BI-1206 / BioInvent, CASI - LARVOL DELTA

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 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

BioInvent to Host Virtual KOL Event on June 18, 2024, to discuss BioInvent’s lead candidates BI-1808 and BI-1206 (BioInvent Press Release) - "BioInvent International AB...announced that it will host a virtual KOL event on Tuesday, June 18, 2024 from 9:00-10:45 AM ET/3-4:45 PM CEST to discuss the recently presented clinical efficacy and safety data from its lead candidates BI-1808 and BI-1206, and TNFR2 and FcyRIIB as promising targets in immuno-oncology."

Clinical • Hematological Malignancies • Oncology • Solid Tumor

BioInvent to Present Additional Promising Phase 1/2a Data at EHA 2024 for BI-1206 with rituximab in NHL (ACCESSWIRE) - P1/2a | N=98 | NCT03571568 | Sponsor: BioInvent International AB | "BioInvent...announced that promising clinical data for BI-1206 in relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), dosed in combination with rituximab, will be presented in a poster at the European Hematology Association congress...'Based on these encouraging results, we plan to initiate a Phase 2a study arm where the BTK inhibitor, acalabrutinib (Calquence), will be added to the rituximab and BI-1206 combination, which should further increase response rates.'...Safety and Efficacy Results (May 2024): Safety: Thrombocytopenia and elevated transaminase levels were the most frequent treatment-emergent adverse events (TEAEs)...In the FL subset of 16 evaluable patients (IV+SC), an ORR of 56% and CRR of 38% were observed....In the SC dosing arm, in 4 evaluable patients, 1 complete response (CR), 2 partial response (PR) and 1 stable disease (SD) were observed."

P1/2 data • Trial status • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

BioInvent to Present Clinical Data from its Two Leading Assets at ASCO 2024 (ACCESSWIRE) - "BioInvent International AB...announced that two abstracts for its two leading assets, BI-1808 and BI-1206, have been selected for presentation at ASCO 2024.....The two poster presentations will report: (i) first combination data from the Phase 1/2a study with BI-1808 in combination with MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as well as an update on monotherapy arm; (ii) combination data from the Phase 1/2a study with BI-1206 in combination with KEYTRUDA for the treatment of patients with solid tumors."

P1/2 data • Solid Tumor

CASI Pharmaceuticals Report Positive Interim Phase 1 Data For BI-1206 In The Treatment Of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma In China (PRNewswire) - P1/2a | N=98 | NCT03571568 | Sponsor: BioInvent International AB | "CASI Pharmaceuticals, Inc...announced preliminary encouraging efficacy data for BI-1206 in combination with rituximab in patients with relapsed/refractory (R/R) indolent Non-Hodgkin's Lymphoma (iNHL) in the ongoing development program in China....The Phase 1 dose-escalation study showed impressive signs of clinical efficacy, with 4 partial responses (PR) and 1 complete response (CR) out of 8 evaluable patients. The results are consistent with the clinical data that have been previously reported by BioInvent. Among the responders in the study being conducted in China, one patient with relapsed Marginal Zone Lymphoma (MZL) patient who achieved CR has maintained a durable complete remission for 20+ weeks."

P1 data • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

BioInvent to Evaluate BI-1206 in Combination with Rituximab and Calquence (ACCESSWIRE) - "BioInvent International AB...announced a clinical supply agreement with AstraZeneca...to evaluate BioInvent's anti-FcyRIIB antibody, BI-1206, in combination with rituximab and Calquence (acalabrutinib), in a Phase 1/2a study in non-Hodgkin's lymphoma (NHL). Under the terms of the supply agreement, AstraZeneca will provide Calquence, a selective inhibitor of Bruton's tyrosine kinase (BTK), for use in combination with BI-1206 and rituximab in the ongoing Phase 1/2a clinical study (NCT03571568) for the treatment of patients with follicular lymphoma who have progressed or are refractory to rituximab."

Licensing / partnership • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

BioInvent announces 2024 strategic priorities and anticipated milestones (BioInvent Press Release) - "Next milestones...YE 2024: Initial data from Phase 2a BI-1808 single-agent trial...H1 2024: Data from the Phase 1 dose escalation segment evaluating BI-1206 SC dosing in combination with rituximab in NHL. Further data from the Phase 1 dose escalation of BI-1206 IV in combination with pembrolizumab for the treatment of solid tumors; YE 2024: Initial Phase 2 data for BI-1206 in NHL."

