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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
Approved	YABS0161	12/26/2023	Socazolimab	ZKAB001, STI-A1014	Shan Keyu	mAb human	Naked monospecific	Full length Ab	None	PD-L1	IgG1	lambda	None	None	None	IgG1 lambda2. Immune checkpoint modulator. ZKAB001 is a fully human anti-PD-L1 monoclonal antibody (mAb), an immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting Natural Killer (NK) cells and other effector cells against the tumor potentially further strengthening the anti-tumor effect of the antibody.	None	None	Approved China	Active	12/15/2017	—	—	Biliary Tract Cancer, Urothelial Carcinoma, Esophageal Squamous Cell Carcinoma, Osteosarcoma, Small Cell Lung Cancer, Solid tumors, cervical cancer	Cancer	Sorrento Therapeutics	Lee's Pharmaceutical Holdings	On December 21, 2023, the official website of the Food and Drug Administration showed that the new drug marketing application for the anti-PD-L1 monoclonal antibody socazolimab injection (Socazolimab) submitted by Zhaoke Oncology Drug Co., Ltd., a subsidiary of Lee's Pharmaceutical Co., Ltd., was approved in China. March 2023: “ANNOUNCEMENT OF ANNUAL RESULTS FOR THE YEAR ENDED 31 DECEMBER 2022”, which was issued on March 30, 2023 - China Oncology Focus Limited (“COF”), a 65% owned subsidiary of the Group, is a clinical development stage company and the Group’s R&D arm focused on oncology with emphasis in immuno-oncology. To date, COF has built a pipeline of 10 oncology assets, including 6 innovative and 4 generics, through internal development and in licensing, and is currently developing several assets, including (1) Socazolimab (an anti-PD-L1 antibody) in recurrent or metastatic cervical cancer in new drug application stage in China; (2) Socazolimab in osteosarcoma in Phase III clinical trial; (3) Socazolimab combined with chemotherapy in small cell lung cancer in Phase III clinical trial and has completed the patient enrollment in May 2022; (4) Zotiraciclib, an oral multi-kinase inhibitor in Phase I clinical trial for glioblastoma; (5) Gimatecan, a topoisomerase I inhibitor in Phase II clinical trial for ovarian cancer and in – 19 – Phase Ib/II clinical trial for small cell lung cancer and a Phase I clinical trial for pancreatic cancer in China; and (6) Socazolimab combined with Pexa-vec (oncolytic virus) which is in Phase Ib clinical trial for melanoma. [https://www.leespharm.com/wp-content/uploads/2023/03/2023033000811.pdf] May 17, 2022 - Sorrento Therapeutics, Inc. announced that its license partner, China Oncology Focus Limited (“COF”), a subsidiary of Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm”), has completed the patient enrollment for a Phase III, multicenter, randomized, double blinded, placebo-controlled clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer. Nov 1, 2021: Sorrento Therapeutics, Inc. announced that its license partner, China Oncology Focus Limited (COF), an affiliate of Lee's Pharmaceutical Holdings Limited has submitted a NDA (new drug application) for the anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF for the greater China territory to treat recurrent or metastatic cervical cancer. The NDA application has been accepted by China NMPA. NCT04878016 / CTR20210969 Phase 3 in small cell lung cancer started in July 2021; July 2021: China Oncology Focus, a subsidiary of Lee’s Pharm, has enrolled the first patient in the Socazolimab double-blinded Phase 3 study in combination with chemotherapy as a first-line treatment of extensive-stage small-cell lung cancer. March 07, 2021: China Oncology Focus Limited (COF), an affiliate of Lee's Pharmaceutical Holdings Limited announced that its anti-PD-L1 antibody, Socazolimab, licensed from Sorrento to COF for the greater China territory, has been cleared to begin a Phase 3 multicenter, randomized, double blinded, parallel-group clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer. Three Phase I clinical trials of Socazolimab monotherapy have been completed: (1) recurrent or metastatic cervical cancer; (2) advanced urothelial carcinoma; and (3) high-grade osteosarcoma after adjuvant chemotherapy for maintenance purposes. For recurrent or metastatic cervical cancer, a pivotal study has been completed and breakthrough therapy designation was granted by the NMPA in February 2021. Lee’s Pharm expects to file the New Drug Application for Socazolimab in recurrent or metastatic cervical cancer in the second quarter of 2021. Apart from monotherapies, several