Dragonfly Therapeutics, Inc.

A Massachusetts lawmaker who frequently criticizes China has become the unlikely face of opposition to legislation that seeks to blacklist Chinese contractors like WuXi Biologics. Last month, Rep. Jim McGovern (D-MA) failed to stop the House of Representatives from passing the Biosecure Act. But he persuaded a surprising number of influential Democrats to vote “no” and is now in conversations with senators and House representatives about amending the legislation as it moves to the Senate. As distrust of China reaches a fever pitch in Congress, drugmakers with supply chains threatened by Biosecure have been unwilling to publicly oppose the legislation for fear of political blowback. The opposition mantle has been assumed by McGovern, who argues the bill lacks due process and resembles how the Chinese government operates. “I’m at the point in my career where I’m going to vote in ways I think [are] right. I’m not going to go along to get along,” McGovern said in an interview with Endpoints News . To his critics, McGovern isn’t taking a principled stand but rather protecting WuXi Biologics’ plans to build a 190,000-square-foot biomanufacturing plant in his district. WuXi reportedly cited Biosecure when pausing work on the facility earlier this year, Endpoints previously reported . “If people say this is about a business in my district, and that’s it, I resent that,” McGovern said. Elected to Congress in 1997 and representing Massachusetts’ 2nd Congressional District, McGovern might seem like a natural ally to the Biosecure Act. The legislation targets five companies — WuXi Biologics, WuXi AppTec, BGI, MGI and Complete Genomics — over fears that they could furnish China’s government with sensitive health information. A member of the Congressional-Executive Commission on China, he sponsored a recent law that advocates for a peaceful resolution of the China-Tibet dispute. “I despise bullies, and I want an even playing field when I think people are being persecuted,” McGovern said. In July, the Chinese government sanctioned him for “frequently interfering” in its domestic affairs, an action that he wears as a badge of honor. Nick Shipley, founder of the biopharma consulting firm Cronus Consulting, said McGovern is uniquely positioned to lead the charge against Biosecure. “He’s not necessarily vulnerable to some of the electoral politics that others are, and his record on China is viewed as strong,” Shipley said. McGovern is widely expected to win reelection in November, in a race in which the economy and border eclipse China as top issues. His independent challenger in the upcoming election acknowledged it would be “really, really, really tough” to prevail . During this election cycle, McGovern has raised $979,000, largely from healthcare facilities and trade unions, according to the campaign spending website OpenSecrets.org. He received contributions from two privately-held biopharma companies: $9,900 from Dragonfly Therapeutics and $6,600 from Ischemix. The companies did not respond to requests for comment. There are limits to McGovern’s hawkish views on China. He cited free speech concerns when voting against the TikTok ban. McGovern believes Biosecure was rushed and doesn’t include strong rationale for why certain companies were added. “If there’s a bill that comes to the floor and it’s anti-China, then they automatically vote for it with very few questions asked,” McGovern said. “I understand where they’re coming from, but I think it’s important that the legislation we pass be good legislation.” BGI, one of the five companies named in Biosecure, has allegedly conducted research alongside the Chinese military. WuXi AppTec, another firm in the bill, has been accused of sharing a US client’s intellectual property with the Chinese government without permission. The companies have denied the accusations. The inclusion of WuXi AppTec’s sister company, WuXi Biologics, has troubled McGovern. He said a review of classified materials and conversations with administration officials didn’t make a clear case for targeting the company. “I asked them, basically, ‘Am I crazy? Is this company a really bad actor and I just don’t know?’” he said. In February, the House Select Committee on the Chinese Communist Party asked the Defense, Commerce and Treasury departments to investigate WuXi Biologics and WuXi AppTec. The leaders of the committee said then that WuXi Biologics closely works with the Chinese government, including to reduce the country’s foreign reliance on biomedicine. WuXi Biologics has stated that it does not pose a threat to national security. The company did not respond to a request for comment. Other members of Congress have walked away from classified briefings with a very different interpretation than McGovern’s. Rep. Brad