Why it matters: The financing brings Nouscom closer to testing whether vaccination can prevent cancer in people with inherited genetic mutations that substantially increase their lifetime risk. Early clinical data show encouraging signals, although the approach has yet to demonstrate a preventive benefit in a controlled trial.
Who’s investing: The round was co-led by M Ventures and Revelation Partners, with new investors Angelini Industries (through Angelini Investments), the European Investment Bank (through its Aurea co-investment facility with Angelini Ventures) and Neva SGR.
- Other existing investors participated: 5AM Ventures, Andera Partners, Angelini Ventures, Bpifrance (through its InnoBio2 fund), CDP Venture Capital (through its Large Ventures Fund), EQT Life Sciences, Indaco Venture Partners, Panakes Partners, Versant Ventures and XGEN Ventures.
How it works: Lynch syndrome is an inherited condition caused by mutations in DNA repair genes. Depending on the genetic mutation, carriers face a lifetime risk of up to 50% for colorectal cancer, 50% for endometrial cancer and 25% for urothelial cancer, according to figures cited by Nouscom.
- NOUS-209 uses two viral vectors to deliver 209 shared frameshift neoantigens associated with tumors that have defective DNA mismatch repair. The goal is to train the immune system to recognize and eliminate abnormal cells before they develop into cancer.
- Unlike personalized cancer vaccines, which are manufactured using mutations identified in an individual patient’s tumor, NOUS-209 is an off-the-shelf immunotherapy designed to target neoantigens shared across patients.
Zoom in: The financing coincides with new long-term data from a Phase 1b/2 study of NOUS-209 in Lynch syndrome carriers, scheduled for presentation at the European Society for Medical Oncology (ESMO) Congress in Madrid on Oct. 25.
- According to the published abstract, none of the 43 evaluable participants at year one or the 17 at year two developed advanced adenomas — precancerous growths — or colorectal cancer, as assessed by colonoscopy.
- The vaccine also generated broad and durable T-cell responses against its targeted cancer antigens. According to Nouscom, annual revaccination further boosted the vaccine-induced T-cell responses.
The comparison: The study uses historical data from Lynch syndrome carriers to assess the observed outcomes against the incidence expected without vaccination. “Lynch Syndrome natural history data describe expected rates of advanced adenomas and colorectal cancer in comparable surveilled populations. Based on this, we would expect approximately 3 events based on 60 (43+17) independent observations,” Marina Udier, Nouscom’s CEO, told European Biotechnology.
- Udier also clarified that the smaller number of patients evaluated at year two reflects differences in follow-up duration. Not all participants had reached their second annual colonoscopy when the data were analyzed.
What’s next: Nouscom plans to advance NOUS-209 into a single global registration-enabling trial. “The primary endpoint is event-free survival — including precancerous events and cancer,” explained Udier. “The pivotal study design has been discussed and agreed with both the FDA and EMA. We plan to disclose further details in the coming months when the trial is registered.” The FDA has already granted NOUS-209 Fast Track designation.
- The €120 million Series D is intended to advance NOUS-209 through its pivotal study toward what Udier describes as “a major value inflection point”. The company did not confirm whether the financing would be sufficient to reach regulatory submission, saying Nouscom would evaluate additional financing needs as development progresses.
Yes, but: Nouscom has also been testing NOUS-209 in combination with Merck’s Keytruda (pembrolizumab) for metastatic colorectal cancer. According to Udier, the company’s Phase 2 combination studies in microsatellite instability-high colorectal cancer met their primary endpoints.
- Nevertheless, Nouscom is now concentrating its clinical and strategic efforts on cancer interception in Lynch syndrome. “Our clinical and strategic focus for NOUS-209 going forward is cancer interception in Lynch Syndrome, which we believe is the setting where an off-the-shelf neoantigen vaccine has the clearest advantage and potential to address a high unmet medical need,” Udier said.
- The company’s personalized cancer immunotherapy, NOUS-PEV, also remains in its broader pipeline, but is not an immediate priority.
What we’re watching: Nouscom will present the long-term Phase 1b/2 findings at ESMO on Oct. 25, followed by further disclosure of its pivotal trial design in the coming months.
- Asked by European Biotechnology about the company’s commercialization plans, Udier explained: “Our focus right now is executing the pivotal trial. We’ll evaluate the best path to patients, including potential partnerships, as the program matures.”
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