BCMA x BAFF-R x TACI

SOUTH SAN FRANCISCO, Calif., Nov. 11, 2022 /PRNewswire/ -- RemeGen Co., Ltd., a leading biopharmaceutical company with fully integrated capabilities in research and discovery, clinical development, manufacturing, and commercialization of biologic drugs, will join the event of the American College of Rheumatology (ACR) 2022, hosted from November 10th to 14th. This event will present Telitacicept phase III clinical trial data on Systematic lupus erythematosus (SLE) and data from the phase II clinical trial for Sjorgren's syndrome. About Telitacicept Continue Reading Telitacicept is a novel fusion protein composed of a transmembrane activator and CAML interactor (TACI) and the Fc portion of IgG, which targets and neutralizes B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). BLyS and APRIL are both involved in the development of B cells from pre-B lymphocytes to mature B cells and ultimately to plasma cells, the professional cells producing antibodies, as well as in the co-stimulation of T-cell proliferation under certain conditions. Telitacicept blocks BLyS and APRIL from binding to BAFF-R, BCMA, and TACI receptors expressed on the B-cell surface, suppressing the BLyS and APRIL signaling, and inhibiting the development and survival of mature B cells and plasma cells. Systemic lupus erythematosus (SLE) is the principal indication of Telitacicept. Through priority review, Telitacicept was approved by China National Medical Products Administration (NMPA) and is included in the National Reimbursement Drug List (NRDL). Telitacicept also received FDA Fast Track Designation as a treatment for SLE with an ongoing global Phase III study. In addition to SLE, the company is actively developing Telitacicept for six other B cell-mediated autoimmune diseases and refractory autoimmune diseases with unmet clinical needs in China, including Neuromyelitis optica spectrum disease, rheumatoid arthritis, IgA nephropathy, primary Sjogren's syndrome, relapsing-remitting multiple sclerosis, and systemic myasthenia gravis. Telitacicept for Systematic Lupus Erythematosus, data from phase III trial This is a 52-week, randomized, double-blind, placebo-controlled, phase III clinical trial (NCT04082416). SLE patients aged 18 to 65 years with positive ANA and/or anti-dsDNA and a SELENA-SLEDAI score ≥8 were randomized 1:1 to receive either Telitacicept 160 mg or placebo subcutaneously once weekly in combination with standard therapy for 52 weeks. A total of 335 patients were randomized to receive Telitacicept 160 mg (n=167) or placebo (n=168). Of the randomized patients, 236 (70.4%) completed 52 weeks of treatment. The primary endpoint at week 52 revealed a significant proportion of patients in the Telitacicept 160 mg group achieving SRI4 response compared with the placebo group (82.6% vs. 38.1%, p< 0.001). The SRI4 response was significantly greater in the Telitacicept group compared with the placebo group as early as Week 4, and the differences sustained between the 2 groups until week 52 (p < 0.01 for all time points) Regarding safety, 91.6% of subjects in the Telitacicept group and 84.5% in the placebo group had treatment-emergent adverse events (TEAEs). There were 17 serious adverse events (SAEs) in 12 subjects (7.2%) treated with Telitacicept and 36 SAEs in 24 subjects (14.3%) treated with placebo. The most common AEs (≥10%) with Telitacicept were upper respiratory tract infection, decreased IgG and IgM, injection site reactions, and urinary tract infection. No death occurred during the study. Telitacicept for Sjogren's Syndrome, data from phase II trial The upcoming event will also present data to evaluate the efficacy and safety of Telitacicept in adult patients with primary Sjogren's syndrome (pSS) in phase II randomized, double-blind, placebo-controlled trial. A total of 42 patients with pSS with positive anti-SSA antibody and ESSDAI≥ 5 were randomly assigned, in a 1:1:1 ratio, to receive weekly subcutaneous Telitacicept 240 mg, 160 mg, or placebo for 24 weeks. Thirty patients who completed their 24 weeks visit were included in the per-protocol set (PPS) (Telitacicept 240 mg, n=8; Telitacicept, 160 mg; n=12; placebo, n=10). The primary endpoint was the change from baseline in the ESSDAI at week 24. Results from the trial revealed that Telitacicept 160 mg showed a significant reduction in ESSDAI score from baseline to week 12 and week 24 compared with placebo (p< 0.05); Telitacicept 240 mg resulted in a considerable decrease in ESSDAI score from baseline to week 24 compared with placebo in the PPS population (p< 0.05). For the secondary endpoint, Telitacicept can significantly reduce from baseline in MFI-20 in weeks 12 and 24. No serious adverse events were observed in the Telitacicept treating group. About RemeGen RemeGen, Ltd. ("RemeGen") is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen's main focus is research and development, manufacturing and commercialization of novel biologics, most notably monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs). Since its inception in 2008, RemeGen has created more than 10 novel drug molecules in various clinical development stages. Currently, there are two products in late-stage clinical development to treat autoimmune and oncology indications. Headquartered in Yantai, Shandong Province, China, RemeGen has labs/offices in Beijing and California. For more information about RemeGen, please visit: For those attending ACR, please come and visit us at our booth #2357 SOURCE RemeGen

SOUTH SAN FRANCISCO, Calif., Nov. 3, 2022 /PRNewswire/ -- RemeGen Co., Ltd., a leading biopharmaceutical company with fully integrated capabilities in research and discovery, clinical development, manufacturing, and commercialization of biologic drugs, will join the event of American Society of Nephrology (ASN) Kidney Week 2022, hosted from November 3rd. to 6th. Related abstract from Telitacicept (RC18) presented in ASN 2021 and NMOSD abstract will be available from the booth. About Telitacicept Continue Reading RemeGen Co., Ltd. Telitacicept is a novel fusion protein composed of a transmembrane activator and CAML interactor (TACI) and the Fc portion of IgG, which targets and neutralizes B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). BLyS (also known as B-cell activating factor, or BAFF) and APRIL are both involved in the development of B cells from pre-B lymphocytes to mature B cells, and ultimately to plasma cells, the professional cells producing antibodies, as well as in the co-stimulation of T-cell proliferation under certain conditions. Telitacicept blocks BLyS and APRIL from binding to BAFF-R, BCMA, and TACI receptors expressed on B-cell surface, suppressing the BLyS and APRIL signaling, and inhibiting the development and survival of mature B cells and plasma cells. Systemic lupus erythematosus (SLE) is the principal indication of Telitacicept. Through priority review, Telitacicept was approved by China National Medical Products Administration (NMPA) and is included in the National Reimbursement Drug List (NRDL). Telitacicept also received FDA Fast Track Designation as a treatment for SLE with an ongoing global Phase III study. In addition to SLE, the company is actively developing Telitacicept for six other B cell-mediated autoimmune diseases and refractory autoimmune disease with unmet clinical needs in China, including Neuromyelitis optica spectrum disease, rheumatoid arthritis, IgA nephropathy, primary Sjogren's syndrome, relapsing-remitting multiple sclerosis, and systemic myasthenia gravis. Telitacicept Indicated for IgA Nephropathy This is a Phase II, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Telitacicept compared with placebo when added to standard therapy in high-risk for progression IgA nephropathy patients. Participants were centrally randomized 1:1:1 to subcutaneous Telitacicept 160mg, 240mg, and placebo group stratified by proteinuria (<3g/day or ≥3g/day). The primary endpoint will evaluate the change of proteinuria at week 24. The secondary endpoints will assess the changes in estimated GFR from baseline over 24 weeks and levels of IgA from baseline at week 24. The incidence of adverse events will also be documented. In this trial, Telitacicept is expected to reduce proteinuria in patients with IgA nephropathy and reduce the risk of progression to end-stage renal disease. About RemeGen RemeGen, Ltd. ("RemeGen") is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen's main focus is research and development, manufacturing and commercialization of novel biologics, most notably monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs). Headquartered in Yantai, Shandong Province, China, RemeGen has labs/offices in Beijing and California. Since its inception in 2008, RemeGen has created more than 10 novel drug molecules that are in various stages of clinical development. Currently, there are two products in late-stage clinical development to treat autoimmune and oncology indications. For more information about RemeGen, please visit: Investor Contact Annaly Godwin [email protected] SOURCE RemeGen

