[Translation] A Phase I study with a safety run-in of BI-1206 (a CD32b [FcγRIIB] monoclonal antibody) in combination with rituximab in patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma

主要目的：评价BI-1206在第一阶段的安全性导入部分的安全性、耐受性；评价BI-1206与利妥昔单抗联合治疗复发性或难治性的惰性B细胞非霍奇金淋巴瘤（NHL）的安全性和耐受性；通过确立BI-1206的最大耐受剂量（MTD）（以静脉输注[IV]方式按周次给药，连续4周，与利妥昔单抗联合用药）来选择推荐的Ⅱ期剂量（RP2D）。如果药代动力学（PK）和药效学（PD）数据表明当前剂量为与国外临床研究17-BI-1206-02可比的最佳治疗剂量，则可在达到临床研究17-BI-1206-02获得的MTD之前，由队列审查委员会（CRC）决定暂停剂量递增，并基于PK和PD数据确定RP2D。

[Translation]

Primary objectives: To evaluate the safety and tolerability of BI-1206 in the safety lead-in part of Phase I; To evaluate the safety and tolerability of BI-1206 in combination with rituximab in the treatment of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma (NHL); To select the recommended Phase II dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 (administered weekly by intravenous infusion [IV] for 4 consecutive weeks in combination with rituximab). If the pharmacokinetic (PK) and pharmacodynamic (PD) data indicate that the current dose is the best therapeutic dose comparable to that obtained in the foreign clinical study 17-BI-1206-02, the cohort review committee (CRC) may decide to suspend dose escalation before the MTD obtained in the clinical study 17-BI-1206-02 is reached, and the RP2D may be determined based on the PK and PD data.

Start Date25 Jul 2022

Sponsor / Collaborator

CASI (China) Pharmaceuticals Technology Co., Ltd.

NCT04219254

/ RecruitingPhase 1/2

A Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Start Date29 Jun 2020

Sponsor / Collaborator

BioInvent International AB

[+1]

NCT03571568

/ RecruitingPhase 1/2

Phase 1/2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab

Start Date16 May 2018

Sponsor / Collaborator

BioInvent International AB

100 Clinical Results associated with BI-1206

100 Translational Medicine associated with BI-1206

100 Patents (Medical) associated with BI-1206

Literatures (Medical) associated with BI-1206

01 Dec 2022·Journal of hematology & oncology

Targeting FcγRIIB by antagonistic antibody BI-1206 improves the efficacy of rituximab-based therapies in aggressive mantle cell lymphoma

Letter

Author: Huang, Shengjian ; Wang, Michael ; Zhang, Rongjia ; Karlsson, Ingrid ; Teige, Ingrid ; Nie, Lei ; Kovacek, Mathilda ; Jordan, Alexa ; Frendéus, Björn ; Liu, Yang ; Li, Yijing ; Jiang, Vivian Changying ; Cai, Qingsong ; Che, Yuxuan ; Leeming, Angela ; Chen, Zhihong ; Mårtensson, Linda ; McIntosh, Joseph

Abstract:

Inevitable relapses remain as the major therapeutic challenge in patients with mantle cell lymphoma (MCL) despite FDA approval of multiple targeted therapies and immunotherapies. Fc gamma receptors (FcγRs) play important roles in regulating antibody-mediated immunity. FcγRIIB, the unique immune-checkpoint inhibitory member of the FcγR family, has been implicated in immune cell desensitization and tumor cell resistance to the anti-CD20 antibody rituximab and other antibody-mediated immunotherapies; however, little is known about its expression and its immune-modulatory function in patients with aggressive MCL, especially those with multi-resistance. In this study, we found that FcγRIIB was ubiquitously expressed in both MCL cell lines and primary patient samples. FcγRIIB expression is significantly higher in CAR T-relapsed patient samples (p < 0.0001) compared to ibrutinib/rituximab-naïve, sensitive or resistant samples. Rituximab-induced CD20 internalization in JeKo-1 cells was completely blocked by concurrent treatment with BI-1206, a recombinant human monoclonal antibody targeting FcγRIIB. Combinational therapies with rituximab-ibrutinib, rituximab-venetoclax and rituximab-CHOP also induced CD20 internalization which was again effectively blocked by BI-1206. BI-1206 significantly enhanced the in vivo anti-MCL efficacy of rituximab-ibrutinib (p = 0.05) and rituximab-venetoclax (p = 0.02), but not the rituximab-CHOP combination in JeKo-1 cell line-derived xenograft models. In patient-derived xenograft (PDX) models, BI-1206, as a single agent, showed high potency (p < 0.0001, compared to vehicle control) in one aggressive PDX model that is resistant to both ibrutinib and venetoclax but sensitive to the combination of rituximab and lenalidomide (the preclinical mimetic of R2 therapy). BI-1206 sensitized the efficacy of rituximab monotherapy in a PDX model with triple resistance to rituximab, ibrutinib and CAR T-therapies (p = 0.030). Moreover, BI-1206 significantly enhanced the efficacy of the rituximab-venetoclax combination (p < 0.05), which led to long-term tumor remission in 25% of mice. Altogether, these data support that targeting this new immune-checkpoint blockade enhances the therapeutic activity of rituximab-based regimens in aggressive MCL models with multi-resistance.

