Alligator’s CEO: “We are not surprised by the positive readout”
Lund-based Alligator Bioscience continue to strengthen the case for their phase II candidate mitazalimab with 24 months data. BioStock reached out to CEO Søren Bregenholt to get his comments on the updated data.
– These results align well with our expectations and further reinforce our confidence in mitazalimab’s potential, says Bregenholt.
This morning biotech Alligator Bioscience, focused on improving cancer treatments, added to the string of good news surrounding lead candidate mitazalimab. The candidate, a CD40-agonstic anitbody, has been evaluated as first-line treatment in metastatic pancreatic cancer in the phase II OPTIMIZE-1 study in combination with a standard treatment, mFOLFIRINOX. During 2024 the company reported very promising data from the trial with compelling top-line data and 18-month survival data. Read more here.
24-month data continues to convince
Following last year’s publication of 18-month results, Wednesday morning saw Alligator release the 24-month analysis. This confirms a strong survival benefit and reinforces mitazalimab’s potential as an effective immunotherapy.
The study showed that 29.4 per cent of patients receiving mitazalimab with mFOLFIRINOX were still alive at 24 months. This is significantly higher than estimated survival rates of 8 per cent for FOLFIRINOX alone. The median follow-up time was 25.4 months, with 16 patients (28 per cent) still alive, including five (9 per cent) who remain on treatment.
Median overall survival (mOS) was 14.9 months, surpassing the 11.1 months seen with FOLFIRINOX or NALIRIFOX, another standard treatment. The duration of response was 12.6 months, compared to 5.9 and 7.3 months for standard treatments. These results confirm that mitazalimab provides stable and durable benefits over time.
Vd kommenterar
Søren, what stands out as the most important data from the 24-month analysis?
– We are very pleased to see that mitzalimab continues to provide long-term survival benefits with a 29.4% survival rate at 24 months in this hard-to-treat cancer. These data are underpinned by the fact that ~10% of the patients remain on treatment at this late timepoint, where the longest ongoing treament duration is more than 32 months.
What do you see as the key factors driving the extended survival benefit compared to standard treatments?
– Published mitazalimab biomarker data show a level of correlation between activation of the patients’ immune system and clinical response. In my view the extended survival benefit is a consequence of sustained immune activation in these patients, which is supported by the fact that some of these patients are maintained on mitazalimab only, without any chemotherapy.
The 900 µg/kg dose shows significantly higher response rates than the 450 µg/kg dose. How do these findings influence your strategy for the upcoming phase III trial?
– It is important to remember that we did the 450 µg/kg cohort to satisfy FDA’s request for additional dose characterization prior to phase 3 initiation. These data confirms, together with other data, that 900 µg/kg remains the recommended phase 3 dose.
With 29% of patients still alive at 24 months and some remaining on treatment for over 32 months, what insights do these long-term outcomes provide about mitazalimab’s durability?
– As just discussed, these data suggest that mitazalimab is able to sustain the tumor-directed immune response in these patients. We are of course digging deeper into the genetic and immune profile of these patients to establish any connections.
You are currently preparing for a phase III trial and engaging with potential partners. What are the next steps in this preparatory work?
– With these data, the confirmed regulatory pathway and the ongoing phase 3 manufacturing, the program is on track for phase 3 initiation in the second half this year. Meanwhile we actively explore strategic collaborations to accelerate late-stage development of mitazalimab.
The market reacted very positively to the results. Why do you think that is?
– The entire Alligator team is of course very pleased that investors, peers, and investigators have reacted to positively to these unprecedented data and the progress we have made pushing mitazalimab forward as a transformative treatment option for pancreatic cancer. Given the strong scientific foundation and the encouraging data we have seen continuously reported from OPTIMIZE-1, we were not surprised by the positive outcome of the readout. These results align well with our expectations and further reinforce our confidence in mitazalimab’s potential.
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