CD23

SAN DIEGO, March 12, 2024 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio Pharma"), a leading biotech company dedicated to developing innovative protein treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the Phase I data of LP-003 (new generation of anti-IgE antibody) at the 2024 American Academy of Dermatology Association annual meeting (2024AAD). The presentation of the poster titled "A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody" by Longbio Pharma marked a significant moment during the conference. Title: A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody Abstract Submission ID: 50484 Presentation Time: Mar 8-12, 2024 Location: Poster Exhibits Center Results: In a randomized, double-blind, single-ascending-dose Phase I clinical study (CTR20221413), 32 healthy subjects were randomly divided into 5 groups to receive a single intravenous dose of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg and 10 mg/kg respectively. Safety, pharmacokinetics, and pharmacodynamics (free IgE levels) profile was evaluated. LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 44.6 days to 76.5 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 168 days at 1 mg/kg group (except one with high baseline IgE level) to 10 mg/kg group. LP-003 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement. Chronic spontaneous urticaria (CSU) stands as a prevalent skin disorder affecting approximately 1–2% of the global population. Despite SoC treatment, the efficacy and duration of relief remain significant challenges for patients and healthcare providers alike. Anti-IgE therapy was approved as a second-line treatment, however, only approximately 40% of patients achieving complete response following 300 mg Omalizumab dosing. Thus, a novel anti-IgE treatments offering higher efficacy and prolonged relief is needed. The successful Phase II study of Ligelizumab points a way that anti-IgE antibody with higher IgE affinity and more potent efficacy (FcεRI inhibition) retains the potential to be superior against Omalizumab. In this study, Longbio Pharma developed a new generation of anti-IgE antibody, LP-003, of higher IgE binding affinity, stronger FcεRI inhibition bioactivity, compared to Omalizumab and even Ligelizumab. Meanwhile, LP-003 has a much longer half-life (approximately 45∽76 days) compared to Omalizumab (approximately 17∽20 days). Moreover, a Phase II clinical trial (NCT06228560) of total 200 adult refractory CSU patients, despite up-dosing anti-histamine (H1) treatment, are being enrolled into 5 distinct groups (n=40/group), including three LP-003 treatment groups, one omalizumab treatment group, to provide a head-to-head comparison, and one placebo group. The topline results are expected to be released in early 2025. About LP-003 LP-003, a novel monoclonal anti-IgE antibody was generated, humanized, and engineered by Dr. Sun, Nai-chau, who is the inventor of Omalizumab, and co-founder of Tanox. Based on the 30+ years R&D experience on IgE target, Dr Sun developed a new generation of anti-IgE antibody (LP-003). Its extensive characterization including: affinity, bioactivity (FcεRI and FcεRII/CD23 inhibition), off-target binding and animal study (Tox and efficacy) was conducted. LP-003 just accomplished its Phase II study of allergic rhinitis. The current data shows LP-003 has the potential to become a best-in-class treatment. About Longbio Pharma LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and complement diseases, serving patients and society. For more information, please visit: or please contact: [email protected]. SOURCE Longbio Pharma

