Hoosier Theatre marks century of movie magic but may hit the market in a few weeks

Joseph S. Pete

WHITING — When past generations of Region residents went to the movies, they went in style.Ushers escorted movie patrons to their seats at grand movie palaces like the Paramount, Parthenon, State, Voge, Indiana and Palace. Searchlights raked the night sky outside. Signs went up all over town advertising the latest feature films. Sometimes movie stars would even make an appearance to promote their latest work.The facades were ornate, the lobbies lined with plush red carpet and thousands of dressed-up movie-goers filled the palatial theaters.But the multiplexes ultimately replaced almost all the grand movie palaces of yesteryear in Northwest Indiana.The Hoosier Theatre in Whiting has soldiered on alone.The extravagant movie palace with a pipe organ at 1335 119th St. in downtown Whiting opened in 1924 and is marking its 100th anniversary this year.

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“We’re the sole surviving single-screen movie theater in Northwest Indiana,” owner John Katris said. “We’re the only one left.” The Hoosier Theatre still shows first-run feature films but may not be much longer.Katris is looking to retire. He plans to put the Hoosier Theatre up for sale in a few weeks. Katris, whose parents owned the Voge Theatre in East Chicago and who restored the Hoosier Theatre and reopened it 33 years ago, expects it likely would return to its roots as a vaudeville stage and be transformed into a performing arts venue.”It has a legitimate stage, an orchestra pit, dressing rooms and a balcony,” he said. “It’s the last of the vaudeville theaters in the Region. They’re all gone. We’re the sole survivor.”Katris was looking last year to turn it over to a nonprofit group that planned to transform it into a live entertainment venue that would host film festivals, holiday screenings of “It’s a Wonderful Life,” standup comedy, concerts, theater and variety shows. But the plans fell apart.”I was talking to the city and the not-for-profit but it never materialized,” he said. The Hoosier Theatre carried on. Then Longtime Hoosier Theatre manager Joe Pranaitis died this summer of a heart attack at the age of 45 years old.”He was a dedicated young man with an eye for detail,” Katris said. “He also was a talented sci-fi writer. Everybody loved him. He started on cleanup duty, became an usher, then worked in concessions and eventually became assistant manager. He was the voice and face of the Hoosier Theatre. Everybody knew what a good job he did. He was like my little brother. I just miss him and think about him all the time.”Katris has continued to run it as a movie theater but increasingly wants to retire.”I’m going to put the building up for sale in the next few weeks. I want to find the right buyer. It’s completely operational. It’s turnkey,” he said. “There’s a lot of history. It’s a gem of a theater.”The building also generates additional income outside of the movie screenings. It includes eight apartments upstairs and three additional commercial storefronts, one of which is home to Erie Insurance and two of which are currently used for storage.Listed on the National Register of Historic Places, the Hoosier Theatre boasts a six-rank Kimball organ, a high vaulted ceiling, ornamental plaster reliefs, a towering screen with plush red curtains and 600 seats. Its ornate terracotta facade and brightly lit vintage marquee are staples of the 119th Street streetscape in downtown Whiting. Photos and paintings of the theater are commonly exhibited at Studio 659 down the street.In the early days, W.C. Fields, the Three Stooges, Rin Tin Tin and Amos & Andy all performed there. Red Grange threw footballs off the roof while selling war bonds during World War II.Balaban and Katz, a prominent entertainment company that owned several theaters around Chicagoland, used it as a test market.”It was a tryout for the acts on their circuit,” Katris said. “Once talking pictures arrived, it focused on movies. It showed movies like ‘Gone with the Wind,’ ‘The Wizard of Oz,’ ‘Patton,’ anything big and major. It showed great musical comedies, dramas, action, all the major movies.”Shorts and newsreels were often shown before the movies back in the early 20th century. The films usually had intermissions.The Hoosier Theatre suffered a fire in the 1980s and was vacant until Katris decided to restore it. His parents long ran the 914-seat Voge Theatre in East Chicago, which burned down in an arson in the 1970s. Katris transferred the projector and other historic artifacts over to the Hoosier Theatre when he was renovating it and looking to get it back open.”I was just in elementary school when they ran it but still loved it and had fond memories,” he said. “I got projectors, popcorn machines, drinking fountains, decor and aisle lights out of storage when I was restoring it and saving it from the wrecking back,” he said. “We incorporated it into the Hoosier Theatre. Some of it came from the Uptown in Chicago.”A design-build contractor by trade, he was an architectural buff who wanted to save the building. Eight-foot-long icicles hung from the bare bricks when he took it over. The heating and electrical systems dated all the way back to the 1920s.”I was young and ambitious back then,” he said. “If you showed me that theater now I would say you are crazy and wouldn’t touch it with a 10-foot pole. There was plaster falling off the wall. The roof was leaky. It took a lot of hard work, love and sweat to bring it back.He did extensive work to salvage the building with the help of a small crew and reopened in 1997 with red-carpet fanfare he likened to the Academy Awards. It routinely sold out movies like “Good Will Hunting” when it first reopened. An organist would play on the weekends.”I got a call from a booker in 1998 saying I was the talk of Hollywood and had the third highest-grossing single screen in the country,” he said. “It was that way for a good five years.”But after the novelty wore off people gravitated more to multiplexes. The Hoosier Theatre went from being a regional draw to mainly a neighborhood theater that found audiences with family films and superhero movies. With only a single screen, Katris had to be careful about what movie he picked.”If it was a bomb, we’d be stuck with it for two or three weeks,” he said. “That’s what killed single-screen theaters.”After the pandemic, more and more people have stayed home to stream instead of going out to the movies.”Streaming is the way of movies now. Even the megaplexes aren’t doing well,” he said. “I believe a performing arts center will be the next chapter. It could have ballets, Shakespeare, anything you can do on a stage. It could be a good mix with maybe classic, art and independent films. We had a comedy show and concert here that did well. It will take a promoter to take it to the next level. I’m ready to retire. Someone needs to take it to the next chapter.”He said he hopes to keep it on the market long enough to find the right buyer.”It brings life to downtown Whiting,” he said. “At night it can get desolate after business hours. It becomes a ghost town. It brings a little bit of life. People grab dinner or drinks. Hopefully, there’s a good organization that will take it to the next level because I’m ready to retire.”Anyone who’s interested can email [email protected], visit hoosiertheatre.com or call (219) 659-0567.

