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HomeHealthcareIn phase 1 trials of an orally administered cancer drug

In phase 1 trials of an orally administered cancer drug


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How STC-15 works – Targets solid tumors, shrinking them and providing anti-cancer protection

Another “weapon” in the battle against cancer is trying to add to the human arsenal the biotech company STORM Therapeutics Ltd. As STORM announced, the first phase of drug testing against him has begun cancer administered orally. The first patient received STC-15, which targets solid tumors and appears to be working.

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The highly selective METTL3 inhibitor, STC-15, is the first molecule that specifically targets an RNA methyltransferase enzyme to enter clinical development. This -Phase 1- study is a multiple-escalation trial aiming to enroll 40-60 patients to measure safety, pharmacokinetics, target binding, biomarkers related to the mechanism of antitumor efficacy in patients with solid volumes.

Preclinical activity was demonstrated with the STC-15 through direct cytotoxic and antitumor immune response mechanisms in solid tumor and leukemia models. The data indicated enhanced interferon signaling and synergy with T cell checkpoint blockade as an important mechanism of action of STC-15, resulting in tumor regression and antitumor immunity in rodents.

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Dr. Jerry McMahon, CEO of STORM Therapeutics, said: “This is an important milestone for STORM as we enter clinical development with our lead candidate STC-15 and continue to advance a pipeline targeting RNA modifying enzymes beyond METTL3. We plan to present preclinical data on STC-15 at future medical conferences this year as the Phase 1 study in patients with solid tumors progresses. We expect to present results from the Phase 1 study in 2023.”

Josefin-Beate Holz, MD, CMO of STORM Therapeutics, added: “Clinical development allows us to create meaningful benefit with RNA-modifying enzyme inhibitors in cancer patients. This first trial is a groundbreaking milestone for the drug class and we look forward to receiving the emerging data from the study.”

Justin Moser, MD, Associate Clinical Investigator at HonorHealth Research Institute, the first clinic to enroll patients in the STC-15 study, commented, “Our goal at HonorHealth Research Institute is to bring the potential treatments of tomorrow to our patients, today. We are excited about our partnership with STORM that allows us to offer STC-15 and other innovative, first-in-class trial options to our patients.”

Who is STORM Therapeutics?

STORM Therapeutics (STORM) is a biotechnology company developing novel therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. More than 150 RNA modifications and approximately 300 RNA-modifying enzymes representing new therapeutic targets have been reported.

STORM leveraged first-mover advantage to build a novel drug discovery and RNA analysis platform leading to the discovery of novel targets and a proprietary pipeline of first-in-class small molecule drug candidates for potential use in oncology, inflammation, viral infections and diseases CNS.

The pipeline example is STORM’s METTL3 inhibitor (STC-15) which received FDA approval to support the start of a Phase 1 clinical trial in cancer patients in 2022. STC-15 represents the first RNA-modifying enzyme inhibitor that entered clinical evaluation in humans. Additional candidates are scheduled to proceed to IND-track activities in 2023.

STORM investors include M Ventures (the venture capital arm of Merck KGaA, Darmstadt, Germany), Pfizer Ventures, Taiho Ventures LLC, Cambridge Innovation Capital I Limited, Seroba Life Sciences, IP Group plc, Fast Track Initiative (FTI) and the University of Tokyo Innovation Platform.

About STC-15

STORM’s lead program STC-15 is a first-in-class clinical candidate and is the first RNA modification inhibitor to enter human clinical development. STC-15 is an oral small molecule that inhibits METTL3 which is an RNA methyltransferase involved in oncology and other diseases. Certain RNA methyltransferases are important regulators of RNA sensing and innate immune activation and represent novel immunoregulatory targets.

STC-15 has also been shown to inhibit tumor growth through mechanisms involving antitumor immune responses such as changes in interferon signaling and synergy with T cell checkpoint blockade. In addition, STC-15 has shown efficacy in models of leukemia through mechanisms involving the inhibition of leukemia stem cell function.

STC-15 began its Phase 1 clinical study in solid tumor cancer patients in November 2022, when the first patient was dosed.

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