Latest news with #Thetis
Yahoo
05-05-2025
- Business
- Yahoo
Thetis Pharmaceuticals Presents New Preclinical and Clinical Data forTP-317 at DDW 2025
Findings Highlight First-in-Class Potential of TP-317 in Inflammatory Bowel Disease and Colorectal Cancer ESSEX, Conn., May 05, 2025--(BUSINESS WIRE)--Thetis Pharmaceuticals LLC ("Thetis"), a clinical-stage company developing TP-317, a first-in-class, small molecule drug candidate targeting the BLT1 receptor to treat inflammatory bowel disease (IBD) and solid tumor cancers, today announced the presentation of four data sets at Digestive Disease Week (DDW) 2025, held May 3-6 in San Diego, California. The data support TP-317's advancement as a novel oral therapy for both IBD and microsatellite stable (MSS) colorectal cancer (CRC). "These data show how TP-317 can meaningfully impact immune-mediated diseases by activating the BLT1 pathway. In IBD, TP-317 promotes epithelial repair and resolves mucosal inflammation. In solid tumors, TP-317 promotes antigen presentation to enhance the efficacy of immune checkpoint inhibitors in tumors that are resistant to immunotherapy," said Gary Mathias, CEO of Thetis Pharmaceuticals. "With encouraging preclinical results in IBD and MSS colorectal cancer and positive safety and PK/PD data from our Phase 1a study, TP-317 is well-positioned for Phase 2 clinical development in both indications." Colorectal Cancer: Immune Reprogramming and Combination Potential In the oral presentation, "TP-317, an Oral BLT1 Agonist, Enhances Immune Checkpoint Inhibitor Therapy by Stimulating Tumor Antigen Presentation in a Microsatellite Stable (MSS) Tumor Model of Colorectal Cancer (CRC)," TP-317 demonstrated potent anti-tumor activity and synergy with checkpoint inhibitors. Key findings include: TP-317 activated STING and IFN-γ pathways and boosted antigen presentation, converting immunologically "cold" MSS tumors into "hot," immune-responsive ones. TP-317 demonstrated robust single-agent efficacy and enhanced activity in combination with chemotherapy and checkpoint inhibitors in MSS CRC models. Tumor control was BLT1-dependent, with broad innate and adaptive immune activation. IBD: Barrier Protection and Mucosal Homeostasis In a second oral presentation, "TP-317, a Novel BLT1 Agonist Oral Therapy for IBD, Exhibits Anti-Inflammatory and Epithelial Barrier Protective Efficacy in Murine DSS Colitis and TNFΔARE Ileitis," data from multiple colitis models showed TP-317 restored epithelial barrier function and reduced inflammation. Key findings include: In DSS colitis, TP-317 significantly reduced disease activity, histologic inflammation, and crypt damage, demonstrating strong anti-inflammatory and mucosal barrier-protective effects on par with a JAK inhibitor and cyclosporine. In TNFΔARE ileitis, TP-317 lowered intestinal permeability and inflammatory cytokines, reinforcing its potential as a disease-modifying therapy for Crohn's disease and ulcerative colitis. Clinical Safety and PK/PD Profile In the poster presentation, "PK/PD, Safety, and Efficacy of Oral Resolvin E1-based Therapy in IBD: Translating Resolvin E1 Activation of BLT1 in Experimental Models to Healthy Volunteers," data from a Phase 1a study confirmed TP-317's safety and target engagement: Single oral doses up to 80 mg were well tolerated with no treatment-related adverse events. Resolvin E1 (RvE1) exposure was dose-proportional and exceeded the EC50 for BLT1 activation. Transient neutrophil margination that reversed within two hours (a known pharmacodynamic effect of RvE1 at BLT1) was observed at the 80 mg dose in all subjects, indicating target engagement. Inflammation and Pain Biomarkers Modulation A second poster presentation, "TP-317, an Oral BLT1 Agonist, Reduces Abdominal Pain to Colorectal Distension and Reduces Key Biomarkers of Colitis in a Mouse Model of Inflammatory Bowel Disease," further demonstrated TP-317's dual efficacy: Significantly reduced visceral pain responses in DNBS colitis mice. Broad transcriptomic suppression of genes associated with inflammation, epithelial-to-mesenchymal transition (EMT), and enteric nervous system signaling. Compared favorably to prednisolone across visceral pain endpoints and modulation of gene expression pathways. These findings build a compelling case for TP-317 as a Phase 2-ready candidate with broad potential to address unmet needs in IBD. About Thetis Pharmaceuticals Thetis is a clinical-stage pharmaceutical company focused on developing innovative treatments for chronic inflammatory diseases and cancer. Its lead candidate, TP-317, is a first-in-class oral Resolvin E1 drug candidate that targets the LTB4-BLT1 pathway to mobilize the body's natural ability to resolve disease and restore immune homeostasis. For more information, please visit and follow us on LinkedIn. View source version on Contacts Tracy LessorSVP, CommunicationsThetis Pharma617-519-9827tracy@ Sign in to access your portfolio
