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COVID-19 infection therapeutic - Charite University of Medicine Berlin/Pluristem Therapeutics

Drug Profile

COVID-19 infection therapeutic - Charite University of Medicine Berlin/Pluristem Therapeutics

Latest Information Update: 19 May 2020

At a glance

  • Originator Charite - Universitatsmedizin Berlin; Pluristem Therapeutics
  • Class Anti-inflammatories; Antivirals; Stem cell therapies
  • Mechanism of Action Cell replacements; Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Clinical Phase Unknown COVID 2019 infections

Most Recent Events

  • 14 May 2020 Efficacy data from a COVID-19 compassionate use program released by Pluristem Therapeutics
  • 13 Apr 2020 Clinical trials in COVID-2019 infections in USA (Parenteral)
  • 07 Apr 2020 Efficacy data from a COVID-19 Compassionate Use Program released by Pluristem

Development Overview

Introduction

Pluristem Therapeutic (previously Pluristem Life Systems) is collaborating with BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at the Charite’ University of Medicine Berlin, for the treatment of respiratory and inflammatory complications associated with the COVID-19 coronavirus, utilising Pluristem's patent-protected PLacental expanded (PLX) cellular drug candidates. The collaboration aims to treat severe pneumonia resulting from COVID-19 and preventing the deterioration of patients towards acute respiratory distress syndrome (ARDS) and sepsis. The PLX cells are available for per patient compassionate use in Israel. Clinical development is underway in USA and Israel and Early research is underway in Germany.

PLX cells are placenta-derived, allogeneic mesenchymal-like adherent stromal cells possessing immunomodulatory properties that invoke the immune system’s natural regulatory T cells and M2 macrophages, thus precluding or reversing the accidental over-activation of the immune system. These attributable characteristics of the cells are expected to potentially reduce the fatal symptoms of COVID-19 induced pneumonia and pneumonitis. The cells release soluble biomolecules, inclusive of cytokines, chemokines and growth factors, which act in a paracrine or endocrine manner, to heal damaged tissue by stimulating the body’s own regenerative mechanisms. The PLX cells are grown utilising the company's proprietary three-dimensional expansion technology, and are amenable to patient administration off-the-shelf, without the need for tissue matching.

In November 2007, Pluristem Life Systems was renamed as Pluristem Therapeutics [1] .

Company Agreements

In March 2020, Pluristem Therapeutics expanded its existing framework and research agreement with Charite’ University of Medicine Berlin, to conduct a joint, collaborative project, to assess the therapeutic effects of Pluristem’s patented PLX cell product candidates, for potential treatment of the respiratory and inflammatory complications related to the COVID-19 coronavirus. Specifically, the collaboration will involve the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charite’ University of Medicine Berlin. Earlier, in October 2015, the company had expanded its five-year collaborative research agreement with the University of Medicine, Berlin. The companies completed orthopedic phase I/II study and have also collaborated on other indications including kidney disease, cardiovascular indications and comprehensive immunological research for Pluristem’s Peripheral Artery Disease clinical programs. Earlier, in August 2012, Pluristem Therapeutics Inc. renewed the five-year collaborative research agreement with the University of Medicine Berlin. BCRT and Pluristem were to collaborate on Pluristem's phase I/II clinical trial in Germany on the regeneration of injured gluteal muscle, as well as on immunological research and the development of new product candidates. The agreement between Pluristem Life Systems and Berlin-Brandenburg Center for Regenerative Therapy (BCRT) at Charité - University Medicine Berlin was originally entered into, in July 2007. Pluristem and BCRT were to collaborate on a variety of indications utilizing mesenchymal stem cells derived from the placenta that have been expanded in the Company's proprietary PluriX™ 3-D bioreactor. The initial focus of the collaboration wsa on neurological indications such as Multiple Sclerosis and Parkinson's disease. The agreement also covered organ transplantation and cardiovascular indications such as inflammatory cardiomyopathy. Pluristem is the exclusive owner of the technology and any products stemming from the collaboration. [2] [3] [4] [5]

Key Development Milestones

In April 2020, Pluristem Therapeutics announced the treatment of first patient with COVID-2019 infection with PLX cell therapy in the US under the US FDA's compassionate use programme. The single patient expanded access programme is a part of the US Coronavirus Treatment Acceleration Program (CTAP). In March 2020, Pluristem announced its intention to initiate development in the US [6] [7] .