Graphical Abstract:

01 Sep 2020·Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, IncQ4 · AGRICULTURAL & FORESTRY SCIENCE

Preparation, identification, and functional analysis of monoclonal antibodies against atypical porcine pestivirus NS3 protein

Q4 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Yang, Wenting ; Huang, Jingling ; Chen, Jianing ; Yan, Miaomiao ; Liu, Guangliang

Atypical porcine pestivirus (APPV) had been detected in many countries. However, to date, a commercial detection kit is not available because of a lack of specific monoclonal antibodies (mAbs) to APPV. We generated 7 mAbs targeting the NS3 protein of APPV. Isotyping results indicated that all of these mAbs are IgG1 with a kappa light chain. We analyzed the epitopes recognized by mAbs 2B6, 6G11, 8D1, 8D3, and 8F12, which recognized the same linear epitope (GRIKSAYSDE); the 6H3 and 7E10 mAbs recognized 2 different conformational epitopes. Applications of these antibodies were verified by ELISA, western blot, indirect immunofluorescence assay, and flow cytometry. The antibodies were functionally workable for these immunoassays except for 8F12, which could not be used in flow cytometry.

01 Sep 2016·Experimental parasitologyQ4 · MEDICINE

Insights into the biological features of the antigenic determinants recognized by four monoclonal antibodies in redia and adult stages of the liver fluke Fasciola hepatica

Q4 · MEDICINE

Article

Author: Hernández, Hilda ; Mosqueda, Maryani ; Sánchez, Jorge ; Rodríguez, Suanel Y ; Marcet, Ricardo ; Alfonso, Carlos ; Sarracent, Jorge ; Otero, Oscar ; Alba, Annia ; Capó, Virginia

Fasciola hepatica is a digenean trematode which infects a wide variety of domestic animals and also humans. Previous studies have demonstrated that four monoclonal antibodies (Mabs) against the total extract of F. hepatica redia (named as 1E4, 6G11, 4E5 and 4G11) also recognized the excretion - secretion antigens (ES Ag) of adult parasites, which is a biologically-relevant mixture of molecules with functional roles during infection and immune evasion on definitive hosts. In the present report we describe the partial characterization of the epitopes recognized by these Mabs by heat treatment, mercaptoethanol reduction, pronase proteolysis and sodium peryodate oxidation, which suggested their predominant protein and conformational nature. Also, a comparative study using immunodetection assays on crude extracts and on histological sections of both rediae and adults of F. hepatica were performed to explore the expression pattern of the antigenic determinants in these developmental stages. From these experiments it was found that the Mabs reacted most likely with the same proteins of approximately 64 and 105 kDa present on both rediae and adult's extracts. However, the 1E4, 6G11 and 4E5 Mabs also recognized other molecules of the total extract of F. hepatica adults, a fact that constitutes an evidence of the antigenic variation between both stages and points at a certain biological relevance of the recognized antigenic determinants. Immunolocalization studies on histological sections revealed that all Mabs reacted with the tegument of F. hepatica in both rediae and adults stages, while the epitopes recognized by 1E4, 6G11 and 4E5 antibodies were also preferentially localized in the intestinal caeca and in different organs of the reproductive system of adult specimens. The immunogenicity of these antigenic determinants, their conserved status among different stages of the life cycle of F. hepatica and their presence in both tegument and ES Ag of adult parasites, are suitable features that suggest their potential use for developing an epitope-based vaccine for fasciolosis control.

