BI-1808 / BioInvent - LARVOL DELTA

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20) (clinicaltrials.gov) - P1/2 | N=250 | Recruiting | Sponsor: BioInvent International AB | N=176 ➔ 250 | Trial completion date: Jan 2028 ➔ Dec 2028 | Trial primary completion date: Dec 2026 ➔ Jan 2028

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • T Cell Non-Hodgkin Lymphoma

From Modest to Meaningful: Targeting TNFR2 with BI-1808 to Unlock Checkpoint Inhibitor Efficacy in Recurrent Platinum Resistant Ovarian Cancer (PROC) (ESMO 2026) - No abstract available

Checkpoint inhibition • Clinical • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

BioInvent Receives FDA Fast Track Designation for BI-1808 for the Treatment of Ovarian Cancer (BioInvent Press Release) - "Cohort expansion is underway, focusing on high-grade serous and clear cell subtypes, with another data readout expected in H2 2026."

Fast track • P1/2 data • Platinum resistant • Ovarian Cancer

Ligand-Blocking and Agonist Antibodies Targeting TNFR2 Employ Distinct Modes of Action to Induce Antitumor Immunity. (PubMed, Cancer Res) - "Both antibodies converged on activating tumor-specific CD8+ T cells mediating tumor rejection. Clinical assessment of both ligand-blocking (BI-1808) and agonist (BI-1910) α-TNFR2 antibodies is currently ongoing."

Journal • Oncology • CD8

BioInvent's BI-1808 Abstract from Modest to Meaningful in Platinum-Resistant Ovarian Cancer Accepted for Poster Presentation at ESMO 2026 (BioInvent Press Release)

P2a data • Platinum resistant • Ovarian Cancer

A TNFR2 biparatopic antagonist reverses immune suppression through a crosslinking-resistant and ADCC- independent mechanism. (PubMed, J Leukoc Biol) - "The clinical efficacy of conventional bivalent TNFR2 antagonists, such as BI1808, is fundamentally constrained by a heavy reliance on Fc-mediated effector functions and a significant risk of 'agonistic conversion' upon crosslinking within the tumor microenvironment...Furthermore, treatment with Duo1 significantly remodeled the tumor microenvironment, markedly reducing immunosuppressive populations and increasing the intratumoral CD8+/Treg ratio. By uncoupling anti-tumor activity from both the risks of cross-linking induced agonistic conversion and a dependence on immune cell mediated effector function, Duo1 represents a highly superior next-generation immunotherapeutic paradigm for TNFR2-rich, immunosuppressive malignancies."

Journal • Oncology • CD4 • CD8

TARGETING TNFR2 WITH BI-1808 WITH OR WITHOUT PEMBROLIZUMAB: IMMUNE ACTIVATION AND PROMISING RESPONSES IN ADVANCED CUTANEOUS T-CELL LYMPHOMAS (EHA 2026) - "More complete data will be disclosed in the poster. Summary/Conclusion Current data from the signal seeking cohort of BI-1808 in CTCL show promising efficacy associated with strong immune activation in patients with advanced CTCL, leading to an impressive objective response rate of 40% in BI-1808 single agent, and 50% in combination with pembrolizumab."

IO biomarker • Metastases • Cardiovascular • Cutaneous T-cell Lymphoma • Dermatopathology • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Pruritus • Pulmonary Embolism • Respiratory Diseases • Sezary Syndrome • Skin Cancer • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD4 • CD8 • DPP4 • GZMB • IL12A

BI‑1808 + pembrolizumab: Responses to a chemotherapy‑free regimen in advanced ovarian cancer. (ASCO 2026) - P1/2 | "Anti-PD-1 therapies such as pembrolizumab have shown modest efficacy in recurrent ovarian cancer as single agent therapy with an ORR of 8% (KEYNOTE-100), while adding pembrolizumab to weekly paclitaxel±bevacizumab regimen (KEYNOTE-B96) demonstrates statistically meaningful improvement in OS and PFS in all comers and the PD-L1 CPS ≥1 population. Early data from this cohort are highly encouraging, with ORR 24% and DCR 65%. BI-1808 plus pembrolizumab demonstrated a manageable safety profile and promising activity in advanced heavily pretreated ovarian cancer. Based on these findings, the cohort will expand by 20 additional patients focusing on clear cell and high-grade serous subtypes."

