Immune-mediated uveitis

- International Journal of Molecular Sciences manuscript demonstrates robust pre-clinical data in two retinal disease models - Studies further demonstrate broad utility of melanocortin agonists in treating inflammatory conditions, especially in the eye CRANBURY, N.J., April 18, 2023 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced The International Journal of Molecular Sciences published a manuscript, "Stimulating the Melanocortin System in Uveitis and Diabetes Preserves the Structure and Anti-Inflammatory Activity of the Retina" by Tat Fong Ng and Andrew W. Taylor from Department of Ophthalmology, Boston University Chobanian and Avedisian School of Medicine, in Boston, Massachusetts. The manuscript summarizes data demonstrating the effects of PL8331 in two mouse models of retinal disease, experimental autoimmune uveoretinitis (EAU) and diabetic retinopathy (DR). Palatin and the National Institute of Health (NIH) and the Massachusetts Lions Eye Research Foundation provided funding for the study. "We have long studied the endogenous mechanisms of anti-inflammatory activity within the healthy eye, in which the melanocortin system is key," stated Andrew W. Taylor, Ph.D., Associate Dean of Research at Boston University. "Our results show that engaging the melanocortin system in eye pathology is more than suppressing inflammation. It promotes cell survival and preserves normal anti-inflammatory activity within the eye." Both models evaluated the efficacy of PL8331 as an agonist at the melanocortin 1 (MC1r) and melanocortin 5 (MC5r) receptors. In the EAU mouse model, PL8331 treatment resulted in resolution of inflammation and preservation of retinal structure. Specifically, PL8331 protected the retinal photoreceptors from the auto-inflammatory damage that normally occurs in the EAU model. In the DR mouse model, PL8331 treatment resulted in enhanced survival of various types of retinal cells and the suppression of vascular endothelial growth factor (VEGF). VEGF plays a major role in the pathology of DR. In addition, the retinal pigmented epithelial cells (RPE) were able to maintain their normal anti-inflammatory activity. "This manuscript summarizes quite nicely the great potential of utilizing melanocortin agonists to treat inflammatory conditions in the back of the eye, specifically the retina," said Carl Spana, Ph.D., President and CEO of Palatin. "This data adds to Palatin's extensive pre-clinical data with melanocortin agonist in retinal disease models and supports future clinical development." The findings from both studies clearly demonstrate the importance of the melanocortin system in protecting the eye from the damage caused by pathological inflammation and support the potential of melanocortin agonists as treatments for various retinal diseases. About Uveitis Non-infectious uveitis is a group of inflammatory diseases not due to an active infection that produces swelling and destroys eye tissue. The disease is caused by inflammatory responses inside the eye, which may be initiated by autoimmune responses, responses to infections or tumors within the eye or other parts of the body, physical injury or toxins. Uveitis is classified by where it occurs in the eye, including intermediate, posterior, pan uveitis and chronic anterior uveitis. Uveitis can be associated with several diseases, including autoimmune diseases. Initial non-infectious uveitis symptoms include blurred vision, eye pain, dark floating spots in vision and light sensitivity. Uveitis can cause vision loss or blindness if left untreated. About Diabetic Retinopathy Diabetic retinopathy, also known as diabetic eye disease, is a medical condition in which damage occurs to the blood vessels of the retina (light-sensitive tissue at the back of the eye) due to diabetes mellitus. It is a leading cause of blindness in people aged 20 to 64 and affects up to 80 percent of those who have had diabetes for 20 years or more and a major cost to the nation's healthcare system. According to the Diabetic Retinopathy Clinical Research Network (DRCR.net), the number of people in the US affected by diabetic retinopathy will reach 11.3M by 2030 and 14.6M by 2050, and 28 million with vision-threatening DR (VTDR) worldwide. The CDC estimates that the prevalence of DR will triple from 2005 (5.5M) to 2050 (16M). About Melanocortin Receptor Agonists and Inflammation The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located throughout the body, including the gut, kidney and eye, express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. Drugs based on melanocortin agonists have been approved by the FDA for treating several conditions, including inflammatory/autoimmune diseases, rare forms of genetic obesity and female sexual dysfunction. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin, such as statements about PL8331 preclinical results in two mouse models of retinal disease, experimental autoimmune uveoretinitis and diabetic retinopathy, and potential utility in treating humans, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. Company Codes: AMEX:PTN

