Bolt Bio Cuts Workforce and CEO; Tenaya Reduces Staff by 20%

Bolt Biotherapeutics and Tenaya Therapeutics have both announced significant workforce reductions as they shift their strategic focus. Bolt Biotherapeutics revealed the most substantial changes, laying off approximately 50% of its staff and reassigning CEO Randall Schatzman and Chief Medical Officer Edith Perez, M.D., to advisory roles. The company is also halting the development of trastuzumab imbotolimod, an immune-stimulating antibody conjugate (ISAC) that had been in trials for HER2-positive cancers.

Bolt had been assessing trastuzumab imbotolimod in a phase 2 study involving patients with colorectal, endometrial, gastroesophageal, or breast cancer. Some breast cancer patients received the drug in combination with Roche’s Perjeta. Phase 1 data presented at the European Society for Medical Oncology Congress in October 2023 indicated a 29% objective response rate, with one complete and three partial responses at the recommended phase 2 dose.

However, a strategic review revealed that the trastuzumab imbotolimod program would not meet its predefined success criteria. Consequently, Bolt will redirect its efforts toward next-generation ISAC programs. This shift will also extend the company’s financial resources into the second half of 2026, allowing for the completion of a phase 1 trial for the Dectin-2 agonist antibody BDC-3042 and the collection of clinical data from BDC-4182, another next-gen ISAC targeting Claudin 18.2.

Newly appointed CEO Willie Quinn emphasized the necessity of focusing limited resources on the most promising product candidates, despite the clinical validation provided by trastuzumab imbotolimod for the ISAC mechanism. This is not the first time Bolt has adjusted its pipeline; in August 2022, the company discontinued an anti-tumor candidate, BDC-2034, due to off-target toxicity concerns.

Meanwhile, Tenaya Therapeutics has also announced workforce reductions as part of its cost-containment measures. The company aims to fund clinical readouts from its two leading heart-focused gene therapies by reducing its workforce by approximately 22%. These changes are expected to be finalized in the coming weeks.

Tenaya CEO Faraz Ali highlighted the company’s commitment to advancing its TN-201 and TN-401 programs. TN-201 is a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy, currently enrolling patients in a phase 1b trial. TN-401 is a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, with patient dosing set to begin in a phase 1 trial in the latter half of the year. Ali stressed the importance of maintaining sufficient resources to achieve key milestones.

In summary, both Bolt Biotherapeutics and Tenaya Therapeutics are undertaking significant restructuring efforts to focus on their most promising programs. Bolt is laying off half of its workforce and halting development of trastuzumab imbotolimod to concentrate on next-generation ISAC programs. Tenaya is reducing its workforce by 22% to ensure the continuation of its key gene therapy programs. These strategic shifts reflect both companies' ongoing efforts to navigate the challenging biotech landscape while aiming to achieve long-term success.