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
Terminated	YABS2569	05/06/2022	None	TY027	None	mAb - source TBD	TBD	TBD	TBD	SARS-CoV-2 (spike protein)	TBD	TBD	None	None	None	Tychan developed TY027 through extensive and rapid research, including the use of advanced proprietary computational platform technology, and leveraged prior experience in the successful development of therapeutics for Zika and Yellow Fever. TY027, made on 25 February 2020 was identified as the most promising amongst several mAbs that demonstrated 100% neutralisation against live SARS-CoV-2 viruses in the lab. It has also successfully completed safety studies in animals and other regulatory requirements including a 3-week drug stability test. These were all completed in less than four months before this first-in-human infusion.	None	None	Terminated at Phase 3	Inactive	06/09/2020	—	12/04/2021	COVID-19	Infectious diseases	Tychan Pte. Ltd.	None	NCT04649515 Phase 3 of TY027 for Early Treatment of COVID-19 started in Dec 2020 was Terminated (Low recruitment rate) as of March 2022. NCT04429529 Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind, Single Ascending Dose Study of TY027 in Healthy Adult Volunteers started on June 9, 2020. June 10, 2020. Singapore's Tychan, a biotechnology firm backed by state investor Temasek Holdings, said it will begin human clinical trials next week for a potential monoclonal antibody treatment for COVID-19. The first phase of the trial to be conducted on 23 healthy volunteers will take about six weeks to evaluate the safety and tolerability of TY027 - a monoclonal antibody that specifically targets SARS-CoV-2, the virus that causes COVID-19. TY027 is being explored for the treatment of patients with COVID-19 to slow the progression of the disease and accelerate recovery, as well as for its potential to provide temporary protection against infection with SARS-CoV-2.	None	—	—	—	None	Singapore	Singapore	Asia	https://sg.linkedin.com/company/tychanltd
Terminated	YABS2572	09/12/2024	Zilovertamab	UC-961	None	mAb humanized	Naked monospecific	Full length Ab	None	ROR1	IgG1	kappa	None	None	None	Cirmtuzumab is a humanized IgG1 monoclonal antibody designed and developed to bind with high affinity to a biologically important epitope on the extracellular domain of Receptor-tyrosine kinase-like Orphan Receptor 1 (ROR1). http://www.oncternal.com/Pipeline/Cirmtuzumab Zilovertamab formerly named Cirmtuzumab	None	None	Terminated at Phase 3	Inactive	08/15/2014	08/06/2020	01/15/2022	Urothelial Carcinoma, Diffuse large B cell lymphoma, Mantle cell lymphoma, Chronic Lymphocytic Leukemia	Cancer	Oncternal Therapeutics	None	Sep 2024: Octernal will discontinue all product development activities and will take other steps to reduce costs, including a reduction in its workforce to preserve cash resources; the company intend to explore strategic options with the hope of advancing and realizing value from their pipeline including ONCT-534, ONCT-808, zilovertamab and ONCT-216. Press release: In April 2023 we announced a strategic reprioritization based on the rapidly changing commercial landscape for Bruton’s tyrosine kinase inhibitors (BTK inhibitors), under which Phase 3 study ZILO-301 and Phase 1/2 study CIRM-001* of zilovertamab in combination with ibrutinib will be closed, in order to extend the company’s cash runway into 2025 and focus efforts upon the clinical development of ONCT-808 and ONCT-534. The decision was not based on any concerns about the safety or efficacy of zilovertamab. We plan to continue exploring the potential value of zilovertamab in areas of high unmet medical need. The robust response rates and prolonged PFS seen for MCL and CLL patients expressing TP53 aberrations will be further investigated preclinically and extended into other tumor types, such as lung cancer and prostate cancer. We expect partnerships and collaborations to be essential for executing future late-stage clinical trials of zilovertamab." https://www.oncternal.com/pipeline/zilovertamab/ NCT05431179 Phase 3 study due to start in Sep 2022. Sep 28, 2022: Oncternal Therapeutics, Inc. announced the initiation of its Phase 3 global registrational study of zilovertamab, ZILO-301 (NCT05431179), for the treatment of patients with