BioInvent International AB

Core Business and Strategic Focus

The company's central mission is to generate innovative and highly differentiated antibody drug candidates, primarily targeting hematological cancers and solid tumors. BioInvent is fully integrated, possessing capabilities from target identification and antibody generation through preclinical and clinical development, supported by an in-house, state-of-the-art manufacturing facility.

BioInvent's business model is two-pronged: 1. Proprietary Pipeline Development: Advancing its own portfolio of first-in-class immuno-oncology (IO) antibodies through clinical trials. 2. Strategic Licensing and Collaborations: Partnering with major pharmaceutical and biotechnology companies to leverage its technology platforms and generate revenue from research, licensing, and manufacturing agreements.

Proprietary Technology Platforms

The foundation of BioInvent's drug discovery engine rests on two proprietary and highly validated technology platforms:

• F.I.R.S.T. (Finding Immunologically Relevant Targets): This unique development tool allows for the simultaneous identification of both clinically relevant therapeutic targets and the corresponding antibodies that bind to them. Crucially, the platform utilizes patient material as the basis for the entire development process, which is designed to identify the most biologically significant targets in a disease model.
• n-CoDeR? Antibody Library: A proprietary and extensive human antibody repertoire that contains antibodies specifically engineered to bind strongly and precisely to their targets. This library is used in conjunction with the F.I.R.S.T. platform to rapidly generate promising drug candidates.

Products and Clinical Pipeline

BioInvent's pipeline features several programs in clinical development, each representing a first-in-class or highly differentiated approach to immuno-oncology:

Clinical-Stage Assets

1. BI-1808 * Target: A high-affinity antibody targeting tumor necrosis factor receptor 2 (TNFR2). * Indication: Solid tumors. * Development Stage: Currently in a Phase 1/2a clinical trial, being evaluated both as a standalone monotherapy and in combination with pembrolizumab (a well-known anti-PD-1 checkpoint inhibitor). This program is a lead candidate due to the potential role of TNFR2 in promoting tumor growth and suppressing anti-tumor immunity.

2. BI-1206 * Target: A monoclonal antibody that blocks the inhibitory Fc-gamma receptor IIB (Fc?RIIB). * Indication: Hematological cancers, specifically non-Hodgkin lymphoma (NHL) and potentially other solid tumors. * Development Stage: In Phase 1/2a clinical development. By blocking Fc?RIIB, BI-1206 is designed to reverse the immune suppression mediated by this receptor, thereby enhancing the efficacy of other anti-cancer antibody treatments. The development of BI-1206 is supported by a clinical collaboration and supply agreement with AstraZeneca.

3. BI-1607 * Target: A CD32b-specific monoclonal antibody engineered for reduced Fc-binding. * Indication: Metastatic melanoma. * Development Stage: Advancing toward a Phase 2 study. The drug candidate is being evaluated in combination with Keytruda (pembrolizumab) and ipilimumab as part of a clinical trial collaboration and supply agreement with MSD International Business GmbH, a subsidiary of Merck & Co Inc.

4. BT-001 (Partnered with Transgene) * Nature: An oncolytic virus encoding a human anti-CTLA-4 antibody (derived from BioInvent???s n-CoDeR? library) and the cytokine GM-CSF. * Indication: Solid tumors. * Development Stage: In a Phase 1/2a clinical study. This program represents a unique approach by combining an oncolytic virus that selectively replicates in and destroys cancer cells with the local delivery of potent immune-activating agents.

Earlier-Stage and Partnered Programs

• mezagitamab (TAK-079): Although the company sold its royalty and milestone interests related to this asset, it was a program developed using BioInvent's technology platform, highlighting the company's past successes in external partnering.

Products and Services Beyond Drug Candidates

In addition to its proprietary drug pipeline, BioInvent provides critical services through its wholly-owned unit:

• BioInvent Manufacturing: The company operates a fully integrated, proprietary, and state-of-the-art Good Manufacturing Practice (GMP) facility. This unit provides contract manufacturing services, producing drug substance for clinical trials not only for BioInvent???s own pipeline but also for external clients and partners. The facility has a long track record, utilizing single-use technology for over two decades to produce drug substance for clinical trials across Europe, the USA, Japan, and Australia.

Market Position and Outlook

BioInvent International AB is positioned as a key player in the European immuno-oncology biotech sector, focusing exclusively on leveraging antibody biology to unleash the immune system against cancer. Its established technology platforms and history of successful collaborations with major pharmaceutical entities including AstraZeneca, Merck, Genentech, Roche, and others underscore its capabilities in both drug discovery and commercial partnerships. The company's in-house manufacturing capacity further enhances its control over its pipeline and provides an additional revenue stream through contract manufacturing services.