Drugs / ES2B-C001
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | female breast nipple and areola cancer | 2024-08-06 | “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.” expres2ionbio.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06746688 | Jun 2025 → Dec 2026 expected | breast cancer | ExpreS2ion Biotechnologies | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-08-12 | ExpreS2ion Biotechnologies | Results ExpreS2ion Reports Positive DSMB Outcome and Expanded Preliminary Phase I Data for ES2B-C001 expres2ionbio.com ↗
Preliminary data show anti-HER2 antibody responses in 12 of 13 evaluable patients, including all five patients who have completed the dosing schedule, with a median 16-fold peak increase in antibody levels among completers. |
| 2026-05-19 | ExpreS2ion Biotechnologies | Results ExpreS2ion Updates ES2B-C001 Phase I Programme and Reports Additional Preliminary Immunogenicity and Safety Observations expres2ionbio.com ↗
ExpreS2ion also reports additional preliminary Phase I observations, including anti-HER2 antibody responses in 9 of 9 evaluable patients and no safety signals of concern identified to date, including in the first patient dosed in the 450 µg cohort. |
| 2026-03-25 | ExpreS2ion Biotechnologies | Results ExpreS2ion reports consistent, durable anti-HER2 responses; advances ES2B-C001 Phase I after independent DSMB review expres2ionbio.com ↗
The updated dataset shows anti-HER2-specific antibody responses in eight of nine evaluable patients, with antibody titres increasing over time following repeated dosing. |
| 2026-02-03 | ExpreS2ion Biotechnologies | Results ExpreS2ion Biotech reports encouraging immunogenicity observations from ongoing Phase I trial of ES2B-C001 expres2ionbio.com ↗
Based on data currently available, five out of six evaluable patients have demonstrated a drug-specific immune response, defined as an increase from baseline in anti-HER2 lambda light-chain antibody titers following treatment with ES2B-C001. |
| 2025-12-19 | ExpreS2ion Biotechnologies | Results ExpreS2ion Reports Updated Immunogenicity Data from First Three Patients and DSMB Recommendation to Progress ES2B-C001 Phase I Trial to Next Dose Cohort expres2ionbio.com ↗
Based on analyses from the first cohort, ExpreS2ion has observed induction of HER2-specific immune responses following vaccination in multiple patients, with antibody levels increasing to levels significantly above pre-dose baseline. |
| 2025-09-04 | ExpreS2ion Biotechnologies | Results ExpreS2ion Reports First Immunogenicity Data from HER2 Breast Cancer Vaccine ES2B-C001 Phase I Trial expres2ionbio.com ↗
Encouragingly, a significant increase in HER2-specific antibodies was observed three weeks after the second dose, compared to pre-dose baseline. |
| 2025-06-30 | ExpreS2ion Biotechnologies | Regulatory Austrian Regulatory Green Light Enables ADC Combination Testing and Phase I Site Expansion for ES2B-C001, a First-in-Class Breast Cancer Immunotherapy expres2ionbio.com ↗
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. |
| 2025-05-21 | ExpreS2ion Biotechnologies | Regulatory ExpreS2ion Biotech Announces Pareto Securities Analyst Update on Q1 2025 Results and Clinical Trial Progress expres2ionbio.com ↗
An amendment request to the clinical trial protocol has been submitted, aiming to enable combination therapy with antibody-drug-conjugates and expand referral centre networks, anticipated to be approved in Q3 2025. |
| 2025-05-13 | ExpreS2ion Biotechnologies | Regulatory ExpreS2ion files clinical trial amendment to enable combination testing of ES2B-C001 with antibody-drug conjugates and to expand the number of study sites expres2ionbio.com ↗
today announced that it has submitted a study protocol amendment to the Austrian regulatory authorities to enable the evaluation of its breast cancer vaccine candidate, ES2B-C001, in combination with antibody-drug conjugates (ADCs) and to expand the number of study sites. |
| 2024-12-02 | ExpreS2ion Biotechnologies | Regulatory ExpreS2ion announces approval to initiate a Phase I clinical trial of ES2B-C001, its novel therapeutic vaccine, being developed for HER2-expressing breast cancer expres2ionbio.com ↗ |
| 2024-08-06 | ExpreS2ion Biotechnologies | Regulatory ExpreS2ion submits Clinical Trial Application (CTA) to conduct Phase I study of ES2B-C001, an innovative therapeutic breast cancer vaccine expres2ionbio.com ↗ |
| 2023-04-18 | ExpreS2ion Biotechnologies | Results ExpreS2ion announces poster presentation on ES2B-C001 at the AACR Annual Meeting 2023 expres2ionbio.com ↗
ES2B-C001 vaccination inhibited the onset, growth, and metastatic spread of HER-2 positive mammary carcinomas in mice. |
| 2022-10-24 | ExpreS2ion Biotechnologies | Results Scientific article published about ExpreS2ion’s human candidate HER-2 virus-like particle vaccine, ES2B-C001 expres2ionbio.com ↗
Preclinical results warrant further development towards human clinical studies. |
| 2022-05-25 | ExpreS2ion Biotechnologies | Results Additional positive preclinical proof-of-concept results for the HER2-cVLP breast cancer vaccine expres2ionbio.com ↗ |
| 2022-01-04 | ExpreS2ion Biotechnologies | Results ExpreS2ion announces further positive preclinical proof-of-concept results for the HER2-cVLP breast cancer vaccine expres2ionbio.com ↗
ES2B-C001 formulated in an adjuvant effectively inhibited tumor development, whereas the control group progressively expanded with tumor development. |
| 2021-12-22 | ExpreS2ion Biotechnologies | Results ExpreS2ion announces positive topline results for its HER2-cVLP breast cancer vaccine, demonstrating animal proof-of-concept expres2ionbio.com ↗
ES2B-C001 formulated in an adjuvant was found to totally block tumor development, whereas the control group progressively expanded with lung metastases and subcutaneously growing local tumors. |
All press releases naming this drug 20 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ES2B-C001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06746688 ↗ |