LUND, SE / ACCESS Newswire / November 3, 2025 / BioInvent International AB ("BioInvent")(STO:BINV)(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 it will present new data from the safety run-in portion of its ongoing trial evaluating BI-1206 in combination with rituximab and Calquence ® (acalabrutinib) for the treatment of non-Hodgkin's lymphoma (NHL) in a poster at the upcoming 2025 American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, Florida.
Abstract data (as of August 4, 2025) published in the November supplemental issue of Blood demonstrates that the triple combination regimen is safe and well-tolerated, with encouraging efficacy data. Due to the current number of patients, it is important to note that the response rates are still fluctuating, and the data set will become more robust as patient numbers increase. A more recent data set will be included in the poster at ASH to be presented on December 8, 2025.
"We are very pleased with the progress of the trial and encouraged by both the safety and efficacy signals emerging from the safety run-in. We are delighted that ASH has accepted our data for a poster presentation" said Martin Welschof, Chief Executive Officer of BioInvent. "The data show that the triple combination is well-tolerated and the overall response rate is well on track to meet our goals. This would provide a strong foundation for advancing into the next phase, where we look forward to further evaluating the potential of this regimen to transform outcomes for patients and improve the standard of care."
Poster presentation details:
Title: Promising efficacy of BI-1206, an antibody targeting Fc?RIIB in combination with rituximab and acalabrutinib in R/R NHL patients
Date and Time: December 8, 2025, 6:00 PM - 8:00 PM ET
Session name: 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Lead Author: Laura Fogliatto, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
Publication Number: 5349
About the Phase 2a Study
The triple combination arm in the ongoing Phase 2a study (NCT03571568) combines the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib) in subjects with indolent B-cell non-Hodgkin's lymphoma (NHL) who have relapsed or are refractory to rituximab. Approximately 30 patients are expected to be enrolled in Spain, Germany, USA, and Brazil. In February 2024, BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence ® for the combination arm.
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. 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 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 2025-11-03 15:00 CET.
Attachments
BioInvent to Present Early Phase 2a Data from Ongoing Trial with Triple Combination of BI-1206, Rituximab, and Calquence in r/r NHL, at ASH 2025
SOURCE: BioInvent International
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/bioinvent-to-present-early-phase-2a-data-from-ongoing-trial-with-triple-combination-o-1096184
