Evaxion has received FDA approval to move forward with a Phase 2b clinical study for EVX-01

Evaxion Biotech A/S, a clinical-stage biotech company, announced that the FDA had given the green light for their Phase 2b clinical trial of EVX-01. The Company submitted an IND and Fast Track application for EVX-01 and KEYTRUDA® for metastatic melanoma in November 2022. The FDA approved the Phase 2b trial on December 22, 2022. The Company expects a response to the Fast Track application in Q1 2023.

Publish Date: 03-01-2023 Source: Evaxion Biotech A/S

Melanoma arises from the melanocytes of cutaneous or other pigmented tissues such as the eyes or intestines. About 90% of melanomas are diagnosed as primary tumors without any evidence of metastasis. Melanoma when malignant, has a marked propensity to metastasize to the brain. Australia has the highest melanoma incidence rate, and New Zealand has the highest melanoma mortality rate. The major oncogenic mutations associated with melanoma are BRAF, NRAS, c-KIT, PTEN and GNAQ/GNA11. BRAF is the most widely studied mutation; prevalence in primary melanoma ranges from 50% to 60%. Around 5% to 12% of the patients with melanoma have a family history of CMM in one or more first-degree relatives. So far, more than 75 somatic mutations in the BRAF gene have been identified in melanoma, and all mutations at V600 in exon 15 constitutively activate BRAF. The mutations are either in the activating segment in exon 15 or the glycine-rich loop (P-loop) in exon 11 of the kinase domain of the BRAF protein.

In BRAF mutant melanoma, 74% to 90% are V600E, and 16% to 29% are V600K mutations. The frequency of BRAF mutation in primary melanomas ranges from 50% to 60%.

However, the current Melanoma treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (CMP-001, BNT111, IMO-2125, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Melanoma treatment. The key companies in the advanced development stage are Regeneron Pharmaceuticals, BioNTech SE, Idera Pharmaceuticals, Inc., etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Melanoma to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.