Toca 5 Phase III trial with Toca 511 & Toca FC fails to meet endpoint in glioma
Tocagen announced that the Toca 5 Phase III, randomized, multi-center clinical trial evaluating Toca 511 & Toca FC in patients with recurrent high grade glioma (HGG) undergoing resection missed the primary endpoint of overall survival compared to standard of care treatment (11.1 months median compared to 12.2 months, HR=1.06, p=0.6154). In addition, all secondary endpoints showed no meaningful difference between the arms of the trial. The safety, tolerability and adverse event profile of Toca 511 & Toca FC was as expected for this patient population. Further analysis of the Toca 5 trial data is currently underway and presentation of the results is planned at an upcoming medical conference.
Comment: Tocagen's lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.
Related news and insights
Zai Lab Limited and its partner Entasis Therapeutics Holdings Inc. announced topline results from the ATTACK trial, a global Phase III registrational trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter baumannii.
Atea Pharmaceuticals, Inc. reported that the global Phase II MOONSONG trial evaluating AT 527 in the outpatient setting did not meet the primary endpoint of reduction from baseline in the amount of SARS-CoV-2 virus in patients with mild or moderate COVID-19 compared to placebo in the overall study population, of which approximately two thirds of patients were low-risk with mild symptoms.