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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
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:)
PARIS (Reuters) – Airbus delivered 766 airliners in 2024 and looked certain to maintain leadership of the jetmaking industry for a sixth year as arch-rival Boeing (NYSE:) recovers cautiously from a prolonged internal crisis, company data showed on Thursday.
The European planemaker fell fractionally short of a headline target of “around 770” jets but was expected to claim victory after leaving itself a margin for error as global supply chains remain hampered by parts and labour shortages.
The widely watched deliveries, confirming a provisional tally of 766 jets reported by Reuters, marked a slowdown in Airbus’ industrial recovery from the pandemic, with annual growth more than halving to 4% from 11% a year earlier.
Although Boeing has yet to report annual data, a cautious ramp-up and regulatory curbs following a mid-air blowout on an Alaska Airlines jet one year ago had already left an unbridgeable gap between Boeing and Airbus deliveries for 2024.
Analysts say the two planemakers continue to compete aggressively for new orders, however.
Airbus posted 878 gross orders or a net total of 826 after cancellations, down 61% from a record 2023. By end-November, Boeing had 370 net orders after cancellations.
By Rollo Ross and Jackie Luna
LOS ANGELES (Reuters) -A pair of massive wildfires menacing Los Angeles from the east and west were still burning uncontained on Thursday, two days after they ignited, but firefighters managed to beat back another fire scorching the Hollywood Hills.
The Palisades fire between Santa Monica and Malibu on the city’s western flank and the Eaton (NYSE:) fire in the east near Pasadena are already the most destructive in Los Angeles history, burning nearly 28,000 acres so far – an area exceeding the size of Disney (NYSE:) World – and turning entire neighborhoods to ash.
At least five people have been killed, thousands of structures have been incinerated and nearly 180,000 people have been ordered to evacuate their homes, officials said. The death toll is likely to rise, Los Angeles Sheriff Robert Luna told a press conference on Thursday morning.
The Eaton fire’s growth has been significantly stopped, Los Angeles County Fire Chief Anthony Marrone said, though it remains 0% contained. While still fierce, winds have slowed slightly since the 100-mile-per-hour gusts seen earlier in the week, permitting crucial aerial support for crews on the ground.
“We have a much better posture than we did on Tuesday and Wednesday,” said Marrone.
But officials warned that wind gusts of up to 60 miles per hour were forecast to persist throughout the day, and Kristin Crowley, Los Angeles City Fire Department Chief, said residents should be prepared to evacuate if ordered.
“It is safe to say that the Palisades fire is one of the most destructive natural disasters in the history of Los Angeles,” Crowley said.
Firefighters, assisted by helicopters dropping retardants and water, managed to make gains overnight in battling the Sunset Fire, which had forced mandatory evacuations in Hollywood and Hollywood Hills – including famous show-business locations such as the TCL Chinese Theatre and the Hollywood Walk of Fame – late on Wednesday.
The fire was in retreat, shrinking to about 43 acres, and firefighters were making forward progress, Crowley said. No buildings were lost in the area, a city fire department spokeswoman said, and the evacuation order was lifted.
It was one of at least five separate wildfires burning in Los Angeles County on Thursday morning as powerful winds spread flames across parched ground that has seen no rain for months. Los Angeles Mayor Karen Bass described it as a “perfect storm” of dangerous conditions.
The two biggest conflagrations – the Palisades and Eaton fires – formed a pincer around the city so enormous that it was visible from space.
The homes of movie stars and celebrities were among those consumed by flames, which tore through some of the world’s most lavish real estate.
“We are heartbroken of course, but with the love of children and friends we will get through this,” said film star Billy Crystal and his wife Janice, announcing the Pacific Palisades home where they had lived since 1979 had been destroyed.
Media personality Paris Hilton said she was “heartbroken beyond words” after watching her beachfront house in Malibu “burn to the ground on live TV.”
