Research programme: siRNA therapeutics - Sirnaomics
Alternative Names: Acurita; STP523; STP601; STP801; STP805; STP900; STP911; STP916Latest Information Update: 31 Mar 2023
At a glance
- Originator Sirnaomics
- Developer Guangdong Zhongsheng Pharmaceutical; Sirnaomics
- Class Antineoplastics; Antivirals; Small interfering RNA
- Mechanism of Action RNA interference
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Discontinued Age-related macular degeneration; COVID 2019 infections; Eye disorders; Glioblastoma; Human papillomavirus infections; Liver cancer; Non-small cell lung cancer; Ovarian cancer; Respiratory syncytial virus infections; Spinal cord injuries; Transplant rejection
Most Recent Events
- 31 Mar 2023 Discontinued - Preclinical for Age-related macular degeneration in Asia (Parenteral) (Sirnaomics Pipeline, March 2023)
- 31 Mar 2023 Discontinued - Preclinical for Age-related macular degeneration in China (Parenteral) (Sirnaomics Pipeline, March 2023)
- 31 Mar 2023 Discontinued - Preclinical for Eye disorders in USA (Parenteral) (Sirnaomics Pipeline, March 2023)
Development Overview
Introduction
Sirnaomics was developing small interfering RNA (siRNA) therapeutics for the treatment of various indications, including ophthalmic disorders, human papillomavirus infection, COVID-2019 infections 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. Preclinical development was being conducted in the US and Asia; however as of March 2023, development seems to be discontinued as the programme and molecules under the programme are no longer available on the company pipeline (Sirnaomics Pipeline, March 2023).
Early research for COVID-2019 infections was underway in the US and China. However as of December 2022, no recent reports of development had been identified.
Sirnaomics has several multi-targeted siRNA lead candidates, including STP 601 (Acurita), and STP 909. STP 601 is in development for the treatment of ocular neovascularisation diseases, such as age-related macular degeneration and diabetic retinopathy. 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].
A lead candidate STP 909 has entered into clinical development [See ADIS Insight Drug profile 800065723]
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, 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
As of March 2023, development of the programme seems to be discontinued as the programme and molecules under the programme are no longer available on the company pipeline (Sirnaomics Pipeline, March 2023).
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 COVID-2019 infections [3] ..
Sirnaomics intended to move STP 601 into clinical development in 2009 [4] . Sirnaomics previously completed a pre-IND meeting with the US FDA and determined ongoing IND enabling studies for the STP 601 programme [1] .
Financing information
In July 2021, Sirnaomics sealed $US 105 million in a Series E financing. Proceeds from the financing will be used to fund the continued development of Sirnaomics' novel RNAi therapeutics for treating diverse human disorders, which include cancers, viral infections, fibrosis, and metabolic diseases [5] .
In October 2020, Sirnaomics sealed $US105 million series D financing, led by Rotating Boulder Fund, Walvax Biotechnology and Sunshine Riverhead Capital. The net proceeds will be used for the continued development of its novel RNAi therapeutics for treatment of disorders, including cancers, fibrosis diseases, metabolic diseases and viral infections [6] [7] .
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 [8] . Later in June 2010, a further SBIR grant from the NCI was granted to Sirnaomics to develop siRNA therapeutics for the treatment of glioblastoma [9] .
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 [10] .
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 Injection, unspecified
- Class Antineoplastics, Antivirals, 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 | - | - | Discontinued (Preclinical) | Asia, China | Parenteral / unspecified | Guangdong Zhongsheng Pharmaceutical, Sirnaomics | 31 Mar 2023 |
| COVID 2019 infections | - | Prevention | Discontinued (Research) | China, USA | unspecified / unspecified | Sirnaomics | 31 Mar 2023 |
| COVID 2019 infections | - | - | Discontinued (Research) | China, USA | unspecified / unspecified | Sirnaomics | 31 Mar 2023 |
| Eye disorders | - | - | Discontinued (Preclinical) | USA | Parenteral / Injection | Sirnaomics | 31 Mar 2023 |
| Glioblastoma | - | - | Discontinued (Preclinical) | USA | Parenteral / unspecified | Sirnaomics | 31 Mar 2023 |
| Human papillomavirus infections | - | - | Discontinued (Preclinical) | USA | Topical / unspecified | Sirnaomics | 31 Mar 2023 |
| Liver cancer | - | - | Discontinued (Preclinical) | USA | Parenteral / unspecified | Sirnaomics | 31 Mar 2023 |
| Non-small cell lung cancer | - | - | Discontinued (Preclinical) | USA | Parenteral / unspecified | Sirnaomics | 31 Mar 2023 |
| Ovarian cancer | - | - | Discontinued (Preclinical) | USA | Topical / unspecified | Sirnaomics | 31 Mar 2023 |
| Respiratory syncytial virus infections | - | - | Discontinued (Preclinical) | USA | Parenteral / unspecified | Sirnaomics | 31 Mar 2023 |