As of March 2020, Pluristem Therapeutics announced that three patients have been treated under a per-patient compassionate use program for the treatment of COVID-19 infections in Israel. The company also expects to enrol other patients in Israel. Earlier, in March 2020, the Israeli Ministry of Health approved Pluristem’s request to seek approval for PLX cell product candidates to treat COVID-19 coronavirus patients under the per-patient compassionate use framework in Israel. In April 2020, preliminary efficacy data form this program was released by Pluristem. In May 2020, a 28 day follow up data were released by Pluristem [8] [9] [10] [11] [12] .

Financing Information: In May 2020, Pluristem Therapeutics entered into a definitive agreements with two institutional investors for offering of common stocks. Net proceeds of approximately $US15 million will be used for working capital, including funding for phase II trial of PLX cell therapy in the treatment of complications secondary from COVID-2019 infections and other clinical trial activities, investment in capital equipment and other general corporate purposes [13] .

In April 2020, Pluristem Therapeutics announced the approval of a €50 million non-dilutive financing from the European Investment Bank (EIB). The finance will be used for Pluristem’s research and development in the EU to further advance its regenerative cell therapy platform, to assist moving the products in its pipeline to market and clinical development of PLX cells as a treatment for complications associated with COVID-19. The expected signing date of the financing agreement relating to the Approved Financing is April 30, 2020 [14]

Patent Information

Pluristem Therapeutics has a large portfolio of issued patents and pending patent applications spanning 30 active patent families and 52 countries, including over 115 issued patents. The portfolio extenstively covers Pluristem’s cells and pharmaceutical compositions containing them, therapeutic uses (second medical uses) thereof, manufacturing methods and devices involved in the expansion and harvesting of adherent stromal cells, along with their subsequent controlled thawing after cryopreservation (Pluristem Therapeutics website, March 2020).

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Anti-inflammatories, Antivirals, Stem cell therapies
  • Target Cell
  • Mechanism of Action Cell replacements; Immunomodulators
  • WHO ATC code

    V03A-X (Other therapeutic products)

  • EPhMRA code

    V3X (All Other Therapeutic Products)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections single patient compassionate use - Clinical Phase Unknown USA Parenteral / unspecified Pluristem Therapeutics 13 Apr 2020
COVID 2019 infections Per patient compassionate use - Clinical Phase Unknown Israel Parenteral / unspecified Charite - Universitatsmedizin Berlin, Pluristem Therapeutics 17 Mar 2020
COVID 2019 infections respiratory and inflammatory complications associated with the COVID-19 coronavirusno - Research Germany Parenteral / unspecified Charite - Universitatsmedizin Berlin, Pluristem Therapeutics 12 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Charite - Universitatsmedizin Berlin Originator Germany
Pluristem Therapeutics Originator Israel
Pluristem Therapeutics Owner Israel
Charite - Universitatsmedizin Berlin Owner Germany
European Investment Bank Funder Luxembourg

Scientific Summary

Therapeutic Trials

Preliminary data from PLX cell against COVID-19 infections reported 87.5% survival rate in eight patients in the 28 day follow up. Improvement in respiratory parameters was observed in 4 out of 6 patients and 75% patients survived without assistance of ventilators. In addition, 62.5% patients were discharged alive from the hospital in comparison to 3.3% patients requiring mechanical ventilation. One patient has shown no change in respiratory parameters, is still breathing with the assistance of a ventilator and remains relatively stable. Deterioration in respiratory parameters was observed in one patient. Two patients out of four with multi-organ failure prior to treatment, showed clinical recovery in addition to the respiratory improvement [8] [9] [12]