Wenstrup (R-OH) said the ties between the companies named in Biosecure and the Chinese government could one day lead to bioweapons that are used against Americans. “If what he’s waiting for is them to be guilty of creating something that kills Americans because of the data they’ve been able to collect, I think that’s a bad idea,” Wenstrup said in an interview with Endpoints. Before Biosecure came up for a House vote, McGovern shared his concerns with the bill’s authors. He was coming from a place of influence: McGovern chairs the powerful House Rules Committee, which plays a role in setting the legislative agenda. What McGovern deemed productive conversations didn’t result in bill changes, he said, and to his surprise, House leadership placed Biosecure on the suspension calendar. That meant the bill couldn’t be amended on the floor and needed a two-thirds majority to pass. McGovern called up legislators and urged them to vote “no.” He failed. The House voted 306-81 in favor of the bill, though he convinced influential Democrats like Reps. Hakeem Jeffries, Katherine Clark and Jamie Raskin to vote against it. Their offices did not respond to requests for comment. McGovern believes he could have swung the vote against the bill if given extra time. “It was rushed to the floor,” McGovern said. “Most of the people I talked to ended up voting ‘no,’ and I think more would have if there was more time.” The Select Committee on the Chinese Communist Party disagrees with his assessment. A committee spokesperson said the bill enjoys bipartisan support and was the result of months of “careful consideration and investigation.” But McGovern’s ability to court big-name Democrats in the House could make the bill’s already complicated path in the Senate even tougher. Sen. Rand Paul (R-KY), who voiced concerns over trade isolationism when casting the lone vote against a Senate committee version of the bill, has pledged to block quick passage of the legislation . His office did not respond to a request for comment. “Even before the House floor vote, it was always questionable what the path forward for this bill was in the Senate,” said Stephen Rademaker, an attorney with Covington & Burling who specializes in international policy. If not a standalone bill, senators could potentially add Biosecure to the annual defense policy bill. McGovern said he’s talking with representatives and senators about amending the bill. He wants to bolster the criteria for which companies are included, notably by working more closely with federal agencies to determine if a company is a bad actor. “I would prefer to go back to the drawing board and start again,” McGovern said.

MultiCare Health System Successfully Leverages Xsolis' Dragonfly to Streamline Operational and Clinical Workflows, Cut Case Review Times by Half and Strengthen Relations with Payers to Provide Better Care Coordination for Patients FRANKLIN, Tenn., Sept. 17, 2024 /PRNewswire/ -- Xsolis, an AI-driven technology company that reduces administrative tasks and avoidable denials, and improves collaboration between healthcare providers and payers, announced today the official launch of Dragonfly®, a first-of-its-kind, next generation AI-powered platform, utilized by health systems and health plans to drive operational and clinical efficiencies and improve patient care management. The official launch of Dragonfly coincides with Xsolis' annual conference, XCHANGE '24, taking place in Nashville, September 29 - October 2, which brings together healthcare industry executives as well as utilization management, care coordination, revenue cycle, and health plan leaders. MultiCare Health System, a leading healthcare system in Washington State, has successfully leveraged Dragonfly's AI insights to gain essential operational and clinical efficiencies, cutting case review times by as much as half. "Xsolis' AI technologies enable our clinicians to work more efficiently and accurately while bringing our payers to the table as partners for better decision-making, which has saved MultiCare more than $8 million in just the past year," said Debbie Schardt, assistant vice president of revenue cycle and utilization management with MultiCare Health System. "Dragonfly elevates our user experience by reducing administrative tasks, ensuring more appropriate reimbursement and increased compliance, while reducing avoidable denials." Dragonfly synthesizes clinical and financial data from the EMR to create a real-time clinical profile of the patient. Through machine learning, Xsolis' AI continuously generates highly precise predictive analytics that determine the level and setting of care that is most appropriate for the patient. Dragonfly's highly extensible architecture results in an improved user experience for payers and providers that: Enables the