Fashion event celebrates 75 years of Indonesia, PH diplomatic tiesTabuya calls for action against online gender-based violenceBAKU, Azerbaijan (AP) — In the wee hours Sunday at the United Nations climate talks, countries from around the world reached an agreement on how rich countries can cough up the funds to support poor countries in the face of climate change. It’s a far-from-perfect arrangement, with many parties still deeply unsatisfied but some hopeful that the deal will be a step in the right direction. World Resources Institute president and CEO Ani Dasgupta called it “an important down payment toward a safer, more equitable future,” but added that the poorest and most vulnerable nations are “rightfully disappointed that wealthier countries didn’t put more money on the table when billions of people’s lives are at stake.” The summit was supposed to end on Friday evening but negotiations spiraled on through early Sunday. With countries on opposite ends of a massive chasm, tensions ran high as delegations tried to close the gap in expectations. Here’s how they got there: read more Here’s what happened when experts at COP29 played a climate change board game Athletes see climate change as threatening their sports and their health. Some are speaking up Papuan women’s mangrove forest in Indonesia is increasingly threatened by development and pollution What was the finance deal agreed at climate talks? Rich countries have agreed to pool together at least $300 billion a year by 2035. It’s not near the full amount of $1.3 trillion that developing countries were asking for, and that experts said was needed. But delegations more optimistic about the agreement said this deal is headed in the right direction, with hopes that more money flows in the future. The text included a call for all parties to work together using “all public and private sources” to get closer to the $1.3 trillion per year goal by 2035. That means also pushing for international mega-banks, funded by taxpayer dollars, to help foot the bill. And it means, hopefully, that companies and private investors will follow suit on channeling cash toward climate action. const iframes=document.querySelectorAll('iframe.ap-embed');const iframeMap=new Map();iframes.forEach(iframe=>iframeMap.set(iframe.contentWindow,iframe));window.addEventListener('message',msg=>{const iframe=iframeMap.get(msg.source);if(!iframe)return;if(msg.data.type==='embed-size'){iframe.setAttribute('height',msg.data.height);iframe.style.height='${msg.data.height}px';return;}});iframes.forEach(iframe=>{const data={type:'embed-size-query'};iframe.contentWindow.postMessage(data,'*');}); The agreement is also a critical step toward helping countries on the receiving end create more ambitious targets to limit or cut emissions of heat-trapping gases that are due early next year. It’s part of the plan to keep cutting pollution with new targets every five years, which the world agreed to at the U.N. talks in Paris in 2015. The Paris agreement set the system of regular ratcheting up climate fighting ambition as away to keep warming under 1.5 degrees Celsius (2.7 degrees Fahrenheit) above pre-industrial levels. The world is already at 1.3 degrees Celsius (2.3 degrees Fahrenheit) and carbon emissions keep rising. Activists participate in a demonstration for climate finance at the COP29 U.N. Climate Summit, Friday, Nov. 22, 2024, in Baku, Azerbaijan. (AP Photo/Sergei Grits) Activists participate in a demonstration for climate finance at the COP29 U.N. Climate Summit, Friday, Nov. 22, 2024, in Baku, Azerbaijan. (AP Photo/Sergei Grits) Share Share Copy Link copied Email Facebook X Reddit LinkedIn Pinterest Flipboard Print Read More What will the money be spent on? The deal decided in Baku replaces a previous agreement from 15 years ago that charged rich nations $100 billion a year to help the developing world with climate finance. The new number has similar aims: it will go toward the developing world’s long laundry list of to-dos to prepare for a warming world and keep it from getting hotter. That includes paying for the transition to clean energy and away from fossil fuels. Countries need funds to build up the infrastructure needed to deploy technologies like wind and solar power on a large scale. Communities hard-hit by extreme weather also want money to adapt and prepare for events like floods, typhoons and fires. Funds could go toward improving farming practices to make them more resilient to weather extremes, to building houses differently with storms in mind, to helping people move from the hardest-hit areas and to help leaders improve emergency plans and aid in the wake of disasters. The Philippines, for example, has been hammered by six major storms in less than a month , bringing to millions of people howling wind, massive storm surges and catastrophic damage to residences, infrastructure and farmland. “Family farmers need to be financed,” said Esther Penunia of the Asian Farmers Association. She described how many have already had to deal