STOCKHOLM, Nov. 6, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas"), today announced data presentations highlighting additional analyses from the Phase 3 NefIgArd study with Nefecon in adults with primary IgA nephropathy (IgAN), as well as pre-clinical data on the treatment of Alport syndrome with setanaxib, a novel NOX inhibitor, presented at the American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA on November 1-5, 2023. "The additional analyses of data from the NeflgArd Phase 3 trial that we and our scientific collaborators presented at ASN Kidney Week showcased our commitment to advancing the science in understanding IgA nephropathy and to shaping a better future for patients with rare diseases," said Richard Philipson, Chief Medical Officer at Calliditas. Oral Presentation Analyses NefIgArd Phase 3 Trial full analysis The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN. The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug. The full analysis of the 364 patients randomized 1:1 to Nefecon or placebo showed: A statistically significantly smaller proportion of Nefecon-treated patients saw a 30% eGFR reduction compared to placebo-treated patients A delayed progression to a confirmed 30% eGFR reduction was observed in the Nefecon arm compared to the placebo arm Use of rescue medication did not alter the response to Nefecon vs placebo according to a pre-defined analysis Late-Breaking Poster Presentation Analyses NefIgArd Phase 3 trial population sub-analysis The 2-year NefIgArd trial included 62 patients with IgAN from mainland China (n=32 in Nefecon arm, n=30 in the placebo arm), with similar baseline characteristics as the global study population. In these patients, Nefecon treatment for 9 months resulted in: Lower time-weighted average change in eGFR from baseline in the Nefecon arm 66% less deterioration in renal function over the 2-year study period in the Nefecon arm, as well as reduced 2-year eGFR total slope 31% greater mean reduction in urine: protein creatinine ratio at 9 months in patients treated with Nefecon vs placebo, which was sustained at 2 years A higher proportion of Nefecon-treated patients did not display microhematuria during the observational follow-up period compared to patients who received placebo Poster Presentations Analyses Additional analyses were conducted from Part A of the Phase 3 NefIgArd trial(n=160) Serum samples collected from patients enrolled in Part A of the NefIgArd study were analyzed for functional protein interaction and showed that Nefecon modulates serum biomarkers associated with proteins known to play a role in the intestinal immune network for IgA production and control of B cell activation. These data further support a disease-modifying effect of Nefecon at the site of IgA synthesis and reinforce the link between the ileal gut-associated lymphoid tissue (GALT) and the kidneys. Levels of circulating anti-gliadin IgA and anti-casein IgA were reduced in IgAN patients treated with Nefecon vs placebo in Part A of the NefIgArd study at the 3-, 6- and 9-month mark after randomization. Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points. Reduction in IgA antibodies directed at dietary antigens supports a local disease-modifying effect for Nefecon via targeted action in the ileal GALT rather than modulation of gut permeability and antigen exclusion. Levels of three soluble biomarkers known for modulating B cell maturation, CD23, CD27, and CD30, were reduced in response to Nefecon 16 mg/day at the 3-, 6-, and 9-month post-randomization mark when compared to placebo responses. The degree of reduction in soluble CD23, CD27, and CD30 correlated with the magnitude of B-cell activating factor (BAFF) reduction at the same three study timepoints. Reduction in CD30 levels also correlated with the magnitude of IgA/IgG immune complex reduction at the 6- and 9-month timepoints. Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation. Additional analysis from the full Phase 3 NefIgArd trial Modeling analyses leveraging the two-year eGFR total slope from 352 patients enrolled in the Phase 3 trial were applied to the records of 192 real-world IgAN patients to evaluate the long-term clinical potential of Nefecon. Using published linear regression analysis, Nefecon was predicted to substantially delay progression to renal failure, with a modeled 62 % risk reduction vs placebo and a median delay to progression of 12.8 years. Setanaxib The potential of setanaxib, a novel dual NOX inhibitor to modulate renal function and fibrosis was evaluated in a mouse model of Alport syndrome, a rare genetic disease characterized by fibrosis and progressive kidney damage. Setanaxib was evaluated alone or in combination with standard of care ramipril, an ACE inhibitor. Combined daily oral administration of setanaxib 60mg/kg and ramipril 10mg/kg resulted in a statistically significant reduction of urine albumin and albumin/creatinine ratio compared to vehicle alone after a 2-week and 4-week treatment duration. Histological analysis showed that this combination treatment decreased fibrosis and glomerular sclerosis. In silico and proteomics analyses demonstrated a reduction in both glomerular basement membrane proteins and collagen proteins in mice treated with both setanaxib and ramipril All presentations are available on the Presentations and Publications page on the Calliditas' corporate website. CONTACT: For further information, please contact: Åsa Hillsten, Head of Investor Relations & Sustanaibility, Calliditas Tel.: +46 76 403 35 43, email: [email protected] The information was sent for publication, through the agency of the contact persons set out above, on November 6, 2023 at 20:30 p.m. CET. The following files are available for download: SOURCE Calliditas Therapeutics

SOFIA, Bulgaria, June 20, 2023 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (abbreviated as "Longbio Pharma"), a pharmaceutical company that develops medicines for the treatment of allergy, asthma, ophthalmology and other autoimmune diseases, announced the phase I data of LP-003 (new generation of anti-IgE antibody) at the 29th Congress of European Rhinologic Society (ERS2023) Poster Title ( awarded as best poster ) : A Phase 1 study in healthy subjects of LP-003, a novel long-acting anti-IgE antibody for allergic rhinitis Abstract Submission ID: 1209 Results: LP-003 has high IgE binding affinity (>100 fold) without off-target binding, more potent FcεRI and FcεRII/CD23 inhibition compared to omalizumab. In a randomized, double-blind, Phase I clinical study (CTR20221413), 32 healthy subjects were randomly divided into five groups to receive a single intravenous dose of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg and 10 mg/kg respectively. Safety, pharmacokinetics, and pharmacodynamics (free IgE levels) profile was evaluated. LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 46.3 days to 75.6 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 70 days at 1 mg/Kg group (except one with high baseline IgE level) to 10 mg/Kg group. LP-003 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement. "This poster presentation provides the opportunity to share our first-in-human data for LP-003 to the international allergy community. And the Phase I data is truly exciting and represents a significant milestone," exclaimed by Dr. Sun, Nai-chau, co-founder of Longbio Pharma, also the inventor of omalizumab and co-founder of Tanox Inc. "The positive results reinforce our belief in the best-in-class potential of LP-003 and its ability to address the urgent needs of patients suffering from allergic diseases, like allergic rhinitis." Longbio Pharma has initiated Phase II clinical trials to build upon the promising results obtained in Phase I and to gather more comprehensive data. The company is also actively seeking collaborations and partnerships with industry stakeholders to accelerate the development and commercialization of LP-003, ultimately aiming to provide a game-changing treatment option to patients worldwide. About LP-003 LP-003, a novel anti-IgE antibody, was generated, humanized, and engineered by Dr. Sun, Nai-chau, who is the inventor of Omalizumab, and co-founder of Tanox. Based on the 30+ years of experience on IgE target, Dr Sun developed a new generation of anti-IgE antibody (LP-003). The current data shows LP-003 is potentially to become a best-in-class treatment. Two phase II study, of allergic rhinitis and chronic spontaneous urticaria, are on-going. The company expects to have the topline result for LP-003 Phase II study by the end of 2023. About Longbio Pharma LongBio Pharma, a biotech company located in Shanghai/Changshu, China, focuses on autoimmune and complement diseases, serving patients and society. For more information, please visit: or please contact: [email protected]. SOURCE Longbio Pharma