The National Weather Service extended Red Flag warnings – issued when the risk for fire is high due to low humidity, high winds and warm temperatures – for Los Angeles and Ventura counties through 6 p.m. Friday.
Water shortages caused some hydrants to run dry in upscale Pacific Palisades, wedged between Malibu and Santa Monica, officials said on Wednesday.
U.S. President Joe Biden was briefed Thursday morning on the impact of the ongoing wildfires and will meet with top administration officials in the afternoon to discuss the federal response, the White House told reporters.
‘SOMETHING OUT OF A MOVIE’
Some residents ventured back to areas the fire had already swept through, where brick chimneys were left looming over charred waste and burnt-out vehicles. The remnants of a tattered and scorched American flag flapped from a pole.
“I had just come from my family home where my mother lives that was burned to a crisp … And then I came up to my home and – same thing. It’s completely dust,” said Oliver Allnatt, 36, wearing ski goggles and a filtered face mask as he took pictures of the ruins. “Basically just a chimney stack and a pile of ash. I mean, it’s something out of a movie.”
Thousands of Angelenos fleeing the flames sought refuge in temporary shelters. Foad Farid found refuge in the gym of the Westwood Recreation Center with nothing but his car and his phone. Neighbors dropped off blankets, clothing, water, pizza and pet food.
Jeff Harris arrived towing his Feisty Fish Poke food truck and began serving meals. “I’m just here to help,” he said.
Kevin Williams, at an evacuation center in Pasadena, said he knew it was time to run when gas canisters at his neighbors’ homes began exploding under the heat.
“The wind whipped up, the flames were up about 30 or 40 feet high, and you hear ‘pop, pop, pop.’ It sounded like a war zone.”
Aerial video by KTLA television showed block after block of smoldering homes in Pacific Palisades, the smoky grid occasionally punctuated by the orange blaze of another home still on fire.
The scale and spread of the blazes stretched exhausted firefighting crews beyond their capacity.
Firefighters from six other U.S. states were being rushed to California, while an additional 250 engine companies with 1,000 personnel were being moved from Northern California to Southern California, Los Angeles County Fire Chief Anthony Marrone told a press conference.
The fires struck at an especially vulnerable time for Southern California, which has not seen significant rainfall for months. Then came the powerful Santa Ana winds, bringing dry desert air from the east toward the coastal mountains, fanning wildfires while blowing over the hilltops and down through the canyons.
By Natalia Siniawski
(Reuters) -Mexico’s headline inflation rate eased more than expected in December, fueling bets that the central bank will keep cutting its benchmark interest rate despite an uptick in the core consumer price index.
Annual headline inflation in Latin America’s second-largest economy hit 4.21% last month, INEGI data showed, below the 4.28% expected by economists in a Reuters poll and down from the November figure of 4.55%.
“Good news,” central bank board member Jonathan Heath wrote in a post on X, “since this is the first time (inflation) comes below the 4.26% logged in October 2023.”
Meanwhile the closely watched core consumer price index, which excludes volatile energy and food prices, accelerated to 3.65% in the 12 months through December from 3.58% the previous month. Economists expected it to come in at 3.62%.
Andres Abadia, chief Latin America economist at Pantheon Macroeconomics, said the uptick in core inflation appears temporary and pointed to a drop in non-core inflation, helped by falling food prices due to favorable weather, as a key factor driving the headline decline.
Last month the Mexican central bank delivered a 25-basis-point cut to its benchmark interest rate, its fifth in 2024, bringing the rate down to 10.00%.
Minutes from the meeting, released later on Thursday, showed most board members were open to considering larger rate cuts going forward.
But December’s inflation data could diminish that prospect, analysts warned.
“The report supports another 25-basis-point rate cut in February but cautioned that sticky core services inflation and external risks, such as U.S. policy uncertainty, may lead Banxico to remain cautious in accelerating rate cuts,” said Kimberley Sperrfechter, emerging markets economist at Capital Economics.
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