Category: CAR-T therapies

  • Bayer bails on $670m CAR-T partnership with Atara

    In February, Atara Biotherapeutics paused enrolment into a trial of a CAR-T cell therapy for mesothelioma after a patient death. Now, its partner Bayer has backed out of a partnership covering two mesothelin-directed CAR-Ts signed in 2020. Bayer licensed rights to the two CAR-Ts in a deal worth up to $670 million, including $60 million […]

  • Kymriah is first CAR-T cleared for follicular lymphoma in EU

    Novartis’ CAR-T Kymriah has become the first therapy in the category to be approved for the treatment of relapsed/refractory follicular lymphoma, ahead of Gilead Sciences’ rival Yescarta. Follicular lymphoma is the second most common form of non-Hodgkin lymphoma (NHL), and is a slow developing but incurable disease that represents around 22% of NHL cases. With […]

  • Implants could transform CAR-T therapy into one-day procedure

    CAR-T therapies have revolutionised the treatment of some blood cancers, but are costly as well as time- and resource-intensive. Now, US researchers think one solution could be an implant that generates T cells within the body to attack the cancer. It is early days for the concept, but its developers – from North Carolina State […]

  • AACR: BioNTech finds value in CAR-T/mRNA vaccine combo

    Adding an mRNA vaccine to CAR-T cell therapy could be the key to unlocking activity in solid tumours, according to German biotech BioNTech. CAR-Ts have revolutionised the treatment of some blood cancers like B cell lymphomas, but have been largely unsuccessful at targeting solid tumours, in part as the cells do not penetrate tumour tissue […]

  • Gilead beats BMS to FDA okay for early lymphoma CAR-T therapy

    Gilead Sciences’ Kite Pharma has become the first drugmaker to get FDA approval to use a CAR-T therapy after just one earlier systemic therapy, moving the approach up the treatment pathway. The US regulator has cleared Kite’s CD19-targeted CAR-T Yescarta (axicabtagene ciloleucel) for people with large B-cell lymphoma (LBCL) refractory to one earlier therapy, or […]

  • CHMP backs J&J’s myeloma CAR-T therapy Carvykti

    Johnson & Johnson is in course for approval of its multiple myeloma CAR-T therapy Carvykti in the EU the next few weeks, after getting a green light from the EMA’s human medicines committee. The CHMP recommended conditional approval for Carvykti (ciltacabtagene autoleucel or cilta-cel) as a treatment for adults with relapsed and refractory multiple myeloma […]

  • Janssen, Legend CAR-T therapy CARVYKTI gets FDA nod

    The US Food and Drug Administration (FDA) has approved a new cell-based therapy for blood cancer, developed by Janssen and China’s Legend Biotech to treat multiple myeloma. CARVYKTI (ciltacabtagene autoleucel), formerly known as cilta-cel, is chimeric antigen receptor T-cell (CAR-T) therapy indicated for the treatment of adults with relapsed or refractory multiple myeloma who have […]

  • ASH: Trial backs Gilead’s Yescarta CAR-T in first-line lymphoma

    Gilead Sciences has taken a big step towards positioning its CAR-T therapy Yescarta as an option for previously-untreated large B cell lymphoma (LBCL) with updated results from the ZUMA-12 trial at the ASH congress this week. The phase 2 trial showed that 78% of high-risk LBCL patients treated first-line with Yescarta (axicabtagene ciloleucel) had a […]

  • Blackstone revs up Autolus’ CAR with $250m fuel injection

    Private equity firm Blackstone has agreed to provide up to $250 million in financing to UK biotech Autolus Therapeutics, to help it take acute lymphoblastic leukaemia (ALL) CAR-T therapy obe-cel through late-stage development. The deal includes a $100 million equity stake, $50 million in financing as soon as it closes, and another $100 million on […]

  • UK startup Leucid raises £11.5m for solid tumour CAR-T therapies

    CAR-T therapies have revolutionised the treatment of some blood cancers, but so far haven’t been able to repeat that success in solid tumours. UK startup Leucid Bio hopes to change that – and has just raised £11.5 million in first-round financing to take its plans forward. The London-based biotech has been set up to develop […]

  • Incyte, MorphoSys’ CAR-T rival tafasitamab approved in EU

    Incyte and MorphoSys’ antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for patients with certain types of lymphoma. The European Commission has approved tafasitamab in combination with Bristol-Myers Squibb’s Revlimid (lenalidomide), followed by the antibody on its own, for the treatment of […]

  • Appeals court reverses $1.2bn judgment against Gilead in BMS CAR-T case

    Gilead Sciences’ Kite Pharma has won a key victory on appeal in its long-running dispute with Bristol-Myers Squibb over patents relating to CAR-T therapies, overturning a $1.2 billion fine levied last year. In December 2019, a jury found that Kite infringed on a patent owned by Juno Therapeutics, a division of BMS acquired through its […]

  • Novartis’ bid to extend Kymriah into earlier use hits a roadblock

    Novartis’ CAR-T therapy Kymriah racked up back-to-back approvals in acute lymphoblastic leukaemia and large B-cell lymphoma a few years ago, but hasn’t added to its label since. Now, a bid to move it onto earlier-stage use in lymphoma has ended in failure. In the phase 3 BELINDA trial, Kymriah (tisagenlecleucel) was unable to extend event-free […]

  • BMS will file for earlier-line use of Breyanzi in lymphoma after trial win

    Bristol-Myer Squibb has only just won FDA approval for its CAR-T Breyanzi in large B-cell lymphoma (LBCL), but is already eyeing an expansion into earlier-line therapy that could overtake rival therapies from Novartis and Gilead Sciences. Breyanzi (lisocabtagene maraleucel or liso-cel) was approved in February for use in LBCL patients after two prior systemic therapies, […]

  • ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data

    Novartis’ Kymriah has had the CAR-T therapy market for acute lymphoblastic leukaemia (ALL) to itself so far, but Gilead Sciences’ Kite subsidiary is now looming in the rear view mirror – armed with new data for its already-filed rival Tecartus. Results of the phase 1/2 ZUMA-3 trial of Tecartus (brexucabtagene autoleucel) reported at the ongoing […]

  • FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel

    Johnson & Johnson has secured a six-month FDA review for its multiple myeloma CAR-T therapy ciltacabtagene autoleucel (cilta-cel), narrowing the lead for Bristol-Myers Squibb and bluebird bio’s rival Abecma. The US regulator is now scheduled to complete its review of cilta-cel by 29 November for adults with relapsed and/or refractory multiple myeloma who have previously […]

  • Janssen files its first CAR-T therapy cilta-cel in Europe

    Johnson & Johnson’s Janssen unit has filed for approval of its multiple myeloma CAR-T ciltacabtagene autoleucel in Europe, chasing after a rival therapy from Bristol-Myers Squibb.  The BCMA-targeting CAR-T – also known as cilta-cel – has been filed with the EMA as a treatment for adults with relapsed/refractory multiple myeloma, an incurable form of blood […]

  • BCMA Targeted Therapies Summit

    Built with thought leaders from Seattle Genetics, Precision Biosciences and Kite Pharma, the inaugural industry-focused BCMA Targeted Therapies Summit will share the field’s cutting-edge and aggressive scientific advances of BCMA therapies within multiple myeloma. This summit is the first of its kind, uniting thought leaders in BCMA therapeutics drug development to discuss their challenges and […]