BI-1607 / BioInvent - LARVOL DELTA

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

Different Doses of BI-1607 in Combination with Pembrolizumab and Ipilimumab, in Participants with Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: BioInvent International AB

New P1/2 trial • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • FCGR2A • PD-1

CONTRAST: BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=18 | Terminated | Sponsor: BioInvent International AB | Active, not recruiting ➔ Terminated; After the completion of phase IA, for business reasons it was decided to terminate the study.

Combination therapy • Metastases • Trial termination • Breast Cancer • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

BioInvent announces first patient enrolled in Phase 1b/2a study of BI-1607 in combination with ipilimumab and KEYTRUDA (pembrolizumab) in patients with unresectable or metastatic melanoma (BioInvent Press Release) - "The study will incorporate four cohorts in which two different dose levels of BI-1607 will be tested with two different dose levels of the CTLA-4 antibody ipilimumab, 3 mg/kg, approved for the treatment of melanoma, and the lower dose 1 mg/kg, in combination with a 200 mg flat dose of pembrolizumab in patients with unresectable or metastatic melanoma previously treated with anti-PD-1/L1. Approximately 35 patients will be enrolled in 10 to 12 sites located in the UK, Germany and Spain with first data expected in H2 2025."

P1/2 data • Trial status • Melanoma

BioInvent announces new clinical trial collaboration and supply agreement with MSD to evaluate BI-1607 in combination with KEYTRUDA (pembrolizumab) and ipilimumab (BioInvent Press Release) - "BioInvent International AB...announced a clinical trial collaboration and supply agreement with MSD International Business GmbH...to evaluate its second FcγRIIB-blocking antibody BI-1607 in combination with ipilimumab, and KEYTRUDA (pembrolizumab) in a Phase 2 study in patients with metastatic melanoma. Under the terms of the supply agreement, MSD will provide its anti-PD-1 therapy KEYTRUDA to be used in combination with BI-1607 and the CTLA-4 antibody ipilimumab. The open-label Phase 2 study will incorporate several dosing levels of BI-1607 and lower dosing levels of ipilimumab in patients with unresectable or metastatic melanoma."

Licensing / partnership • New P2 trial • Melanoma

CONTRAST: BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: BioInvent International AB | Recruiting ➔ Active, not recruiting | N=116 ➔ 18 | Trial completion date: Dec 2026 ➔ Apr 2024 | Trial primary completion date: Mar 2025 ➔ Feb 2024

Combination therapy • Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase 1/2a Open-label Clinical Trial of BI-1607, an Fc Engineered Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors – CONTRAST (SABCS 2023) - "This concept was demonstrated in preclinical in vivo models showing increased efficacy of the combination therapy with the murine surrogate of BI-1607 and an anti-HER2, an anti–cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), and an anti-CD20 (rituximab) as compared to monotherapy...The choice of trastuzumab as the combination agent in this trial was based on promising preclinical studies, a recognized need for additional options for those patients who fail to respond or stop responding to trastuzumab, and promising results from the newly approved Fc-engineered anti-HER2 mAb margetuximab...Phase 2a will enroll 15 subjects each in two cohorts of HER2+ advanced/metastatic breast cancer or HER2+ gastric/GEJ adenocarcinoma respectively. For information regarding the study, please contact: anna.ropenga@bioinvent.com"

Clinical • Combination therapy • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CTLA4 • HER-2

BioInvent Presents Positive First Clinical Data on Anti-FcyRIIB Antibody BI-1607 (Issuer Direct) - P1/2a | N=116 | CONTRAST (NCT05555251) | Sponsor: BioInvent International AB | "The Phase 1 data, presented in a poster at the San Antonio Breast Cancer Symposium, covered 18 patients treated at doses ranging from 75 mg up to 900 mg flat dose. Treatment was well tolerated and no serious adverse events related to BI-1607 were observed. The best clinical response reported in the poster was stable disease (SD) in 4/11 evaluable patients, with disease control lasting up to 7 cycles (21 weeks). To date two additional SDs have been observed, adding to 6/11 evaluable patients....Pharmacokinetic and pharmacodynamic data allowed identification of a wide dose range, where complete target engagement throughout a 3-week dose interval can be achieved, and this will provide the basis for further investigation in a Phase 2a trial, which planned to start 2024."

P1 data • Trial status • HER2 Positive Breast Cancer

BioInvent International AB: Interim report January–September 2023 (Issuer Direct) - "The dose-escalation part of the BI-1607 study was completed without any safety concerns. First clinical data to be presented at the San Antonio Breast Cancer Symposium on December 6, 2023."

P1/2 data • Trial status • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer

BioInvent International AB: Interim report January-June 2023 (Yahoo Finance) - "The dose-escalation part of the BI-1607 study was completed without any safety concerns. Exploratory work at intermediate dose levels is now being conducted to determine the best dose to move forward in subsequent studies."

Trial status • Breast Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A novel FcγRIIB-blocking antibody to enhance FcγR-dependent antitumor immunity with anti-HER2 therapy (AACR 2022) - P1/2 | "BI-1206 was found to have cytolytic activity against malignant B cells and the ability to block rituximab internalization from tumor cells, as well as enhance rituximab therapeutic activity in mice humanized for CD20 and FcγRIIB or bearing relapsed/refractory CLL in vivo. Emerging data demonstrate that FcγRs modulate the therapeutic activity of many therapeutic antibodies among them HER2 targeting antibodies such as Trastuzumab...We report the generation of a fully human FcγRIIB-blocking antibody (BI-1607) engineered to eliminate Fc-mediated FcγR binding and function (Fc-null anti-FcγRIIB)...This enhanced therapeutic efficacy is associated with increased tumor influx of myeloid and NK-cells. Collectively our results provide proof-of-concept for Fc-null anti-FcγRIIB to enhance anti-HER2 in the treatment of cancer."

