Israel

Pluristem Therapeutics

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Pluristem Announces Activation of Clinical Sites and Commencement of Patient Enrollment in U.S. FDA Phase II COVID-19 ARDS Trial

Lead Product(s): PLX-PAD

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

Details:

The randomized, double-blind, placebo-controlled, multicenter, parallel-group 140 patient study is evaluating the efficacy and safety of intramuscular (IM) injections of PLX-PAD for the treatment of severe COVID-19 cases complicated by ARDS.

RedHill Biopharma

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ISRAEL Israel

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RedHill Biopharma Submits COVID-19 Clinical Trial Application for Phase 2/3 Study with Opaganib

Lead Product(s): Opaganib

Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 10, 2020

Details:

The multi-center, open-label Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors with the goal of identifying a recommended dose and schedule. Curis expects to initiate this study in the second half of 2020.

Can-Fite BioPharma

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ISRAEL Israel

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Following Pre-IND Guidance from FDA Can-Fite to Advance Piclidenoson into Phase II COVID-19 Trial in the U.S.

Lead Product(s): Piclidenoson

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 09, 2020

Details:

The planned Phase II trial will evaluate the efficacy and safety of Piclidenoson, when added to the current standard of care treatment, for COVID-19 infected patients with moderate-to-severe symptoms.

Can-Fite BioPharma

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ISRAEL Israel

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Can-Fite Announces Pre-IND Submission to USFDA for Piclidenoson to Treat COVID-19 Infected Patients with Moderate-to-Severe Symptoms

Lead Product(s): Piclidenoson

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 15, 2020

Details:

Piclidenoson’s anti-viral, anti-inflammatory, anti-rheumatic properties and excellent safety profile make it a strong candidate for the potential treatment of COVID-19.

K S Kim International

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ISRAEL Israel

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MGC Signs Multi-Country Distribution Agreement for Anti-Infective Drug

Lead Product(s): ArtemiC

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: MGC Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 13, 2020

Details:

The Term Sheet stipulates that KS KIM will distribute ArtemiC throughout Israel, Russia, and the Commonwealth of Independent States and the countries of the Balkan region.

RedHill Biopharma

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ISRAEL Israel

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RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.

Lead Product(s): Opaganib

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 08, 2020

Details:

IND application for a Phase 2a clinical study evaluating RedHill's investigational drug, opaganib, in patients with confirmed moderate-to-severe SARS-CoV-2 infection (the cause of COVID-19).

Pluristem Therapeutics

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ISRAEL Israel

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U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study

Lead Product(s): PLX-PAD

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 08, 2020

Details:

The objective of the study is to evaluate the efficacy and safety of one or two intramuscular injections, in three different dosages, of PLX-PAD for the treatment of ARDS resulting from COVID-19.

Enlivex Therapeutics

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ISRAEL Israel

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Enlivex Announces Initiation of Multi-Center Phase II Investigator-Initiated Clinical Trial of Allocetra in COVID-19 Patients

Lead Product(s): Allocetra

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 07, 2020

Details:

Investigation backed by preliminary results from the Phase Ib trial that demonstrated safety and an indication of efficacy of AllocetraTM in patients with severe sepsis admitted to the ICU.

Can-Fite BioPharma

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ISRAEL Israel

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Can Fite Received Approval for COVID-19 Clinical Trial in Israel, Patient Enrollment and Dosing to Commence Immediately

Lead Product(s): Piclidenoson

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 13, 2020

Details:

Study will treat 40 COVID-19 infected patients with Piclidenoson, who are hospitalized with moderate-to-severe symptoms.

PolyPid

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ISRAEL Israel

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Drug developer PolyPid to file for Wall Street IPO

Lead Product(s): Doxycycline Monohydrate

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Aurum Ventures

Deal Size: $105.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 24, 2020

Details:

The proceeds from the round would be used to finance advanced clinical development of its leading product, D-Plex100.

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Companies

Pluristem Therapeutics

Pluristem Announces Activation of Clinical Sites and Commencement of Patient Enrollment in U.S. FDA Phase II COVID-19 ARDS Trial

RedHill Biopharma

RedHill Biopharma Submits COVID-19 Clinical Trial Application for Phase 2/3 Study with Opaganib

Can-Fite BioPharma

Following Pre-IND Guidance from FDA Can-Fite to Advance Piclidenoson into Phase II COVID-19 Trial in the U.S.

Can-Fite BioPharma

Can-Fite Announces Pre-IND Submission to USFDA for Piclidenoson to Treat COVID-19 Infected Patients with Moderate-to-Severe Symptoms

K S Kim International

MGC Signs Multi-Country Distribution Agreement for Anti-Infective Drug

RedHill Biopharma

RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.

Pluristem Therapeutics

U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study

Enlivex Therapeutics

Enlivex Announces Initiation of Multi-Center Phase II Investigator-Initiated Clinical Trial of Allocetra in COVID-19 Patients

Can-Fite BioPharma

Can Fite Received Approval for COVID-19 Clinical Trial in Israel, Patient Enrollment and Dosing to Commence Immediately

PolyPid

Drug developer PolyPid to file for Wall Street IPO