News (Medical) associated with BI-1206

08 Dec 2025

·www.bioinvent.com

BioInvent Presents Impressive Response Data from Ongoing Phase 2a Trial of Triple Combination BI-1206, Rituximab, and Calquence in r/r NHL at ASH 2025

Early data indicate that BI-1206 has the potential to reset one of the main resistance mechanisms to rituximab 47% of patients exhibited complete responses (CR), with an overall response rate of 80% Favorable safety profile with most (87%) adverse events being mild or moderate and no treatment-related discontinuations The safety run-in portion is complete with no apparent differences in safety or efficacy between the two dose levels; the signal-seeking expansion phase of the study is ongoing Lund, Sweden – December 8, 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 the presentation of new data from the safety run-in portion of its ongoing trial evaluating BI-1206, an anti-FcγRIIB antibody, in combination with rituximab and Calquence® (acalabrutinib) for the treatment of non-Hodgkin's lymphoma (NHL) at the 2025 American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. Anti-CD20 antibodies like rituximab are essential for treating NHL. However, 15% of patients do not respond to treatment, and 25% relapse within 3 years. Resistance to rituximab is often driven by FcγRIIB-mediated internalization. BI-1206 blocks this mechanism, restoring rituximab activity, and the doublet rituximab+BI-1206 combination has previously demonstrated a highly encouraging response rate in relapsed/refractory NHL. The early data presented at ASH this year indicate that combining BI-1206 with rituximab and Bruton's tyrosine kinase (BTK) inhibitor acalabrutinib may offer a synergistic approach to overcoming resistance and improving outcomes. “These results demonstrate that BI-1206, in combination with rituximab and acalabrutinib, could represent a promising new option for patients with indolent NHL who have limited treatment alternatives,” said Martin Welschof, Chief Executive Officer of BioInvent. “These impressive early signs of efficacy, along with a remarkable safety profile provide a strong rationale for advancing BI-1206 for the treatment of CD20 expressing blood cancers.” The 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. Summary of data:Among 15 evaluable patients in the safety run-in (data cut off December 1, 2025), the overall response rate was 80% (7 CR, 5 partial responses, PR), with 47% achieving complete responses. Disease control rate was 100%, and the majority of subjects were still on treatment as of the data cut off. The treatment regimen was remarkably well-tolerated and most (87%) treatment-related adverse events were mild or moderate. Seven subjects had Grade 3 events considered related or possibly related to at least one of the study drugs, including neutropenia and lymphopenia. Two serious adverse events were recorded: grade 2 pain in extremity, grade 3 neutropenia. There were no discontinuations due to adverse events. Notably, no cytokine release syndrome, neurologic toxicity or serious infections related to treatment have been observed. The safety run-in portion of the trial is complete with no apparent differences in safety or efficacy between the two dose levels. Results support continued enrollment into the expansion phase and suggest that the triplet regimen may offer a valuable therapeutic option for patients with indolent NHL who are refractory to rituximab. Poster presentation details:Title: Promising efficacy of BI-1206, an antibody targeting FcγRIIB in combination with rituximab and acalabrutinib in R/R NHL patientsDate and Time: December 8, 2025, 6:00 PM - 8:00 PM ETSession name: 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster IIILead Author: Laura Fogliatto, Hospital de Clínicas de Porto Alegre, Porto Alegre, BrazilPublication Number: 5349 The poster will be posted to the Scientific Publications section of the company website (https://www.bioinvent.com/en/our-science/scientific-publications). ### About the Phase 2a StudyThe 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-1206FcγRIIB 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 FcγRIIB 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 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 current 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.com BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.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.

Phase 2License out/inImmunotherapyClinical ResultASH

18 Nov 2025

·www.bioinvent.com

BioInvent Announces Publication of Preclinical and Early Phase 1 Data for BI-1607 in HER2-Positive Advanced Solid Tumors

