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Research programme: siRNA therapeutics - Sirnaomics

Drug Profile

Research programme: siRNA therapeutics - Sirnaomics

Alternative Names: Acurita; FluQuit; STP523; STP601; STP702; STP801; STP805; STP900; STP909; STP911; STP916

Latest Information Update: 05 Feb 2020

At a glance

  • Originator Sirnaomics
  • Developer Guangdong Zhongsheng Pharmaceutical; Sirnaomics
  • Class Small interfering RNA
  • Mechanism of Action RNA interference
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Research Coronavirus infections
  • No development reported Age-related macular degeneration; Eye disorders; Glioblastoma; Human papillomavirus infections; Influenza virus infections; Liver cancer; Non-small cell lung cancer; Ovarian cancer; Respiratory syncytial virus infections; Spinal cord injuries; Transplant rejection

Most Recent Events

  • 27 Jan 2020 Early research in Coronavirus infections (Prevention) in China (unspecified route)
  • 27 Jan 2020 Early research in Coronavirus infections (Prevention) in USA (unspecified route)
  • 27 Jan 2020 Early research in Coronavirus infections in China (unspecified route)

Development Overview

Introduction

Sirnaomics is developing small interfering RNA (siRNA) therapeutics for the treatment of various indications, including ophthalmic disorders, influenza virus infections, human papillomavirus infection, coronavirus infection and cervical cancer. RNA interference is a naturally occurring phenomenon in which short oligoribonucleotides (siRNAs) exert their effect by causing messenger RNA degradation, which results in gene silencing. The company has developed proprietary techniques including the "Tri-Blocker" siRNA cocktail and "Snano" series of nanoparticle delivery systems. Tri-Blocker is a multi-targeted approach whereby siRNA targeting multiple genes in the same cellular and biochemistry pathways are designed in silico. The drugs are then tested in vitro for potency in individual gene knockout and finally in preclinical models of disease. In addition, Sirnaomics has developed and licensed nanoparticle technologies to deliver siRNA therapeutics. Early research for coronavirus infections is underway in the US and China and preclinical development is being conducted in the US and Asia.

Sirnaomics has several multi-targeted siRNA lead candidates, including STP 601 (Acurita), STP 702 (FluQuit), and STP 909. STP 601 is in development for the treatment of ocular neovascularisation diseases, such as age-related macular degeneration and diabetic retinopathy. STP 702 is an inhalation aerosol formulation of an siRNA therapeutic in development for the treatment of pandemic influenza virus infections. STP 909 is a topically delivered siRNA treatment being developed for the treatment of human papillomavirus (HPV) infection and cervical cancer. Other candidates include STP 523 (glioblastoma), STP 801 (non-small cell lung cancer), STP 900 (organ transplantation), STP 805 (spinal cord injury), STP 911 (HPV/cancer) and STP 916 (liver cancer).

STP 705 (wound healing) and STP 503 (solid tumours) are being developed in conjunction with General Research Laboratory [see RDI profile 800027951].

As at July 2016, no recent reports of development had been identified for preclinical development in age related macular degeneration in Asia, China, preclinical development in eye disorders, glioblastoma, human papillomavirus-infections, influenza virus infections, liver cancer, non-small cell lung cancer, ovarian cancer, respiratory syncytial virus infections, spinal cord injuries, transplant-rejection in the US.

Company Agreements

Sirnaomics partnered with Guangdong Zhongsheng Pharmaceutical in June 2011 to develop STP 601, a small interfering RNA therapeutic, for the treatment of diabetic retinopathy and age-related macular degeneration. This partnership will pursue clinical development and commercialisation of the candidate in the Greater China and Southeast Asia markets. Guangdong Zhongsheng Pharmaceutical is committing RMB63 million yuan ($US9.75 million), including upfront and milestone payments to the partnership in addition to a royalty sharing and market territory sharing arrangement with Sirnaomics [1] .

In January 2010, Sirnaomics licensed a polypeptide nanoparticle technology from the University of Maryland Medical School which grants Sirnaomics exclusive rights to a patent covering use of Histidine-Lysine polymer (HKP) for siRNA therapeutics in the areas of scarless wound healing and ocular diseases [2] .

Key Development Milestones

In January 2020, Sirnaomics announced the advancement of its RNAi-Based prophylactics and therapeutics for the treatment of severe acute respiratory infection (SARI) caused by novel coronavirus (2019-nCoV) in the US and China. Sirnaomics team has already identified potentially potent siRNAs, specifically targeting the viral genes critical for the viral infection and replication. The unique siRNA drug design and chemical modification, respiratory specific siRNA delivery formulation, and the handheld nebulizer device are providing a clear pathway for developing novel siRNA therapeutics and prophylactics against 2019-nCoV infection [3] .

