BI-1808 / BioInvent - LARVOL DELTA

BioInvent International AB…announced that it will present updated data from the ongoing Phase 2a monotherapy of BI-1808, a first-in-class anti-TNFR2 antibody, in cutaneous T-cell lymphoma (CTCL) in a poster at the upcoming 2025 American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, Florida. (BioInvent Press Release) - "Out of nine CTCL evaluable cases, one Sézary Syndrome (SS) patient exhibited complete response (CR), four patients (three Mycosis Fungoides (MF), one SS) exhibited partial response (PR) as best clinical response; the remaining four patients showed stable disease (SD); Out of two evaluable PTCL patients (peripheral T-cell lymphoma, both stage IV), one patient showed SD as best clinical response, while the other patient exhibited a substantial PR at first assessment."

P2a data • Cutaneous T-cell Lymphoma • Peripheral T-cell Lymphoma

BI-1808, a tumor necrosis factor receptor 2 (TNFR2) blocker/depleter, showing promising efficacy in T cell lymphoma patients (ASH 2025) - "Current data from the signal seeking cohort of BI-1808 in TCL show promising efficacy associated withstrong immune activation in patients with advanced CTCL, leading to an objective response rate of 46% and a 100% disease control rate in the evaluable population, warranting the study to proceed to nextstage of dose optimization. 1Ungewickell et al Nat Genet. 2015"

Clinical • CD4 • CD8 • DPP4 • GZMB

Biparatopic TNFR2 antagonist reverses immunosuppression and elicits robust anti-tumor responses without crosslinking agonism and ADCC dependence (AACR-NCI-EORTC 2025) - "However, current monoclonal antagonists such as BI1808 suffer from limitations including antibody-dependent cellular cytotoxicity (ADCC) reliance and risks of agonistic conversion upon crosslinking...Furthermore, the ADCC-independent mechanism of Duo1 may minimize on-target, off-tumor toxicity against TNFR2+ non-malignant cells, potentially offering a superior therapeutic window compared to ADCC-dependent competitors. The biparatopic design enables robust target suppression without eliciting unintended immune activation, potentially enabling broader clinical application in combination with PD-1/PD-L1 inhibitors and other immunotherapies for patients with TNFR2-high tumors."

IO biomarker • Late-breaking abstract • Oncology • CD8

ROBUST SINGLE AGENT ACTIVITY OF BI-1808, A TUMOR NECROSIS FACTOR RECEPTOR 2 BLOCKER/DEPLETER, IN T CELL LYMPHOMA PATIENTS (ICML 2025) - "Early data from the signal seeking cohort of BI-1808 in TCL show promising efficacy associated with strong immune activation in patients with advanced CTCL, leading to an objective response rate of 50% in the evaluable population and a 100% disease control rate. 1Ungewickell et al., Nat Genet. 2015"

Clinical • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD4 • CD8 • DPP4 • GZMB • TNFA

ROBUST SINGLE AGENT ACTIVITY OF BI-1808, A TUMOR NECROSIS FACTOR RECEPTOR 2 (TNFR2) BLOCKER/DEPLETER, IN CUTANEOUS T CELL LYMPHOMA (CTCL) PATIENTS (EHA 2025) - "Early data from the signal seeking cohort of BI-1808 in TCL show promising efficacy associated with strong immune activation in patients with advanced CTCL, leading to an objective response rate of 50% in the evaluable population and a 100% disease control rate."

Clinical • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Pruritus • Sezary Syndrome • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD4 • CD8 • DPP4 • GZMB

BioInvent Presents Promising Phase 2a Monotherapy Data for BI-1808 in CTCL at EHA 2025 (BioInvent Press Release) - P1/2a | N=176 | Keynote-D20 (NCT04752826) | Sponsor: BioInvent International AB | "BioInvent International AB...announced updated positive data from the ongoing Phase 2a dose expansion study of BI-1808 monotherapy in cutaneous T-cell lymphoma (CTCL). The data will be presented in a poster at the European Hematology Association (EHA) 2025 congress....As of the cut-off date May 15, 2025, data showed a 100% disease control rate in nine evaluable patients with CTCL. Forty-five percent of these patients achieved an objective response, with one patient achieving a complete response (CR), three achieving a partial response (PR), and five exhibiting stable disease (SD). Additionally, two patients with peripheral T-cell lymphoma (PTCL) were evaluable, of which one showed a PR, while the other showed SD. Overall, BI-1808 monotherapy demonstrates promising clinical activity and robust immune engagement."