relapsed/refractory mantle cell lymphoma NCT05139017 Phase 2/3 in DLBCL started in January 2022. Jan 2022: The company is planning a Phase 3 superiority clinical trial ZILO-301 entitled, “Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of Zilovertamab (A ROR1 Antibody) Plus Ibrutinib Versus Ibrutinib Plus Placebo in Patients with Relapsed or Refractory Mantle Cell Lymphoma.” Michael Wang MD, Endowed Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, will serve as the U.S. Principal Investigator and Chairman of the steering committee for this study. The study will randomize patients with relapsed or refractory MCL who have experienced stable disease or a partial response after receiving four months of oral ibrutinib therapy to receive either blinded zilovertamab or placebo, and all patients will continue receiving oral ibrutinib. The primary endpoint, intended to support submission of a Biologics License Application (BLA) seeking regular FDA approval, will be progression-free survival (PFS). an 2022: NCT04501939 Phase 2 study of Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax (Venetoclax) not yet recruiting when first posted on Aug 6, 2020. In June 2019, the company presented data at the American Society of Clinical Oncology (ASCO) annual meeting, reporting that results from the first 12 patients with CLL treated in Part 1 of the Phase I portion of the study showed an observed interim objective response rate (ORR) of 91.7% for the combination of cirmtuzumab plus ibrutinib, including three patients with clinical or confirmed complete responses, and a well-tolerated safety profile consistent with that seen for ibrutinib treatment alone. June 2020: The FDA has granted an Orphan Drug designation to the ROR1 antibody cirmtuzumab (UC-961) for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). June 2019: Oncternal Therapeutics announced that the reverse merger with GTx closed on June 7, 2019. The combined company will operate under the name Oncternal Therapeutics and its shares will commence trading on the Nasdaq stock exchange on June 10, 2019. NCT02776917 Phase 1 study in breast cancer recruiting as of Aug 15, 2018; Oncternal is listed as collaborator. Phase 1/2 NCT03088878 and NCT03420183 studies in lymphoid malignancies recruiting as of Sep 2018. Phase I Trial: Cirmtuzumab Inhibits ROR1 Signaling and Stemness Signatures in Patients with Chronic Lymphocytic Leukemia (Cell Stem Cell. 2018 Jun 1;22(6):951-959.e3. doi: 10.1016/j.stem.2018.05.018). April 12, 2016 – Oncternal Therapeutics, Inc, a new oncology-focused biotechnology company, today announced that it has received an exclusive worldwide license to develop and commercialize antibodies and antibody-related binding agents recognizing Receptor-tyrosine kinase-like orphan receptor 1 (ROR1) from University of California San Diego. The licensing agreement also encompasses rights for all therapeutic indications to cirmtuzumab, an anti-ROR1 monoclonal antibody that is currently in a clinical trial for patients with chronic lymphocytic leukemia (CLL), as well as rights to develop antibody-drug conjugates (ADCs), genetically modified effector immune cells, such as chimeric antigen receptor T-cells (CAR-T), and bispecific antibodies	None	—	—	—	None	12230 El Camino Real, Suite 230, San Diego, CA 92130	United States of America	North America	https://www.oncternal.com/contact/
Terminated	YABS2578	07/12/2023	Oportuzumab monatox	VB4-845	Vysyneum™, Vicineum	mAb humanized	Immunoconjugate, Immunotoxin	Fragment-Fc fusion	TBD	EpCAM	None	TBD	None	None	Pseudomonas exotoxin A	Humanized single-chain antibody fragment specific for the epithelial cell adhesion molecule (EpCAM) antigen linked to ETA(252-608) Pseudomonas exotoxin. ETA252-608 is a truncated form lacking cell-binding domain	None	None	Terminated at regulatory review	Inactive	05/15/2003	12/15/2005	08/15/2015	Bladder cancer, head and neck cancer	Cancer	Sesen Bio	Qilu Pharmaceutical Co. Ltd.	