Breast Cancer • Chronic Lymphocytic Leukemia • HER2 Breast Cancer • Oncology • Solid Tumor

[VIRTUAL] A novel FcγRIIB-blocking antibody to enhance FcγR-dependent antitumor immunity (AACR 2021) - P1/2 | "Based on its cytolytic activity against B cell cancer cells and ability to block rituximab internalization from tumor cells, as well as enhance rituximab therapeutic activity in mice humanized for CD20 and FcγRIIB or bearing relapsed/refractory CLL in vivo, BI-1206 is being explored in clinical trials (NCT03571568; NCT04219254)...Here, we report the generation of a novel, fully human FcγRIIB-blocking antibody (BI-1607) engineered to eliminate Fc-mediated FcγR binding and function (Fc-null anti-FcγRIIB)...Of relevance to the clinical setting where low dose anti-CTLA-4/anti-PD-1 combination therapies have been approved for different indications, we further demonstrate that triplet therapy significantly enhanced survival in the checkpoint blockade-poorly responsive B16 tumor model. Collectively our results provide proof-of-concept for Fc-null anti-FcγRIIB to enhance anti-CTLA-4 ICB in the treatment of cancer."

Chronic Lymphocytic Leukemia • Oncology • Solid Tumor

BioInvent Receives Notice of Allowance in the US for Patent Covering BI-1206 and BI-1607 (Issuer Direct) - "BioInvent International AB...announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance, informing the company that a patent application covering i.a. the anti-FcγRllB antibodies BI-1206 and BI-1607 will be granted contingent on payment of the issue fee. This allowance is an important hallmark in the development of BI-1206 and BI-1607. BI-1607 differs from BI-1206 in that BI-1607 has been engineered for reduced Fc-binding to Fc.....A patent in the same patent family has previously been granted by the USPTO and patents have also been granted by the European Patent Office and in several other countries, including China and Japan. The company also has related patent applications pending in some countries."

Patent • Oncology

BioInvent Receives FDA IND Approval for Anti-FcyRIIB Antibody BI-1607 (Issuer Direct) - "BioInvent International AB...announces the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its FcyRIIB-blocking antibody BI-1607....The IND approval allows for a Phase 1/2a trial with BI-1607, in combination with trastuzumab in HER2+ solid tumors, to be extended to U.S. centers....The study is currently in the dose-escalation phase, with the selected dose of BI-1607 to be studied in the subsequent Phase 2a part of the trial along with trastuzumab in advanced breast, metastatic gastric and gastroesophageal junction HER2+ cancers."

IND • Trial status • Breast Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

CONTRAST: Phase 1/2a Open-label Trial of BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=116 | Recruiting | Sponsor: BioInvent International AB

Combination therapy • New P1/2 trial • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

BioInvent Enrolls First Patient in Phase 1/2a Trial of BI-1607 in HER2 Positive Solid Tumors (Issuer Direct) - "BioInvent International AB...announces treatment of the first patient in a Phase 1/2a trial of its second anti-FcyRIIB antibody BI-1607 in combination with trastuzumab in HER2+ solid tumors. The first-in-human Phase 1 trial is a dose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors....The first patient has been recruited to the Phase 1 part of the study which is expected to recruit between 12 and 26 subjects."

Trial status • Oncology • Solid Tumor • HER-2

Phase 1/2a Open-label Trial of BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors Ensayo abierto de fase I/IIa de BI-1607 en combinación con trastuzumab en sujetos con tumores sólidos avanzados positivos para HER2 (clinicaltrialsregister.eu) - P1/2 | N=116 | Ongoing | Sponsor: BioInvent International AB

Combination therapy • New P1/2 trial • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

BioInvent's BI-1607 to Extend Reach of Anti-FcyRIIB Approach to Breast Cancer (Bloomberg) - "BioInvent International AB...announces that the company will be presenting the first data for BI-1607 at the forthcoming annual meeting of the American Association for Cancer Research in April 2022 (AACR22)....The AACR22 data show that a BI-1607 surrogate antibody enhances the therapeutic efficacy of anti-HER2 antibodies in a syngeneic in vivo tumor model system....The BI-1607 clinical Phase 1/2a study is planned to enroll its first patient during the second quarter 2022."

Preclinical • Trial status • Breast Cancer • Oncology

BioInvent presents proof-of-concept data on anti-FcyRIIB antibody BI-1607 at AACR Annual Meeting 2021 (PRNewswire) - “BioInvent International…announces the publication of proof-of-concept data on a novel, fully human FcγRIIB-blocking antibody, BI-1607, at the American Association for Cancer Research (AACR) Annual Meeting 2021, being held virtually April 10-15 and May 17-21. ‘The data on BI-1607 are very exciting and provide proof-of-concept of its ability to enhance anti-cancer immunity, illustrated by its ability to boost activity and overcome resistance to CTLA-4-based therapy’…‘We are looking forward to advancing BI-1607 into clinical development and expect to submit a clinical trial application during H2 2021.”

Preclinical • Trial status • Oncology • Solid Tumor