IO biomarker • Metastases • Oncology • Ovarian Cancer • Solid Tumor • CD8 • PD-L1

BioInvent Reveals Solid Data with its TNFR2 Antibody BI-1808 and KEYTRUDA (pembrolizumab) in Advanced Ovarian Cancer at ASCO (BioInvent Press Release) - "Among 25 response-evaluable patients, the chemotherapy-free combination demonstrated promising antitumor activity, achieving a confirmed objective response rate (ORR) of 24%, driven by one complete response (CR) and five partial responses (PR). An additional eight patients achieved stable disease, resulting in a disease control rate (DCR) of 56%. Importantly, prolonged stable disease was observed in multiple patients, with several responses ongoing beyond 10 months, and early analyses indicate a median progression-free survival (mPFS) of 10.3 months....BioInvent is preparing for opening of Part C of the study, evaluating the triplet combination of BI-1808, pembrolizumab and paclitaxel in H2 2026."

P2a data • Trial status • Ovarian Cancer

BioInvent to Host Virtual KOL Event to Discuss BI-1808 for the Treatment of Ovarian Cancer, on May 27, 2026 (ACCESS Newswire) - "The event will provide an overview of BI-1808, which has shown highly encouraging clinical activity both as single agent as well as in combination with pembrolizumab."

Clinical data • Ovarian Cancer

BioInvent's TNFR2 Antibody BI-1808 Shows Strong Activity and Immune Activation as Single Agent and in Combination with KEYTRUDA (pembrolizumab) in Advanced CTCL (EHA 2026) (Yahoo Finance) - "Across evaluable patients (n=15), BI-1808 treatment resulted in objective clinical responses, including 1 durable complete response in a patient with Sézary syndrome, ongoing at two years, and multiple confirmed partial responses in both MF and SS. Overall, objective response rates (ORR) were 40% with BI-1808 monotherapy and 50% with the BI-1808 plus pembrolizumab combination, with additional patients achieving stable disease....BI-1808 was generally well-tolerated, with most treatment-related adverse events reported as mild to moderate in severity. Limited Grade 3 events were observed, and no new safety signals were identified."

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

BI-1808 plus KEYTRUDA data in recurrent ovarian cancer to be presented at the 2026 ASCO Annual Meeting (ACCESS Newswire)

P2a data • Ovarian Cancer

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

BioInvent Reports Promising Data from Ongoing Phase 2a study for BI-1808 with KEYTRUDA (pembrolizumab) in Recurrent Ovarian Cancer (Yahoo Finance) - "24% ORR for BI-1808 combined with pembrolizumab represents a meaningful improvement over pembrolizumab monotherapy in recurrent ovarian cancer (8% ORR in KEYNOTE-100); The combination demonstrated a favorable safety and tolerability profile...BioInvent will expand the ovarian cancer cohort by enrolling an additional 20 patients focusing on high-grade serous and clear cell subtypes, expected data read-out H2 2026"

P2a data • Ovarian Cancer

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

BioInvent International AB…announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has adopted a positive opinion for Orphan Drug Designation (ODD) to the company’s investigational medicinal product BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of Cutaneous T-cell Lymphoma (CTCL). (Yahoo Finance) - "BI-1808 has demonstrated promising clinical activity in an ongoing Phase 2a trial with 100% disease control rate and a majority of patients with advanced CTCL achieving an objective response: one complete response, four partial responses, and four stable diseases in nine evaluable patients (ASH 2025 abstract)."

European regulatory • Cutaneous T-cell Lymphoma

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

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