Israel

PolyPid

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ISRAEL Israel

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PolyPid Granted Fast Track Designation from FDA for D-PLEX₁₀₀ for Prevention of Surgical Site Infections in Abdominal Surgery

Lead Product(s): Doxycycline Monohydrate

Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2020

Details:

PolyPid's D-PLEX100 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the prevention of post abdominal surgery incisional infections.

PolyPid

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ISRAEL Israel

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PolyPid to Present Phase 2 Results of D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Surgery at the American So...

Lead Product(s): Doxycycline Monohydrate

Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2020

Details:

CLS-AX was observed to be well tolerated in all animal species evaluated, with no overt signs of toxicity.

BiondVax Pharmaceuticals

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ISRAEL Israel

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Last of 12,400 Participants Completes Final Visit in BiondVax's M-001 Universal Flu Vaccine Pivotal Phase 3 Clinical Trial

Lead Product(s): Proglumide

Therapeutic Area: Infections and Infectious Diseases Product Name: M-001

Highest Development Status: Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 01, 2020

Details:

The purpose of the study is to assess M-001's ability as a standalone non-adjuvanted vaccine to provide clinical protection from circulating influenza strains as measured by reduction of influenza illness rate and severity, as well as to assess M-001's safety.

PolyPid

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PolyPid Initiates First Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Post-Abdominal Surgery Incisional Infections

Lead Product(s): Doxycycline Monohydrate

Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 01, 2020

Details:

SHIELD I is a multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy & safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC) vs SoC-treated control arm, to prevent post- abdominal surgery incisional infection.

BiondVax Pharmaceuticals

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NIH Report on Phase 2 Clinical Trial of BiondVax's M-001 Universal Influenza Vaccine Candidate Concludes Both Primary Endpoints Achieved

Lead Product(s): Proglumide

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 10, 2020

Details:

The NIAID-supported Phase 2 trial was conducted under an FDA Investigational New Drug application (IND), and NIAID’s Division of Microbiology and Infectious Diseases (DMID) has submitted the final CSR to the FDA.

PolyPid

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Surgical Infection Biotech PolyPid Refiles for a $58 Million IPO

Lead Product(s): Doxycycline Hyclate

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Aurum Ventures

Deal Size: $58.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 05, 2020

Details:

PolyPid's lead candidate D-PLEX100 is currently in a Phase 3 trial for bone surgical site infections (SSIs) and the company is planning to initiate a Phase 3 trial for abdominal SSIs set to begin in the 3Q 2020.

BiondVax Pharmaceuticals

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ISRAEL Israel

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BiondVax Announces Receipt of $4.2 Million Through Exercise of Warrants

Lead Product(s): M-001

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $4.2 million Upfront Cash: Undisclosed

Deal Type: Funding May 20, 2020

Details:

BiondVax's pivotal, Phase 3 trial in Europe is ongoing. The trial, which is assessing M‑001's ability to provide clinical protection from any circulating influenza strain, is being conducted with volunteers aged 50+ (with half aged 65+) over two flu seasons in 7 countries.

PolyPid

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PolyPid Announces the Initiation of a Phase 3 Clinical Trial of D-PLEX100 for Sternal Wound Infection Post-cardiac Surgery

Lead Product(s): Doxycycline Monohydrate

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 27, 2020

Details:

SHIELD will evaluate D-PLEX100 plus the standard of care (SoC) versus SoC only for the prevention of sternal wound infection post-cardiac surgery.

BiondVax Pharmaceuticals

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ISRAEL Israel

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NIAID-sponsored Trial of M-001 Validates Previous Clinical Trials

Lead Product(s): Proglumide

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 05, 2020

Details:

The data, indicate that both primary objectives were achieved. Analysis of the data is ongoing, and the clinical study report (CSR) is expected in Q2 2020.

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PolyPid

PolyPid Granted Fast Track Designation from FDA for D-PLEX₁₀₀ for Prevention of Surgical Site Infections in Abdominal Surgery

PolyPid

PolyPid to Present Phase 2 Results of D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Surgery at the American So...

BiondVax Pharmaceuticals

Last of 12,400 Participants Completes Final Visit in BiondVax's M-001 Universal Flu Vaccine Pivotal Phase 3 Clinical Trial

PolyPid

PolyPid Initiates First Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Post-Abdominal Surgery Incisional Infections

BiondVax Pharmaceuticals

NIH Report on Phase 2 Clinical Trial of BiondVax's M-001 Universal Influenza Vaccine Candidate Concludes Both Primary Endpoints Achieved

PolyPid

Surgical Infection Biotech PolyPid Refiles for a $58 Million IPO

BiondVax Pharmaceuticals

BiondVax Announces Receipt of $4.2 Million Through Exercise of Warrants

PolyPid

PolyPid Announces the Initiation of a Phase 3 Clinical Trial of D-PLEX100 for Sternal Wound Infection Post-cardiac Surgery

BiondVax Pharmaceuticals

NIAID-sponsored Trial of M-001 Validates Previous Clinical Trials