Behind the Headlines: What the U.S. Election Results Mean for Industry, In Vivo CAR-T Applications, and more

Behind the Headlines is a bi-weekly panel discussion examining the latesttrends, readouts, and other factors that drive pharmaceutical news and innovation.Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seekingto highlight the more enduring lessons that hide behind the headlines.

In episode 6, Brian Feth, CEO atXcell Biosciences, and Jonathan Grinstein, North American Editor, Inside Precision Medicine, go behind the headlines to understand how a recently elected Republican administration in the U.S. might spur investment into the biopharmaceutical industry, particularly through tax breaks and loosening of certain regulations. They also discuss how stem cell research might be slowed and how nontraditional leadership of HHS might influence vaccine policy and pandemic preparedness.

In other news, the panel discussed the FDA approval of Autolus Therapeutics' obecabtagene autoleucel (Aucatzyl) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) (1). This autologous CAR T-cell therapy, targeting CD19-positive B-cells, has shown promising results in the FELIX trial, with a notable complete remission rate. However, in line with FDA’s current warnings for treatment-related secondary cancer, “The approval includes a boxed warning for risks of cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), and potential T-cell malignancies.”(1) The panel also noted Autolus’ other updates, including the first dosing of patients in their phase 1 CARLYSLE trial of obecabtagene autoleucel in refractory systemic lupus erythematosus (SLE)(2).

Sticking to CAR-T breakthroughs for B-cell abnormalities, the panel also pointed out that Interius BioTherapeutics dosed the first-ever patient with an in vivo CAR gene therapy for the treatment of B-cell malignancies. This is a possible game-changer for advanced therapies as in vivo therapies remove many of the lengthy and expensive manufacturing steps currently required for cell and gene therapies. Interius president and CEO, Phil Johnson, MD, said, “This milestone marks the first time that a durable in vivo CAR therapy has been used in the clinic. INT2104 has the potential to overcome ex vivo CAR therapy challenges with a single-dose, off-the-shelf, widely accessible therapy for the treatment of B cell malignancies enabled by Interius’ programmable platform.” (3)

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References

1. FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. FDA. November 8, 2024. Accessed November 8, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute

2. Autolus Therapeutics reports third quarter 2024 financial results and business updates. Press release. Autolus Therapeutics. November 12, 2024. https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-reports-third-quarter-2024-financial

3. Interius BioTherapeutics doses first patient with in vivo chimeric antigen receptor (CAR) gene therapy for B-cell malignancies. Press release. Interius BioTherapeutics. October 23, 2024. https://interiusbio.com/2024/10/interius-biotherapeutics-doses-first-patient-with-in-vivo-chimeric-antigen-receptor-car-gene-therapy-for-b-cell-malignancies/