BI-1206 / BioInvent, CASI - LARVOL DELTA

TARGETING RESISTANCE TO RITUXIMAB THROUGH FCGRIIB (CD32B) BLOCKADE: BI‑1206 + RITUXIMAB + ACALABRUTINIB SHOWS POWERFUL ACTIVITY IN R/R NHL (EHA 2026) - "The ROSEWOOD trial showed that adding the BTKi zanubrutinib (Z) to the Fc-engineered anti-CD20 antibody obinutuzumab (O) increased ORR from 45% to 69%...Aims Assess safety and efficacy of BI-1206 in combination with rituximab and acalabrutinib in R/R NHL...B) Spider plot depicting tumor burden (sum of perpendicular diameter) versus time from treatment start. Color indicate NHL subtype."

Hematological Disorders • Hematological Malignancies • Immunology • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • Urticaria • FCGR2B

Tailored FcγR blockade enhances immune checkpoint therapy and overcomes resistance. (PubMed, J Exp Clin Cancer Res) - "Our studies provide in vivo proof of concept that tailored FcγR blockade enhances immune checkpoint therapy and overcomes resistance through mechanistically distinct pathways. Clinical trials with tailored human FcγRIIB-blocking antibodies are ongoing."

IO biomarker • Journal • Oncology • CD8 • CXCL10 • IFNG

BioInvent Publication in JECCR: Tailored FcγR Blockade with BI-1206 and BI-1607 Enhances Cancer Antibody Therapies and Overcomes Resistance in Preclinical Models (BioInvent Press Release) - "BI-1206, an anti-FcγRIIB antibody with a wild-type Fc domain, was shown to enhance the activity of the approved αPD-1 antibodies nivolumab and pembrolizumab by protecting effector CD8+ T cells from macrophage-mediated depletion. These findings provide the mechanistic foundation for BioInvent's ongoing Phase 2a evaluation of BI-1206 in combination with pembrolizumab in first-line NSCLC and uveal melanoma, with initial data expected in the second half of 2026. In the same study, structurally distinct anti-FcγRIIB antibody variants, BI-1607 and its murine surrogate, engineered with an Fc-silenced Fc domain, were shown to enhance αCTLA-4 antibodies, including ipilimumab, through selective FcγRIIB blockade."

P2a data • Preclinical • Non Small Cell Lung Cancer • Uveal Melanoma

About the BI-1206 Phase 2a part of the study (Yahoo Finance) - "The 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."

Trial status • B Cell Non-Hodgkin Lymphoma

BioInvent's BI-1206 Triplet Achieves 83% Response Rate in Refractory NHL with Improved Safety vs. SOC (EHA 2026) (Yahoo Finance) - "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) combination; Markedly 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 regimens."

P1/2 data • Follicular Lymphoma • Non-Hodgkin’s Lymphoma

BioInvent to Present Clinical Data on FcγRIIB Antibody BI-1206 Triplet Combination Therapy with rituximab and Calquence(R) in Relapsed/Refractory NHL at EHA 2026 (Yahoo Finance) - "The presentation will summarize emerging efficacy and safety observations and mechanistic insights 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....BioInvent will host a KOL event at GT30, Grev Turegatan 30 in Stockholm on June 11, more information to follow within short."

P1/2 data • Follicular Lymphoma • Non-Hodgkin’s Lymphoma

Expected Key Catalysts 2026 (ACCESS Newswire) - "(i) Mid-2026: First combination data for BI-1808 and pembrolizumab for the treatment of cutaneous T-cell lymphoma (CTCL), as well as additional CTCL monotherapy data; Additional data for BI-1206 triplet combination for the treatment of non-Hodgkin's lymphoma (NHL); (ii) H2 2026: Additional Phase 2a data for BI-1808 in combination with Keytruda (pembrolizumab) for the treatment of solid tumors; First read-out from the Phase 2a study of BI-1206 in combination with pembrolizumab for treatment-naïve NSCLC patients and uveal melanoma patients."