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Tom Holland and Austin Butler team up for new film

Tom Holland and Austin Butler will team up for a new racing movie, with the pair set to play brothers. As per Variety, the duo will star in American Speed, which is based on the true story of the Whittington Brothers. The film will reportedly depict the 1980s IMSA Scandal, which saw several drivers charged after financing their campaigns with money from illegal ventures.Holland and Butler are the only confirmed cast members for the project, which has been acquired by Amazon MGM Studios. Charles Roven is confirmed to be a producer, with Dan Wiedenhaupt signed up to pen the screenplay. Matt Winkelmeyer//Getty ImagesRelated: Austin Butler and Emma Stone’s new movie gets exciting updateWhilst American Speed is very much in its infancy, Holland – best known for his role as Peter Parker/Spider-Man in the Marvel Cinematic Universe – recently landed a role in Christopher Nolan’s highly-anticipated new film, joining Matt Damon in the cast. Holland, who has also starred as Nathan Drake in the Uncharted film adaptation, spoke of his excitement at joining the currently untitled film, sharing: “When the opportunity came in, it was the phone call of a lifetime. “[It was] reminiscent of getting that call about Spider-Man 10 years ago. It’s an amazing thing for me. I’m super proud and I’m really, really excited. All I can say is that I’m incredibly excited and obviously honoured, but that’s all I can say because to be honest that’s really all I know.” Nina Westervelt/Variety//Getty ImagesRelated: Best film and TV tours for 2024Whilst Holland has a while to wait to appear in both Nolan’s mystery project and American Speed, the star recently provided an update on a fourth Spider-Man film, sharing that he was impressed by the first draft of the script. “The idea is crazy. It’s a little different to anything we’ve done before, but I think the fans are gonna really respond to it,” he said, following a previous comment in which he said the script had “lit a fire” within him. American Speed has no release date. November 2024 gift ideas and dealsReporter, Digital Spy George is a freelance writer who specialises in Movies and TV. After graduating with a degree in Film Studies and Journalism from De Montfort University, in which he analysed the early works of Richard Linklater for his dissertation, he wrote for several websites for GRV Media.  His film tastes vary from blockbusters like Mission: Impossible and John Wick to international directors such as Paolo Sorrentino and Hirokazu Kore-eda, and has attended both the London and Berlin film festivals. 

