Latest news with #PaulMoore
Hamilton Spectator
a day ago
- Business
- Hamilton Spectator
Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW251, a Novel Glypican 3-Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate
VANCOUVER, British Columbia, July 28, 2025 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW251, a novel glypican-3 (GPC3)-targeted ADC incorporating the company's proprietary topoisomerase 1 inhibitor (TOPO1i) payload, ZD06519, for the treatment of HCC. HCC is the most common type of primary liver cancer, with GPC3 expressed in over 75% of cases1. ZW251 is a potential first-in-class ADC engineered to selectively target GPC3. It is composed of a humanized IgG1 antibody conjugated to a novel camptothecin-based TOPO1i using a validated peptide cleavable linker. A drug-antibody-ratio (DAR) of four was selected for ZW251 as a lower DAR potentially could unlock a broader range of dose levels, a potential benefit as HCC patients are commonly challenged by impairment of liver function as a result of chronic liver disease and cirrhosis. In preclinical studies, ZW251 demonstrated strong activity in a range of HCC models, including a range of patient derived xenografts exhibiting a breadth of GPC3 expression and noteworthy tolerability in non-human primate toxicology studies at doses up to 120 mg/kg. 'This advancement marks the second ADC from our wholly-owned pipeline, utilizing our proprietary TOPO1i payload, to progress into clinical development, reinforcing confidence in our approach,' said Paul Moore, Ph.D., Chief Scientific Officer of Zymeworks. 'Like ZW191, which is currently in clinical trials, ZW251 utilizes the same payload paired with an optimized antibody. Our observations with ZW191 in the clinic to date provide a strong foundation as we initiate clinical development of this second ADC. With its novel design, unique mechanism of action, and promising preclinical activity, ZW251 offers the potential to meaningfully improve upon the current standard of care for HCC either as a monotherapy or in combination.' We plan to commence Phase 1 clinical studies for ZW251 in 2025. About Zymeworks Inc. Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks' mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The Company's complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company's proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval and China' s NMPA granted conditional approval for zanidatamab to treat adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. The European Commission (EC) has granted conditional marketing authorization for Ziihera® as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) biliary tract cancer previously treated with at least one prior line of systemic therapy. Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive biliary tract cancer in the U.S., Europe, and China. In addition, zanidatamab is being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Phase 1 studies for ZW171 and ZW191 are actively recruiting and ZW251 is expected to enter clinical trials in 2025. In addition to Zymeworks' pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes 'forward-looking statements' or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to the efficacy and safety of zanidatamab and Zymeworks' product candidates; ongoing clinical studies and regulatory reviews; the potential addressable market of zanidatamab and Zymeworks' product candidates; the timing of and results of interactions with regulators; Zymeworks' clinical development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future studies, clinical trials and the related data; expectations regarding future regulatory filings and approvals and the timing thereof; potential safety profile and therapeutic effects of zanidatamab and Zymeworks' product candidates; and the commercial potential of technology platforms and product candidates. When used herein, words such as 'plan', 'believe', 'expect', 'may', 'anticipate', 'potential', 'will', 'intend', 'continues', 'progress', and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks' current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: clinical trials, including any required confirmatory trials, may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; any of Zymeworks' or its partners' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; conditional regulatory approval may be withdrawn or revoked if any of Zymeworks' or its partners' product candidates fail to satisfy the requirements of any such conditional regulatory approvals; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks' business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks' behalf; zanidatamab and Zymeworks' product candidates may not be successfully commercialized; clinical trials and any future clinical trials may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under 'Risk Factors' in Zymeworks' quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at and ). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Contacts: Investor Inquiries: Shrinal Inamdar Senior Director, Investor Relations (604) 678-1388 ir@ Media Inquiries: Diana Papove Senior Director, Corporate Communications (604) 678-1388 media@ _______________________ 1 Wang HL et al., Arch Pathol Lab Med 2008.
