ES2B-C001 / ExpreS2ion, AdaptVac - LARVOL DELTA

Austrian Regulatory Green Light Enables ADC Combination Testing and Phase I Site Expansion for ES2B-C001, a First-in-Class Breast Cancer Immunotherapy (Cision) - "ExpreS2ion Biotech Holding AB...announced that the Austrian regulatory authorities have approved the Company’s protocol amendment to evaluate its breast cancer immunotherapy candidate, ES2B-C001, in combination with HER2-targeted antibody-drug conjugates (ADCs) and to expand the number of trial sites. Filed on 13 May 2025, the amendment enables concurrent administration of ES2B-C001 alongside HER2-targeted ADCs (such as trastuzumab deruxtecan) in select patients and allows for an increase in the number of clinical trial sites in Austria. The Company had anticipated approval by mid-Q3 2025; this was received ahead of schedule on 30 June. The expanded protocol is expected to support improved patient recruitment."

Clinical protocol • HER2 Positive Breast Cancer

ExpreS2ion announces dosing of first patient in Phase I clinical trial of ES2B-C001, its novel therapeutic breast cancer immunotherapy (Cision) - "Today ExpreS2ion Biotech Holding AB...is pleased to announce that the first patient has been dosed in the Phase I clinical trial of ES2B-C001 (HER2-VLP), the company’s novel therapeutic breast cancer immunotherapy candidate. The first patient was dosed with ES2B-001, and it was well tolerated. The trial is being conducted in collaboration with the clinical staff at the Medical University of Vienna and investigates the safety and tolerability of ES2B-C001 in patients with metastatic HER2-expressing breast cancer."

Trial status • HER2 Positive Breast Cancer

A First-in-human, Clinical Trial Assessing the Safety of ES2B-C001-S01 With or Without [Adjuvant] in Patients With HER2 Expressing Metastatic Breast Cancer. (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: ExpreS2ion Biotechnologies | Initiation date: Dec 2024 ➔ Jun 2025

Trial initiation date • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

ExpreS2ion Biotech Announces Analysguiden Publishes Equity Research Report (TradingView) - "The Phase I study of ES2B-C001 has not yet enrolled patients, with protocol amendment under review to include patients treated with antibody drug conjugates, such as Enhertu. Approval of the protocol amendment is expected in Q3 2025, which could accelerate enrolment and timeline for interim data."

Clinical protocol • Breast Cancer

ExpreS2ion to Present in Upcoming Investor and Scientific Events (Cision) - "16 January 2025 | Institutional Investor Seminar...ExpreS2ion’s CEO, Bent Frandsen, will present at an Institutional Investor Seminar hosted by HC Andersen Capital. The presentation will focus on ES2B-C001, ExpreS2ion’s novel therapeutic breast cancer vaccine, which recently received Clinical Trial Application (CTA) approval from Austrian regulatory authorities for a Phase I clinical trial."

Clinical • HER2 Positive Breast Cancer

The Trial is a First-in-human, Phase I, Open-label, Dose-escalating Trial to Assess the Safety and Tolerability of ES2B-C001 Combined with Montanide or Without Montanide, in Patients with Human Epidermal Growth Factor Receptor 2 (HER2) Expressing Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: ExpreS2ion Biotechnologies | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Cardiovascular • HER2 Breast Cancer • Ischemic stroke • Oncology • Solid Tumor

The Trial is a First-in-human, Phase I, Open-label, Dose-escalating Trial to Assess the Safety and Tolerability of ES2B-C001 Combined With Montanide or Without Montanide, in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Expressing Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: ExpreS2ion Biotechnologies

New P1 trial • Breast Cancer • Cardiovascular • HER2 Breast Cancer • Ischemic stroke • Oncology • Solid Tumor

ExpreS2ion announces approval to initiate a Phase I clinical trial of ES2B-C001, its novel therapeutic vaccine, being developed for HER2-expressing breast cancer (Cision) - "ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies...is proud to announce the approval of its Phase I clinical trial application (CTA) by the Austrian Agency for Health and Food Safety for its novel therapeutic vaccine candidate, ES2B-C001, against HER2-expressing breast cancer....The open label, dose-escalation Phase 1 trial will assess the safety, tolerability, and maximum tolerated dose (MTD) of ES2B-C001, either alone or combined with the adjuvant Montanide. Up to 30 patients with metastatic breast cancer will participate in the study."