P2a data • Cutaneous T-cell Lymphoma

BioInvent Presents Additional CTCL Phase 2a Data for BI-1808 Monotherapy at EHA 2025 (BioInvent Press Release) - P1/2a | N=176 | Keynote-D20 (NCT04752826) | "The submitted abstract data from the CTCL cohort include results from ten patients treated with BI-1808 with eight deemed evaluable. As of the cut-off date February 20, 2025, one patient had achieved a complete response (CR), three achieved partial response (PR), and four demonstrated stable disease (SD). The treatment was well tolerated with primarily mild to moderate adverse events with no grade 3 or higher events reported. Notably, immune activation was observed in the early weeks of treatment, specifically depletion of regulatory T cells and an influx of CD8+ T cells into the skin, suggesting that BI-1808 effectively stimulates the targeted response in CTCL. The upcoming poster presentation will include more detailed and recent data, including findings in patients with PTCL (Peripheral T-cell lymphoma)."

P2a data • Cutaneous T-cell Lymphoma

BioInvent Receives FDA Fast Track Designation for BI-1808 for the Treatment of Cutaneous T-cell Lymphoma (BioInvent Press Release) - "BioInvent International AB...announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of adults with relapsed or refractory mycosis fungoides and Sézary syndrome, subtypes of cutaneous T-cell lymphoma (CTCL)....'We are committed to continue advancing the development of BI-1808 and look forward to providing an update from the ongoing Phase 2a by mid-2025'."

Fast track • P2a data • Cutaneous T-cell Lymphoma • Mycosis Fungoides • Sezary Syndrome

BioInvent Receives FDA Orphan Drug Designation for BI-1808 for the Treatment of T-cell Lymphoma (BioInvent Press Release) - "BioInvent International AB...announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BI-1808, a first-in-class anti-TNFR2 antibody for the treatment of T-cell Lymphoma (TCL). T-cell lymphomas include a number of subtypes of T cell-derived non-Hodgkins’s lymphoma, including cutaneous T-cell lymphoma (CTCL)."

Orphan drug • Cutaneous T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

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

BI-1808 As a Single Agent and with Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20) (clinicaltrials.gov) - P1/2 | N=176 | Recruiting | Sponsor: BioInvent International AB | N=100 ➔ 176

Enrollment change • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • T Cell Non-Hodgkin Lymphoma • ALK • EGFR • ROS1

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20) (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: BioInvent International AB | Trial completion date: Dec 2026 ➔ Jan 2028 | Trial primary completion date: May 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • ALK • EGFR • ROS1

BioInvent Announces Additional Positive Efficacy Data with Single Agent BI-1808 from the Phase 2a anti-TNFR2 program (BioInvent Press Release) - P1/2a | N=100 | Keynote-D20 (NCT04752826) | Sponsor: BioInvent International AB | "BioInvent International AB...announced additional positive preliminary efficacy data from its ongoing Phase 2a dose expansion study of BI-1808 as a single agent....Three partial responses (PR) and one stable disease (SD) out of four evaluable patients with Cutaneous T-cell Lymphoma (CTCL) have been observed in the single agent part of the Phase 2a study. Three other patients in the cohort were considered non-evaluable. All patients had progressed after standard therapy. The three responding patients had received 9, 3 and 3 previous lines of treatment respectively, and one of them included previous anti-PD1 treatment....In addition, an abstract for a trial in progress poster presentation on BI-1910, BioInvent’s second anti-TNFR2 program was published today by the European Society for Medical Oncology. The poster is due to be presented at the ESMO conference..."

P2a data • Trial status • Cutaneous T-cell Lymphoma • Solid Tumor

BioInvent Presents Poster Highlighting Model-Informed Early Clinical Development of anti-TNFR2 agent BI-1808 at PAGE 2024 (BioInvent Press Release) - P1/2a | N=100 | Keynote-D20 (NCT04752826) | Sponsor: BioInvent International AB | "BioInvent...announced the presentation of a poster highlighting the model-informed early clinical development of the company's anti-TNFR2 program BI-1808 at the Population Approach Group in Europe (PAGE) 2024 meeting, being held in Rome, Italy from June 26 to 28, 2024...As earlier communicated, initial efficacy and safety data from the ongoing Phase 1/2a study show so far: One complete response (CR), one partial response (PR) that is still improving, and nine patients with stable disease (SD) of 26 evaluable patients in the single agent arm of BI-1808; Promising signs of efficacy and favorable safety profile in the Phase 1 dose escalation part studying BI-1808 in combination with KEYTRUDA (pembrolizumab)."

P1/2 data • Hematological Malignancies • Oncology • Solid Tumor

BioInvent gains patent for BI-1808 in China (BioInvent Press Release) - "BioInvent International AB...announced that the China National Intellectual Property Administration (CNIPA) has issued a notice of allowance, informing the company that a patent application relating to the anti-TNFR2 antibody BI-1808 will be granted. The patent provides composition-of matter protection for BI-1808 and the use of the antibody for the treatment of cancer."