Development History

Event Date Update Type Comment
14 May 2020 Scientific Update Efficacy data from a COVID-19 compassionate use program released by Pluristem Therapeutics [8] Updated 19 May 2020
13 Apr 2020 Phase Change - Clinical Clinical trials in COVID-2019 infections in USA (Parenteral) Updated 21 Apr 2020
07 Apr 2020 Scientific Update Efficacy data from a COVID-19 Compassionate Use Program released by Pluristem [9] Updated 21 Apr 2020
26 Mar 2020 Trial Update Pluristem plans a phase II study in COVID-2019 infections in USA (Parenteral) in 2020 [6] [8] Updated 01 Apr 2020
18 Mar 2020 Patent Information Pluristem Therapeutics has patent protection for its PLX cells and associated technologies (Pluristem Therapeutics website, March 2020) Updated 18 Mar 2020
18 Mar 2020 Patent Information Pluristem Therapeutics has patents pending for its PLX cells and associated technology (Pluristem Therapeutics website, March 2020) Updated 18 Mar 2020
17 Mar 2020 Phase Change - Clinical Clinical trials in COVID-2019 infections in Israel (Parenteral) [10] Updated 19 Mar 2020
17 Mar 2020 Regulatory Status The Israeli Ministry of Health approves per patient compassionate use of PLX cell product candidates for COVID-2019 infections in Israel [10] Updated 19 Mar 2020
12 Mar 2020 Licensing Status Pluristem Therapeutics expands its collaborative research agreement with Charite University of Medicine Berlin for respiratory and inflammatory complications associated with the COVID-19 coronavirus [5] Updated 18 Mar 2020
12 Mar 2020 Phase Change Early research in COVID-2019 infections in Germany (Parenteral) [5] Updated 18 Mar 2020
12 Mar 2020 Phase Change Early research in COVID-2019 infections in Israel (Parenteral) [5] Updated 18 Mar 2020
10 Jul 2007 Licensing Status Pluristem Therapeutics signs a collaborative research agreement with Charite University of Medicine Berlin for multiple indications utilizing Pluristem's placental mesenchymal stem cells (MSCs) [2] Updated 18 Mar 2020

References

  1. Pluristem's Reverse Stock Split Effective Today.

    Media Release
  2. Pluristem and Center for Regenerative Therapies at Charite University Hospital of Berlin Enters into Collaborative Research Agreement.

    Media Release
  3. Pluristem and World Renowned Charite Berlin-Brandenburg Center for Regenerative Therapies Renew Five-Year Collaborative Research Agreement.

    Media Release
  4. Pluristem & Charite Expand Cooperation Agreement to Include Orthopedic Indications.

    Media Release
  5. Pluristem and Charit University of Medicine Berlin Join Forces Targeting Potential Treatment for Respiratory and Inflammatory Intratissue Complications Caused by COVID-19.

    Media Release
  6. Pluristem Provides Update on COVID-19: Preparedness, Current Phase III Clinical Trials Status and Treatment Development Activity.

    Media Release
  7. Expanded Access Program for the potential use of PLX cells in the treatment of Single Patient suffering from complications associated with COVID-19

    ctiprofile
  8. Pluristem Provides 28-Day Follow Up for Ventilator-Dependent COVID-19 Patients under Compassionate Use Program in Israel and U.S.

    Media Release
  9. Pluristem Reports Preliminary Data from its COVID-19 Compassionate Use Program, Treating Seven Patients with Acute Respiratory Failure.

    Media Release
  10. Israeli Ministry of Health Clears a Path to Allow Per Patient Compassionate Use Treatment of Covid-19 Patients with Pluristems PLX Cells.

    Media Release
  11. Pluristem Treated First Three COVID-19 Patients in Israel under Compassionate Use.

    Media Release
  12. A trial conducted under a compassionate program for COVID-19 patients

    ctiprofile
  13. Pluristem Announces Pricing of Its Registered Direct Offering for Aggregate Proceeds of $15 Million.

    Media Release
  14. Pluristem Secures 50 Million Non-Dilutive Financing from the European Investment Bank to Support its COVID-19 Project and Phase III Studies.

    Media Release
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