the U.S., a move he says would eliminate the trade deficit. But critics say it would lead to higher prices for American consumers and global economic instability.

He has also said he should have the authority to set higher tariffs on countries that have put tariffs on U.S. imports. He has threatened to impose a 200% tariff on some imported cars, saying he is determined in particular to keep cars from Mexico from coming into the country. 

But he has also suggested that allies such as the European Union could see higher duties on their goods.

Trump has targeted China in particular. He proposes phasing out Chinese imports of goods such as electronics, steel and pharmaceuticals over four years. He seeks to prohibit Chinese companies from owning U.S. real estate and infrastructure in the energy and tech sectors.

Trump has said “tariff” is his favorite word and views them as revenue generators that would help fill government coffers. 

MASS DEPORTATIONS

Trump has vowed to reinstate his first-term policies targeting illegal border crossings and to forge ahead with sweeping new restrictions.

He has pledged to limit access to asylum at the U.S.-Mexico border and to embark on the biggest deportation effort in American history, which would likely trigger legal challenges and opposition from Democrats in Congress.

He has said he will employ the National Guard, and, if necessary, federal troops, to achieve his objective, and he has not ruled out setting up internment camps to process people for deportation.

Trump has said he would seek to end automatic citizenship for children born to immigrants, a move that would run against the long-running interpretation of the U.S. Constitution’s 14th Amendment. 

He has also suggested he would revoke protected legal status for some populations such as Haitians or Venezuelans.

Trump says he will reinstitute the so-called “travel ban” that restricts entry into the United States of people from a list of largely Muslim-dominant countries, which sparked multiple legal battles during his first term.

Some of Trump’s earliest appointments reflected an urgency to follow through on his immigration agenda. Trump has named a “border czar,” Tom Homan, and will make Stephen Miller, the architect of his immigration plans, a White House deputy chief of staff.

DRILLING AWAY

Trump has vowed to increase U.S. production of fossil fuels by easing the permitting process for drilling on federal land and would encourage new pipelines. He has said he would reauthorize oil drilling in the Arctic National Wildlife Refuge in Alaska.

Trump has pledged to create a National Energy Council to coordinate policies to boost U.S. energy production that will be led by his pick for interior secretary, North Dakota Governor Doug Burgum.

Whether the oil industry follows through and raises production at a time when oil and gas prices are relatively low remains to be seen.

Trump has said he will again pull the United States out of the Paris Climate Accords, a framework for reducing global greenhouse gas emissions, and would support increased nuclear energy production. 

He would also roll back Democratic President Joe Biden’s electric-vehicle mandates and other policies aimed at reducing auto emissions.

He has argued that the U.S. needs to be able to boost energy production to be competitive in developing artificial intelligence systems, which consume large amounts of power.

TAX RELIEF

Along with his trade and energy agendas, Trump has promised to slash federal regulations that he says limit job creation. He has pledged to keep in place a broad 2017 tax cut that he signed while in office, and his economic team has discussed a further round of individual and corporate tax cuts beyond those enacted in his first term.

Trump has pledged to reduce the corporate tax rate from 21% to 15% for companies that make their products in the U.S. 

He  has said he would seek legislation to end the taxation of tips and overtime wages to aid waiters and other service workers. He has pledged not to tax or cut Social Security benefits.

Trump also has said that as president he would pressure the Federal Reserve to lower interest rates – but would stop short of demanding it.

Most, if not all, of his tax proposals would require congressional action. Budget analysts have warned that the bevy of tax cuts would balloon the federal debt.

DOING AWAY WITH DIVERSITY PROGRAMS

Trump has pledged to require U.S. colleges and universities to “defend American tradition and Western civilization” and to purge them of diversity programs. He said he would direct the Justice Department to pursue civil rights cases against schools that engage in racial discrimination.

At K-12 schools, Trump would support programs allowing parents to use public funds for private or religious instruction.

Trump also wants to abolish the federal Department of Education, and leave states in control of schooling.

