Exciting Breakthrough: Nouscom Completes Patient Enrollment in Phase 2 Study for Revolutionary Cancer Immunotherapy

In a critical advancement towards cancer treatment, Nouscom, a pioneering immuno-oncology company, has successfully completed patient enrollment for its randomized Phase 2 clinical trial evaluating NOUS-209, an innovative neoantigen immunotherapy. This therapy is being tested in combination with pembrolizumab against pembrolizumab alone for patients suffering from Deficient Mismatch Repair/Microsatellite Instability (dMMR/MSI) unresectable and metastatic colorectal cancer (mCRC). The results for the primary efficacy endpoint, the Objective Response Rate (ORR), are anticipated in mid-2025, highlighting the promising future for this groundbreaking treatment.

What Makes NOUS-209 Stand Out?

NOUS-209 is a unique off-the-shelf immunotherapy that encompasses 209 neoantigens that are primarily common across both sporadic and hereditary MSI tumors. Its design enables the activation of the immune system, generating robust responses from CD8 and CD4 T cells aimed at these specific neoantigens derived from defective DNA mismatch repair genes.

Phase 1b studies indicated that NOUS-209 paired with pembrolizumab was not only well-tolerated but also induced significant and lasting immune responses, resulting in considerable tumor shrinkage in patients suffering from gastrointestinal tumors. In fact, 90% of participants experienced the strong and durable induction of CD8 and CD4 T cells, which are crucial for targeting tumors effectively.

Potential Beyond Metastatic Colorectal Cancer

The implications of NOUS-209 extend beyond mCRC. Currently, it is being investigated in a variety of clinical studies for other MSI-related cancers, ranging from early-stage interventions to advanced metastatic cases. The wider potential for tumor interception at the pre-malignant stage illustrates the transformative capacity of this immunotherapy.

During a recent conference where new data was presented, Dr. Marina Udier, CEO of Nouscom, emphasized the significance of this milestone, stating, “With important data readouts expected in 2025, we are getting closer to answering whether NOUS-209 immunotherapy significantly enhances clinical efficacy beyond existing standard treatments for MSI mCRC patients.”

Addressing a Dire Medical Need

Colorectal cancer remains a leading cause of cancer-related deaths globally, underscoring a pressing need for novel therapies like NOUS-209. The ongoing Phase 2 trial, conducted across multiple centers in the US and Europe, comprises both an experimental cohort and a control group. This comprehensive approach aims to produce robust data that could change the treatment landscape for MSI cancers.

As Dr. Sven Gogov, Nouscom's Chief Medical Officer, pointed out, “This trial, along with positive data from our ongoing trials in Lynch Syndrome carriers, reinforces the potential of NOUS-209 immunotherapy, from intercepting cancer at early stages to tackling advanced diseases.”

Final Thoughts

As Nouscom embarks on this promising journey, healthcare professionals and cancer patients alike eagerly await the trial results. The data from these studies could pave the way for broader applications of NOUS-209 not only in colorectal cancer but in a spectrum of tumor types associated with MSI. Stay tuned for more updates on this innovative immunotherapy that has the potential to revolutionize cancer treatment as we know it!