Adagene Doses First Patient in Phase 2 Colorectal Cancer Trial

Adagene Commences Phase 2 Trial with First Patient Dosed

Adagene Inc., a pioneering biotechnology company focused on innovative antibody-based therapies, has taken a significant step forward in its latest clinical trial. The company recently announced the dosing of the first patient in their Phase 2 study of muzastotug, an advanced anti-CTLA-4 agent, in combination with KEYTRUDA (pembrolizumab). This trial specifically targets patients suffering from microsatellite stable colorectal cancer (MSS CRC) without liver metastases. Adagene’s aim is to explore optimal dosing strategies that could pave the way to a Phase 3 trial.

Overview of the Phase 2 Study

The Phase 2 study is designed as a randomized trial, in which patients are assigned to receive either 10 or 20 mg/kg doses of muzastotug alongside KEYTRUDA. This strategic combination aims to enhance the overall response rates among participants, with up to 30 patients enrolled in each dosing group. The primary endpoint for this study is the overall response rate (ORR), which will reflect the efficacy of the therapy in the targeted population.

Trial Goals and Timeline

Adagene anticipates wrapping up the trial by early 2027, with hopes of sharing crucial updates as early as 2026. The company is confident that their innovative approach will yield positive results and lead to more effective treatment options for patients with MSS CRC.

Insights from Adagene's Leadership

"We are incredibly pleased to announce the initiation of this important trial to confirm the preferred dosing for Phase 3 in alignment with Project Optimus,” shared Dr. Peter Luo, CEO of Adagene. The company has not only demonstrated the safety of muzastotug at 20 mg/kg administered every six weeks but has also noted minimal Grade 3 adverse events, supporting the agent's promising therapeutic profile.

Significance of muzastotug

Muzastotug operates by employing a unique mechanism that targets regulatory T cells in the tumor environment, effectively aiming to improve therapeutic outcomes. This innovative treatment method has garnered attention, especially following recent acknowledgments in the field of immunology.

Trial Design and Patient Population

The trial's design includes an indication for enrolling late-line MSS CRC patients who do not have liver metastases, emphasizing the critical need for effective therapies in this challenging area. Adagene's design ensures flexibility with dosing regimens and allows researchers to gather vital data on the drug's effectiveness.

Expected Endpoints

In terms of study endpoints, the primary objective for the Phase 2 cohort is the ORR, while secondary metrics will include duration of response, progression-free survival, and overall survival. The upcoming Phase 3 trial is set to further validate these findings with a focus on long-term patient outcomes.

Update on Earlier Trials

Previously, Adagene reported on their Phase 1b/2 trial results, with a total of 67 MSS CRC patients being evaluated. Results indicated a promising overall response rate with various dosing strategies, showcasing the potential efficacy of muzastotug in conjunction with KEYTRUDA. These findings will help guide future study designs and drug applications in clinical settings.

About Adagene

Adagene Inc. is dedicated to advancing the field of cancer therapeutics through their innovative SAFEbody platform. The company utilizes cutting-edge computational biology and artificial intelligence to generate novel antibody therapies that address critical unmet patient needs. Recent strategic partnerships have enhanced their research and development capabilities, focusing on precision masking technologies to ensure targeted treatment with minimal side effects.

Contact Information

For more information or inquiries, please contact: Raymond Tam at raymond_tam@adagene.com. You may also reach out to Corey Davis of LifeSci Advisors at cdavis@lifesciadvisors.com.

Frequently Asked Questions

What is the primary goal of Adagene's Phase 2 trial?

The primary goal is to assess the overall response rate (ORR) of muzastotug combined with KEYTRUDA in patients with MSS CRC.

How many patients will be enrolled in the trial?

Up to 30 patients will be enrolled in each arm of the trial, with two dosing groups of muzastotug.

What are the characteristics of target patients?

The trial focuses on late-line MSS CRC patients without liver metastases, aiming for an effective treatment strategy.

When is the expected completion date for the trial?

The trial is expected to be completed in early 2027, with updates anticipated in 2026.

What unique technologies does Adagene utilize in their therapies?

Adagene incorporates the SAFEbody platform, leveraging precision masking technology to enhance the targeting of their antibody therapies.

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