SHANGHAI, China, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the supplemental application for additional indications of adalimumab injection (project code: UBP1211, trade name: 君邁康®) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohn’s disease in children has been approved by the National Medical Products Administration (“NMPA”). Tumor necrosis factor-α (TNF-α) is secreted by macrophages, mast cells and activated Th cells. It is a potent inducer of inflammatory response and a key regulator of innate immunity, playing a key role in the occurrence and development of various inflammatory conditions. The binding of TNF-α to TNF-α receptors can induce inflammatory responses, and it has been proven that rheumatoid arthritis, psoriasis, Crohn’s disease, ankylosing spondylitis and many other autoimmune diseases are closely related to TNF-α. Anti-TNF-α monoclonal antibodies can bind to TNF-α receptors and reduce the immune response activated by TNF-α, thereby preventing the occurrence of inflammation. 君迈康 is jointly developed by Junshi Biosciences and Mabwell (Shanghai) Bioscience Co., Ltd. In March 2022, its indications including rheumatoid arthritis, ankylosing spondylitis and psoriasis were approved by the NMPA. “We are very pleased with the rapid commercialization of 君迈康—since its clinical use less than a year ago, it has already been approved for 8 indications and become one of the domestic adalimumab with the most indications approved in the nation,” said Dr. Ning Li, CEO of Junshi Biosciences. “We will continue collaborating with Mabwell Biosciences to provide more treatment options for a wider range of patients with autoimmune diseases, including children and adults with specific diseases, and further the Healthy China Innitiative with our dedicated efforts.” "It was wonderful to see 君迈康 achieve 5 indication approvals all at once within a relatively short amount of time,” said Dr. Datao Liu, co-founder and CEO of Mabwell Bioscience. “To this day, many patients in China are still suffering from autoimmune diseases, which severely affect their physical functions and quality of life. The extension of 君迈康’s indications will further benefit patients in China as well as the rest of the world, providing them with treatment options that are both more effective and accessible.” About UveitisNon-infectious intermediate, posterior or panuveitis (NIIPPU) is a group of immune-mediated intraocular inflammatory diseases that may cause complications such as synechia, glaucoma, cataracts, macular edema and retinopathy in patients, causing impaired vision or even blindness, and usually co-occurs with immune-mediated systemic diseases such as psoriasis and ankylosing spondylitis. According to the epidemiological research data in mainland China, its incidence rate is 152/100,000, and the incidence peaks at 24 to 44 years old. About Crohn’s DiseaseIt is a chronic and relapsing inflammatory gastrointestinal disease, which is categorized as inflammatory bowel disease (IBD) together with ulcerative colitis (UC). In China, the prevalence rate of Crohn’s disease is 2.29/100,000, the average incidence rate is 1.21/100,000, and it is showing a rapid upward trend. There is currently no complete cure for Crohn’s disease. The goal of treatment is to induce and sustain remission, prevent complications, and improve quality of life. About Crohn’s Disease in ChildrenAccording to statistics, 25% to 30% of all IBD patients in the world are children, of which Crohn’s disease accounts for the vast majority, and its incidence rate has been increasing year by year. About Polyarticular Juvenile Idiopathic ArthritisJuvenile idiopathic arthritis is a common rheumatic disease in childhood, with chronic joint synovitis as its main symptom. Accompanied by systemic multiple organ dysfunction, it is also an important cause of childhood disability and blindness. Polyarticular juvenile idiopathic arthritis is the most common subtype of juvenile idiopathic arthritis, accounting for about 18% to 30%. About Plaque Psoriasis in ChildrenPediatric psoriasis is an immune-mediated chronic, recurrent, inflammatory, systemic disease that occurs in children. Different populations, races, and genders are equally susceptible, and about 1/3 of patients have onset of psoriasis in childhood. The common type of psoriasis in older children is plaque psoriasis (75%), followed by guttate psoriasis (15% to 30%) and generalized pustular psoriasis (1% to 5.4%). About Junshi BiosciencesFounded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

