- Successfully transferred IND for BNT321 to BioNTech. All necessary safety and other reports and an updated protocol filed with the FDA. Phase 1/2 trial of BNT321 expected to be re-initiated in the fourth quarter of 2019.
- Initiated a first-in-human global Phase 1/2a trial in collaboration with Genmab for GEN1042 (BNT312), a bispecific antibody targeting CD40 and 4-1BB for the treatment of multiple solid tumors.
- Entered into a clinical trial supply agreement with Regeneron to supply cemiplimab for use in combination with BioNTech’s BNT112 in a first-in-human Phase 1/2 trial of FixVac in advanced prostate cancer and received approval of clinical trial applications (CTAs) in various European countries to support the initiation of this trial.
- Filed IND for BNT411. Phase 1/2a clinical trial of BNT411 expected to be initiated as a mono- or combination therapy in solid tumors in the first half of 2020. The selective toll-like receptor 7 agonist has shown activity in numerous mouse tumor models, such as reduced tumor growth and tumor clearance.
- Ended the third quarter of 2019 with cash equivalents of $505m (€463.3m1).
- Raised additional $149m (approx. €135m) in net proceeds (after underwriting discounts and commissions) in Nasdaq IPO in October/November 2019.
Monday, November 25, 2019
BioNTech SE Provides Update on Corporate Progress
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