BBC News
22-07-2025
- General
- BBC News
Nab Lane waste tip reopening ruled out by Kirklees council leader
The decision to shut a West Yorkshire waste tip will not be reversed, a council has said, despite claims fly-tipping has increased as a Council shut Nab Lane Household Waste Recycling Centre in Birstall last November in a move it said was needed to save money. But several councillors have continued to call for the site to be revived, with the impact on neighbouring waste tips also cited as a problem. Speaking at the full council meeting however, Kirklees Council Leader Carole Pattinson said changes to recycling processes meant "less waste will be created in the first place". At the same time as the closure of the Nab Lane site last year, the council, which is run by a Labour as a minority administration, also cut the operating hours of two other waste sites. Bromley Farm in Upper Cumberworth is now closed on Wednesdays and Thursdays, while Meltham's Bent Ley Road site is shut on Mondays and Tuesdays, the Local Democracy Reporting Service Alliance councillor Paul Moore said there had been longer queues and waiting times at Dewsbury's Weaving Lane tip and the impact had pushed staff to "breaking point".Conservative councillor Josh Sheard called for a cost-sharing model between the local authority, Leeds City Council and the West Yorkshire Combined Authority (WYCA) to reopen the site. He said: "The more that we delay, the more environmental harm comes, the more fly-tipping, the more service inequality we allow to grow. Regional problems require regional thinking but it has to start somewhere."However, Pattinson said the chances of a regional agreement to reopen the site were "absolutely zilch", stating one reason was that different local authorities have different waste also said that new recycling processes would be in place within the area next year. She added: "The use of waste disposal sites should go down because simpler recycling will mean that, certainly in Kirklees, there'll be more waste removed at the kerb side."There are other things coming on board that will mean less waste will be created in the first place." Listen to highlights from West Yorkshire on BBC Sounds, catch up with the latest episode of Look North.
The Independent
16-07-2025
- Politics
- The Independent
University of Michigan faces federal investigation after two Chinese students arrested for smuggling biological materials
The University of Michigan has been placed under federal investigation by the Education Department following the separate arrests of two Chinese scientists linked to the institution on charges of smuggling biological materials into the United States. The department announced its probe into the university's foreign funding on Tuesday, citing the "highly disturbing criminal charges" that emerged within days of each other in June. It expressed significant concerns regarding Michigan's susceptibility to national security threats originating from China. Paul Moore, chief investigative counsel for the department, stated: "Despite the University of Michigan's history of downplaying its vulnerabilities to malign foreign influence, recent reports reveal that UM's research laboratories remain vulnerable to sabotage." The scrutiny aligns with a broader push under President Donald Trump to enhance transparency surrounding foreign gifts and contracts to US universities, particularly those with ties to China. Similar investigations have been initiated at Harvard University, the University of Pennsylvania, and the University of California, Berkeley. This also echoes calls from Republicans in Congress for universities to sever research ties with China, alleging exploitation for technology theft. Michigan itself ended a partnership with a Shanghai university in January amid pressure from House Republicans who deemed it a security risk. The new investigation demands comprehensive financial records from Michigan, alongside details of its research collaborations with institutions outside the US. The Education Department has accused the university of providing "incomplete, inaccurate and untimely" public disclosures concerning funding from foreign sources. In response, Colleen Mastony, a spokesperson for the University of Michigan, affirmed the institution's commitment to cooperate with federal investigators, stating it takes its responsibility to comply with the law "extremely seriously." Ms Mastony added: "We strongly condemn any actions that seek to cause harm, threaten national security or undermine the university's critical public mission." The federal charges in June involved a Chinese scientist and his girlfriend, who worked at a University of Michigan lab, after the FBI reportedly thwarted their attempt to bring a toxic fungus into the US. Days later, another Chinese scientist was arrested upon arrival in the US, accused of shipping biological material to a University of Michigan laboratory. The university announced a review of its research security protocols in June. However, in a letter to the university, the Education Department criticised certain school officials for downplaying the risks of research collaborations with Chinese institutions. It specifically singled out Ann Chih Lin, director of the university's Center for Chinese Studies, who has publicly dismissed the threat of technology theft from China as overstated. Department officials wrote that Ms Lin's "apparent indifference to the national security concerns of the largest single source of funding for UM's annual research expenditures — the American taxpayer — is particularly unsettling." Federal law mandates universities to report all foreign gifts and contracts totalling \$250,000 or more. This law saw limited enforcement until Donald Trump's first term, when the Education Department launched numerous inquiries into universities suspected of underreporting foreign funds. While the Biden administration closed most of these cases, the enforcement effort has recently been renewed. Many US universities acknowledge the need to bolster research security but caution against treating Chinese scholars with undue hostility, noting that only a small number have been implicated in espionage. Last year, a report by House Republicans claimed that hundreds of millions of dollars in federal funding had inadvertently supported Chinese advancements in artificial intelligence, semiconductor technology, and nuclear weapons. China remains the second-largest country of origin for foreign students in the US, after India, with over 270,000 Chinese students making up roughly a quarter of all international students in the 2023-24 academic year.
