-- On April 30, 2021, BioNTech and Pfizer submitted to the EMA a variation 
      to the European Conditional Marketing Authorization (CMA) for 
      COMIRNATY(R) to request an extension of the indication for use in 
      adolescents 12 to 15 years of age. If the EMA approves the variation, the 
      amended CMA will be valid in all 27 member states of the European Union. 
 
   -- On April 30 and May 4, 2021, BioNTech and Pfizer submitted new stability 
      data of BNT162b2 to the FDA and EMA in order to update the product's 
      label to extend the storage at standard refrigerator temperatures of 
      2degC to 8degC to four weeks. 
 
   -- On May 5, 2021, BioNTech and Pfizer Canada announced that Health Canada 
      has expanded the Interim Order authorization for BNT162b2 to include 
      individuals 12 to 15 years of age. This is the first COVID-19 vaccine 
      authorized in Canada for use in this age group. 
 
   -- On May 7, 2021, BioNTech and Pfizer announced the initiation of a 
      Biologics License Application (BLA) with the FDA for approval of BNT162b2 
      to prevent COVID-19 in individuals 16 years of age and older. Data to 
      support the BLA will be submitted by the companies to the FDA on a 
      rolling basis over the coming weeks, with a request for Priority Review. 
      BioNTech is the Marketing Authorization Holder in the European Union, and 
      the holder of emergency use authorizations or equivalent in the United 
      States (together with Pfizer), United Kingdom, Canada and other countries 
      in advance of a planned application for full marketing authorizations in 
      these countries. 
 
 
   Commercial updates 
 
 
   -- On April 19, 2021, BioNTech and Pfizer announced an agreement with the 
      European Commission (EC) to supply an additional 100 million doses of its 
      COVID-19 vaccine, as a result of the EC's decision to exercise its 
      option. The total number of doses to be delivered to the European Union 
      by the end of 2021 is now 600 million. 
 
   -- In April 2021, Pfizer and BioNTech entered into an agreement with Israel 
      to supply several million doses in 2022, with an option to purchase 
      additional doses. The companies also entered into an agreement with 
      Canada to supply up to 125 million doses in 2022 and 2023, with options 
      to purchase up to 60 million additional doses in 2024. Discussions for 
      additional dose commitments with governments and territories worldwide 
      are also ongoing for 2021 and beyond. 
 
   -- On May 6, 2021, BioNTech and Pfizer announced that they have signed a 
      Memorandum of Understanding with the International Olympic Committee to 
      donate doses of COVID-19 Vaccine to help vaccinate athletes, and their 
      delegations, participating in the Olympic and Paralympic Games Tokyo 
      2020, which are scheduled to take place in July 2021. 
 
   -- On May 7, 2021, the EC announced that BioNTech and Pfizer plan to supply 
      the EC with 900 million doses of COMIRNATY(R), the Companies' COVID-19 
      vaccine, to the 27 European Union (EU) member states beginning December 
      2021 through 2023, with an option for the EC to request up to an 
      additional 900 million doses. This contract is expected to close upon 
      final confirmation by the EC. 
 
 
   Manufacturing updates 
 
 
   -- BioNTech expects capacity to reach up to 3 billion doses by end of 2021, 
      and expects to have capacity to manufacture more than 3 billion doses in 
      2022. 
 
   -- In March 2021, the EMA approved the manufacturing of BioNTech's COVID-19 
      vaccine drug product at its facility in Marburg, Germany. This 
      manufacturing facility is one of the largest mRNA vaccine manufacturing 
      sites worldwide with an annual production capacity of up to one billion 
      doses of COVID-19 vaccine, once fully operational. The first batches of 
      vaccines manufactured at the Marburg facility were delivered in 
      mid-April. 
 
   -- BioNTech plans to deliver up to 250 million doses of BNT162b2 in the 
      first half of 2021. 
 
 
   Oncology 
 
   BioNTech is accelerating the development of a broad oncology pipeline, 
which has now advanced 14 product candidates in 15 ongoing trials. In 
April 2021 the Company started a first-in-human Phase 1 trial for the T 
cell therapy, targeting personalized neoantigens, named BNT221. 
Additional important milestones in the advancement of BioNTech's 
immuno-oncology pipeline in the first quarter of 2021 included the 
initiation of first-in-human trials for CARVac (BNT211) and 
RiboCytokines (BNT151). BioNTech also expects to further advance its 
oncology pipeline in 2021 with up to three additional programs expected 
to move into randomized Phase 2 trials. Additionally, three preclinical 
programs are expected to move into Phase 1 trials in the second half of 
2021. 
 
   During the remainder of 2021, BioNTech expects at least four data 
updates from its ongoing clinical trials. 
 
   mRNA programs 
 
   FixVac 
 
 
   -- BNT111 -- In collaboration with Regeneron, a randomized Phase 2 trial for 
      the treatment of patients with advanced melanoma progressing during or 
      after prior therapy with a PD-1 inhibitor, utilizing a combination of 
      BNT111 and Regeneron and Sanofi's Libtayo(R) (cemiplimab) is planned to 
      start in the first half of 2021. 
 