July 2023: No evidence of further development. Sep 2022: Sesen Bio, Inc. and Carisma Therapeutics announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on the advancement of Carisma’s proprietary cell therapy platform that utilizes engineered macrophages and monocytes to potentially transform the treatment of cancer and other serious disorders. Jul. 18, 2022-- Sesen Bio announced that it has made the strategic decision to voluntarily pause further development in the US of its lead asset, Vicineum. The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase 3 clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC), following recent discussions with the US Food & Drug Administration (FDA). This decision enables Sesen Bio to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value. Additionally, the Company intends to seek a partner for the further development of Vicineum. On August 20, 2021, Sesen Bio, Inc. (the “Company”) withdrew its marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”) for Vysyneum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”). https://ir.sesenbio.com/static-files/4b10acb3-3750-4995-b9ce-48a820549f0b On August 13, 2021, Sesen Bio announced that it received a Complete Response Letter from the FDA) regarding the BLA for Vicineum™ (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The FDA provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality. Feb 2021: Sesen Bio announced that the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and granted the application Priority Review. In addition, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum. PDUFA date for a decision on the BLA is August 18, 2021. On July 30, 2020, Sesen Bio, Inc. (the “Sesen”) and Viventia Bio, Inc., a wholly-owned subsidiary of Sesen (“Viventia” and collectively with Sesen, the “Company”) entered into an Exclusive License Agreement (the “License Agreement”) with Qilu Pharmaceutical Co., Ltd. (“Qilu”), pursuant to which the Company granted Qilu an exclusive, sublicensable, royalty-bearing license, under certain intellectual property owned or exclusively licensed by the Company, to develop, manufacture and commercialize the Company’s product candidate VB4-845, also known as Vicineum™ (the “Licensed Product”), for the treatment of non-muscle invasive bladder cancer and other types of cancer (the “Field”) in China, Hong Kong, Macau and Taiwan (the “Territory”). The Company also granted Qilu a non-exclusive, sublicensable, royalty-bearing sublicense, under certain other intellectual property licensed by the Company to develop, manufacture and commercialize the Licensed Product in the Territory. The Company retains development, manufacturing and commercialization rights with respect to Vicineum in the rest of the world. On June 17, 2020, the U.S. Food and Drug Administration (FDA) informed Sesen Bio that the FDA has conditionally accepted the proprietary brand name Vicineum for the Company’s product candidate, oportuzumab monatox. Dec 6, 2019: Rolling BLA for BCG-unresponsive non-muscle invasive bladder cancer started. May 2019: announced that the Company has completed its Type C CMC meeting and has reached agreement with the U.S. Food and Drug Administration on the Analytical Comparability Plan, and that, subject to final comparability data to be provided in the BLA submission, no additional clinical trials to establish comparability are deemed necessary at this time. Aug. 9, 2018-- Sesen Bio, Inc., a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Vicinium™ for the treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium, Sesen Bio’s lead product candidate, is currently being evaluated in a Phase 3 registration trial, the VISTA Trial, for the treatment of patients with high-grade NMIBC who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Sesen Bio was formally Eleven Biotherapeutics; Eleven Therapeutics acquired Viventia Bio in Sep 2016. Phase 3 NCT02449239 study in bladder cancer still recruiting as of Oct 2017. Vicinium contains the active pharmaceutical ingredient VB4-845, which is produced in Escherichia coli (E. coli) expressing a humanized single-chain antibody fragment specific for the epithelial cell adhesion molecule (EpCAM) antigen linked to ETA(252-608) Pseudomonas exotoxin. Once bound to the EpCAM antigen on the surface of carcinoma cells, Vicinium is internalized through an endocytic pathway. The ETA(252-608) is cleaved off and induces cell death by irreversibly blocking protein synthesis. Orphan desginations in EU and US.	None	—	—	—	None	245 First Street Suite 1800 Cambridge, MA 02142 United States	United States of America	North America	https://pitchbook.com/profiles/company/52624-72#overview