Vir Biotechnology, Inc. (NASDAQ:VIR) Q3 2024 Earnings Call Transcript

Vir Biotechnology, Inc. (NASDAQ:VIR) Q3 2024 Earnings Call Transcript October 31, 2024Vir Biotechnology, Inc. misses on earnings expectations. Reported EPS is $-1.56 EPS, expectations were $-0.96.Operator: [Call starts abruptly] …Vir’s Third Quarter 2024 Financial Results and Business Update Call. As a reminder, this conference call is being recorded. [Operator Instructions] I will now turn the call over to Rich Lepke, Senior Director, Investor Relations. You may begin, Mr. Lepke.Richard Lepke: Thank you and good afternoon. With me today are Dr. Marianne De Backer, our Chief Executive Officer; Dr. Mark Eisner, our Chief Medical Officer; and Jason O’Byrne, our Chief Financial Officer. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by such forward-looking statements. These risks and uncertainties and risks associated with our business are described in the company’s reports filed with the Securities and Exchange Commission, including Forms 10-K, 10-Q and 8-K. I will now turn the call over to our CEO, Marianne De Backer.Marianne De Backer: Thank you, Rich. Good afternoon, everyone and thank you for joining us today. I’m pleased to provide an update on the significant progress we’ve made this quarter, beginning with the successful closing of our exclusive worldwide licensing agreement with Sanofi. This landmark agreement includes 3 clinical stage masked T-cell engagers and use of Sanofi’s proprietary PRO-XTEN protease-cleavable masking platform for oncology and infectious diseases. This strategic move aligns seamlessly with our mission to use the power of the immune system to fight disease. We believe that the 3 dual-masked T cell engagers VIR-5818 for HER2, VIR-5500 for PSMA and VIR-5525 for EGFR have the potential to be best-in-class therapies. These investigational treatments aim to minimize toxicity challenges typically associated with T-cell engagers, allowing for higher dosing and thereby enhancing efficacy. As part of this agreement, we have welcomed key employees from Sanofi which bring extensive scientific and development expertise in oncology and the PRO-XTEN masking platform technology. These talented individuals have quickly proven to be an excellent fit within our organization. We believe that their expertise, combined with our deep understanding of T-cell immunology, our robust infrastructure and leading machine learning and antibody engineering capabilities will create significant synergies. Moving on to our mid-stage clinical pipeline. We are making strong progress across our hepatitis programs with important upcoming data readouts. I’ll now highlight our recent progress in the ongoing Phase II SOLSTICE trial in patients with chronic hepatitis delta. Hepatitis delta represents a highly promising growth opportunity for Vir, marking the next significant inflection point in our journey towards becoming a fully integrated and sustainable commercial company. Much like other orphan disease markets, the HDV market is characterized by significant unmet medical needs and severe clinical outcomes for patients. This underscores an opportunity for innovative and impactful therapies that address critical health challenges and offer substantial value to both patients and the health care system. We estimate there are approximately 100,000 people living with hepatitis delta in United States and approximately 200,000 in Europe.Q&A Session Follow Vir Biotechnology Inc. (NASDAQ:VIR) Follow Vir Biotechnology Inc. (NASDAQ:VIR) We may use your email to send marketing emails about our services. Click here to read our privacy policy. Despite the severe and often life-threatening impact of HDV, patients currently have very limited treatment options. There are no approved therapies in the U.S. and in Europe, the only available treatment requires daily self-administered subcutaneous injections, presenting challenges for long-term patient compliance and quality of life. Based on the preliminary Phase II clinical data we have shared to date, we believe our combination regimen of tobevibart and elebsiran is highly differentiated compared to the current standard of care and has the potential to be a transformative treatment option for these patients in need. As we continue to advance this promising treatment, we anticipate an increase in both diagnosis and treatment rates. Feedback from physicians and advocacy groups has highlighted a growing interest in reflex testing for hepatitis delta. Reflex testing involves automatically testing for hepatitis delta in patients who test positive for hepatitis B without requiring a separate order from the health care provider. This proactive approach ensures early identification of HDV infections even in regions like the United States, where treatment options are currently limited. By identifying patients early, we can help ensure they receive timely treatment once a therapy is approved. While we are at the early stages of driving this awareness, we aim to improve early diagnosis and pave the way for effective treatment outcomes for patients with hepatitis delta as our HDV program advances closer towards a potential approval. We are committed to partnering with key stakeholders across the health care landscape to advocate for and adopt these testing practices. Looking ahead, we will present data from the SOLSTICE trial at the AASLD conference taking place November 15 to 19 in San Diego. We are making excellent progress advancing this program in the clinic and have engaged with the FDA to discuss our planned registrational program in HDV which is expected to begin next year. Next, I’d like to address our functional cure program for chronic hepatitis B which represents another substantial opportunity for our combination regimen of tobevibart and elebsiran with or without regulated pegylated interferon alpha. Our goal is a functional cure in this setting, defined as a sustained loss of detectable hepatitis B surface antigen and hepatitis B virus DNA after a finite course of treatment. There are an estimated 1.6 million hepatitis B patients in the United States alone and approximately $254 million globally. We are looking forward to reporting end of treatment data from the MARCH Part B trial in a Late Breaking presentation at the upcoming AASLD meeting in November. This end-of-treatment data will be followed by the functional cure data readout in the second quarter of 2025. Based on KOL feedback, our target for a functional cure is 30% for the interferon-containing regimen and 20% for the regimen excluding interferon. Before I close, I would like to provide an update on our upcoming events and reaffirm our commitment to keeping you informed about our progress. While we had initially planned to host an R&D Day in the fourth quarter, we will instead conduct an in-depth investor event focused on our hepatitis franchise in November. Given the addition of the T-cell engagers to our portfolio and the subsequent reprioritization of our pipeline, we have adjusted our plans. We now intend to discuss our T-cell engager programs, at a dedicated investor event in first quarter of 2025. This timing also allows us to present initial clinical results, ensuring we provide insights into our progress and the future prospects of these programs. As mentioned, we will host an exclusively hepatitis focused investor event immediately following the AASLD conference in November. During this event, we will provide detailed updates on both the MARCH and SOLSTICE programs. This focused approach will allow us to delve deeply into these 2 critical development programs and their implications for patients and our broader clinical strategy. We understand the importance of clear and timely communication with our investors and we are committed to keeping you updated on all the significant developments. Finally, I’m thrilled to have welcomed Jason O’Byrne as our new Executive Vice President and Chief Financial Officer earlier this month. Jason is an accomplished executive with more than 20 years of experience in finance and operations and a proven track record in financial strategy across public companies. His exceptional leadership and focus on excellence in execution, make him a perfect fit as we embark on the next chapter for our organization. Since joining here, one of Jason’s key priorities has been to ensure continued disciplined capital deployment and financial stewardship. As we recently announced, we have implemented a strategic restructuring initiative to prioritize our clinical stage pipeline opportunities and streamline our operations. These efforts are allowing us to allocate our resources more efficiently and focus on our core programs. In closing, I couldn’t be more optimistic about Vir’s future and the potential impact of our innovative therapies. We have a strong balance sheet which allows us to fund operations through our next major inflection points. We are prudently managing our expenses with a focus on our most promising programs and maximizing shareholder value. I would like to thank our dedicated team, including our new colleagues for their hard work and our investors for their continued support. And with that, I’ll now turn the call over to our Executive Vice President and Chief Medical Officer; Mark Eisner, to provide an update on our clinical development programs and pipeline.Mark Eisner: Thank you, Marianne and good afternoon, everyone. Let’s begin with the SOLSTICE trial in hepatitis delta. As a reminder, we presented strong preliminary data from our Phase II SOLSTICE trial in HDV at the EASL Congress in June. In our rollover cohort of 6 non-cirrhotic participants, we reported that all 6 achieved virologic suppression below the lower limit of quantification and 5 out of 6 achieved target not detected indicating no measurable presence of HDV RNA. Additionally, 3 out of 6 achieved ALT normalization, durable virologic suppression was observed in the combination rollover cohort, suggesting the potential for sustained antiviral activity. There are 32 participants in the de novo combination cohort and 33 participants are in the monotherapy cohort. At the time of the analysis, 11 participants in the de novo combination cohort and 7 participants in the monotherapy cohort had reached 24 weeks of treatment. There were no discontinuations in the combination cohort. After 24 weeks of treatment, all 11 participants in the de novo combination cohort achieved virologic suppression below the lower limit of quantification and 6 out of 11 achieved target not detected. Seven out of 11 also achieved ALT normalization. From a safety perspective, we observed no treatment-related serious adverse events or ALT flares in either the monotherapy or de novo combination treatment regimens. The majority of adverse events were transient and mild grade 1 or 2 with a low incidence of injection