isSCC
BCC
Liver Cancer1 (Basket) *
Liver Cancer, combo with anti-PD-(L)1⁵
Delivery Platform:
PNP-IT
PNP-IT
PNP-IT
PNP-IT
Commercial Rights:
Global
Global
Global
Global
Our core product candidate, STP705, is a dual TGF-ß1/COX-2 inhibitor. TGF-ß1 and COX-2 are well-validated gatekeeper targets for oncology and fibrosis disease drug development. STP705 leverages our locally administered PNP formulation for direct administration to diseased tissue. We are developing STP705 for NMSC including isSCC, dermal fibrosis and solid liver tumors.
STP705 has received U.S. orphan drug designation for the treatment of certain hepatocellular carcinomas and liver fibrosis, including: primary sclerosing cholangitis (PSC), cholangiocarcinoma (CCA) and hepatocellular carcinoma (HCC).
Multiple solid tumors
cSCC
NSCLC
Liver Cancer, cSCC, NSCLC, combo with anti-PD-(L)1
Delivery Platform:
PNP-IV
PNP-IV
PNP-IV
PNP-IV
Commercial Rights:
Global
Global
Global
Global
STP707, our second core product, is in early-stage development for the treatment of solid tumors, liver cancer, squamous cell carcinoma, and non-small cell lung cancer (NSCLC). The annual incidence of NSCLC in 2020 was larger in China (approximately 757,000 new cases) than in the U.S. (approximately 176,000 new cases), and is only expected to grow. STP707 is an intravenously administered TGF-ß1 and COX-2 inhibitor that leverages an RNAi-based response using the company’s proprietary PNP delivery platform. It is being studied as a monotherapy and in combination with anti-PD(L)-1 therapy in early-stage clinical trials taking place in the U.S. and China.
Pan Cancer
Delivery Platform:
PNP-IV
Commercial Rights:
Global
STP355 is an siRNA-based treatment for multiple cancer types, including breast cancer, melanoma, and colorectal cancer. It targets TGF-ß1 and VEGFR2 proteins, and is formulated with our PNP delivery platform.
Head & Neck Cancer/Bladder Cancer
Delivery Platform:
PNP-IT
Commercial Rights:
Global
STP369 is an siRNA treatment for head and neck cancer, and bladder cancer which targets BCL-xL and MCL-1 proteins and is formulated with our PNP delivery platform. We are also exploring the use of STP369 in combination with platinum-based chemotherapy cisplatin to evaluate the potential for STP369 to improve the efficacy of cisplatin or replace its use.
Liver Cancer/Lung Cancer/Pancreatic Cancer
Delivery Platform:
PNP-IV
Commercial Rights:
Global
STP779 comprises siRNA targeting TGF-ß1 and SULF-2, another validated tumorigenesis-associated gene, formulated with our PNP delivery platform for systemic administration. We are developing STP779 for the treatment of liver cancer, lung cancer and pancreatic cancer.
We maintain the global rights to develop and commercialize STP779.
Keloid Scarless Healing
Hypertrophic Scarring
Delivery Platform:
PNP-ID
PNP-ID
Commercial Rights:
Global
Global
Sirnaomics’ lead product candidate STP705 is a topically applied TGF-ß1 and COX-2 inhibitor that leverages an RNAi-based response using the company’s proprietary polypeptide nanoparticle (PNP) delivery platform. STP705 currently is in phase II clinical trials in the U.S. for keloid scarless healing and hypertrophic scarring, common dermatological conditions affecting more than 16 million patients in the U.S. and China annually, which can result in permanent functional loss and disfigurement. STP705 is also being studied in several cancer indications.
Liver Fibrosis/PSC
Lung Fibrosis
Delivery Platform:
PNP-IV
PNP-IV
Commercial Rights:
Global
Global
STP707 is in early-stage development for the treatment of primary sclerosing cholangitis (PSC), liver and lung fibrosis. The prevalence of PSC in the U.S. was 45,000 as of 2020, and 194,000 in China in 2020. STP707 is an intravenously administered TGF-ß1 and COX-2 inhibitor that leverages an RNAi-based response using the company’s proprietary PNP delivery platform optimized for systemic administration. It also is being studied in several cancer indications.
Fat Sculpting
Delivery Platform:
PNP-ID
Commercial Rights:
Global
Sirnaomics’ lead product candidate STP705 is a topically applied TGF-ß1 and COX-2 inhibitor that leverages an RNAi-based response using the company’s proprietary polypeptide nanoparticle (PNP) delivery platform. In addition to the oncology and fibrosis indications in which STP705 currently is being studied, STP705 is in early-stage studies as a fat sculpting indication.
Influenza
Delivery Platform:
Airway / PNP-IV
Commercial Rights:
OL China
STP702 is in early-stage development for the treatment of influenza targeting the M1 and PA segments of Influenza viruses utilizing an RNAi-based response. The siRNAs against each segment are designed to target multiple flu strains and the combination provides even greater coverage across variants including seasonal flu and avian strains.
