A long-heralded area of interest in oncology is p53, a tumor suppressor protein encoded by the gene TP53 coined the “Guardian of the Genome” because of its role in controlling cell cycles by enabling the repair of damaged cells or triggering their death (apoptosis). Cancer cells proliferate in part because they block or trick the body’s immune system from recognizing and attacking them, forming the foundation of immuno-oncology. They also affect p53, abrogating the pathway (wild type p53) or causing mutations (mutant type p53) in nearly every form of solid or liquid tumors so the key protein doesn’t perform its duties as commander sitting atop the cell cycle defense hierarchy. With that enormous potential patient population, p53 has for years been one of the most well known, but largely untouchable, targets in oncology. There’s been limited progress since a wider knowledge base of p53 started being constructed in the late-1980’s, but advancements seem to be accelerating in recent years.
Two notable leaders in this space are smaller companies by Wall Street standards. Privately held Aileron Therapeutics is hoping to advance its ALRN-6924, a stapled peptide believed to target the p53 tumor suppressor proteins MDM2 and MDMX, into the clinic this year. Cellceutix Corp. (OTC: CTIX) (the Company announced it intends to uplist to NASDAQ) is nearing the completion of a Phase 1 trial against solid tumors for Kevetrin, a novel small molecule shown in extensive pre-clinical research to promote p53 activation in a lengthy list of tumor types. The trials are being hosted at the venerable cancer hospitals Harvard Cancer Center’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. Elsewhere, the University of Bologna is waiting for the trial to determine the maximum tolerated dose of Kevetrin before setting its dosing protocol and commencing a Phase 1/2 trial of Kevetrin in combination with cytarabine in patients with acute myelogenous leukemia (AML).
Reports from the trial have been impressive, showing Kevetrin to be well tolerated and non-genotoxic (doesn’t damage healthy DNA). Importantly, news this week detailed a dose-dependent increase in the p21 biomarker and a metastatic lesion in the spleen of a stage 4 ovarian cancer that has “disappeared,” an almost unheard of event in an early trial of such a hard-to-treat cancer. <snip
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