site reactions. Taken together, these preliminary data are extremely promising as all 3 cohorts demonstrated rapid and sustained virologic responses. We will be sharing the full data set for both cohorts of approximately 30 participants at 24 weeks of treatment as well as available data for participants beyond 24 weeks of treatment at AASLD. We are pleased to have received Fast Track Designation from the U.S. FDA for a combination of tobevibart and elebsiran. We’re also actively exploring all possible acceleration pathways to bring this promising investigational therapy to patients as quickly as possible. We have recently engaged with health authorities to align on our clinical development strategy for hepatitis delta. Based on these discussions, we are actively working to expedite the initiation of our registrational program. We look forward to sharing more information at our hepatitis focused investor event following the AASLD conference. Moving on to our Phase II program for chronic hepatitis B. At AASLD, we look forward to sharing the end-of-treatment data from the MARCH Part B trial which evaluates our doublet and triplet regimens. The data will include approximately 50 participants receiving our combination treatment and approximately 30 participants receiving the combination therapy plus interferon. This readout will be followed by post-treatment data in the second quarter of 2025 which will allow us to assess functional cure for both regimens. Now let’s transition to oncology and discuss the T-cell engager programs. As we described in our second quarter call, the agreement with Sanofi provided us with a robust portfolio of assets targeting clinically validated antigens in oncology. I’ll briefly touch on the status of each program. VIR-5818, our dual-masked HER2xCD3 T-cell engager, it’s a highly differentiated asset with the potential to address significant unmet needs in HER2-expressing cancers. As the only masked HER2 T-cell engager currently in clinical development, VIR-5818 is designed to offer lower off-tumor toxicity allowing for higher doses and potentially improved efficacy compared to existing HER2-targeted therapies. There is a significant unmet need in HER2-positive cancers, particularly in metastatic breast cancer and metastatic colorectal cancer. The Phase I study is ongoing, evaluating VIR-5818 as both a monotherapy and in combination with pembrolizumab initially in a basket of solid tumor indications. The study is currently being conducted at 10 active sites in Europe and Australia and we are making good progress with continued dose escalation. We anticipate sharing preliminary monotherapy data in the first quarter of 2025. VIR-5500 is a dual-masked PSMA directed T-cell engager currently in Phase I clinical trials. Prostate cancer represents a significant disease burden with many patients in need of more effective and well-tolerated treatment options. As the only dual-masked PSMA directed T-cell engager currently in clinical development, VIR-5500 is designed to offer lower off-tumor toxicity allowing for higher doses and potentially improved efficacy compared to existing PSMA-targeted therapies. The study is currently ongoing, evaluating VIR-5500 as a monotherapy in a step-up dose escalation design with the potential to expand into combination therapy. The Phase I study for VIR-5500 is earlier in its progression with fewer participants compared to VIR-5818. We anticipate sharing early monotherapy data in the first quarter of 2025. Finally, VIR-5525, a dual-masked EGFRxCD3 T-cell engager has a cleared IND and we’re preparing to initiate the Phase I clinical study. Despite available treatments, the unmet need for patients with EGFR-expressing tumors remains high. The initial target tumor types for VIR-5525 are metastatic head and neck squamous cell carcinoma, metastatic squamous non-small cell lung cancer and metastatic colorectal cancer. We believe that VIR-5525 has the potential to provide a safe and tolerable treatment option for patients in the second line and beyond settings for these difficult-to-treat cancers. We are on track to initiate enrollment in a Phase I clinical study in the first quarter of 2025. With that, I’ll now hand the call over to Jason.Jason O’Byrne: Thank you, Mark. And thank you, Marianne for the warm welcome. It’s an honor to join the talented Vir team at this important time in the company’s evolution. I have long admired Vir’s commitment to preventing and treating serious infectious disease and the team’s impressive history of proven successful execution. Today, as Mark just shared, Vir continues its focus on infectious disease while also expanding into oncology with the addition of 3 T-cell engager assets and the underlying PRO-XTEN masking platform. In my role as CFO, I look forward to working alongside the executive team and all the dedicated Vir employees to deliver meaningful benefit to patients and to create shareholder value. As Marianne mentioned, One of my early focus areas will be disciplined capital deployment and financial stewardship. I am confident that with our strong financial position, compelling clinical programs and exceptional team, we are well positioned to deliver Vir’s mission. I will now share highlights of the third quarter 2024 results. R&D expenses for the third quarter of 2024 were approximately $195 million compared to $145 million for the same period in 2023. The increase was primarily driven by approximately $103 million of expense related to the Sanofi transaction this quarter, partially offset by reduced clinical development and manufacturing costs associated with the discontinued flu asset, VIR-2482. SG&A expenses for the third quarter of 2024 were $25.7 million compared to $40.9 million for the same period in 2023. The decrease was largely related to cost-saving initiatives announced at the end of 2023. Restructuring long-lived asset impairment and related charges for the third quarter of 2024 were $12.7 million compared to $3.4 million for the same period last year. The increase was primarily driven by our August 2024 restructuring severance charges and asset impairment charges related to the closing of our Portland, Oregon facility. We ended the third quarter with cash, cash equivalents and investments of approximately $1.19 billion compared to $1.43 billion at the end of the second quarter. Excluding the effects of the Sanofi transaction, the decrease in cash and investments during the third quarter was approximately $66 million. Including the effects of the Sanofi agreement, the total decrease in cash and investments during the quarter was approximately $245 million which included $104 million in cash payments made to Sanofi at closing, plus a $75 million escrowed milestone payment. The escrowed $75 million milestone is subject to VIR-5525 achieving first-in-human dosing by 2026 and that amount was reclassified to restricted cash in the quarter. As we approach the latter part of the year, we are adjusting our GAAP full year 2024 expense guidance to a range of $660 million to $680 million which includes the Sanofi transaction expenses, stock-based compensation expense and restructuring Excluding those 3 items, our updated net guidance is now modestly lower at a range of $430 million to $470 million compared to our second quarter guidance of $450 million to $500 million. With that, I’ll turn the call back over to Rich to begin the Q&A session.Richard Lepke: Thank you, Jason. This concludes our prepared remarks and we will now start the Q&A section. [Operator Instructions] I’ll turn it over to you, operator.Operator: [Operator Instructions] We’ll go first to Paul Choi at Goldman Sachs.Paul Choi: My first question is, can you just update us on the status of your planned end of Phase II meeting with the FDA? Apologies if I missed a mention of it in the press release. So I was just curious what the status of your regulatory discussions was? And my second question is for your new T-cell engager program for 5818. Can you maybe comment on how you’re thinking about the relative measures you’re looking for, for both the monotherapy versus the pembrolizumab combination?Marianne De Backer: Thank you very much for the question, Paul. I give it to Mark, our CMO, to answer those questions.Mark Eisner: Yes. Thanks for the question, Paul. We have engaged with the FDA as you mentioned. We are just putting the very finishing touches on our clinical development program and we expect to be able to share further details about that at our hepatitis focused investor meeting on November 19. In terms of the T-cell engager program in the 5818 HER2xCD3 program, in particular, your question about efficacy is a good one. We are planning to share preliminary monotherapy data from that program, also the PSMA program in quarter 1 next year. And at that time, we’ll be able to provide a bit more perspective on the data.Operator: Next, will go to Eric Joseph at JPMorgan.Eric Joseph: If I remember correctly, just in terms of the pivotal path forward in HDV, you previously outlined a randomized study with Hepcludex as a comparator arm. I guess based on your latest regulatory interaction, should we still kind of carry at that expectation? And I guess within that, how should we be thinking about sort of the continued inclusion of — or evaluation of combination or monotherapy with tobevibart?Mark Eisner: Yes. Thanks for the question. So as we’ve stated before, we are committed to going forward with a combination of tobevibart and elebsiran because we achieved deep and sustained virologic responses with the combination regimen. And to remind everyone, we got Fast Track Designation for the combination regimen for the FDA. In terms of further details of the program, we do plan on discussing this in more detail in our investor event around AASLD.Operator: We’ll move next to Mike Ulz at Morgan Stanley.Mike Ulz: Maybe I could just ask a follow-up on the Phase III trial design and your interactions with the FDA. I’m just curious if you’re getting any feedback that might be unexpected at this point? Or are things just on track and you’re going to sort of reveal the final details at your investor event?Mark Eisner: Yes. Thank you for the question. I will say we had a very productive meeting with the FDA. I think we aligned with them very closely on the plan and we’ll be prepared to share more details at the investor event around AASLD.Operator: Next, we’ll go to Gena Wang at Barclays.Huidong Wang: I have two questions. The first one is regarding the HDV data. Thank you very much to putting the data together from the prior study. So Slide 21, you lay out the several data points here. But I assume the key focus for us should be the target not detectable rate and also ALT normalization. Should we expect those are the benchmark and that should be the level — minimum level should achieve with more patient