studies of Socazolimab combining with chemotherapy are being conducted in advanced urothelial carcinoma (Phase Ib), extensive-stage small-cell lung cancer (Phase III), and neoadjuvant treatment in esophageal carcinoma (Phase Ib+II). Feb 2021: China Oncology Focus Limited (COF), an affiliate of Lee's Pharmaceutical Holdings Limited (Lee's Pharma, HKEX: 950), and Sorrento Therapeutics, Inc., announced that its anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF for the greater China territory, has been granted breakthrough therapy designation (BTD) by the China National Medical Products Administration (NMPA) to treat recurrent or metastatic cervical cancer. NCT04359550 Phase 3 study in Osteosarcoma not yet recruiting when posted on April 24, 2020. NCT04346914 Phase 1 study in small cell lung cancer started in March 2020. As of April 2019, trial readouts expected in Q4 2019 for cervical cancer, urothelial carcinoma and sarcoma studies; ZKAB001 CTA filing (1H20, anticipated, conditional filing, no date announced). NCT03676959 Phase 1 in cervical cancer started in Sep 2018. Jan. 29, 2018: Lee’s Pharm and Sorrento Therapeutics announce that the Chinese authorities have approved China Oncology Focus Limited (COF, an affiliate of Lee’s Pharmaceutical Holdings Limited, Hong Kong Stock Symbol: 0950.HK) to proceed with the clinical trials for ZKAB001, an anti-PD-L1 monoclonal antibody exclusively licensed to COF for Greater China territories, by Sorrento Therapeutics.Working on stable cell line development of human mAbs as of Oct 2013; STI-A1014 licensed to China Oncology Focus Limited, an Affiliate of Lee's Pharmaceutical Holdings Limited (Lee's Pharma) in Oct 2014 (https://www.sec.gov/Archives/edgar/data/850261/000119312514425173/d826599dex102.htm). Lee's Pharmaceutical Holdings Ltd, entered into agreement with Shenogen Pharma Group Ltd, to jointly develop and commercialize a combination product that is composed of their respective compounds, ZKAB001 (PD-L1 monoclonal antibody) and icaritin, for treatment of late stage cancers in China. The transaction enables Lee's Pharma and Shenogen Pharma to develop and commercialize ZKAB001 and icaritin.	None	2023	—	—	Socazolimab	9380 Judicial Drive San Diego, CA 92121	United States of America	North America	https://sorrentotherapeutics.com/contact/
Approved	YABS0162	04/06/2017	Belimumab	GSK1550188, HGS-1006, LSB, LymphoStat-B	Benlysta	mAb human	Naked monospecific	Full length Ab	None	BAFF	IgG1	lambda	None	None	None	None	Phage display (CAT library)	None	Approved EU, US, Japan, Australia	Active	11/15/2001	09/25/2003	12/15/2006	Systemic Lupus Erythematosus, rheumatoid arthritis, Sjögren's Syndrome, Symptomatic Waldenstroms Macroglobulinaemia, Normalization of Alloantibody Levels in Sensitized Patients Awaiting Kidney Transplantation	Immune-mediated / inflammatory disorders	GlaxoSmithKline	None	Fast track; GlaxoSmithKline acquired Human Genome Sciences in 2012.	None	2011	06/09/2010	03/09/2011	Belimumab	980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom	United Kingdom	Europe	https://www.gsk.com/en-gb/contact-us/
Approved	YABS0163	03/01/2019	Trastuzumab	None	Herceptin	mAb humanized	Naked monospecific	Full length Ab	None	HER2	IgG1	kappa	None	None	None	None	None	None	Approved EU, US, Japan, Australia	Active	04/21/1992	05/15/1994	06/15/1995	Breast, ovarian Cancer	Cancer	Genentech	Novartis, Tanox	Feb 2019: US Food and Drug Administration has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease	None	1998	05/04/1998	09/25/1998	Trastuzumab	South San Francisco, California, United States	United States of America	North America	https://www.gene.com/contact-us/visit-us
Approved	YABS0164	04/05/2022	Trinbelimab	None	Rhoclone	mAb human	Naked monospecific	Full length Ab	None	Rhesus D	IgG1	lambda	None	None	None	immunoglobulin G1-lambda3, anti-[Homo sapiens RHD (Rhesus blood group D antigen, RhD, CD240D)], Homo sapiens monoclonal antibody; Recombinant version produced in CHO (Chinese Hamster Ovary) dihydrofolate reductase (DHFR)-deficient cells; marketed product from hybridoma. In-house development of monoclonal Anti-D was initiated in 2003. Traditional method involving EBV transformation of human B- cells was employed to generate hybridomas secreting Anti-D. Several hundreds of clones were screened for biological activity and other properties before the clones were selected for clinical development. The final hybridoma clone for clinical application was selected and the cell banks were established and characterized