Cutasil (cotsiranib) / Guangzhou Xiangxue Pharma, Sirnaomics - LARVOL DELTA

A Novel Injectable Polypeptide Nanoparticle Encapsulated siRNA Targeting TGF-β1 and COX-2 for Localized Fat Reduction II: Phase I Clinical Trial. (PubMed, J Cosmet Dermatol) - P1 | "STP705 was safe and very well-tolerated and showed preliminary efficacy in inducing adipocyte apoptosis and tissue remodeling, suggesting a safer alternative or adjunct to existing fat reduction therapies. These findings support further trials to establish the safety and efficacy of STP705 for targeted fat reduction and body contouring."

Journal • P1 data • Aesthetic Medicine • Genetic Disorders • Obesity • TGFB1

Novel injectable polypeptide nanoparticle encapsulated siRNA targeting TGF-β1 and COX-2 for localized fat reduction I: Preclinical in vitro and animal models. (PubMed, J Cosmet Dermatol) - "The results of these studies support the use of targeted siRNA therapy specifically targeting TGF-β1 and COX-2, for localized fat reduction, offering a potential minimally invasive alternative to current fat reduction methods."

Journal • Preclinical • Genetic Disorders • Obesity • TGFB1

Sirnaomics Announces 2023 Annual Results (PRNewswire) - "STP705 for the treatment of squamous cell carcinoma in situ (isSCC) has advanced into late-stage clinical development. The Group is in active communication with the U.S. FDA to seek further guidance on late-stage clinical development. After discussing the Phase IIa and Phase IIb results with the U.S. FDA in an End-of-Phase II meeting...The Group have now proposed a well-designed Phase II/III study to serve as a pivotal trial to achieve alignment with the U.S. FDA and expects to provide an update to the FDA in the second quarter of 2024."

FDA event • New P2/3 trial • Squamous Cell Skin Cancer

A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC (clinicaltrials.gov) - P2 | N=44 | Completed | Sponsor: Sirnaomics | Active, not recruiting ➔ Completed | N=100 ➔ 44

Enrollment change • Trial completion • Bowens Disease • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma

A Study to Evaluate Safety, Tolerability of Subcutaneous Injection in Adult Subjects Undergoing Abdominoplasty (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Sirnaomics | Active, not recruiting ➔ Completed

Trial completion • Aesthetic Medicine • Genetic Disorders • Obesity

Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy (clinicaltrials.gov) - P1 | N=5 | Completed | Sponsor: Sirnaomics | Active, not recruiting ➔ Completed | N=50 ➔ 5

Enrollment change • Metastases • Trial completion • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Adults With Facial isSCC (clinicaltrials.gov) - P1/2 | N=9 | Completed | Sponsor: Sirnaomics | Active, not recruiting ➔ Completed | N=30 ➔ 9 | Trial completion date: Jul 2023 ➔ Mar 2023 | Trial primary completion date: Jul 2023 ➔ Mar 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Bowens Disease • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma

Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell Carcinoma (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: Sirnaomics | Active, not recruiting ➔ Completed | N=15 ➔ 32

Enrollment change • Trial completion • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

A Study for Safety and Efficacy Evaluation of Various Doses of STP705 in Reducing Keloid Recurrence (clinicaltrials.gov) - P2 | N=29 | Completed | Sponsor: Sirnaomics | Active, not recruiting ➔ Completed | N=60 ➔ 29

Enrollment change • Trial completion • Fibrosis

Sirnaomics Announces 2023 Interim Results (BioSpace) - "Following the discussions with the U.S. FDA in early 2023, the Group was ready to proceed with a confirmatory clinical study for the treatment of isSCC, based on positive Phase IIa and IIb results. It is preparing to move forward to conduct a single dosage study as a sub-group of subjects in a larger Phase III clinical trial. Moreover, the final data of the Phase II study of STP705 for the treatment of BCC is expected to be available in the latter half of 2023, and the Group aims to take its STP705 skin cancer franchise into late-stage development by the end of the year."

P2 data • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Sirnaomics Advances STP705 for Squamous Cell Carcinoma In Situ into Late-Stage Clinical Development (PRNewswire) - "Sirnaomics Ltd...announced the advancement of STP705 for the treatment of Squamous Cell Carcinoma in situ (isSCC) into late-stage clinical development after encouraging Phase IIa and Phase IIb clinical results were shared with the U.S. Food and Drug Administration (FDA) in an End of Phase-2 meeting. The FDA provided Sirnaomics guidance to move forward with late-stage clinical development because of the efficacious data provided as well as the widespread prevalence of Squamous Cell Carcinoma (SCC) lesions."

