EVX-02 / Evaxion - LARVOL DELTA

Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 (clinicaltrials.gov) - P1/2 | N=15 | Terminated | Sponsor: Evaxion Biotech A/S | Active, not recruiting ➔ Terminated; Based on the promising interim results of study part 1, it was decided to further accelerate the development of the 2nd generation DNA plasmid immunotherapy. Therefore enrolment of patients was completed after study part 1

Metastases • Trial termination • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • CD4 • CD8

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

AI-designed personalized neoantigen vaccine, EVX-02, induces robust T-cell responses in melanoma patients (SITC 2023) - "Background EVX-02, a personalized neoantigen DNA vaccine, was assessed in combination with an anti-PD-1 therapy (nivolumab) in patients with fully resected melanoma and at high risk of disease recurrence. The EVX-02 vaccine mobilized robust and long-lasting CD4+ and CD8+ T-cell responses, both of which are believed to be relevant for obtaining a clinical effect. The measured T-cell responses correlated with the predictions generated by PIONEER, validating the precision and predictive power of the platform."

Clinical • IO biomarker • Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • IFNG

New and Exciting Clinical Data on Evaxion’s AI-Immunolog-Based Personalized Cancer Vaccines to be Presented (GlobeNewswire) - "Evaxion Biotech A/S...is proud to announce that it will be presenting clinical readouts on its two personalized cancer vaccine trials at SITC’s 38th annual meeting, taking place in San Diego, California from November 1-5, 2023...The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, together with leading principal investigators and research centers from Italy and Australia, and aims at evaluating the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 treatment (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma....This open-label, multi-center study aims at assessing the safety, tolerability, pharmacodynamic responses, and efficacy of EVX-02 neoantigen vaccine and anti-PD-1 treatment (nivolumab) in patients who have had a complete resection of a Stage IIIB/IIIC/IIID or Stage IV melanoma..."

P1/2 data • P2 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

A personalized neoantigen vaccine is well tolerated and induces specific T-cell immune response in patients with resected melanoma (AACR 2023) - "Encouraged by the preclinical results, we conducted a first-in-human multicenter Phase I clinical study of EVX-02 in combination with nivolumab in patients with resected malignant melanoma. The measured T-cell responses were robust and long lasting. Together, these findings validate the precision and predictive power of our proprietary AI platform, PIONEER, and provide proof of mechanism for the DNA-delivery technology in that the encoded neoantigens gave rise to significant immune reactions."

Clinical • IO biomarker • Late-breaking abstract • Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • CD4 • CD8

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 Biotech to announce clinical data for the personalized DNA cancer vaccine EVX-02 at the 2023 American Association for Cancer Research Annual Meeting (AACR) (GlobeNewswire) - "Evaxion Biotech A/S...announced that the company will present clinical readout of the Phase 1/2a trial of EVX-02 at the upcoming 2023 American Association for Cancer Research Annual Meeting (2023 AACR), taking place from April 14th to April 19th in Orlando, Florida."

P1/2 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

Evaxion to present a full clinical readout on two personalized cancer immunotherapies in Q2 2023 (GlobeNewswire) - "Evaxion Biotech A/S...announced that they expect to present data from their two clinical trials of personalized cancer immunotherapies (cancer vaccines) EVX-01 and EVX-02 in the second quarter of 2023....By mid-2023, Evaxion will present the full clinical readout of EVX-01 in metastatic melanoma and of EVX-02 in patients with resected malignant melanoma."

P1/2 data • P2 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

Evaxion announces promising results from Phase 1/2a clinical trial of personalized DNA cancer immunotherapy EVX-02 (GlobeNewswire) - P1/2a | N=15 | NCT04455503 | Sponsor: Evaxion Biotech A/S | "Evaxion Biotech A/S...announced promising clinical data from the Phase 1/2a first-in-human study of its DNA-based cancer immunotherapy, EVX-02....In the clinical study, EVX-02 is given in combination with a checkpoint inhibitor and targets cancer mutations, neoantigens, in patients with resected melanoma....Interim results in summary: Safety: Treatment appeared to be well tolerated in all patients, with only very mild adverse events (AEs) observed in relation to EVX-02 treatment; EVX-02 induced CD4+ and CD8+ specific T-cell responses in all patients, providing proof of mechanism for our DNA-delivery technology, in that the delivered EVX-02-DNA gave rise to immune reactions to its encoded neoantigen peptides; The T-cell responses were robust and long-lasting. A full clinical trial report for the EVX-02 Phase 1 study is expected in the second quarter of 2023."