P1/2 data • P2a data • Cutaneous T-cell Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Uveal Melanoma

Promising efficacy of BI-1206, an antibody targeting FcγRIIB in combination with rituximab and acalabrutinib in R/R NHL patients NHL (ASH 2025) - "The combination of obinutuzumab + zanubrutinib in the ROSEWOOD1 trial demonstrated the beneficialeffect of adding BTK inhibition to CD20 blockade for the treatment of follicular lymphoma. The combination of BI-1206 with rituximab and acalabrutinib shows highly promising efficacy in R/R NHL,with 89% ORR and 100% DCR. The combination appears to be safe and adverse drug reactions aremanageable. We would like to thank AstraZeneca for providing acalabrutinib in this study."

Clinical • Combination therapy • B Cell Lymphoma • Dermatology • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Immunology • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • Urticaria

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 (ACCESS Newswire) - "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...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."

P2a data • Non-Hodgkin’s Lymphoma

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 (BioInvent Press Release) - "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."

P2a data • Non-Hodgkin’s Lymphoma

BioInvent Announces Initiation of BI-1206 Phase 2a Trial in Advanced or Metastatic NSCLC and Uveal Melanoma (BioInvent Press Release) - "The Phase 2a trial (NCT04219254) will evaluate the safety and efficacy of BI-1206 in combination with pembrolizumab in patients with advanced or metastatic NSCLC and uveal melanoma. Patients will be enrolled at sites in Georgia, Germany, Poland, Rumania, Spain, Sweden and the US, with first data expected in H2 2026."

P2a data • Trial status • Non Small Cell Lung Cancer • Uveal Melanoma

BI-1206, AN ANTIBODY TARGETING FCγRIIB, GIVEN IN COMBINATION WITH RITUXIMAB AND ACALABRUTINIB IN SUBJECTS WITH INDOLENT B-CELL NON-HODGKIN'S LYMPHOMA (EHA 2025) - "Obinutuzumab (o) or obinutuzumab + zanubrutinib (o+z), showed an ORR increase from 45% to 69% (CRR o: 14%; o+z: 57%). The combination of BI-1206 with rituximab together with acalabrutinib shows promising efficacy in R/R NHL. The combination appears to be safe and adverse drug reactions are manageable.We acknowledge AstraZeneca for providing acalabrutinib for this study"

Clinical • Combination therapy • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia

A PHASE 1 STUDY OF BI-1206, A MONOCLONAL ANTIBODY TO CD32B (FCγRIIB), IN COMBINATION WITH RITUXIMAB AFTER A BI-1206 SAFETY RUN-IN PHASE IN SUBJECTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA (EHA 2025) - "Based on the preliminary data, addition of BI-1206 to rituximab treatment demonstrated a manageable safety profile, encouraging efficacy and a favorable PK profile in already rituximab R/R indolent B-NHL subjects."

Clinical • Combination therapy • P1 data • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • FCGR2B

BioInvent Announces Promising Phase 1 Data of BI-1206 in Combination with KEYTRUDA (pembrolizumab) in Solid Tumors (BioInvent) - P1/2a | N=197 | KEYNOTE-A04 (NCT04219254) | Sponsor: BioInvent International AB | "Based on the encouraging data, the company intends to expand its investigation of BI-1206 SC...by initiating a Phase 2a study arm with focus on first-line patients with advanced or metastatic NSCLC and uveal melanoma. The Phase 2a study is planned to be initiated during H2 2025. The updated Phase 1 data in heavily pre-treated patients - including several lines of IO agents - show encouraging clinical activity of the combination, with one patient with metastatic cutaneous melanoma experiencing a complete response (CR), one patient with metastatic uveal melanoma achieving a long-lasting partial response (PR) and 11 patients experiencing stable disease (SD) out of a total of 36 evaluable patients. The product was well-tolerated, enabling continued dose expansion exploring the use of higher dose levels."

