Skin Cancer & Surgery

Evaxion to Present New EVX-01 Immune Data at SITC 2026

Updated

Evaxion sets November EVX-01 immune data presentation - Mugglehead Investment Magazine
AI-generated

Evaxion A/S (NASDAQ: EVAX) will present new immune profiling data for its personalized cancer vaccine EVX-01 at the Society for Immunotherapy of Cancer 2026 annual meeting, with an oral presentation scheduled for Nov. 6 and a poster on Nov. 7. The data will examine systemic immunomodulatory effects of EVX-01 combined with pembrolizumab, moving beyond vaccine-specific T-cell responses.

"The new data will reflect the systemic immunomodulatory effects of EVX-01 plus pembrolizumab beyond vaccine-specific T-cell responses using comprehensive immune profiling," Evaxion said in its Oct. 2 release.

The announcement contains no new response rate or safety results. It also points to a separate three-year clinical update at the European Society for Medical Oncology congress on Oct. 24.

The two-year baseline

The reference point for both presentations is the study's two-year analysis, first reported on Oct. 17, 2025. In that filing, 12 of 16 patients with melanoma had responded to the vaccine plus pembrolizumab, a 75 percent objective response rate including four complete responses. The rate stood at 69 percent at one year.

Eleven of the 12 responders were still responding at 24 months, which Evaxion described as 92 percent durability, with no relapses at that cutoff. The company called the combination well tolerated but did not provide an adverse-event breakdown in the release. Progression-free and overall survival were not yet reportable because most patients remained in response at the data cutoff.

The study has clear limitations that dermatology and oncology audiences should weigh. The filing reported no concurrent pembrolizumab-only comparison arm and no p value. Evaxion stated it did not formally analyze the planned primary endpoint — improvement in response category — because enrollment fell below the original protocol. The company reported that 54 percent of patients moved to a better response category, but the primary analysis remained undone.

A number that shifted

One figure moved between documents. The October 2025 filing put the immune response rate to vaccine targets at 81 percent; the Oct. 2 release cites 86 percent. Neither document provides matching target denominators for the comparison, so the difference alone does not establish stronger immune activity. The SITC presentation may clarify how Evaxion measured the broader immune effects.

Why the ESMO update matters

Patients received EVX-01 alone during the third year of follow-up, according to the Oct. 2 release. The Oct. 24 ESMO presentation therefore offers the first scheduled look at response durability after pembrolizumab was removed — a critical question for any personalized neoantigen vaccine intended for adjuvant or maintenance use in melanoma.

Evaxion, a Denmark-based clinical-stage developer, uses its AI platform to design personalized immunotherapies for cancer. In its 2025 filing, the company said further clinical development of EVX-01 would proceed only with a partner, framing the upcoming data as potential evidence to support a partner-led trial.

Competitive and market context

The competitive backdrop is demanding. Moderna (NASDAQ: MRNA) listed its personalized mRNA-4157 program in adjuvant melanoma in Phase 3 as of May 28, 2026, with its metastatic melanoma program in Phase 2.

On the market side, EVAX shares opened at US$3.23 as of 9:30:01 a.m. EDT Friday. The iShares Biotechnology ETF (NASDAQ: IBB) closed Wednesday at US$210.53.

The Oct. 24 ESMO presentation will show the three-year clinical follow-up after patients spent the final year on EVX-01 alone, and the Nov. 6–7 SITC sessions will disclose the new immune analyses — together showing whether this small cohort's responses have persisted and whether the immune readout strengthens the case for partner-funded development.

Original: globenewswire.com

Share this article:

Olivia Hart

Show full bio

News editor covering technology and product news in Clinical dermatology, inflammatory skin disease and biologics at Derm Field.

More from Olivia Hart →

Related articles

« Previous articleNext article »