data now, 32 patients, 33 patients at week 24? And my second question is regarding the T-cell engagers. I remember, Marianne, you said you saw some initial Phase I data when the Sanofi deal discussion was ongoing. So now with the next year data update, have you seen the more patient data? And with the more patients, does the monotherapy activity hold as your initial expectation?Marianne De Backer: Okay. Thank you very much, Gena. Mark, do you want to comment on the HDV data?Mark Eisner: Yes, absolutely. So this SOLSTICE study in HDV, we’re going to have an oral presentation at the AASLD meeting which I think will give a lot more information, particularly all the patients made it through week 24 of the study and some of the patients beyond that. So we’re going to be presenting those data. In terms of your question around TND, yes, absolutely. I mean getting below the limit of quantification target not detected means there’s undetectable delta viral levels. So that is kind of the most rigorous measurement that’s out there. Our combination regimen what we revealed at EASL is a very, very profound reduction in the viral load in achieving high rates of target not detected above 50% at week 24. In terms of ALT normalization, that’s also important and those data will be included. The FDA guidance include a composite endpoint of TND plus ALT normalization. So that will be data we will also present at the AASLD meeting coming up.Marianne De Backer: Yes. And then on your question related to the T-cell engager, Gena, remember that our agreement with Sanofi closed on September 9. So we are in the midst of transitions, for example, trial sponsorship and so on. Obviously, we have all the data available on the programs. And as I mentioned, we will be in a position to share initial data on the monotherapy of both the 5500 and 5818 assets in the first quarter of 2025.Operator: We’ll move next to Alec Stranahan at Bank of America.Alec Stranahan: Two for me as well. I was hoping you could help frame the sort of data we should expect for 5818 and 5500 in the first quarter. Will it be mostly focusing on maybe safety and dosimetry or could we see some initial efficacy metrics as well? And if you could speak to how the dual-mask for your assets might benefit your ability to reach a higher target dose? Is this baked into the dose escalation? Or is driving to reach MTD, maybe not even the right way to be thinking about things here?Mark Eisner: Sure. So in terms of your first question, we — as we stated, we are planning to share preliminary monotherapy data from the ongoing Phase I studies both for VIR-5818 HER2 program and VIR-5500, the PSA T-cell engager program. At this point, we’re not really providing more color on that but we will be providing most data updates in quarter 1 of next year. And then your question about the dual-masking, I think, is important. All of our programs do have the dual-masking. So we’re masking both the CD3 T-cell engager part of the molecule and the tumor antigen binding part of the molecule. So the working hypothesis here is that, that will allow us to achieve a better therapeutic index. So higher levels of safety — I mean, higher levels of efficacy with good safety. As we mentioned before, for the HER2 program, we’re the only dual-masked program in clinical development for PSMA. The Janux program masks the CD3 part but leaves the PSMA unmasked. So we think we may have a differentiated asset in terms of our dual masking of the PSMA molecule.Operator: We’ll go next to Roanna Ruiz at Leerink Partners.Nikola Gasic: This is Nik Gasic on for Roanna. Maybe first on the HDV Phase III trial design, thinking about the target patient population. Are you going to be focusing on those cirrhotic and non-cirrhotics. And I guess, are there any specific baseline characteristics you could enrich for here? A quick follow-up on HDV after that.Mark Eisner: Sure. So thanks for the question. In terms — so in SOLSTICE, we presented data, including both cirrhotic and non-cirrhotic patients, CPTAs and back in EASL, when we presented these data, you’ll recall that the antiviral efficacy effect on ALT was very, very good in both cirrhotics and non-cirrhotics. If anything, the cirrhotic patients fared a little bit better. So clearly, we want to base our Phase III program on the observations from the Phase II program so we would include both cirrhotic and non-cirrhotic patients. In terms of baseline characteristics, that kind of predict response in any enrichment, I think we’ll be able to provide more color on that at our investor-focused hepatitis presentation around AASLD. So stay tuned for more detail there.Nikola Gasic: Got it. That’s helpful. And then in HBV, looking ahead, what sort of read-through could the 48-week end-of-treatment data have to the possible functional cure data in the second quarter of ’25. Just curious what sort of HBs antigen suppression rates, you could see at the 48 weeks, how that might mature heading into the off-treatment data in 2Q?Mark Eisner: Yes. No, that’s a really good question. So just to summarize, we’ll have the end-of-treatment data for the doublet of tobevibart and elebsiran and the triplet with pegylated interferon in addition of the upcoming liver meeting in San Diego. The functional cure data, as you said, comes in Q2 next year. So really, what we said before for functional cure is we’re looking for a minimum of 30% in the triplet functional cure, 20% in the doublet. In terms of end-of-treatment data, it’s clear that there is going to be at least based on prior programs of various mechanisms of action, there’s a drop-off between end-of-treatment in 24 weeks post treatment to a functional cure. But predicting that drop-off is not straightforward and there is no clearly establish markers to do that. So what I’d say, just in summary, is we will have end-of-treatment data soon. The functional cure rate will take a little bit longer, Q2 next year. And taken together, that will give a very complete picture of the regimens and what they can achieve for HBV patients.Operator: We’ll move next to Phil Nadeau at TD Cowen.Phil Nadeau: Two from us. So first, on the HDV pivotal program, you’ve suggested you’ll be able to give us an update at the AASLD Analyst Meeting. Will you have the final trial design at that time? And would you be able to disclose the design and time lines at the meeting? That’s the first question. And then second question, just broadly on the TCEs. You mentioned the potential for differentiation versus either other TCEs in development or just broadly in the spaces of HER2 and PMSA to begin. Do you need to see differentiation in order to move those beyond Phase I? Or is simply safe and effective good enough at this point with additional differentiation to be established in future studies?Mark Eisner: So for the HDV question, we are planning to disclose more information about the final trial design, the Phase III design. So you’ll be able to see that at the investor event around AASLD. So that more coming there. In terms of time lines, right now, we’re not disclosing additional information about that and we will look to do that when we have full clarity on time lines. In terms of the TCE question, Marianne, would you like me…Marianne De Backer: Sure.Mark Eisner: Okay. So your question is around what we would need to see to move these programs forward for HER2 and PSMA. To be honest, really something that is going to be a data-driven decision. I think we are looking at this very early stage, of course, to look at proof of concept, then the preliminary monotherapy data that we’ll present in quarter 1, I think we’ll give — start to give a picture of what the programs look like. In terms of the more specific answer to your question, I think we’re quite ready to opine on that yet but we will look to provide more color on that at a future time point.Operator: And we’ll go next to Patrick Trucchio at H.C. Wainwright.Patrick Trucchio: Just a couple of follow-up questions for me. First, in the HDV program, can you discuss more how the combination of elebsiran and tobevibart would be expected to be different from bulevirtide including at higher doses and the level of confidence that patients would maintain ALT normalization and virologic response to switch from bulevirtide to the combination treatment regimen based on what we’ve seen in the clinical data so far. And then separately, with the HBV program regarding the 20% functional cure rate without interferon and 30% functional cure rate with interferon. Can you tell us if these rates would be anticipated in all-comers? Or is it in the low S-antigen at baseline patients? And if we look ahead to a potential Phase III pivotal program, can you talk about or tell us more if you’re thinking about maybe stratifying base on S-antigen at baseline, would it make sense to explore combination — this combination in patients with low S-antigen at baseline?Mark Eisner: Okay. So on your first question about HDV. The first part of that was about the combination of tobevibart and elebsiran versus bulevirtide. We do — with the 2-milligram improved dose, we do expect to get much higher levels of target not detected based on our data we presented at EASL than bulevirtide which is 12% at 48 weeks. Your question about the higher dose, I mean that dose isn’t really — isn’t approved anywhere. So — but even so I think the level of TND efficacy that we expect to have should be superior to bulevirtide just thinking about what we’re likely to see. In terms of level of confidence from bulevirtide switch, yes. I mean in terms of the patient population who has been on bulevirtide who is likely to enter such a trial or in a clinical practice, we would expect to be much higher in terms of our virologic response with our combination and continued treatment with bulevirtide. In terms of your HBV question, fundamentally, I think your question is around is this going to be an all-comers versus a stratified population based on baseline surface antigen. I guess I’d just ask you to stay tuned for the data and those questions should become much clearer at the March presentation at the liver meeting.Operator: And this concludes the Q&A session of the call. Thank you for participating and I’ll turn the call back over to Rich.Richard Lepke: Thank you all for your interest in Vir and for participating in today’s earnings call. We appreciate your continued support and look forward to providing further updates on our progress in the future. Andre, this concludes our call. Thank you, you may close the call.Operator: Thank you. And that does conclude today’s conference call. Thank you for your participation. You may now disconnect. Follow Vir Biotechnology Inc. (NASDAQ:VIR) Follow Vir Biotechnology Inc. (NASDAQ:VIR) We may use your email to send marketing emails about our services. Click here to read our privacy policy.