Business Wire
05-05-2025
- Business
- Business Wire
Thetis Pharmaceuticals Presents New Preclinical and Clinical Data forTP-317 at DDW 2025
ESSEX, Conn.--(BUSINESS WIRE)--Thetis Pharmaceuticals LLC ('Thetis'), a clinical-stage company developing TP-317, a first-in-class, small molecule drug candidate targeting the BLT1 receptor to treat inflammatory bowel disease (IBD) and solid tumor cancers, today announced the presentation of four data sets at Digestive Disease Week (DDW) 2025, held May 3-6 in San Diego, California. The data support TP-317's advancement as a novel oral therapy for both IBD and microsatellite stable (MSS) colorectal cancer (CRC). 'With encouraging preclinical results in IBD and MSS colorectal cancer and positive safety and PK/PD data from our Phase 1a study, TP-317 is well-positioned for Phase 2 clinical development in both indications.' 'These data show how TP-317 can meaningfully impact immune-mediated diseases by activating the BLT1 pathway. In IBD, TP-317 promotes epithelial repair and resolves mucosal inflammation. In solid tumors, TP-317 promotes antigen presentation to enhance the efficacy of immune checkpoint inhibitors in tumors that are resistant to immunotherapy,' said Gary Mathias, CEO of Thetis Pharmaceuticals. 'With encouraging preclinical results in IBD and MSS colorectal cancer and positive safety and PK/PD data from our Phase 1a study, TP-317 is well-positioned for Phase 2 clinical development in both indications.' Colorectal Cancer: Immune Reprogramming and Combination Potential In the oral presentation, ' TP-317, an Oral BLT1 Agonist, Enhances Immune Checkpoint Inhibitor Therapy by Stimulating Tumor Antigen Presentation in a Microsatellite Stable (MSS) Tumor Model of Colorectal Cancer (CRC), ' TP-317 demonstrated potent anti-tumor activity and synergy with checkpoint inhibitors. Key findings include: TP-317 activated STING and IFN-γ pathways and boosted antigen presentation, converting immunologically 'cold' MSS tumors into 'hot,' immune-responsive ones. TP-317 demonstrated robust single-agent efficacy and enhanced activity in combination with chemotherapy and checkpoint inhibitors in MSS CRC models. Tumor control was BLT1-dependent, with broad innate and adaptive immune activation. IBD: Barrier Protection and Mucosal Homeostasis In a second oral presentation, ' TP-317, a Novel BLT1 Agonist Oral Therapy for IBD, Exhibits Anti-Inflammatory and Epithelial Barrier Protective Efficacy in Murine DSS Colitis and TNF ΔARE Ileitis,' data from multiple colitis models showed TP-317 restored epithelial barrier function and reduced inflammation. Key findings include: In DSS colitis, TP-317 significantly reduced disease activity, histologic inflammation, and crypt damage, demonstrating strong anti-inflammatory and mucosal barrier-protective effects on par with a JAK inhibitor and cyclosporine. In TNF ΔARE ileitis, TP-317 lowered intestinal permeability and inflammatory cytokines, reinforcing its potential as a disease-modifying therapy for Crohn's disease and ulcerative colitis. Clinical Safety and PK/PD Profile In the poster presentation, ' PK/PD, Safety, and Efficacy of Oral Resolvin E1-based Therapy in IBD: Translating Resolvin E1 Activation of BLT1 in Experimental Models to Healthy Volunteers,' data from a Phase 1a study confirmed TP-317's safety and target engagement: Single oral doses up to 80 mg were well tolerated with no treatment-related adverse events. Resolvin E1 (RvE1) exposure was dose-proportional and exceeded the EC50 for BLT1 activation. Transient neutrophil margination that reversed within two hours (a known pharmacodynamic effect of RvE1 at BLT1) was observed at the 80 mg dose in all subjects, indicating target engagement. Inflammation and Pain Biomarkers Modulation A second poster presentation, 'TP-317, an Oral BLT1 Agonist, Reduces Abdominal Pain to Colorectal Distension and Reduces Key Biomarkers of Colitis in a Mouse Model of Inflammatory Bowel Disease,' further demonstrated TP-317's dual efficacy: Significantly reduced visceral pain responses in DNBS colitis mice. Broad transcriptomic suppression of genes associated with inflammation, epithelial-to-mesenchymal transition (EMT), and enteric nervous system signaling. Compared favorably to prednisolone across visceral pain endpoints and modulation of gene expression pathways. These findings build a compelling case for TP-317 as a Phase 2-ready candidate with broad potential to address unmet needs in IBD. About Thetis Pharmaceuticals Thetis is a clinical-stage pharmaceutical company focused on developing innovative treatments for chronic inflammatory diseases and cancer. Its lead candidate, TP-317, is a first-in-class oral Resolvin E1 drug candidate that targets the LTB4-BLT1 pathway to mobilize the body's natural ability to resolve disease and restore immune homeostasis. For more information, please visit and follow us on LinkedIn.