Terminated	YABS2594	07/28/2024	Upinitatug rilsodotin, Upifitamab rilsodotin	XMT-1536	None	mAb humanized	ADC	Full length Ab conjugate	None	NaPi2b	IgG1	kappa	Dolaflexin polymer scaffold	10 to 15 drugs per mAb	Tubulin inhibitor, Auristatin F-hydroxypropylamide	XMT-1536 is a highly potent immunoconjugate targeting the sodium-dependent phosphate transport protein (NaPi2b) and is comprised of an average of 10-15 DolaLockTM payload molecules conjugated to XMT-1535, a proprietary humanized anti-NaPi2b antibody, via the Dolaflexin ADC platform. NaPi2b is an antigen highly expressed in the majority of non-squamous NSCLC and epithelial ovarian cancer. https://www.gog.org/wp-content/uploads/2021/04/04-ADC-Napi2b-as-the-Target-Presentation.pdf	None	None	Terminated at Phase 3	Inactive	12/12/2017	—	06/23/2022	Ovarian cancer, Cancers Likely to Express NaPi2b	Cancer	Mersana Therapeutics Inc.	None	July 2023: UPLIFT trial did not meet endpoint. Mersana’s restructuring plan includes a wind-down of UpRi-related development activities, including its UP-NEXT and UPGRADE-A clinical trials and the company’s regulatory and commercial readiness efforts. If analyses of data enable the identification of a path forward for UpRi, the company will consider strategic alternatives for the asset, including partnering. June 15, 2023: Mersana Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a partial clinical hold pausing new patient enrollment in UP-NEXT and UPGRADE-A, the company’s ongoing clinical trials of UpRi in platinum-sensitive ovarian cancer. Mersana’s recent assessment determined that serious bleeding events appear to occur at a higher rate than background. While most bleeding cases in this aggregate safety analysis were low-grade, five (<1%) Grade 5 (fatal) bleeding events were observed among the approximately 560 patients dosed to date. The causes of bleeding events remain under investigation. Dec 2022: European Commission (EC) has designated upifitamab rilsodotin (UpRi) as an orphan medicinal product for the treatment of ovarian cancer. NCT05329545 UP-NEXT, a Phase 3 trial of UpRi monotherapy maintenance in platinum-sensitive recurrent ovarian cancer with a design informed by FDA and CHMP feedback, due to start May 26, 2022. NCT04907968 Phase 1/2 in ovarian cancer started in April 2021. Jan 2021: “2021 promises to be another transformative year for Mersana’s pipeline. Our focus will be to initiate the UPLIFT single-arm registration strategy for XMT-1536 in platinum-resistant ovarian cancer and to initiate the UPGRADE combination umbrella study with the goal of informing the path into earlier lines of ovarian cancer therapy. Aug 2020: The FDA granted fast track designation to XMT-1536 for the treatment of women with high-grade serous ovarian cancer, according to a press release from the agent’s manufacturer. Phase 1 study still recruiting as of Aug 2019. Sep 2018: Mersana and the FDA reached alignment on changes to XMT-1522's study protocol, including increased monitoring as well as the exclusion of patients with advanced hepatic impairment. Although XMT-1536, Mersana’s Dolaflexin ADC targeting NaPi2b, was not subject to a clinical hold, Mersana has decided to implement similar modifications to the XMT-1536 protocol. Alternative dosing regimens will be evaluated for both clinical trials. NCT03319628 and NCT06517433 are both First-in-Human Studies of XMT-1536 in Cancers Likely to Express NaPi2b started in Dec 2017. XMT-1536 uses Mersana’s proprietary Dolaflexin platform to generate an ADC with a drug to antibody ratio (DAR) of 12-15.	None	—	—	—	None	840 Memorial Drive, Cambridge, MA 02139	United States of America	North America	https://www.mersana.com/contact/