Most (78%) patients experienced disease control (stable disease), including heavily pretreated individuals with HER2-positive breast and gastric cancers A favorable clinical safety profile and early signs of efficacy further support the potential of FcγRIIB-blocking monoclonal antibodies in multiple solid tumors BioInvent remains focused on BI-1206, its lead FcγRIIB‑blocking antibody, and BI-1808, its anti-TNFR2 antibody, and the BI‑1607 program is currently paused Lund, Sweden – November 18, 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 that preclinical data and early clinical results from its first‑in-human study of BI‑1607, a novel FcγRIIB-blocking monoclonal antibody, have been published in the peer-reviewed journal Clinical Cancer Research, a journal of the American Association for Cancer Research. The publication, entitled “A First-in-Class Monoclonal Antibody (BI-1607) Targeting FcRIIB: Preclinical Data and First-in-Human Studies in Patients with HER2-Positive Advanced Solid Tumors,” highlights the preclinical rationale and early clinical findings from the Phase 1 dose-escalation study (NCT05555251). While the BI-1607 program is currently on pause as BioInvent prioritizes its more advanced clinical-stage programs BI‑1206 and BI-1808, the Company remains encouraged by the scientific and clinical insights generated from this study.[1] "The publication of our BI-1607 study in Clinical Cancer Research underscores the potential of FcγRIIB blockade as a novel strategy to enhance the efficacy of tumor-targeting antibodies,” said Martin Welschof, Chief Executive Officer of BioInvent. “While we have paused this program to focus on our lead clinical candidates, the data further validate tailored FcyR-blockade to enhance antibody immunotherapy. Our lead FcγRIIB blocking antibody, BI-1206, is developed to enhance efficacy and overcome rituximab resistance in NHL, as well as to enhance anti-PD-1 in solid cancers." "BI-1607 was well-tolerated and showed encouraging disease control in a heavily pretreated population,” said Andres McAllister, Chief Medical Officer at BioInvent. “The ability to safely achieve full receptor saturation opens the door to future studies combining BI-1607 with other therapeutic antibodies”. In this first-in-human study, data demonstrate that BI-1607 can be safely administered and combined with trastuzumab (anti-HER2) at doses achieving sustained and complete FcγRIIB saturation. Given its mode of action, BI-1607 is not expected to have single agent activity. The choice of trastuzumab as the combination agent in this trial was based on promising preclinical studies and a recognized need for additional options for those patients who fail to respond or stop responding to trastuzumab. Ultimately, if shown to be safe and effective in combination with trastuzumab, BI-1607 can also be used in combination with other cytotoxic or immunomodulatory antibodies for cancer treatment. The full article is available here: A First-in-Class mAb (BI-1607) Targeting FcγRIIB: Preclinical Data and First-in-Human Studies in Patients with HER2-Positive Advanced Solid Tumors | Clinical Cancer Research | American Association for Cancer Research Key findings in summary: Early signs of clinical efficacy A majority of the evaluable patients (78%) experienced disease control (stable disease), including heavily pretreated individuals with HER2-positive breast and gastric cancers, with the longest duration of 6 months Tumor progression in target lesions was observed in 2 subjects, both from the low dose groups BI-1607 showed excellent drugability BI-1607 was well-tolerated across the dose range, and maximum tolerated dose could not be identified The pharmacokinetic and pharmacodynamic profile in humans were very favorable, and sustained target saturation could be achieved with every three weeks dosing. About BI-1607 Like BI-1206, BioInvent’s lead FcyRIIB antibody, BI-1607 is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. Trastuzumab alone or in combination with chemotherapy significantly improves overall survival of HER2 postive breast cancer patients. However, many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607 differs from BI-1206 in that BI-1607 has been engineered for reduced Fc-binding to FcyRs. This alteration generates a major differentiating factor between the two antibodies, and specifically with respect to the best combination partners. 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 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 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. [1] As announced in August of this year (more details here), 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 has paused the development of Phase 1 programs for BI-1910 and BI-1607.

ImmunotherapyPhase 1Clinical ResultPhase 2AACR

07 Nov 2025

·www.bioinvent.com

BioInvent's BI-1910 Data Validates TNFR2 as a Novel Immunotherapy Approach in Advanced Solid Tumors: Phase 1 Data at SITC 2025

