BioInvent has decided to streamline its development efforts by prioritizing BI-XNUMX and BI-XNUMX, two antibody-based immunotherapies that have already delivered promising clinical data. BI-1206 and BI-1808, two antibody-based immunotherapies that have already delivered promising clinical data.
The decision follows a review of the company's pipeline and resources. The development of the early-stage programs BI-1910 and BI-1607 will be paused, while the oncolytic virus BT 001 will continue in an investigator-led study in collaboration with Transgene. The company emphasizes that these adjustments are not a retreat but rather a reallocation of resources to the programs with the highest potential for clinical and commercial impact.
Progress so far in 2025
For BioInvent, the sharpened focus on BI-1206 and BI-1808 is supported by tangible progress: promising trial results in lymphoma and solid tumors, regulatory recognition, and a financial performance that has turned positive this quarter. Rather than signaling retreat, the company frames the decision to build on recent progress and accelerate the path toward its key objectives and major inflexion points. The latest quarterly results highlight how this strategy is already taking shape.
At the EHA 2025 congress, the company presented promising phase IIa monotherapy data for BI-1808 in CTCL, where all evaluable patients achieved disease control and nearly half showed objective responses. The program was further strengthened by the FDA Fast Track Designation for BI-1808 in CTCL.
In solid tumors, BI-1206 delivered encouraging phase I results in combination with pembrolizumab, including durable responses in heavily pretreated patients, paving the way for an upcoming phase II trial in first-line metastatic NSCLC and uveal melanoma later this year. In NHL, the triple combination of BI-1206, rituximab, and acalabrutinib produced a 63 per cent response rate among the first eight patients, reinforcing its potential as a safe, well-tolerated and convenient treatment approach for Non-Hodgkin lymphoma.
BioInvent reported net sales of SEK 198,1 million in Q2, royalty agreement of USD 30 million w/ XOMAThe company reported a profit of SEK 38,8 million compared to a loss last year, with SEK 797,5 million in cash, which provides financial sustainability into 2027.
Comments from the CEO
We contacted the CEO Martin Welschof to get his perspective on the strategic shift and the way forward.
The market response to the portfolio change was cautious. Why do you believe this decision is positive for BioInvent?
– We understand the market’s initial reaction, but this strategic shift is rooted in discipline and opportunity. By focusing our resources on BI-1206 and BI-1808—our most advanced and promising assets—we’re positioning BioInvent to deliver meaningful clinical impact and shareholder value. These programs have multiple upcoming catalysts, and we believe this streamlined approach enhances our ability to execute with precision and speed.
How did you weigh the decision to pause development of BI-1910 and BI-1607 against continuing with BI-1206 and BI-1808?
- This was not a decision taken lightly. BI-1910 and BI-1607 show promise, but our priority is to maximize the potential of our lead programs. BI-1206 has demonstrated encouraging efficacy in combination therapies for non-Hodgkin’s lymphoma and solid tumors, and BI-1808 has received Fast Track and Orphan Drug designations for cutaneous T-cell lymphoma. These signals from regulators and strong early data gave us confidence to double down where the impact could be greatest.
Can you comment on upcoming milestones for BI-1206 and BI-1808?
– We expect key readouts from the Phase 2a triple combination study of BI-1206 with rituximab and Calquence by H1 2026. The early responses—two complete and three partial out of eight evaluable — are very encouraging and data are still maturing. In solid tumors, we are preparing for the start of Phase 2 with BI-1206 in first line treatment of metastatic NSCLC and uveal melanoma. Since BI-1206 addresses a mechanism of resistance to anti-PD1, the potential extends to all indications where pembrolizumab is approved. Indeed, this combination has the potential of significantly contributing to the ongoing transformation of cancer care. For BI-1808, we’re expanding trials in CTCL and anticipate further data presentations from the solid tumor setting later this year. Both programs are progressing well, with additional sites opening and patient enrolment on track.
You now expect funding to last into Q1 2027. What are the key inflection points you believe could strengthen your financial position before then?
– Our current runway into early 2027 gives us breathing room. But we’re not standing still. Key inflection points include clinical data readouts, potential licensing deals, milestone payments and further regulatory designations. Positive clinical data from BI-1206 and BI-1808 could also unlock new partnership opportunities and strengthen our financial position.
Finally, what is your message to shareholders and patients following this restructuring?
- To our shareholders: thank you for your continued trust. This restructuring is about focusing, execution, and delivering value. To patients: our mission remains unchanged—to bring novel, effective cancer therapies to those who need them most. Every decision we make is guided by that purpose. We’re very excited about the road ahead.
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