On May 14, 2024, announced BioInvent that promising clinical data for BI-1206 in relapsed/refractory non-Hodgkin's lymphoma (NHL), dosed in combination with rituximab, will be presented in a poster at the European Hematology Association Congress to be held in Madrid, Spain from 13 to 16 June 2024. Read more here.
Promising clinical data for BI-1808 – a potential new class of immunomodulatory drugs
The company has made significant progress with its anti-TNFR2 antibody BI-1808The new results that will be presented at ASCO shows promising early signals of efficacy as monotherapy and a robust safety profile with this anti-TNFR2 program.
Initial efficacy and safety data from the ongoing Phase I/IIa study show one complete response, one partial response that continues to improve, and nine patients with stable disease with BI-1808 as monotherapy.
Promising efficacy signals and a favorable safety profile in the Phase I dose escalation portion evaluating BI-1808 in combination with Keytruda further strengthen BioInvent's project portfolio.
BioInvent CEO Martin Welschof commented on the progress:
“These data evaluating BI-1808 as monotherapy and in combination with pembrolizumab in patients with solid tumors support our belief that BI-1808 may represent a new class of immunomodulatory drugs with the potential to improve the efficacy of cancer treatment. These strong signals of antitumor activity, particularly in these heavily pretreated patients, are very encouraging and we look forward to presenting these data at the prestigious ASCO conference.”
More positive data for BI-1206 in solid tumors
The data package supporting BioInvent's other lead product, BI-1206, continues to grow, with new clinical results reported in late May showing promising and long-lasting responses in patients who have previously failed anti-PD-1/L1 therapy. These data support BioInvent's view that BI-1206 can augment the efficacy of anti-PD-1/L1 therapies, as a major challenge for treating physicians today is that patients either do not respond to or stop responding to current standard checkpoint inhibitor therapies. Importantly, the data also showed that the combination was well tolerated in this heavily pretreated patient population.
Data show one complete response, one partial response, and seven patients with stable disease, including one long-term, out of 24 evaluable patients. In addition, it has now been noted that subcutaneous administration of BI-1206, which is being developed in parallel with intravenous administration, is well tolerated with no notable injection-related reactions.
The company's Chief Medical Officer, Andres McAllister, comments on the progress in a press release:
“The ability to induce treatment responses in heavily pretreated patients, including two durable responses and stable disease lasting more than 24 months, is truly encouraging and supports the importance of blocking FcgRIIB to increase the activity of checkpoint inhibitors.”
New data for BI-1206 in NHL presented at EHA
Initial data for the subcutaneous arm of BI-1206 in NHL show 1 complete response, 2 partial responses, and 1 stable disease in 4 evaluable patients. In the intravenous arm, a fifth complete response has been observed, bringing the total to 5 complete responses, 1 partial response, and 6 stable disease in 17 evaluable patients. Based on these encouraging results, BioInvent plans to initiate a Phase IIa trial arm in which the BTK inhibitor acalabrutinib (Calquence) will form a triple component in the combination with rituximab and BI-1206, which is expected to further increase response rates.
Martin Welschof commented:
“There is a great need to develop treatments that can overcome resistance and improve the duration of treatment effect of rituximab, an important part of the treatment of NHL. We see that BI-1206 has the potential to meet this need. To identify the best options and meet the needs of clinicians and patients, we are evaluating BI-1206 as both intravenous and subcutaneous treatment. IV dosing has so far yielded response rates of 35% ORR (overall response rate), 29% CRR (cumulative response rate) and 71% DCR (disease control rate), with promising early efficacy data from the subcutaneous dosing. In addition, we report an ORR of 56% in the subgroup of patients with follicular lymphoma (FL).”
The positive development is reflected in a rising share price
BioInvent's progress over the past year, and especially over the past few months, has been recognized by the market. The company's share has risen by almost one hundred percent in three months, positioning BioInvent as one of the most successful investments on the Scandinavian stock exchanges this year.
BioInvent seems determined to continue on the same path and maintain its positive momentum: In addition to presenting its promising new data to the combined global expertise at ASCO and EHA, BioInvent will soon turn its attention to Key Opinion Leaders to market its drug candidates.
The Company will host a virtual COPD event on Tuesday, June 18, 2024 to discuss its recently presented clinical efficacy and safety data with BI-1808 and BI-1206, as well as TNFR2 and FcyRIIB as promising targets for cancer treatment with immunotherapy. Read more here.