EVX-03 / Evaxion - LARVOL DELTA

Personalized DNA Vaccine Immunogenic Against Melanoma. (PubMed, Cancer Discov) - "A personalized neoantigen vaccine built around a DNA backbone, EVX-02, elicited robust and lasting T-cell responses in patients with melanoma after surgery. The first-in-human data, presented at the Society for Immunotherapy of Cancer Annual Meeting, have inspired a next-generation DNA vaccine candidate, EVX-03, that includes an additional payload and a more sophisticated antigen-selection process."

Journal • Melanoma • Oncology • Solid Tumor

Evaxion announces financing commitments totaling up to USD 20 million with Negma Group (GlobeNewswire) - "Evaxion Biotech A/S...announced that it has entered into a binding agreement for a financing of up to USD 20 million with Negma Group Investment Ltd, a Paris-based leading financial institution focused on supporting growth and capturing value through a multi-strategy approach....The financing commitments are intended to cover the Company’s working capital needs, including the ongoing clinical phase 2 trial of EVX-01, and the advancement of EVX-03 towards the initiation of a Phase 1 clinical trial. If Evaxion fully utilizes the convertible note program, the company will have sufficient financing to fund its planned activities into Q4 2024. Evaxion plans to announce the interim results of the clinical Phase 2 study with EVX-01 in patients with metastatic melanoma in Q4 2023...In addition, the Company plans to initiate a Phase 1 clinical trial with EVX-03 in patients with lung cancer and other solid tumors."

Financing • New P1 trial • P2 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

Evaxion Announces Business Update and First Quarter 2023 Financial Results (GlobeNewswire) - "Anticipated milestones: (i) Q3 2023 - CTA filing for EVX-03; (ii) Q4 2023 - Initiate enrollment of EVX-03 Phase 1 trial...subject to additional funding in the range of $ 5-10 million."

New P1 trial • Oncology

Fourth quarter and full year 2022 financial results and business update (GlobeNewswire) - "Expected milestones in 2023; Q2 2023 - Full readout EVX-01 Phase 1/2a – to be presented at ASCO in June 2023; Q4 2023 - Report interim results from EVX-01 Phase 2 trial; Q4 2023 - Initiate patient recruitment in a Phase 1 study for EVX-03..."

Enrollment status • P1/2 data • P2 data • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Thoracic Cancer • Urothelial Cancer

Evaxion announces promising clinical data for DNA-based personalized cancer immunotherapy EVX-02: Phase 1/2a trial met both primary and secondary endpoints (GlobeNewswire) - P1/2a | N=15 | NCT04455503 | Sponsor: Evaxion Biotech A/S | "Evaxion Biotech A/S...presented promising clinical data from its Phase 1/2a first-in-human study of its DNA-based personalized cancer immunotherapy, EVX-02 in combination with the checkpoint inhibitor nivolumab. Data were presented in the Late Breaking Research: Clinical Research 2 session at the 2023 AACR (American Association for Cancer Research) meeting in Orlando, Florida....All 10 patients who received the full dosing schedule of 8 immunizations with EVX-02 were relapse-free at their last assessment...The combination of EVX-02 and nivolumab was well tolerated and only mild EVX-02-associated AEs were observed; Robust and long-lasting neoantigen-specific T-cell immune responses were confirmed in all EVX-02 completers....'They also support our plan to fast track our next-generation DNA-based personalized cancer immunotherapy, EVX-03, to the clinic in Q4'."

Late-breaking abstract • New P1/2 trial • New trial • Melanoma • Oncology • Skin Cancer • Solid Tumor

Evaxion Announces Increased Focus and Fast-Tracking of its New AI Discovery to Patients (GlobeNewswire) - "Evaxion Biotech A/S...announces an increased focus on its strategy around its core AI capabilities allowing fast and de-risked development of its pipeline....Evaxion’s next clinical program, EVX-03, will target such personalized ERVs and is scheduled to start clinical development in Q4, 2023, subject to additional funding....'By optimizing the strategy around EVX 01, we can deliver the Phase 2b interim data in Q4 2023 as planned while deploying important clinical resources to EVX-03, where we are likely to be first in the world bringing a personalized ERV-immunotherapy to cancer patients'."

New trial • P2 data • Melanoma • Oncology • Skin Cancer

Evaxion CEO comments on strategic focus (GlobeNewswire) - "Evaxion Biotech A/S...today announced that it intends to further increase its focus on its lead oncology assets EVX-01 and EVX-02/03 to bring them to clinical proof of concept followed by out-licensing....Our primary focus will be on our Phase IIb program for EVX-01 and our Phase I/IIa program for EVX-02/03.... At the same time, the Phase I/IIa trial of the DNA-based EVX-02 is progressing as planned, with data readout currently expected by mid-2023...The Company plans to submit a regulatory filing of EVX-03, following EVX-02 data, which may allow Evaxion to advance EVX-03 faster to clinical proof of concept."

