Data from the ongoing Phase 1/2 ATALANTA-1 study in a heavily pretreated R/R NHL patient population demonstrate high antitumor activity and an encouraging safety profile in all NHL subtypes studied. 96% of patients received an infusion of fresh, fit, stem-like, early memory CD19 CAR T-cell therapy with a median vein-to-vein time of seven days, avoiding the need for cryopreservation and bridging therapy. These data reinforce the potential of Galapagos’ decentralized cell therapy manufacturing platform to deliver fresh, fit cells, fast, driving positive patient outcomes. Mechelen, Belgium; December 7, 2024, 18:30 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced additional data from the ongoing Phase 1/2 ATALANTA-1 study of its CD19 CAR T-cell therapy, GLPG5101. The results, featured in an oral presentation at the 66 th American Society of Hematology (ASH) Annual Meeting and Exposition, demonstrate an encouraging efficacy and safety profile in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). Most patients in the study received GLPG5101 as a fresh, fit, stem-like, early memory CD19 CAR T-cell therapy, with a median vein-to-vein time of seven days. “Shorter vein-to-vein time can lead to improved patient outcomes and remains an important unmet need in CAR-T therapy,” said Marie José Kersten, MD, ATALANTA-1 Principal Investigator and Professor of Hematology at the Department of Hematology at Amsterdam University Medical Center. “I am impressed by the latest data on GLPG5101, which demonstrate a promising efficacy and safety profile. With a median vein-to-vein time of just seven days, GLPG5101 has the potential to offer speed and scheduling flexibility, comparable to off-the-shelf therapies.” “CAR-T therapies are highly personalized treatments that currently undergo a time-intensive manufacturing process taking multiple weeks to months. For many patients with rapidly progressing cancers, every day counts, and treatment delays can be detrimental,” said Jeevan Shetty, MD, Head of Clinical Development Oncology at Galapagos. “We are steadfast in our commitment to bring innovation to cell therapies to address the most significant medical challenges. Our latest data at ASH strongly support the feasibility of our innovative decentralized cell therapy manufacturing platform in delivering fresh, fit cells with a median vein-to-vein time of just seven days, driving positive patient outcomes.” The new ATALANTA-1 data are summarized below: The ongoing ATALANTA-1 study included updated data on patients with mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL). As of the April 25, 2024, data cut-off, 49 patients received CD19 CAR T-cell therapy infusion, and safety and efficacy results were available for 45 patients and 42 patients, respectively. High objective response rates (ORR) and complete response rates (CRR) were observed in the pooled Phase 1 and Phase 2 efficacy analysis set, split by indication: In patients with MCL, all 8 of 8 efficacy-evaluable patients responded to treatment (ORR and CRR 100%). In patients with MZL, FL, objective and complete responses were observed in 20 of 21 efficacy-evaluable patients (ORR and CRR 95%). In patients with DLBCL, 9 of 13 efficacy-evaluable patients responded to treatment (ORR 69%), with 7 patients achieving a complete response (CRR 54%). Of the 7 patients with DLBCL who received the higher dose, 6 responded to treatment (ORR 86%) with 5 achieving a complete response (CRR 71%). Of the 15 minimal residual disease (MRD)-evaluable patients with a complete response, 12 patients (80%) achieved MRD negativity and remained in complete response at data cut-off. The median study follow-up was 3.3 months for FL and DLBCL with a range of 0.9-21.2 months, and 4.4 months for MCL with a range of 1-24.4 months. GLPG5101 showed an encouraging safety profile, with the majority of Grade ≥ 3 treatment emergent adverse events being hematological. One case of CRS Grade 3 was observed in Phase 1 and one case of ICANS Grade 3 was observed in Phase 2. 96% of patients (47 of 49) received an infusion with fresh, fit, stem-like early memory CD19 CAR T-cell therapy, with 91.5% (43 of 47) achieving a vein-to-vein time of seven days, thereby avoiding cryopreservation, and eliminating the need for bridging therapy. Strong and consistent in vivo CAR-T expansion levels and products consisting of stem-like, early memory phenotype T cells were observed in all doses tested. About the ATALANTA-1 study (EudraCT 2021-003272-13) ATALANTA-1 is an ongoing Phase 1/2, open-label, multicenter study to evaluate the safety, efficacy and feasibility of decentralized manufactured GLPG5101, a CD19 CAR-T product candidate, in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The primary objective of the Phase 1 part of the study is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×10 6 (DL1), 110×10 6 (DL2) and 250×10 6 (DL3) CAR+ viable T cells. The primary objective of the Phase 2 part of the study is to evaluate the objective response rate (ORR), while the secondary objectives include complete response rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months. About Galapagos’ cell therapy manufacturing platform Galapagos’ innovative decentralized cell therapy manufacturing platform has the potential for the administration of fresh, fit, stem-like, early memory T-cells within a median vein-to-vein time of seven days, greater physician visibility, and improved patient experience. The platform consists of an end-to-end xCellit® workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy. About Galapagos We are a biotechnology company with operations in Europe and the U.S. dedicated to transforming patient outcomes through life-changing science and innovation for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules and cell therapies in oncology and immunology. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, and the financial strength to invest strategically for the near- and long-term, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most. For additional information, please visit www.glpg.com or follow us on LinkedIn or X . For further information, please contact: Forward-looking statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements are often, but are not always, made through the use of words or phrases such as “anticipate,” “expect,” “plan,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,” “potential,” “could,” “indicate,” “forward,” “may,” as well as similar expressions. Forward-looking statements contained in this press release include, but are not limited to, statements regarding preliminary, interim and topline data from the ATALANTA-1 study and other analyses related to Galapagos’ CD19 CAR-T programs, statements related to Galapagos’ plans, expectations and strategy with respect to the ATALANTA-1 study, and statements regarding the expected timing, design and readouts of the ATALANTA-1 study, including the expected recruitment for such studies, and the potential benefits of Galapagos’ product candidates, including GLPG5101, and partnered programs, including uza-cel. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause Galapagos’ actual results to be materially different from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, without limitation, the risk that preliminary or interim clinical results may not be replicated in ongoing or subsequent clinical studies, the risk that ongoing and future clinical studies with Galapagos’ product candidates, including GLPG5101, may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical study and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG5101 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partners Lonza and Adaptimmune), and that Galapagos’ estimations regarding its GLPG5101 development programs and regarding the commercial potential of GLPG5101 may be incorrect, as well as those risks and uncertainties identified in Galapagos’ Annual Report on Form 20-F for the year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (SEC) and its subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations. Attachment Galapagos Press Release_ASH ATALANTA-1_ENG_Final
DAMASCUS, Syria (AP) — Syria's prime minister said Monday that most cabinet ministers were back at work after rebels overthrew President Bashar Assad , but some state workers failed to return to their jobs, and a United Nations official said the country's public sector had come “to a complete and abrupt halt." Meanwhile, streams of refugees crossed back into Syria from neighboring countries, hoping for a more peaceful future and looking for relatives who disappeared during Assad's brutal rule. There were already signs of the difficulties ahead for the rebel alliance now in control of much of the country. The alliance is led by a former senior al-Qaida militant who severed ties with the extremist group years ago and has promised representative government and religious tolerance. The rebel command said Monday they would not tell women how to dress. “It is strictly forbidden to interfere with women’s dress or impose any request related to their clothing or appearance, including requests for modesty,” the command said in a statement on social media. Nearly two days after rebels entered the capital, some key government services had shut down after state workers ignored calls to go back to their jobs, the U.N. official said, causing issues at airports and borders and slowing the flow of humanitarian aid. Rebel leader Ahmad al-Sharaa, who was long known by his nom de guerre Abu Mohammed al-Golani, also met for the first time with Prime Minister Mohammad Ghazi Jalali, who stayed in Syria when Assad fled. “You will see there are skills" among the rebels, al-Sharaa said in a video shared on a rebel messaging channel. Israel said it carried out airstrikes on suspected chemical weapons sites and long-range rockets to keep them from falling into the hands of extremists. Israel also seized a buffer zone inside Syria after Syrian troops withdrew. In northern Syria, Turkey said allied opposition forces seized the town of Manbij from Kurdish-led forces backed by the United States, a reminder that even after Assad's departure, the country remains split among armed groups that have fought in the past. The Kremlin said Russia has granted political asylum to Assad , a decision made by President Vladimir