for safety as per ICH guidelines at Charles River Laboratory, USA. The cells producing Anti-D immunoglobulin are grown in bioreactor using micro carrier beads. The antibody secreted by the cells is purified by a series of chromatographic methods followed by nano filtration to give the final purified bulk API. The purified bulk API bulk is further formulated to give the final product-Rhoclone. https://indiankanoon.org/doc/54798880/	None	None	Approved India	Active	07/01/2003	—	—	Hemolytic disease of newborn	Cardiovascular / hemostasis disorders	Bharat Serums and Vaccines (Maharashtra India)	None	Oct 2018: Bharat Serum and Vaccines completes a phase II/III trial for Haemolytic disease of newborn (Prevention) in India (IM) (CTRI/2017/03/008101). Approval in 2010 is estimated. Clinical Trials Registry of India Identifier: CTRI/2017/03/008101. Compares recominant to hybridoma produced monoclonals ( Most of these limitations were addressed by the introduction of monoclonal anti-D (Mono anti-D), manufactured using the hybridoma technique. A commercial preparation (Rhoclone®) is available in some countries, including India. The antibody genes from this hybridoma were isolated and introduced in Chinese hamster ovarian cells (CHO), thus enabling the cells to express recombinant anti-D (R-anti-D).) Obstetrics & Gynecology Science 2020;63(3):315-322. https://www.ogscience.org/journal/view.php?number=8527	None	2010	—	—	Trinbelimab	3rd Floor, Liberty Towers, Plot No. K-10, Behind Reliable Plaza, Kalwa Industrial Estate, Airoli, Navi Mumbai 400708	India	Asia	https://bsvgroup.com/contact/
Terminated	YABS0171	04/28/2024	Bavituximab	3G4	Tarvacin	mAb chimeric	Naked monospecific	Full length Ab	None	Phosphatidylserine	IgG1	TBD	None	None	None	None	None	None	Terminated at Phase 3	Inactive	06/15/2005	01/15/2008	12/29/2013	Liver Cancer, Pancreatic Cancer, breast cancer, solid tumors, Non-small-cell Lung Cancer, hepatitis C,	Cancer	OncXerna Therapeutics Inc.	Avid Bioservices Inc.	Apr 2024: No company-sponsored studies are active; OncXerna Therapeutics website not found. Mar 2023: Listed as Phase 2 asset in OncXerna Therapeutics pipeline accessed Mar 27, 2023. January 23, 2023, OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA expression-based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, announced final results from a Phase 2 trial of bavituximab plus pembrolizumab (NCT03519997) in patients with previously untreated advanced hepatocellular carcinoma and new biomarker data demonstrating that the Xerna™ TME Panel clearly identified trial participants more likely to benefit from treatment. September 18, 2020 – Oncologie, Inc., a precision medicine company using an innovative RNA-based biomarker platform to predict patient responses for potentially first-in-class targeted oncology therapies, today announced new data and analyses from its lead clinical programs, bavituximab and navicixizumab. On the basis of these positive data, the company also announced its rebranding to OncXerna Therapeutics, Inc., a change that reinforces the company’s focus on using its RNA-based approach to guide novel, targeted treatments to specific people with cancer. Study data are being presented at the European Society for Molecular Oncology (ESMO) Virtual Congress 2020 taking place September 19-21, 2020. OncXerna plans to conduct additional clinical trials designed to prospectively enrich for TME Panel-1 biomarker positive patients, as well as to explore additional solid tumor types. Oct 2019: Oncologie announced the enrollment of the first patient in its global Phase 2 study of bavituximab in combination with Merck’s (known outside of the U.S. as MSD), anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced gastric or gastroesophageal cancer. Sep 11, 2019: NCT04099641 Phase 2, Multicenter Open-label, Non-randomized Study of Bavituximab Plus Pembrolizumab in Patients With Advanced Gastric or Gastroesophageal Cancer Who Have Progressed on or After at Least One Prior Standard Therapy started. August 2019: Oncologie announced that it has entered into a clinical collaboration agreement with Merck to evaluate the combination of Oncologie’s investigational drug Bavituximab, an antibody that blocks the activity of phosphatidylserine (PS), and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced gastric or gastroesophageal cancer. Under the terms of the agreement, Oncologie will conduct a Phase II single arm open-label study to determine the efficacy and safety of Bavituximab