   -- BNT113 -- A Phase 2 trial evaluating BNT113 in combination with 
      pembrolizumab versus pembrolizumab monotherapy as a first-line treatment 
      in patients with unresectable recurrent or metastatic HPV16+ head and 
      neck squamous cell carcinoma (HNSCC) expressing PD-L1, is planned to 
      start in the first half of 2021 in the United States and the European 
      Union. BNT113 has not been combined with anti-PD1 before and the Phase 2 
      trial will start with a run in portion designed to demonstrate the safety 
      of the combination of BNT113 and pembrolizumab. These data are required 
      to address the partial clinical hold on the subsequent randomized part of 
      the Phase 2 trial. 
 
 
   Individualized neoantigen specific immunotherapy (iNeST) 
 
 
   -- BNT122 (Autogene Cevumeran) -- BioNTech's iNeST product candidate is 
      partnered with Genentech. 
 
 
   For the adjuvant treatment of colorectal cancer, first patient dosing in 
a randomized Phase 2 trial in circulating tumor DNA positive, surgically 
resected Stage 2 (high risk)/Stage 3 colorectal cancer is now planned in 
the second half of 2021. 
 
   RiboCytokines 
 
 
   -- BNT151 -- A Phase 1/2a dose escalation trial evaluating BNT151 with 
      expansion cohorts in multiple solid tumor indications is ongoing. 
 
 
   -- BNT152+153 -- BioNTech plans to start a Phase 1 trial for BNT152 
      (encoding IL-7) plus BNT153 (encoding IL-2) in multiple solid tumors in 
      the first half of 2021. 
 
 
   RiboMabs 
 
 
   -- BNT141 -- In February 2021, the FDA approved the IND for a Phase 1 
      first-in-human clinical trial for BNT141. BioNTech plans to start the 
      trial in the second half of 2021. 
 
   -- BNT142 -- BioNTech plans to start a Phase 1 clinical trial for BNT142 in 
      the second half of 2021. 
 
 
   Antibodies 
 
   Next-generation checkpoint immunomodulators 
 
   BNT311 and BNT312 are partnered with Genmab. 
 
 
   -- BNT311/GEN1046 -- A Phase 1/2a dose escalation trial with multiple 
      expansion cohorts in patients with malignant solid tumors is ongoing. A 
      data update for the trial is planned in the second half of 2021. 
 
   -- BNT312/GEN1042 -- A Phase 1/2a dose escalation trial with expansion 
      cohorts in patients with solid tumors is ongoing. The first data 
      disclosure for the trial is planned in the second half of 2021. 
 
 
   Cell therapies 
 
   CAR-T cell immunotherapy 
 
 
   -- BNT211 -- A first-in-human Phase 1/2a open-label, multi-center dose 
      escalation and dose expansion basket trial of BNT211 with Claudin-6 CAR-T 
      cells as monotherapy, or in combination of Claudin-6 CAR-T cells with 
      Claudin-6 CARVac, is ongoing. The trial is enrolling patients with 
      CLDN6-positive relapsed or refractory advanced solid tumors including 
      ovarian, testicular, lung, gastric and endometrial cancers. The 
      combination of CLDN6 CAR-T cell immunotherapy and CARVac is expected to 
      improve expansion and persistence of CLDN6 CAR-T. 
 
 
   BioNTech plans to present early data from the ongoing BNT211 Phase 1/2a 
trial on three patients treated with a starting dose of CLDN6 CAR-T 
cells at the upcoming 18th Association for Cancer Immunotherapy (CIMT) 
Annual Meeting 2021. In these heavily pretreated patients with solid 
tumors, neither acute nor dose-limiting toxicities were observed and all 
adverse events were transient and mild to moderate. Robust CAR-T cell 
engraftment could be detected in all three patients, as well as early 
signs of clinical activity. Following completion of the first dose level 
with CAR-T cell monotherapy, the trial is now progressing to the next 
dose level and a combination treatment involving CAR-T cells with an RNA 
vaccine, which BioNTech refers to as CARVac. A data update is planned in 
the second half of 2021. 
 
   Neoantigen-targeting T cell therapy 
 
 
   -- BNT221 -- In April 2021, the first patient was dosed in a first-in-human 
      Phase 1 dose escalation trial for the treatment of metastatic melanoma in 
      patients who are refractory or unresponsive to checkpoint inhibitors. 
      Part 1 consists of the monotherapy dose escalation of BNT221. In part 2, 
      BNT221 will be added to anti-PD1 after first-line therapy. The primary 
      objectives of the trial are to evaluate the safety and feasibility of 
      administering BNT221, in addition to an evaluation of immunogenicity and 
      clinical efficacy. 
 
 
   BNT221 (NEO-PTC-01) is a personal neoantigen-targeted T cell therapy 
candidate derived from patients' peripheral blood cells. The product 
candidate consists of multiple CD8+ and CD4+ T cell populations

(MORE TO FOLLOW) Dow Jones Newswires

May 10, 2021 07:00 ET (11:00 GMT)