P1 data • P1/2 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

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

Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 (clinicaltrials.gov) - P1/2 | N=15 | Active, not recruiting | Sponsor: Evaxion Biotech A/S | Recruiting ➔ Active, not recruiting | N=46 ➔ 15 | Trial completion date: Jul 2026 ➔ Mar 2023 | Trial primary completion date: Mar 2024 ➔ Mar 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • CD4 • CD8

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 Successful Production of Personalized Cancer Immunotherapies in Phase 1/2a Clinical Trial for EVX-02 (GlobeNewswire) - "Evaxion Biotech A/S...announced today that it has successfully produced all batches of personalized cancer immunotherapies for all patients enrolled in the Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma...The production process of the personalized drug product consists of multiple steps. The sequencing of the tumor DNA is followed by AI-powered identification of the most promising therapeutic targets developed by Evaxion's proprietary PIONEER™ technology. This leads to designing the personalized multi-target vaccine drug product, which is then manufactured, released to the clinical sites, and administered to the patient."

Trial status • Melanoma • Oncology

"BioStock: Evaxion completes EVX-02 clinical trial recruitment https://t.co/ARd6Com1qE" (@CisionNews)

Clinical

"BioStock: Evaxion slutför patientrekryteringen till EVX-02 https://t.co/zZFqajMfCy" (@CisionNews)

Clinical

Evaxion Biotech Completes Recruitment for Phase 1/2a Clinical Trial for EVX-02 (GlobeNewswire) - “Evaxion Biotech A/S…has now finalized recruitment for Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma patients….Evaxion Biotech has completed recruitment of 16 patients and will now move directly into a dedicated phase 2b clinical trial in adjuvant melanoma. Final data from the current phase 1/2a clinical trial are expected to be announced and reported second quarter of 2023, which is earlier than previously communicated. Expected milestones for the EVX-02 phase 2b study are: Regulatory filing in H1 2022, First patient first visit in H2 2022 and an interim readout in 2023.”

Enrollment status • P1/2 data • P2b data • 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 Reports Data from Phase 1/2a Trials of EVX-01 and EVX-02 (GlobeNewswire) - P1/2a, N=9; “Combined therapy with EVX-01 demonstrated an objective response rate of 67% across all nine patients compared with historical data of 40% with anti-PD1 treatment alone1. The study also demonstrated a complete response rate of 22%, compared with a historical 7%1 with anti-PD1 treatment alone, and a partial response rate of 44%, versus 33% compared with anti-PD1 treatment alone1. Among the four patients on the highest two doses, there was an objective response rate of 75%...The study also revealed encouraging biomarker information supporting EVX-01’s mechanism of action. There was broad T-cell activation in all patients, with 76.2% of the administered neoepitopes inducing reactive T cells, while 84.8% of EVX-01 induced reactive T cells were de novo responses….We also intend to present the data at a upcoming medical society meeting in first half of 2022.”

P1/2 data • Melanoma • Oncology

Evaxion Biotech Reports Data from Phase 1/2a Trials of EVX-01 and EVX-02 (GlobeNewswire) - P1/2a, N=46; NCT04455503; Sponsor: Evaxion Biotech A/S; “Data from the first patients in the trial showed T-cell activation, even in assays which had not been prestimulated. Based on this readout, Evaxion will continue to generate more data from the trial with the aim of initiating a Phase 2 trial with EVX-02 in an adjuvant setting in the second quarter of 2022.”

P1/2 data • Melanoma • Oncology

Evaxion Biotech to Host Conference Call on EVX-01 and EVX-02 Phase 1/2a Data on July 8 (GlobeNewswire) - "Evaxion Biotech A/S...announced today that it will hold a conference call to discuss Phase 1/2a data on EVX-01 and EVX-02 on Thursday, July 8, 2021."

P1/2 data • 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