BioInvent's BI-1206 Triplet Achieves 83% Response Rate in Refractory NHL with Improved Safety vs. SOC (EHA 2026)

BioInvent will host an in-person KOL lunch briefing (11:45 a.m. - 2:00 p.m. CEST / 5:45 - 8:00 a.m. EDT) in conjunction with EHA 2026 Congress today (virtual event link here)83% ORR across all evaluable patients in the total non-Hodgkin's lymphoma (NHL) population (n=23)81% objective response rate (ORR) and 44% complete response rate (CRR) in relapsed/refractory follicular lymphoma (FL), on par with the recently approved tafasitamab+R2 (rituximab + Revlimid) combinationMarkedly lower rate of serious adverse events (14%) versus tafasitamab+R2 (34%), obinutuzumab+zanubrutinib (35%), rituximab+lenalidomide "R2" (29-32%), and epcoritamab+R2 (56%)Only 3% TEAE (treatment emergent adverse events)-related treatment discontinuation, compared to 7%-19% across R2-based standard-of-care regimensAcalabrutinib (Calquence®) with BI-1206 + rituximab boosted efficacy without increasing toxicity LUND, SE / ACCESS Newswire / June 11, 2026 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a leader in the discovery of novel immune-modulatory antibodies, today announced new clinical data from the BI-1206 triplet combination in relapsed/refractory (R/R) non-Hodgkin's lymphoma (NHL) to be presented in a poster at the 31st European Hematology Association (EHA2026) Congress, taking place June 11-14, 2026 in Stockholm, Sweden.The poster summarizes key efficacy, safety, and mechanistic data from the ongoing Phase 1/2 study (NCT03571568) evaluating BI-1206 in combination with rituximab and Calquence® (acalabrutinib) in patients with relapsed or refractory NHL, including follicular lymphoma. BI-1206 directly targets FcγRIIB-mediated rituximab internalization, a major driver of resistance to CD20-directed therapy, while leveraging BTK inhibition with acalabrutinib to enhance anti-tumor activity."These EHA data reinforce our conviction that BI-1206 has the potential to meaningfully change the treatment landscape for patients with relapsed or refractory follicular lymphoma," said Martin Welschof, Chief Executive Officer of BioInvent. "An 81% response rate that matches or exceeds recently approved combinations - coupled with a safety profile that is markedly more favorable than the widely used R2-based regimens - is exactly the kind of differentiated clinical profile we set out to build. BI-1206 is now the cornerstone of our NHL strategy, and we look forward to advancing this program toward pivotal development as we work to bring a compelling new option to patients who urgently need it."Overview of data included in the poster at EHA 2026The BI-1206 triplet exhibits an ORR and safety profile consistent with established clinical benchmarks, including standard-of-care (SOC) R2 therapy and the recently approved tafasitamab+R2 combination, underscoring its potential as a highly competitive therapeutic option in R/R FL.As of data cut-off May 6, 2026, the triplet of BI-1206 + rituximab + acalabrutinib delivered an 83% objective response rate (ORR) in the total population (n=23 evaluable), with 11 complete responses (CR) and 8 partial responses (PR).In the follicular lymphoma (FL) subset (n=16), ORR was 81% and complete response rate (CRR) was 44%.All remaining patients exhibited stable disease as best response, giving a disease control rate (DCR) of 100%.The cohort has been completely enrolled, though response assessment has not yet occurred for all patients; as the majority of patients are still on treatment, any PFS (progression-free survival) calculation is yet premature.The regimen showed a very favorable tolerability profile, with treatment-related serious adverse events observed in only 4 (14%) patients and discontinuation due to a drug-related adverse event in 1 patient. Grade 3+ treatment-related adverse events observed in only 31% of patients, versus 54-84% for comparator regimens.Poster presentation detailsTitle: Targeting resistance to rituximab through FcγRIIB (CD32B) blockade: BI-1206 + rituximab + acalabrutinib shows powerful activity in R/R NHLPresenter: Dr. Laura Fogliatto, Hospital de Clínicas de Porto Alegre, BrazilSession Date/Time: Friday, June 12, 6:45 pm-7:45 pm CEST (12:45 pm-1:45 pm EDT)Location: EHA2026 Congress, StockholmThe poster will be posted to the Scientific Publications section of the company website (https://www.bioinvent.com/en/our-science/scientific-publications) when the presentation has occurred.About the BI-1206 Phase 2a part of the studyThe triple combination arm in the ongoing Phase 2a part of the study (NCT03571568) combines the subcutaneous formulation of BI-1206 with rituximab and acalabrutinib in subjects with indolent B-cell non-Hodgkin's lymphoma (NHL) who have relapsed or are refractory to rituximab. Patient enrolment (approximately 30 patients) has been completed in Spain, Germany, USA, and Brazil. BioInvent has a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) providing Calquence® (acalabrutinib) for the combination arm.About BI-1206FcγRIIB is overexpressed in several forms of NHL and its overexpression has been associated with poor prognosis in difficult-to-treat subtypes, including mantle cell lymphoma. FcγRIIB-mediated internalization of rituximab is a well-established driver of resistance to CD20-directed therapy. By blocking this receptor on tumor cells, BI-1206 is designed to restore and enhance rituximab activity in combination regimens. The clinical rationale for the BI-1206 triplet is supported by the ROSEWOOD trial (Zinzani et al., JCO 2023), which showed that adding the BTK inhibitor zanubrutinib to the Fc-engineered anti-CD20 antibody obinutuzumab - which has reduced but not absent FcγRIIB-mediated internalization - increased ORR from 45% to 69% and median PFS from 10.4 to 28 months in R/R FL. By contrast, acalabrutinib added to standard rituximab yielded only 31% ORR and a median PFS of 8.3 months (Strati et al., Br J Haem 2024), despite similar BTK kinase profiles for the two inhibitors. These data point to improved CD20 targeting - not BTK inhibition per se - as the key driver of superior outcomes. Because BI-1206 directly targets FcγRIIB-mediated internalization, combining it with rituximab and acalabrutinib offers a mechanistically distinct approach to overcoming rituximab resistance. The 81% ORR observed in the EHA 2026 data, substantially exceeding the 31% seen with acalabrutinib plus rituximab alone, is consistent with this hypothesis. BI-1206 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 BioInventBioInvent 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 drug candidates in 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 RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.comThe 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.AttachmentsBioInvent's BI-1206 Triplet Achieves 83% Response Rate in Refractory NHL with Improved Safety vs. SOC (EHA 2026)SOURCE: BioInvent InternationalView the original press release on ACCESS Newswire

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