P1/2 data • Pipeline update • Regulatory • Melanoma • Oncology • Skin Cancer • Solid Tumor

Evaxion Biotech Announces Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Expected Milestones in the Second Half of 2022: Phase 1 regulatory filing for EVX-03 in patients with non-small cell lung cancer (targeted DNA-based personalized cancer therapy). Initiation of the study is contingent upon securing new capital to fund the costs of the clinical trial; Expected Milestones in First Half of 2023: Clinical readout of Phase 1/2a clinical study to evaluate EVX-02 in patients with resectable melanoma."

P1/2 data • Regulatory • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Evaxion Biotech Expands Its EVX-03 DNA Vaccine Program Into Non-Small Cell Lung Cancer (GlobeNewswire) - "Evaxion Biotech A/S...announced that it has selected EVX-03 as the product candidate within its DNA technology platform to target a new indication with planned regulatory filing in H2 2022...Evaxion has decided to continue the development of EVX-03 in patients with advanced disease and plans to target non-small cell lung cancer (NSCLC) with EVX-03...Evaxion has a DNA technology platform with two different product candidates: EVX-02 is currently being tested in a phase 1/2a clinical trial in patients with resectable melanoma. The ongoing clinical trial is expected to be finalized according to plan with a full clinical readout in Q2 2023. EVX-03 is currently ready for the clinic. Moving forward, Evaxion has chosen EVX-03 as the product candidate for a Phase 1/2a clinical trial in NSCLC due to very encouraging data in the pre-clinical study."

New indication • P1/2 data • Regulatory • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology

Evaxion Biotech Announces First Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Evaxion Biotech A/S...announced today the first quarter 2022 financial results and provided an operational update....Expected milestones in 2022: Phase 2b first patient, first visit with EVX-01 for metastatic melanoma (peptide-based, personalized cancer therapy); Phase 2b regulatory filing for EVX-02/03 in patients with resectable melanoma (DNA-based, personalized cancer therapy); Phase 2b first patient, first visit with EVX-02/03..."

New P2b trial • Regulatory • Trial status • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor

Evaxion Biotech Announces Q3 2021 Financial Results and Provides Business Update (GlobeNewswire) - "EVX-01, our peptide-based patient-specific cancer therapy, demonstrated anti-tumor effect in combination with anti-PD-1 treatment, for metastatic melanoma. Results from the combination therapy compares favorably to historical data from anti-PD-1 treatment alone. A Phase 2b clinical trial of EVX-01 is planned to start by the end of 2021; Preliminary data with EVX-02, our DNA-based patient-specific cancer therapy, demonstrated T-cell activation induced by EVX-02 and appeared to be well tolerated. We intend to submit a regulatory filing for a Phase 2b clinical trial of EVX-02 and EVX-03, in combination with anti-PD-1 in adjuvant melanoma in a three-arm trial, in the first half of 2022. Expected milestones in 2021 & 2022: Phase 2b Investigational New Drug (IND) / Clinical Trial Application (CTA) of EVX-01 in metastatic melanoma – H2 2021. Phase 2b IND / CTA filing for EVX-02 in combination with EVX-03 in adjuvant melanoma – H1 2022."

IND • New P2b trial • Melanoma • Oncology

Evaxion Biotech Announces Q2 2021 Financial Results and Provides Business Update (GlobeNewswire) - “EVX-01...demonstrated anti-tumor effect in combination with anti-PD-1 treatment...for metastatic melanoma....A Phase 2b trial of EVX-01 is planned to start in December 2021....A Phase 2b trial of EVX-02, in combination with EVX-03, our novel patient-specific therapy for multiple cancer indications, is planned to start in Q2 2022 as a combination therapy with anti-PD-1 in adjuvant melanoma....Expected milestones in 2021 & 2022: Phase 2b trial regulatory filing for EVX-02 in combination with EVX-03 in adjuvant melanoma – Q2 2022.”

New P2b trial • Regulatory • Melanoma • Oncology

Evaxion Biotech Announces Q1 2021 Financial Results and Provides Business Update (GlobeNewswire) - “Expected milestones in 2021: Phase 1/2a data readout on EVX-01 in metastatic melanoma - Q2 2021; Phase 1/2a data readout on EVX-02 in adjuvant melanoma - Q2 2021; Regulatory filing for clinical trial of EVX-03 in multiple cancers - H2 2021.”

P1/2 data • Regulatory • Melanoma • Oncology

Evaxion Biotech Announces Q4 and Full-Year 2020 Financial Results and Provides Business Update (GlobeNewswire) - "Expected milestones in 2021: Phase 1/2a data on EVX-01 in metastatic melanoma - Q2 2021; Phase 1/2a data on EVX-02 in adjuvant melanoma - Q2 2021; Regulatory filing for clinical trial of EVX-03 in multiple cancers - H2 2021."

P1/2 data • Regulatory • Melanoma • Oncology