Brexucabtagene Autoleucel

Bengaluru: Gilead Sciences ' unit Kite Pharma said on Thursday it will acquire privately-held biotech firm Interius BioTherapeutics for $350 million in cash to advance CAR T-cell cancer therapies that are delivered directly into patients. WHY IT'S IMPORTANT The acquisition will enable Kite to use Interius' platform to deliver cell therapy directly into patients, simplifying treatment processes and reducing costs, the company said. BY THE NUMBERS Kite said the deal, expected to close pending regulatory approvals, will reduce Gilead's 2025 profit per share by about 23 cents to 25 cents. CONTEXT In CAR T-cell therapy , a patient's T-cells, a key part of the immune system, are modified to better recognize and attack cancer cells. Traditional CAR T-cell therapies, including Kite's approved blood cancer treatments Yescarta and Tecartus, involve taking immune cells from a patient. These are modified in a lab, and then put back into the patient's body - a process that is both complex and expensive. Interius' so-called "in-vivo" approach uses intravenous infusion to deliver DNA directly into cells, potentially accelerating and simplifying treatments, according to the Kite. Interest in in-vivo CAR T-cell platforms has surged, with over $2 billion invested and multiple partnerships formed recently, according to a report by clinical research firm Novotech. The report noted that more than five in-vivo CAR T-cell programs have entered clinical trials, and disclosed assets are expected to surpass 100 by the end of 2025. WHAT'S NEXT After the deal is approved, Interius' operations will merge with Kite's research team in Philadelphia, the Gilead unit added. (Reporting by Siddhi Mahatole in Bengaluru, additional reporting by Sneha S K; Editing by Leroy Leo)

Analysis by GlobalData indicates that in vivo CAR-T therapies sidestep many of the drawbacks seen in ex vivo counterparts. Credit: Michael Vi via Shutterstock.com. Gilead is soaring to new heights in the CAR-T therapeutics sector, acquiring in vivo cell therapy specialist Interius BioTherapeutics via its subsidiary Kite for $350m. The deal will integrate Interius’ in vivo platform into Kite’s existing cell therapy framework, along with the uniting of research teams. The end goal is to generate CAR T-cells directly within the patient’s body, an approach that may “offer a more durable and long-lasting therapeutic effect”, according to Kite. Gilead acquired Kite for $11.9bn in 2017, and it operates as the big pharma’s cell therapy subsidiary. By inserting DNA into a patient’s genome, unlike traditional CAR-T approaches in which cells are infused back into the blood, Interius aims to deliver therapy via a single intravenous infusion. Kite said that this has the added benefit of eliminating the need for preconditioning chemotherapy and complex cell processing. Gilead is eying the technology to improve upon its two US Food and Drug Administration (FDA) approved CAR-Ts for types of blood cancer — Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). These are traditional ex vivo therapies that require cell harvesting, engineering and reinfusion – the steps that Interius seeks to eliminate. “In vivo therapy is a promising frontier with the potential to transform how we approach treating patients, shifting to more accessible and scalable solutions,” said Cindy Perettie, Kite’s executive vice-president. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Analysis by GlobalData indicates that in vivo CAR-T therapies sidestep many of the drawbacks seen in ex vivo counterparts. Though warns that one concern is the inability to quality check before dosing, adding that more clinical data is needed to demonstrate safety. Gilead is not the only big pharma company enticed by CAR-T-centric acquisitions so far this year. AbbVie bought CAR-T developer Capstan Therapeutics for $2.1bn in July while AstraZeneca spent $425m to acquire Belgium-based EsoBiotec in March. The deal for AstraZeneca comes a year and a half after it acquired Chinese CAR-T biotech Gracell for $1.2bn in December 2023. For Interius, the deal marks a successful validation of its clinical activities. It was the first biotech to progress an in vivo CAR-T therapy into clinical trials. Its B-cell malignancy treatment candidate, called INT2104, entered a Phase I trial (NCT06539338) in October 2024. Despite being armed with Interius’ innovative platform, Kite will have to navigate a currently volatile cell and gene sector in the US. Vinay Prasad, director at the FDA’s Center for Biologics Evaluation and Research (CBER) – the department responsible for regulating cell and gene therapies, stepped down from his role in July only to return to his job two weeks later. Prasad has been against the use of surrogate endpoints as evidence for accelerated approvals in the cell and gene therapy sector, leading to uncertainty in the field for biotechs using this approach in clinical trials. Surrogate endpoints, such as overall response rate (ORR) and progression-free survival (PFS), are frequently used in CAR-T therapy trials to accelerate evaluation. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic You have a right to withdraw your consent at any time, by clicking here . We may still continue to send you service-related and other non-promotional communications. For more information relating to our privacy practices, we invite you to review our privacy policy . 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