FDA event • Pipeline update • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Sirnaomics to Present Latest Developments in Polypeptide Nanoparticle Platform at the 4th Annual RNAi-Based Therapeutics Summit (PRNewswire) - "Dr. Lu will present the Company's proprietary Polypeptide Nanoparticle (PNP) technology for RNAi Cancer Therapeutics, with demonstration of dual-targeted drug design using either a local formulation or a systemic formulation for treatment of various types of cancers, such as non-melanoma skin cancers, cholangiocancinoma, pancreatic cancer and metastasized melanoma. The positive clinical readouts from multiple Phase II studies regarding treatments of Squamous Cell Carcinoma in situ and Basal Cell Carcinoma of STP705 allow the company moving forward into the late stage clinical development."

P2 data • Basal Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Skin Cancer

Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Adults With Facial isSCC (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Sirnaomics | Trial completion date: Feb 2023 ➔ Jul 2023 | Trial primary completion date: Dec 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Bowens Disease • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma

A Study to Evaluate Safety, Tolerability of Subcutaneous Injection in Adult Subjects Undergoing Abdominoplasty (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Sirnaomics | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2023 ➔ Jul 2023 | Trial primary completion date: Jan 2023 ➔ Jul 2023

Enrollment closed • Trial completion date • Trial primary completion date • Aesthetic Medicine • Genetic Disorders • Obesity

A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Sirnaomics | Trial completion date: Dec 2023 ➔ Jul 2023 | Trial primary completion date: Dec 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Bowens Disease • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma

Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell Carcinoma (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: Sirnaomics | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2022 ➔ Jul 2023 | Trial primary completion date: Sep 2022 ➔ Jul 2023

Enrollment closed • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

A Study for Safety and Efficacy Evaluation of Various Doses of STP705 in Reducing Keloid Recurrence (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Sirnaomics | Trial completion date: Dec 2022 ➔ Jul 2023 | Trial primary completion date: Dec 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Fibrosis

Sirnaomics Accelerates Clinical Development of STP705 for the Treatment of Non-Melanoma Skin Cancers (PRNewswire) - "Sirnaomics Ltd....announced that it is advancing the clinical development of STP705 for the treatment of two non-melanoma skin cancers: Squamous Cell Carcinoma in situ (isSCC) and Basal Cell Carcinoma (BCC). Based on positive clinical readouts from a Phase IIb study for isSCC and a Phase II study for BCC, Sirnaomics is formulating a communication package for the U.S. Food and Drug Administration (FDA) to seek guidance for conducting a late-stage clinical development for the treatment of isSCC and BCC. Additionally, the Company has developed a commercialization plan to position STP705 when upcoming clinical studies reach primary endpoints."

Clinical • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

A Study for Safety and Efficacy Evaluation of Various Doses of STP705 in Reducing Keloid Recurrence (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Sirnaomics | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis

Safety, Tolerability, PK, Anti-Tumor Activity of STP705 Injected IT in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Sirnaomics | Recruiting ➔ Active, not recruiting

Enrollment closed • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Sirnaomics | Recruiting ➔ Active, not recruiting

Enrollment closed • Bowens Disease • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma

Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Adults With Facial isSCC (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Sirnaomics | Recruiting ➔ Active, not recruiting

Enrollment closed • Bowens Disease • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma

Sirnaomics Announces Positive Interim Data from Phase IIb Clinical Trial of STP705 in Adults with Cutaneous Squamous Cell Carcinoma In Situ (PRNewswire) - P2b | N=100 | NCT04844983 | Sponsor: Sirnaomics | "Sirnaomics Ltd...announced today the interim results of part-one of an ongoing Phase IIb clinical trial of STP705 for the treatment of Cutaneous Squamous Cell Carcinoma In Situ (isSCC). The interim results showed that the majority (78%) of 32 patients with STP705 treatment achieved histological clearance. One of the three treatment cohorts achieved 89% histological clearance. STP705 is an siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down bothTGF-β1 and COX-2 gene expression."

P2b data • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of STP705 in Adult Patients With Hypertrophic Scars (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Sirnaomics | Trial completion date: Mar 2023 ➔ Dec 2024 | Initiation date: Sep 2022 ➔ Jun 2023 | Trial primary completion date: Jan 2023 ➔ Dec 2024

Trial completion date • Trial initiation date • Trial primary completion date • TGFB1

Sirnaomics to Present Latest Developments on siRNA Therapeutics for Cancer and GalAhead Platform Programs at the 2nd Annual Oligonucleotide Therapeutics and Delivery Conference (PRNewswire) - "Sirnaomics Ltd...announced...that it will present the latest developments on delivery of novel RNAi therapies for cancer, and its GalAhead™ platform and programs, at the 2nd Annual Oligonucleotide Therapeutics and Delivery Conference."

Clinical • Oncology