Time of India
16-07-2025
- Time of India
Is American research safe? Why US officials are zeroing in on the University of Michigan
University of Michigan under US investigation after Chinese scientists charged with biological smuggling The University of Michigan is facing a federal investigation by the US Department of Education following the arrests of two Chinese scientists linked to its research facilities. The inquiry centers on the university's handling of foreign funding and potential risks to national security, particularly concerning collaborations with Chinese institutions. The investigation was announced after federal authorities charged two individuals in separate incidents involving the smuggling of biological materials into the US. Both scientists were associated with the University of Michigan and were apprehended within days of each other. Federal probe linked to national security concerns The Department of Education cited "highly disturbing criminal charges" as the basis for the investigation. According to documents obtained by the Associated Press , the department expressed concern that the university's research labs remain "vulnerable to sabotage." Paul Moore, the department's chief investigative counsel, stated, as reported by the Associated Press , that "despite the University of Michigan's history of downplaying its vulnerabilities to malign foreign influence, recent reports reveal that UM's research laboratories remain vulnerable." by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like The Most Successful Way of Intraday Trading is "Market Profile" TradeWise Learn More Undo The university is now required to submit financial records and detailed information on research collaborations with institutions outside the US. Officials accuse the university of being "incomplete, inaccurate and untimely" in its disclosures about foreign funding, according to the Associated Press. Criminal cases prompt action from US authorities The first arrest involved a Chinese scientist and his girlfriend, who were working at a University of Michigan laboratory. According to the FBI, the pair attempted to smuggle a toxic fungus into the US, but the effort was intercepted. Days later, another Chinese scientist was arrested upon arrival in the US. He is accused of shipping biological material to a lab at the university. In response, the university announced a review of its research security protocols in June. However, the Education Department, in a formal letter, raised concerns that some officials at the university had previously downplayed potential risks associated with Chinese research partnerships. Focus on foreign funding and transparency US law requires all universities to report foreign gifts and contracts that total $250,000 or more. While the law had seen little enforcement for years, the Trump administration renewed efforts to investigate underreporting. The Education Department has opened similar investigations into Harvard University, the University of Pennsylvania, and the University of California, Berkeley. The Department's letter singled out Ann Chih Lin, director of the university's Center for Chinese Studies, for allegedly minimizing the national security threat. Officials wrote that "Lin's apparent indifference to the national security concerns of the largest single source of funding for UM's annual research expenditures — the American taxpayer — is particularly unsettling," as quoted by the Associated Press . University response and broader context University spokesperson Colleen Mastony stated the institution "will cooperate with federal investigators and takes its responsibility to comply with the law extremely seriously," as reported by the Associated Press . She added, "We strongly condemn any actions that seek to cause harm, threaten national security or undermine the university's critical public mission." The University of Michigan ended its partnership with a university in Shanghai in January, following pressure from House Republicans. The decision aligned with broader congressional efforts urging US universities to sever ties with Chinese institutions deemed security risks. According to the Associated Press , more than 270,000 Chinese international students were enrolled in US institutions during the 2023–24 academic year, accounting for approximately one-fourth of all foreign students. TOI Education is on WhatsApp now. Follow us here . Ready to navigate global policies? Secure your overseas future. Get expert guidance now!
