Kite Pharma, Inc.

When Galapagos and Gilead Sciences entered a global drug R&D collaboration six years ago, the deal focused on Galapagos’s capabilities as a developer of small molecule drugs. Fast forward to today, and the strategies and ambitions of both companies are less complementary. Galapagos, no longer interested in developing small molecules, is focusing on cell therapy, an area where Gilead already has a strong presence. Since the 2019 deal, both companies and the biotech industry have evolved, Galapagos CEO Paul Stoffels said during a presentation Wednesday at the annual J.P. Morgan Healthcare Conference. Those changes led to Galapagos’s plans for a business separation, but in a way that does not completely sever ties with Gilead. The planned business separation was announced last week. Legacy Galapagos will focus on developing cancer cell therapies while “SpinCo” will build a drug pipeline spanning oncology, immunology, and virology. Gilead will have an equity stake in both companies. When the deal closes, the terms of the 2019 Gilead collaboration agreement will apply only to SpinCo. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical In the past two years, Galapagos has been executing a strategic pivot to focus on cell therapies, specifically, cell therapies that are made at the point of care. Currently available autologous cell therapies take a month or more to manufacture at a lab far from where a patient is receiving care. These cells are shipped frozen and must be thawed before they can be infused into a patient Galapagos aims to deliver these engineered cells with a seven-day turnaround time made possible with technology that produces the therapies at the point of care and does not require freezing. “Not only does this bring logistical and cost benefits, but also, by providing patients with fit cells, we believe that we are improving efficacy and safety, and providing a solution for all lines of therapy, especially those patients with a very short life expectancy,” Stoffels said. In a separate Gilead briefing with journalists on Wednesday, Gilead Chief Financial Officer Andy Dickinson said Galapagos and Gilead came to the realization that Galapagos management was spending time on the assets it wanted to move forward, which are cell therapies. The business development deals that could expand the company’s pipeline (and be developed and commercialized by Gilead) were not a focus. To achieve that goal, a new company would be needed. The SpinCo transaction is about executing two distinct strategies with the capital that is available, Dickinson said. The new spinoff will have €2.45 billion (about $2.5 billion) from Galapagos to apply toward business deals. The business separation highlights how Galapagos cell therapy strategy diverges from Gilead’s. Yescarta an FDA-approved autologous cell therapy from Gilead, is produced at the site of its Kite subsidiary with a 14-day turnaround time, said Cindy Perettie, executive vice president of Kite. With that speed, Kite isn’t getting into point-of-care manufacturing any time soon, if at all. The turnaround time for the Kite-produced cell therapies is the fastest in the industry, and the company hasn’t needed to move into point-of-care manufacturing, Perettie said. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech Galapagos initially intended for its therapies to be produced at the same hospital where a patient receives care. Stoffels said that strategy has since shifted due to the complexities of making each hospital a GMP manufacturing site. Galapagos is now taking a regional approach to supplying its cell therapies. The company is building or acquiring production sites that will be staffed by Galapagos. So far, Galapagos has five operational and approved manufacturing sites in Europe. In the U.S., a Boston site will serve hospitals in that market; the company is also planning a site for San Francisco. Cell therapies first reached patients as treatments for advanced cases of certain blood cancers. Galapagos’s internal cell therapy pipeline currently spans three programs in clinical development for various blood cancers. In a note sent to investors, Leerink Partners analyst Faisal Khurshid said Galapagos management has emphasized that decentralized manufacturing could make cell therapy more broadly accessible, providing patients with cells that do not have to be frozen. For further differentiation, Galapagos will prioritize indications that do not yet have a CAR T-cell therapy available as a treatment, he said.