BI posts 12% increase in int’l travelers amid ‘Undas’

International passengers at the immigration counter of Ninoy Aquino International Airport Terminal 3 in Pasay City.INQUIRER PHOTO / RICHARD A. REYES
MANILA, Philippines – The Bureau of Immigration (BI) recorded a 12-percent increase in international travel amid the observance of All Saints’ and All Souls’ Days.
In a statement, the BI reported that it processed 167,538 passengers on Oct. 31 and Nov. 1, higher than the 149,257 recorded during the same period in 2023.
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It noted that the influx, fueled by the “Undas” season, brought high passenger volumes to major Philippine airports, particularly on those two days.FEATURED STORIES
On Oct. 31, BI recorded 41,078 arrivals and 43,341 departures across the country.
READ: Occult practices during Undas invite the devil, says lead PH exorcistArticle continues after this advertisement

The Ninoy Aquino International Airport (NAIA) Terminal 1 processed 14,010 arrivals and 15,666 departures, while Terminal 3 saw the highest volume with 19,223 arrivals and 20,495 departures.Article continues after this advertisement

On Nov. 1, the BI recorded similar international traffic with 42,858 arrivals and 40,261 departures.
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NAIA Terminal 1 saw 14,931 arrivals and 13,381 departures, and Terminal 3 handled 19,136 arrivals and 19,431 departures.
Earlier, the BI deployed 58 newly appointed immigration officers across key airports, as well as its rapid response and augmentation teams, to provide more manpower during the peak season.
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Likewise, it encouraged travelers to use electronic gates at the arrival areas to expedite entry and exit, in a bid to reduce queuing times.Commissioner Joel Anthony Viado, meanwhile, acknowledged the efforts of BI employees who worked during the holidays.
“Our officers have demonstrated commendable commitment and sacrifice, spending time away from their families to ensure our borders remain secure and to facilitate smooth travel,” he said.

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Banyan Tree Vabbinfaru titled as #3 resort in Indian Ocean at Condé Nast Traveler’s 2024 Readers’ Choice Awards

Banyan Tree Vabbinfaru has been honoured as the #3 Resort in the Indian Ocean in the prestigious Condé Nast Traveler 2024 Readers’ Choice Awards, the longest-running and most distinguished accolades in the travel industry, symbolising excellence and commitment to providing unforgettable guest experiences.
In 2024, Condé Nast Traveler ran separate surveys in the United States and the United Kingdom for the first time in five years. More than 575,000 readers in the United States and over 126,000 readers in the UK submitted their responses. This esteemed recognition underscores the Banyan Tree Vabbinfaru’s unparalleled luxury, exceptional service, and deep connection to the surrounding natural beauty.
“We are thrilled to be recognised among the top resorts in the Indian Ocean,” said Hery Kuswoyo, General Manager of Banyan Tree Vabbinfaru. “This award is a reflection of our team’s dedication to creating a perfect blend of Maldivian charm, luxury, and personalised service for every guest. We thank our loyal guests for their continuous support and for making this achievement possible.”

