YAbS

YAbS

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Record category	Entry ID	Status check date	INN	Drug code(s)	Brand name	MAb sequence source	General Molecular Category	Format, general category	Format details	Target(s)	Isotype (Fc)	Light chain isotype	Linker	Ave. DAR	Conjugated moiety	Description	Discovery method	Anticipated events	Most advanced stage of development	Status	Start of clinical phase	Start of first Phase 2	Start of first Phase 3	Indications of clinical studies	Primary therapeutic area	Company	Licensee/Partner	Comments	Factors to discontinuation	Initial approval year	FDA submission date	US approval date	US product name	Company address	Company country	Company region	Company website
Regulatory review	YABS0250	01/27/2025	Gumokimab	AK111	(Pending)	mAb chimeric/humanized	Naked monospecific	Full length Ab	None	IL-17A	IgG1	kappa	None	None	None	Target is IL-17A according to https://www.akesobio.com/en/media/akeso-news/20210929/	None	None	Regulatory review China	Active	07/01/2019	04/28/2021	03/15/2023	Psoriasis, ankylosing spondylitis	Immune-mediated / inflammatory disorders	Akesobio Australia Pty Ltd	None	January 26, 2025 I Akeso, Inc. announced that the New Drug Application (NDA) of its internally-developed IL-17-targeting monoclonal antibody gumokimab (AK111) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. NCT06378697 Phase 3 in ankylosing spondylitis started in Nov 2023. CTR20230111 / NCT06066125 Phase-3 clinical trial in Plaque psoriasis (Treatment-resistant) in China (SC) started in April 2023. NCT05096364 Phase 2 in psoriasis started in April 2021. Phase 2 in Ankylosing Spondylitis started in June 2021. First patient with moderate-to-severe plaque psoriasis was dosed with AK111 in Phase Ib study in China (June 2020); Phase 1 as per company pipeline update dated Aus 2020. https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.pdf In addition to psoriasis, we may potentially expand our evaluation of AK111 into additional indications such as ankylosing spondylitis (AS) and axial spondyloarthritis (axSpA). We have completed a Phase I clinical trial of AK111 in New Zealand. We have also obtained an IND approval for psoriasis in China and plan to enroll patients in a Phase Ib trial in the first half of 2020. https://www1.hkexnews.hk/app/sehk/2020/101281/a103181/sehk20020303464.pdf	None	—	—	—	None	Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia	Australia	Australia	https://www.akesobio.com/en/about-us/contact-us/
Clinical	YABS0252	10/31/2024	Ligufalimab	AK117	None	mAb humanized	Naked monospecific	Full length Ab	None	CD47	IgG4	kappa	None	None	None	Immune checkpoint target.	None	None	Phase 3	Active	05/15/2020	02/15/2022	10/15/2024	Head & neck cancer, Higher-risk myelodysplastic syndrome, Gastric or Gastroesophageal Junction Adenocarcinoma, Colorectal Cancer, Triple-negative Breast Cancer, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Solid Tumors or Lymphomas	Cancer	Akesobio Australia Pty Ltd	None	October 30, 2024 I Akeso Biopharma announced the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso’s next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck. NCT06601335 Phase 3 Study of AK112 in Combination with AK117 in head & neck cancer due to start in Oct 2024. August 6, 2024 I Akeso has announced the completion of the first patient enrollment in the US for the phase II clinical trial of its innovative CD47 monoclonal antibody, ligufalimab (AK117), in combination with azacitidine for patients with newly diagnosed higher-risk myelodysplastic syndrome (NCT06196203 started in Feb 2024). NCT05960955 Phase 2 in GI cancers started in Nov 2023. Mar 2023: Listed as Phase 2 asset in Akesobio pipeline. CTR20221153 / NCT05382442 Phase 2 in colorectal cancer enrolled first patient in July 2022. May 2021: AK117, a novel immuno-oncology drug independently developed by the Company, obtained approval from the National Medical Products Administration (NMPA) of the People’s Republic of China (“China”) for phase I/II clinical trials on the treatment of medium- to high-risk myelodysplastic syndromes; NCT04900350 Phase 1/2 study started in May 2021. NCT04728334 Phase 1 started recruiting in Jan 2021. First patient was dosed in Phase I study in May 2020 (Slide 30, https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.pdf). NCT04349969 Phase 1 study not yet recruiting when posted on April 16, 2020. In January 2020, we submitted an IND application in Australia for our AK117 (CD47). https://www1.hkexnews.hk/app/sehk/2020/101281/a103181/sehk20020303464.pdf	None	—	—	—	None	Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia	Australia	Australia	https://www.akesobio.com/en/about-us/contact-us/
