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Can-Fite BioPharma

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ISRAEL Israel

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FDA Clears Can-Fite to Commence Phase II Study of Piclidenoson COVID-19 Study

Lead Product(s): Piclidenoson

Therapeutic Area: Infections and Infectious Diseases Product Name: CF101

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 August 31, 2020

Details:

FDA has issued a “safe to proceed” notice for Can-Fite’s Investigational New Drug (IND) application for a Phase II study of its lead drug candidate Piclidenoson in the treatment of COVID-19.

Pluristem Therapeutics

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ISRAEL Israel

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Pluristem Launches FDA-Cleared COVID-19 Expanded Access Program, Enabling Patient Treatment Outside of Clinical Trial

Lead Product(s): PLX-PAD

Therapeutic Area: Infections and Infectious Diseases Product Name: PLX-PAD

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 August 27, 2020

Details:

U.S. Food and Drug Administration (FDA) has cleared the Company’s Expanded Access Program (EAP) for the use of its PLX-PAD cells to treat Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19outside ofthe Company’s ongoing Phase II COVID19 study in the U.S.

Enlivex Therapeutics

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ISRAEL Israel

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Enlivex Announces Dosing of First Patient in Clinical Trial of Allocetra in COVID-19 Patients with Severe Illness Respiratory Failure

Lead Product(s): Allocetra-OTS

Therapeutic Area: Infections and Infectious Diseases Product Name: Allocetra-OTS

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 August 10, 2020

Details:

The clinical trial has been designed to assess AllocetraTM in combination with standard of care therapy in patients with COVID-19 associated lung dysfunction.

Pluristem Therapeutics

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ISRAEL Israel

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Pluristem Expands its COVID-19 Program to Europe, Receives PEI Clearance to Commence Phase II Study in Germany

Lead Product(s): PLX-PAD

Therapeutic Area: Infections and Infectious Diseases Product Name: PLX-PAD

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 August 10, 2020

Details:

The Paul Ehrlich Institute has cleared the Company’s Phase II clinical protocol for its Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of severe COVID-19.

Can-Fite BioPharma

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Can-Fite Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study

Lead Product(s): Piclidenoson

Therapeutic Area: Infections and Infectious Diseases Product Name: CF101

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 July 27, 2020

Details:

Can-Fite BioPharma has submitted an Investigational New Drug application to U.S. FDA for a Phase II study of its lead drug candidate Piclidenoson in the treatment of COVID-19. The IND application is based on feedback and guidance from the FDA from prior pre-IND advice.

Pluristem Therapeutics

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Pluristem Provides Clinical Updates on its Phase III Critical Limb Ischemia (CLI) Study

Lead Product(s): PLX-PAD

Therapeutic Area: Infections and Infectious Diseases Product Name: PLX-PAD

Highest Development Status: Phase II 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:

Pluristem held discussions with theU.S. FDA and the EMA to reaffirm understandings related to the interim readout of its global pivotal Phase III study of PLX-PAD in CLI.

Can-Fite BioPharma

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Can-Fite Completes Phase II COVID-19 Protocol Based on FDA Guidance, Plans to File IND Shortly

Lead Product(s): Piclidenoson

Therapeutic Area: Infections and Infectious Diseases Product Name: CF101

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 July 15, 2020

Details:

The Phase II study titled, “Piclidenoson for Treatment of COVID-19 – A Randomized, Double Blind, Placebo-Controlled Trial” is a pilot trial in a population of hospitalized patients who all receive standard supportive care.

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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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.

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Can-Fite BioPharma

FDA Clears Can-Fite to Commence Phase II Study of Piclidenoson COVID-19 Study

Pluristem Therapeutics

Pluristem Launches FDA-Cleared COVID-19 Expanded Access Program, Enabling Patient Treatment Outside of Clinical Trial

Enlivex Therapeutics

Enlivex Announces Dosing of First Patient in Clinical Trial of Allocetra in COVID-19 Patients with Severe Illness Respiratory Failure

Pluristem Therapeutics

Pluristem Expands its COVID-19 Program to Europe, Receives PEI Clearance to Commence Phase II Study in Germany

Can-Fite BioPharma

Can-Fite Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study

Pluristem Therapeutics

Pluristem Provides Clinical Updates on its Phase III Critical Limb Ischemia (CLI) Study

Can-Fite BioPharma

Can-Fite Completes Phase II COVID-19 Protocol Based on FDA Guidance, Plans to File IND Shortly

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.