USA Today
16-07-2025
- Politics
- USA Today
University of Michigan under federal scrutiny after arrest of Chinese scientists
Probe comes after three Chinese citizens tied to the University of Michigan were accused of smuggling biological hazards into the U.S. DETROIT — The Trump administration is investigating potential foreign influence at the University of Michigan, claiming the school was indifferent to national security concerns raised by the FBI. In a letter sent to the university on July 15, the U.S. Department of Education gave the university 30 days to turn over more than five years' worth of records related to foreign donations, foreign research collaboration, international students and their visas, as well as the names and contact information of school personnel who supervise all those things. The letter said the university received $375 million in foreign funding since 2020 and has been late in reporting about $86 million of that amount. The letter also notes that the school spends more than $2 billion on research each year, and about half of that comes from the federal government. "Additionally, many of UM's disclosure reports appear to include transactions in which the counterparty was erroneously identified by UM as nongovernmental," Paul Moore, chief investigative counsel for the Department of Education, wrote in the letter. Universities must file semiannual reports with the department detailing their foreign contacts and funding. The letter said a review of the university's filings "reveals that incomplete, inaccurate, and untimely disclosures may have been submitted by UM, in possible violation of its foreign source funding statutory disclosure obligations." University spokeswoman Colleen Mastony said in a statement that the school is committed to advancing knowledge and serving the people of Michigan and the world. "The University of Michigan takes its responsibility to comply with the law extremely seriously, and we will cooperate fully with federal investigators," she said. "We strongly condemn any actions that seek to cause harm, threaten national security or undermine the university's critical public mission." The investigation is the latest battle between the Trump administration and the school over things like antisemitism on campus, its use of diversity, equity, and inclusion, and the overhead costs it charges on federal research grants. Does China benefit from it? Trump has been defunding university research. Department of Education cites recent cases involving Chinese scientists Universities with ties to China have also been under federal scrutiny as the administration has become increasingly concerned that China is potentially using open and federally funded research environments in the United States to circumvent export controls and other national security laws, according to Reuters. In May, State Department spokesperson Tammy Bruce said the United States will not tolerate "exploitation" of universities by the Chinese Communist Party or theft of U.S. research and intellectual property. The Department of Education's investigation comes after three Chinese citizens were recently charged with attempting to smuggle dangerous biological materials into the United States for use at the University of Michigan labs. In June, federal authorities accused two Chinese scientists of smuggling into the United States a "dangerous" fungus that causes a disease in crops so that one of them could research the pathogen at a university laboratory. Days later, another Chinese scientist was charged with allegedly bringing biological materials related to roundworms for research at the university. "Despite the University of Michigan's history of downplaying its vulnerabilities to malign foreign influence, recent reports reveal that UM's research laboratories remain vulnerable to sabotage," Moore said in a separate statement. Chinese student visas: Marco Rubio says US will revoke visas from Chinese students, add new restrictions The Department of Education's letter also noted that the university in January closed a joint research institute it ran with Shanghai Jiao Tong University, after U.S. Rep. John Moolenaar, a Republican from Caledonia, highlighted ties that the school had to the Chinese military. "UM continues to engage in substantial research collaborations with Tsinghua University, Peking University, Fudan University, and Zhejiang University — all universities deeply involved in China's emerging science and technology research efforts directly linked to military programs," the letter said. According to the letter, Ann Chih Lin, director of the University of Michigan's Center for Chinese Studies, met with the director of the FBI in December 2022 and accused the bureau of overstating the threat of technology transfer to China in academic settings. "Lin's assertions appear to be ill-conceived," Moore wrote in the letter. "Lin's apparent indifference to the national security concerns of the largest single source of funding for UM's annual research expenditures — the American taxpayer — is particularly unsettling." Contributing: Christina Hall, Detroit Free Press; Thao Nguyen, USA TODAY; Reuters
