Focusing on lead programs BI-1206 and BI-1808, with strong clinical data and upcoming value-creation milestones
Phase 2a study of BI-1206 in combination with pembrolizumab in first-line NSCLC to initiate in H2 2025
LUND, SE / ACCESS Newswire / August 26, 2025 / 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 a strategic portfolio optimization initiative to maximize the probability of success for its lead clinical programs and optimize resource allocation across its portfolio, with an intensified focus on our most promising clinical assets.
Following a comprehensive strategic review, BioInvent will concentrate resources on advancing BI-1808, its first-in-class anti-TNFR2 antibody, currently in Phase 2a clinical development in solid cancer and cutaneous T-cell lymphoma (CTCL), as well as BI-1206, an FcyRIIB-blocking antibody, currently in Phase 2a in non-Hodgkin's lymphoma (NHL), and starting a Phase 2a trial in the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC). As part of this strategy, BioInvent will pause the development of Phase 1 programs for BI-1910 and BI-1607. Development of the oncolytic virus BT-001 will be pursued in an investigator-led trial in collaboration with Transgene. This refined focus is designed to accelerate the lead programs towards key clinical milestones and strengthen their pathway towards regulatory approval while ensuring operational excellence.
"This is an important next step for BioInvent," said Martin Welschof, Chief Executive Officer of BioInvent. "We are sharpening our clinical focus on our most advanced assets with the greatest potential impact and multiple upcoming catalysts, thus maintaining a strong foundation for future growth. Our decision reflects a disciplined, opportunity-driven approach that we believe will maximize both patient impact and shareholder value."
Dr. Welschof continued, "We see promising data supporting the potential of BI-1206 as part of a triple combination for the treatment of NHL and BI-1808 as a novel treatment of CTCL. Furthermore, we are about to initiate a Phase 2a study of BI-1206 in combination with pembrolizumab in the first line NSCLC setting, which represents a broad, high-value opportunity for the company."
The company will focus research and preclinical operations to fully support the lead clinical programs with cutting-edge science, retaining core capabilities to generate new clinical candidates ensuring long-term pipeline strength. Subject to negotiations with the trade unions, the Company will implement a workforce reduction of approximately 25 positions. The Swedish Public Employment Service will be notified today.
Following implementation of the new focus, the company expects its current cash resources to fund operations into Q1 2027, beyond multiple key clinical data readouts.
Expected Key Catalysts
The company has a number of upcoming milestones, including:
H2 2025: Phase 2a data for BI-1808 in combination with Keytruda (pembrolizumab) for the treatment of solid tumors
H1 2026: Additional data for BI-1206 triplet combination for the treatment of non-Hodgkin's lymphoma (NHL)
H1 2026: Additional data for BI-1808 for the treatment of cutaneous T-cell lymphoma (CTCL)
H2 2026: First read-out from the Phase 2a study of BI-1206 in combination with pembrolizumab for treatment-naïve NSCLC patients and uveal melanoma patients
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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 T-cell lymphoma. 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 an ongoing Phase 1/2a study.
About BI-1206
Fc?RIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking the receptor Fc?RIIB on tumor cells, BI-1206 is expected to recover and enhance the activity of rituximab and acalabrutinib in the treatment of several forms of NHL. BI-1206 is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is evaluated in two separate clinical Phase 1/2a programs, one for the treatment of solid tumors and one for the treatment of non-Hodgkin's lymphoma (NHL, a type of blood cancer). Both programs show encouraging clinical activity along with a good tolerability.
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 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.
This information is information that BioInvent International is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-08-26 08:29 CEST.
Attachments
BioInvent Announces Strategic Changes in Portfolio to Accelerate Lead Clinical Programs and Enhance Value Creation
SOURCE: BioInvent International
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/bioinvent-announces-strategic-changes-in-portfolio-to-accelerate-lead-clinical-progra-1065374