P1 data • Trial status • Cutaneous Melanoma • Non Small Cell Lung Cancer • Uveal Melanoma

BioInvent Announces Updated Phase 2a Triple Combination Arm Data of BI-1206, rituximab, and Calquence for the treatment of non-Hodgkin's lymphoma (BioInvent Press Release) - P1/2a | N=140 | NCT03571568 | Sponsor: BioInvent International AB | "The data released today show the first eight patients in the triple combination arm of BioInvent’s ongoing Phase 2a in non-Hodgkin’s lymphoma. All patients exhibited disease control at first assessment (DCR 100%), and results show an overall objective response rate of 63% with two patients achieving a complete response (CR) and three patients with partial responses (PR). Stable disease (SD) was observed in the three remaining patients. The combination has been well tolerated in all patients treated at the cut-off-date. These data are further updated compared to the data included in the EHA abstract."

P2a data • B Cell Non-Hodgkin Lymphoma

CASI Pharmaceuticals Enters Into Definitive Agreement for the Divestiture of Assets in China (ACCESSWIRE) - "CASI Pharmaceuticals...announced that it has entered into a definitive Equity and Assets Transfer Agreement...with Kaixin Pharmaceuticals Inc...and CEO of the Company and two direct wholly-owned subsidiaries of the Company in China...pursuant to which the Company shall sell and transfer, and Kaixin Pharmaceuticals shall purchase and acquire, 100% equity interests in both Target Companies...and all licensing rights, distribution rights, supply arrangements and related rights related to BI-1206 (in China), CID-103 (in Asia excluding Japan) and Thiotepa (in China excluding Hong Kong, Macau and Taiwan)...for an aggregate purchase price of $20.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company....After the closing of the Transaction, the Company expects to retain the rights related to CID-103 (in Japan and non-Asian regions), EVOMELA, FOLOTYN, CNCT19 and CB-5339, and remain firmly committed to progressing CID-103 at an accelerated pace."

Commercial • Hematological Malignancies • Immunology • Solid Tumor

BioInvent International AB: Year-End Report January 1 - December 31, 2024 (ACCESSWIRE) - "ANTICIPATED 2025 MILESTONES: (i) Additional Phase 2a monotherapy data of BI-1808 in solid tumors and T-cell lymphoma to be shared in mid-2025; (ii) Data from Phase 2a dose-expansion study of BI-1808 in combination with KEYTRUDA in patients with advanced solid tumors and T-cell lymphoma anticipated in H2 2025; (iii) Data from the ongoing Phase 2a trial of BI-1206 in combination with rituximab and Calquence (acalabrutinib) in NHL expected in mid-2025; (iv) Phase 1 data of BI-1206 as a subcutaneous formulation in combination with KEYTRUDA in solid tumors anticipated in mid-2025."

P1 data • P2a data • Solid Tumor • T Cell Non-Hodgkin Lymphoma

BioInvent announces promising initial efficacy data from triple combination arm of BI-1206, rituximab and Calquence for the treatment of non-Hodgkin's lymphoma (BioInvent Press Release) - P1/2a | N=140 | NCT03571568 | Sponsor: BioInvent International AB | "BioInvent International AB...announces promising initial clinical response data from the two enrolled patients in the triple combination arm of the Phase 1/2a study of its anti-FcyRIIB antibody, BI-1206, combined with rituximab and AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib), in non-Hodgkin's lymphoma (NHL). The preliminary data demonstrates that the combination treatment is well tolerated with the two enrolled patients already showing clinical responses. One patient has obtained a complete response (CR), and one patient shows a partial response (PR). Patient enrollment remains on schedule. Further Phase 2a data are expected by mid-2025."

