On August 30, 2023 Sirnaomics reported positive Clinical Readouts Validate Potential of Proprietary Delivery Platforms and Cement Global Leadership in RNAi Therapeutics (Press release, Sirnaomics, AUG 30, 2023, View Source [SID1234634786]).

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Business Highlights

Promising progress in clinical development

After an End of Phase-II meeting and with guidance from the U.S. FDA, the Group is advancing the late-stage clinical development of STP705 for the treatment of isSCC, a significant milestone that has cemented the Group’s global leadership in RNAi therapeutics for cancer treatment.
Based on promising interim STP707 data, the Group is actively exploring collaborations for a Phase II combination trial to investigate the potential of combining STP707 with novel approved cancer therapies.
The Group’s first GalAhead product STP122G has received regulatory clearance from the U.S. FDA and commenced the Phase I clinical trial.
The Group’s subsidiary RNAimmune, Inc. has received regulatory clearance from the U.S. FDA to initiate Phase I clinical trial for RV-1730, a SARS-CoV-2 vaccine booster candidate.
Production capacity enhancement

Having produced a full GMP batch of STP707 for human injection in the first quarter of 2023, the Guangzhou Facility is expected to achieve full GMP-compliant manufacturing of Sirnaomics’s pipeline products. The Group also started expanding capacity of the filling line to include liquid dose fill in 2R vial to support the GalAhead platform.
Recognition by HKSTP

Sirnaomics received grants of HKD8 million from the HKSTP Clinical Translational Catalyst Programme, and HKD2 million from the HKSTP MedTech Co-create Programme.
HONG KONG, GERMANTOWN, Md., SUZHOU, China, Aug. 30, 2023 /PRNewswire/ — Sirnaomics Ltd. (the "Company"; together with its subsidiaries, "Sirnaomics" or the "Group"; stock code: 2257), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, has announced its interim results for the six months ended 30 June 2023 (the "Period").

In the first half of 2023, Sirnaomics made significant progress in pipeline and business development. To ensure it had a sufficient cash runway amid global economic uncertainties, the Group focused resources on high-potential programs and optimized its internal structure, solidifying its international team specializing in RNAi therapeutics, with a strong focus on the U.S. and Asia markets. With extensive expertise in RNA therapeutics and innovative delivery platform technologies, the Group effectively implemented its clinical development strategy, which paved the way for it to start clinical trials in the U.S. for its leading clinical drug candidates, namely STP705, STP707 and STP122G.

The Group’s loss for the Period narrowed to US$ 41.1 million from US$46.1 million for the six months ended 30 Jun 2023. The lesser loss was primarily attributable to decrease in research and development expenses; and decrease in loss on changes in fair value of financial liabilities at FVTPL. As at 30 June 2023, the Group was in a healthy financial position with cash and cash equivalents and current time bank deposits amounting to US$77.3 million.

Clinical trials of leading product candidates have yielded promising results, giving impetus to the commercialization process

Sirnaomics has been advancing a prioritized drug product pipeline of innovative RNA-based medicines to improve the lives and well-being of patients worldwide. The following milestones and achievements exemplify the Group’s ongoing clinical execution across its pipeline.

STP705

Sirnaomics has used human data from STP705 to expand its clinical trials. With the data from STP705 proving its effectiveness in treating squamous cell carcinoma in situ (isSCC), the Group moved on to explore its use in a broader range of oncology indications including basal cell carcinoma (BCC), liver cancer, and medical aesthetics. 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. To support these programs and advance clinical development, Sirnaomics’s clinical teams in the U.S. and Asia are conducting multi-center global trials. By including subject populations from different regions, they aim to gather comprehensive and diverse data for various indications, including isSCC and liver cancer.

In addition, in June 2023, the Group announced interim data of its proof-of-concept Phase I STP705 trial, studying fat remodeling in abdominoplasty patients. All tissue samples examined in the review using variable doses of STP705 showed histological evidence suggestive of fat remodeling. The Group plans to use the information from the study to expand into the treatment of submental fat and other areas of noninvasive fat remodeling. The development program is expected to open up a new therapeutic area in medical aesthetics for the Group’s pipeline and the market has thus far responded positively.

