Schrödinger Halts Blood Cancer Drug Development After Patient Deaths

Schrödinger, a New York-based biotech company, has announced the discontinuation of its investigational CDC7 blocker SGR-2921 following two patient deaths in a Phase I dose-escalation study. The drug, which was being tested for relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndromes, showed early evidence of monotherapy activity but was ultimately deemed to have an unfavorable risk/benefit profile.

Impact on Schrödinger and Market Response

The news of SGR-2921's discontinuation has had a significant impact on Schrödinger's stock, which dropped 17.5% before the opening bell on Thursday. Chief Medical Officer Margaret Dugan stated that while the decision is "disappointing," it is "the right decision for patients."

Despite this setback, Schrödinger maintains a diverse oncology portfolio. The company recently released promising initial Phase I data for SGR-1505, a small molecule drug targeting relapsed/refractory B cell malignancies. Additionally, Schrödinger is advancing SGR-3515 for solid tumors, with preclinical data suggesting improved anti-tumor activity compared to previous inhibitors.

Industry-wide Concerns Over Patient Safety

The termination of SGR-2921's development comes amid a series of patient deaths reported in clinical trials across the pharmaceutical industry. Notable cases include:

• Sarepta Therapeutics: Three mortalities associated with its gene therapy portfolio, including two with the Duchenne muscular dystrophy treatment Elevidys and one with an investigational product for limb-girdle muscular dystrophy.

• CytomX: One patient death linked to its antibody-drug conjugate CX-2051 in a colorectal cancer trial.

• Allogene: A mortality reported in the Phase II study of its lymphoma CAR T cell therapy cemacabtagene ansegedleucel, attributed to the immune-suppressing antibody ALLO-647.

• Agios Pharmaceuticals: Three patient deaths associated with its anemia therapy Pyrukynd, though the company maintains that these events have not altered the drug's established benefit-risk profile.

These incidents underscore the critical importance of patient safety in clinical trials and the challenges faced by pharmaceutical companies in developing new treatments for serious diseases.