BioInvent International AB has announced encouraging initial clinical response data from its ongoing Phase 1/2a study evaluating a triple combination therapy for non-Hodgkin's lymphoma (NHL). The preliminary results show that the first two patients enrolled in the trial have already demonstrated positive responses to treatment.
The study is investigating the combination of BioInvent's anti-FcyRIIB antibody BI-1206 with rituximab and AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in patients with NHL. Of the two patients enrolled so far, one has achieved a complete response (CR) and the other a partial response (PR).
"It is highly encouraging to see that the move to subcutaneous administration of BI-1206 has led to the improved safety profile we had predicted and hoped for, while also continuing to deliver on the promising efficacy signals already observed," said Martin Welschof, Chief Executive Officer of BioInvent. "We are also very pleased with the initial data from the Phase 2a triple combination study showing that the first two patients enrolled at the lower dose in the safety run-in are showing responses."
Study Design and Enrollment Status
The triplet arm in the Phase 2a study combines the subcutaneous formulation of BI-1206 and rituximab with Calquence. The trial is expected to enroll approximately 30 patients across clinical sites in Spain, Germany, the United States, and Brazil. Patient enrollment is reportedly on schedule, with further Phase 2a data expected by mid-2025.
In February 2024, BioInvent signed a clinical supply agreement with AstraZeneca to provide Calquence for the combination arm of the study.
Mechanism of Action and Therapeutic Rationale
BI-1206 is one of BioInvent's lead drug candidates, designed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The antibody targets FcyRIIB, a receptor that can inhibit the anti-tumor activity of therapeutic antibodies like rituximab.
All patients in the ongoing Phase 1/2a study have previously been treated with one or more rituximab-containing regimens, highlighting the potential of BI-1206 to overcome resistance to standard therapies.
Previous Clinical Data
Earlier results from the study were presented at the European Hematology Association (EHA) congress in June 2024. The intravenous Phase 1 part demonstrated responses across the dose range of 30-100 mg, including 5 patients with complete response, 1 with partial response, and 6 patients with stable disease out of 17 evaluable patients.
The subcutaneous formulation of BI-1206 in combination with rituximab has shown 2 complete responses, 3 partial responses, and 3 stable disease outcomes among 9 evaluable patients.
Safety Profile
The preliminary data indicates that the triple combination treatment is well-tolerated with no safety or tolerability concerns reported. The subcutaneous administration of BI-1206 appears to have improved the safety profile compared to intravenous administration, as anticipated by the researchers.
Parallel Development in Solid Tumors
In addition to the NHL study, BioInvent is also conducting a Phase 1/2a trial of BI-1206 in combination with MSD's anti-PD-1 therapy KEYTRUDA (pembrolizumab) in heavily pre-treated patients with solid tumors. This study has also shown promising results, including a complete response in a patient with metastatic melanoma that has been maintained for nearly two years.
Given the favorable safety and tolerability profile observed to date in the solid tumor study, an additional dose cohort with increased dose frequency has been added to the Phase 1 part to further characterize the dose-response and safety of subcutaneous BI-1206.
Implications for Cancer Treatment
"With BI-1206, we are continuing to produce compelling clinical data in both non-Hodgkin's lymphoma and solid tumors that demonstrate the potential of targeting FcyRIIB to restore the activity of existing cancer treatments which could lead to life-transforming therapies for patients," commented Welschof.
The approach of targeting FcyRIIB to enhance the efficacy of established cancer therapies represents a novel strategy that could potentially address resistance mechanisms that limit the effectiveness of current treatments.
About BioInvent
BioInvent International AB is a clinical-stage biotech company focused on discovering and developing novel and first-in-class immuno-modulatory antibodies for cancer therapy. The company currently has five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors.
The company's proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating promising immune-modulatory candidates for the company's clinical development pipeline and providing licensing and partnering opportunities.