Kyverna Therapeutics\' new CEO Warner Biddle has identified stiff person syndrome, a rare autoimmune neurological disorder launched into public attention by Céline Dion\'s diagnosis, as the initial indication for the company\'s lead CAR-T program, KYV-101.\n About 100 days into the CEO role at Kyverna Therapeutics, Warner Biddle has determined the strategic priorities for the California biotech, which aims to deliver the first approved CAR-T therapy in an autoimmune disease.The former Kite Pharma executive has identified stiff person syndrome (SPS), a rare autoimmune neurological disorder launched into public attention by Céline Dion’s diagnosis, as the initial indication for Kyverna’s lead CAR-T program, CD19-directed KYV-101.Lupus, which spurred the industry’s ongoing gold rush for developing cell therapies against autoimmune diseases and originally KYV-101’s first indication, is instead taking the third place on Kyverna’s priority list, as myasthenia gravis occupies the second spot.SPS is “our tip of the spear that will allow us to establish a base as the first autoimmune CAR company,” Biddle said in an interview with Fierce Biotech ahead of this year\'s J.P. Morgan Healthcare Conference. “And then we’ll be able to build on that, and we’ll be able to amplify our presence with another neuroinflammation franchise but with the patient population that’s going to be about 10 times larger than SPS.”The biotech chief will outline his plan in detail during this week\'s conference. Biddle joined Kyverna in September after a stint as the commercial chief at Gilead’s cell therapy arm Kite Pharma. The task in front of him is to blaze a winning trail for a bellwether biotech that has lost nearly 90% in stock price since a high-profile IPO in February 2024.Interest in CAR-T therapies for autoimmune disease exploded last year, following a series of promising results in patients with systemic lupus erythematosus (SLE) from academic studies out of Germany. The enthusiasm led to Kyverna’s upsized IPO in 2024.As one of the first companies to report clinical CAR-T data in lupus, Kyverna’s KYV-101 is considered a benchmark that followers must at least match up to in order to remain in the game. For patients with heavily pretreated lupus nephritis, a single infusion of KYV-101 has shown it could achieve deep B-cell depletion and put an end to disease activity, restoring stable kidney function and normal complement levels, while eliminating the need for immunosuppressants and toxic steroids.But the field is quickly getting crowded. Besides large pharmas such as Bristol Myers Squibb and Novartis, a growing list of biotechs, including the likes of Cabaletta Bio and Cullinan Therapeutics, are eyeing lupus either with CAR therapy or T-cell engagers.And a patient relapse—although from a lower dose of KYV-101—after five months of treatment speaks to the potential challenge and many unknowns of the cell therapy industry’s push into autoimmune diseases. Kyverna is currently finishing enrolling in KYV-101’s phase 1 lupus nephritis trial, with the goal to report data from nine patients—including six at the target dose of 100 million cells—in the second half of 2025, according to Biddle. The phase 1 results will then be used to design the pivotal clinical trial.The company is focusing on lupus nephritis instead of the larger SLE population “because we believe that lupus nephritis patients are at the highest risk of progressing to late-stage renal disease,” he said. Lupus nephritis is a serious complication of SLE, or commonly referred to as lupus. About 40% of lupus patients could develop nephritis, and 60% of them are expected to fail standard treatments, according to Kyverna.“We’re not moving away from lupus,” Biddle said. “It’s still a key priority for us.”As the red-hot lupus indication is already full of competition, with different programs likely fighting over trial participants, Biddle has decided to use SPS as an entry point.SPS is a progressive disorder marked by debilitating muscle stiffness in the torso, arms and legs with no approved therapies. The rare disease gained wider public knowledge after Céline Dion’s diagnosis and her comeback performance at the 2024 Paris Olympics opening ceremony.Because there’s a significant unmet need and patients experience deteriorating symptoms over a short period of time, Kyverna believes it can execute on a clinical trial relatively quickly, thereby giving KYV-101 the opportunity to be the first CAR-T to launch in an autoimmune disease, Biddle explained.While a late addition to KYV-101’s clinical program, the phase 2 SPS trial, coded KYSA-8, has already accrued 40% of patients with full enrollment expected mid-2025. Kyverna expects to report top-line data from the pivotal trial in the first half of 2026, followed by an application in 2026. As to myasthenia gravis, for which KYV-101 is undergoing phase 2 testing in the KYSA-6 trial, Kyverna intends to confirm a registrational path with regulators in the first half of 2025 and report interim phase 2 data in the second half of the year.“It’s important for us to be hyper focused in the short term,” Biddle said. “We’re going to be focusing on delivering meaningful short-term catalysts in a capital-efficient way. But there’s still lots of opportunities for growth, and we’re going to use a data-driven approach to prioritize future indications.”Besides those three priority indications, KYV-101 is also being tested in multiple sclerosis and systemic sclerosis. Kyverna in December reported initial data from five patients in the phase 2 KYSA-7 multiple sclerosis study, although it was hard to draw any conclusions on efficacy.The company’s second candidate, KYV-102, is designed to remove the apheresis process in CAR-T manufacturing. Kyverna aims to file for an investigational new drug application in the second half of 2025.With cash runway into 2027, Kyverna is “building the internal expertise in order to deliver these key milestones,” Biddle said, but added that the company is open to partnerships, “if they can add and contribute to the future growth of our company.”