| Spinal cord injuries | - | - | Discontinued (Preclinical) | USA | Parenteral / unspecified | Sirnaomics | 31 Mar 2023 |
| Transplant rejection | - | - | Discontinued (Preclinical) | USA | Parenteral / Injection | Sirnaomics | 31 Mar 2023 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Sirnaomics | Originator | USA |
| Sirnaomics | Owner | USA |
| Guangdong Zhongsheng Pharmaceutical | Licensee | China |
| University of Maryland School of Medicine | Technology Provider | USA |
| National Institutes of Health (USA) | Funder | USA |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Age-related macular degeneration in Asia (Parenteral) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Age-related macular degeneration in China (Parenteral) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Eye disorders in USA (Parenteral) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Glioblastoma in USA (Parenteral) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Human papillomavirus infections in USA (Topical) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Liver cancer in USA (Parenteral) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Non-small cell lung cancer in USA (Parenteral) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Ovarian cancer in USA (Topical) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Respiratory syncytial virus infections in USA (Parenteral) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Spinal cord injuries in USA (Parenteral) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Transplant rejection in USA (Parenteral) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued | Discontinued for COVID-2019 infections (Prevention) in China (unspecified route) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued | Discontinued for COVID-2019 infections (Prevention) in USA (unspecified route) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued | Discontinued for COVID-2019 infections in China (unspecified route) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 31 Mar 2023 | Phase Change - Discontinued | Discontinued for COVID-2019 infections in USA (unspecified route) (Sirnaomics Pipeline, March 2023) Updated 31 Mar 2023 |
| 28 Dec 2022 | Phase Change - No development reported | No development reported for COVID-2019 infections (Prevention) in China (unspecified route) (Sirnaomics Therapeutics Pipeline, December 2022) Updated 31 Mar 2023 |
| 28 Dec 2022 | Phase Change - No development reported | No development reported for COVID-2019 infections (Prevention) in USA (unspecified route) (Sirnaomics Therapeutics Pipeline, December 2022) Updated 31 Mar 2023 |
| 28 Dec 2022 | Phase Change - No development reported | No development reported for COVID-2019 infections in China (unspecified route) (Sirnaomics Therapeutics Pipeline, December 2022) Updated 31 Mar 2023 |
| 28 Dec 2022 | Phase Change - No development reported | No development reported for COVID-2019 infections in USA (unspecified route) (Sirnaomics Therapeutics Pipeline, December 2022) Updated 31 Mar 2023 |
| 27 Jan 2020 | Phase Change | Early research in COVID-2019-infections (Prevention) in China (unspecified route) [3] Updated 05 Feb 2020 |
| 27 Jan 2020 | Phase Change | Early research in COVID-2019-infections (Prevention) in USA (unspecified route) [3] Updated 05 Feb 2020 |
| 27 Jan 2020 | Phase Change | Early research in COVID-2019-infections in China (unspecified route) [3] Updated 28 Jan 2020 |
| 27 Jan 2020 | Phase Change | Early research in COVID-2019-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 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 SBIR grant from the US National Cancer Institute for siRNA-based drug development in Glioblastoma 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 Transplant rejection in USA (Parenteral) Updated 28 Dec 2007 |
References
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Sirnaomics Seals a Second Partnership Deal with a Chinese Pharmaceutical Company for Developing siRNA Therapeutics.
Media Release -
Sirnaomics Licenses Polypeptide Nanoparticle Technology for Its siRNA Therapeutic Product Development.
Media Release -
Sirnaomics Advances RNAi-Based Prophylactics and Therapeutics to Battle SARI Caused by 2019-nCoV.
Media Release -
Sirnaomics Receives SBIR Grant from NCI For Its Multi-Targeted Cancer siRNA Therapeutics.
Media Release -
Sirnaomics Secures $105 Million in Series E Financing.
Media Release -
Sirnaomics Sealed US$105 Million Series D Financing to Fund Development of RNAi Therapeutics for Treatment of Cancers, Fibrotic Diseases and Viral Infections.
Media Release -
Sirnaomics Seals US$105 Million Series D Financing to Fund Development of RNAi Therapeutics for Treatment of Cancers, Fibrotic Diseases and Viral Infections.
Media Release -
Sirnaomics Receives SBIR Grant from NIH/NCI for Its Multi-Targeted Lung Cancer siRNA Therapeutics.
Media Release -
Sirnaomics Receives Two SBIR Grants from NIH for Developing siRNA Therapeutics to Treat Glioblastoma and Influenza Infection.
Media Release -
Sirnaomics Strengthens Its IP Position for Advancing the Company's Novel siRNA Therapeutics Programs.
Media Release
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