STP707

The Group is actively advancing clinical trials for STP707 and expanding its therapeutic reach through systemic administration, pushing to open more opportunities to treat indications that could not be addressed by STP705. STP707 stands as proof of the safety and efficacy of the Group’s proprietary PNP delivery systems in IV administration. Encouraged by the promising interim data, the Group plans to explore collaborations for a Phase II combination trial, combining STP707 with novel approved cancer therapies such as immune check point inhibitors as well as traditional chemotherapy. Such potential combination therapies may include CCA, HCC, melanoma, and pancreatic cancer. The Group will also continue to explore other indications for Phase II trials and expand its clinical development programs. Given the significant market potential of STP707 through IV administration and partnership possibility, the Group believes allocating capital and corporate resources into advancing those valuable assets is the optimal growth strategy.

Additionally, Sirnaomics has announced the Group completed all dosing regimens for its Phase I study of STP707 for the treatment of multiple solid tumors in patients with various types of late-stage cancers who did not respond to multiple rounds of other oncology treatments. Approximately 74% of evaluable patients demonstrated a best response of stable disease (SD) and patients exhibited reduction in tumor burden per Response Evaluation Criteria in Solid Tumors.

Accelerating advancing additional ground-breaking first-in-class preclinical assets into clinical stage

During the Period, the Group advanced STP122G, the first representative candidate for the GalAhead delivery platform, into clinical stage, marking the first time Sirnaomics use its proprietary GalNAc RNAi platform technology, GalAhead, in one of its siRNA-based candidates and kicking off a trial for addressing the unmet need of a large patient population suffering from anticoagulation disorders. The Phase I clinical study commenced in April, with the first participant receiving a dose for anticoagulant treatment in June. The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of STP122G.

The Group plans to accelerate research and development of the next-generation GalAhead platform. Its robust pipeline comprises an array of nine GalAhead preclinical candidates. Subsequent to approval gained for STP122G, the Group expects to file IND in the U.S. for STP125G and STP144G, the good line up of assets from the GalAhead delivery platform, in the fourth quarter of 2023 and the first half of 2024.

Laying the foundation for future development with the Fill and Finish (F&F) Plant Facility in Guangzhou set up

After a successful first full year of operation, the Group’s Guangzhou F&F Facility has continued to optimize its clinical supplies strategy in Asia. The facility has continuously improved in GMP compliance and operational assurance for aseptic processing. Having produced recently a full GMP batch of STP707 for human injection, the facility is expected to be in full GMP-compliant manufacturing of the Group’s pipeline products, including formulation, fill and finish for both liquid and solid dose production, as well as testing and release. Expected to put out annually around 50,000 vials of lyophilized solid dose and 150,000 to 200,000 vials of liquid dose for human injectables, the facility will be able to support all clinical trials currently planned and future clinical development of the Group. In the first half of 2023, the Guangzhou Facility primarily backed the Group’s efforts with STP707 and initiated expanding filling line capacity for the GalAhead platform. Further expansions are planned to support the Group’s growing GalAhead product line.

Strategically reinforcing business presence in Hong Kong, aspiring to turn the city into a leading RNA medicine harbor in Asia

After Sirnaomics became listed in Hong Kong at end of 2021, it made a strategic decision to establish a meaningful R&D presence in the city. Today, Sirnaomics, its subsidiaries RNAimmune and EDIRNA have all set up Hong Kong offices and been admitted into the Hong Kong Science and Technology Park (HKSTP). Moreover, Sirnaomics received grants of HKD8 million from the HKSTP Clinical Translational Catalyst Program and HKD2 million from the HKSTP MedTech Co-create Program. The Group’s objectives are to pursue collaborations in RNA medicine-related research and development and clinical studies, as well as to establish a commercial-scale manufacturing plan in the Lok Ma Chau Loop.

Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics said, "Capitalizing on our dual proprietary technology delivery platforms, PNP and GalAhead, leading clinical programs, and well-established R&D and manufacturing facilities, we have advanced drug candidates through various stages of development and achieved positive results. In addition, our Guangzhou Facility has operated smoothly and effectively, not only speaking well to our manufacturing capabilities, but also to our smooth transition from a biotech company into a biopharma corporation. We are also delighted to have secured funding from HKSTP, representing its endorsement of the unwavering commitment of our team to innovation and our mission of enhancing patients’ lives. Looking ahead, we aim to reinforce our competitive advantages, pursue global and local partnerships, and accelerate development of preclinical and clinical assets, so as to enlarge market coverage and ultimately improve the well-being and quality of life of patients worldwide."