On August 8, 2024, Insilico Medicine’s investigational drug ISM6331 took a significant step forward when it received approval from the U.S. Food and Drug Administration (FDA) to begin testing in humans for the treatment of mesothelioma.
The approval, known as Investigational New Drug (IND) clearance, is a critical milestone in the development of new medications to treat this asbestos-related disease. Just a few months earlier, ISM6331 was designated as an orphan drug by the FDA, a status that encourages the development of treatments for rare diseases affecting fewer than 200,000 Americans.
Mesothelioma is a rare and aggressive cancer that’s notoriously difficult to treat. The need for new effective therapies has never been more urgent.
“We are thrilled to receive the FDA’s orphan drug designation and approval to initiate clinical evaluation of ISM6331,” said Sujata Rao, Chief Medical Officer of Insilico. “We will move forward with patient enrollment in the U.S. as soon as possible.”
With IND clearance, ISM6331 is now set to begin clinical trials, marking the start of the drug’s journey from the lab to potentially becoming a new source of hope for mesothelioma patients.
Find out more about ISM6331, how it works, and how close it is to reaching patients like you.
What Is ISM6331?
ISM6331 is a promising new drug that could help treat cancers like mesothelioma. It works by blocking a protein called TEAD that helps cancer cells grow.
This drug is particularly effective in cases where the Hippo pathway, a key regulator of cell growth, isn’t functioning properly.
ISM6331 has shown strong potential to fight cancer, possibly making it one of the best treatments of its kind.
Along with shrinking tumors, ISM6331:
- Caused few side effects
- Had a minimal risk of drug interaction
- Proved to be safe in animals
- Was well tolerated, even at high doses
- Worked well when taken as a pill
“The potential applications are vast, including the promising enhancement of chemotherapy efficacy, bolstering tumor immunity, improving small molecule targeting, and overcoming current drug resistance challenges,” explained Dr. Feng Ren, co-CEO of Insilico.
To learn more about cutting-edge treatments like ISM6331 and how they can impact your care, get our Free Mesothelioma Guide today.
How Does ISM6331 Work?
Mesothelioma is a cancer that often has a mutation in the NF2 gene, which causes disruptions in the Hippo signaling pathway.
“About 10% of cancer patients are affected by abnormalities in the Hippo signaling pathway,” explained Dr. Ren. “By effectively targeting the TEAD family of proteins, ISM6331 provides a strategic approach.”
The Hippo pathway plays an essential role in:
- Cancer metabolism
- Drug resistance
- Immunity
- Metastasis (cancer spread)
- Tumor progression
By blocking TEAD, ISM6331 helps to prevent cancer cells from growing and surviving.
Even better, ISM6331 is believed to have broad benefits when combined with chemotherapy and immunotherapy, a newer approach to treating cancer that works by boosting the patient’s immune system.
ISM6331 Treatment Timeline: What Comes Next?
The time it takes for a new mesothelioma treatment to be researched, tested, and deemed safe can vary. Our team will keep you updated on the results of upcoming ISM6331 clinical trials and if the drug will be made available to the wider public.
ISM6331 has achieved several key milestones so far:
- September 2020: The launch of Chemistry42, Insilico’s generative AI platform, leads researchers to develop ISM6331.
- June 2023: Insilico recommends the drug for preclinical studies, giving researchers a chance to see if the drug is effective.
- April 2024: At the American Association for Cancer Research (AACR) Annual Meeting, Insilico shares that ISM6331 showed broad cancer-killing effects and high safety margins in animal studies.
- June 2024: The FDA grants ISM6331 Orphan Drug Designation, granting more funding and support to the company to encourage development.
- August 2024: ISM6331 receives Investigational New Drug (IND) clearance to begin evaluation of the drug in humans during clinical studies.
“We remain committed to harnessing the power of AI to push the boundaries of medical science, offering new hope and potential therapies for patients with rare and challenging conditions,” said Dr. Ren.
Now, patients who can’t undergo traditional mesothelioma treatments may be able to access ISM6331 in clinical trials.
Get Help Finding Mesothelioma Clinical Trials & Care
If you or a loved one has been diagnosed with mesothelioma, the right doctor can make all the difference in your ability to get treated and fight this cancer.
Top mesothelioma doctors can help by:
- Assembling a care team of nurses and cancer specialists
- Creating a treatment plan customized to your diagnosis
- Recommending clinical trials that could work for you
At Mesothelioma Hope, we can help patients and their families at every stage of the cancer journey, offering personalized support tailored to your individual needs.
We can match you with a mesothelioma doctor and help you access potentially life-saving care. Reach out to us at (866) 608-8933 right now to get started.