Yahoo
19-02-2025
- Business
- Yahoo
Thetis Pharmaceuticals Presents New Preclinical and Clinical Data for TP-317 at ECCO 2025
Phase 1a Clinical Results Demonstrate a Favorable Safety Profile and BLT1 Engagement In Healthy Volunteers Preclinical Data Highlight TP-317's Anti-Inflammatory, Epithelial Barrier-Protective Effects ESSEX, Conn., February 19, 2025--(BUSINESS WIRE)--Thetis Pharmaceuticals LLC ("Thetis"), a clinical-stage company developing TP-317, a first-in-class, small molecule drug candidate targeting the BLT1 receptor to treat inflammatory bowel disease (IBD), Crohn's disease and ulcerative colitis, today announced the presentation of new preclinical and clinical data at the 20th Congress of the European Crohn's and Colitis Organization (ECCO) in Berlin, Germany, February 19-22, 2025. "These new data further validate TP-317's unique mechanism of action and its potential as an oral, first-in-class therapy for IBD," said Gary Mathias, CEO of Thetis Pharmaceuticals. "The preclinical results demonstrate gut barrier protection, inflammation reduction, and pain relief, while our clinical data confirm safety, predictable PK, and BLT1 engagement in humans. We're excited to advance TP-317 into Phase 1b/2a trials in IBD patients." The poster presentations include: Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Oral Resolvin E1-based Therapy in Inflammatory Bowel Disease (IBD): Translating Resolvin E1 Activation of BLT1 in Experimental Models to Healthy Volunteers Abstract Number: P0627, Abstract Session: Friday, February 21 from 12:40 PM - 1:40 PM CEST (6:40 AM-7:40 AM EST) This Phase 1a clinical trial evaluated the pharmacokinetics, pharmacodynamics, and safety profile of oral TP-317 in healthy volunteers. Key findings include: Single ascending doses (10, 40, and 80 mg) of TP-317 were well tolerated, with no treatment-related adverse events. TP-317 achieved systemic Resolvin E1 (RvE1) levels well above the EC50 for BLT1 activation, confirming target engagement. At the 80 mg dose, transient neutropenia (a known pharmacodynamic effect of RvE1 at BLT1) was observed but quickly rebounded within two hours in all subjects. PK analysis showed dose-proportional increases in RvE1 exposure, supporting a predictable oral dosing profile. "The data from this first-in-human study provide support for target engagement by TP-317 in humans and establish a strong foundation for further clinical development in ulcerative colitis and Crohn's disease," said Silvio Danese, M.D., Ph.D., Gastroenterologist and Professor of Gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan. "This compound presents a unique therapeutic profile distinct from and complementary to current IBD therapies." TP-317, a Novel BLT1 Agonist Oral Therapy for Inflammatory Bowel Disease, Exhibits Anti-Inflammatory and Epithelial Barrier Protective Efficacy in Murine DSS Colitis and TNFΔARE Ileitis Abstract Number: P0069, Abstract Session: Friday, February 21 from 12:40 PM - 1:40 PM CEST (6:40 AM-7:40 AM EST) This study assessed the efficacy and mechanism of action of TP-317 in preclinical models of colitis. Key findings include: In a two-cycle DSS colitis model, oral TP-317 treatment significantly reduced disease activity index (DAI) scores, histologic inflammation, and crypt damage, demonstrating strong anti-inflammatory and mucosal barrier-protective effects. In TNFΔARE ileitis models, TP-317 lowered intestinal permeability and reduced pro-inflammatory cytokines, reinforcing its potential as a disease-modifying therapy for Crohn's disease and ulcerative colitis. In a visceral pain study, TP-317 reduced pain responses to colorectal distension to levels comparable to prednisolone, suggesting potential benefits for IBD-associated abdominal pain. "These findings highlight TP-317's ability to restore gut barrier integrity, suppress inflammation, and alleviate visceral pain, reinforcing its promise as a novel oral therapy for both ileal and colonic forms of IBD," said Bram Verstockt, M.D., Ph.D., Consultant Gastroenterologist IBD, University Hospitals Leuven, Belgium. About Thetis Pharmaceuticals Thetis is a clinical-stage pharmaceutical company focused on developing innovative treatments for chronic inflammatory diseases and cancer. Its lead candidate, TP-317, is a first-in-class oral RvE1 drug candidate that targets the LTB4-BLT1 pathway to mobilize the body's natural ability to resolve disease and restore immune homeostasis. For more information, please visit and follow us on LinkedIn. View source version on Contacts Tracy LessorSVP, CommunicationsThetis Pharma617-519-9827tracy@ Sign in to access your portfolio
Yahoo
28-01-2025
- Politics
- Yahoo
Denmark To Boost Greenland Military Presence Amid Trump's Quest To Obtain Island