Terminated	YABS2605	11/01/2022	Cosfroviximab, larcaviximab, porgaviximab	Zmapp	ZMapp	mAb chimeric	Mixture of 3	Full length Ab	None	Ebola virus glycoprotein	IgG1	kappa	None	None	None	Mixture of 3 antibodies (https://pubmed.ncbi.nlm.nih.gov/27279622/)	None	None	Terminated at Phase 2/3	Inactive	02/15/2015	—	11/20/2018	Ebola infection	Infectious diseases	Mapp Biopharmaceutical	None	Terminated; company is continuing development of MBP134, which is a 2-antibody combination with pan-ebola efficacy in non-clinical studies. June 2021: No recent development reported. Considering 2 mAb products (REGN-EB3 or mAb114) are aleady approved for Ebola, and both of these had better clinical study results, it is not clear if the company will pursue further development. Aug 2019: Pamoja Tulinde Maisha (PALM [together save lives]) study announced early termination of the four-arm study and changes in treatment for patients with Ebola. The preliminary results in 499 study participants indicated that those individuals receiving REGN-EB3 or mAb114 had a greater chance of survival compared to those participants in the other two arms. The PALM study is a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114 and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on November 20, 2018 in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces. As of August 9, 2019, the trial had enrolled 681 patients toward an enrollment goal of 725. NCT03719586 Phase 2/3 study started in Nov 2018; listed as Phase 2 when first posted in Oct 2018. Nov 2018: An international research team has begun patient enrollment in a clinical trial testing multiple investigational Ebola therapies in the Democratic Republic of the Congo (DRC). The randomized, controlled trial is enrolling patients of any age with confirmed Ebola virus disease (EVD) at a treatment unit in the city of Beni The trial aims to compare mortality among patients who receive one of three investigational Ebola drugs with a control group of patients who receive the investigational monoclonal antibody cocktail treatment ZMapp, developed by Mapp Biopharmaceutical, Inc. The therapies being tested include: mAb114, a single monoclonal antibody developed by NIAID, with early support from the INRB; and remdesivir (also known as GS-5734), an antiviral drug developed by Gilead Sciences, Inc. The trial has been approved to begin enrolling patients in these three groups, and plans are underway to amend the trial to include REGN-EB3 (also known as REGN3470-3471-3479), a monoclonal antibody cocktail developed by Regeneron Pharmaceuticals, Inc. Sep 29, 2017: Mapp Biopharmaceutical, Inc., announced today that it has been awarded a Project BioShield contract (HHSO100201700017C) of approximately $46 million by The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to advance ZMappTM to licensure by the Food and Drug Administration. IND filed with FDA for clinical studies to be started in Liberia. August 8, 2016: Mapp Biopharmaceutical, Inc. (Mapp Bio) announced it has received funding from Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to offer an expanded access protocol (EAP) for ZMapp™ to the four countries that participated in the PREVAIL II trial. An expanded access protocol is a U.S. regulatory mechanism for making an unlicensed drug available for the treatment of a serious or life-threatening disease for which no approved therapeutic is available. The PREVAIL II trial – sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted in Liberia, Sierra Leone, Guinea and the United States – evaluated the efficacy of ZMapp™ in treating Ebola Virus Disease (EVD). While the trial did not ultimately enroll enough patients to produce definitive results, the drug was well-tolerated and showed promise in improving survival of patients with EVD	None	—	—	—	None	4921 Directors Pl #100, San Diego, CA 92121, USA	United States of America	North America	https://mappbio.com/contact-us/
Terminated	YABS2606	04/05/2022	Abagovomab	None	None	mAb murine	Vaccine, Anti-idiotype antibody	Full length Ab	None	MUC16 idiotype	IgG1	kappa	None	None	None	Abagovomab is an anti-idiotypic monoclonal antibody that mimics a specific epitope on the tumour-associated antigen, CA125. Cancer vaccine mechanism of action	None	None	Terminated at Phase 2/3	Inactive	12/15/2002	—	12/15/2006	Ovarian cancer	Cancer	Menarini Group	Memorial Sloan Kettering Cancer Center	Menarini terminates the phase III MIMOSA trial in Ovarian cancer in USA and European Union (NCT00418574, started in Dec 2006). NCT00058435 Phase 1 started in Dec 2002; non-commercial sponsor.	None	—	—	—	None	Florence, Italy	Italy	Europe	https://www.menarini.com/en-us/about-us
