Editors' (re)View: Exploring cell therapy in autoimmune disease; AbbVie on the hunt

Dec. 8, 2023
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of December 4

Exploring cell therapy’s potential in autoimmune disease

This week, as we anxiously await the FDA’s thumbs-up/thumbs-down on exa-cel, Switzerland-based CRISPR Therapeutics made other moves in the world of cell therapy.

Earlier this week, CRISPR shared that it is switching up its cell therapy plans, venturing into autoimmune disorders. Specifically, the biotech announced that it is expanding the evaluation of its allogeneic CAR-T candidate, CTX112, beyond oncology into autoimmune diseases. According to CRISPR, early clinical studies have shown that CD19-directed autologous CAR-T therapy can produce long-lasting remissions in multiple autoimmune indications.

Last fall, a paper in Nature made waves in the autoimmune space when it detailed how five patients with lupus enrolled in a compassionate-use CAR T-cell program achieved remission after three months.

CRISPR thinks CTX112 has the potential to provide similar results with several advantages, including greater scalability, lower cost of goods, and no patient apheresis. The biotech plans to initiate a clinical trial in systemic lupus erythematosus in the first half of 2024, with the potential to expand into additional autoimmune indications in the future.

The move could be lucrative for CRISPR from a business perspective. Whereas the patient population eligible for a gene-editing treatment for diseases such as sickle cell is limited, the autoimmunity sector includes more than 80 disorders affecting more than 20 million people in the U.S.

More importantly, if cell therapies prove to have a curative effect on autoimmune disease, it could represent a paradigm shift for cell therapy treatments. —Karen Langhauser

AbbVie on the hunt

This week, we reported that AbbVie is set to acquire Cerevel Therapeutics in a $8.7 billion deal, strengthening its position in the neuroscience sector with a focus on psychiatric and neurological disorders.

Cerevel's assets include emraclidine, a positive allosteric modulator in phase 2 trials for schizophrenia, and a pipeline featuring tavapadon for Parkinson's disease, CVL-354 for major depressive disorder, and darigabat for treatment-resistant epilepsy and panic disorder.

The acquisition is expected to be finalized by mid-2024, contingent on regulatory approvals and shareholder consent.

Unlike other drugs of its kind, emraclidine possesses M4 receptor subtypes that are selectively expressed in the striatum, a subcortical region of the brain located near the center. The activation of these receptors has been shown to indirectly regulate dopamine levels without blocking D2/D3 receptors. This differentiation is essential, as it helps prevent the undesirable motor side effects commonly associated with current antipsychotics.

This marks the second recent acquisition for AbbVie, after recently announcing a $10.1 billion purchase of ImmunoGen, marking an entry into the ovarian cancer space and giving AbbVie access to ImmunoGen's promising next-generation ADC pipeline with transformative potential across solid tumors and hematologic malignancies.

While the ink is still drying on these year-end transactions, 2024 is looking strong for AbbVie. — Andrea Corona



About the Author

Andrea Corona | Senior Editor

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Formerly the editor-in-chief of Food Manufacturing magazine, Karen was particularly successful at eating all of the snacks that were mailed to her from food companies, as well as reaching readers by establishing her own unique voice and tone on the brand. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing.

As an award-winning journalist with 20+ years experience in the manufacturing space, Karen passionately believes that B2B content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'