Evaxion Biotech has announced completing the recruitment for the phase I/IIa trial of one of their top programmes, EVX-02, which treats patients suffering from adjuvant melanoma. Due to very positive preliminary findings around the potential clinical benefit of EVX-02, the company is now accelerating its development programmes, increasing the prospects of commercialisation for the Danish company.
Evaxion Biotech uses artificial intelligence (AI) technology to generate predictive models to identify and develop unique immunotherapies for patients. The company currently uses three proprietary AI platforms for its drug development: PIONEER, EDEN and RAVEN. Through this technology, the company has generated a broad pipeline of candidate immunotherapies that addresses two of the most significant unmet medical needs worldwide – cancer and infectious diseases.
Read more about the company’s pipeline and vision here.
Clinical phase candidates
One of the company’s proprietary AI platforms is PIONEER, designed to develop immuno-oncology therapies. So far, the company has derived three programmes from the platform: EVX-01, EVX-02, and EVX-03. The first two are in clinical-stage development.
Lead programme EVX-01 recently received the green light from the Australia Therapeutic Goods Administration to go into phase IIb in Australia. The trial aims to evaluate the safety and efficacy of EVX-01 combined with Merck & Co’s blockbuster anti-PD-1 CPI Keytruda in approximately 100 patients with unresectable or metastatic melanoma across Australia, Europe, and the US following regulatory clearance.
EVX-02 can head to phase IIb
Now, EVX-02 is being evaluated in phase I/IIa trial combined with a CPI but with adjuvant melanoma patients. This means that their tumours have been successfully removed (surgically); thus, the focus of the therapy is to prevent relapse.
Preliminary findings around the potential clinical benefit of EVX-02 have been encouraging, allowing the company to accelerate the development program.
Evaxion’s CEO Lars Wegner commented on the completed recruitment:
»Completion of recruitment for the phase I/IIa clinical trial of EVX-02 is an important milestone, which supports our belief that the Evaxion approach is feasible. EVX-02 appears to be well tolerated and shows encouraging signs as a treatment for adjuvant melanoma patients. The T-cell activation is promising, which allows us to take data and insights from this clinical trial and move into a dedicated phase II clinical trial.«
Pushing forward with confidence
By moving EVX-02 into phase II, Evaxion will have two immuno-oncology candidates in the middle to later stages of clinical development. This increases Evaxion’s prospects for commercialisation. It also strengthens the company’s case for being a significant contender in the biotech sphere. Overall, this gives Evaxion extra confidence as it pushes forward with not only EVX-01 and EVX-02 but also the other programmes in the company’s broad portfolio.