Twelve patients achieved stable disease, whereof five with disease control lasting over six months; this correlates with strong CD4⁺ and CD8⁺ memory T-cell expansion As previously reported, the single agent dose escalation of BI-1910 in the Phase 1 study was completed without any notable adverse events Company remains focused on BI-1808, its lead anti-TNFR2 antibody, and the BI-1910 program is currently paused Lund, Sweden – November 7, 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 the presentation of Phase 1 clinical data for BI‑1910, a TNFR2 agonist antibody, at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting. The data, presented in the poster titled “Preliminary Phase 1 results of clinical trial investigating BI-1910, a Tumor Necrosis Factor Receptor 2 (TNFR2) agonist in solid cancer tumor patients” highlight BI-1910’s ability to activate immune responses and induce disease control in patients with advanced solid tumors. BI-1910 has been developed as part of BioInvent’s tumor-associated regulatory T cells (Treg)-targeting program, but as announced in August of this year, BioInvent decided after a comprehensive strategic review to focus on its most advanced program BI-1808 (as well as BI-1206, an FcyRIIB-blocking antibody). As a result of this review, BioInvent has temporarily paused the development of BI-1910. “The Phase 1 data for BI-1910 provide compelling validation of TNFR2 as a mechanism for immune activation and disease control in advanced solid tumors,” said Martin Welschof, CEO of BioInvent. “These results reinforce the therapeutic relevance of the TNFR2 pathway and support our continued focus on BI-1808, our lead ligand-blocking TNFR2 antibody, which is progressing in Phase 2 clinical development.” Poster summary:As of September 6, 2025, the single agent BI-1910 Phase 1 study had enrolled and treated 26 patients with advanced/metastatic solid tumors who had progressed after standard therapy. BI-1910 was administered intravenously every three weeks across dose levels ranging from 4 mg to 900 mg. Stable disease was the best clinical response in 12 patients out of 26 treated, of whom five patients (diagnosed with neuroendocrine, salivary gland, endometrial, and ovarian tumors) are currently experiencing disease control for more than six months. Durable response was associated with strong T-cell activation, and reduction in one or several sub lesions. The treatment was well tolerated, with no dose-limiting toxicities observed. Fatigue was the most common adverse event. Poster details:Title: Preliminary Phase 1 results of clinical trial investigating BI-1910, a Tumor Necrosis Factor Receptor 2 (TNFR2) agonist in solid cancer tumor patientsAbstract number: 581Date: November 7, 2025Authors: Hernandez T., Doger B., Yachnin J., Staahl Rorberg K., Moreno I., Carneiro A., Falcon Gonzalez A., Holmkvist P., Karlsson I., Lindahl D., Meller M., Mårtensson L., Schoenborn-Kellenberger O., Sundstedt A., Teige I., Piliuhin D., Vaapil M., Wallin J., Frendéus B., McAllister A. The abstract was published in the Journal for ImmunoTherapy of Cancer (JITC) Abstract Supplement and the poster is available on the company’s website: https://www.bioinvent.com/en/our-science/scientific-publications. BI-1910 Phase 1/2a Clinical Trial (NCT06205706)During this part of the Phase 1/2a study the safety, tolerability, and potential signs of efficacy of BI-1910 as a single agent were evaluated in patients with advanced solid tumors. As previously reported in January of this year, the single agent dose escalation of BI-1910 in the Phase 1 study has successfully been completed without any notable adverse events. Early results indicated favorable pharmacokinetic data and robust target engagement, with patients in the target dose range showing evidence of induction of T cell proliferation. However, as a result of a strategic priority review, BioInvent is currently pausing the ongoing trial. About BI-1910BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent’s first-in-class anti-TNFR2 antibody currently in a Phase 1/2a development. Both monoclonal antibodies were chosen as potential best-in-class, from a large family of binders generated through BioInvent’s proprietary F.I.R.S.T™ technology platform. BI-1910 is an agonistic human IgG2 mAb targeting TNFR2. 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 currently 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.com The press release contains statements about the future, consisting of patientive 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.

