COPENHAGEN – Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company, has announced results from a Phase 1 study of its personalized cancer vaccine, EVX-01, in patients with metastatic melanoma. The study, published in the Journal for ImmunoTherapy of Cancer, showed that 67% of participants experienced objective clinical responses. This outcome supports the precision of Evaxion's AI-Immunology™ platform in developing tailored immunotherapies.
The EVX-01 vaccine is designed to target neoantigens specific to each patient's tumor, potentially offering a broad application in cancer treatment. The Phase 1 trial results indicated that out of 12 patients, eight achieved objective responses, with six partial and two complete responses. Additionally, the vaccine did not induce serious adverse events when combined with anti-PD-1 therapy.
At the recent annual meeting of the American Society of Clinical Oncology (ASCO), Evaxion presented data from the ongoing Phase 2 study of EVX-01. The data revealed that 71% of administered neoantigens induced a T-cell response, and a positive correlation was found between the neoantigen prediction score and the immune response.
Christian Kanstrup, CEO of Evaxion, expressed satisfaction with the 67% objective response rate, noting its favorable comparison to historical data from anti-PD-1 monotherapy trials. The company anticipates reporting a one-year clinical efficacy readout from the Phase 2 study in the third quarter of 2024.
The Phase 2 trial is a collaboration with Merck Sharp (OTC:SHCAY) & Dohme LLC and involves principal investigators and research centers from Italy and Australia. It aims to assess the efficacy and safety of EVX-01 in combination with pembrolizumab, an anti-PD1 treatment, in patients with advanced melanoma.
Evaxion's AI-Immunology™ platform utilizes artificial intelligence to decode the human immune system and develop immunotherapies for cancer, bacterial diseases, and viral infections. The company is focused on transforming patient care with innovative treatment options.
This article is based on a press release statement from Evaxion Biotech.
In other recent news, Evaxion Biotech has reported significant progress in its Phase 2 clinical trial of the EVX-01 cancer vaccine, with the first patient completing the dosing regimen. The company has also provided an update on its financial results and strategy during its latest earnings call.
The financial report for 2023 showed a decrease in R&D expenses to $11.9 million, but an increase in net loss to $22.1 million. Despite the financial challenges, Evaxion's CEO, Christian Kanstrup, highlighted the company's financial stability, stating that funding is secured until at least Q1 2025.
On the other hand, Evaxion's Chief Scientific Officer, Birgitte Rono, shared updates on the company's vaccine trials, including positive data for the EVX-B1 vaccine. The company is also exploring multiple indications for its ERV-based cancer vaccines and planning to manufacture and test the EVX-B3 vaccine in preclinical models by year-end.
The company's AI-Immunology™ platform is being utilized to develop novel immunotherapies for cancer, bacterial diseases, and viral infections. The results of these recent developments are eagerly awaited by the medical community and investors alike.
InvestingPro Insights
As Evaxion Biotech (NASDAQ: EVAX) continues to progress with its personalized cancer vaccine, EVX-01, the financial landscape presents a mixed picture. InvestingPro data shows that Evaxion holds a market capitalization of $16.77 million, which is modest for a biotech firm in the competitive cancer immunotherapy space.
The company's revenue over the last twelve months as of Q1 2024 stands at $0.12 million with a gross profit margin of 100%, indicating effective cost management relative to its revenue scale. Still, the operating income margin of -16289.52% reflects significant investment in research and development, which is typical for clinical-stage biotech companies.
An InvestingPro Tip highlights that Evaxion has more cash than debt on its balance sheet, which is a positive sign for investors looking for financial stability in a high-risk industry. Moreover, while analysts do not anticipate the company will be profitable this year, they do foresee sales growth in the current year. This could be an indicator of Evaxion's potential to capture market share with its innovative EVX-01 vaccine and other therapies in development.
The stock's performance, however, has been under pressure, with a 1-year price total return of -76.34%, which aligns with another InvestingPro Tip noting that the stock price often moves in the opposite direction of the market. Investors should also note that Evaxion is trading at a high Price / Book multiple of 6.44, which may suggest a premium valuation compared to its tangible assets.
For those interested in a deeper dive into Evaxion's financial health and future prospects, there are additional InvestingPro Tips available. Using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access these insights. There are currently 14 additional InvestingPro Tips for Evaxion Biotech that could help investors make a more informed decision regarding their investment in the company.
As Evaxion pushes forward with its clinical studies, investors and stakeholders will be closely monitoring both the scientific outcomes and the financial metrics that will shape the company's trajectory in the high-stakes biotech industry.
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