with millions of dollars of storm damage, some of which includes trees that won’t again bear fruit for months or years, or animals that die, wiping out a main source of income. “If you think of a rice farmer who depends on his or her one hectare farm, rice land, ducks, chickens, vegetables, and it was inundated, there was nothing to harvest,” she said. Mukhtar Babayev, COP29 President, applauds as he attends a closing plenary at the COP29 U.N. Climate Summit, Sunday, Nov. 24, 2024, in Baku, Azerbaijan. (AP Photo/Rafiq Maqbool) Mukhtar Babayev, COP29 President, applauds as he attends a closing plenary at the COP29 U.N. Climate Summit, Sunday, Nov. 24, 2024, in Baku, Azerbaijan. (AP Photo/Rafiq Maqbool) Share Share Copy Link copied Email Facebook X Reddit LinkedIn Pinterest Flipboard Print Read More Why was it so hard to get a deal? Election results around the world that herald a change in climate leadership, a few key players with motive to stall the talks and a disorganized host country all led to a final crunch that left few happy with a flawed compromise. The ending of COP29 is “reflective of the harder geopolitical terrain the world finds itself in,” said Li Shuo of the Asia Society. He cited Trump’s recent victory in the US — with his promises to pull the country out of the Paris Agreement — as one reason why the relationship between China and the EU will be more consequential for global climate politics moving forward. Developing nations also faced some difficulties agreeing in the final hours, with one Latin American delegation member saying that their group didn’t feel properly consulted when small island states had last-minute meetings to try to break through to a deal. Negotiators from across the developing world took different tacks on the deal until they finally agreed to compromise. Meanwhile, activists ramped up the pressure: many urged negotiators to stay strong and asserted that no deal would be better than a bad deal. But ultimately the desire for a deal won out. Some also pointed to the host country as a reason for the struggle. Mohamed Adow, director of climate and energy think tank Power Shift Africa, said Friday that “this COP presidency is one of the worst in recent memory,” calling it “one of the most poorly led and chaotic COP meetings ever.” The presidency said in a statement, “Every hour of the day, we have pulled people together. Every inch of the way, we have pushed for the highest common denominator. We have faced geopolitical headwinds and made every effort to be an honest broker for all sides.” Shuo retains hope that the opportunities offered by a green economy “make inaction self-defeating” for countries around the world, regardless of their stance on the decision. But it remains to be seen whether the UN talks can deliver more ambition next year. In the meantime, “this COP process needs to recover from Baku,” Shuo said. ___ Associated Press reporters Seth Borenstein and Sibi Arasu contributed to this report. ___ The Associated Press’ climate and environmental coverage receives financial support from multiple private foundations. AP is solely responsible for all content. Find AP’s standards for working with philanthropies, a list of supporters and funded coverage areas at AP.org .
Rich get richer: The $164 trillion inheritance windfallCOPENHAGEN, Denmark--(BUSINESS WIRE)--Dec 8, 2024-- Genmab A/S (Nasdaq: GMAB): Genmab A/S (Nasdaq: GMAB) today announced results from the Phase 1b/2 EPCORE ® CLL-1 clinical trial evaluating epcoritamab (Abstract #883), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 61 percent and a complete response (CR) rate of 39 percent in difficult-to-treat adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) treated with epcoritamab monotherapy. These results, from the monotherapy expansion (EXP) cohort (n=23) of the trial, along with the first safety data from the optimization (OPT) cohort, were presented at the 66 th Annual Meeting and Exposition of the American Society of Hematology (ASH), during the ASH Annual Meeting Press Program. The data will be presented during an oral session on December 9, 2024. In the EXP cohort, the median time to response was two (2.0) months and the median time to CR was 5.6 months. Among all patients in the cohort, median progression-free survival (PFS) was 12.8 months and median overall survival (OS) was not reached (median follow-up was 22.8 months). An estimated 65 percent of patients were alive at 15 months. Among 12 responders evaluable for minimal residual disease (MRD) by next-generation sequencing in peripheral blood, nine patients (75 percent) had undetectable MRD. The most frequent non-hematologic treatment-emergent adverse events (TEAEs) in the EXP cohort were cytokine release syndrome (CRS; 96 percent), diarrhea (48 percent), peripheral edema (48 percent), fatigue (43 percent), and injection-site reaction (43 percent). Cytopenias were common (anemia, 65 percent; thrombocytopenia, 65 percent; neutropenia, 48 percent); however, most patients had baseline