Genmab — November 2020

[E_L]

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

[E_L]

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

[E_L]

Presentation easier to read as earlier poster
https://investors.biontech.de/static-files/b6206133-040a-4f71-96eb-22cfcb982a52

[DevOp]

Thx E L, now with easily read dosing.

[E_L]

So on my earlier question, will they open expansion cohorts for the other diseases?' there will be 7 expansion cohorts with up to 40 patients per cohort

[E_L]

2x NSCLC, Urothelial, Endometrial, TNBC (Triple-negative breast cancer), SCCHN (
Squamous Cell Carcinoma of the Head and Neck) and Cervical

[peter12]

Judith also mentioned CR's at the cc ?

[peter12]

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,

[Bulder]

det er epco Peter

[peter12]

ok tak

[E_L]

on P20 of the presentation , fig A, the best change in SoD from baseline =-100%; does that mean the tumor disappeared?

[E_L]

should we conclude that Colorectal cancer and Ovarian cancer will not continue to the expansion phase?

[Bulder]

looks like it, both Q

[E_L]

what is it then that you where hoping for / expecting?

[GeorgeBest]

Thanks E L for the fantastic job you are doing

[gdn55]

Ditto her. Tak

[E_L]

I did - and no need to say thanks.

[E_L]

but seriously curious what people where expecting/ why they are disapointed. We have seen these sort of early data sets many times before now, it ususally isn't more then this

[GeorgeBest]

Yes, I must admit, I got carried away with Jans words again again...;-)

[GeorgeBest]

But I am sure they will deliver again