Clinical	YABS0254	04/25/2024	Manfidokimab	AK120	None	mAb humanized	Naked monospecific	Full length Ab	None	IL-4R alpha	IgG4	kappa	None	None	None	AK120 is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) directed against the IL-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes. https://pubmed.ncbi.nlm.nih.gov/37668898/	None	None	Phase 3	Active	12/15/2019	09/15/2021	04/15/2024	Asthma, Atopic Dermatitis, Phase 1 in healthy subjects	Immune-mediated / inflammatory disorders	Akesobio Australia Pty Ltd	None	NCT06383468 Phase 3 in atopic dermatitis started in Apr 2024 NCT06092762 Phase 2 in atopic dermatitis due to start in Nov 2023. Mar 2023: Listed as Phase 2 asset in company pipeline. NCT05155020 Phase 2 in asthma started in Feb 2022 terminated in Aug 2022 (The clinical development strategy has been changed) Sep 2021: Akeso, Inc. announces that the Company’s self-developed innovative drug candidate, IL-4Ra monoclonal antibody , initiated a global phase II clinical study for the treatment of moderate-to-severe atopic dermatitis which was approved by the Food and Drug Administration of the United States NCT05048056 in atopic dermatis started in Sep 2021 recruiting as of last update in July 2022. NCT04256174 Phase 1 in healthy subjects started June 15, 2020 completed in Oct 2021. In December 2019, we submitted an IND application in Australia for AK120. https://www1.hkexnews.hk/app/sehk/2020/101281/a103181/sehk20020303464.pdf	None	—	—	—	None	Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia	Australia	Australia	https://www.akesobio.com/en/about-us/contact-us/
Clinical	YABS0274	11/24/2024	Gefurulimab	ALXN1720	None	mAb humanized	Bispecific	Fragment	sdAb, VHH-VHH'	Complement C5, Albumin	None	None	None	None	None	ALXN1720 is a novel anti-C5 albumin-binding bi-specific mini-body optimized for sub-cutaneous delivery that binds and prevents activation of human C5. MW = 25 kDa; VH - VH' Heavy-chain variable region antigen-binding fragment (VHH) antibodies targeting C5 and human serum albumin (HSA) were isolated from llama immune-based libraries and humanized. Gefurulimab comprises an N-terminal albumin-binding VHH connected to a C-terminal C5-binding VHH via a flexible linker. https://doi.org/10.1016/j.molimm.2023.12.004	Camelid-derived	None	Phase 3	Active	09/04/2019	—	10/15/2022	Generalized Myasthenia Gravis, Proteinuria, Phase 1 in healthy volunteers	Immune-mediated / inflammatory disorders	AstraZeneca	None	NCT06607627 Phase 3 study in Generalized Myasthenia Gravis due to start in Mar 2025. Gefurulimab was granted orphan drug designation by the FDA for the treatment of patients with gMG. (September 2023) Phase 3 study for Generalized myasthenia gravis (NCT05556096) started in Nov 2022 is recruiting as of June 7, 2023 According to company website, 7 of nine cohorts are complete in a Phase 1 healthy volunteer study of ALXN1720. Due to COVID-19, the study was temporarily paused but is planned to restart in the third quarter of 2020. AstraZeneca acquired Alexion (formerly Syntimmune) NCT04920370 Phase 1 started in Sep 2019.	None	—	—	—	None	Cambridge, United Kingdom	United Kingdom	Europe	https://www.astrazeneca.com/our-company/contact-us.html
