Clinical trials for the cancer drug initiative led by Schrodinger have been suspended following the unfortunate deaths of two participants during the initial phase.

In a recent development, biopharmaceutical company Schrodinger has decided to halt the development of its drug candidate SGR-2921, following the deaths of two patients in a Phase I trial. The trial, designated as NCT05961839, is a dose-escalation study of SGR-2921 in adults with relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes.

The deaths occurred in "two emergent events where SGR-2921 was considered to have contributed to the deaths in patients with AML." According to Schrodinger, the drug's CDC7 inhibition may have been potentially related to these fatalities.

Margaret Dugan, Schrodinger's chief medical officer, stated that patient safety is the company's first priority. Mani Foroohar, MD, senior managing director, genetic medicines, and a senior research analyst with Leerink Partners, concurred, stating that the decision to terminate the trial is prudent, given the susceptibility of patients in these indications to treatment-related adverse events (TRAEs) of this sort.

Prior to this, the trial had shown "early evidence of monotherapy activity," although the details were not provided in the statement. Schrodinger believes that SGR-2921 could ultimately be used in combination with standard of care agents.

It is worth noting that Schrodinger is not alone in halting the development of CDC7 inhibitor candidates. Other companies such as Bristol-Myers Squibb, Nerviano Medical Sciences, Eli Lilly, Chia Tai Tianqing, Takeda Pharma, Zai Lab, Ignyta, and Roche have also ceased their CDC7 inhibitor programs following clinical or preclinical studies.

Meanwhile, Schrodinger expects to report initial clinical data for SGR-3515, a Wee1/Myt1 co-inhibitor, in the fourth quarter from a Phase I trial in patients with advanced solid tumors. Additionally, positive initial data from a Phase I trial (NCT05544019) of SGR-1505, a MALT1 inhibitor, in relapsed/refractory B-cell malignancies was presented in June. SGR-1505 was seen to be well tolerated and clinically active with responses observed in patients with chronic lymphocytic leukemia and Waldenstroem macroglobulinemia.

However, SGR-1505 is currently under review for strategic alternatives. MorphoSys, Schrodinger's partner for the further development of SGR-1505, continues to have an active CDC7 inhibitor program in development, along with Lin BioScience and Carna Biosciences.

The sudden halt in the development of SGR-2921 has led to a dip in Schrodinger's share prices, with investors sending shares down nearly two percent due to the news of the patient deaths. The company will continue to monitor the situation and provide updates as more information becomes available.

Clinical trials for the cancer drug initiative led by Schrodinger have been suspended following the unfortunate deaths of two participants during the initial phase.