Faced with increasing pressure from President Donald Trump to hand over the strategically important island of Greenland to the U.S., Denmark has announced plans to beef up its military presence there. Key to the $2 billion effort is the purchase of three new Arctic patrol boats, two long-range drones, and an unspecified number of new maritime patrol aircraft. These looming acquisitions are meant to replace worn-out equipment and provide additional surveillance and sensing capabilities over and around one of the world's largest islands. The plan was announced as Greenland, an autonomous territory of Denmark, is at the center of an increasingly strategic race to expand control and military influence across the Arctic region. The U.S., China, and Russia are all vying for the region's military, geostrategic, and economic benefits and the island is already home to one of the U.S. military's most strategically important outposts. You can read all about this history and current status of American forces on the island, as well as its overall growing strategic significance, in our recent feature linked here. 'We are facing serious security policy challenges,' Danish Defense Minister Troels Lund Poulsen said in a statement on Monday which did not specifically mention Trump's Greenland interest. 'The Danish Defense Intelligence Service assesses that the threat level in the Arctic and the North Atlantic has worsened. Therefore, we must significantly strengthen the Danish Defense presence in the regions.' New agreement strengthens the presence of the Danish Defence in the Arctic and North Atlantic region. To ensure peace and stability and strengthen defence cooperation with close Allies #StrongerTogetherhttps:// — Denmark at NATO (@DK_NATO) January 28, 2025 This new procurement program is part of a broader security pact between Denmark, the Faroe Islands and Greenland. These governments seek to increase their ability to patrol and gain situational awareness over a 660,000-square-mile landmass with about 27,000 miles of coastline. That presence is quite limited. In addition to the ships and aircraft, Denmark has a dozen dog sled teams to monitor an area three times the size of Texas. One of the main lines of effort in the Danish plan is replacing the Royal Danish Navy's four Thetis class patrol boats. Commissioned in 1991 and 1992, they are becoming increasingly unreliable, according to Danish officials. 'If you look at those ships, they are of course worn out,' Chief of the Navy, Rear Admiral Henrik Ryberg told the Danish DR news outlet last year. 'They are almost 40 years old. That is why I need people to start thinking about what should be next.' The Thetis class ships, he added, 'often break down and therefore cannot be operational.' The 369-foot-long vessels, which displace 3,500 tons, have a maximum speed of 20 knots when working and can operate for about 8,500 nautical miles. Designed for the harsh Arctic conditions, they feature double-skinned hulls up to 2 meters above the waterline and can sustain damage up to eight meters in length without endangering stability. The hulls have ice-breaking bows and stern lines suitable for operations in ice with only one propeller. These ships are armed with one Otobreda 76 mm Super Rapid main gun, one or two Oerlikon 20 mm guns, and depth charge dispensers. They also embark with an MH-60R Seahawk helicopter. The three new Arctic ships Denmark seeks 'will be able to more effectively and flexibly solve tasks in Greenland and carry capabilities such as helicopters and drones,' Poulsen stated. He did not provide details about what specifications he seeks or the timeline for delivery. We reached out to the Danish Defense Ministry for additional details and will update this story with any pertinent details. For maritime patrol, inspection and transport, Denmark relies on four Canadair CL-604 Challenger bizjet aircraft. The CL-604s are militarized variants of the Bombardier Challenger 604 with saddle tanks to enhanced fuel capacity, a new undercarriage to support higher takeoff and landing weights, structural improvements to the wings and tail, as well as a modern Rockwell Collins Pro Line 4 avionics system. A decade ago, Denmark embarked on a midlife upgrade program that included a new downlink and a multirole radar capable of carrying out surface surveillance, weather monitoring and oil slick detection. 'The Challenger aircraft are near the end of their operational lifespan and need to be replaced,' the Danish Defense Ministry stated. 