Regulatory review	YABS0276	02/25/2025	None	ALXN2220, NI006, NI301A	(Pending)	mAb human	Naked monospecific	Full length Ab	None	Amyloid transthyretin	IgG1	TBD	None	None	None	NI006 is a human monoclonal antibody that binds with high affinity to TTR amyloid, but not to the physiological forms of transthyretin. https://www.nejm.org/doi/10.1056/NEJMoa2303765?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed and is also know as NI301A https://www.nature.com/articles/s41467-021-23274-x	None	None	Regulatory review Japan	Active	02/10/2020	—	01/15/2024	Transthyretin amyloid cardiomyopathy	Cardiovascular / hemostasis disorders	Neurimmune AG	AstraZeneca	Listed as Priority Review ATTR-CM in Japan (https://www.astrazeneca.com/content/dam/az/PDF/2024/fy/Full-year-and-Q4-2024-results-clinical-trials-appendix.pdf) NCT06183931 Phase 3 started as per AZ presentation at Jan 2024 JMP conference (https://www.astrazeneca.com/content/dam/az/Investor_Relations/events/AZ-JPM-2024-presentation.pdf) Orphan designations in EU, Japan (https://www.astrazeneca.com/content/dam/az/PDF/2024/fy/Full-year-and-Q4-2024-results-clinical-trials-appendix.pdf) ALXN2220 was granted orphan drug designation by the FDA for the treatment of patients with ATTR-CM84. (September 2023) Listed as Phase 1 asset in AZ pipeline accessed Feb 2023. March 2022: AstraZeneca and Neurimmune close exclusive global collaboration and licence agreement to develop and commercialise NI006 July 2021: AstraZeneca completed the acquisition of Alexion Pharmaceuticals, Inc NCT04360434 Phase 1 study. February 27, 2020 – Neurimmune AG, the discoverer of aducanumab and cinpanemab, announced enrollment of the first patient in a Phase 1 clinical trial to evaluate NI006 in transthyretin amyloid cardiomyopathy (ATTR cardiomyopathy). ATTR cardiomyopathy is characterized by the intramyocardial deposition of TTR amyloid fibrils that increase heart wall thickness and cause heart muscle stiffness leading to ventricular dysfunction.	None	—	—	—	None	Wagistrasse 18, 10th floor, 8952 Schlieren / Zurich, Switzerland	Switzerland	Europe	https://www.neurimmune.com/contact
Clinical	YABS0282	03/05/2025	Maridebart cafraglutide	AMG 133, MariTide	None	mAb human	Bispecific, Immunoconjugate	Full length Ab	None	GIPR, GLP-1R	IgG1	kappa	None	None	GLP-1 peptides	AMG 133 is a bispecific glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist and glucagon-like peptide-1 (GLP-1) receptor agonist molecule. AMG 133 mimics the agonist effects of GLP-1 and antagonizes the effects of glucose-dependent insulinotropic polypeptide (GIP). The genetic findings by deCODE and others led Amgen to start working on a first-in-class antibody-based multispecific molecule currently dubbed AMG 133, with a novel mechanism of action that simultaneously activates the GLP-1 receptor and inhibits GIPR. To create AMG 133, researchers started with an antibody that blocks GIPR. To this antibody backbone, they then added two modified GLP-1 peptides that activate the GLP-1 receptor. (https://www.amgen.com/stories/2022/12/targeting-obesity-using-biology-not-behavior) AMG 133 (maridebart cafraglutide) is a bispecific molecule engineered by conjugating a fully human monoclonal anti-human GIPR antagonist antibody to two GLP-1 analogue agonist peptides using amino acid linkers. https://doi.org/10.1038/s42255-023-00966-w	None	None	Phase 3	Active	08/07/2020	01/30/2023	03/01/2025	Type 2 Diabetes Mellitus, Obesity	Metabolic disorders	Amgen	None	NCT06858878 Phase 3 in Type 2 Diabetes Mellitus started in Mar 2025. NCT06858839 Phase 3 in obesity started in Mar 2025 Nov. 26, 2024: Amgen announced positive data at 52 weeks in a double-blind, dose-ranging Phase 2 study with MariTide (NCT05669599); Amgen Announces "MARITIME," a Phase 3 Clinical Development Program in Obesity and Obesity-Related Conditions. https://investors.amgen.com/static-files/0176d78e-920b-45b3-b9cc-a727e58e80da NCT06660173 Phase 2 in Type 2 Diabetes Mellitus started in Oct 2024. NCT05669599 is a Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus started in Jan 2023. Included as Phase 1 in pipeline dated July 28, 2020: https://www.amgenpipeline.com/-/media/Themes/Amgen/amgenpipeline-com/amgenpipeline-com/PDF/amgen-pipeline-chart.pdf	None	—	—	—	None	Thousand Oaks, California, United States	United States of America	North America	https://www.amgen.com/