In December 2012, Sirnaomics reported that that two siRNA duplexes targeting both HPV16 and HPV18, the two major cancerous strains, were formulated with a histidine-lysine co-polymer into nanoparticles to create STP 909, which abolished HPV growth in a rabbit skin papilloma model [4] .

Sirnaomics intended to move STP 601 into clinical development in 2009 [5] . Sirnaomics previously completed a pre-IND meeting with the US FDA and determined ongoing IND enabling studies for the STP 601 programme [1] .

Sirnaomics received a Small Business Innovation Research (SBIR) grant in July 2009 from the National Cancer Institute (NCI) for its siRNA therapeutics to treat lung cancer [6] . Later in June 2010, a further two SBIR grants from the NCI and the NIAID were granted to Sirnaomics to develop siRNA therapeutics for the treatment of glioblastoma and influenza virus infections [7] .

Patent Information

In July 2014, Sirnaomics received an Issue Notification form the United States Patent and Trademark Office for the US patent (US 8 375 567, PCT/US2008/012498), entitled "Mult-Targeted RNAi Therapeutics for Scarless Wound Healing of Skin". The company also holds Chinese patent ZL 200880124132.8 covering siRNA therapeutics [8] .

The licensing agreement with University of Maryland Medical School grants Sirnaomics exclusive rights to a patent (U.S. patent application 60/173,576 filed on 29 December 1999) covering use of Histidine-Lysine polymer (HKP) for siRNA therapeutics in the areas of wound healing and ocular diseases [2] .

Sirnaomics also holds exclusive rights to patents US 8 691 781 B2, PCT/US2005/040048, entitled "Compositions for Treating Respiratory Viral Infections And Their Use", US 8 541 568, PCT/US09/03196, entitled "Compositions and Methods Using siRNA Molecules for Treatment of Gliomas", PCT/US2009/69950, entitled "Multi-Targeted RNAi Therapeutics For Treatment of Breast Cancer", and PCT/IB2008/003661, entitled "Combinational Therapeutics For Treatment Of Prostate Cancer Using Epoxy Encapsulated Magnetic Particles And RNAi Medicine"), among others.

Drug Properties & Chemical Synopsis

  • Route of administration Inhalation, Parenteral, Topical
  • Formulation Aerosol, Injection, unspecified
  • Class Small interfering RNA
  • Mechanism of Action RNA interference
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

    L01 (Antineoplastic Agents)

    N07X (Other Nervous System Drugs)

    S01 (Ophthalmologicals)

    V03 (All Other Therapeutic Products)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

    L1 (Antineoplastics)

    N7X (All other CNS drugs)

    S1 (Ophthalmologicals)

    V3 (All Other Therapeutic Products)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Age-related macular degeneration - - No development reported (Preclinical) Asia, China Parenteral / unspecified Guangdong Zhongsheng Pharmaceutical, Sirnaomics 16 Jul 2016
Coronavirus infections Severe Acute Respiratory Infection (SARI) caused by the 2019 novel Coronavirus (2019-nCoV). - Research China, USA unspecified / unspecified Sirnaomics 27 Jan 2020
Coronavirus infections Severe Acute Respiratory Infection (SARI) caused by the 2019 novel Coronavirus (2019-nCoV) Prevention Research China, USA unspecified / unspecified Sirnaomics 27 Jan 2020
Eye disorders - - No development reported (Preclinical) USA Parenteral / Injection Sirnaomics 16 Jul 2016
Glioblastoma - - No development reported (Preclinical) USA Parenteral / unspecified Sirnaomics 16 Jul 2016
Human papillomavirus infections - - No development reported (Preclinical) USA Topical / unspecified Sirnaomics 16 Jul 2016
Influenza virus infections - - No development reported (Preclinical) USA Inhalation / Aerosol Sirnaomics 16 Jul 2016
Liver cancer - - No development reported (Preclinical) USA Parenteral / unspecified Sirnaomics 16 Jul 2016
Non-small cell lung cancer - - No development reported (Preclinical) USA Parenteral / unspecified Sirnaomics 16 Jul 2016
Ovarian cancer - - No development reported (Preclinical) USA Topical / unspecified Sirnaomics 16 Jul 2016
Respiratory syncytial virus infections - - No development reported (Preclinical) USA Parenteral / unspecified Sirnaomics 16 Jul 2016
Spinal cord injuries - - No development reported (Preclinical) USA Parenteral / unspecified Sirnaomics 16 Jul 2016
Transplant rejection - - No development reported (Preclinical) USA Parenteral / Injection Sirnaomics 16 Jul 2016

Commercial Information

Involved Organisations

Organisation Involvement Countries
Sirnaomics Originator USA
Sirnaomics Owner USA
Guangdong Zhongsheng Pharmaceutical Licensee Asia
University of Maryland School of Medicine Technology Provider USA

