Immunology

 On the 19th, Daishin Securities analyzed that there is a need to pay attention to Shaperon (378800) due to the high technology export potential of its atopic dermatitis treatment, NuGel. No investment opinions or target prices were provided.Shaperon is a biotech venture company originating from Seoul National University, focusing on the development of treatments for various diseases based on new mechanism inflammatory complex inhibitors and nanobody antibody technology. Its major pipelines include NuGel, an atopic dermatitis treatment that has completed Phase 2 clinical trials in Korea and is currently undergoing Phase 2 trials in the US; NuCerin, an Alzheimer’s disease treatment that has completed technology transfer for domestic rights and is undergoing Phase 1 trials in Korea; and Papiliximab, a dual-target nanobody antibody immuno-oncology drug with a goal for technology transfer after completing preclinical studies.Song-Hyup Han, a researcher at Daishin Securities, stated, “Due to the nature of new drug development companies, research and development costs are increasing, leading to a widening operating loss, and the current stock price has decreased by approximately 40% compared to the IPO price. However, there is potential for increased corporate value if the innovative pipelines, including the atopic dermatitis treatment NuGel, are recognized for their market potential and technological capabilities.”The researcher further noted, “The global atopic dermatitis treatment market is showing high growth, but current market products, including steroids and non-steroidal treatments, have limitations in terms of effectiveness and safety. NuGel, with its differentiated mechanism of action and excellent safety profile, is expected to overcome the limitations of existing treatments and secure a significant market share.”Han Song-kyup also mentioned, “Shaperon is actively pursuing global technology transfer for NuGel and has achieved success by signing confidentiality agreements (CDAs) with multiple companies. If efficacy and safety are further demonstrated during the US Phase 2 trials, there is potential for technology export.”He added, “If short-term financial risks are well managed and achievements in technology transfer contracts, clinical progress, and government project awards for major pipelines are visualized, there could be a re-rating of corporate value. Since Shaperon was listed on KOSDAQ as a growth technology company in October 2022, the revenue-based criteria for management designation will apply until 2027, and the loss criteria will apply until 2028.” 

 Shaperon: "Atopic Dermatitis Treatment Shows Safety in US FDA Phase 2 Clinical Trials" [Whole News Article in English]Shaperon (Kosdaq: 378800), a biotech company specializing in innovative immunotherapy drug development, announced on the 3rd that its next-generation atopic dermatitis treatment has been verified for safety in a Phase 2 clinical trial by the US Food and Drug Administration (FDA).The FDA's Independent Data Monitoring Committee (IDMC) has recommended that Shaperon proceed with the next stage of dosing and continue clinical trials for its atopic dermatitis treatment, Nugel. This marks significant progress for the Phase 2 trial of Nugel.Following the IDMC’s recommendation to continue the trial in May, safety was confirmed once again in the second set of data collected from both high-dose and placebo groups. Based on this second IDMC decision, Shaperon plans to complete the final cohort dosing trial with a higher dosage by November.Shaperon is currently conducting a Phase 2 FDA clinical trial for Nugel, targeting 210 patients with mild to moderate atopic dermatitis of various ethnic backgrounds across the US. This trial is designed to determine the optimal therapeutic dose of Nugel, divided into two parts: dose escalation and fixed-dose administration. Efficacy and safety, including metrics such as the Eczema Area and Severity Index (EASI), are being evaluated in a randomized, double-blind, placebo-controlled format.Nugel is the world’s first atopic dermatitis treatment that inhibits the inflammasome by targeting the ‘GPCR19’ receptors on immune and epithelial cells. While existing inflammasome inhibitors block the activation phase of inflammation, Nugel acts on both the initiation and amplification phases, allowing for more effective inflammation control.Nugel works by effectively blocking T-cell-mediated inflammatory responses, treating atopic dermatitis. It is specifically designed to inhibit selective T-cells, minimizing effects on other immune systems, which sets it apart from existing competitors. Other treatments suppress the overall function of T-cells, potentially leading to excessive immune suppression, increasing the risk of cancer and infections. In contrast, Nugel avoids such side effects, giving it strong global competitiveness.A Shaperon representative stated, "Nugel demonstrated safety and efficacy in a 0.5% dose during a Phase 2a clinical trial in Korea, showing positive results in 80% of biomarker-positive patients. The recent IDMC decision confirms safety at a 2% high dose, four times higher than in the Korean trial, and across a diverse range of ethnic groups, which is a highly encouraging outcome."He added, "By November this year, we plan to complete dosing at a maximum 4% concentration. Based on the results, we will determine the optimal therapeutic dose. From next year, we will administer the confirmed dose to a variety of patients and continue follow-up trials, examining dose-response relationships, drug safety, and correlations with biomarkers. Our goal is to complete the Phase 2 clinical trial by the first half of 2026." 

