On January 22, 2025, Insilico Medicine announced that a mesothelioma patient has received the first dose of its new treatment ISM633 in an ongoing trial.

Mesothelioma is a rare and aggressive cancer that’s very hard to treat. The need for new therapies remains urgent, and ISM6331 could be a promising option if it shows benefits in clinical trials.

The drug works by stopping mesothelioma cells from growing and spreading, with the goal of helping patients with advanced cancer live longer.

Right now, Insilco’s phase I clinical trial is recruiting mesothelioma patients in China and will soon be enrolling stateside.

“We will move forward to advance patient enrollment in the United States and accelerate the clinical translation to deliver innovative therapies that address unmet medical needs.”
– Dr. Sujata Rao, Chief Medical Officer of Insilico Medicine

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 therapy for mesothelioma and other cancers. It works by blocking a protein called TEAD that helps cancer cells grow.

It’s already shown strong potential to fight metastatic cancer that’s spread to other parts of the body, possibly making it one of the most effective treatments of its kind.

Along with shrinking tumors, ISM6331:

  • Caused few side effects
  • Had a low risk of drug interaction
  • Proved to be safe in animals
  • Was well tolerated, even at high doses
  • Worked effectively 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 and Chief Scientific Officer of Insilico.

Get our Free Mesothelioma Guide now to learn more about different treatments that could help you or someone you love.

How Does ISM6331 Work?

When ISM6331 blocks the TEAD protein, it helps restore balance to the Hippo signaling pathway, which controls cell growth and division.

Mesothelioma patients often have mutations in the NF2 gene, which disrupts the Hippo pathway and allows cancer cells to grow and spread.

The Hippo pathway affects:

  • Cancer metabolism
  • Drug resistance
  • Metastasis (cancer spread)
  • Tumor progression

“About 10% of cancer patients are affected by abnormalities in the Hippo signaling pathway,” explained Dr. Ren. “By inhibiting TEAD, ISM6331 has the potential to suppress tumor growth and progression.

Even better, ISM6331 may have broad benefits when combined with chemotherapy, immunotherapy (which works by boosting the immune system), and targeted therapy (which works by attacking specific substances in cancer cells).

Adding ISM6331 to treatment plans could possibly kill more mesothelioma cells or help patients if their cancer doesn’t respond to other therapies.

ISM6331 Treatment Timeline: What Comes Next?

The time it takes for a new mesothelioma treatment like ISM6331 to be researched, tested, and deemed safe can vary.

Our team will keep you updated on the results of the ongoing ISM6331 clinical trial and when it begins enrolling patients in the U.S.

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 ISM6331 for preclinical studies, allowing researchers to see if the drug is effective.
  • April 2024: Insilico shares that ISM6331 shows broad cancer-killing effects and high safety margins in animal studies at the American Association for Cancer Research (AACR) Annual Meeting.
  • June 2024: The U.S. Food and Drug Administration (FDA) grants ISM6331 Orphan Drug Designation, offering more funding and support to encourage its development.
  • August 2024: ISM6331 receives Investigational New Drug (IND) clearance from the FDA, allowing clinical testing in humans to start.
  • January 2025: The first ISM6331 dose is given to a Chinese mesothelioma patient in a phase I clinical trial.

“We look forward to further clinical validation of ISM6331 and to translating these promising preclinical findings into tangible clinical benefits for patients,” said Dr. Ren.

Get Help Accessing Mesothelioma Treatment

If you or a loved one has been diagnosed with mesothelioma, new treatments like ISM6331 have the potential to improve your survival.

A mesothelioma doctor can determine the best treatment plan for your case, which may include emerging therapies.

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 assist patients and families at any stage of their cancer journey and offer personalized support.

We can even match you with a mesothelioma doctor in your area and help you prepare for your first appointment. Reach out to us at (866) 608-8933 right now to get started.

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Laura WrightWritten by:

Lead Editor

Laura Wright is a journalist and content strategist with more than 17 years of professional experience. She attended college at the University of Florida, graduating magna cum laude with a bachelor’s degree in journalism in 2008. Her writing has been featured in The Gainesville Sun and other regional publications throughout Florida.

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References
  1. American Association for the Advancement of Science. (2024, March 29). Insilico Medicine presents progress of 5 novel AI cancer drugs at AACR. Retrieved February 5, 2025, from https://www.eurekalert.org/news-releases/1039605
  2. Clinicaltrials.gov. (2025, January 06). Study of ISM6331 in Participants With Advanced/​Metastatic Malignant Mesothelioma or Other Solid Tumors. Retrieved February 5, 2025, from https://clinicaltrials.gov/study/NCT06566079?cond=mesothelioma&intr=ISM6331&rank=1
  3. Insilico Medicine. (2025, January 22). Insilico Medicine announces first patient dosed in phase I clinical trial of ISM6331, the novel inhibitor for the treatment of mesothelioma and other solid tumors. Retrieved February 5, 2025, from https://www.eurekalert.org/news-releases/1071279
  4. Insilico Medicine. (n.d.). TEAD inhibitor. Insilico Medicine. Retrieved February 5, 2025, from https://insilico.com/pipeline_target_tead
  5. Life Sciences. (n.d.). Chemistry42™ molecule design software. Retrieved February 5, 2025, from https://www.life-sciences-usa.com/product/chemistry42-molecule-design-software-insilico-medicine-inc-group-2001-33530.html
  6. News-Medical. (2025, January 22). Insilico Medicine doses first patient in Phase I Trial of ISM6331 for mesothelioma. Retrieved February 5, 2025, from https://www.news-medical.net/news/20250122/Insilico-Medicine-doses-first-patient-in-Phase-I-Trial-of-ISM6331-for-mesothelioma.aspx
  7. News-Medical. (2024, August 8). Insilico Medicine’s pan-TEAD inhibitor ISM6331 receives FDA IND clearance for mesothelioma treatment. News-Medical. Retrieved February 5, 2025, from https://www.news-medical.net/news/20240808/Insilico-Medicines-pan-TEAD-inhibitor-ISM6331-receives-FDA-IND-clearance-for-mesothelioma-treatment.aspx

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