Patent • Oncology

19-BI-1808-01, a phase 1/2a clinical trial of BI-1808, a tumor necrosis factor receptor 2 (TNFR2) blocker/depleter with or without pembrolizumab. (ASCO 2024) - P1/2 | "Preliminary data from dose escalation phase is promising. BI-1808 has a favorable safety profile, with early signs of monotherapy activity, and is well tolerated when combined with pembrolizumab."

Clinical • P1/2 data • Cutaneous T-cell Lymphoma • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma

BioInvent Presents Promising Clinical Efficacy and Safety for anti-TNFR2 agent BI-1808 at ASCO 2024 (BioInvent Press Release) - P1/2a | N=100 | Keynote-D20 (NCT04752826) | Sponsor: BioInvent International AB | "BioInvent International AB...today announced further promising early signs of single agent efficacy and a robust safety profile for the company’s anti-TNFR2 program BI-1808. The Phase 2a single agent part is in the dose expansion phase testing the activity in four different tumor types: ovarian cancer (OC), melanoma, non-small cell lung cancer (NSCLC) and other tumor types (e.g., gastrointestinal stromal tumors (GIST)), and TCL/CTCL....Safety: Across the dose range (25 to 1000 mg dose), no Grade 3/4 adverse events (AEs) related to BI-1808 were observed....Efficacy: Of 26 evaluable patients treated with monotherapy, best clinical responses were one complete response (CR), one partial response (PR) and nine patients with stable disease (SD)."

P1/2 data • Cutaneous T-cell Lymphoma • Melanoma • Non Small Cell Lung Cancer • Ovarian Cancer

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 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

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

BioInvent Presents Positive Data at SITC from Clinical Phase 1/2a Trial of BI-1808 as Single Agent (Issuer Direct) - P1/2 | N=100 | Keynote-D20 (NCT04752826) | Sponsor: BioInvent International AB | "BioInvent International... presents the latest data from a Phase 1/2a trial of...BI-1808 as a single agent, at the Society of Immunotherapy for Cancer (SITC) 38th Annual Meeting....BI-1808 administered as single agent induced a robust partial response (PR) in a patient with a gastrointestinal tumor (GIST) who had received 12 previous lines of treatment....The patient is still receiving BI-1808 treatment, and the most recent scan showed a tumor burden reduced to 48% compared to baseline, with 2/4 target lesions no longer detectable. There are a further 7 cases of stable disease out of 21 evaluable patients and pharmacokinetic/pharmacodynamic data has enabled identification of a wide dose range where complete target coverage can be achieved with a remarkable safety profile....Phase 1 data on the combination of BI-1808 with pembrolizumab is due in H1 2024."

P1 data • Gastrointestinal Stromal Tumor

Phase 1/2a clinical trial of BI-1808, a monoclonal antibody to tumor necrosis factor receptor 2 (TNFR2) as single agent and in combination with pembrolizumab (SITC 2023) - "SD was observed in 7/19 evaluable patients. Doses of 675 mg and higher are expected to provide complete RO throughout the dose interval, and will be further explored in Ph2a."

Clinical • Combination therapy • P1/2 data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD8 • TNFA • TNFRSF1B

BioInvent presents preclinical data at SITC providing clear evidence of the potential of anti-TNFR2 antibody BI-1910 (Issuer Direct) - "BioInvent...will present preclinical data on its anti-tumor necrosis factor receptor 2 (TNFR2) agonistic antibody BI-1910 at the Society of Immunotherapy for Cancer (SITC) 38th Annual Meeting in San Diego, California. The presentation, scheduled for November 4, 2023...demonstrates that BI-1910 has broad anti-tumor activity, activating T cells and natural killer (NK) cells and showing antitumor activity independent of Fc gamma receptor (FcyR) expression....'These studies provide clear evidence of the potential of BI-1910 to treat cancer patients and support the upcoming phase 1/2a study in solid cancer patients planned to start in H2 2023'....The latest data from the other Treg program, i.e. the BI-1808 single agent Phase 1 study, will be presented at SITC on November 3, 2023."

New P1/2 trial • P1 data • Preclinical • Solid Tumor

BI-1808 as a Single Agent and With Pembrolizumab in Treatment of Advanced Malignancies(Keynote-D20) (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: BioInvent International AB | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ May 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • ALK • CD14 • EGFR • ROS1 • TNFRSF1B

BioInvent to hold two poster presentations at SITC 38th Annual Meeting (BioInvent Press Release) - "BioInvent International AB... announces it will hold two poster presentations on its anti-tumor necrosis factor receptor 2 (TNFR2) programs at the Society of Immunotherapy for Cancer (SITC) 38th Annual Meeting, held November 3-5, 2023, in San Diego, California. The posters will showcase the latest data from a clinical Phase 1 trial evaluating the first-in-class antibody BI-1808 as single agent, as well as preclinical data for BI-1910."

P1 data • Preclinical • Solid Tumor