Genmab — November 2020
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BioNTech: Next-generation checkpoint immunomodulators
BNT311 – Interim data from a first-in-human Phase 1/2a trial of BNT311 (PD-L1x4-1BB; Gen1046) in 61 heavily pretreated patients with advanced solid tumors was presented at SITC 2020. In the dose escalation phase, BNT311 demonstrated a manageable safety profile and encouraging early single-agent clinical activity. Most adverse events were mild to moderate and treatment-related Grade 3 transaminase elevations resolved with corticosteroids.
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No treatment-related bilirubin increases or Grade 4 transaminase elevations were observed. Clinical benefit was observed across tumor types and dose levels, including in patients resistant to prior immunotherapy and with tumor types less sensitive to immune checkpoint inhibitors. Disease control was achieved in 65.6% of patients in the dose escalation portion, including partial responses in one TNBC patient, one ovarian cancer patient and two immune checkpoint inhibitor pre-treated NSCLC patient
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In the expansion cohort, which includes patients with PD-L1 relapsed/refractory NSCLC, two of 12 patients that could be objectively assessed achieved confirmed single-agent partial responses. One patient had an unconfirmed partial response and four patients demonstrated stable disease. BNT311/GEN1046 is partnered with Genmab. https://www.globenewswire.com/news-release/2020/11/10/2123650/0/en/BioNTech-Announces-Third-Quarter-2020-Financial-Results-and-Corporate-Progress.html
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Presentation easier to read as earlier poster
https://investors.biontech.de/static-files/b6206133-040a-4f71-96eb-22cfcb982a52 -
And as disclosed in the abstract, by the time of the cut, the median follow-up was 8.3 months, and 25 patients were still ongoing. And I think that with this, I give you a signal, that 25 patients were still ongoing. And if you look at the data again at the tail, in above 48 milligrams for the DLBCL from 7 patients, the ORR was 100%; CR, 28%; 72% PRs, and those patients were ongoing. So – and the FPL, same thing, above 12. And the cut is arbitrary,
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Thanks E L for the fantastic job you are doing
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