BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced that one of the company's lead program; BI-1808 as monotherapy in Cutaneous T Cell Lymphoma (CTCL) will be presented at the 16th Annual T-Cell Lymphoma Forum held March 20-22, 2025 in La Jolla, California.

The data, previously disclosed in a press release in September 2024, will be featured in a poster presentation highlighting the early efficacy of BI-1808 monotherapy in the ongoing Phase 2a dose expansion study in CTCL. So far three partial responses (PR) and one stable disease (SD) out of four evaluable patients have been reported. The Company anticipates reporting additional data from the study in mid-2025.

BI-1808, a first-in-class anti-TNFR2 antibody, was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of TCL.

Poster presentation details:

Title: Evidence of T reg depletion and Corresponding Early Efficacy after Tumor Necrosis Factor Receptor 2 (TNFR2) Blockade by BI-1808 in Cutaneous T Cell Lymphoma (CTCL) Patients
Session Date and Time: March 21st, 2025, 5:30 pm PT
Lead Author: Stefan Barta, University of Pennsylvania Hospital, PA, USA
Abstract Number: TCLF34

The poster will be uploaded on the company website in the Scientific Publications section: https://www.bioinvent.com/en/our-science/scientific-publications.

About BI-1808
The anti-TNFR2 antibody BI-1808 is part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapy. BI-1808 is a first-in-class drug candidate in clinical development for the treatment of solid tumors and blood cancer. BI-1808 has shown single agent activity and excellent tolerability in an ongoing Phase 2a study and signs of efficacy and favorable safety profile in combination with pembrolizumab in the ongoing Phase 1/2a study.

About the Phase 1/2a study
During the first part of the Phase 1/2a study (NCT04752826) the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent (part A) and in combination with the anti-PD-1 therapy pembrolizumab (part B) are evaluated in patients with advanced solid tumors and T-cell lymphoma. The efficacy of BI-1808 as single agent is currently explored in the Phase 2a part of the trial in a larger sample of patients. Expansion cohorts include ovarian cancer, all tumor types and T-cell lymphoma (including CTCL). The dose escalation in Phase 1 part B has been completed and the Phase 2a dose expansion study for the combination is ongoing. The expansion cohorts are planned to include ovarian cancer, all tumor types and T-cell lymphoma (including CTCL).

To date, results from the single agent CTCL cohort show three patients with partial response (PR) and one with stable disease (SD) out of four evaluable patients. All these patients had previously deteriorated after standard treatment. These data support the single agent data disclosed earlier in 2024, showing one complete response (CR), one PR and nine patients with SD, presented at the American Society of Clinical Oncology conference (ASCO) in June 2024. Additional data from Phase 2a study of single agent BI-1808 are expected by mid-2025.

About BioInvent
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities.

The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com.

For further information, please contact:
Cecilia Hofvander, VP Investor Relations
Phone: +46 (0)46 286 85 50
Email: cecilia.hofvander@bioinvent.com

BioInvent International AB (publ)
Co. Reg. No.: 556537-7263
Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
www.bioinvent.com

The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.

Attachments

BioInvent's anti-TNFR2 antibody BI-1808 showcased at the 16th Annual T-Cell Lymphoma Forum