in combination with KEYTRUDA in patients who have advanced gastric and gastroesophageal cancer, after they have failed at least one line of treatment. The study is expected to enroll approximately 80 patients in the U.S., United Kingdom, Korea and Taiwan. The study is anticipated to start enrollment in the second half of 2019.June 2019: Oncologie will initiate key clinical trials in the coming months, including a global proof of concept gastric cancer study with its lead compound, bavituximab, in combination with pembrolizumab (Keytruda). In February 2018, Avid Bioservices and Oncologie announced that the companies have entered into an Asset Assignment and Purchase Agreement for Avid’s phosphatidylserine (PS)-targeting program including bavituximab. In addition to bavituximab, the deal includes Avid’s other PS-targeting antibodies, including betabodies, as well as certain other assets and licenses useful and/or necessary for the potential commercialization of bavituximab. Feb 1, 2018: Avid BioServices (formerly Peregrine Pharmaceuticals) has discontinued all R&D activity for bavituximab. There is no intent to reinitiate such activities in the future. Rather, the company is committed to being a dedicated CDMO. Peregrine announced that it is changing its name to Avid Bioservices, Inc. as part of its transition to a dedicated contract development and manufacturing organization (CDMO). In addition to the name change, the company is also adopting the new NASDAQ ticker symbol "CDMO" (NASDAQ:CDMO). The name and ticker symbol changes will both be effective as of market open on Monday, January 8, 2018. Phase II study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins planned. March 2017: Peregrine's clinical development strategy for bavituximab currently focuses on small, early-stage, proof-of-concept trials evaluating the drug in combination with other cancer treatments. As part of this approach the National Comprehensive Cancer Network (NCCN) has awarded grants to support three different clinical trials of bavituximab treatment combinations. These trials will evaluate novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination. Sep 2016: Peregrine's clinical development strategy for bavituximab is currently focused on small, early-stage proof-of-concept trials evaluating the drug in combination with other cancer treatments. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab's combination potential that will be critical to bringing onboard a partner to help advance the program. March 2016: Phase 2/3 study in breast cancer suspended. Feb 2016: Company discontinued the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The decision to stop the trial was based on the recommendation of the study's Independent Data Monitoring Committee (IDMC) following a pre-specified interim analysis performed after 33% of targeted overall events (patient deaths) in the study were reached. Results of the analysis demonstrated that the bavituximab plus docetaxel group did not show a sufficient improvement in overall survival as compared to the docetaxel group to warrant continuation of the study. Phase 2/3 NCT02651610 in HER2-neg breast cancer started in Dec 2015. AstraZeneca will collaborate with Peregrine Pharmaceuticals in a Phase I/Ib study to evaluate the combination of AstraZeneca's durvalumab and Peregrine's bavituximab, along with chemotherapy, as a treatment for multiple solid tumors. As of July 2013, the company reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase III registration trial design of bavituximab in second-line non-small cell lung cancer (NSCLC). NCT01999673 Phase 3 SUNRISE study started in Dec 2013. Fast track designation for NSCLC indication recd in Jan 2014	None	—	—	—	None	Waltham, Massachusetts	United States of America	North America	https://www.linkedin.com/company/oncxernatherapeutics