Regulatory review	YABS2611	11/25/2024	Belantamab mafodotin	GSK2857916, J6M0-mcMMAF	BLENREP	mAb humanized	ADC	Full length Ab conjugate	None	BCMA	IgG1	kappa	mc, Non-cleavable linker	4	Tubulin inhibitor, Monomethyl auristatin F (MMAF)	Afucosylated; ave. 4 drugs/Ab, non-cleavable mc linker. The drug linker technology is licensed from Seattle Genetics; the antibody is produced using POTELLIGENT Technology licensed from BioWa.	None	None	Regulatory review EU, US, Japan, China, UK	Active	07/15/2014	—	06/18/2018	Multiple myeloma	Cancer	GlaxoSmithKline	None	Nov 2024: The US Food and Drug Administration (FDA) has accepted a biologics license application (BLA) for Blenrep in combination with Takeda’s Velcade (bortezomib) plus the steroid dexamethasone, as well as Bristol Myers Squibb’s Pomalyst (pomalidomide) plus dexamethasone. The application seeks approval for the treatment of multiple myeloma patients who have received at least one prior line of therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of 23 July 2025. Blenrep was originally approved by the FDA in August 2020 as a monotherapy for relapsed or refractory multiple myeloma. However, the drug was later withdrawn from the market after failing to demonstrate superiority over the combination of Pomalyst plus dexamethasone in a Phase III confirmatory study. The European Medicines Agency (EMA) followed suit by not renewing the conditional marketing authorisation for Blenrep in 2023. The current US application is based on results from the DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) Phase III trials. Both trials met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the Blenrep combinations compared to standard-of-care triplet combinations. Both studies also showed clinically meaningful improvements across all other secondary efficacy endpoints. The safety and tolerability profiles of the Blenrep combinations were consistent with the known profiles of the individual agents. Sep 2024: GSK plc announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has accepted for review a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma. MHLW also has granted orphan drug designation for Blenrep, which reflects the high unmet medical need and ensures priority NDA review in multiple myeloma. This is the third major regulatory filing acceptance for belantamab mafodotin combinations in the treatment of relapsed/refractory multiple myeloma, following marketing authorisation application acceptance by the European Medicines Agency (EMA) in July 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK earlier this month. July 19, 2024: GSK plc announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will begin the formal review process to make a recommendation to the European Commission regarding this potential authorisation. Sep 2023: CHMP recommended not renewing the conditional marketing authorisation BlenRep (belantamab mafodotin) Nov 2022: GSK plc announced it has initiated the process for withdrawal of the US marketing authorisation for Blenrep (belantamab mafodotin-blmf) following the request of the US Food and Drug Administration (FDA). This request was based on the previously announced outcome of the DREAMM-3phase III confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations. On Aug 26, 2020, GlaxoSmithKline plc announced the European Commission has granted conditional marketing authorisation for BLENREP (belantamab mafodotin) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. BLENREP is a first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose disease has progressed despite the current standard of care. On August 5, 2020, the Food and Drug Administration granted accelerated approval to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. FDA granted orphan drug designation, breakthrough therapy designation, and priority review to belantamab mafodotin-blmf for this indication. GlaxoSmithKline announced the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the company’s Biologics License Application (BLA) for belantamab mafodotin for the potential treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The ODAC will meet virtually on July 14, 2020. Priority review granted. Dec 16, 2019: Submission of BLA announced. NCT04091126 Phase 1 in MM