New P1 trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

At the gates of phase 1 (ExpreS2ion Biotech Press Release) - "ExpreS2ion Biotech has recently filed for starting a first-in-human study of its breast cancer vaccine candidate ES2B-C001 in women with a HER2 positive breast cancer. The application is a major step forward in its proprietary pipeline and the company expects first patient to start study treatment in Q1 next year...The Clinical Trial Application was submitted to the Austrian Agency for Health and Food Safety, BASG. Assuming no further questions are raised, we understand the agency has 35 calendar days to review the application. Once cleared by the authority and the ethics committee, the study will be conducted at the Medical University of Vienna...The full study is expected to last for 20 months, which should allow a final result by the end of 2026...we expect sales of ES2B-C001 to surpass USD 3bn....Our optimistic base case is a marketing approval of ES2B-C001 by 2030."

Approval • New P1 trial • P1 data • Sales projection • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

ExpreS2ion submits Clinical Trial Application (CTA) to conduct Phase I study of ES2B-C001, an innovative therapeutic breast cancer vaccine (Firstwordpharma Press Release) - "ExpreS2ion Biotech Holding AB’s...is proud to announce the submission of ExpreS2ion’s first CTA, to the Austrian Agency for Health and Food Safety (BASG/AGES) for its novel therapeutic candidate, ES2B-C001 against breast cancer. This submission marks an important milestone in the company’s objective to address significant unmet medical needs in oncology....The submission follows a series of successful preclinical safety and efficacy studies in animal models for breast cancer vaccine. In vitro data obtained with sera from vaccinated animals demonstrated ES2B-C001's potential to overcome resistance to the current immunotherapies used as standard of care inhibiting tumour cell growth, which could in-turn extend and improve patients’ quality of life."

New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

ExpreS2ion hosts informative webinar on 2024 Rights Issue and Highlights Key Updates on HER2+ Breast Cancer Vaccine (Nasdaq) - "ExpreS2ion Biotech...announces that its recent webinar covering the 2024 rights issue, hosted by CEO Bent Frandsen and CFO Keith Alexander, is now available for on-demand viewing. The webinar provided insights into the background and rationale for the rights issue, detailed the intended use of proceeds, outlined the structure of the offering, and explained how to participate. Additionally, CEO Bent Frandsen has recently delivered significant presentations at major life science forums, highlighting the progress and potential of the ES2B-C001 therapeutic HER2+ breast cancer vaccine....He emphasized that the additional capital will bolster the Company's ongoing efforts in advancing its pipeline of innovative therapeutics and vaccines. In particular, this capital injection is critical for initiating the phase I clinical trial of ES2B-C001, the Company’s groundbreaking therapeutic HER2+ breast cancer vaccine."

Financing • Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

ExpreS2ion announces a rights issue of units of approximately SEK 60 million (Nasdaq) - "The Board of Directors of ExpreS2ion Biotech Holding AB...has today, subject to subsequent approval by the Annual General Meeting to be held on 5 June 2024, resolved on a rights issue of units consisting of shares and warrants of series TO 10 and warrants of series TO 11 ('Units'), with preferential rights for existing shareholders, amounting to approximately SEK 60 million....Upon full subscription in the Rights Issue, the net proceeds from the Rights Issue will be used for (i) ES2B-C001 clinical phase initiation and progression, (ii) discovery pipeline and platform development, (iii) early preclinical development of a cytomegalovirus vaccine candidate, (iii) internal costs related to grant-sponsored projects and (iv) working capital including discovery pipeline and platform development."

Financing • Breast Cancer • Oncology • Solid Tumor

ExpreS2ion announces completion of GLP safety study for ES2B-C001 (HER2-VLP) breast cancer vaccine candidate (Cision) - "ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS...is pleased to announce the completion of the final report for the Good Laboratory Practice (GLP) safety study in non-human primates of the ES2B-C001 (HER2-VLP) breast cancer vaccine candidate....This significant milestone marks an important step towards enabling a clinical trial application. The Company is currently focusing on Good Manufacturing Practice (GMP) production and designing the Phase I clinical trial, with the aim to initiate the Phase I trial within the next year."

New P1 trial • Preclinical • Breast Cancer • Oncology • Solid Tumor

ExpreS2ion evaluates strategic options for its breast cancer vaccine candidate (Cision) - "ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS...today announces that the Board has decided to assess strategic options for the ES2B-C001 breast cancer project, aimed at conserving capital resources to further advance the company’s exploratory vaccine pipeline and technology platforms...Certain activities to advance the breast cancer program towards CTA readiness will continue, including the ongoing GLP preclinical safety toxicology study. '...despite the remarkable preclinical proof-of-concept data for the breast cancer vaccine candidate ES2B-C001, the decision has been made to pause the program and focus on identifying new ways to bring the asset forward.'"