P1 data • P2 data • P2a data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (KEYNOTE-A04) (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: BioInvent International AB

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

CASI PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2023 BUSINESS AND FINANCIAL UPDATES (PRNewswire) - "'Some of our noteworthy recent achievements include the license transfer of Folotyn^® with an expected launch in Q1 2024, progress in the clinical development of BI-1206, transitioning CID-103 development to China for malignant hematology indications.'...Revenue consists of product sales of EVOMELA^®. Revenue was $8.8 million for the three months ended September 30, 2023, compared to $10.2 million for the three months ended September 30, 2022....Research and development expenses for the three months ended September 30, 2023 were $2.4 million, compared with $3.9 million for the three months ended September 30, 2022. The decrease is mainly attributable to reduced research and development expenses on certain projects, such as CID-103."

Commercial • Launch • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

BioInvent initiates subcutaneous arm of Phase 1/2 trial with BI-1206 in solid tumors (Issuer Direct) - "BioInvent International AB...announces the enrollment of the first patient in a Phase 1/2 trial (NCT04219254; KEYNOTE-A04) in combination with KEYTRUDA...investigating a subcutaneous (SC) formulation of its lead drug candidate, the novel anti-FcyRIIB antibody BI-1206, in solid tumors....The trial is recruiting patients with advanced solid tumors who had progressed after prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients will receive three-week cycles of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression."

Trial status • Solid Tumor

BioInvent Announces Abstract Presentation of BI-1206 at the 17th International Conference of Malignant Lymphoma 2023 (Issuer Direct) - P1/2a | N=98 | NCT03571568 | Sponsor: BioInvent International AB | "BioInvent International AB...announces that an abstract reporting the clinical profile of its lead drug candidate BI-1206...has been accepted at the the International Conference of Malignant Lymphoma (ICML) Annual Meeting 2023....In the ongoing Phase 1/2a study of BI-1206 in combination with rituximab for the treatment of non-Hodgkin's lymphoma (NHL), the dose escalation phase of intravenously (IV) administered BI-1206 has been completed and the recommended IV Phase 2 dose (RP2D) has been identified. A subcutaneous (SC) formulation is being developed in parallel to the IV and the first results will be available during H1 2023....In the IV dose escalation cohort, responses have been observed across the dose range of 30-100 mg, including 4 complete responders (CR), 3 partial responders (PR) and 4 cases of stable disease (SD) out of 15 evaluable patients."

P1/2 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

PHASE 1/2A CLINICAL TRIAL OF BI-1206, A MONOCLONAL ANTIBODY TO CD32B (FCGRIIB), IN COMBINATION WITH RITUXIMAB IN SUBJECTS WITH INDOLENT B-CELL LYMPHOMA (ICML 2023) - "During induction therapy, patients receive one dose of single-agent rituximab (375 mg/m2) followed by dosing of BI-1206 with subsequent rituximab on weeks 2, 3, and 4. Patients showing clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) at week 6 are eligible for continued maintenance therapy with dosing of BI-1206 and rituximab every 8 weeks for up to 7 cycles."

Clinical • Combination therapy • P1/2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • FCGR2B

BioInvent Announces Additional Efficacy Data from Intravenous Part of Phase 1/2 Trial with BI-1206 in Solid Tumors (Issuer Direct) - P1/2a | N=90 | KEYNOTE-A04 (NCT04219254) | Sponsor: BioInvent International AB | "BioInvent International AB...announces six additional patients have been treated in the intravenous (IV) arm of its Phase 1/2 trial (NCT04219254; KEYNOTE-A04) of the novel anti-FcyRIIB antibody BI-1206 in combination with KEYTRUDA...in solid tumors. The additional patients have been treated at a dose of 1 mg/kg....In addition to the patients previously reported, (1 case of pseudo progression and 1 partial response (PR), new data now show one patient experiencing a long-lasting stable disease, with more than 80 weeks of treatment in the study, and another patient experiencing a PR. Both patients have melanoma, and both had previously been treated with immune checkpoint inhibitors....The first PR observed is still responding and has been on treatment for more than 90 weeks. BioInvent will share additional updates from the IV arm of the trial during the second half of 2023."

P1/2 data • Melanoma • Oncology • Skin Cancer • Solid Tumor