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BioNTech SE

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BioNTech and Pfizer Receive Regulatory Approval From Paul-Ehrlich-Institut to Commence German Part of Global Phase 2/3 Trial for COVID-19 Va...

Lead Product(s): BNT162

Therapeutic Area: Infections and Infectious Diseases Product Name: BNT162

Highest Development Status: Phase II/ Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 07, 2020

Details:

German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 2/3 clinical trial in Germany for their BNT162b2 vaccine candidate. The trial evaluates the safety and efficacy of BNT162b2 in up to 30,000 participants between 18 and 85 years of age.

BioNTech SE

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BioNTech and Fosun Pharma to Supply 10 Million Doses of BioNTech’s BNT162 mRNA-based Vaccine Candidate Against SARS-CoV-2 to Hong Kong SAR...

Lead Product(s): BNT162

Therapeutic Area: Infections and Infectious Diseases Product Name: BNT162

Highest Development Status: Phase II/ Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Fosun Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 27, 2020

Details:

Collaboration aims to supply 10 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, to Hong Kong.

BioNTech SE

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Pfizer and Biontech Report Promising Phase I/Ii Data of Covid-19 Vaccine

Lead Product(s): BNT162b1

Therapeutic Area: Infections and Infectious Diseases Product Name: BNT162b1

Highest Development Status: Phase II/ Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 12, 2020

Details:

BNT162b1 was administered in a dose that was well tolerated and generated dose-dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers.

BioNTech SE

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BioNTech and Fosun Pharma Announce Start of Clinical Trial of mRNA-based COVID-19 Vaccine Candidate in China

Lead Product(s): BNT162

Therapeutic Area: Infections and Infectious Diseases Product Name: BNT162

Highest Development Status: Phase II/ Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Shanghai Fosun Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 05, 2020

Details:

Phase 1 study will evaluate safety and immunogenicity in Chinese participants to support potential regulatory approval pathway in China.

BioNTech SE

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US signs $1.95bn deal for Pfizer and BioNTech’s Covid-19 vaccine

Lead Product(s): BNT162

Therapeutic Area: Infections and Infectious Diseases Product Name: BNT162

Highest Development Status: Phase II/ Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: U.S. government

Deal Size: $1,950.0 million Upfront Cash: Undisclosed

Deal Type: Agreement July 22, 2020

Details:

BioNTech SE and Pfizer Inc. Announced Agreement with the U.S. Department of Health and Human Services and the Department of Defense to Deliver 100 Million Doses of BNT162, the COVID-19 Vaccine.

InflaRx

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InflaRx Announces Decision to Enter Phase III Development of IFX-1 in Severe COVID-19 Induced Pneumonia

Lead Product(s): Ifx-1

Therapeutic Area: Infections and Infectious Diseases Product Name: IFX-1

Highest Development Status: Phase II/ Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

Company has decided to continue development with IFX-1 in severe COVID-19 induced pneumonia. The Company plans to initiate a double-blinded, randomized, placebo-controlled Phase III trial that will be adequately powered for statistical analyses.

Berlin Cures

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Berlin Cures to Evaluate BC 007, an Aptamer, in Patients for the Treatment of COVID-19

Lead Product(s): BC007

Therapeutic Area: Infections and Infectious Diseases Product Name: BC007

Highest Development Status: Phase II/ Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 24, 2020

Details:

Berlin Cures Holding AG is evaluating BC 007, a β1-adrenoceptor autoantibody neutralizing ssDNA product, for the treatment of COVID-19. BC 007 consists of a synthetically produced short and unmodified aptamer, which is able to bind to the spike protein of the coronavirus..

InflaRx

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InflaRx Reports Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19

Lead Product(s): Ifx-1

Therapeutic Area: Infections and Infectious Diseases Product Name: IFX-1

Highest Development Status: Phase II/ Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 17, 2020

Details:

IFX-1 treatment showed a trend in lower 28-day all-cause mortality rate, along with trends of maintained kidney function, faster normalization in lymphocyte counts and greater reduction in LDH in patients with severe COVID-19 pneumonia.

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BioNTech SE

BioNTech and Pfizer Receive Regulatory Approval From Paul-Ehrlich-Institut to Commence German Part of Global Phase 2/3 Trial for COVID-19 Va...

BioNTech SE

BioNTech and Fosun Pharma to Supply 10 Million Doses of BioNTech’s BNT162 mRNA-based Vaccine Candidate Against SARS-CoV-2 to Hong Kong SAR...

BioNTech SE

Pfizer and Biontech Report Promising Phase I/Ii Data of Covid-19 Vaccine

BioNTech SE

BioNTech and Fosun Pharma Announce Start of Clinical Trial of mRNA-based COVID-19 Vaccine Candidate in China

BioNTech SE

US signs $1.95bn deal for Pfizer and BioNTech’s Covid-19 vaccine

InflaRx

InflaRx Announces Decision to Enter Phase III Development of IFX-1 in Severe COVID-19 Induced Pneumonia

Berlin Cures

Berlin Cures to Evaluate BC 007, an Aptamer, in Patients for the Treatment of COVID-19

InflaRx

InflaRx Reports Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19