Autolus Therapeutics Plc is a biopharmaceutical company, which engages in the development and commercialization of gene therapies. It uses proprietary and modular T cell programming technologies that are designed to recognize cancer cells, break down their defense mechanisms, and attack and kill these cells. The company was founded by Martin Pule in September 2014 and is headquartered in London, the United Kingdom.
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2014
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- Autolus Therapeutics received the 2026 Prix Galien UK Award for Best Biotechnology Product from the Galien Foundation. - The award was selected by a UK Awards Committee comprising 12 leading experts in UK healthcare. - Dr. Martin Pule, Founder and CSO of Autolus, highlighted the company's collaboration with University College London in translating pioneering research into new treatments. - The Prix Galien is widely regarded as the equivalent of the Nobel Prize in biopharmaceutical research, recognizing excellence in scientific innovation.
- Asgard Therapeutics has appointed Professor Dr. Wolfram Brugger as Chief Medical Officer to lead the clinical development of AT-108, a first-in-class gene therapy. - AT-108 represents a breakthrough "personalized off-the-shelf" immunotherapy that reprograms tumor cells into dendritic cells to trigger personalized immune responses against cancer. - Dr. Brugger brings extensive experience from over 130 Phase I-III oncology trials and successful drug development programs at AstraZeneca, MorphoSys, and Autolus Therapeutics. - The company is currently advancing IND-enabling studies for AT-108, with key proof-of-concept data published in Science journal in 2024.
- Autolus presented updated data from the CARLYSLE trial showing obe-cel achieved 83% DORIS response rates in severe refractory systemic lupus erythematosus patients with deep B-cell depletion and no high-grade toxicities. - The CATULUS pediatric trial demonstrated a 95.5% overall response rate in high-risk relapsed/refractory B-ALL patients, with low rates of severe cytokine release syndrome and neurotoxicity. - Post-hoc analyses from the FELIX study identified CAR-T persistence at three months and central memory cell composition as potential predictors of long-term outcomes in adult B-ALL patients.
- The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending AUCATZYL (obecabtagene autoleucel) for use in the NHS as a treatment option for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. - AUCATZYL will be available through routine commissioning by the NHS, with Autolus Therapeutics planning an imminent launch in England and Wales following MHRA conditional marketing authorization in April 2025. - The recommendation is based on results from the FELIX study, an open-label, multi-center, single-arm study published in the New England Journal of Medicine in November 2024. - Patient advocacy organizations including Anthony Nolan, Leukaemia UK, and Leukaemia Care welcomed the decision as an important step toward expanding treatment options for this aggressive disease with poor prognosis.
- The NHS has approved obe-cel, a personalized CAR-T cell therapy that achieved 77% remission rates in clinical trials for patients with relapsed or refractory B-cell acute lymphoblastic leukemia. - The treatment involves reprogramming patients' immune cells to target cancer and demonstrated lower toxicity compared to other CAR-T therapies, with half of patients showing no detectable cancer after 3.5 years. - Developed by UK-based Autolus Therapeutics, the therapy will be available within weeks at specialist centers for patients aged 26 and over, potentially treating around 50 patients annually in England.
- Autolus Therapeutics has dosed the first patient in its Phase 1 BOBCAT trial evaluating obecabtagene autoleucel (obe-cel) for progressive multiple sclerosis, marking a significant milestone in CAR-T therapy expansion beyond oncology. - The trial will enroll up to 18 adult patients with refractory progressive MS to assess safety, tolerability, and preliminary efficacy of the CD19-directed CAR-T therapy. - Obe-cel features a unique fast target binding off-rate mechanism designed to minimize excessive T cell activation and has been studied in over 400 patients with a well-characterized safety profile. - Progressive MS affects approximately 300,000 individuals in the US, with more than half experiencing disability progression despite current disease-modifying treatments, representing a significant unmet medical need.
- ArriVent BioPharma has appointed Brent S. Rice as Chief Commercial Officer, bringing over 25 years of biotechnology and pharmaceutical commercial experience to the clinical-stage company. - Rice previously served as global Chief Commercial Officer at Autolus Therapeutics, where he successfully transitioned the company from clinical-stage to commercial operations and led the launch of their first commercial product. - The appointment comes as ArriVent's lead candidate firmonertinib approaches potential approval for EGFR mutant non-small cell lung cancer, with the company also developing a pipeline of antibody drug conjugates. - Rice's expertise in launching novel therapies and building commercial organizations positions ArriVent for success as it prepares for potential product commercialization in oncology markets.
- Autolus Therapeutics will present updated data from the Phase I CARLYSLE study of obecabtagene autoleucel (obe-cel) in severe refractory systemic lupus erythematosus at ACR Convergence 2025. - Initial findings show a manageable safety profile with no dose limiting toxicities, immune effector cell-associated neurotoxicity syndrome, or Grade ≥2 cytokine release syndrome reported. - All patients demonstrated SLEDAI-2K score reduction and clinical benefit, with three patients achieving complete renal response. - The study represents one of the first attempts to apply CAR-T cell therapy to treat systemic lupus erythematosus, a chronic autoimmune disease with limited treatment options.
- BioNTech will lay off 63 employees and wind down cell therapy manufacturing at its Gaithersburg, Maryland facility by the end of 2025 following disappointing Phase 1 trial results. - The company discontinued development of its CAR-T candidate BNT211 targeting CLDN6 in testicular cancer and germ cell tumors due to insufficient efficacy data. - Despite the setback, BioNTech continues studying BNT211 in other CLDN6-expressing cancers including ovarian, sarcoma, endometrial, and gastric cancers. - The facility closure is part of broader oncology pipeline restructuring as BioNTech realigns resources and reduces global workforce by up to 1,350 jobs by 2027.
- AstraZeneca's surovatamig demonstrated promising efficacy in the Phase I/II SYRUS trial, achieving complete remission rates of 46%, 58%, and 83% at dose levels 1, 2, and 3 respectively in patients with relapsed/refractory B-cell acute lymphoblastic leukemia. - The next-generation CD19xCD3 bispecific T-cell engager showed a manageable safety profile with cytokine release syndrome occurring in 31% of patients at dose level 1, and no patients discontinued treatment due to drug-related adverse events. - Surovatamig's Fc-engineered design enables intermittent dosing and controlled T-cell activation, offering a potentially more convenient alternative to Blincyto's continuous infusion requirement. - Despite promising results, surovatamig faces significant market competition with projected global sales of $138 million by 2031 compared to Blincyto's $1.7 billion, though Blincyto's patent expiry may create opportunities.
