BioInvent to Present More Phase 1/2a Data at EHA 2024 for BI-1206 with Rituximab in NHL

BioInvent International AB (BioInvent), a Swedish biotech firm, has disclosed promising clinical data concerning its investigational drug BI-1206, aimed at treating relapsed and refractory non-Hodgkin lymphoma (NHL). This data will be showcased in a poster presentation at the European Hematology Association congress in Madrid, Spain, from June 13-16, 2024.

Martin Welschof, CEO of BioInvent, highlighted the importance of these findings by noting the urgent need to develop therapies that can overcome resistance to current treatments like rituximab, which is a crucial component of NHL therapy. Approximately 15% of patients do not respond to rituximab, and another 25% relapse within three years post-treatment. BI-1206, an anti-FcγRIIB monoclonal antibody, is designed to inhibit a mechanism that causes tumor cells to internalize and thus neutralize rituximab. The goal is to enhance the efficacy of rituximab and potentially other similar treatments.

BI-1206 is being tested in both intravenous (IV) and subcutaneous (SC) formulations. In the IV administration cohort, the treatment has shown a response rate of 35%, with 29% of patients achieving complete responses and 71% showing disease control. For follicular lymphoma (FL), a subtype of NHL, the overall response rate was 56%. Subcutaneous administration is also showing early promise, with initial data indicating 1 complete response, 2 partial responses, and 1 stable disease in 4 evaluable patients.

Based on these encouraging results, BioInvent plans to launch a Phase 2a study that includes a triple combination therapy involving BI-1206, rituximab, and acalabrutinib, a BTK inhibitor marketed as Calquence®. This combination aims to further boost response rates and provide clinicians and patients with more effective treatment options.

Additionally, BI-1206 is being studied for its potential in treating solid tumors, with data expected to be presented at the upcoming ASCO meeting in 2024. The drug works by targeting the FcγRIIB receptor, which is not only present on tumor cells but also on certain immune cells like macrophages. Blocking this receptor is thought to help overcome resistance to targeted therapies, thereby enhancing their efficacy.

In terms of safety, the most common adverse events observed were thrombocytopenia and elevated transaminase levels. These side effects were manageable, resolving within a median duration of four days without significant complications. Importantly, no dose-limiting toxicities were observed with the IV dosing after pre-treatment with corticosteroids.

BioInvent's pipeline includes multiple drug candidates in various stages of clinical trials, focusing on both blood cancers and solid tumors. The company employs its proprietary F.I.R.S.T™ technology platform, which helps identify both targets and the antibodies that bind to them, to fuel its clinical development pipeline and provide opportunities for licensing and partnerships.

As for BI-1206, its development continues with both IV and SC formulations being explored in clinical trials. The SC formulation is particularly notable as it offers the potential for easier administration, which could improve patient compliance and convenience.

Through collaborations and licensing agreements with several top-tier pharmaceutical companies, BioInvent generates revenue while also producing antibodies for third parties in its fully integrated manufacturing unit. This multi-faceted approach not only supports its ongoing clinical programs but also opens up additional commercial opportunities.

BioInvent's commitment to advancing cancer therapy through innovative antibody treatments is evident in its strategic development and promising clinical data, which signal a potentially significant impact on the treatment landscape for NHL and beyond.