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 (EU), Breakthrough Therapy (US)

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

177

Literatures (Medical) associated with Atacicept

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 Sep 2024·Journal of Neurology

Stroke heart injury: the effect of cerebral reperfusion treatment. A 3-year retrospective study

Article

Author: Naccarato, Marcello ; Prandin, Gabriele ; Palacino, Federica ; Scali, Ilario ; Manganotti, Paolo ; Mancinelli, Laura ; Furlanis, Giovanni ; Caruso, Paola ; Vincis, Emanuele

BACKGROUNDCardiac involvement following an acute stroke (Stroke Heart Syndrome-SHS) is an established complication and it is linked to the involvement of sympathetic activation, inflammation, and neuro-endocrine response. Troponin "rise and fall pattern" > 30% is one marker of SHS. The aim of this study was to evaluate the role of reperfusion treatments in the prevention/pathogenesis of SHS with different stroke sizes and locations (OCSP classification).METHODSWe retrospectively analyzed data of 890 patients admitted to the Stroke Unit of Trieste (Italy) between 2018 and 2020. Out of them, 411 met the inclusion criteria (acute ischemic non-lacunar stroke). Clinical data were collected for each patient, imaging characteristics, and markers of cardiac injury [troponin I (TnI), NT-proBNP, "rise and fall pattern" > 30%]. We compared different stroke subtypes according to OCSP, while evaluating any differences in patients with and without SHS.RESULTSIn treated total anterior circulation infarct (TACI) patients, the rate of SHS is lower than in non-treated TACI. Similar SHS rate was found in partial anterior (PACI) and posterior stroke (POCI), and between treated and non-treated patients. Focusing on TACI group, we compared SHS-TACI and non-SHS-TACI, we performed a univariate and multivariate analysis; treatment (OR 0.408 CI95% 0.185-0.900; p = 0.026) and diabetes (OR 2.618 CI95% 1.181-5.803; p = 0.018) were significantly associated to SHS. No clear insular effect was found in SHS development.CONCLUSIONSIn severe anterior stroke (TACI), reperfusion treatment may be effective in preventing SHS. Conversely, diabetes is an independent risk factor for SHS. PACI and POCI have similar troponin elevation rate.

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

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.

News (Medical) associated with Atacicept

30 Oct 2024

·www.globenewswire.com

Vera Therapeutics Announces Pricing of Public Offering of Class A Common Stock

BRISBANE, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (“Vera”), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced the pricing of an underwritten public offering of 7,142,858 shares of its Class A common stock at a price to the public of $42.00 per share. The gross proceeds to Vera from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $300.0 million. In addition, Vera has granted the underwriters a 30-day option to purchase up to an additional 1,071,428 shares of Class A common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on October 31, 2024, subject to the satisfaction of customary closing conditions. J.P. Morgan, Goldman Sachs & Co. LLC, Evercore ISI and Cantor are acting as joint book-running managers for the proposed offering. The proposed offering is being made pursuant to an automatic shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (the “SEC”) on October 28, 2024 and became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering were filed with the SEC and are available for free on the SEC’s website located at http://www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at ecm.prospectus@evercore.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th St., 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Vera Vera 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. Forward-looking Statements Statements contained in this press release regarding Vera’s expectations regarding the offering are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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, Vera’s expectations regarding the completion of the offering. 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. Investor Contact: Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact: Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

Clinical StudyImmunotherapy

29 Oct 2024

·endpts.com

Vera’s $300M offering; Abeona resubmits treatment for rare skin disease

Plus, news about Astellas, Clover, ElevateBio, Monopar, Idorsia and Neurocrine Biosciences: Vera Therapeutics plans $300M offering: The California biotech is selling shares after presenting Phase 2b data for an experimental drug called atacicept over the weekend. The company shared 96-week data for patients with immunoglobulin A nephropathy. — Kyle LaHucik Abeona Therapeutics resubmits rare skin disease therapy: Back in April, the FDA rejected Abeona’s cell therapy, called pz-cel, requesting more information about manufacturing. Abeona is developing pz-cel for recessive dystrophic epidermolysis bullosa, a rare genetic skin disease. — Lei Lei Wu Astellas yanks Izervay’s submission in Europe: The company said it withdrew its marketing authorization application for Izervay, a C5 protein inhibitor for geographic atrophy secondary to age-related macular degeneration. Astellas did not detail feedback from the Committee for Medicinal Products for Human Use, but said it is still “confident” in Izervay’s risk-benefit profile and will continue to engage with regulators in Europe and elsewhere. There are currently no treatments approved for GA secondary to AMD outside of the US, where Izervay was greenlit in August of last year. — Ayisha Sharma Clover releases early RSV vaccine data: The Shanghai-based biotech said its bivalent vaccine candidate, SCB-1019, produced “comparable” levels of RSV neutralizing antibodies to GSK’s Arexvy at 28 days in a Phase 1 test. Based on these data, Clover plans to advance the asset into studies focused on re-vaccination next year. — Ayisha Sharma ElevateBio lays off 4%: The genetic medicines company, which employs about 500 people, is ending its preclinical cellular engineering work, a spokesperson told Endpoints News on Monday. The Waltham, MA-based biotech laid off about 13% of its staff in October 2023. It’s one of the most well-funded private biopharma startups after having raised about $1.25 billion, including its $401 million Series D last year. Partnerships with companies like Novo Nordisk, Moderna, Kyverna and Affini-T are unaffected, the spokesperson confirmed. — Kyle LaHucik Monopar Therapeutics prices $19.2M offering: The Chicago-area biotech sold shares to Janus Henderson, RA Capital and others. A few days ago, Monopar licensed a Wilson disease drug candidate from AstraZeneca’s Alexion. — Kyle LaHucik Idorsia ends work with Neurocrine Biosciences: The companies were developing Idorsia’s T-type calcium channel blocker for patients with a rare form of pediatric epilepsy. The treatment failed a Phase 2 study in 2022, and further analysis led to the decision to stop work. — Jaimy Lee

VaccinePhase 2Drug Approval

28 Oct 2024

·www.globenewswire.com

Vera Therapeutics Announces Proposed Public Offering of Class A Common Stock

BRISBANE, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (“Vera”), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced its plans to commence a public offering, subject to market and other conditions, to issue and sell $300.0 million of shares of its Class A common stock. All of the shares are being offered by Vera. In connection with the proposed offering, Vera expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of Class A common stock sold in the public offering. There can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering. J.P. Morgan, Goldman Sachs & Co. LLC, Evercore ISI and Cantor are acting as joint book-running managers for the proposed offering. The proposed offering is being made pursuant to an automatic shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (the “SEC”) on October 28, 2024 and became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may be obtained, when available from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at ecm.prospectus@evercore.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th St., 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Vera Vera 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. Forward-looking Statements Statements contained in this press release regarding Vera’s expectations regarding the offering are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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, market conditions and satisfaction of customary closing conditions related to the proposed public offering. 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. ContactsInvestor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

Clinical Study

100 Deals associated with Atacicept

External Link

KEGG	Wiki	ATC	Drug Bank
D09704	Atacicept	-	DB06399

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 3	-	ZymoGenetics, Inc.	-
Systemic Lupus Erythematosus	Phase 3	-	Merck Serono SA	-
Lupus Nephritis	Phase 2	MY	ZymoGenetics, Inc.	01 Dec 2007
Lupus Nephritis	Phase 2	US	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Phase 2	TW	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Phase 2	SG	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Phase 1	US	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Phase 1	MY	ZymoGenetics, Inc.	01 Dec 2007
Lupus Nephritis	Phase 1	SG	EMD Serono, Inc.	01 Dec 2007
Lupus Nephritis	Phase 1	TW	EMD Serono, Inc.	01 Dec 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04716231 (ORIGIN, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	116	Atacicept	cpkynuynch(xufukftkns) = nfgicfctii jaoyiorssx (ufsxzhmrmj ) View more	Positive	26 Oct 2024
				Placebo	-
ISN WCN2024	Not Applicable	Glomerulonephritis, IGA	-	Atacicept 150 mg	owlldswvmi(hfiwpjxzva) = cypednsmkg eyitodjmst (eosgzryjvc )	-	01 Apr 2024
				Placebo	owlldswvmi(hfiwpjxzva) = zdnroabeyy eyitodjmst (eosgzryjvc )
ISN WCN2024	Not Applicable	Glomerulonephritis, IGA	-	Atacicept 150 mg	sjqgfvcncr(hezehpraqu) = vzpwpinhxj uvylhckvwu (gvwqwooyar ) View more	-	01 Apr 2024
				Placebo	qrjobvoewv(xlapotlykc) = svnacghdon gsllopwrep (kjqpepkghb )
NCT04716231 (ORIGIN, Literature) Manual	Phase 2	Glomerulonephritis, IGA	116	atacicept 25 mg	(avziukmozu) = similar across the atacicept dose groups and placebo. bltpvfiblg (ltzltfuxrt )	Positive	27 Mar 2024
				atacicept 75 mg
NCT04716231 (ORIGIN, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	-	Atacicept	(npxsmdjyor) = met its primary endpoint qlcgmadsjh (vcbpevlyin ) Met View more	Positive	08 Jan 2024
				Placebo
NCT04716231 (ORIGIN \| JANUS, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	-	atacicept (JANUS)	(rtluiuvhah) = Through the randomized, placebo-controlled period, infections were balanced between atacicept and placebo in both the Phase 2a JANUS and Phase 2b ORIGIN studies. lcoplcjgqe (qngedbmquu )	Positive	04 Nov 2023
				placebo (JANUS)
NCT02808429 (Phase II study, CTgov)	Phase 2	Glomerulonephritis, IGA	16	Placebo (Placebo)	dgyezjdraz(jseugabvwa) = ffrprzsszx jbapkvnqxz (brlyamydal, wiqcxpaqzk - pdzmpncqlc) View more	-	25 Feb 2021
				Atacicept 25 mg (Atacicept 25 mg)	dgyezjdraz(jseugabvwa) = uyaoruncgg jbapkvnqxz (brlyamydal, mfyfijnexy - tauvlhmeqz) View more
NCT02070978 (ADDRESS II, Pubmed \| Rheumatology (Oxford))	Phase 2	Systemic Lupus Erythematosus	253	Atacicept 75 mg	(zbpqlbytrj) = rntrabzqhn kuyrgnqdoc (zgywozgycd ) View more	-	06 Feb 2021
				Atacicept 150 mg	(zbpqlbytrj) = ccnwdrgixi kuyrgnqdoc (zgywozgycd ) View more
NCT02808429 (Phase II study, ERA2020)	Phase 2	Proteinuria \| Glomerulonephritis, IGA Gd-IgA1	-	Placebo	pjmyhwmdnv(znpidafhrd) = vydabnccfx uggbngbtqi (fhnlkfgkft )	Positive	06 Jun 2020
				Atacicept 25mg	pjmyhwmdnv(znpidafhrd) = fsvmbhtjdk uggbngbtqi (fhnlkfgkft )
NCT01972568 (ADDRESS II, Pubmed \| Rheumatology (Oxford))	Phase 2	Systemic Lupus Erythematosus	306	Atacicept 150 mg	(nlbrnlqptb): OR = 3.82 (95% CI, 1.44 - 10.15), P-Value = 0.007 View more	-	27 Feb 2020
				Placebo

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