Pharmaceutical Companies Refocus Clinical Pipelines Amid Financial Constraints

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Pharmaceutical Companies Refocus Clinical Pipelines Amid Financial Constraints

Century, Candel, and MacroGenics Adjust Trial Strategies

In a series of strategic moves aimed at conserving cash and optimizing resources, three prominent biotech companies—Century Therapeutics, Candel Therapeutics, and MacroGenics—have announced significant changes to their clinical pipelines. These decisions, disclosed in their respective third-quarter earnings releases, reflect the ongoing challenges faced by pharmaceutical firms in balancing innovative research with financial sustainability.

Century Therapeutics Discontinues CALiPSO-1 Trial

Century Therapeutics has made the decision to halt its CALiPSO-1 trial, which was evaluating the allogeneic cell therapy CNTY-101 in patients with B cell-mediated autoimmune diseases. Despite enrolling five patients and observing a "favorable safety profile" with no dose-limiting toxicities, the company has opted to discontinue the study as part of its clinical development re-prioritization efforts.

The limited data collected thus far has shown "encouraging clinical activity in refractory patient populations," according to Century. However, the company will now focus its resources on the ongoing phase 1/2 Caramel trial, which is also assessing CNTY-101 for B-cell-mediated autoimmune disease.

Candel Therapeutics Pauses Pancreatic Cancer Program

Candel Therapeutics has announced a pause in the development of CAN-2409 (aglatimagene besadenovec), its off-the-shelf adenovirus immunotherapy, for borderline resectable pancreatic cancer (PDAC). This decision comes despite the FDA's previous grant of fast track and orphan drug designations for CAN-2409 in this indication.

The company cited the need to concentrate on its top priorities for CAN-2409, namely prostate cancer and non-small cell lung cancer (NSCLC). CAN-2409 has already completed a phase 3 trial in prostate cancer, and a midstage study in NSCLC is scheduled to begin in the second quarter of 2026.

Candel has stated that it will only resume the PDAC program if it can secure "external, non-dilutive funding," emphasizing the financial considerations behind this strategic shift.

MacroGenics Realigns Pipeline Priorities

MacroGenics has decided to "realign" its pipeline priorities regarding lorigerlimab, a bispecific DART molecule targeting both PD-1 and CTLA-4. The company had been conducting a phase 2 study of lorigerlimab in 150 patients with metastatic castration-resistant prostate cancer.

After reviewing interim data from the study, MacroGenics has chosen not to pursue further development of lorigerlimab in prostate cancer. However, the company remains committed to exploring the drug's potential in ovarian and other gynecologic cancers, continuing enrollment in the phase 2 LINNET study.

These strategic decisions by Century, Candel, and MacroGenics underscore the complex landscape of pharmaceutical development, where promising therapies must be balanced against financial realities and the need to focus resources on the most promising avenues of research.

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