No development reported	YABS0174	11/22/2024	None	9MW0211, MW02, TMAB001	None	mAb - source TBD	Naked monospecific	Full length Ab	None	VEGF	TBD	TBD	None	None	None	9MW0211 is an anti-VEGF antibody https://mabwell.com/en/rd.html	Rabbit B cell derived	Termination	Phase 2/3	No development reported	03/15/2011	—	05/07/2021	Macular degeneration	Ophthalmic disorders	Mabwell (Shanghai) Bioscience Co. Ltd.	Apexigen	Nov 2024: No new information found. Aug 2022: Out-licensed Programs: Apexigen’s APXiMAB™ discovery platform has enabled the discovery of multiple protein therapeutic product candidates against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. In addition to the product candidates that the company wholly owns, several product candidates discovered through the use of the APXiMAB platform are in clinical development by the company’s licensees. The most advanced of these programs is Novartis’ Beovu® (brolucizumab-dbll) product, which received FDA approval in 2019 and is marketed in over 70 countries. Two of the company’s licensees are developing other programs in later-stage development: Simcere’s BD0801 is in Phase 3 clinical development in ovarian cancer and Mabwell’s 9MW0211 is in an adaptive, pivotal Phase 2/3 clinical trial in wet age-related macular degeneration. April 8, 2022: Apexigen filing with SEC: In May 2008, Jiangsu T-Mab Biotechnology Ltd., Co. (“T-Mab”) entered into a license, co-development and contract manufacture agreement (the “T-Mab Agreement”) with Epitomics for the development and commercialization of therapeutic candidates in two therapeutic programs, each directed to a specified target for specified fields, including VEGF for the treatment of ocular diseases, in China. Epitomics assigned the T-Mab Agreement to us in connection with our spin-out from Epitomics. Mabwell (Shanghai) Bioscience Co., Ltd. (“Mabwell”) acquired T-Mab in 2015. Mabwell is responsible for conducting the development and commercialization of the therapeutic candidates in China. We may, at our discretion, develop and commercialize such therapeutic candidates outside of China, however, we must pay Mabwell a royalty on sales of such therapeutic candidates made outside of China if we do so. Under the agreement, we granted Mabwell an exclusive, royalty-bearing, perpetual license (without the right to sublicense) to our rights in certain intellectual property that we licensed from Epitomics to develop and commercialize such therapeutic candidates. Mabwell is obligated to pay us a mid-single-digit percentage royalty on net sales of such therapeutic candidates in China. If we choose to commercialize such therapeutic candidates outside of China, we would be obligated to pay Mabwell a mid-single-digit percentage royalty on net sales of such therapeutic candidates outside of China that we sell directly to end users and a mid-single-digit percentage of revenue we receive as sublicense fees, milestone payments and royalties related to the sale of such therapeutic candidate. Each party’s obligations to pay royalties to the other party continue until a mid-teen number of years after first commercial sale of licensed product in each party’s respective territory. Mabwell is currently in Phase 3 development of 9MW0211, an anti-VEGF antibody licensed under the T-Mab Agreement. (https://www.sec.gov/Archives/edgar/data/1814140/000119312522100592/d323670ds4.htm) NCT05297292 / CTR20202561 A multicenter, randomized, double-blind study evaluating the efficacy and safety of recombinant anti-VEGF humanized monoclonal antibody injection (code MW02) in the treatment of subjects with neovascular (wet) age-related macular degeneration (nAMD) , Phase II/III clinical research with seamless design of positive control started in May 2021. Start of first Phase 1 estimated; similar / same as Suvemcitug?	None	—	—	—	None	BLDG 3, No 576, Libing Rd, Pudong New District, Shanghai, PRC	China	Asia	https://www.mabwell.com/en/about.html?ab=l#mwView
Clinical	YABS0178	01/09/2025	Bulumtatug fuvedotin	9MW2821	None	mAb humanized	ADC	Full length Ab conjugate	None	Nectin-4	IgG1	kappa	Valine-Citrulline (Cleavable linker) + Idconnect	4 (Site-specific)	Tubulin inhibitor, Monomethyl auristatin E (MMAE)	9MW2821 created based on interchain-disulfide drug conjugate technology. This novel drug contained a site-specifically conjugated humanized antibody and the cytotoxic moiety monomethyl auristatin E. Linker IDconnectTM is designed to form site-specific disulfide bonds by cross-linking the reduced cysteines in the Fab and hinge regions of an antibody, thereby rendering a highly homogeneous drug-to-antibody ratio of 4. doi.org/10.1158/1535-7163.MCT-22-0743 This drug candidate has achieved site-specific modification based on the ADC conjugate technology jointly developed by Mabwell and Shanghai Institute of Materia Medica. immunoglobulin G1-kappa, anti-[Homo sapiens NECTIN4 (nectin-4, nectin cell adhesion molecule 4, PVRL4, poliovirus receptor-related 4, PPR4, LNIR)], conjugated on an average of 8 cysteinyl residues to monomethylauristatin E (MMAE), with a ratio of 1 to 4, via a cleavable divalent linker;	None	None	Phase 3	Active	01/01/2022	—	04/15/2024	Cervical Cancer, Triple-Negative Breast Cancer, Urothelial Carcinoma, Solid tumors	Cancer	Mabwell (Shanghai) Bioscience Co. Ltd.	