Phase 1ImmunotherapyClinical ResultASCO

100 Deals associated with BI-1206

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Hodgkin Lymphoma	Phase 2	United Kingdom	CASI (China) Pharmaceuticals Technology Co., Ltd.	30 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 2	United States	BioInvent International AB	29 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 2	Germany	BioInvent International AB	29 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 2	Poland	BioInvent International AB	29 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 2	Romania	BioInvent International AB	29 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 2	Spain	BioInvent International AB	29 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 2	Sweden	BioInvent International AB	29 Jun 2020
Uveal Melanoma	Phase 2	United States	BioInvent International AB	29 Jun 2020
Indolent B-Cell Non-Hodgkin Lymphoma	Phase 2	United States	BioInvent International AB	16 May 2018
Indolent B-Cell Non-Hodgkin Lymphoma	Phase 2	Brazil	BioInvent International AB	16 May 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PS1897 (EHA2025)	Phase 1	Indolent B-Cell Non-Hodgkin Lymphoma	16	BI-1206 + Rituximab	avvcrlhqxp(prgojrimoo) = decreases of platelet count were observed in 93.8% of subjects treated with BI-1206 + Rituximab vhtzrfbyei (fgaxwpduac ) View more	Positive	14 May 2025
EHA2025	Not Applicable	Indolent B-Cell Non-Hodgkin Lymphoma CD32b \| CD20	30	BI-1206 + Rituximab + Acalabrutinib	qhpuweoktj(clsktdduqu) = 3 patients had recorded AE related to study medication. Most adverse events were classified as mild or moderate. One subject had Gr3 neutropenia which has been downgraded after 3 days. This was the only Gr3 event recorded. With regards to safety events of interest, one patient had Gr2 thrombocytopenia, resolved to Gr1 within 3 days. No serious adverse events were recorded. znudhiwbfr (mbcjauvljx ) View more	Positive	14 May 2025
NCT03571568 (Accesswire) Manual	Phase 1/2	Non-Hodgkin Lymphoma	2	BI-1206+Calquence+Rituximab	mkacuxikic(njmamjgule) = jglyseesgn zazbpdhfyp (mslekafpbw ) View more	Positive	08 Jan 2025
NCT03571568 (Company_Website) Manual	Phase 2	Non-Hodgkin Lymphoma	2	BI-1206 + rituximab + Calquence	fbkillbbpc(eqaktmplnk) = zskxpqihnu geqycptynd (urwvjoxejj ) View more	Positive	08 Jan 2025
NCT04219254 (Phase 1/2a clinical trial of BI-1206, ASCO2024)	Phase 1/2	Advanced Malignant Solid Neoplasm CD32b (FcγRIIB)	15	BI-1206 IV	hqvwrfbues(eobfdgjsxj) = The most frequent related adverse events were infusion-related reactions, thrombocytopenia and elevated liver enzymes. All were transient without any clinical consequences, and adequate pre-medication with corticosteroids or split dose administration reduced the risk and/or intensity of these events. kkegjeqrnf (oyqhfmabgz ) View more	Positive	24 May 2024
EHA2024 Manual	Phase 1/2	Indolent B-Cell Non-Hodgkin Lymphoma CD32B (FCGRIIB)	-	BI-1206 Irituximab	vnzbffmxto(enkswmkgye) = the most frequent related treatment-emergent adverse events after BI-1206 IV wasthrombocytopenia and elevated transaminases. Thrombocytopenia ≥G3 occurred in 4 out of 10 subjectswithout premedication and 6 out of 13 subjects with premedication. No associated bleeding occurred. Allevents were resolved with a median duration of 5 days. Elevated liver enzymes ≥G3 occurred in 4 out of 10subjects without premedication and 3 out of 13 subjects with premedication. Events were resolved with amedian duration of 4 days without any clinical complication. gkrxidihxx (hsesluqxlt ) View more	Positive	14 May 2024
EHA2024 Manual	Phase 1/2	Indolent B-Cell Non-Hodgkin Lymphoma CD32B (FCGRIIB)	-	BI-1206 +rituximab (SC)		Positive	14 May 2024
CTR20220706 (Company_Website) Manual	Phase 1	Refractory Indolent Non-Hodgkin Lymphoma \| Recurrent Indolent Non-Hodgkin Lymphoma \| Non-Hodgkin Lymphoma	8	BI-1206	cjrvyrjgsr(czpvaupkxu) = wzuwrtoevn fjfwcnpgbj (aagucrvlge ) View more	Positive	05 Mar 2024
NCT02933320 (CTgov)	Phase 1/2	Chronic Lymphocytic Leukemia \| Waldenstrom Macroglobulinemia \| B-Cell Malignant Neoplasm	14	BI-1206 single agent dose escalation phase (Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase)	fdylvzayvy = kxazssvxoq lgpicrcrdx (txsigatqmw, wgiuipzpum - zhjnuehrpa) View more	-	08 Jul 2021
NCT02933320 (CTgov)	Phase 1/2		14	BI-1206+rituximab (Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase)	fdylvzayvy = npmsopgxny lgpicrcrdx (txsigatqmw, thqcnjzjpt - nyvxkzjgxm) View more	-	08 Jul 2021

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