Schrödinger Halts SGR-2921 Leukaemia Programme After Two Deaths

Schrödinger has discontinued development of its experimental cancer drug SGR-2921 following two patient deaths in a Phase I trial examining its use for relapsed or refractory acute myeloid leukaemia (AML) and high-risk myelodysplastic syndromes (MDS)1345.

SGR-2921 is a CDC7 inhibitor, and the company stated the drug was considered to have contributed to both deaths during the dose-escalation monotherapy study134.

The main purpose of the halted Phase I trial (NCT05961839) was to evaluate safety, tolerability, and the maximum tolerated dose of SGR-2921 in these patient populations13.

Schrödinger cited patient safety as its primary concern and acknowledged the observed early clinical activity of SGR-2921, but decided to halt the program given the risk to patients13.

The company noted that, with these safety issues, future development of the drug as a combination therapy (its original intent) would also be difficult to pursue3.

The announcement of the clinical halt led to a drop in Schrödinger's stock price of over 12% following the news3.

Patient demographics (age, sex) associated with the deaths were not publicly disclosed by Schrödinger at the time of the announcement13.

Sources:

1. https://www.genengnews.com/topics/cancer/schrodinger-halts-cancer-drug-program-after-two-patients-die-in-phase-i-trial/

3. https://www.clinicaltrialsarena.com/news/schrodinger-ends-development-of-blood-cancer-drug-after-patient-deaths/

4. https://aacrjournals.org/cdnews/news/2601/CDC7-Inhibitor-Dropped-after-Patient-Deaths

5. https://insights.citeline.com/scrip/business/schrodinger-drops-cdc7-inhibitor-sgr-2921-after-two-patient-deaths-MYSNR53AYRAPVI6TB2OZBGH4JA/