-- Additional indications: treatment for Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis and pediatric Crohn’s disease SHANGHAI, China, Aug. 17, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the Company has received an Acceptance Notice issued by the National Medical Products Administration (“NMPA”). The supplemental application for additional indications of the company’s adalimumab injection (project code: UBP1211, trade name: 君迈康), including the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohn’s disease in children, has been accepted. Tumor necrosis factor-α (TNF-α) is secreted by macrophages, mast cells and activated Th cells. It is a potent inducer of inflammatory response and a key regulator of innate immunity, playing a key role in the occurrence and development of various inflammatory conditions. The binding of TNF-α to TNF-α receptors can induce inflammatory responses, and it has been proven that rheumatoid arthritis, psoriasis, Crohn’s disease, ankylosing spondylitis and many other autoimmune diseases are closely related to TNF-α. Anti-TNF-α monoclonal antibodies can bind to TNF-α receptors and reduce the immune response activated by TNF-α, thereby preventing the occurrence of inflammation. 君迈康 is jointly developed by Junshi Biosciences and Mabwell (Shanghai) Bioscience Co., Ltd. In March 2022, its indications including rheumatoid arthritis, ankylosing spondylitis and psoriasis were approved by the NMPA. About UveitisNon-infectious intermediate, posterior or panuveitis (NIIPPU) is a group of immune-mediated intraocular inflammatory diseases that may cause complications such as synechia, glaucoma, cataracts, macular edema and retinopathy in patients, causing impaired vision or even blindness, and usually co-occurs with immune-mediated systemic diseases such as psoriasis and ankylosing spondylitis. According to the epidemiological research data in mainland China, its incidence rate is 152/100,000, and the incidence peaks at 24 to 44 years old. About Crohn’s DiseaseIt is a chronic and relapsing inflammatory gastrointestinal disease, which is categorized as inflammatory bowel disease (IBD) together with ulcerative colitis (UC). In China, the prevalence rate of Crohn’s disease is 2.29/100,000, the average incidence rate is 1.21/100,000, and it is showing a rapid upward trend. There is currently no complete cure for Crohn’s disease. The goal of treatment is to induce and sustain remission, prevent complications, and improve quality of life. About Crohn’s Disease in ChildrenAccording to statistics, 25% to 30% of all IBD patients in the world are children, of which Crohn’s disease accounts for the vast majority, and its incidence rate has been increasing year by year. About Polyarticular Juvenile Idiopathic ArthritisJuvenile idiopathic arthritis is a common rheumatic disease in childhood, with chronic joint synovitis as its main symptom. Accompanied by systemic multiple organ dysfunction, it is also an important cause of childhood disability and blindness. Polyarticular juvenile idiopathic arthritis is the most common subtype of juvenile idiopathic arthritis, accounting for about 18% to 30%. About Plaque Psoriasis in ChildrenPediatric psoriasis is an immune-mediated chronic, recurrent, inflammatory, systemic disease that occurs in children. Different populations, races, and genders are equally susceptible, and about 1/3 of patients have onset of psoriasis in childhood. The common type of psoriasis in older children is plaque psoriasis (75%), followed by guttate psoriasis (15% to 30%) and generalized pustular psoriasis (1% to 5.4%). About Junshi BiosciencesFounded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. As of December 3, 2021, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 versus nirmatrelvir/ritonavir (“PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800