BI-1910 / BioInvent - LARVOL DELTA

Preliminary Phase 1 results of clinical trial investigating BI-1910, a tumor necrosis factor receptor 2 (TNFR2) agonist, in solid tumor cancer patients (SITC 2025) - "In preclinical models, BI-1910 combined with anti-PD-1 showed additive anti-tumor activity, justifying clinical evaluation with pembrolizumab.Methods We report here Phase 1 dose escalation results from a Ph1/2 clinical trial of BI-1910 as single agent in subjects with advanced/metastatic solid tumors who had progressed after standard therapy. Sustained T cell proliferation was associated with disease controlAbstract 581 Figure 2Request permissionsCD4+ T cell proliferation was measured day 1-57 after treatment and AUC was calculated for patients receiving >100 mg. Patients exhibiting disease control showed a 3-fold higher expansion of Ki-67+ memory CD4+ T cells during the time to first CT scan"

Clinical • P1 data • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • TNFA • TNFRSF1A

BioInvent to Present Phase 1 Clinical Data for BI-1910, a TNFR2 Agonist for the Treatment of Solid Tumors, at SITC (BioInvent Press Release) - "The abstract title, which was released today, is 'Preliminary Phase 1 results of clinical trial investigating BI-1910, a Tumor Necrosis Factor Receptor 2 (TNFR2) agonist in solid cancer tumor patients'."

P1 data • Solid Tumor

KEYNOTE F82: BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=35 | Active, not recruiting | Sponsor: BioInvent International AB | Recruiting ➔ Active, not recruiting | N=104 ➔ 35

Enrollment change • Enrollment closed • First-in-human • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BioInvent Presents at PAGE 2025 a Poster Highlighting Model-Informed Early Clinical Development of anti-TNFR2 drug candidate BI-1910 (TradingView) - "BioInvent International AB...announced the presentation of a poster highlighting the model-informed early clinical development of the company’s anti-TNFR2 program BI-1910 at the Population Approach Group in Europe (PAGE) 2025 meeting, being held in Thessaloniki, Greece from June 4 to 6, 2025....The Phase 2a study of BI-1910 as a single agent (Part A) in several tumor types including HCC (hepatocellular cancer) patients is planned to start in H2 2025. Furthermore, BioInvent will also initiate Phase 2a part of the study evaluating BI-1910 with pembrolizumab (Part B) in the same indications during H2 2025."

New P2a trial • Trial status • Hepatocellular Cancer • Non Small Cell Lung Cancer

BioInvent International AB: Year-End Report January 1 - December 31, 2024 (ACCESSWIRE) - "ANTICIPATED 2025 MILESTONES: (i) First BI-1910 Phase 2a single agent data expected H2 2025; (ii) Phase 1 data from Part B, dose escalation of BI-1910 in combination with pembrolizumab expected H2 2025; (iii) Initial data from the Phase 1b trial evaluating BI-1607 in combination with ipilimumab and KEYTRUDA in patients with unresectable or metastatic melanoma expected in H2 2025."

P1 data • P2a data • Melanoma • Solid Tumor

BioInvent announces promising data for BI-1910 as single agent from Phase 1 study in solid tumors (BioInvent Press Release) - P1/2a | N=104 | NCT06205706 | Sponsor: BioInvent International AB | "Single agent dose escalation of BI-1910 in the ongoing Phase 1 study has successfully been completed without any notable adverse events. Out of the 12 currently evaluable patients, 6 patients display stable disease. Early results indicate favorable pharmacokinetic data and a robust target engagement, with patients in the target dose range showing evidence of induction of T cell proliferation. With the maturation of clinical response and biomarker data from the Phase 1 patients, Phase 2a studying BI-1910 as single agent is planned to start in H1 2025 and will be performed in several tumor types including HCC (hepatocellular cancer) patients....The Phase 2a combination arm of the study evaluating BI-1808 with pembrolizumab is ongoing with patient enrollment into the ovarian cancer cohort underway. Phase 2a data from this combination arm is expected to be presented in H2 2025."

P1 data • P2a data • Trial status • Hepatocellular Cancer • Ovarian Cancer

A phase I/IIa first in-human phase I study of BI 1910, a monoclonal antibody agonistic to TNFR2, as a single agent and in combination with pembrolizumab in subjects with advanced solid tumors (ESMO 2024) - P1/2 | "Phase 2a will be performed in advanced/metastatic NSCLC and HCC patients in parallel cohorts. Safety and efficacy of BI-1910 as monotherapy and in combination will be evaluated at two separate dose levels for dose optimization."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • TNFRSF1A

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 Receives Notice of Allowance from USPTO for BI-1910 Patent Application (ACCESSWIRE) - "BioInvent International AB...announced that the US Patent and Trademark office (USPTO) has issued a Notice of Allowance for a patent application relevant to the anti-TNFR2 antibody BI-1910....The patent, once granted, provides a composition-of-matter protection for BI-1910 and the use of the antibody for the treatment of cancer....Patent will further strengthen IP protection of BioInvent's innovative portfolio of clinical assets."