 Hudson Therapeutics Seeks Strategic Partners and Institutional Investors at ChinaBio® Partnering Forum September 2024 [Cambridge, MA / Research Triangle Park, NC / Seoul, Korea – Sep 3, 2024] Hudson Therapeutics, Incorporated a leading innovator in therapeutic solutions and a US subsidiary of Shaperon, Incorporated is pleased to announce its participation in the upcoming Bio China Partnering Forum 2024. The partnering event is September 10th to 11th in Shanghai China, bringing together global industry leaders, investors, and innovators in the biotechnology and pharmaceuticals sectors.At the conference, Hudson Therapeutics and Shaperon will actively seek strategic partners to out-license and meet investors to expand its footprint in the Chinese market. With a robust pipeline of innovative therapeutic candidates, the company aims to leverage this platform to establish key partnerships that will drive the development and commercialization of its innovative products in China.“Our participation in Bio China Partnering Forum 2024 represents a significant step in our strategic plan to expand into the Chinese market,” said Janice Marie McCourt, CEO of Hudson Therapeutics. “We are eager to engage with potential partners and investors who share our vision of advancing healthcare through innovative therapeutics. This forum offers a unique opportunity to collaborate with leading companies and investors in China, and we look forward to exploring mutually beneficial partnerships.”Hudson Therapeutics and Shaperon’s Global Business Development Team will lead meetings with global pharmaceutical partners and new potential collaborators to discuss technology transfer of NuGel – Atopic Dermatitis Treatment in Phase 2B clinical trials in the US, Nucerin – Alzheimer Disease Treatment in Phase 1 clinical trials in Korea and Papiliximab – dual-target Nanobody Antibody that was highlighted at the American Association for Cancer Research (AACR) in April., along with additional preclinical programs in ulcerative colitis, Crohn’s Disease, MASH, and obesity along with additional opportunities in veterinary medicine focused in companion animals.  

 ▶ Introducing Precision Medicine Efficacy Evaluation Technology for Dementia Treatments Based on Companion Diagnostic Technology[Seoul, Korea / Cambridge, MA, USA – May 1, 2024] Hudson Therapeutics, Inc. announced that Shaperon, Inc. (Kosdaq: 378800), a biotechnology company dedicated to developing innovative immunology and immuno-oncology drugs, will participate in the "Alzheimer’s Association International Conference (AAIC 2024) to present preclinical results of its next-generation dementia treatment, “NuCerin,” which is under development. Additionally, they will unveil precision medicine efficacy evaluation technology for treatments based on new dementia companion diagnostic techniques utilizing blood biomarkers.AAIC is the largest global conference on Alzheimer's and dementia research, scheduled to be held in Philadelphia, USA, from July 28 to August 1. This international academic conference serves as a platform for researchers, clinicians, and dementia experts worldwide to share the latest research results and understand trends in new drug development.NuCerin is an Alzheimer's treatment developed by Shaperon. It works by regulating the "GPCR19-P2X7" mechanism to block the activation of the "NLRP3" inflammasome, thereby inhibiting the production of pro-inflammatory cytokines (such as IL-1β, IL-18, IL-6, TNF-α) triggered by accumulated amyloid-beta in the brain. This prevention of neuronal cell death helps preserve cognitive function. NuCerin can control both the early and active stages of brain inflammation in dementia, preventing neuronal cell death caused by complex and diverse inflammatory pathways, thereby preserving memory function.Shaperon confirmed significant improvement in cognitive function through behavioral tests of memory and cognition after orally administering NuCerin in an Alzheimer's mouse model. Researchers plan to present findings that show NuCerin activates the phagocytosis of microglia, the brain's immune cells, reducing neuroinflammation by inhibiting the accumulation of amyloid-beta plaques, which are a cause of dementia.In preclinical trials, Shaperon also successfully identified companion diagnostic biomarkers through proteomic analysis of blood, allowing predictive evaluation of NuCerin's efficacy. They are currently researching whether these biomarkers can be used for companion diagnosis in dementia patients to evaluate NuCerin's efficacy. Furthermore, Shaperon found that these biomarkers increase in many Alzheimer's patients compared to normal individuals, indicating that preclinical results could be replicated in dementia patients, and these findings will be included in the presentation.Dr. Seung-Yong Seong, CEO of Shaperon, stated, "Using blood biomarkers for Alzheimer's diagnosis is emerging as a global trend, replacing expensive positron emission tomography and cerebrospinal fluid tests." He added, "The biomarkers discovered by Shaperon can be applied not only to dementia diagnosis but also to companion diagnostics for predicting the efficacy of treatments, making it a key technology for advancing the treatment of dementia, a representative intractable disease." He continued, "NuCerin is currently undergoing phase 1 clinical trials in Korea, and we are actively considering applying blood biomarkers starting from phase 2 clinical trials." He emphasized, "We will strive to accelerate tangible outcomes, such as joint research and technology transfers based on next-generation dementia treatment key technologies, through close networking with global pharmaceutical companies at this conference."Janice Marie McCourt, CEO of Hudson Therapeutics, commented, "Shaperon's participation in the AAIC underscores our shared commitment to advancing the field of dementia treatment. The innovative approach of using blood biomarkers not only holds promise for more accurate diagnoses but also paves the way for personalized treatment options. We are excited to collaborate with Shaperon and support their efforts to bring these groundbreaking technologies to patients worldwide."