None	January 9, 2025 I Mabwell announced 9MW2821 was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. NCT06692166 Phase 3 in cervical cancer started in Nov 2024. NCT06592326 Phase 3 in UC started in Aug 2024. Aug 2024: Mabwell announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. July 2024: Mabwell (Shanghai) Bioscience Co., Ltd. announced that its self-developed novel Nectin-4-targeting antibody-drug conjugate (ADC: R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic Nectin-4 positive triple negative breast cancer. May 7, 2024: The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. 9MW2821) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), for the treatment of esophageal cancer. https://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-to-9mw2821-302137498.html Feb 2024: 9MW2821 has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. NCT06196736 / CTR20234024 is a Phase 3 study in patients with unresectable locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy and a PD-(L)1 inhibitor due to start in Dec 2023. December 11, 2023 I Mabwell announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration for the "A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Trial of 9MW2821 versus Investigator's Choice of Chemotherapy for Treating Unresectable Locally Advanced or Metastatic Urothelial Carcinoma in Patients Previously Treated with Platinum-Containing Chemotherapy and PD-(L)1 Inhibitors" has been approved. The company will now officially initiate the Phase III clinical study of 9MW2821 for treating locally advanced or metastatic urothelial carcinoma in patients previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors. NCT06079112 Phase 1/2 in Urothelial Carcinoma due to start in Oct 2023. NCT05773937 Phase 1 started in June 2022. NCT05216965 Phase 1/2 study started in June 2022. Jan 2022: The Center for Drug Evaluation (CDE) of China National Medical Products Administration has approved the investigational new drug application (IND) for 9MW2821, an anti-Nectin-4 ADC drug candidate, being developed by Shanghai Mabwell. A phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary effectiveness in patients with advanced solid tumors started earlier this month.	None	—	—	—	None	BLDG 3, No 576, Libing Rd, Pudong New District, Shanghai, PRC	China	Asia	https://www.mabwell.com/en/about.html?ab=l#mwView
Clinical	YABS0185	11/17/2024	Domvanalimab	AB154	None	mAb humanized	Naked monospecific	Full length Ab	None	TIGIT	IgG1	kappa	None	None	None	Immune checkpoint target. AB154 is a fully humanized, Fc silent antibody that blocks human TIGIT with sub-nanomolar affinity, as determined using a CHO.hTIGIT over-expressing cell line and primary human T-cells. https://cancerimmunolres.aacrjournals.org/content/7/2_Supplement/A124	None	None	Phase 3	Active	08/07/2018	01/13/2020	02/01/2021	Head and neck carcinoma, Gastrointestinal Tract Malignancies, Melanoma, Non-small Cell Lung Cancer, Advanced malignancies	Cancer	Arcus Biosciences Inc.	Gilead Sciences, Taiho Pharma	NCT06727565 Phase 2 in head & neck cancer due to start in Dec 2024. NCT05211895 Phase 3 study still recruiting as of last update in Oct 2024. Phase 3 studies for Gastrointestinal tract adenocarcinoma (NCT05568095); Non-small cell lung cancer (NCT05211895, NCT05502237, NCT04736173) are recruiting as of April-May 2023. NCT05568095 Phase 3 in GI cancer due to start in Oct 2022 Aug 2022 presentation: ARC-7 topline data (2H), presentation (2023); no mention of submission timeline Taiho Pharma has Option rights exercised for majority of Arcus’s clinical-stage portfolio— domvanalimab, zimberelimab, etrumadenant, and AB308 NCT04736173 is a Phase 3 Study to Evaluate Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined With AB154 in Front-Line, PD-L1-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer October 29, 2020 I Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced a collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to evaluate domvanalimab (AB154), Arcus’s investigational anti-TIGIT antibody, in combination with Imfinzi (durvalumab) in a registrational Phase 3 clinical trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC). A Registrational Trial for Domvanalimab plus Imfinzi is Expected to Begin in 2021 Feb 2020: Arcus Biosciences, Inc. and Taiho Pharmaceutical Co. Ltd. announced Taiho’s exercise of its option