'The opening of new airports across Greenland means new opportunities for establishing partnerships with airlines regarding inspection, surveillance, and transportation.' The details of the funding and procurement schedule for the replacement aircraft are being worked out with officials from the Faroe Islands and Greenland as part of a broader security agreement, the Danish MoD explained. Denmark also wants two new 'long-range drones with advanced image acquisition capacity that can monitor large areas over long distances and obtain detailed images,' Poulsen explained. He did not say what kinds of drones, what kind of sensors or when they would be procured or fielded. While Denmark has been seeking a lot of these capabilities for several years, the plan unveiled Monday comes in the wake of increasingly contentious relations between Trump and the Danish government over the future of Greenland. Even before he was inaugurated, Trump reportedly berated Danish Prime Minister Mette Frederiksen, with the former insisting 'he wanted the United States to take over Greenland,' The New York Times reported. That was after he refused to rule out military or economic coercion to bring Greenland and the Panama Canal under U.S. control during a press conference on Jan. 8. 'I can't assure you on either of those two,' Trump told reporters. 'But I can say this, we need them for economic security.' Question on Greenland and Panama Canal: "Can you assure the world that as you try to get control of these areas you are not going to use military or economic coercion?President-Elect Trump: "No…I can't assure you on either of those two. We need them for economic security…" — CSPAN (@cspan) January 7, 2025 The same day, Trump's son, Donald Trump Jr., touched down in Greenland for what was described as a tourist visit, during which he reportedly handed out hats bearing the slogan 'Make Greenland Great Again.' Meanwhile, Trump's National Security Adviser Mike Waltz said the strategy is bigger than Greenland itself. 'This is about the Arctic,' he said. 'You have Russia that is trying to become king.' Frederiksen earlier this month ruled out the possibility of coming to a deal with the United States that would see Greenland handed over. Instead, the future of the territory would be decided by its people. 'Greenland is not for sale,' Frederiksen said. The U.S., as we have previously reported, already has a significant military presence in Greenland. That includes the former Thule Air Base, which was turned over to the U.S. Space Force in 2020 and renamed Pituffik Space Base in 2023. Overseen by the Space Force's 821st Space Base Group, its mission is 'to enable force projection, space superiority, and scientific research in the Arctic region for our nation and allies through integrated base support and defense operations,' according to the Space Force. With Pituffik Space Base, the 821st Space Base Group is responsible for the U.S. military's northernmost installation. Beyond the airfield, the massive radar system used for early warning and tracking of ballistic missiles is of extreme strategic importance to the United States. Meanwhile, Russia has placed a huge strategic importance on the Arctic, with many investments in the region. In recent years, Moscow has been heavily committed to increasing its air and naval power in the Arctic Circle and has been establishing new bases in the region, as well as reactivating ones that fell into disuse after the Cold War. China has also been expanding its presence in the Arctic. These two nations have also been stepping up their joint military operations in the Arctic region. Last July, two Chinese H-6 bombers and a pair of Russian Tu-95 Bear bombers flew through a portion of the Air Defense Identification Zone (ADIZ) around Alaska. It marked the first time China's H-6s operated in that part of the world. Beyond the military implications of this region are potential new shipping routes and mineral resources that will become available as the ice continues to melt. These factors are largely perpetuating the looming struggle for control over wide swathes of the Arctic region. Amid all this, Denmark is seeking European help in opposing Trump's Greenland quest. 'Frederiksen dashed between Berlin, Brussels and Paris on Tuesday to shore up support in the face of Trump's increasingly aggressive overtures toward the territory,' Politico noted on Tuesday. Trump's interest in Greenland will likely be a big part of an informal meeting of EU leaders in Brussels on Feb. 3, Politico reported, citing several people familiar with the plans. Denmark's PM seeks support on trip to Berlin and other EU capitals as fears grow over Trump's threats against Greenland — DW Politics (@dw_politics) January 28, 2025 Buying a few new ships, aircraft and drones is clearly no game-changer in Denmark's efforts to maintain control over Greenland. The announcement of the plan, however, seems to be another indication that it has no intention of giving up the island. Contact the author: howard@