Clinical	YABS0287	11/18/2024	Xaluritamig	AMG 509	None	mAb humanized	Bispecific	Fragment-Fc	Fab-h-CH2-CH3 x Fab-scFv-h-CH2-CH3, 2 + 1 XmAb	STEAP1, CD3	TBD	TBD	None	None	None	Xmab 2+1 technology. Fc engineered with various mutations including but not limited to S267K (reduced effector function), N293G (no glycosylation), R302C, V302C (additional disulfide bridges). Xencor: Amgen applied our bispecific Fc technology to create, AMG 509, a STEAP1 x CD3 2+1 bispecific antibody, which Amgen is developing for patients with prostate cancer and Ewing sarcoma. Preclinical data were presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting I in April 2020.	Xmab	None	Phase 3	Active	12/15/2019	—	12/15/2024	Prostate cancer	Cancer	Amgen	Xencor, BeiGene	NCT06691984 Phase 3 in prostate cancer started in Dec 2024. NCT06555796 Phase 1 due to start in Sep 2024. NCT04221542 Phase 1 in Subjects With Metastatic Castration-Resistant Prostate Cancer. Xmab. 60th ASH meeting presentation (http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-presentations) US Orphan drug for Treatment of Ewing Sarcoma, granted July 7, 2020.	None	—	—	—	None	Thousand Oaks, California, United States	United States of America	North America	https://www.amgen.com/
Clinical	YABS0295	02/04/2025	Imsidolimab	ANB019	None	mAb humanized	Naked monospecific	Full length Ab	None	IL-36R	IgG4	kappa	None	None	None	ANB019 is a specific high affinity anti-human IL-36R antibody, generated using AnaptysBio’s proprietary antibody discovery platform. In preclinical studies, ANB019 exhibited potent IL36 inhibitory activity, as demonstrated by inhibition of IL-8 release by primary human keratinocytes stimulated with IL-36γ (similar results were obtained using IL-36 alpha and β). ANB019 inhibition of IL-36R was 100-fold more potent than IL-36RA, the physiological antagonist of IL-36 signaling.	Generated using AnaptysBio's proprietary somatic hypermutation-based antibody platform, known as SHM-XEL	BLA, MAA submissions anticipated in 2025	Phase 3	Active	04/01/2017	06/15/2018	11/01/2021	Ichthyosis, EGFRi/MEKi-associated acneiform rash, Generalized pustular psoriasis, Phase 1 in healthy volunteers	Immune-mediated / inflammatory disorders	AnaptysBio Inc.	Vanda Pharmaceuticals Inc.	Feb. 3, 2025: Vanda Pharmaceuticals Inc. and AnaptysBio, Inc. announced an exclusive, global license agreement for the development and commercialization of imsidolimab (IL-36R antagonist mAb), which has successfully completed two registration-enabling global Phase 3 trials, GEMINI-1 and GEMINI-2, evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis. Vanda expects to immediately begin preparing BLA and MAA applications for the US and EU Company Intends to out-license imsidolimab in 2024 (https://ir.anaptysbio.com/news-releases/news-release-details/anaptys-announces-first-quarter-2024-financial-results-and) Oct 2023: GEMINI-1 Met Primary Endpoint Achieving Rapid Clearance of GPP Through Week 4 After a Single Dose; company plans BLA in Q3 2024 and to out-license imsidolimab in 2024 NCT05366855 Phase 3 study is GEMINI2; anticipate top-line data from the GEMINI-1 Phase 3 clinical trial in Q4 2023. Aug 2022: AnaptysBio, Inc. announced top-line data from its HARP Phase 2 trial for the treatment of moderate-to-severe hidradenitis suppurativa (HS). The trial indicated imsidolimab was safe and well tolerated, however did not demonstrate efficacy over placebo in the trial’s primary endpoint and key secondary endpoints. Clinical development of imsidolimab is being discontinued in hidradenitis suppurativa. The company plans to outlicense investigational imsidolimab prior to potential FDA approval for the treatment of GPP. Company website accessed April 28, 2022: We held an end-of-Phase 2 meeting with the FDA during Q2 2021 to review an orphan disease development plan for imsidolimab for the treatment of GPP and initiated our first Phase 3 trial, called GEMINI-1, in Q3 2021. GEMINI-1 will enroll approximately 45 moderate-to-severe GPP patients, each undergoing an active flare at baseline, which will be randomized equally to receive a single dose of 750mg intravenous (IV) imsidolimab, 300mg IV imsidolimab or placebo. The primary endpoint of the Phase 3 program is the proportion of patients achieving clear or almost clear skin as determined by a Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) score of zero or 1 at week 4 of GEMINI-1. Patients will subsequently be re-enrolled in GEMINI-2, where they will receive monthly doses of 200mg subcutaneous imsidolimab or placebo depending upon whether they are responders, partial responders or non-responders to treatment under GEMINI-1. The objective of GEMINI-2 is to assess the efficacy and safety of imsidolimab after 6 months of monthly dosing. March 08, 2021: AnaptysBio, Inc. announced that top-line data from its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe palmoplantar pustulosis (PPP), also known as the POPLAR trial, failed to meet its primary endpoint. NCT04697069 Phase 2 study in in the Treatment of Acneiform Rash in Subjects With Cancer Receiving EGFRi or MEKi Therapy and NCT04697056 Phase 2 study in Ichthyosis due to start in Jan 2021. July 8, 2020: AnaptysBio announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, the company’s proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with Generalized Pustular Psoriasis (GPP). The company reported that additional data and regulatory strategy update from generalized pustular psoriasis (GPP) Phase II GALLOP trial is anticipated during H2 2020. Palmoplantar pustulosis (PPP) Phase II POPLAR trial top-line data anticipated in 2021. Company anticipates initiating a Phase II trial of imsidolimab for Ichthyosis during the fourth quarter of 2020. Company anticipates initiating a Phase II trial of imsidolimab, in combination with EGFRi/MEKi inhibitors, to assess its efficacy in the treatment of skin toxicity in Q4 2020. NCT03633396 Phase 2 study started in May 2019 still recruiting in Aug 2019. Phase 2 POPLAR study of ANB019 in palmoplantar pustulosis was initiated in the second half of 2018. AnaptysBio has initiated a 10-patient open-label Phase 2 trial of ANB019 in GPP, also known as the GALLOP trial and top-line data are anticipated by early 2019. Patients are dosed with a 750mg intravenous loading dose of ANB019 upon enrollment, followed by 100mg subcutaneously-administered monthly doses of ANB019 for a treatment period of up to 16 weeks post enrollment and followed an eight-week follow-up period. The company plans to initiate a placebo-controlled 50-patient multi-dose Phase 2 trial in PPP, also known as the POPLAR trial, where top line data is anticipated in the second half of 2019.Data from Phase 1 trial presented at the 2018 European Academy of Allergy and Clinical Immunology (EAACI) Congress on May 28th 2018; Phase 2 study started after this. Company plans to initiate a separate Phase 2 trial in palmoplantar pustulosis during 2018. April 2017: AnaptysBio initiated a Phase 1 clinical trial in healthy volunteers in Australia in which ANB019 will be administered in single and multiple doses through subcutaneous and intravenous routes of administration, with top-line results expected during the second half of 2017. Phase 2 studies for the treatment of two orphan inflammatory diseases, generalized pustular psoriasis and palmo-plantar pustular psoriasis, are anticipated to begin during 2018. The Company’s anti-IL-36R therapeutic antibody, called ANB019, is a novel treatment for generalized pustular psoriasis (GPP), an orphan systemic inflammatory disease with high unmet medical need. ANB019 is wholly owned within AnaptysBio’s proprietary antibody pipeline. ANB019 is a potent functional antagonist of IL-36R signaling generated using AnaptysBio's proprietary somatic hypermutation-based antibody platform, known as SHM-XEL	None	—	—	—	None	10770 Wateridge Circle, Suite 210, San Diego, CA 92121-5801	United States of America	North America	https://www.anaptysbio.com/contact/
Clinical	YABS0299	09/20/2024	Potravitug	AntiBKV, MTX-005, mAb129	None	mAb human	Naked monospecific	Full length Ab	None	BK virus	TBD	TBD	None	None	None	AntiBKV is a fully human highly neutralising antibody against BKV; derived from clinically selected convalescent BKV patients	None	None	Phase 2/3	Active	05/15/2022	—	04/10/2023	BK virus infection	Infectious diseases	Memo Therapeutics AG	None	May 2023: Fast track designation granted by FDA NCT05769582 Phase 2/3 study BKV Infection in Kidney Transplant Recipients is started in April 2023. May 31, 2022 – Memo Therapeutics AG announced today the initiation of a phase 1 clinical study targeting BK polyomavirus (“BKV”) infection in renal transplant patients. The phase 1, single-blind, partially randomized, placebo-controlled study will assess safety, tolerability, and pharmacokinetics of single and multiple ascending intravenous doses of MTX-005 in up to 56 healthy adult volunteers (ClinicalTrials.gov Identifier: NCT05358106). NCT05358106 Phase 1 started in May 2022; BLA expected in 2024.	None	—	—	—	None	Wagistrasse 27 8952 Schlieren / Zurich Switzerland	Switzerland	Europe	https://memo-therapeutics.com/contact.html
Clinical	YABS0302	06/05/2024	None	ANX005	None	mAb humanized	Naked monospecific	Full length Ab	None	Complement C1q	IgG4	kappa	None	None	None	Produced in CHO cells. Nonclinical Development of ANX005: A Humanized Anti-C1q Antibody for Treatment of Autoimmune and Neurodegenerative Diseases (http://journals.sagepub.com/doi/10.1177/1091581817740873). Dec 2016 ASH abstract 1265 ANX005, an Inhibitory Antibody Against C1q, Blocks Complement Activation Triggered By Cold Agglutinins in Human Disease: Humanized monoclonal antibody (ANX005) binds with high-affinity (~10 pM) to C1q and blocks classical complement activation & hemolysis in an in vitro sheep RBC assay. We evaluated the impact of ANX005 on hemolysis and complement deposition on human RBCs that were pre-sensitized with sera from CAD subjects. ANX005 showed a dose-dependent reduction in hemolysis using both individual and pooled CAD sera as the source of cold agglutinin. We further demonstrated that C1q blockade led to a robust reduction in C4 and C3 fragment deposition onto human RBCs. These results demonstrate that C1q inhibition is an effective way to impede C4 and C3 activation and downstream assembly of the lytic complex in sera from CAD patients, and support the clinical development of ANX005 in CAD and other antibody-mediated diseases	None	BLA submission are expected in the first half of 2025	Phase 3	Active	12/15/2016	08/17/2020	12/15/2020	Guillain-Barré Syndrome, Warm Autoimmune Hemolytic Anemia, Huntington Disease, Amyotrophic Lateral Sclerosis, Phase 1 in healthy volunteers	Neurological disorders	Annexon Inc.	None	June 2024: BLA submission are expected in the first half of 2025. Annexon plans to present Phase 3 data at the 2024 Peripheral Nerve Society Annual Meeting on June 25, 2024. https://ir.annexonbio.com/news-releases/news-release-details/annexon-announces-positive-topline-results-pivotal-phase-3-trial Phase 3 study for Guillain-Barré syndrome (NCT04701164) is recruiting as of March 9, 2023 As of Jan 2023, Annexon has prioritized resources and execution of late-stage development of its flagship programs: Guillain-Barré syndrome (GBS), Huntington’s disease (HD), geographic atrophy July 2022: Still listed as Phase 2/3 in G-B syndrome in corporate presentation; data expected in 2023. Phase 2 for Huntington's disease and ALS Dec 21, 2020: Annexon, Inc, a clinical stage biopharmaceutical company developing novel therapies for patients with classical complement-mediated disorders of the brain, body, and eye, announced that patient dosing has started in a Phase 2/3 clinical study (NCT04701164) of full-length monoclonal antibody, ANX005, to treat Guillain-Barré Syndrome (GBS). Annexon has completed a Phase 1b monotherapy clinical trial of ANX005 in GBS and has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for the treatment of GBS. NCT04691570 Phase 2 study in Warm Autoimmune Hemolytic Anemia not yet recruiting when first posted on Dec 31, 2020. NCT04569435 Phase 2 in Amyotrophic Lateral Sclerosis not yet recruiting when first posted on Sep 29 2020. NCT04035135 Phase 1/2 in GBS started in Jan 2020. Sep 2019: FDA granted fast track designation to Annexon Biosciences' investigational candidate ANX005 as a treatment for the autoimmune disease Guillain-Barre syndrome. Annexon has completed its Phase Ib trial for ANX005 and plans to launch later-stage studies. Phase 1 NCT03010046 study, as of June 2018, terminated (ANX005 well tolerated at doses studied; study discontinued and initiated in patient population)	None	—	—	—	None	1400 Sierra Point Parkway, Building C, 2nd Floor, Brisbane, CA 94005	United States of America	North America	https://annexonbio.com/