to exclusively license zimberelimab, an anti-PD-1 monoclonal antibody, from Arcus Biosciences for commercialization in Japan and certain other territories in Asia (excluding China). NCT04262856 is a Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer started in Jan 2020. NCT03628677 Phase 1 started in Aug 2018 still recruiting as of Aug 2019. In September 2016, Arcus Biosciences, Inc raised an additional USD 70 million in equity capital from Taiho Ventures, GV, Invus, DROIA Oncology Ventures and Stanford University, together with its Series A investors, including The Column Group, Foresite Capital, Novartis and Celgene. This funding allows Arcus to continue its rapid drug development activities for the small molecule and antibody immuno-oncology approaches with the goal of building its own internal combinations. IND filing planned for mid-2018.	None	—	—	—	None	California, United States	United States of America	North America	https://arcusbio.com/
Clinical	YABS0191	02/01/2024	Livmoniplimab	ABBV-151, ARGX-115, PR-1762844	None	mAb chimeric/humanized	Naked monospecific	Full length Ab	None	GARP/TGF beta complex	IgG4	kappa	None	None	None	Immune checkpoint target. ABBV-151 is a monoclonal antibody (mAb) that binds to the GARP-TGFβ1 complex and blocks TGFβ1 release. Glycoprotein A repetitions predominant (GARP), also known as Leucine-rich repeat containing 32 (LRRC32). Hinge-stabilized	Camelid-derived; SIMPLE Antibody	None	Phase 2/3	Active	02/21/2019	—	01/15/2024	NSCLC, Hepatocellular Carcinoma, Solid tumors	Cancer	argenx	Eli Lilly and Company	NCT06236438 Phase 2/3 in NSCLC to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab started in April 2024. NCT06109272 Phase 2/3 in Hepatocellular Carcinoma in combination with budigalimab started in January 2024. NCT05822752 Phase 2 in hepatocellular carcinoma started in Aug 2023. NCT03821935 Phase 1 study started in Feb 2019 recruiting as of last update in Dec 2022. August 2018: argenx announced the exercise by AbbVie of its exclusive license option to develop and commercialize ARGX-115, an antibody targeting the novel immuno-oncology target glycoprotein A repetitions predominant (GARP). April 2017: arGen-X recd. $10 million for preclinical milestone AbbVie Inc. acquired an exclusive option from argenx N.V. to license ARGX-115, a preclinical mAb against leucine-rich repeat containing 32 (LRRC32; GARP), to treat cancer. argenx will be responsible for R&D through IND-enabling studies, after which AbbVie may exercise the option. Licensed from de Duve Institute/Uni Catholique de Louvain; discovery using SIMPLE Antibody platform. GARP is a check-point inhibitor	None	—	—	—	None	1101 EB Amsterdam, Netherlands	Netherlands	Europe	https://www.argenx.com/contact-us
Clinical	YABS0193	05/29/2024	Budigalimab	ABBV-181	None	mAb humanized	Naked monospecific	Full length Ab	None	PD-1	IgG1	kappa	None	None	None	Immune checkpoint target. ABBV-181 is a humanized, recombinant, IgG1 monoclonal antibody targeting programmed cell death 1 (PD-1). L234A L235A mutations reduce effector functions https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6220479/. ABBV-1882 is a combination of ABBV-181 (anti-PD1) and ABBV-382 (anti-a4b7 mAb)	None	None	Phase 2/3	Active	12/15/2016	05/15/2021	01/15/2024	NSCLC, Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, Hepatocellular Carcinoma, Head and neck cancer, Solid tumors, ovarian cancer, colorectal cancer, HIV	Cancer	AbbVie	None	NCT06236438 Phase 2/3 in NSCLC to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab started in April 2024. NCT06109272 Phase 2/3 in Hepatocellular Carcinoma in combination with budigalimab started in January 2024. NCT06032546 Phase 2 in HIV due to start in Oct 2023. NCT05822752 Phase 2 in hepatocellular carcinoma started in Aug 2023. NCT04807972 Phase 1/2 in pancreatic cancer started in May 2021 active not recruiting as of last update in Aug 2023. NCT04799353 Phase 1 in HIV started in March 2021. NCT04223804 Phase 1 in HIV started in Jan 2020 completed in Feb 2023. NCT03893955 Phase 1 study started in May 2019 recruiting as of Aug 2019; NCT03818542 in Head and Neck cancer started in Jan 2020 terminated in Sep 2020 for strategic considerations April 2019: AbbVie terminates a phase I studies in colorectal and ovarian cancers in USA due to strategic considerations (NCT03035279 and NCT03138408). Five Phase 1 studies recruiting as of July 2018.	None	—	—	—	None	North Chicago, Illinois, United States	United States of America	North America	https://www.abbvie.com/