Putin . Kremlin spokesperson Dmitry Peskov declined to comment on Assad’s specific whereabouts and said Putin did not plan to meet with him. Damascus was quiet Monday, with life slowly returning to normal, though most shops and public institutions were closed. In public squares, some people were still celebrating. Civilian traffic resumed, but there was no public transport. Long lines formed in front of bakeries and other food stores. There was little sign of any security presence though in some areas, small groups of armed men were stationed in the streets. Across swathes of Syria, families are now waiting outside prisons , security offices and courts, hoping for news of loved ones who were imprisoned or who disappeared. Just north of Damascus in the feared Saydnaya military prison, women detainees, some with their children, screamed as rebels broke locks off their cell doors. Amnesty International and other groups say dozens of people were secretly executed every week in Saydnaya, and they estimate that up to 13,000 Syrians were killed between 2011 and 2016. “Don’t be afraid," one rebel said as he ushered women from packed cells. "Bashar Assad has fallen!” In southern Turkey , Mustafa Sultan was among hundreds of Syrian refugees waiting at border crossings to head home. He was searching for his older brother, who was imprisoned under Assad. “I haven’t seen him for 13 years," he said. "I am going to go see whether he’s alive.” Prime minister says government is operational, but UN official says it's paralyzed Jalali, the prime minister, has sought to project normalcy since Assad fled. “We are working so that the transitional period is quick and smooth,” he told Sky News Arabia TV on Monday, saying the security situation had already improved from the day before. At the court of Justice in Damascus, which was stormed by the rebels to free detainees, Judge Khitam Haddad, an aide to the justice minister in the outgoing government, said Sunday that judges were ready to resume work quickly. “We want to give everyone their rights,” Haddad said outside the courthouse. “We want to build a new Syria and to keep the work, but with new methods.” But a U.N. official said some government services had been paralyzed as worried state employees stayed home. The public sector “has just come to a complete and abrupt halt," said U.N. Resident and Humanitarian Coordinator for Syria Adam Abdelmoula, noting, for example, that an aid flight carrying urgently needed medical supplies had been put on hold after aviation employees abandoned their jobs. “This is a country that has had one government for 53 years and then suddenly all of those who have been demonized by the public media are now in charge in the nation’s capital,” Abdelmoula told The Associated Press. "I think it will take a couple of days and a lot of assurance on the part of the armed groups for these people to return to work again.” Britain, U.S. considering removing insurgent group from terror list Britain and the U.S. are both considering whether to remove the main anti-Assad rebel group from their lists of designated terrorist organizations. Hayat Tahrir al-Sham began as an offshoot of al-Qaida but cut ties with the group years ago and has worked to present a more moderate image. The group's leader, al-Sharaa, “is saying some of the right things about the protection of minorities, about respecting people’s rights,” British Cabinet minister Pat McFadden said, adding that a change would be considered “quite quickly.” But British Prime Minister Keir Starmer, speaking later during a visit to Saudi Arabia, said it was "far too early” to make that decision. In Washington, a Biden administration official noted that HTS will be an “important component” in Syria's future and that the U.S. needs to “engage with them appropriately.” Another administration official said the U.S. remains in a “wait and see” mode on whether to remove the designation. Both officials requested anonymity to discuss the ongoing internal deliberations. State Department spokesman Matthew Miller told reporters that such designations are constantly under review. Even while it is in place, the designation does not bar U.S. officials from speaking with members or leaders of the group, he said. The U.S. also announced it was sending its special envoy for hostage affairs to Beirut to seek information about the whereabouts of Austin Tice, a journalist who vanished in Syria 12 years ago and who President Joe Biden has said is believed to be alive. Israel confirms it struck suspected chemical weapons and rockets Israelis welcomed the fall of Assad, who was a key ally of Iran and Lebanon's Hezbollah militant group, while expressing concern over what comes next. Israel says its forces temporarily seized a buffer zone inside Syria dating back to a 1974 agreement after Syrian troops withdrew in the chaos. “The only interest we have is the security of Israel and its citizens," Israeli Foreign Minister Gideon Saar told reporters Monday. Saar did not provide details about the targets, but the British-based Syrian Observatory for Human Rights said they included weapons warehouses, research centers, air defense systems and aircraft squadrons. Israel has carried out hundreds of airstrikes in Syria in recent years, targeting what it says are military sites related to Iran and Hezbollah . Israeli officials rarely comment on individual strikes. Syria agreed to give up its chemical weapons stockpile in 2013, after the government was accused of launching an attack near Damascus that killed hundreds of people . But it is widely believed to have kept some of the weapons and was accused of using them again in subsequent years. Turkey says its allies have taken northern town Officials in Turkey, which is the main supporter of the Syrian opposition to Assad, say its allies have taken full control of the northern Syrian city of Manbij from a U.S.-supported and Kurdish-led force known as the Syrian Democratic Forces, or SDF. The SDF said a Turkish drone struck in the village of al-Mistriha in eastern Syria, killing 12 civilians, including six children. Turkey views the SDF, which is primarily composed of a Syrian Kurdish militia, as an extension of the banned Kurdistan Workers’ Party, or PKK, which has waged a decades-long insurgency in Turkey. The SDF has also been a key ally of the United States in the war against the Islamic State group. Turkish Foreign Minister Hakan Fidan on Monday warned against allowing Islamic State or Kurdish fighters to take advantage of the situation, saying Turkey will prevent Syria from turning into a “haven for terrorism.” Mroue reported from Beirut and Goldenberg from Tel Aviv, Israel. Associated Press writers Suzan Fraser in Ankara, Turkey, Mehmet Guzel at the Oncupinar border crossing in Turkey, Jamey Keaten in Geneva, and Aamer Madhani and Matthew Lee in Washington contributed to this report. Follow the AP's Syria coverage at https://apnews.com/hub/syriaArticle content KINGSTON, Ont. — Wilfrid Laurier Golden Hawks head coach Michael Faulds feels his team plays its best football when the competition is tough. The unbeaten squad should be put to the test Saturday against the Quebec powerhouse Laval Rouge et Or in the Vanier Cup. “We’ve been saying to the guys all week that it was very fitting that the Yates Cup had to go through the Western Mustangs, the team that has won the most (Ontario titles),” Faulds said. “And it’s very fitting, too, that the Vanier Cup has to go through the Laval Rouge et Or, the team that has won the most Vanier Cups. “Our guys are excited. We respect the heck out of Laval and know it’s going to take all four quarters.” Led by Hec Crighton Trophy winner Taylor Elgersma at quarterback, the Golden Hawks have outscored the opposition 128-76 over three playoff wins after an 8-0 regular season. Rouge et Or quarterback Arnaud Desjardins, a finalist for the outstanding player honour, leads a Laval team that needed two close victories to reach the Canadian university football title game. Laval boasts a stingy defence that led U Sports with only 106 points against over a 7-1 campaign. The Rouge et Or are looking for their second Vanier Cup title in the last three years. “We’re definitely a younger edition, but we’ve grown and tomorrow is our final exam,” said Laval head coach Glen Constantin. “So we’re looking forward to playing really good football against a quality opponent.” The Golden Hawks held a walkthrough for about an hour on Friday morning at Richardson Stadium in rainy, windy conditions. The clouds mostly cleared for the Rouge et Or session in the afternoon. A sellout crowd at the 8,000-seat Queen’s University stadium is expected with cool, overcast conditions in the forecast. “It’ll be a real celebration of football here in Canada,” Faulds said. “With the Grey Cup being last weekend, this is the last football game in Canada in 2024 and what a matchup.” Laurier enjoyed home-field advantage in a 29-21 win over Queen’s in the Ontario semifinal before topping Western 51-31 in the conference championship. The Golden Hawks looked just as strong on the road, handing the Atlantic champion Bishop’s Gaiters their first loss last weekend with a 48-24 rout. Laval, meanwhile, opened the playoffs with a comfortable 41-18 victory over Concordia. The Rouge et Or beat the 2023 Vanier champion Montreal Carabins 22-17 for the Quebec title before edging the Canada West champion Regina Rams 17-14 last week at Mosaic Stadium. A fourth-year kinesiology and physical education major from London, Ont., Elgersma led U Sports in passing yards and touchdown completions. He also rushed for seven TDs himself. Receiver Olivier Cool and running back William Tremblay have four playoff touchdowns apiece for Laval. Tanner Nelmes and Tayshaun Jackson have been productive out of the Laurier backfield while Ryan Hughes has been one of Elgersma’s favourite targets. The Golden Hawks, who last won the Vanier Cup in 2005, have a 2-3 all-time record in the national championship game, while Laval is 11-2. “We have a culture of playing good disciplined football,” Constantin said. “If we stick to the process, then we believe we have a good chance.” The Rouge et Or have won both previous meetings against the Golden Hawks. Laval beat Laurier in the Uteck Bowl in 2004 and 2016 at Quebec City.A North Korean voice Kim Jong-un would love to silence