Mahakumbh to boost tourism in UP, create jobs for over 45,000 families

The Uttar Pradesh government is making significant efforts to enhance the tourism sector in the state, with the upcoming Mahakumbh in Prayagraj poised to play a crucial role towards this end. It is anticipated that over 45,000 families will benefit from direct or indirect employment opportunities linked to this grand event, tourism department officials here disclosed. Notably, to boost tourism, a series of training programmes are being conducted across Prayagraj. These initiatives aim to enhance the skills of vendors and service providers, ensuring they are well-prepared to cater to the influx of visitors during the event.
In addition to supporting existing businesses, these training programmes are expected to create new sources of employment around various religious tourist sites, further contributing to the economic growth of the region. The state government has undertaken several initiatives to revitalize the tourism sector in the state, including approving the new Tourism Policy-2022 on November 16, 2022, which enhanced tourism in the state. The policy aims to attract an investment of Rs 20,000 crores and create jobs for 10 lakh people. A key focus is to connect service providers in the tourism industry with skill development and management training. The Prayagraj Mahakumbh is serving as a major platform for this effort.

Aparajita Singh, the Regional Tourism Officer of Prayagraj, said here on Saturday that a training campaign has been launched for all service providers who interact with tourists during the Mahakumbh. This includes training for boatmen, tour guides, street vendors, and others in skill development and management. The Yogi government is enhancing the role of boatmen who operate in the rivers near religious sites in Uttar Pradesh by increasing their income and developing their skills. The Tourism Department is providing training to 2,000 boatmen for this purpose.

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Israel should be on all knees, asking wayward tourists for forgiveness

Life of a tourist in Israel, at least these days, are fraught with trials and tribulations. I came to this realization immediately upon landing at Ben Gurion Airport from Los Angeles. My first stop was the car rental desk on the second floor of the airport. “I hope you didn’t take the insurance they offered you,” the agent remarked. “Actually, I did,” I replied, puzzled. “Oh, that insurance doesn’t apply in Israel,” he said with a smile, turning to the other agent at the desk. “Another one fell for it.”4 View gallery Sign says Welcome, but are they? (Photo: shutterstock)After calling the company where I booked the reservation, I learned the insurance covered the car against theft or accidents but did not cover me if the accident was my fault, nor did it cover the other party. In such cases, I would have to pay for all the damages.The rental company insisted I had no insurance, and if I wanted it, I would need to pay about $280 for non-comprehensive insurance with a $700 deductible, or $450 for comprehensive insurance for two weeks. Reluctantly, I purchased additional insurance for peace of mind while driving. “Do you have an Israeli passport?” the agent asked after I handed over my American passport. I nodded. “Then it will cost you an extra 17%.”This is the tax every Israeli must pay, even if they don’t live in Israel and were born in the U.S. As long as you hold an Israeli passport, you’re “penalized” with this tax.4 View gallery Tel Aviv traffic (Photo: Shaul Golan)The next day, after resting from the long flight, we drove to explore Jaffa. Heavy traffic didn’t particularly bother us since we’re accustomed to it from Los Angeles. Although we heard there was a parking space shortage in the city, finding a spot wasn’t the issue—paying for it was. A yellow sign declared: “Parking only allowed for vehicles with a local parking permit. Paid parking Mon-Thu from 9:00 to 17:00.”Okay, but where do we pay? After consulting with a local shop owner, we were told to pay via the Pango app, which is an online parking payment service. We downloaded the app to our phone, but we couldn’t receive a confirmation code because we still had a US number.We gave up parking there and searched for a parking lot that would allow us to park without using the app, which is apparently only for residents. However, even in the lot we found, the only payment method was through Pango.We returned to the hotel, parked the car, and decided to use public transport. We reached the station, about a 10-minute walk from the hotel, only to find out that payment was only possible with a Rav-Kav card or by downloading the app to the phone. This time, we managed to download the app and pay. Great, we felt like we were finally getting the hang of things. By the time we got back to Jaffa, an hour and a half had passed.At the Jaffa Flea Market, vendors looked quite miserable due to the lack of customers. “Since October 7, tourists haven’t come here at all,” a jewelry and souvenir shop owner told me. “Many shops have already closed, and those of us who remain open from 11 AM to 4 PM have no one to sell to.”4 View gallery No tourists, closed shops (Photo: Ayala Or-El)Jacob, who has been there for 40 years, is living off his savings and wants to sell his shop, but there’s no one to buy it. I hear the same from other shop owners in the area. “Last year, before the war, 780,000 tourists visited here; this year, we’ve barely seen 780 tourists all year.”We bought some souvenirs from them and returned to the hotel. At 3 PM, we went to Metzitzim Beach, not far from the hotel. Since it was midweek and incoming tourism is virtually non-existent, most of the beach chairs were available. We wanted to rent three chairs and umbrellas at the kiosk, but it was out of order.A man with a hat and sunglasses working there, kindly explained that we could pay via an app. It seems that every action in the country is done through some app, and cash payment is a luxury of the past.Several days later, we left Tel Aviv and continued south. I stopped at a gas station. When I inserted my credit card into the fuel machine, I was prompted with a questionnaire: enter your ID number and vehicle number. I gave up and went inside the station, patiently standing in line behind two soldiers and three civilians. “What if I don’t remember or don’t have an ID number?” I asked the clerk when it was finally my turn. “It’s okay; you don’t need to enter it, just refuel.” Another ten minutes wasted.A week later, while checking my credit card charges, I noticed I had been charged four times between $15-20 by the car rental company. I called to inquire about the charges. “Oh yes, you drove on Highway 6,” the clerk replied. “We charge 17 shekels each time, in addition to the regular toll. If you want to avoid this, you need to purchase a subscription through Pango.”4 View gallery Pango app (Photo: Orel Cohen)Pango again. “Too bad you didn’t tell me in advance,” I said in frustration. “Well, these are things we don’t need to say; you should know,” the clerk replied, not understanding how an Israeli could not know such basic things. Try explaining to her that I haven’t lived in Israel for most of my life but in the U.S.Next time I visit the country, I will only use taxis. It will be much cheaper and save me from finding parking, downloading Pango, filling out questionnaires at gas stations, using an Israeli Green Card on buses, paying exorbitant tolls on Highway 6, and shelling out $1,400 for two weeks of car rental.Get the Ynetnews app on your smartphone:

La Crescent-Hokah students get up close look at the body during Science of Medicine Day

Third and fourth graders at La Crescent-Hokah Elementary School got the opportunity Oct. 16 to learn a little about their bodies and how they work during the Science of Medicine Day program, an initiative of the Wisconsin Science Festival, which this year was celebrated Oct. 14-20.A team of health care professionals from Bellin and Gundersen Health System, St. Clare Health Mission, Gundersen Tri-State Ambulance, and Gundersen medical students from UW-Madison led quick 20-minute lessons for students in areas like human anatomy, germs, vaccinations and shots, the sounds of medicine, and x-rays and casting.

Gundersen medical student Ann Holmes applies a head bandage to La Crescent-Hokah student Kylee Waddell during the Science of Medicine Day at the school on Oct. 16.

Gundersen, contributed

That morning, the students cycled through the various stations, which provided hands-on learning opportunities that organizers hope get the kids interested in the medical field.“We’re recruiting future doctors, future nurses, future health care workers,” said Dr. Robyn Borge, medical vice president at Bellin and Gundersen Health System. “And we’re trying to inspire some of these kids to consider fields in medicine.”

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But even if medical field won’t become the students’ chosen career path, Borge said the program will help them in their everyday interaction with health care. They might potentially be more comfortable when going to a doctor appointment, or they might better understand why they receive the vaccinations they do.“We do hope to build trust and provide some basic knowledge that may help kids be more comfortable at clinic visits,” Borge said.For Jeff Copp, the principal at La Crescent-Hokah Elementary, the program lined up perfectly with curricular standards the school has in place.

La Crescent-Hokah Elementary students got to see and touch real organs during a human anatomy lesson at Science of Medicine Day, which was presented by Gundersen Health System.

Gundersen, contributed

“Our third- and fourth-grade teachers are passionate, and this summer, they worked on aligning our instruction with the Next Generation Science Standards, and this activity was a natural fit,” Copp said. “We have world-class medical facilities and professionals just a few miles away, so it was a no-brainer to bring in their expertise, resources and technology to help our students learn about medical science, anatomy and medical technology.”It’s these collaborative efforts in the schools that fourth-year Gundersen medical student Shanaya Hebgen enjoys most about Science Day. It was her second year participating in the program, and this year, she and three fellow med students taught an anatomy lesson – complete with real human organs.“I love the community engagement, getting kids excited about science, excited about health, and kind of introducing it at a young age so they understand,” Hebgen said. “Like when we talked about smoking and how that affects the lungs, and having them be able to see it and seeing the excitement on their faces is super fun.”Hebgen wants to go into family medicine, so opportunities like this to teach are a good way for her to practice how to talk to people about certain things that need an explanation.“It also helps me be able to engage with the community and be able to give back and be involved in more ways than just seeing them in the clinic,” she said.Being able to experience the sights, sounds and feel of health care goes a long way in terms of student comprehension, Copp said. That special interaction sticks in their minds.

Gundersen medical student JP Antonelli tests the reflexes of La Crescent-Hokah student Cooper Gates during the Science of Medicine Day program on Oct. 16

Gundersen, contributed

“Our students learn each and every day, and the things they will remember most are how they felt when they were learning,” he said. “I guarantee our students will remember these lessons because of how engaging they were.”Copp hopes the students learned more about themselves and others that day and how important it is to develop healthy habits as young people. He was grateful that Gundersen was able to lend its support in that mission.“Welcoming Gundersen’s Day of Medicine into our building is a great example of the power of community partnerships and connecting our students to the amazing things they can learn right in our own community,” he said.It’s a program Gundersen believes in and enjoys providing for the communities it serves.“We have more fun than the kids do,” Borge said. “We look forward to this every year.”

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Traffic up, Green Gables House and cruise numbers boom, in ‘relatively strong’ tourism year

The final numbers are not yet in on P.E.I.’s peak tourism season months, but those statistics that are in are pointing toward a good year that has the industry feeling bullish.”Overall it was a relatively strong year,” said Corryn Clemence, CEO of the Tourism Industry Association of P.E.I.”We had started to hear maybe there was some soft spots in July, but you know, August was really a good month for us. We had a lot of activity happening in September — and some great weather, which always helps.”Traffic over the Confederation Bridge from June through September was up four per cent over 2023, and nine per cent over the pre-pandemic record year of 2019. Charlottetown Airport posted virtually identical increase rates.Back in July, the season was not looking so great, says Corryn Clemence of the Tourism Industry Association of P.E.I., but it finished strong.

Scientists decode when and how kissing evolved in humans – and it’s gross

Your support helps us to tell the storyFrom reproductive rights to climate change to Big Tech, The Independent is on the ground when the story is developing. Whether it’s investigating the financials of Elon Musk’s pro-Trump PAC or producing our latest documentary, ‘The A Word’, which shines a light on the American women fighting for reproductive rights, we know how important it is to parse out the facts from the messaging.At such a critical moment in US history, we need reporters on the ground. Your donation allows us to keep sending journalists to speak to both sides of the story.The Independent is trusted by Americans across the entire political spectrum. And unlike many other quality news outlets, we choose not to lock Americans out of our reporting and analysis with paywalls. We believe quality journalism should be available to everyone, paid for by those who can afford it.Your support makes all the difference.CloseRead moreCloseKissing in humans evolved as a symbolic expression of love from grooming behaviours seen in ancestral great apes, a comprehensive new study says.The kiss has been a versatile way by which humans across civilisations and societies have shown affection, intimacy, or social bonding, most often in a way that is regulated by cultural conventions.A study published last year points to Mesopotamia around 4,500 years ago as one of the earliest known places where kissing was a “well-established practice”.Thousands of clay tablets recovered from early human cultures that lived between the Euphrates and Tigris rivers in modern-day Iraq and Syria reveal that kissing was considered a part of romantic intimacy during these times.However, how exactly our species began communicating affection this way remains a topic of debate.Babylonian clay model showing couple on couch engaged in sex and kissing