Development History

Event Date Update Type Comment
27 Jan 2020 Phase Change Early research in Coronavirus infections (Prevention) in China (unspecified route) [3] Updated 05 Feb 2020
27 Jan 2020 Phase Change Early research in Coronavirus infections (Prevention) in USA (unspecified route) [3] Updated 05 Feb 2020
27 Jan 2020 Phase Change Early research in Coronavirus infections in China (unspecified route) [3] Updated 28 Jan 2020
27 Jan 2020 Phase Change Early research in Coronavirus infections in USA (unspecified route) [3] Updated 28 Jan 2020
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Age-related-macular-degeneration in Asia (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Age-related-macular-degeneration in China (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Eye-disorders in USA (Parenteral, Injection) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Glioblastoma in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Human-papillomavirus-infections in USA (Topical) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Influenza-virus-infections in USA (Inhalation, Aerosol) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Liver-cancer in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Non-small-cell-lung-cancer in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Ovarian-cancer in USA (Topical) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Respiratory-syncytial-virus-infections in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Spinal-cord-injuries in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Transplant-rejection in USA (Parenteral, Injection) Updated 16 Jul 2016
24 Dec 2012 Phase Change - Preclinical Preclinical trials in Liver cancer in USA (Parenteral) Updated 24 Dec 2012
24 Dec 2012 Phase Change - Preclinical Preclinical trials in Respiratory syncytial virus infections in USA (Parenteral) Updated 24 Dec 2012
24 Dec 2012 Phase Change - Preclinical Preclinical trials in Spinal cord injuries in USA (Parenteral) Updated 24 Dec 2012
19 Dec 2012 Phase Change - Preclinical Preclinical trials in Human papillomavirus infections in USA (Topical) Updated 24 Dec 2012
19 Dec 2012 Phase Change - Preclinical Preclinical trials in Ovarian cancer in USA (Topical) Updated 24 Dec 2012
23 Jun 2011 Licensing Status Sirnaomics and Guangdong Zhongsheng Pharmaceutical agree to co-promote and co-develop siRNA therapeutics in Greater China and Southeast Asia for diabetic retinopathy and age-related macular degeneration [1] Updated 27 Jun 2011
23 Jun 2011 Phase Change - Preclinical Preclinical trials in Age-related macular degeneration in Asia (Parenteral) Updated 27 Jun 2011
23 Jun 2011 Phase Change - Preclinical Preclinical trials in Age-related macular degeneration in China (Parenteral) Updated 27 Jun 2011
29 Jun 2010 Company Involvement Sirnaomics receives two SBIR grants from the US National Cancer Institute and NIAID for siRNA-based drug development in Glioblastoma and Influenza virus infections Updated 01 Jul 2010
29 Jun 2010 Phase Change Early research in Glioblastoma in USA (Parenteral) Updated 01 Jul 2010
22 Jul 2009 Company Involvement Sirnaomics receives SBIR grant from National Cancer Institute for siRNA therapeutics development in Lung cancer Updated 30 Jul 2009
22 Jul 2009 Phase Change - Preclinical Preclinical trials in Non-small cell lung cancer in USA (Parenteral) Updated 30 Jul 2009
26 Dec 2007 Phase Change - Preclinical Preclinical trials in Eye disorders in USA (Parenteral) Updated 28 Dec 2007
26 Dec 2007 Phase Change - Preclinical Preclinical trials in Influenza virus infections in USA (Inhalation) Updated 28 Dec 2007
26 Dec 2007 Phase Change - Preclinical Preclinical trials in Transplant rejection in USA (Parenteral) Updated 28 Dec 2007

References

  1. Sirnaomics Seals a Second Partnership Deal with a Chinese Pharmaceutical Company for Developing siRNA Therapeutics.

    Media Release
  2. Sirnaomics Licenses Polypeptide Nanoparticle Technology for Its siRNA Therapeutic Product Development.

    Media Release
  3. Sirnaomics Advances RNAi-Based Prophylactics and Therapeutics to Battle SARI Caused by 2019-nCoV.

    Media Release
  4. Sirnaomics Advances Its Novel siRNA Therapeutics Against HPV Infection and Cervical Cancer.

    Media Release
  5. Sirnaomics Receives SBIR Grant from NCI For Its Multi-Targeted Cancer siRNA Therapeutics.

    Media Release
  6. Sirnaomics Receives SBIR Grant from NIH/NCI for Its Multi-Targeted Lung Cancer siRNA Therapeutics.

    Media Release
  7. Sirnaomics Receives Two SBIR Grants from NIH for Developing siRNA Therapeutics to Treat Glioblastoma and Influenza Infection.

    Media Release
  8. Sirnaomics Strengthens Its IP Position for Advancing the Company's Novel siRNA Therapeutics Programs.

    Media Release
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