Significant Progress in Clinical Trials for Core Products Reinforces Leading Position in RNA Therapeutics with Strong Product Pipeline Matrix
- The part-one Phase IIb interim data on STP705 for the treatment of isSCC was announced, with the majority (78%) of patients achieving histological clearance
- Exceptional results for BCC trial were announced, achieving 100% complete response using a 180 ug dosage with an excellent safety profile
- Regulatory clearance was received from the Taiwan Ministry of Health and Welfare (TMHW) for IND application to join the global Phase I trial of STP705 for the treatment of patients with advanced liver tumors
- Phase I clinical trial of STP707 was launched for the treatment of solid tumors in the U.S. and the study has been approved to expand to Taiwan as part of the global multicenter clinical trail
- Successful launch of a Phase I clinical trial in the U.S. to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single ascending dose of STP707 when administered by intravenous infusion to healthy subjects
HONG KONG, Germantown, Md., and SUZHOU China, March 28, 2023 /PRNewswire/ -- Sirnaomics Ltd. (the "Company"; together with its subsidiaries, "Sirnaomics" or the "Group"; stock code: 2257), a leading biopharmaceutical company engaged in the discovery and development of advanced RNAi therapeutics, has announced its audited annual results for the year ended 31 December 2022 (the "Year").
The Group's loss for the year narrowed significantly from US$215.9 million in 2021 to US$97.4 million in 2022. The decrease in loss was primarily attributable to the decrease in loss on changes in fair value of financial liabilities at fair value through profit or loss (FVTPL) and listing expenses, though partly offset by the increase in research and development expenses and administrative expenses, which is in line with the Group's continuous research and development efforts to support its steadily advancing and expanding pipeline of drug candidates.
Breakthroughs in Clinical-Stage Research and Development of Core Product Candidates
The Group has consistently strived to push the boundaries of innovation and continuously improved its technology platform. Two drug product formulations formulated with our PNP delivery platform have been evaluated for local therapeutic treatment (STP705) and systemic therapeutic treatment (STP707), both of which are currently undergoing late-stage clinical trials.
The interim results of the part-one Phase IIb clinical trial have demonstrated the efficacy of STP705 treatment, with the majority (78%) of the 32 patients evaluated achieving histological clearance. Impressively, the lowest dosage achieved 89% histological clearance. In the first quarter of 2023, the Group has commenced communication with the U.S. Food and Drug Administration (FDA) regarding its Phase III clinical study proposal for the treatment of isSCC.
STP705 for the treatment of BCC has demonstrated an improved cosmetic result with no significant cutaneous skin reaction and achieved an excellent safety profile with a 100% complete response using a 180 ug dosage. The Group has now completed the 240 ug dosage cohort and expects to have the final data readout in the second quarter of 2023. The latest results demonstrated very favourable efficacy without any drug related AEs and SAEs, further validating the broad potential of this drug candidate for the treatment of non-melanoma skin cancers and beyond.
Sirnaomics' Phase I proof of concept clinical trial of STP705 for medical aesthetics treatment in adults undergoing abdominoplasty represents its first activity to apply an RNAi therapeutic candidate for localized fat remodeling. The Group expects interim data to be available in the second quarter of 2023 and the study should be completed in the second half of 2023.
Regulatory clearance for the Group's IND application to participate in the global Phase I trial of STP705 for the treatment of patients with advanced liver tumors was granted by the Taiwan Ministry of Health and Welfare (TMHW) in July 2022 and the first patient will be initiated into the study during second half of 2023.
In February 2022, the Phase I clinical trial of STP707 for treating various solid tumor types was launched in the U.S. The interim data for the first three dosing cohorts was announced by the Group in December 2022. To date STP707 has demonstrated an excellent safety profile with the first three dosing cohorts and has exhibited a positive efficacy signal with many participants exhibiting the best response of stable disease with a meaningful number of participants remaining on study past the 100-day mark. In addition, this study has also been approved in the second half of 2022 to expand to Taiwan as part of the global multicenter clinical trial. The Group plans to expand oncology clinical studies in the Asia-Pacific, a region with a high unmet demand for innovative therapies.
Exciting Progress in IND Enabling Studies and Anticipated Clinical Studies
STP122G, the Group's leading GalNAc-based therapeutic candidate targeting Factor XI, showed long-lasting target silencing activity, up to 28-week after one dose and in toxicology studies in mics and non-human primates. A U.S. IND was submitted in March 2023, and the Group is on track to start filing the clinical study application in the second quarter of 2023, if greenlight is given by the FDA.
RIM730, developed by RNAimmune Inc., a non-wholly owned subsidiary of the Group, comprises mRNA coding for a modified full length spike protein from the variant, and is formulated with LNP delivery technology for intramuscular administration. The Group expects to submit a U.S. IND in the first quarter of 2023.
Successful Commissioning of Guangzhou Facility Enables Flexibility and Capacity for Clinical Trials and Production Needs
Sirnaomics' Guangzhou Facility successfully completed the full commissioning tasks with media fill simulation and trial run of STP705 in a lyophilized solid dose. During the Year, the Guangzhou Facility has supported the production of lyophilized toxicity lots for STP707, STP908, STP355 and STP369. With the recent full GMP batch of STP707 for human injection produced in the first quarter of 2023, the Guangzhou Facility is expected to be in full GMP-compliant manufacturing of pipeline products. In early 2023, the Guangzhou Facility initiated filling line capacity expansion to include liquid dose fill in 2R vial to support the Group's GalAheadTM platform. An anticipated annual capacity of around 50,000 vials of lyophilized solid dose and 150,000 to 200,000 vials of liquid dose for human injectables dose capacity is sufficient to support all clinical trials the Group has currently planned.
Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics said, "Over the years, we have been dedicated to enriching our innovative RNA drug product pipeline and taking it to the next level, as part of our commitment to improving the wellbeing of patients worldwide. 2022 was a remarkable year for us. We made significant strides in advancing the research and development of our core products, which help us solidify a leadership position in RNA medicine for cancer treatment on the global stage, and was recognized by the capital market through our selection as a constituent stock of the Hang Seng Composite Index. Looking ahead, we will focus on expanding our competitive advantages by advancing the development of our lead product candidates STP705 and STP707 through clinical trials and capitalizing on our dual proprietary delivery platforms furthering more innovative first-in-class preclinical assets into the clinical stage, and selectively pursuing synergistic partnership opportunities to maximize the potential of our clinical product candidates. We will also strive to secure sustainable value growth for our shareholders."
About Sirnaomics Ltd. (Stock Code: 2257)
Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase II clinical outcomes in oncology for an RNAi therapeutic for its core product, STP705. Learn more at www.sirnaomics.com .
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