BioInvent has presented additional positive interim data from the company’s phase I/IIa clinical trial with drug candidate BI-1206 for immunotherapy treatment in patients with non-Hodgkin’s lymphoma. Biostock reached out to the company’s Chief Medical Officer, Andres McAllister, who is excited about seeing clinical responses this early in the trial. He is also very impressed by the quality and long duration of the responses.
BioInvent develops first-in-class immunomodulatory antibodies that strengthen, stimulate or activate the body’s immune system for the treatment of cancer. The goal is to develop those antibodies into new therapies for high unmet needs in cancer. The strategy is to (re-)activate anti-cancer immunity in patients who do not respond or stop responding to existing treatment options.
While some of the company’s drug candidates may have single agent activity, the notion of combination is very much present in the company’s strategy, as the future of cancer treatments lies on the combination of several agents including several agents targeting the immune system.
Ongoing studies with BI-1206
BI-1206, the leading compound in BioInvent’s pipeline, is currently being developed in combination with Roche/Genentech‘s anti-CD20 monoclonal antibody Rituxan/Mabthera (rituximab) for the treatment of patients with indolent non-Hodgkin’s B-cell lymphoma (NHL) who have relapsed or have become resistant to current treatment. In parallel, the candidate is being evaluated for the treatment of solid cancers in combination with Merck’s Keytruda(pembrolizumab).
For just over a year as of now, BioInvent has a license agreement with CASI Pharmaceuticals regarding China, Hong Kong, Macau and Taiwan. The agreement entails that BioInvent and CASI will jointly develop BI-1206 for the treatment of both haematological and solid tumours, where CASI is responsible for commercialisation in China and related markets. The two companies have developed a very smooth working relationship and are working hard to begin the clinical development of BI-1206 in China.
New positive data
In January, BioInvent communicated data from the first reading of the BI-1206/rituximab combination treatment. The response in six of the nine evaluated patients showed that BI-1206 has the potential to restore the efficacy of rituximab in patients with non-Hodgkin’s lymphoma who have relapsed after treatment with the drug. At that timepoint, a sustained and complete response could be observed in two patients lasting beyond 12 months.
In announcing this data, CEO Martin Welschof noted that the complete responses were particularly impressive and indicates that BI-1206 has the potential to significantly improve the quality of life for NHL patients who relapsed from the disease after several different treatments. On November 4, BioInvent communicated new data from a read-out made in July.
The data showed that six out of 12 patients had a complete or partial response to the combination therapy, corresponding to an objective response rate of 50 per cent. NHL is currently considered an incurable disease, but the new results from July suggest that BI-1206 not only restores the anti-tumour response, but also provides a lasting effect in many patients. Three patients were still on treatment at the July cutoff date.
The dose escalation is still ongoing, which means that the company can further fine-tune the dose, with the ultimate goal of improving the treatment for a patient group that currently has limited therapeutic options.
A poster with the latest results will be presented at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021) and virtually on December 11 at 23:30 CET. However, the abstract is already available online here.
BioInvent’s CMO comments
BioStock reached out to BioInvent’s Chief Medical Officer Andres McAllister, who talks about the interim data from July presented last week.
Andres, can you elaborate on the treatment potential seen already at this early stage of development?
– We have put the finger on what we believe is an important “long-sought-for” mechanism of resistance to rituximab. Rituximab is the backbone for the treatment of several hematological diseases and has truly changed the life of patients and their treating physicians. The strong negative impact that the Fcg receptor IIB (the target for BI-1206) has on disease progression has been known for quite some time. However, being able to selectively block the receptor has been challenging despite several attempts.
– BioInvent is the first company to be able to exclusively recognise and block the receptor. Restoring or enhancing the activity of rituximab will have a major impact on the treatment algorithm, spanning from last resorts of therapeutic intervention, to potentially all lines of treatment. The fact that we are observing long-lasting complete responses speaks loudly about the potential of BI-1206, and how this could help shift the treatment paradigm to chemotherapy-free regimens.
What implications will the results have on the BI-1206 programme with Rituximab?
– The results observed so far are prompting us to accelerate and optimise our clinical development strategy so that the drug can make it to the market in the quickest possible manner. The targeted indications allow us to pursue accelerated regulatory pathways based on orphan drug designation, fast track designation and conditional approval. In this context, we have already obtained the first milestone – orphan drug designation for mantle cell lymphoma. The situation is similar in follicular lymphoma and marginal zone lymphoma, the three entry indications that we are pursuing.
When are you expecting the next set of data?
– Further data from the ongoing phase I/IIa study with BI-1206 in combination with rituximab for the treatment of NHL will be presented as a poster at the ASH annual meeting held December 11-14. After that, BioInvent will hold a KOL event to discuss the data in more detail and also to present the first data from the phase I/IIa study with BI-1206 in combination with pembrolizumab in solid tumours.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.