use of Generative AI to support nurses and caregivers by removing redundant tasks Facilitates deeper collaboration among healthcare stakeholders by enabling interoperability and data sharing between the platform and other native systems Provides AI-driven length of stay management "We are thrilled to announce the official launch of the Dragonfly platform to better empower health systems and health plans to align on medical necessity and care transition decisions earlier in the process," said Joan Butters, co-founder and CEO of Xsolis. "Dragonfly takes productivity to the next level and represents our commitment to streamline the industry's friction points – reducing unnecessary and crippling administrative waste to create a healthcare industry that is more sustainable for the future." As a pioneer in the practical, effective application of AI in healthcare, Xsolis has been helping its clients make more informed decisions related to medical necessity and patient throughput since 2013. This includes the company's proprietary Care Level Score™, which allows providers and health plans to discern which cases need to be handled immediately so they can focus on the right cases at the right time using predictive analytics and machine learning. Xsolis' Care Level Score is in use by more than 500 hospitals nationwide, with two-thirds having shared access with their networked health plans. To date, Xsolis has generated more than 2.7 billion predictions to drive improvements in level of care authorizations, length-of-stay management, and to reduce avoidable denials. For more information on the Dragonfly platform, visit . For more information on Xsolis' XCHANGE '24, visit . About Xsolis Xsolis is an AI-driven technology company with a human-centered approach, fostering collaboration between health systems and health plans through real-time transparency, objective data for increased accuracy and alignment of medical necessity decisions, and more efficient outcomes. Dragonfly®, its AI-driven proprietary platform, is the first and only solution to use real-time predictive analytics to continuously assign an objective medical necessity score and assess the anticipated level of care for every patient, enabling more efficiency across the healthcare system. Xsolis is headquartered in Franklin, Tennessee. For more information, visit . SOURCE Xsolis WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pictured: NK cells attacking a cancer cell/ selvanegra for iStock When the first CAR T cell therapy was approved by the FDA in 2017, it was heralded as a breakthrough in cancer treatment. The approach allowed for a targeted attack on cancer cells using a patient’s own immune cells, as compared with the broad-strokes assault levied by traditional treatments such as chemotherapy and radiation. While a total of six CAR-Ts have been approved to date, the approach works only for a subset of patients, has shown promise mainly for blood cancers and has notable side effects. To overcome these shortcomings, many researchers and biotech companies have turned their attention to natural killer (NK) cells, which are a part of the innate immune response—the body’s first line of defense against any infection. Historically, NK cells have been notoriously difficult to culture, leading them to be overlooked, said Alicja Copik, associate professor of medicine and core scientist at the University of Central Florida. “Better understanding of how to grow [NK cells] in the laboratory has led to an immense research interest in these cells,” she told BioSpace. “A decade ago, just one company was looking at NK cells. Now, several groups are exploring different ways to use them as cell therapies.” Overcoming CAR-T’s Challenges CAR-T therapies involve reengineering T cells, typically derived from the patient. Once isolated, these cells are genetically modified to express chimeric antigen receptors (CARs) on their surface, arming them to better recognize and attack cancer cells. However, CAR-Ts have been shown to cause several side effects, including cytokine release syndrome, neurotoxicity and blood disorders such as anemia and thrombocytopenia. In terms of allogeneic CAR-Ts, where donor T cells are used, there is the risk of graft-versus-host disease, a strong immune reaction that leads to a rejection of the transplanted cells. “T cells with CARs can go crazy and grow uncontrollably, which leads to some of the major side effects,” said Sumiti Jain, chief scientific officer of ImmuneBridge, a San Francisco–based biotech startup that raised $12 million in seed funding in 2023 to develop NK cells from the umbilical cord. NK cell–based therapies do not cause cytokine release syndrome and neurotoxicity because “they don’t grow as robustly,” Jain said. CAR-Ts have also been associated with secondary