Commercial • Breast Cancer • Oncology • Solid Tumor

Preclinical activity of ES2B-C001, a human candidate HER-2 virus-like particle (VLP) vaccine, against mammary carcinoma onset and metastasis (AACR 2023) - "Antibodies inhibited the 3D growth of human HER-2+++ and HER-2++ breast cancer cells, of trastuzumab resistant cells and of gastric carcinoma cells. Vaccination increased interferon-gamma secreting cells in the spleen, as evaluated by ELISPot (21±3 spots/2x105 cells). The results warrant further development of ES2B-C001 for the therapy of HER-2 positive human breast cancer and of other tumors expressing HER-2."

Preclinical • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • IFNG

Prevention and Therapy of Metastatic HER-2 Mammary Carcinoma with a Human Candidate HER-2 Virus-like Particle Vaccine. (PubMed, Biomedicines) - "Antibodies inhibited the 3D growth of human HER-2 trastuzumab-sensitive and -resistant breast cancer cells. ES2B-C001 is a promising candidate vaccine for the therapy of tumors expressing HER-2. Preclinical results warrant further development towards human clinical studies."

Journal • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2 • IFNG

"ExpreS2ion provides an update on its novel breast cancer vaccine candidate ES2B-C001 https://t.co/YrwCDIo5bs" (@CisionNews)

Clinical • Breast Cancer • Oncology • Solid Tumor

Lead candidate selected in ExpreS2ion’s HER2-cVLP breast cancer vaccine project (Cision) - “ExpreS2ion Biotech…announces the selection of its lead candidate HER2-cVLP breast cancer vaccine. The project runs according to plan…The ES2B-C001 breast cancer vaccine programme continues to be on path towards expected preclinical proof of concept data at the end of 2021, as well as starting the clinical program in 2022 with GMP manufacturing of ES2B-C001 with the plan to start a clinical Phase I safety and immune response study in beginning of 2023.”

Commercial • New P1 trial • Preclinical • Breast Cancer • HER2 Breast Cancer • Oncology

ExpreS2ion updates on its pipeline outlook, including for COVID-19 and HER2 breast cancer projects (Cision) - “ExpreS2ion Biotech…presents an updated outlook for its pipeline development projects…ES2B-C001 HER2-cVLP breast cancer vaccine…Preclinical proof of concept data for ES2B-C001 is expected at the end of 2021. The clinical program is expected to start in 2022 with GMP manufacturing of ES2B-C001. A clinical Phase I safety and immune response study is planned to start in Q1 2023. The study will explore key variables for immunization success. Based on the expected vaccine profile, ES2B-C001 is anticipated to replace current HER2-directed agents like trastuzumab and pertuzumab, both in metastatic and later adjuvant settings, leading to potential blockbuster sales scenarios.”

Commercial • New P1 trial • Preclinical • Breast Cancer • HER2 Breast Cancer • Oncology

ExpreS2ion will participate at key industry and investor events in March 2021 (Cision) - “ExpreS2ion Biotech…will participate and hold presentations at key industry and investor events in March, all of which will be held digitally. These include Aktiespararna’s Aktiedagen (March 16), the St. Gallen International Breast Cancer Conference (March 17-21), and BIO-Europe Spring (March 22-25)… The company aims to increase the awareness of the ExpreS2 technology platform and its exciting development pipeline, including the novel ES2B-C001 HER2-cVLP breast cancer vaccine.”

Clinical • Breast Cancer • HER2 Breast Cancer • Oncology

ExpreS2ion and University of Bologna announce research collaboration to test HER2-cVLP in state-of-the-art breast cancer mice models (Cision) - “ExpreS2ion Biotech…and the University of Bologna…announce a research collaboration agreement (‘Agreement’) which covers testing of the novel HER2-cVLP breast cancer vaccine program, including the selected lead candidate ES2B-C001, in proprietary state-of-the-art breast cancer mice models. The collaboration follows the recently presented in-licensing of the HER2-cVLP technology from AdaptVac. The outcome of the collaboration is expected to support ExpreS2ion’s breast cancer vaccine project and will constitute a proof of preclinical concept.”

Licensing / partnership • Breast Cancer • Oncology