BioNTech Results Presentation Deck
1 BNT111 Fixvac Melanoma: Planning to initiate randomized phase 2 trial
10
Ongoing Phase
1 trial in
Advanced
Melanoma
published in
Nature
Regeneron
strategic
collaboration
and planned
Phase 2 trial
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Phase 1 trial data in CPI-experienced patients in monotherapy and in combination with anti-PD1
previously reported in July 2020 and published in Nature
All patients showed tumor associated antigen (TAA) specific T cell responses with In vitro
stimulation, and > 75% of patients showed immune responses against ≥ 1 TAA on an ex vivo basis
- T cells responses ramped up over 4-8 weeks and increased or remained stable up to over
one year with monthly maintenance therapy.
Reported durable clinical responses in monotherapy and in combination with anti-PD1
accompanied by high magnitude CD4+ and CD8+ response
Signed strategic collaboration to jointly conduct randomized Phase 2 trial with BNT111 and
Libtayo® (cemiplim ab anti-PD-1 therapy)
Targeting patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous
melanoma
Companies to share development costs equally and keep full commercial rights to own programs
Plan to initiate potentially registrational Phase 2 trial by the end of 2020 - more details on
anticipated trial design to be released in Q3
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