Covid-19 vaccine
Delivery Platform:
LNP Intramuscular
Commercial Rights:
Global
RIM730, developed by RNAimmune, our non-wholly owned subsidiary, is in early-stage development for the active immunization against the Delta variant of the SARS-CoV2 using messenger RNA (mRNA) coding technology and an LNP delivery system for intramuscular administration.
Anticoagulation/Thrombosis
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP122G is in early-stage development as an anticoagulant in settings where antithrombotic therapeutics are needed such as stroke patients and orthopedic surgery patients. Utilizing Sirnaomics’ proprietary GalAhead™ platform of GalNAc-siRNA conjugates, STP122G targets Factor XI, a plasma glycoprotein that is primarily synthesized in the liver and plays a role in clot stabilization and expansion.
Hypertriglyceridemia
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP125G is in preclinical development for hypertriglyceridemia. STP125G is comprised of RNAi triggers targeting and utilizing Sirnaomics’ proprietary GalAhead™ platform of GalNAc-siRNA conjugates.
Complement-mediated diseases
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP144G is in preclinical development for complement-mediated disease indications using an RNAi-based response targeting Complement Factor B, formulated with Sirnaomics’ proprietary GalAhead™ platform.
Complement-mediated diseases
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP145G is in preclinical development for complement-mediated diseases using an RNAi-based response targeting Complement C5, formulated with Sirnaomics’ proprietary GalAhead™ platform.
Complement-mediated diseases
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP146G is in preclinical development for complement-mediated diseases, formulated with Sirnaomics’ proprietary GalAhead™ platform.
Complement-mediated diseases
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP247G is in preclinical development for complement-mediated diseases using an RNAi-based response targeting Complement Factor CFB/C5, formulated with Sirnaomics’ proprietary GalAhead™ platform.
Hemochromatosis & Hypertriglyceridemia
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP251G is in preclinical development for Hemochromatosis and Hypertriglyceridemia, formulated with Sirnaomics’ proprietary GalAhead™ platform.
Rare disease
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP152G is in preclinical development formulated with Sirnaomics’ proprietary GalAhead™ platform.
Hypertension
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP136G is in preclinical development for Hypertension, formulated with Sirnaomics’ proprietary GalAhead™ platform.
Hypertension & Hypertriglyceridemia
Delivery Platform:
GalAhead™ subcutaneous
Commercial Rights:
Global
STP237G is in preclinical development for Hypertension & Hypertriglyceridemia, formulated with Sirnaomics’ proprietary GalAhead™ platform.
Hypercholesterolemia
Delivery Platform:
PDoV-GalNAc subcutaneous
Commercial Rights:
Global
STP135G is in preclinical development for a hypercholesterolemia indication using an RNAi-based response targeting PCSK9, formulated with Sirnaomics’ proprietary PDoV-GalNAc platform.
Hepatitis B virus
Delivery Platform:
PDoV-GalNAc subcutaneous
Commercial Rights:
Global
STP155G is in preclinical development for the treatment of hepatitis B using an RNAi-based response targeting HBV sequences, formulated with Sirnaomics’ proprietary PDoV-GalNAc platform.
|
Notes: |
*denotes orphan drug |
Abbreviations:
isSCC= cutaneous squamous cell carcinoma in situ;
BCC= basal cell carcinoma;
cSCC= metastatic cutaneous squamous cell carcinoma;
NSCLC= non-small cell lung cancer;
CRC= colorectal carcinoma;
BC= bladder cancer;
PSC= primary sclerosing cholangitis;
PNP= our polypeptide nanoparticle (PNP) RNAi delivery platform;
PNP-IT= PNP platform formulated for intratumoral administration;
PNP-IV= PNP platform formulated for intravenous administration;
PNP-ID= PNP platform formulated for intradermal administration；
GalAhead™= our GalNAc RNAi delivery platform that conjugates GalNAc moieties to RNAi triggers;
PDoV-GalNAc= our GalNAc RNAi delivery platform that conjugates;
GalNAc moieties to Peptide Docking Vehicle (PDoV) peptide linkers and up to two siRNAs to the peptide;
LNP= lipid nanoparticle (LNP) formulation for delivery of mRNA;
HPV= human papilloma virus;
HBV=hepatitis B virus;
OL China= out licensed mainland China, Hong Kong, Macau and Taiwan rights under agreement with Walvax but we retain the rights for rest of the world;
MRCT= multi regional clinical trial in which we will be the sponsor for all clinical trial sites.
1. Liver cancer (basket) includes cholangiocarcinoma, hepatocellular carcinoma, liver metastases etc.
2. Sirnaomics filed an IND in China, which is currently awaiting approval from NMPA, for study sites in China. The study sites will be part of a global multicenter study for our Phase IIb clinical trial for isSCC.
3. Sirnaomics expects to file an IND in Greater China as part of the global multicenter clinical trials.
4. Sirnaomics expects to file an IND solely for HCC in China as part of the global multicenter clinical trials.
5. Studies in combination with anti-PD-(L)1 inhibitors conducted pursuant to collaborations with Innovent and Shanghai Junshi.
6. Research and development conducted by our subsidiary RNAimmune.