Shaperon, a Korean biopharmaceutical company developing innovative immune therapeutics, announced that it would embark on global expansion by showcasing its proprietary inflammatory complex inhibition technology at the 2023 BIO International Convention, to be held in Boston, the U.S., from June 5 to 8. 

Shaperon has been selected as a presenting company as well as an exhibitor at BIO 2023. The company’s presentation will take place at the Boston Convention & Exhibition Center on Friday afternoon, local time.

The presentation will highlight the company's biomarker-based atopic dermatitis treatment NuGel, Alzheimer's disease treatment NuCerin, and nanobody bispecific cancer immunotherapy Papiliximab. 

Shaperon is preparing to enter phase 1b/2 trials of NuGel in the U.S. to treat atopic dermatitis. The company is conducting a phase 1 study of NuCerin for Alzheimer's disease. Papiliximab is in preclinical development.

"The upcoming BIO 2023 will be an opportunity to actively promote the achievements and potential of our pipelines," said Shaperon CEO Seong Seung-yong. "We plan to explore various business development opportunities such as licensing out through a number of partnering meetings. We will also actively pursue collaborative research and out-licensing with multinational pharmaceutical companies through our recently established US subsidiary, Hudson Therapeutics."

Shaperon was founded in October 2008 by Professor Sung Seung-yong of Seoul National University College of Medicine based on the world's first theory of inflammation initiation, DAMP (Damage Associated Molecular Patterns), published in Nature Review Immunology in 2004. 

The company has been developing first-in-class anti-inflammatory drugs to treat inflammatory diseases such as atopic dermatitis, Alzheimer's disease, and idiopathic pulmonary fibrosis, with the aim of developing innovative immunotherapy drugs. 

Shaperon’s inflammatory complex inhibitor technology in the spotlight

The inflammatory complex inhibitor technology, one of Shaperon's core technologies, targets GPCR19, which exists in the upstream pathway, unlike those of many multinational pharmaceutical companies such as Janssen, Lilly, and Pfizer, which target substances in the downstream pathway such as P2X7 and NLRP3. 

This allows for a broader spectrum of effects, according to Shaperon.

Since GPCR19 is predominantly found in immune cells, Shaperon's inflammatory complex inhibitor also has the advantage of having fewer side effects. 

The company said preclinical studies have confirmed a high level of anti-inflammatory efficacy similar to steroids, with a high level of safety. The investigational drug added the benefit of increasing immunoregulatory cells to suppress further inflammatory expression, it said.

Shaperon's moderate-to-severe atopic dermatitis treatment NuGel, developed using this mechanism, demonstrated excellent efficacy and safety in a phase 2 trial interim analysis. 

To enter the U.S. market, which accounts for half of the global atopic dermatitis market, Shaperon will begin a U.S. phase 2 study in Westerners in 2023 and expects to complete the study next year. 

Based on data from a phase 2 study in Korean patients, the company applied for a patent confirming that biomarkers in the blood can be effectively used to predict treatment response to NuGel in patients with atopic dermatitis. 

Targeting Alzheimer's disease, idiopathic pulmonary fibrosis

Shaperon is also actively developing treatments for Alzheimer's disease using its inflammatory complex inhibition technology. Shaperon's NuCerin, an oral formulation for Alzheimer's disease, has shown preclinical results of inhibiting inflammation of microglia and improving cognition, the ultimate goal of treatment.

Based on this, the company signed a technology transfer agreement with Kukjeon Pharmaceutical in March 2021. 

In addition, the company received IND approval from the Ministry of Food and Drug Safety in 2022 and is preparing for a phase 1 trial in Korea. 

Shaperon will seek technology transfer to a foreign company based on this, it said.

NuSepin, which is being developed as a treatment for idiopathic pulmonary fibrosis, is an oral formulation, and in preclinical studies, Shaperon confirmed significant pathological findings and biomarker improvements that demonstrated shorter treatment duration compared to placebo, higher therapeutic effectiveness and safety compared to major competitors, the company said.

Based on these results, the company completed a technology transfer to Bridge Biotherapeutics in April 2022 for global development and is preparing for a U.S. phase 1 study.

NuSepin is also being developed as an anti-inflammatory treatment for patients with moderate to severe Covid-19 (injectable formulation). By blocking the inflammatory signaling caused by the infection, rather than the virus itself, it is expected to reduce systemic inflammation in infected patients, making treatment independent of the virus strain. 

The drug was tested in a phase 2 trial as a treatment for Covid-19 pneumonia at five centers in Romania to confirm its effectiveness and safety. 

The drug received 9.1 billion won in clinical development funding from the Korea Drug Development Foundation (KDDF) in 2022 and is being tested in a multinational phase 2b/3 study.

Shaperon aims to launch NuSepin in Korea this year with conditional approval, as well as enter the global market through technology transfer. NuSepin has also been tested in a pneumonia model of influenza and is in clinical trials.

"We are developing drugs for various inflammatory diseases through research on next-generation inflammasome inhibitors with better effectiveness and safety than the first generation," said an official at Shaperon. 

"Through four rounds of screening, we have secured 10 drug candidates with better effectiveness and safety than the existing first-generation inflammasome inhibitors, and some of them have shown high effectiveness in animal models of atopy and non-alcoholic fatty liver disease.” 

Shaperon plans to expand into other indications such as lupus nephritis, systemic lupus erythematosus, hearing loss, and non-alcoholic steatohepatitis, he added.