Patent • Solid Tumor

BioInvent to Present Pipeline Progress on BI-1910 and BT-001 at ESMO (BioInvent Press Release) - "BioInvent International AB...announced abstracts for BI-1910 and BT-001 have been selected for presentation at ESMO 2024, being held in Barcelona, Spain from September 13th to 17th, 2024.....Two posters to be presented on early clinical projects from BioInvent’s robust pipeline totaling six clinical programs: (i) Progress with the Phase 1 trial studying BI-1910 as single agent in solid tumors; (ii) Initial clinical data from the BT-001 Phase 1 study evaluating the candidate both as single agent and in combination with KEYTRUDA (pembrolizumab) in patients with solid tumors."

P1 data • Trial status • Solid Tumor

BioInvent announces a new clinical trial collaboration and supply agreement with MSD to evaluate BI-1910, the company’s second anti-TNFR2 antibody in combination with KEYTRUDA (pembrolizumab) (BioInvent Press Release) - "BioInvent International AB...announces a clinical trial collaboration and supply agreement with MSD International Business GmbH...for a Phase 1/2a study of its monoclonal antibody BI-1910 in combination with KEYTRUDA (pembrolizumab). Under the terms of the supply agreement, MSD will provide its anti-PD-1 therapy KEYTRUDA to be used in combination with BI-1910. The Phase 1/2a trial will be conducted in the US and Europe and has an innovative, adaptive design to allow for ideal dose escalation....The single agent arm of the Phase 1/2a BI-1910 study was initiated in December 2023 and first data is expected by YE 2024."

Licensing / partnership • P1/2 data • Hepatocellular Cancer • Non Small Cell Lung Cancer

BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=104 | Recruiting | Sponsor: BioInvent International AB

Combination therapy • Metastases • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BioInvent Enrolls First Patient in Phase 1/2a Clinical Trial with TNFR2 Antibody BI-1910 (Issuer Direct) - "BioInvent International AB...announces it has enrolled the first patient in its Phase 1/2a trial of the monoclonal antibody BI-1910, the company's second anti-tumor necrosis factor receptor 2 (TNFR2) program to enter clinical development. The Phase 1/2a clinical trial will be conducted in the US and Europe and is using an innovative, adaptive design for dose escalation. The first phase of the trial will enroll all solid cancer entities initially as single agent, followed by a dose escalation phase with BI-1910 in combination with pembrolizumab. Subsequently, exploratory expansion cohorts are planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC)."

Enrollment open • Hepatocellular Cancer • Non Small Cell Lung Cancer

Preclinical development of an agonistic anti-TNFR2 antibody (BI-1910) for cancer immunotherapy (SITC 2023) - "Conclusions The strong similarities in BI-1910 induced immune response between mice and cynomolgus macaques shows promise that similar T cell activation and following anti-tumor effects will occur also in humans. Collectively, these studies support the upcoming phase I/II study in solid cancer patients planned to start in H2 2023."

IO biomarker • Preclinical • Oncology • Solid Tumor • 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

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

BioInvent Obtains IND Approval for Clinical Trial with anti-TNFR2 Antibody BI-1910 (Issuer Direct) - "BioInvent International AB...announces it has received Investigational New Drug (IND) approval for the monoclonal antibody BI-1910, which will now become its second anti-tumor necrosis factor receptor 2 (TNFR2) program to enter clinical development....The planned Phase 1/2a clinical study will be conducted in the US and Europe and will have an innovative, adaptive design to allow for ideal dose optimization. Exploratory cohorts are planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC) and initial investigations will be as both a single agent and in combination with pembrolizumab."

IND • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

[VIRTUAL] Targeting TNFR2 for cancer immunotherapy: Ligand blocking depletors versus receptor agonists (AACR-II 2020) - "In addition, the two antibodies similarly modulated the tumor myeloid content. Based on careful MoA-characterization, two human lead candidate anti-TNFR2 antibodies are being developed for treatment of solid cancer; BI-1808, a ligand-blocking T reg depleting antibody and BI-1910, a TNFR2 agonist."

IO Biomarker • Oncology • Solid Tumor • CD8 • TNFRSF1B