anemia and thrombocytopenia, suggesting that these events were largely disease-related. Three cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported (one Grade 1; two Grade 2), and there was one clinical tumor lysis syndrome (CTLS) case (Grade 2). These cases did not lead to treatment discontinuation. Four fatal TEAEs occurred - two cases of pneumonia, one case of sepsis and one case of squamous cell carcinoma of the skin. The EXP cohort followed a 2-step step-up dose regimen, and CRS was manageable and primarily low grade (9 percent Grade 1, 70 percent Grade 2, 17 percent Grade 3). In the first data from the separate OPT cohort, which followed a 3-step step-up dose regimen, CRS severity was substantially reduced with only low-grade events (71 percent Grade 1, 12 percent Grade 2). In both cohorts, CRS events primarily occurred following the first full dose, and none led to treatment discontinuation. No ICANS or CTLS cases were reported in the OPT cohort. “These EPCORE CLL-1 data are encouraging, especially as the majority of patients were heavily pre-treated with at least four lines of therapy,” said Alexey Danilov, MD, PhD, Marianne and Gerhard Pinkus, Professor and Director of Early Clinical Therapeutics and Associate Director of the Toni Stephenson Lymphoma Center, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope. “Despite progress in treating chronic lymphocytic leukemia, there remains a tremendous need for additional therapeutic options for high-risk patients whose disease has progressed following standard chemoimmunotherapy and targeted therapies.” Additional data from the EXP cohort showed high response rates in patients with high-risk factors treated with epcoritamab, including TP53 aberrations, IGHV-unmutated disease and double-exposed disease – prognostic markers that are associated with disease progression and decreased survival. i,ii,iii In patients with TP53 aberrations (n=15), the ORR was 67 percent with a CR of 33 percent. Among patients with IGHV-unmutated disease (n=16), the ORR was 63 percent, and the CR was 44 percent. In double-refractory patients, the ORR was 53 percent, and the CR was 37 percent. All patients in the trial had prior chemoimmunotherapy, and most patients had previously received targeted therapies such as BTK and BCL2 inhibitors (double-exposed) and had high-risk disease characteristics. “Chronic lymphocytic leukemia is incurable, and patients often need a variety of treatments throughout their lifetime, especially if their disease has high-risk prognostic factors, has relapsed or has become refractory to the current standard-of-care, including targeted therapies,” said Dr. Judith Klimovsky, Executive Vice President & Chief Development Officer, Genmab. “These early data show the potential therapeutic applicability of epcoritamab in relapsed or refractory chronic lymphocytic leukemia, and further reinforce the potential of epcoritamab as a core therapy for the treatment of B-cell malignancies.” Use of epcoritamab in CLL is not approved in the U.S. or in the EU or in any other territory. The safety and efficacy of epcoritamab for use in CLL have not been established. About Chronic Lymphocytic Leukemia (CLL) Chronic lymphocytic leukemia (CLL) is the most prevalent type of leukemia, affecting over 200,000 people in the United States alone. iv Chronic lymphocytic leukemia can be classified as either slow growing (indolent) or fast growing (aggressive). v CLL is incurable, and many patients will likely relapse and progress on frontline therapies. vi Most patients will experience consecutive episodes of disease progression and will require several lines of treatment in their lifetime. vii,viii About the EPCORE ® CLL-1 Trial EPCORE ® CLL-1 is a Phase 1b/2, open-label, multi-center trial to evaluate the safety and preliminary efficacy of epcoritamab as a monotherapy and in combination with standard of care agents in patients with difficult-to-treat relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), R/R small lymphocytic lymphoma (SLL) and Richter's Syndrome (RS). The trial consists of two parts: a dose-escalation phase (Phase 1b) and an expansion phase (Phase 2). Patients with RS are only included in the expansion phase. The primary objective of Phase 1b is to determine the recommended Phase 2 dose and the maximum tolerated dose as well as establish the safety profile of epcoritamab monotherapy and epcoritamab plus venetoclax in participants with R/R CLL. The purpose of Phase 2 is to assess and evaluate the preliminary efficacy, safety and tolerability profiles of epcoritamab monotherapy and epcoritamab plus venetoclax for patients with R/R CLL and SLL. Additionally, epcoritamab monotherapy and combination therapy will be evaluated in patients with RS to assess their efficacy, safety and tolerability profiles. More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT: 04623541). About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody ® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. ix Epcoritamab (approved under the brand name EPKINLY ® in the U.S. and Japan, and TEPKINLY ® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigator's choice chemotherapy ( NCT04628494 ), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL ( NCT05578976 ), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R 2 ) in patients with R/R FL ( NCT05409066 ), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R 2 ) compared to chemoimmunotherapy in patients with previously untreated FL ( NCT06191744 ), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL ( NCT06508658 ). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. EPKINLY ® (epcoritamab-bysp) U.S. INDICATIONS & IMPORTANT SAFETY INFORMATION What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come back or that did not respond to previous treatment after receiving 2 or more treatments. EPKINLY is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. Important Warnings—EPKINLY can cause serious side effects, including: People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets. In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Full Prescribing Information and Medication Guide , including Important Warnings. Globally, prescribing information varies; refer to the individual country product label for complete information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO ® ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov . Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ®; the Y-shaped Genmab logo ®; Genmab in combination with the Y-shaped Genmab logo ®; HuMax ®; DuoBody ®; HexaBody ®; DuoHexaBody ®, HexElect ® and KYSOTM. EPCORE ®, EPKINLY ®, TEPKINLY ® and their designs are trademarks of AbbVie Biotechnology Ltd. i Campo, et al. TP53 Aberrations in Chronic Lymphocytic Leukemia: An Overview of the Clinical Implications of Improved Diagnostics. Haematologica . 2018 Nov 15;103(12):1956–1968. https://haematologica.org/article/view/8691 . ii Galieni, et al. Unmutated IGHV at Diagnosis in Patients With Early Stage CLL Independently Predicts for Shorter Follow-Up Time to First Treatment (TTFT). Leukemia Research. 2024. https://doi.org/10.1016/j.leukres.2024.107541 . iii Zuber, et al. Efficacy and Effectiveness Outcomes of Treatments for Double-Exposed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients: A Systematic Literature Review. Cancer Medicine . 2024. https://doi.org/10.1002/cam4.70258 . iv Fedele, et al. Chronic Lymphocytic Leukemia: Time to Care for the Survivors. Journal of Clinical Oncology . 2024. https://ascopubs.org/doi/10.1200/JCO.23.02738 . v Penn Medicine. Chronic Lymphocytic Leukemia (CLL). Accessed November 2024. https://www.pennmedicine.org/cancer/types-of-cancer/leukemia/types-of-leukemia/chronic-lymphocytic-leukemia . vi Odetola, et al. Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL). Curr Hematol Malig Rep . 2023 Jun 6:1–14. doi: 10.1007/s11899-023-00700-z vii Moreno, Carol. Standard Treatment Approaches for Relapsed/Refractory Chronic Lymphocytic Leukemia After Frontline Chemoimmunotherapy. Hematology Am Soc Hematol Educ Program . 2020 Dec 4;2020(1):33-40. doi: 10.1182/hematology.2020000086. viii Leukemia & Lymphoma Society. Relapsed and Refractory CLL. Accessed November 2024. https://www.lls.org/leukemia/chronic-lymphocytic-leukemia/treatment/relapsed-and-refractory . ix Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine . 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625. 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The announcement of the jury's decision to acquit Smith of all charges sent shockwaves through the community, particularly among advocates for racial justice. Many viewed the verdict as a glaring example of the systemic bias and inequities that continue to plague the legal system, especially in cases involving violence against marginalized groups. The perceived lack of accountability for Smith's actions further fueled existing tensions and frustrations over the treatment of African Americans in the judicial process.Chelsea defender Marc Cucurella changed his cleats just 12 minutes into the game after his slips contributed to both of Tottenham's early goals in the teams' London derby in the Premier League on Sunday. The Spain international ceded possession by slipping on the turf at Tottenham Hotspur Stadium in the fifth and 11th minutes — and from the ensuing attacks, Spurs scored through Dominic Solanke and Dejan Kulusevski. Immediately after Kulusevski's shot hit the net to make it 2-0, Cucurella sprinted to the sideline while shrugging his shoulders and pointed to his cleats. He took them off and threw them away in disgust before putting on new ones. It seemed to work. Within six minutes, he provided the pass that led to Jadon Sancho scoring for Chelsea to make it 2-1. Chelsea went on to win 4-3 — and Cucurella on social media after the match, showing the first cleats he wore nestled in a bin. “It almost slipped away,” Cucurella wrote on Instagram Stories, “but proud of the amazing team effort to turn things around.” AP soccer:
