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	YABS0909	07/04/2024	Bifikafusp alfa, Onfekafusp alfa	L19-IL2/L19-TNF, L19IL2/L19TNF, L19(scFv)-IL2/L19(scFv)2-TNF	Nidlegy, Daromun	mAb human	Immunoconjugate, Immunocytokine, Mixture	Fragment fusion	scFv-IL2, scFv-TNF	Fibronectin EDB	None	kappa	None	None	IL-2, TNF	L19TNF component called Fibromun; L19IL2 component called Darleukin. Described in Weiss et al. Immunocytokines are a promising immunotherapeutic approach against glioblastoma (https://stm.sciencemag.org/content/12/564/eabb2311) Darleukin (L19-IL2) is an immunostimulatory compound consisting of the human vascular targeting antibody L19 and the human cytokine, interleukin 2 (http://www.philogen.com/en/products/pipeline/darleukin_9.html)	Phage display-derived	None	Regulatory review EU	Active	10/15/2005	09/15/2012	07/15/2016	Non-melanoma skin cancer, metastatic melanoma, Pancreatic Cancer, Solid Tumours	Cancer	Philogen S.p.A.	Sun Pharma	June 4, 2024 - Philogen S.p.A. and Sun Pharmaceutical Industries Limited are pleased to announce the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy™, an investigational treatment for neoadjuvant (i.e., prior to surgery) locally advanced fully resectable melanoma. October 2023 - Philogen S.p.A. and Sun Pharmaceutical Industries Limited announce positive results from the Phase III PIVOTAL trial in patients with locally advanced fully resectable melanoma (NCT02938299) and intention to submit marketing applications. Phase 3 studies for: Soft tissue sarcoma (NCT04650984) is recruiting as December 23, 2022; melanoma (in combination with L19IL2) (NCT03567889 is recruiting as of April 10, 2023 and NCT02938299 is recruiting as of April 11, 2022) May 2023: Sun Pharma and Philogen enter into an Exclusive Distribution, License, and Supply Agreement for Commercializing specialty product, NIDLEGY™ in Europe, Australia and New Zealand. NCT04362722 combo with L19TNF started in Sep 2020 recruiting as of last update in April 2022. NCT03705403 Phase 2 trial is testing if the combination of stereotactic ablative body radiotherapy (SABR) and L19-IL2 improve the progression-free survival in patients with limited metastatic non-small cell lung cancer (NSCLC); non-commercial sponsors; recruitin as of Jan 2021. NCT02938299 Phase 3 Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients due for completion in Dec 2018 has unknown status as of Jan 2021: It is in a Phase I trial of darleukin + stereotactic body radiation therapy (SBRT) in Netherlands for the treatment of oligometastatic solid tumour. Phase 3 study of darleukin and fibromun Oked in Germany and Italy in December 2015, started in July 2016. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation status to Daromun for the treatment of melanoma stages IIb through IV.	None	—	—	—	None	Via Bellaria, 35 53018 Sovicille (SI) – ITALY	Italy	Europe	https://www.philogen.com/contacts/
Clinical	YABS0911	03/12/2025	Onfekafusp alfa	L19-TNF, L19TNF, L19(scFv)2-TNF	Fibromun	mAb human	Immunoconjugate, Immunocytokine	Fragment fusion	scFv-TNF	Fibronectin EDB, TNF	None	kappa	None	None	TNF	L19TNF component called Fibromun; numerous studies in combination with L19IL2 component called Darleukin. Described in Weiss et al. Immunocytokines are a promising immunotherapeutic approach against glioblastoma (https://stm.sciencemag.org/content/12/564/eabb2311)	Phage display-derived	None	Phase 3	Active	06/01/2007	09/15/2012	07/15/2016	Glioblastoma, non-melanoma skin cancer, Glioma, soft tissue sarcoma, solid tumors; colorectal cancer; melanoma	Cancer	Philogen S.p.A.	Sun Pharma, Merck Sharp & Dohme	February 4, 2025 - Philogen Completes Patient Enrollment of the Phase III FIBROSARC Trial in Soft Tissue Sarcoma Oct 1 2024: Sun Pharmaceuticals and Philogen S.p.A. announced that they have entered into a global licensing agreement for commercializing Philogen’s specialty product, Fibromun (L19TNF). 16 October, 2023 - Philogen S.p.A. and Sun Pharmaceutical Industries Limited announce positive results from the Phase III PIVOTAL trial in patients with locally advanced fully resectable melanoma (NCT02938299). Phase 3 studies for: Soft tissue sarcoma (NCT04650984) is recruiting as December 23, 2022; melanoma (in combination with L19IL2) (NCT03567889 is recruiting as of April 10, 2023 and NCT02938299 is recruiting as of April 11, 2022) May 2023: Sun Pharma and Philogen enter into an Exclusive Distribution, License, and Supply Agreement for Commercializing specialty product, NIDLEGY™ in Europe, Australia and New Zealand. June 2022: Besides the Phase III trial of Nidlegy™ in Stage IIIB,C melanoma in Europe, Philogen is currently running six additional clinical studies with pivotal potential with Nidlegy™ and Fibromun, in Europe and in the United States.” June 26, 2020 I Philogen S.p.A., a privately-owned biotechnology company, is pleased to announce that the Swiss national competent authority Swissmedic issued the authorization to run a clinical phase II study in patients with locally advanced, not metastatic nonmelanoma skin cancer. A favorable opinion about the study has now also been obtained by EKOS (Ethics Committee of Eastern Switzerland). Patients enrolled in the clinical study will be treated with intralesional injections of NidlegyTM. NidlegyTM, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional neoadjuvant treatment of patients with resectable Stage III melanoma in two phase III clinical trials.Jan 2019: US Food and Drug Administration (FDA) has granted Orphan Drug Designation status to Fibromun for the treatment of soft tissue sarcoma. NCT03779230 Phase 1/2 study started in May 2019. Philogen lists that a pivotal clinical trial for Fibromun in combination with doxorubicin in metastatic soft tissue sarcoma has started in Europe and is about to start in the USA; NCT03420014 Phase 2 study (A Randomized Study Comparing the Efficacy of the Combination of Doxorubicin and the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF to Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma) started recruiting in Dec 2018. NCT03567889 Phase 3 study started in Sep 2018 (Phase 3 Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients). NCT02938299 Phase 3 study of darleukin and fibromun Oked in Germany and Italy in December 2015, started in July 2016; EudraCT Number: 2015-002549-72. NCT02938299 Phase 3 study still recruiting as of Sep 2018. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation status to Daromun for the treatment of melanoma stages IIb through IV. Daromun is the combination of darleukin and fibromun.	None	—	—	—	None	Via Bellaria, 35 53018 Sovicille (SI) – ITALY	Italy	Europe	https://www.philogen.com/contacts/
Clinical	YABS0927	11/25/2024	None	LBL-024	None	mAb - source TBD	Bispecific	Appended Ig	scFv-IgG	PD-L1, 4-1BB	TBD	TBD	None	None	None	LBL-024 is a PD-L1/4-1BB double antibody, consisting of a high-affinity anti-PD-L1 monoclonal antibody and an anti-4-1BB single-chain antibody.	None	None	Phase 2 pivotal	Active	06/30/2021	07/15/2024	—	Solid tumors	Cancer	Nanjing Leads Biolabs Co. Ltd	None	Nov 22, 2024: Nanjing Leads Biolabs Co., Ltd., announced that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by the company with global intellectual property rights for the treatment of neuroendocrine cancer, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). Oct 2024: Breakthrough Therapy Designation granted to LBL-024 by the Center for Drug Evaluation of National Medical Products Administration in China. July 2024: LBL-024 has entered into a single-arm pivotal trial for extrapulmonary neuroendocrine carcinomas (NCT06157827) April 30, 2024: Nanjing Leads Biolabs Co., Ltd. announced that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by Leads Biolabs with global intellectual property rights has received approval to conduct the single-arm pivotal study for registration and market authorization from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. https://www.biospace.com/article/releases/a-potential-first-in-class-drug-cde-approved-single-arm-pivotal-clinical-study-of-lbl-024-an-anti-pd-l1-4-1bb-bispecific-antibody-developed-by-leads-biolabs/ NCT05170958 Phase 1/2 study started in Jan 2022 recruiting as of last update in Feb 2023 LBL-024 received IND approvals from both FDA and NMPA on July 30, 2021 and September 9, 2021	None	—	—	—	None	122 Huakang Rd,Bldg.05,jiangbei New Area,Nanjing,210031,P.R.C	China	Asia	https://en.leadsbiolabs.com/contactus.html
Clinical	YABS0937	09/27/2024	None	LMN-201	None	mAb - source TBD	Mixture of 3	Fragment	sdAb, VHH dimers	C. difficile (exotoxin TcdB)	None	None	None	None	None	LMN-201 consists of orally delivered whole, dried, non-viable biomass of spirulina (Arthrospira platensis) grown from 4 separate strains, each of which has been engineered to express one of the following therapeutic proteins: 3 toxin-binding proteins that bind and inhibit C. difficile toxin B (TcdB), an essential virulence factor for C. difficile 1 lysozyme-like enzyme that selectively degrades the cell wall of C. difficile and causes rapid destruction of the organism. The cocktail is comprised of homodimeric versions of three toxin-binding proteins (5D, E3, and 7F) derived from camelid single-domain antibody fragments known as VHHs or nanobodies. Each protein was previously shown to inactivate TcdB. Binding of 5D to TcdB prevents its pH-driven conformational change that enables pore formation and transit into the cytoplasm from internalised endosomes. E3 binds to the glucosyltransferase domain (GTD) of TcdB, interfering with the autoproteolysis step necessary for enzyme activation. 7F also binds to the GTD, inhibiting catalytic glucosylation/inactivation of Rho-family GTPases by the mature N-terminal glucosyltransferase. The fourth cocktail component is a C. difficile-specific endolysin. (https://www.biorxiv.org/content/10.1101/2021.12.21.473715v1.full)	Camelid-derived	None	Phase 2/3	Active	08/15/2021	—	08/29/2024	Clostridioides Difficile Infection	Infectious diseases	Lumen Bioscience Inc.	None	NCT05330182 Phase 2/3 study of Prevention of C. Difficile Infection Recurrence started in Aug 2024. May 17, 2023: Lumen Bioscience announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for LMN-201, an investigational, orally delivered biologic drug to treat and prevent C. difficile infection (CDI). The FDA previously cleared a planned Phase 2/3 study of LMN-201, which will begin enrolling approximately 375 patients at sites across the United States later this year.	None	—	—	—	None	Seattle, WA 98103	United States of America	North America	https://www.lumen.bio/contact
Clinical	YABS0945	02/14/2025	Amlenetug	Lu AF82422	None	mAb human	Naked monospecific	Full length Ab	None	Alpha synuclein	IgG1	kappa	None	None	None	Lu AF82422 is a human IgG1 mAb that recognizes all major species of alpha-synuclein. Extracellular alpha-synuclein is believed to play a major role in disease pathology and progression in Parkinson’s disease.	None	None	Phase 3	Active	07/25/2018	11/15/2021	11/15/2024	Multiple System Atrophy, Parkinson's disease	Neurological disorders	H. Lundbeck A/S	Genmab	Feb 2025: FDA has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy. Nov 27, 2024: H. Lundbeck A/S announced the advancement of the clinical development of amlenetug (Lu AF82422) for the treatment of MSA with the initiation of MASCOT, a randomized, double-blind, phase III trial. NCT06706622 Phase 3 in Multiple System Atrophy due to start in Dec 2024. Listed as Phase 2 asset in company pipeline accessed Mar 2023. NCT05104476 Phase 2 study in Multiple System Atrophy started in Nov 2021 active not recruiting as of last update in Dec 2022. NCT03611569 Phase 1 study in Parkinson's disease started in July 2018 completed in July 2021. Lu AF82422 was invented by Lundbeck in collaboration with Genmab.	None	—	—	—	None	Ottiliavej 9, 2500 Valby, Denmark	Denmark	Europe	https://www.lundbeck.com/global
Clinical	YABS0954	10/22/2024	Remternetug	LY3372993	None	mAb human	Naked monospecific	Full length Ab	None	Amyloid beta (N3pG)	IgG1	kappa	None	None	None	Described as a monoclonal antibody in: Cummings, J., Lee, G., Ritter, A., Sabbagh, M., Zhong, K. (2019). Alzheimer's Disease Drug Development Pipeline: 2019. Alzheimer's and Dementia: Translational Research and Clinical Interventions, 5 272-293. Elsevier. http://dx.doi.org/10.1016/j.trci.2019.05.008 Remternetug (LY3372993) is an IgG1 monoclonal antibody directed at the pyroglutamate modification of the third amino acid of amyloid-beta peptide that is present only in brain amyloid plaques https://assets.ctfassets.net/mpejy6umgthp/51Sv0wOrFxfiHJNqcyuNYu/0c5df804e8a23256262fcb40489ae181/REMIPT3_ADPD2023_JIN_SAFETY_PLAQUE_REDUCTION_Ph1LAKB.pdf	None	None	Phase 3	Active	11/15/2018	—	08/01/2022	Alzheimer disease	Neurological disorders	Eli Lilly and Company	None	NCT06653153 Phase 3 in AD due to start in Oct 2024. NCT06647498 Phase 2/3 in AD due to start in Nov 2024. NCT05463731 Phase 3 started in Aug 2022 is recruiting as of last update on May 17, 2023. NCT04451408 Phase 1 started in July 2020; NCT03720548 Phase 1 started in Nov 2018.	None	—	—	—	None	Indianapolis, Indiana, United States	United States of America	North America	https://www.lilly.com/contact-us
Clinical	YABS0962	11/22/2024	Sonelokimab	M1095, MSB0010841, ALX-0761	None	mAb humanized	Multispecific, Trispecific	Fragment	sdAb, VHH-VHH'-VHH	IL-17A, IL-17F, Albumin	None	None	None	None	None	Trivalent, half-life extended nanobody; 3 nanobodies head-to-tail, anti-IL17F-anti-HSA- anti-IL17A	Camelid-derived	BLA possible in 2025, but may be more likely in 2026	Phase 3	Active	06/15/2013	07/31/2018	05/15/2024	Psoriatic arthritis, Hidradenitis suppurativa, psoriasis; Phase 1 in healthy volunteers	Immune-mediated / inflammatory disorders	Merck Serono	MoonLake Immunotherapeutics AG, Bond Avillion 2 Development LP	Phase 3 studies NCT06641076, NCT06641089 in Psoriatic arthritis started in October 2024. Aug 2024: VELA is the first Phase 3 program in HS to use the higher clinical response (HiSCR75); topline primary endpoint readout (week 16) expected as of mid-2025 May 16, 2024: MoonLake Immunotherapeutics announced that the first patients have been screened at a U.S. trial site in its global Phase 3 clinical program, VELA, evaluating sonelokimab, an investigational Nanobody designed to treat inflammatory disease, in patients with moderate-to-severe hidradenitis suppurativa. NCT06411899 and NCT06411379 Phase 3 studies in Hidradenitis Suppurativa due to start in May 2024. Feb 2024: The Phase 3 sonelokimab program, named VELA, is expected to enroll 800 patients and in combination with the data from Phase 2 MIRA trial will support both a Biologics License Application (BLA) and E.U. Marketing Authorization Application. The readout of the primary endpoint is anticipated in mid-2025. NCT05640245 Phase 2 in Psoriatic arthritis started in Dec 2022 active not recruiting as of last update in Aug 2023. March 24, 2022 MoonLake Immunotherapeutics AG announced that it is proceeding with a global Phase 2 clinical study to evaluate sonelokimab in patients with moderate-to-severe hidradenitis suppurativa. May 4, 2021: MoonLake Immunotherapeutics AG announced that it has in-licensed the Tri-specific Nanobody® Sonelokimab (M1095/ALX 0761) from Merck KGaA, Darmstadt, Germany. NCT03384745 Phase 2 study in psoriasis started in July 2018 still recruiting as of Aug 2019. Jan 2018: Ablynx acquired by Sanofi. March 2017: Merck KGaA is partnering Phase II and Phase III development of its therapeutic anti-interleukin-17 (IL-17) A/F Nanobody® (M1095; ALX-0761) for treating plaque psoriasis, with Avillion, a U.K.-based firm focused on financing and co-developing late-stage drug candidates. Listed in EMD Serono pipeline dated July 2017. Clinical development done by Merck Serono. NCT02156466 Phase 1 study completed in Sep 2015	None	—	—	—	None	Frankfurter Strasse 250, Darmstadt, 64293, Germany	Germany	Europe	https://www.merckgroup.com/en/company.html
Clinical	YABS0965	02/13/2024	None	M701	None	mAb chimeric	Bispecific	Fragment-Fc	YBODY	EpCAM, CD3	TBD	TBD	None	None	None	Based on YBODY® platform, we have developed three T cell-engaging BsAbs, namely M701, M802 and Y150.	YBODY platform	None	Phase 3	Active	10/15/2018	11/15/2021	03/20/2024	Malignant Ascites Caused by Advanced Epithelial Solid Tumors, Gastrointestinal or Ovarian Cancer, malignant Pleural Effusions Caused by NSCLC, Malignant Ascites	Cancer	Wuhan YZY Biopharma Co. Ltd.	Chia Tai Tianqing Pharmaceutical Group Co Ltd	NCT06432296 Phase 3 in malignant ascities started in Mar 2024 NCT06266091 Phase 2 in Gastrointestinal or Ovarian Cancer started in Nov 2021. We completed a Phase I clinical trial of M701 in treating malignant ascites (MA) in January 2022. We are currently conducting a Phase II clinical trial to evaluate the efficacy of M701 in combination with systematic treatment in MA patients. In addition, we commenced a Phase Ib/II clinical trial of M701 in treating malignant pleural effusion (MPE) in China in November 2022. NCT05543330 Phase 1/2 due to start in Sep 2022. NCT04501744 Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability and PK/PD of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody Via Intraperitoneal Infusion in Malignant Ascites started in Oct 2018. IND filed in China in 2016.	None	—	—	—	None	Biolake, C2-1, No. 666 High-tech Avenue, Wuhan, Hubei, China	China	Asia	https://en.yzybio.com/
Clinical	YABS0968	02/11/2025	Abelacimab	MAA868, NOV-12	None	mAb human	Naked monospecific	Full length Ab	None	Factor XI	IgG1	lambda	None	None	None	A commercially available phage display library (HuCAL PLATINUM library)20 was used to conduct liquid phase phage panning with full-length biotinylated FXIa and FXI and with the biotinylated catalytic/protease domain (CD) of FXIa. Variable domain fragments of heavy (VH) and light chains of specific binders were used to generate full-length immunoglobulin G1 (IgG1). Six light chain framework mutations were introduced to make the MAA868 amino acid sequence as similar as possible to the human germline Vλ1_1c sequence (“germlining”). The VH framework (VH3-23) did not require any changes. Genetic and pharmacologic evidence in humans and animals suggests that reducing factor XI (FXI) levels has the potential to effectively prevent and treat thrombosis with a minimal risk of bleeding. We generated a fully human antibody (MAA868) that binds the catalytic domain of both FXI (zymogen) and activated FXI. Our structural studies show that MAA868 traps FXI and activated FXI in an inactive, zymogen-like conformation, explaining its equally high binding affinity for both forms of the enzyme. This binding mode allows the enzyme to be neutralized before entering the coagulation process, revealing a particularly attractive anticoagulant profile of the antibody. MAA868 exhibited favorable anticoagulant activity in mice with a dose-dependent protection from carotid occlusion in a ferric chloride-induced thrombosis model. MAA868 also caused robust and sustained anticoagulant activity in cynomolgus monkeys as assessed by activated partial thromboplastin time without any evidence of bleeding. Based on these preclinical findings, we conducted a first-in-human study in healthy subjects and showed that single subcutaneous doses of MAA868 were safe and well tolerated. MAA868 resulted in dose- and time-dependent robust and sustained prolongation of activated partial thromboplastin time and FXI suppression for up to 4 weeks or longer, supporting further clinical investigation as a potential once-monthly subcutaneous anticoagulant therapy. (Koch et al, Blood. 2019 Mar 28;133(13):1507-1516. doi: 10.1182/blood-2018-10-880849)	Phage display, HuCAL PLATINUM library	None	Phase 3	Active	07/01/2016	07/01/2017	01/15/2022	Atrial Fibrillation, Thrombotic Disorders	Cardiovascular / hemostasis disorders	Novartis Pharmaceuticals	Anthos Therapeutics, MorphoSys	February 11, 2025 – Novartis announced that it has entered into an agreement to acquire Anthos Therapeutics, Inc. Nov 2024: Three Phase 3 studies are recruiting. Sep 2023: AZALEA-TIMI 71 Phase 2 study in 1,287 patients with atrial fibrillation at moderate-to-high risk of stroke, met its primary endpoint. NCT05712200 Phase 3 in Atrial Fibrillation started in Dec 2022 Sep 2022: The US Food and Drug Administration (FDA) has granted Fast Track designation for Anthos Therapeutics’ fully human monoclonal antibody abelacimab to investigate it for preventing stroke and systemic embolism in atrial fibrillation (AF) patients. July 2022: FDA granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. NCT05171075 and NCT05171049 Phase 3 studies in Venous Thromboembolism due to start in Jan 2022. July 2021: Phase 2 ANT-005 study results published in the New England Journal of Medicine. Phase 2 NCT04755283 study started in Feb 2021. Blackstone Life Sciences, the biopharma investing arm of private equity firm Blackstone Group, has joined with Novartis to start a new biotech, Anthos Therapeutics, backed with $250 million in cash and rights to an experimental drug originally discovered by the Swiss firm. The Cambridge, MA, startup, Anthos Therapeutics, will use the investment to advance MAA868, a Novartis antibody drug that is meant to treat blood clots by targeting two clotting proteins, Factor XI and Factor XIa. Phase 2 NCT03398434 and NCT03393481 in Atrial Fibrillation and Thrombotic Disorders, respectively, withdrawn in Sep 2018. Listed as in clinical studies in Novartis Jan 2017 pipeline, Phase 2 by mid-2017. July 2016: MorphoSys AG announced that it has received a milestone payment from Novartis in connection with the initiation of a clinical phase 1 trial with a novel HuCAL antibody. The antibody will be tested in the field of prevention of thrombosis.	None	—	—	—	None	Basel, Switzerland	Switzerland	Europe	https://www.novartis.com/contacts
Approved	YABS0978	12/04/2024	Zenocutuzumab	MCLA-128	BIZENGRI®	mAb humanized	Bispecific	Full length Ab	None	HER2, HER3	IgG1	kappa	None	None	None	cLC-hetero-H-chain IgG; ADCC-enhanced, full-length IgG bispecific antibody that simultaneously targets the growth factor receptors HER2 and HER3 (i.e., targets dimer). Humanized as per De Nardis et al, JBC 2017, 292:14706-17. Defucosylated using GlymaxX technology	None	None	Approved US	Active	01/15/2015	01/15/2018	—	Breast cancer, pancreatic cancer, solid tumors	Cancer	Merus B.V.	Partner Therapeutics, Inc.	Dec 2, 2024: Merus N.V., a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) and Partner Therapeutics, Inc., a private, fully-integrated biotechnology company with a focus in hematology and oncology, announced they have entered into an agreement in which Merus has exclusively licensed to PTx the right to commercialize zenocutuzumab for the treatment of NRG1 fusion-positive (NRG1+) cancer in the United States. Nov 5, 2024: Merus N.V. announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for zenocutuzumab Biologics License Application (BLA) currently under priority review. The US FDA has extended the PDUFA goal date to February 4, 2025 to enable sufficient time to review information recently submitted by the Company in response to a CMC information request. May 06, 2024: Merus N.V. announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer. https://ir.merus.nl/news-releases/news-release-details/merus-announces-us-fda-acceptance-and-priority-review-biologics Oct 2023: After discussions with regulators, Merus is planning to seek approval for Zeno in the first half of 2024. The therapy was granted a breakthrough tag from the FDA this summer. Sufficient clinical data expected in 1H24 to support potential BLA submissions. June 29, 2023 Merus N.V. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. This designation for Zeno follows a Fast Track Designation for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancer) that have progressed on standard of care therapy on January 7, 2021 and Orphan Drug Designation for the treatment of patients with pancreatic cancer on July 27, 2020. NCT05588609 Phase 2 study in NSCLC or prostate cancer started in Nov 2022 recruiting as of last update in Dec 2022. Jan 2021: Merus N.V., a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™) for cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Zenocutuzumab (Zeno) for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) that have progressed on standard of care therapy. July 2020: Merus N.V, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zenocutuzumab (Zeno) for the treatment of patients with pancreatic cancer. NCT04100694 early access study in solid tumors posted as 'available' as of Sep 24, 2019; no phase given. Phase 2 metastatic breast cancer cohort update planned for 4Q 2019; Phase 1/2 single agent trial amended to focus on solid tumors harboring Neuregulin 1 (NRG1) gene fusions. 2018-01-26: Merus N.V., a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 2, open-label, multi-center international clinical trial to evaluate MCLA-128 in two metastatic breast cancer (MBC) populations including HER2-positive MBC patients and hormone receptor positive/HER2-low MBC patients. NCT03321981 Phase 2 study still recruiting as of Aug 2018. Phase 1/2 started in Europe; NCT02912949 Phase 1/2 study still recruiting as of Oct 2017	None	2024	—	12/04/2024	Zenocutuzumab, zenocutuzumab-zbco	CT Utrecht, The Netherlands	Netherlands	Europe	https://merus.nl/about/contact/