Bristol Myers Squibb, in a bold move unveiled during an R&D Day event, has pruned its development portfolio by axing two mid-stage and shelving four early-stage clinical projects, citing efficacy and safety concerns as the driving force behind these decisions.
One of the casualties in the Phase II category is an experimental therapy targeting heat shock protein 47 (HSP47), using small interfering RNA (siRNA) to combat nonalcoholic steatohepatitis (NASH). This asset, originally licensed from Nitto Denko for a staggering $100 million upfront in 2016, aimed to curtail the excessive collagen buildup seen in NASH, a severe form of fatty liver disease. However, after an unsatisfactory Phase II trial involving 61 patients with post-hepatitis C infection liver scarring, where neither dosage outperformed a placebo, BMS has pulled the plug.
Meanwhile, the decision to halt this siRNA project coincides with Madrigal Pharmaceuticals’ thrilling news of FDA priority review for its NASH treatment, resmetirom, further intensifying the competition in the NASH arena.
BMS also decided to halt an anti-TIGIT solid tumor program, focusing on the efficacy of an antibody in non-small cell lung cancer (NSCLC). NSCLC, known for its resistance to traditional treatments, had a clinical trial that only enrolled one patient before it was terminated, with BMS attributing it to ‘safety reasons’ and an ‘adverse change in the risk/benefit’ ratio.
However, in the midst of these cutbacks, BMS is pressing ahead with an early-stage bispecific anti-TIGIT therapy, showing resilience in the face of Roche’s Genentech’s Phase III setbacks in the same arena. Recent, albeit preliminary, data from Genentech have injected fresh hope into anti-TIGIT therapies for NSCLC.
Notably, the pharmaceutical landscape has seen its share of ups and downs in the anti-TIGIT space, with Novartis ending its collaboration with BeiGene for the option rights to ociperlimab, an anti-TIGIT checkpoint inhibitor, after just two years.
On the early-stage front, BMS also waved goodbye to four clinical programs, including a CD47xCD20 bispecific initiative and a novel approach using molecular glue for acute myeloid leukemia. Additionally, a receptor-protein kinase 1 (RIPK1) inhibitor, once considered for autoimmune disease treatment, met a similar fate.
Despite these cutbacks, Bristol Myers Squibb remains steadfast in its pursuit of expansion, aiming to increase its registrational assets from six to 12 in the next 18 months. These include innovative therapies ranging from CD19-directed NEX T cell therapy to promising options in cancer treatment and autoimmune diseases.
CMO Samit Hirawat emphasized, ‘Our integrated approach to R&D will allow us to maximize innovation and deliver breakthrough medicines to patients more rapidly than ever before.’