Denmark-based Evaxion Biotech A/S EVAX announced that it has enrolled the first patient in a phase IIb study evaluating its personalized cancer therapy, EVX-01, for the treatment of melanoma.
The global phase IIb study will enroll patients who will receive standard-of-care treatment along with Merck’s MRK blockbuster PD-1 inhibitor, Keytruda, in combination with EVX-01, for treating metastatic melanoma.
Shares of Evaxion were up 14.2% on Wednesday, following the announcement of the news. However, the stock declined in pre-market trading on Thursday.
The above study, which is being conducted in collaboration with MRK, will evaluate the safety and efficacy of EVX-01 in the given patient population. The study is being held at various clinical sites across the United States, Europe and Australia.
While Merck will supply Keytruda, Evaxion will be responsible for conducting the study. Interim top-line data from the phase IIb study is expected in the second half of 2023.
Shares of Evaxion have plunged 47.3% this year compared with the industry’s decline of 26.8%.
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Investors must note that Evaxion’s EVX-01, a novel personalized cancer immunotherapy, is being developed based on the company’s proprietary PIONEER AI technology for the treatment of patients with melanoma.
Data from a phase I/IIa study has earlier demonstrated that 67% of nine patients benefitted from the combo of EVX-01 + Keytruda compared to only 40% benefiting from treatment with a PD-1 inhibitor alone.
Also, treatment with EVX-01 + Keytruda led to a complete response (full recovery) in 22% of the patients in the phase I/IIa study.
Merck’s biggest revenue generator, Keytruda, is approved for treating several types of cancer indications. MRK continues to study Keytruda for addressing more cancer indications.
Apart from EVX-01, Evaxion is also developing other personalized cancer therapies, targeting various types of cancer indications.
We note that Evaxion currently has no approved product in its portfolio. Hence, in the absence of a marketed drug, pipeline development remains in key focus for the company.
Zacks Rank & Other Stocks to Consider
Evaxion currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the biotech sector are Aptose Biosciences Inc. APTO and ORIC Pharmaceuticals, Inc. ORIC, both carrying Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aptose Biosciences’ loss per share estimates narrowed 14% for 2022 and 10% for 2023 in the past 60 days.
Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.
ORIC Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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