Highly experienced corporate development leader with a track record of international pharma and biotech deal-making New CEO to drive growth strategy to maximise the potential of drug discovery pipeline to treat cancer LONDON, Dec. 16, 2024 /PRNewswire/ -- NeoPhore Limited, a small molecule neoantigen immuno-oncology company, today announces the appointment of Michael Shih as Chief Executive Officer (CEO) and to the Board of Directors, effective immediately. Michael Shih has nearly 20 years of experience in business development, licensing and mergers & acquisitions. Michael was most recently Vice President of Corporate Development at Kite Pharma, where he led multiple business development opportunities for the Company. Before this, Michael was Senior Vice President, Head of Business Development at Biogen, leading the team responsible for sourcing, structuring and executing strategic collaborations and merger and acquisition opportunities. Prior to joining Biogen, Michael was Vice President and Head of Global Transactions at Sanofi, where he oversaw the structuring and negotiation of business development transactions across Sanofi's business units. Michael has also held senior business development roles at Epizyme, Forest Laboratories and Eisai. Robert James, Chairman of the Board, NeoPhore, said: "Michael joins at an exciting stage in NeoPhore's development having raised a significant Series B financing round which was supported by Bristol Myers Squibb. As we move closer to being a clinical Company Michael's experience as a corporate development leader in pharma and biotech will be instrumental in driving NeoPhore's next phase of growth." Michael Shih, newly appointed Chief Executive Officer and Board of Director, NeoPhore commented: "NeoPhore's differentiated approach to targeting the MMR pathway has huge potential to treat cancer. I am looking forward to working with the highly experienced NeoPhore team, who are all clearly aligned to advance the Company's pipeline." An attorney by training, Mr. Shih previously practiced law at several New York firms and held senior legal positions in-house at Eisai Inc., specialising in licensing, corporate transactions, and litigation. NeoPhore is developing a pipeline of highly validated, first-in-class small molecule drugs targeting proteins across the MMR pathway to improve the efficacy and durability of revolutionary immunotherapies to treat cancer. The appointment of Michael Shih as CEO follows the close of the Company's oversubscribed Series B financing. The financing and new appointment of the CEO strengthen NeoPhore's position to drive its growth strategy and maximise the potential of its pipeline. About NeoPhore Ltd NeoPhore, UK is focused on the discovery and development of novel small molecule therapies to treat cancer through stimulation of the immune system. Generation of cancer neoantigens in tumours can be exploited by the patients' immune system to overcome natural defence mechanisms in cancer. The Company's approach targets the DNA mismatch repair (MMR) pathway, which has been proven to promote neoantigen creation and subsequent immunity against numerous cancers. Using these insights, NeoPhore aims to generate next-generation immuno-oncology therapeutics to improve clinical outcomes for cancer patients. NeoPhore was spun-out of the University of Turin and PhoreMost Ltd by the CRT Pioneer Fund. For more information, please visit SOURCE NeoPhore WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED