Delving into the Latest Updates on Atacicept with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Anti-Blys/anti-APRIL fusion protein, Atacicept (USAN/INN), BLyS/APRIL-heterotrimers

+ [3]

Target

APRIL x BAFF

Action

inhibitors

Mechanism

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, IGASystemic Lupus Erythematosus

Inactive Indication

Clinically isolated syndromeLupus NephritisMultiple sclerosis relapse+ [3]

Originator Organization

ZymoGenetics, Inc.

Active Organization

Vera Therapeutics, Inc.Merck Serono SA

ZymoGenetics, Inc.

Inactive Organization

Merck KGaA

EMD Serono, Inc.

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (European Union), Breakthrough Therapy (United States)

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Structure/Sequence

Sequence Code 102889

Source: *****

INTRODUCTIONTo evaluate the impact of TACI fusion protein (TACI-Ig) on IgA nephropathy (IgAN) in rats, and to explore its mechanism and relationship with TLR4/MyD88/NF-κB pathway.METHODSprague Dawley(SD)rats were divided into six groups: control, model, TACI-Ig low dose (TACI-Ig-L), medium dose (TACI-Ig-M), high dose (TACI-Ig-H), and prednisone acetate (PAT) group. The control group and model group received physiological saline injections, while the TACI-Ig groups were administered doses of 7.18, 14.36, and 28.72 mg/kg of TACI-Ig, respectively. PAT group was pretreated with prednisone acetate. After 8 weeks, kidney weight/body weight ratios, 24-hour urine protein (24 h UP), serum creatinine (SCr), and blood urea nitrogen (BUN) levels were measured. Additionally, concentrations of B cell activating factor (BAFF), APRIL, and Gd-IgA1 were evaluated by using ELISA. Pathological changes in kidney tissues were scored, and TLR4, MyD88, NF-κB expression levels were detected through western blot (WB) and RT-qPCR. Results. Renal function assessments showed that the IgAN model group exhibited increased in 24 h UP, SCr, BUN, and elevated serum levels of BAFF, APRIL, Gd-IgA1, alongside higher TLR4/MyD88/NF-κB protein expression. TACI-Ig treatment significantly reduced proteinuria, SCr, BUN, levels of BAFF, APRIL, and Gd-IgA1 in IgAN rats. Pathologically, TACI-Ig ameliorated glomerular mesangial deposition and fibrosis. It also inhibited TLR4/MyD88/NF-κB protein expression, demonstrating anti-inflammatory and immune regulatory effects.CONCLUSIONSTACI-Ig mitigates renal injury in IgAN rats by reducing inflammatory infiltration and IgA deposition and suppressing the pathway of TLR4/MyD88/NF-κB, offering data for developing effective treatments for IgAN.

01 Nov 2024·International Journal of Clinical Oncology

Current status of BAFF targeting immunotherapy in B-cell neoplasm

Review

Author: Tagami, Nami ; Goto, Yasuyuki ; Yuda, Junichiro

AbstractB-cell activating factor belonging to the TNF family (BAFF), also known as B-lymphocyte stimulator (BLyS), plays a crucial role in B-cell development. It has multiple receptors, including BCMA, TACI, and BAFF-R, with diverse roles in different cell types. BAFF induces B-cell proliferation and immunoglobulin secretion, and acts as a survival factor for immature, naive, and activated B cells. Consequently, BAFF-deficient mice often show suppressed humoral responses, while BAFF-overexpressing mice show the higher number of mature B cells and may develop autoimmune-like manifestations and B-cell lymphoproliferative diseases. Elevated BAFF levels are also associated with various hematological malignancies, and its expression correlates with disease progression in some cases. Therefore, BAFF-targeted therapies, such as belimumab, atacicept, and tabalumab, are being explored in clinical trials for conditions like chronic lymphocytic leukemia (CLL) and multiple myeloma. Belimumab, an anti-BAFF monoclonal antibody, is being investigated in combination with rituximab/venetoclax for CLL. Atacicept, a decoy receptor for BAFF and APRIL, showed tolerability in a phase 1b trial for CLL. Tabalumab, another monoclonal antibody targeting BAFF, did not demonstrate significant efficacy in a phase 2 study for relapsed/refractory multiple myeloma. BAFF ligand-based CAR-T cells are designed to target BAFF receptors and show promise in preclinical studies, particularly for B-cell malignancies. The review emphasizes the importance of understanding the roles of BAFF and its receptors in the microenvironment of hematologic malignancies. Targeting BAFF and its receptors presents potential therapeutic avenues, and ongoing clinical trials provide valuable insights.

01 Jun 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 ; Maes, Bart ; Tesař, Vladimír ; Barratt, Jonathan ; Kim, Sung Gyun ; Israni, Rubeen ; Floege, Jürgen ; Wei, Xuelian ; Singh, Harmeet ; Eren, Necmi ; 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.

81

News (Medical) associated with Atacicept

14 Jan 2025

·www.globenewswire.com

Vera Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BRISBANE, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that on January 8, 2025, the Compensation Committee granted inducement awards consisting of a non-qualified stock option to purchase 35,250 shares of Class A common stock and restricted stock units (RSUs) for 17,625 shares of Class A common stock to six new employees under the Inducement Plan. The Compensation Committee approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4). Each stock option granted on January 8, 2025 has an exercise price per share equal to $42.19, Vera’s closing trading price on January 8, 2025. Each stock option will vest over four years, with 25% of the underlying shares vesting on the first anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with Vera through the applicable vesting dates. Each of the RSUs will vest over four years, with 25% of the underlying shares vesting on each anniversary of February 20, 2025, subject to the new employee’s continued service relationship with Vera through the applicable vesting dates. The awards are subject to the terms and conditions of the Inducement Plan and the terms and conditions of an applicable award agreement covering the grant. 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. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

ImmunotherapyClinical Result

13 Jan 2025

·www.globenewswire.com

Vera Therapeutics Acquires Global Rights to Novel, Next Generation Dual BAFF/APRIL Inhibitor

BRISBANE, Calif., Jan. 13, 2025 (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 an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. “This novel approach is part of Vera’s broad lifecycle management strategy to expand and extend our leadership position within B cell modulation, which we believe has the potential to transform how we treat patients suffering from a variety of B cell mediated diseases. We plan to leverage our research, translational medicine, clinical development and commercial expertise to define and advance the potential of this molecule,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “This transaction furthers our commitment to transforming outcomes for patients with grievous autoimmune diseases.” This agreement will enable Vera to develop and market VT-109 in return for undisclosed upfront and milestone payments. 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 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 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, VT-109’s potential to transform how patients suffering from B cell mediated diseases are treated and Vera’s plans to advance development of VT-109. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believe,” “plan,” “potential” 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:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

License out/inImmunotherapy

09 Dec 2024

·www.globenewswire.com

Vera Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BRISBANE, Calif., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that on December 3, 2024, the Compensation Committee granted inducement awards consisting of a non-qualified stock option to purchase 171,750 shares of Class A common stock and restricted stock units (RSUs) for 86,625 shares of Class A common stock to seventeen new employees under the Inducement Plan. The Compensation Committee approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4). Each stock option granted on December 3, 2024 has an exercise price per share equal to $49.38, Vera’s closing trading price on December 3, 2024. Each stock option will vest over four years, with 25% of the underlying shares vesting on the first anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with Vera through the applicable vesting dates. Each of the RSUs will vest over four years, with 25% of the underlying shares vesting on each anniversary of February 20, 2025, subject to the new employee’s continued service relationship with Vera through the applicable vesting dates. The awards are subject to the terms and conditions of the Inducement Plan and the terms and conditions of an applicable award agreement covering the grant. 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. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

