Evaxion reports 75% response rate in melanoma vaccine trial

COPENHAGEN - Evaxion A/S (NASDAQ:EVAX), a biotechnology company with a market capitalization of $60.64 million, announced Friday that its personalized cancer vaccine EVX-01 demonstrated a 75% objective response rate in advanced melanoma patients after two years of treatment, according to phase 2 clinical trial data. The announcement has contributed to the stock’s remarkable 62.71% gain over the past week, though InvestingPro analysis indicates the stock is currently trading above its Fair Value.

The biotechnology company reported that 12 out of 16 patients showed objective clinical responses, with four achieving complete responses. Eleven of the 12 responders continued to respond at the 24-month follow-up, with no relapses observed. According to InvestingPro data, the company maintains strong financial flexibility with a healthy current ratio of 3.42, indicating solid ability to meet short-term obligations.

According to the data presented at the European Society for Medical Oncology Congress in Berlin, 15 of the 16 enrolled patients experienced tumor reduction, and 54% of patients showed deepened responses during treatment, improving from stable disease or partial response to partial or complete response.

The trial evaluated EVX-01 in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced melanoma. Each patient received a personalized vaccine designed using Evaxion’s AI-Immunology platform to target multiple neoantigens.

The company reported that the treatment induced immune responses in all patients, with 81% of the targeted neoantigens generating specific T-cell responses. The treatment was described as well-tolerated.

"A 75% ORR is unprecedented in this hard-to-treat patient population," said Birgitte Rønø, CSO and interim CEO of Evaxion, in the press release. She added that further clinical development would only proceed through partnerships.

The trial has been extended for an additional year, during which participants will receive EVX-01 as monotherapy, with results expected in 2026.

Evaxion will host a webinar on October 22 featuring Professor Muhammad Adnan Khattak, one of the trial investigators, to discuss the data and treatment challenges in advanced melanoma. With analyst price targets ranging from $6 to $19.75, investors seeking deeper insights into EVAX’s potential can access comprehensive analysis and 12 additional ProTips through InvestingPro’s detailed research reports, available as part of its coverage of over 1,400 US stocks.

In other recent news, Evaxion A/S has announced several significant developments. The company will present two-year clinical data from its phase 2 trial of the personalized cancer vaccine EVX-01 at the European Society for Medical Oncology Congress. This presentation will include data on efficacy, immunogenicity, and safety, with a focus on response rates and T-cell measurements. Additionally, Evaxion has launched an AI-powered automated vaccine design module aimed at reducing vaccine development time from months to days. In a notable business development, MSD, known as Merck & Co. in the United States, has exercised its option to license Evaxion’s preclinical vaccine candidate EVX-B3, providing Evaxion with $7.5 million upfront. The agreement also includes the potential for up to $592 million in future milestone payments and royalties. Following this news, H.C. Wainwright raised its price target for Evaxion Biotech to $16, maintaining a Buy rating. These recent developments highlight Evaxion’s ongoing efforts in vaccine innovation and strategic partnerships.

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