P2a data • Non-Hodgkin’s Lymphoma

A Study of BI-1206 in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (KEYNOTE-A04) (clinicaltrials.gov) - P1/2 | N=197 | Recruiting | Sponsor: BioInvent International AB | N=90 ➔ 197 | Trial completion date: Jan 2026 ➔ Nov 2027 | Trial primary completion date: Nov 2025 ➔ Nov 2027

Enrollment change • IO biomarker • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • PD-1 • ROS1

17-BI-1206-02: A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: BioInvent International AB | N=98 ➔ 140 | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CRP

A Competition-Based Strategy for the Isolation of an Anti-Idiotypic Blocking Module and Fine-Tuning for Conditional Activation of a Therapeutic Antibody. (PubMed, Biotechnol J) - "This strategy was used to isolate a scFv masking unit for the therapeutic antibody 6G11 (BI-1206), which is currently in clinical trials for the treatment of B-cell lymphoma to block the inhibitory Fcγ receptor IIB (CD32b)...The substitution of one key amino acid in the masking scFv reduced the affinity toward the 6G11 paratope by factor 10 but still mediated 9800-fold blocking of receptor binding. Proteolytic demasking allowed full recovery of therapeutic antibody function in vitro, supporting the concept of conditional antibody activation using this anti-idiotypic binding module."

Journal • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • MMP9

BioInvent announces the enrollment of the first patient in triple combination arm of BI-1206, rituximab and Calquence for the treatment of non-Hodgkin's lymphoma (BioInvent Press Release) - "BioInvent International AB... announces it has enrolled the first patient in the triple combination arm of the Phase 1/2a study of its anti-FcgRIIB antibody, BI-1206 in non-Hodgkin's lymphoma (NHL). The Phase 2a study arm will combine the subcutaneous formulation of BI-1206 and rituximab with Calquence (acalabrutinib), a selective inhibitor of Bruton's tyrosine kinase (BTK). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. Preliminary data are expected by the end of 2024."

Enrollment status • P1/2 data • Non-Hodgkin’s Lymphoma

SAFETY AND PRELIMINARY EFFICACY OF BI-1206, AN ANTIBODY TO CD32B (FCGRIIB), GIVEN IN COMBINATION WITH RITUXIMAB IN SUBJECTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA (EHA 2024) - "Background: Anti-CD20 antibodies, such as rituximab, are an essential therapy resource in patients with non-Hodgkin's B-cell lymphoma. Addition of BI-1206 to rituximab treatment shows promising efficacy in R/R NHL. The combination appears tobe safe and adverse drug reactions are manageable. Implementation of premedication with corticosteroidsminimized risk and intensity of transaminase elevations."

Clinical • Combination therapy • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • FCGR2B

Phase 1/2a clinical trial of BI-1206, an anti-CD32b (FcγRIIB) antibody, in combination with pembrolizumab in subjects with advanced solid tumors previously treated with anti-PD-1/PD-L1. (ASCO 2024) - P1/2 | "Coadministration of BI-1206 with pembrolizumab was well tolerated in a heavily pretreated population, with promising hints of responses to be further explored in Ph2."

Clinical • Combination therapy • Metastases • P1/2 data • Eye Cancer • Hematological Disorders • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia • Uveal Melanoma • CD8

BioInvent Presents Promising Phase 1 Data for BI-1206 in Combination with KEYTRUDA (pembrolizumab) in Patients with Solid Tumors at ASCO 2024 (BioInvent Press Release) - P1/2a | N=90 | KEYNOTE-A04 (NCT04219254) | Sponsor: BioInvent International AB | "BioInvent International AB...today announced promising Phase 1 data for BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in heavily pre-treated patients with solid tumors. The data show promising and durable responses in patients who previously failed on anti-PD-1/L1 therapy. The combination was well-tolerated in this heavily pre-treated population of patients...In 24 evaluable patients, the combination demonstrated one CR (metastatic melanoma, 3 prior anti-PD-1 treatments including one anti-CTLA-4), one long-lasting PR (uveal melanoma, >24 months) and seven cases of stable disease, including one long-lasting (metastatic melanoma, >24 months)....An IV dose level (RP2D) has been selected for signal seeking in the subsequent Phase 2a study..."

P1 data • Solid Tumor