- AB001 is an engineered high-affinity soluble BCMA decoy receptor that traps APRIL and BAFF, critical cytokines controlling B cell development and survival - AB001 effectively inhibits the development of Multiple Myeloma and Diffuse Large B Cell Lymphoma via modulating protein translation machinery - AB001 demonstrated impressive safety pro on-target mechanism of action in non-human primates LOS ANGELES & LONDON & BEIJING--(BUSINESS WIRE)-- AKSO Biopharmaceutical, Inc. (“AKSO”), a global biopharmaceutical company with an innovative and comprehensive approach to treat cancer, autoimmune disease, and genetic disorder, announced the publication in the Journal of Experimental Medicine of preclinical data demonstrating that AKSO’s late preclinical stage molecule AB001 effectively inhibits growth of Multiple Myeloma (“MM”) and Diffuse Large B Cell Lymphoma (“DLBCL”) in mice. Importantly, AB001 was also found to be nontoxic in non-human primates. “AB001 is a first-in-class and potentially best-in-class ligand trap targeting APRIL and BAFF, which are known to be difficult to sequester due to high native binding affinities to their receptors, but also critical regulators of B cell development and survival,” said Professor Amato Giaccia, AKSO’s Chairman and Senior Scientific Strategist. “Our study demonstrated the novel mechanism of APRIL and BAFF in modulating protein translation; and suggest that engineered soluble BCMA could be a superior alternative to therapeutics either approved or in development for MM and DLBCL.” “Safe and effective targeted therapies are urgently needed for MM and DLBCL patients who exhaust currently available treatment options,” said Dr. Rebecca Miao, AKSO’s Chief Scientific Officer. “Collectively, our data support AB001 as a clinically viable candidate for the treatment of MM and DLBCL. Furthermore, the biological functions of BAFF and APRIL are not limited to B cell malignancies but extend to autoimmune disorders and other diseases triggered by pathological B cells, indicating a broad clinical application of AB001.” Key findings from the study performed under the guidance of Professor Giaccia and Dr. Miao, reported in the publication titled “Developing High-Affinity Decoy Receptor Optimized for Multiple Myeloma and Diffuse Large B Cell Lymphoma Treatment”, include: APRIL and BAFF mediated signalling is required for MM progression; When compared to the wild-type soluble BCMA receptor, AB001 shows 500-fold stronger binding toward BAFF and 4-fold stronger binding toward APRIL; AB001 is capable of neutralizing APRIL and BAFF and their receptor activities, impacting protein translation and production in MM and DLBCL cells; Treatment with AB001 led to enhanced antitumor activity in a number of MM and DLBCL mouse models; AB001 also demonstrated an adequate toxicity pro on-target mechanism of action in nonhuman primate studies. ABOUT AB001 AB001 is a late preclinical stage first-in-class and best-in-class engineered soluble BCMA decoy receptor. AB001 traps APRIL and BAFF with ultra-high binding affinities thereby inhibiting ligand mediated activation of receptors BCMA, BAFF Receptor and TACI. ABOUT AKSO AKSO Biopharmaceutical, Inc., is a late preclinical stage global biopharmaceutical company focused on the discovery and development of first-in-class therapeutics for the treatment of cancer, autoimmune diseases, and genetic disorder. Leveraging the proprietary DEEP engineering platform and deep knowledge in disease biology, AKSO has developed a portfolio of innovative drug candidates covering a wide range of modalities including decoy receptors, bispecific fusion proteins, antibody-drug conjugates, and precision gene editing therapies. For additional information, please visit .