ImmunotherapyClinical Result

100 Deals associated with Atacicept

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External Link

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
Systemic Lupus Erythematosus	Phase 3	-	Merck Serono SA	-
Systemic Lupus Erythematosus	Phase 3	-	ZymoGenetics, Inc.	-
Lupus Nephritis	Phase 2	United States	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Phase 2	Singapore	ZymoGenetics, Inc.	01 Dec 2007
Lupus Nephritis	Phase 2	Taiwan Province	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Phase 2	Czechia	ZymoGenetics, Inc.	01 Dec 2007
Lupus Nephritis	Preclinical	United States	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Preclinical	Czechia	ZymoGenetics, Inc.	01 Dec 2007
Lupus Nephritis	Preclinical	Singapore	ZymoGenetics, Inc.	01 Dec 2007
Lupus Nephritis	Preclinical	Taiwan Province	EMD Serono, Inc.	01 Dec 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04716231 (ORIGIN, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	116	Atacicept	qjfuehtcqs(gmmxctuwfp) = lqhnvyjhvc vzhvtpvsro (klodfhfkfx ) View more	Positive	26 Oct 2024
				Placebo	-
ISN WCN2024	Not Applicable	Glomerulonephritis, IGA	-	Atacicept 150 mg	bmampvfzjd(wtasikzdgh) = kpchuvsyms itwrjtydjj (qksuhciqbb ) View more	-	01 Apr 2024
				Placebo	rdczcvvztb(fcbiicjeub) = gqmiljddur xmcasaygzz (vjvlhxfvyw )
ISN WCN2024	Not Applicable	Glomerulonephritis, IGA	-	Atacicept 150 mg	jrjiwgaogs(gdzgclelzs) = euzgcpkdfb wtwutfduzz (nqhxmtzgro )	-	01 Apr 2024
				Placebo	jrjiwgaogs(gdzgclelzs) = uqpewwtsgv wtwutfduzz (nqhxmtzgro )
NCT04716231 (ORIGIN, Literature) Manual	Phase 2	Glomerulonephritis, IGA	116	atacicept 25 mg	(jsqphomgab) = similar across the atacicept dose groups and placebo. uojvypsltg (yncgppniti )	Positive	27 Mar 2024
				atacicept 75 mg
NCT04716231 (ORIGIN, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	-	Atacicept	(kplgbezsfr) = met its primary endpoint mbjikbwtyh (jwqrpoftmw ) Met View more	Positive	08 Jan 2024
				Placebo
NCT04716231 (ORIGIN \| JANUS, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	-	atacicept (JANUS)	(jdenaddpts) = Through the randomized, placebo-controlled period, infections were balanced between atacicept and placebo in both the Phase 2a JANUS and Phase 2b ORIGIN studies. mjcwnjebpu (cpqsschhil )	Positive	04 Nov 2023
				placebo (JANUS)
NCT02808429 (Phase II study, CTgov)	Phase 2	Glomerulonephritis, IGA	16	Placebo (Placebo)	ticibibkef(unxqmvdims) = euuqlvbsol nxphbaosgl (ysvxxamdcf, gehnrerpvn - dxvbrrulse) View more	-	25 Feb 2021
				Atacicept 25 mg (Atacicept 25 mg)	ticibibkef(unxqmvdims) = xgedyqvmmf nxphbaosgl (ysvxxamdcf, sggsyovvig - zcrsvciowz) View more
NCT02808429 (Phase II study, ERA2020)	Phase 2	Proteinuria \| Glomerulonephritis, IGA Gd-IgA1	-	Placebo	kfcyypweuc(skbzzennos) = snwbdltoda ldzlmrtwbu (mpfwqohqes )	Positive	06 Jun 2020
				Atacicept 25mg	kfcyypweuc(skbzzennos) = mivecrunqa ldzlmrtwbu (mpfwqohqes )
NCT01972568 (ADDRESS II, Pubmed \| Rheumatology (Oxford))	Phase 2	Systemic Lupus Erythematosus	306	Atacicept 150 mg	(zkztrxfqai): OR = 3.82 (95% CI, 1.44 - 10.15), P-Value = 0.007 View more	-	27 Feb 2020
				Placebo
NCT00624338 \| NCT01972568 (ACR2019)	Phase 1/2	Systemic Lupus Erythematosus BLyS \| APRIL	540	Atacicept 25 mg	(xmibrvtxds) = qykwqwzbyu dugjmeenbq (ypjddbbuvq ) View more	-	12 Nov 2019
				Atacicept 75 mg	(xmibrvtxds) = peuwivgbnb dugjmeenbq (ypjddbbuvq ) View more

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Atacicept

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation