APRIL inhibitors(Tumor necrosis factor ligand superfamily member 13 inhibitors), BAFF inhibitors(B-cell-activating factor/B lymphocyte stimulator inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesUrogenital Diseases

Active Indication

Glomerulonephritis, IGALupus NephritisSystemic Lupus Erythematosus

Inactive Indication

Clinically isolated syndromeMultiple sclerosis relapseNeoplasms+ [2]

Originator Organization

ZymoGenetics, Inc.

Active Organization

Vera Therapeutics, Inc.

ZymoGenetics, Inc.Merck Serono SA

Inactive Organization

EMD Serono, Inc.EMD Serono Research & Development Institute, Inc.Merck KGaA

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 102889

Source: *****

Clinical Trials associated with Atacicept

SLCTR/2023/021 / SuspendedPhase 3

A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)

Start Date15 Nov 2023

Sponsor / Collaborator

Vera Therapeutics, Inc.

NCT04716231 / RecruitingPhase 3

A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IgAN)

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

Start Date23 May 2023

Sponsor / Collaborator

Vera Therapeutics, Inc.

NCT05609812 / SuspendedPhase 3

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Active Lupus Nephritis

The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.

Start Date02 Nov 2022

Sponsor / Collaborator

Vera Therapeutics, Inc.

100 Clinical Results associated with Atacicept

100 Translational Medicine associated with Atacicept

100 Patents (Medical) associated with Atacicept

174

Literatures (Medical) associated with Atacicept

01 Mar 2024·Chronic Diseases and Translational Medicine

Advances in the treatment of IgA nephropathy with biological agents

Review

Author: Li, Junxia ; Zhuang, Yongze ; Lu, Hailing

AbstractImmunoglobulin A nephropathy (IgAN) is the most common primary glomerular disease, and the “four‐hit” theory represents its currently accepted pathogenic mechanism. Mucosal immunity triggered by infections in the respiratory tract, intestines, or other areas leads to antigen presentation, T cell stimulation, B cell maturation, and the production of IgA‐producing plasma cells. The proteins B‐lymphocyte stimulator (BLyS) and a proliferation‐inducing ligand (APRIL) are involved in this process, and alternative complement and lectin pathway activation are also part of the pathogenic mechanism. Kidney Disease Improving Global Outcomes guidelines indicate that a specific effective treatment for IgAN is lacking, with renin–angiotensin–aldosterone system inhibitors being the primary therapy. Recent research shows that biological agents can significantly reduce proteinuria, stabilize the estimated glomerular filtration rate, and reverse some pathological changes, such as endocapillary proliferation and crescent formation. There are four main categories of biological agents used to treat IgA nephropathy, specifically anti‐CD20 monoclonal antibodies, anti‐BLyS or APRIL monoclonal antibodies, monoclonal antibodies targeting both BLyS and APRIL (telitacicept and atacicept), and monoclonal antibodies inhibiting complement system activation (narsoplimab and eculizumab). However, further research on the dosages, treatment duration, long‐term efficacy, and safety of these biological agents is required.

01 Mar 2024·Kidney International

A phase 2b, randomized, double-blind, placebo-controlled, clinical trial of atacicept for treatment of IgA nephropathy

Article

Author: Jha, Vivekanand ; Lafayette, Richard ; Tesař, Vladimír ; Maes, Bart ; Barratt, Jonathan ; Kim, Sung Gyun ; Israni, Rubeen ; Floege, Jürgen ; Singh, Harmeet ; Eren, Necmi ; Wei, Xuelian ; Barbour, Sean ; Lin, Celia J F ; Phoon, Richard K S

Atacicept is a first-in-class, dual anti-B-cell Activation Factor-A Proliferation-Inducing Ligand fusion protein in clinical evaluation for treatment of IgA nephropathy. To compare efficacy and safety of atacicept versus placebo in patients with IgAN, this randomized, double-blind, placebo-controlled phase 2b clinical trial ORIGIN enrolled 116 individuals with biopsy-proven IgA nephropathy. Participants were randomized to atacicept 150, 75, or 25 mg versus placebo once weekly for up to 36 weeks. Primary and key secondary endpoints were changes in urine protein creatinine ratio based on 24-hour urine collection at weeks 24 and 36, respectively, in the combined atacicept 150 mg and 75 mg group versus placebo. The primary endpoint was met at week 24 as the mean urine protein creatinine ratio was reduced from baseline by 31% in the combined atacicept group versus 8% with placebo, resulting in a significant 25% reduction with atacicept versus placebo. At week 36, the key secondary endpoint was met as the mean urine protein creatinine ratio reduced from baseline by 34% in the combined atacicept group versus a 2% increase with placebo, resulting in a significant 35% reduction with atacicept versus placebo. The reduction in proteinuria was accompanied by stabilization in endpoint eGFR with atacicept compared to a decline with placebo at week 36, resulting in significant between-group geometric mean difference of 11%, approximating an absolute difference of 5.7 mL/min/1.73m². Endpoint galactose deficient IgA1 levels significantly decreased from baseline by 60% versus placebo. The safety profile of atacicept was like placebo. Thus, our results provide evidence to support a pivotal, phase 3 study of atacicept in IgA nephropathy.

04 Dec 2023·Clinical Kidney Journal

The contribution of a proliferation-inducing ligand (APRIL) and other TNF superfamily members in pathogenesis and progression of IgA nephropathy

Review

Author: Barratt, Jonathan ; Yeo, See Cheng

ABSTRACTAdvances in our understanding of the pathogenesis of immunoglobulin A nephropathy (IgAN) have led to the identification of novel therapeutic targets and potential disease-specific treatments. Specifically, a proliferation-inducing ligand (APRIL) has been implicated in the pathogenesis of IgAN, mediating B-cell dysregulation and overproduction of pathogenic galactose-deficient IgA1 (Gd-IgA1). Animal and clinical studies support the involvement of APRIL in the pathogenesis and progression of IgAN. An elevated level of APRIL is found in IgAN when compared with controls, which correlates with the level of Gd-IgA1 and associates with more severe disease presentation and worse outcomes. Conversely, anti-APRIL therapy reduces pathogenic Gd-IgA1 and IgA immune complex formation and ameliorates the severity of kidney inflammation and injury. Genome-wide association studies in IgAN have identified TNFSF13 and TNFRSF13B, a cytokine ligand-receptor gene pair encoding APRIL and its receptor, respectively, as risk susceptibility loci in IgAN, further supporting the causal role of the APRIL signalling pathway in IgAN. Several novel experimental agents targeting APRIL, including atacicept, telitacicept, zigakibart and sibeprenlimab, are currently under investigation as potential therapies in IgAN. Preliminary results suggest that these agents are well-tolerated, and reduce levels of Gd-IgA1, with corresponding improvement in proteinuria. Further studies are ongoing to confirm the safety and efficacy of anti-APRIL approaches as an effective therapeutic strategy in IgAN.

News (Medical) associated with Atacicept

09 May 2024

·www.globenewswire.com

Vera Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results

Presented positive 72-week data from the Phase 2b ORIGIN clinical trial, setting a new standard in IgAN with no loss of kidney function over the duration of treatmentTopline 96-week data from ORIGIN 2 trial expected in Q4 2024Pivotal Phase 3 ORIGIN 3 trial estimated to complete enrollment for primary endpoint in Q3 2024; topline data expected in 1H 2025Completed $287.5 million financing, further strengthening the Company’s balance sheet BRISBANE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the first quarter ended March 31, 2024. “This quarter, we shared results from our Phase 2b clinical trial that demonstrated for the first time in this field that atacicept can resolve kidney inflammation and stop kidney function decline in young patients with IgAN who are at risk of kidney failure, offering a potentially transformative treatment for these young patients,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Later this year we plan to announce long-term 96-week clinical data from our ORIGIN 2b trial, and in the first half 2025 we anticipate reading out the primary endpoint results from our pivotal ORIGIN Phase 3 trial, which are expected to support our submission for regulatory approval of atacicept. We look forward to providing updates of our progress leading up to these significant events.” First Quarter and Recent Business Highlights Presented positive 72-week data from ORIGIN Phase 2b trial of atacicept in IgAN that show consistent and sustained reductions in Gd-IgA1, hematuria, and UPCR, with stable eGFR over the duration of treatmentExpanded management team with key appointments, including industry veterans Robert M. Brenner, M.D., as Chief Medical Officer and William D. Turner as Chief Development OfficerActively adding sites and enrolling pivotal Phase 3 ORIGIN 3 study of atacicept for the treatment of IgANCompleted $287.5 million financing in February, further strengthening the Company’s balance sheet with $403.7 million in cash and equivalents as of March 31, 2024 and extending the Company’s expected cash runway through potential approval and commercial launch Upcoming Milestones in 2024 Two abstracts selected for oral presentations – including “Best-Ranked Abstract” – at the 61st European Renal Association Congress (ERA24) on May 25, 2024Plan to present topline 96-week data from ORIGIN Ph 2b clinical trial of atacicept in IgAN in the fourth quarter of 2024Pivotal Phase 3 ORIGIN 3 trial estimated to complete enrollment in the third quarter of 2024; on track to announced preliminary data in the first half of 2025 Financial Results for the Quarter Ended March 31, 2024For the quarter ended March 31, 2024, the company reported a net loss of $28.4 million, or a net loss per diluted share of $0.56, compared to a net loss of $30.1 million, or a net loss per diluted share of $0.80, for the same period last year. During the quarter ended March 31, 2024, net cash used in operating activities was $33.8 million, compared to $26.3 million for the same period last year. Vera reported $403.7 million in cash, cash equivalents, and marketable securities as of March 31, 2024, which the Company believes to be sufficient to fund operations through approval and US commercial launch of atacicept. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.com. About AtaciceptAtacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. About MAU868MAU868, a potential first-in-class monoclonal antibody, has the potential to neutralize infection by blocking BKV virions from binding to host cells. BKV is a polyoma virus that can be reactivated in settings of immunosuppression, such as in kidney transplant. It is a leading cause of kidney transplant loss and transplant-associated morbidity; there are currently no approved treatments for BKV. Vera holds an exclusive worldwide license from Amplyx Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., for the development and commercialization of MAU868 in all indications. Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera’s anticipated presentations at the European Renal Association Congress (ERA24), and Vera’s product candidates, strategy, and regulatory matters. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “potential,” “will,” “plan,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Mari PurpuraLifeSci Advisorsmpurpura@lifesciadvisors.com VERA THERAPEUTICS, INC.Condensed Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023 (unaudited)Operating expenses: Research and development$23,200 $25,108 General and administrative 7,912 6,150 Total operating expenses 31,112 31,258 Loss from operations (31,112) (31,258) Other income, net 2,729 1,189 Net loss$(28,383) $(30,069) Change in unrealized gain(loss) on marketable securities$(424) $220 Comprehensive loss$(28,807) $(29,849) Net loss per share attributable to common stockholders, basic and diluted$(0.56) $(0.80) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 50,971,933 37,667,566 VERA THERAPEUTICS, INC.Condensed Balance Sheets(in thousands) March 31, December 31, 2024 2023 (unaudited) Assets Current assets: Cash, cash equivalents and marketable securities$403,664 $160,716 Prepaid expenses and other assets, current 12,706 11,307 Total current assets 416,370 172,023 Operating lease right-of-use assets 2,432 2,949 Other noncurrent assets 554 574 Total assets$419,356 $175,546 Liabilities and stockholders' equity Current liabilities: Accounts payable$5,209 $11,118 Operating lease liabilities 2,275 2,436 Accrued expenses and other liabilities, current 7,059 8,749 Total current liabilities 14,543 22,303 Long-term debt 50,066 49,877 Operating lease liabilities, noncurrent 919 1,395 Accrued and other noncurrent liabilities 286 286 Total liabilities 65,814 73,861 Stockholders' equity Common stock 54 44 Additional paid-in-capital 691,146 410,492 Accumulated other comprehensive income (loss) (173) 251 Accumulated deficit (337,485) (309,102) Total stockholders' equity 353,542 101,685 Total liabilities and stockholders' equity$419,356 $175,546

License out/inFinancial StatementClinical ResultPhase 2

02 Apr 2024

·www.biospace.com

Vera Therapeutics Announces Two Oral Presentations at the 61st European Renal Association Congress

72-week data of atacicept in IgAN accepted as a best-ranked abstract Analysis of impact of atacicept on hematuria in IgAN accepted as a focused oral presentation BRISBANE, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced two presentations of data from the Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) will be made at the 61st European Renal Association Congress (ERA24), which is taking place May 23—26, 2024, both virtually and in Stockholm. ERA24 Presentation Details: Free Communication Presentation – selected as a best-ranked abstract by the ERA24 Congress Paper Selection Committee Title: Phase 2b ORIGIN Study Open Label Extension with Atacicept in Patients with IgA Nephropathy and Persistent Proteinuria: Week 72 Interim Analysis Presenting Author: Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center Session: FC 17 - Novel treatments of immune mediated kidney diseases Room: A5 Date, time: May 25, 2024, 15:36-15:48 CEST Focused Oral Presentation Title: Impact of Atacicept on Hematuria in IgA Nephropathy: Post-Hoc Analysis of the Phase 2b ORIGIN Study Presenting Author: Jürgen Floege, M.D., Senior Professor, Division of Nephrology and Rheumatology, University of Aachen, Germany Session: Glomerular, tubulo-interstitial diseases & general nephrology Room: Focused Oral Room 3 Date, time: May 25, 2024, 12:00-13:15 CEST For more information on these abstracts, please visit the 61st ERA Congress website. About Vera Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit . About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. About the Phase 2b ORIGIN clinical trial The Phase 2b ORIGIN clinical trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of atacicept in 116 patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite being on a stable prescribed regimen of a renin-angiotensin-aldosterone system inhibitor (RAASi) for at least 12 weeks that is the maximum labeled or tolerated dose. The Phase 2b ORIGIN clinical trial evaluated three dose strengths of atacicept versus placebo, administered weekly by prefilled syringe. Patients were randomized 2:2:1:2 to atacicept 150 mg, atacicept 75 mg, atacicept 25 mg, or matching placebo. Upon completion of the 36-week blinded treatment period, all patients were offered open-label atacicept 150 mg for an additional 60 weeks. The primary endpoint was the change in proteinuria as evaluated by urine protein to creatinine ratio (UPCR) at week 24 and the key secondary endpoint was the change in proteinuria as evaluated by UPCR at week 36. Additional exploratory endpoints include change in proteinuria as evaluated by UPCR at weeks 12, 48, and 96; change in estimated glomerular filtration rate (eGFR); change in serum immunoglobulin levels, and serum galactose-deficient IgA1 (Gd-IgA1) levels; safety and tolerability; and serum pharmacokinetics (PK). The trial met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through week 36. The safety pro comparable between atacicept and placebo. For more information about the Phase 2b ORIGIN clinical trial, please visit . Forward-looking Statements Statements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, atacicept’s potential to be a transformational treatment for patients with IgAN and a best-in-class therapy and expectations regarding presenting Phase 2b data in May 2024. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “potential,” “will,” “plan,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 jallaire@lifesciadvisors.com Media Contact: Mari Purpura LifeSci Advisors mpurpura@lifesciadvisors.com

Phase 2Clinical Result

21 Mar 2024

·www.biospace.com

Alpine Immune Sciences Presents New Translational Data on Povetacicept at the European Lupus Meeting 2024

-- Povetacicept demonstrates greater reductions in disease activity in a mouse model of lupus compared to WT TACI-Ig or B cell depletion -- -- Povetacicept exhibits greater distribution to disease-related end organs compared with WT TACI-Ig -- -- A phase 2 study in SLE (DENALI) is in preparation for initiation in 2H 2024 -- SEATTLE--(BUSINESS WIRE)-- Alpine Immune Sciences Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced today that the Company presented new translational data for povetacicept (ALPN-303) at the SLEuro 14th European Lupus Meeting in Bruges, Belgium, March 19-22, 2024. Presentation Highlights Include: BAFF- and APRIL-related genes are increased in myeloid and B cells in systemic lupus erythematosus (SLE) patients compared to healthy adults. Povetacicept significantly reduces multiple disease parameters in the NZB/W mouse model of lupus, more effectively than WT TACI-Ig or B cell depletion. Povetacicept exhibits greater distribution to multiple tissues – 19-fold higher in the kidney and 3-4-fold higher in the lung, skin, and brain – in normal mice, compared to WT TACI-Ig, potentially related to advantageous differences in molecular weight, target affinity and/or isoelectric point. "We have long known that povetacicept possesses unique molecular attributes that were conferred by our discovery platform’s directed evolution process,” remarked Stanford Peng, MD, PhD, President and Head of Research and Development at Alpine. “At least one of these attributes is its ability to distribute to disease-relevant tissues to a greater extent than wild-type TACIs, which may explain its superiority in multiple preclinical or translational disease models. These findings are particularly intriguing considering that these organs are of particular relevance to our lead indications, systemic lupus erythematosus and IgA nephropathy. These findings further support our intent to initiate both a pivotal trial in IgA nephropathy, RAINIER, as well as a phase 2 study in SLE, DENALI, later this year.” Table 1: Greater Tissue Distribution vs. WT TACI-Ig Tissue % Positive (Mean ± SE) Fold Difference (Povetacicept/Telitacicept) Povetacicept Telitacicept Kidney 1.9 ± 0.2 0.1 ± 0.0 19.0 Lung 0.49 ± 0.13 0.13 ± 0.05 3.8 Skin 2.7 ± 0.4 0.8 ± 0.2 3.4 Brain 0.10 ± 0.03 0.03 ± 0.01 3.3 Table 2: Molecular Attributes Attribute Povetacicept Telitacicept MW (kDa)1 62.6 75.3-75.42 pI1 6.5-7.0 7.1-8.4 KD, BAFF 59 pM 491 pM KD, APRIL 1 pM CNBD 1 Theoretical, calculated by Expasy (web.expasy.org/compute_pi/), Prot pI (Protpi.ch/Calculator/Protein Tool), or at Alpine based on Anal. Biochem 179:319 (1989). 2 MW reported as 80.24 kDa in J Clin Pharmacol 56:948 (2016) SLEuro 14th European Lupus Meeting Poster Presentation Details Date: Thursday, March 21, 2024 Poster Title: The Enhanced Dual BAFF/APRIL Inhibitor Povetacicept (TACI vTD-Fc; ALPN-303) More Potently Reduces Disease Activity in Murine Lupus Compared to CD20 Depletion and WT TACI-Ig, Associated with Greater End-Organ Distribution Poster Number: Tour 2, P104 About Povetacicept (ALPN-303) Povetacicept (ALPN-303) is a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, particularly antibody-secreting cells, as well as T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept has exhibited greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and B cell depletion. Povetacicept is in development for multiple autoimmune diseases, including IgA nephropathy and other autoimmune kidney diseases, systemic lupus erythematosus, and autoimmune cytopenias. About Alpine Immune Sciences Alpine Immune Sciences is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit . Follow @AlpineImmuneSci on X and LinkedIn. Forward-Looking Statements This release contains 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 the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies; the timing of and results from clinical trials and preclinical development activities; clinical and regulatory objectives and the timing thereof; expectations regarding the sufficiency of cash, including cash equivalents and restricted cash, and investments to fund our planned operations into 2026; our ability to achieve additional milestones in our collaborations and proprietary programs; the progress and potential of our development programs; future development plans and clinical and regulatory milestones and objectives, including the timing and achievement thereof; the efficacy of our clinical trial designs; anticipated enrollment in our clinical trials and the timing thereof; expectations regarding the anticipated reporting of data from our ongoing and planned clinical trials and potential publication of future clinical data; our ability to potentially advance povetacicept directly into a pivotal trial in the second half of 2024 as well as a phase 2 study in systemic lupus erythematosus, pending engagement with and approval of the Food and Drug Administration; and the potential efficacy, safety profile, addressable market, regulatory success and commercial or therapeutic potential of our product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; our discovery stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; we may be unable to advance povetacicept directly into a pivotal trial or a phase 2 study in systemic lupus erythematosus in the second half of 2024; the impact of pandemics, or other related health crises on our business, research and clinical development plans and timelines and results of operations, including the impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

ImmunotherapyPhase 2Clinical Result

100 Deals associated with Atacicept

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KEGG	Wiki	ATC	Drug Bank
D09704	Atacicept	-	DB06399

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Nephritis	NDA/BLA	MY	EMD Serono, Inc.	01 Dec 2007
Glomerulonephritis, IGA	Phase 3	US	Vera Therapeutics, Inc.	23 May 2023
Lupus Nephritis	Phase 3	CN	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Phase 3	CZ	EMD Serono, Inc.	01 Dec 2007
Systemic Lupus Erythematosus	Phase 3	-	Merck Serono SA	-
Systemic Lupus Erythematosus	Phase 3	-	ZymoGenetics, Inc.	-
Lupus Nephritis	Phase 2	SG	EMD Serono, Inc.	01 Dec 2007
Rheumatoid Arthritis	Phase 2	-	Merck Serono SA	-
Lupus Nephritis	Phase 1	TW	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Phase 1	US	EMD Serono, Inc.	01 Dec 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADDRESS II (EULAR2018)	Phase 2	Systemic Lupus Erythematosus	306	Placebo	(fwdjsycdae) = tshteswroy tfkwlmiphl (jqwkoiyqxi ) View more	Positive	13 Jun 2018
				Atacicept 75 mg	(fwdjsycdae) = ewozkhtwqb tfkwlmiphl (jqwkoiyqxi ) View more
NCT01972568 (ADDRESS II, EULAR2017)	Phase 2	Systemic Lupus Erythematosus autoantibody-positive \| SLEDAI 2K ≥10	262	Atacicept 75 mg	(fmtshxhpdi) = All three treatment groups had similar rates of treatment-emergent adverse events (TEAEs) spouasycgx (gzankirimz ) View more	Positive	14 Jun 2017
				Atacicept 150 mg
NCT02070978 (ADDRESS II, Pubmed \| Rheumatology (Oxford))	Phase 2	Systemic Lupus Erythematosus	253	Atacicept 75 mg	(ohlvstbeih) = ivcilzkueb jclzialsnj (lmcgyeclyg ) View more	-	06 Feb 2021
				Atacicept 150 mg	(ohlvstbeih) = nhyobgaawi jclzialsnj (lmcgyeclyg ) View more
NCT00664521 (Pubmed \| Arthritis Rheumatol) Manual	Phase 2	Rheumatoid Arthritis	27	atacicept	(wduyaqehbp) = lveqlgdoyb ljpidhlknt (jjbxfdmuzr )	Negative	01 Nov 2015
				Placebo	(wduyaqehbp) = rmkmdbgrkr ljpidhlknt (jjbxfdmuzr )
NCT04716231 (JANUS \| ORIGIN, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	-	atacicept (JANUS)	(ldvknilwkf) = Through the randomized, placebo-controlled period, infections were balanced between atacicept and placebo in both the Phase 2a JANUS and Phase 2b ORIGIN studies. qqjgjpiqqz (txkbyflgta )	Positive	04 Nov 2023
				placebo (JANUS)
NCT04716231 (ORIGIN, Literature) Manual	Phase 2	Glomerulonephritis, IGA	116	atacicept 25 mg	(tdpwlnfgxr) = similar across the atacicept dose groups and placebo. sprytmxzpv (rdygbstqpb )	Positive	27 Mar 2024
				atacicept 75 mg
NCT04716231 (ORIGIN, ERA2023)	Phase 2	Glomerulonephritis, IGA	116	Atacicept 150 mg	(nvjalqbrea) = stability at 24 weeks dzszdikvyh (hfhhsmjpsj )	-	15 Jun 2023
NCT04716231 (ORIGIN, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	-	Atacicept	(kfindhfqsu) = met its primary endpoint nfdpplrpxs (hcunboanks ) Met View more	Positive	08 Jan 2024
				Placebo
NCT01972568 (ADDRESS II, Pubmed \| Rheumatology (Oxford))	Phase 2	Systemic Lupus Erythematosus	306	Atacicept 150 mg	(vwhbaqekvx): OR = 3.82 (95% CI, 1.44 - 10.15) View more	-	27 Feb 2020
				Placebo

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