malignancies such as leukemias, skin cancers and T cell non-Hodgkin lymphomas. Noting this potential side effect, the FDA recently announced that it will require an update to the boxed warnings of CAR T cell therapies, alerting patients and prescribers to a heightened risk of secondary T cell malignancies. Furthermore, David Shook, chief medical officer of Nkarta, which is developing allogeneic CAR-NK cells, told BioSpace that CAR T cell therapies, despite their benefits, have remained largely inaccessible to patients due partly to a “cumbersome” manufacturing process. The process of isolating and engineering a patient’s T cells takes over two weeks before the cells can be infused back into the patient. “There are patients who are eligible for CAR-Ts and are on the waitlist but are not able to access them because of manufacturing constraints,” Shook said. Advantages of NK Cell Therapy Ann Cheung, chief scientific officer and head of R&D at Dragonfly Therapeutics, which is developing NK cell–stimulating antibodies, noted that, unlike CAR-T therapies, NK cell therapies do not require patients to undergo lymphodepletion chemotherapy with toxic agents such as fludarabine and cyclophosphamide. “Not every patient is eligible for these chemotherapies,” she told BioSpace, because of other immune conditions or a susceptibility to infections. “In that sense, the safety pro NK cell therapies is much better.” Moreover, she said, NK cells work by recognizing multiple antigens, making them strong contenders to destroy cancer cells. NK cell therapies have also shown promise for treating solid cancers, an area where CAR-Ts have largely failed to show benefits, Jain said. “CAR-Ts are amazing for blood cancers, but put them in solid tumors, and they seem to freeze.” NK cells seem to have the ability to migrate into solid tumors better than CAR-Ts, she explained. These characteristics have inspired several biotech and research groups to explore the potential of turning NK cells into therapies. Nkarta is developing CAR-NK cells from a donor-derived pool of NK cells. But after seeing initial success with one candidate, NKX101, an interim evaluation of Phase I data in 14 acute myeloid leukemia patients showed a “meaningfully lower” response rate than in the first six reported patients, causing the company to deprioritize the program. Other companies are moving forward with CAR NK cell therapy candidates. Fate is in Phase I trials with FT522 for B cell lymphoma, and Century has a CD19-targeting therapy, CNTY-101, in Phase I for B cell malignancies. And while some are focused on genetically modifying NK cells to enhance their cancer-fighting abilities, others are harnessing the inherent qualities of NK cells. For example, San Diego–based Artiva Biotherapeutics, in partnership with Merck, is developing a non–genetically modified NK cell therapy that enhances antibody responses to specific cancers and autoimmune diseases. Meanwhile, NKGen Biotech just released interim Phase I data for its allogeneic non–genetically modified NK cell therapy, SNK02, showing that it was well tolerated—all patients completed the eight treatment cycles—and showed signs of clinical activity against pretreated solid tumors. And ImmuneBridge wants to harness the pool of NK cells from hematopoietic stem cells derived from umbilical cords, which Jain said are most likely to show anti-tumor activities against specific cancers. The Road Ahead Despite recent advancements, experts suggest the road ahead for upscaling NK cell therapies may not be straightforward. “NK cells don’t live for very long,” Shook said, so patients may require a high dose and multiple rounds of injections. Jain added that differentiating NK cells derived from donors can exhaust the cells and mellow their potential to be effective cancer killers. “We need durable cell NK therapies,” she said. According to a study of clinical trial data recently published in Nature, the clinical benefits from NK cell–based therapies often lasted only a few months before relapse, likely due to resistance or low NK cell persistence. “NK cell persistence typically ranges from a few days to 4 months, with an average of 7 days,” the authors noted, adding that cryopreservation of NK cells further impacts their ability to grow. While there are currently no FDA-approved NK cell therapies for cancer, Copik is hopeful that some of these therapies will make it to market. “More studies are showing us that the NK cell therapies are effective and have better safety profiles compared to CAR-Ts,” she said. Jain holds a similar view. “Patients are battling every day. Having a new therapy that is readily accessible will be a huge advancement.” Aayushi Pratap is a New York-based health and science journalist and an alum of Columbia Journalism School. Reach her on LinkedIn.