NO FEDERAL ABORTION BAN

Trump appointed three justices to the U.S. Supreme Court who were part of the majority that did away with Roe v. Wade’s constitutional protection for abortion. He likely would continue to appoint federal judges who would uphold abortion limits.

At the same time, he has said a federal abortion ban is unnecessary and that the issue should be resolved at the state level. He has argued that a six-week ban favored by some Republicans is overly harsh and that any legislation should include exceptions for rape, incest and the health of the mother. 

Trump has suggested he would not seek to limit access to the abortion drug mifepristone after the U.S. Supreme Court rejected a challenge to the government’s approach to regulating it. 

He supports policies that advance in vitro fertilization (IVF), birth control and prenatal care.

A PUSH TO END WARS

Trump has been critical of U.S. support for Ukraine in its war with Russia, and has said he could end the war in 24 hours if elected – although he has not said how he would achieve this. 

He has suggested Ukraine may have to yield some of its territory if a peace deal is to be struck, an idea Ukraine has consistently rejected.

Trump’s pick for his national security adviser, U.S. Representative Michael Waltz, was critical of the Biden administration’s decision in November to allow Ukraine to use U.S.-provided missiles to strike within Russian territory.

Trump has also said that under his presidency the U.S. would fundamentally rethink “NATO’s purpose and NATO’s mission.”

Trump named U.S. Senator Marco Rubio, a China hawk, as his secretary of state, charged with carrying out his foreign policy goals.

Trump has backed Israel in its fight against Hamas in Gaza but has urged it to wrap up its offensive. He can be expected to continue the Biden administration’s policy of arming Israel. At the same time, Trump is likely to push for historic normalization of relations between Israel and Saudi Arabia, an effort he made during his 2017-2021 presidency and which Biden has also pursued.

Trump has said if he becomes president, he will “stop the suffering and destruction in Lebanon,” but has not said how he will achieve that.

He has suggested building an “iron dome” – a massive missile-defense shield similar to Israel’s – over the entire continental United States.

Trump has also floated sending armed forces into Mexico to battle drug cartels and using the U.S. Navy to form a blockade of that country to stop the smuggling of fentanyl and its precursors.

His transition team has been drawing up lists of potential high-ranking U.S. military officers to fire as part of a purge of the Pentagon of those believed to be “disloyal” to Trump.

INVESTIGATING ENEMIES, AIDING ALLIES

Trump has pledged at times to use federal law enforcement agencies to investigate his political foes, including election officials, lawyers and party donors. 

Trump tapped former U.S. congressman Matt Gaetz as his attorney general. Gaetz has suggested he is sympathetic to Trump’s revenge agenda.

Along that line, Trump has said he will consider appointing a special prosecutor to probe Biden, though he has not specified the grounds for such an investigation. 

And he has said he would consider firing a U.S. attorney who did not follow his directives – which would constitute a break with the longstanding U.S. policy of an independent federal law enforcement apparatus.

Trump has said he will consider pardoning all of those who have been convicted of crimes in connection with the Jan. 6, 2021, attack on the U.S. Capitol.

In addition to criminal investigations, he has suggested using the government’s regulatory powers to punish those he views as critics, such as television networks.

PURGING THE FEDERAL BUREAUCRACY

Trump would seek to decimate what he terms the “deep state” – career federal employees he says are clandestinely pursuing their own agendas – through an executive order that would reclassify thousands of workers to enable them to be fired. That would likely be challenged in court. 

© Reuters. Republican presidential nominee and former U.S. President Donald Trump takes the stage following early results from the 2024 U.S. presidential election in Palm Beach County Convention Center, in West Palm Beach, Florida, U.S., November 6, 2024. REUTERS/Callaghan O'Hare     TPX IMAGES OF THE DAY

He has said he will set up an independent government efficiency panel headed by billionaire supporter Elon Musk and former presidential candidate Vivek Ramaswamy to root out waste in the federal government. The government already has watchdogs such as the Office of Management and Budget, and investigators general at federal agencies.

Trump would crack down on federal whistleblowers, who are typically shielded by law, and would institute an independent body to “monitor” U.S. intelligence agencies.

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