started in Dec 2019. August 23, 2019: GlaxoSmithKline plc announced positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916). Data from the DREAMM-2 study will be the basis for regulatory filings starting later this year. DREAMM-3 Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GSK’916 Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma planned. March 2019: Updated results from GlaxoSmithKline's Phase I clinical trial evaluating its candidate GSK2857916 for multiple myeloma showed a 60% overall response rate and a 15% complete response rate during the 12-month follow-up period, as reported in Blood Cancer Journal. NCT03848845 Phase 2 study started recruiting in March 2019. NCT03828292 Phase 1 study in Japanese Subjects With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments not yet recruiting as of Feb 5 2019. NCT03525678 Phase 2 (DREAMM 2) study in multiple myeloma started June 18 2018. Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for GSK2857916 monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent; PRIME designation for treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. Orphan designations in US and EU for multiple myeloma. NCT02064387 Phase 1 study recruiting patients as of June 10, 2015. mAb also known as J6M0-mcMMAF utilizes Seattle Genetics technology; humanized afucosylated mAb, uncleavable linker. Listed as Phase 1/2 in GSK press release dated July 26 2017 (https://www.gsk.com/media/3866/press-release-gsk-delivers-further-progress-in-q2-and-sets-out-new-priorities-for-the-group-26-july-2017.pdf).	None	2020	12/05/2019	08/05/2020	Belantamab mafodotin, belantamab mafodotin-blmf	980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom	United Kingdom	Europe	https://www.gsk.com/en-gb/contact-us/
Clinical	YABS2644	03/29/2024	None	KN057	None	mAb - source TBD	TBD	TBD	None	Tissue factor pathway inhibitor	TBD	TBD	None	None	None	KN057 is a monoclonal antibody independently developed by Suzhou Alphamab with independent intellectual property rights. By specifically targeting TFPI , it neutralizes the inhibitory effect of TFPI on FXa and TF/FVIIa complexes, maintains thrombin levels, and prevents bleeding.	None	None	Phase 3	Active	12/21/2019	07/15/2022	01/09/2024	Hemophilia	Cardiovascular / hemostasis disorders	Suzhou Alphamab Biotechnology Co. Ltd	Sichuan Yuanda Shuyang Pharmaceutical Co. Ltd.	NCT06569108 Phase 3 study started in April 2024. March 2024: US ophan drug designation for treatment of hemophilia A (https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=994023) NCT06312475 Phase 3 study started in January 2024 January 9, 2024, the "Evaluation of KN057 Injection in Hemophilia A and Hemophilia B Patients with Inhibitors" sponsored by Suzhou Alphamab Biotechnology Co., Ltd. (hereinafter referred to as "Suzhou Alphamab") "A Randomized, Open Study on the Efficacy and Safety of Injection Prophylaxis (KN057-A-301)" and "Evaluating the Effectiveness of KN057 Injection Prophylaxis in Patients with Hemophilia A and Hemophilia B Without Inhibitors Randomized, open-label study of safety and safety (KN057-A-302), two phase III clinical studies were officially launched at the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences), the leader unit of this study. September 20, 2023: Suzhou Alphamab Biotechnology Co., Ltd. and Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yuanda Life Sciences Group Co., Ltd. jointly announced that the two parties have signed a cooperation agreement for the Greater China rights license of the tissue factor pathway inhibitor ( TFPI ) monoclonal antibody KN057 independently developed by Suzhou Alphamab. NCT05421429 Phase 2 started in July 2022. CXSL1900141 host date is Dec 21, 2019.	None	—	—	—	None	175 Fangzhou Road, SIP, Suzhou, China · Zip code : 215127	China	Asia	https://www.alphamabonc.com/en/contact/contactus/index.html
Clinical	YABS2854	09/26/2024	Verenafusp alfa	GNR-055	None	mAb chimeric	Immunoconjugate	Fragment fusion	None	Insulin receptor	None	kappa	None	None	IDS	chimeric immunoglobulin G1-kappa antigen-binding fragment (Fab) anti-[human insulin receptor (INSR)] fused at the C-terminus of the heavy chain via peptide linker 221LSS223 to human iduronate-2- sulfatase fragment, glycoform alfa;	None	None	Phase 2/3	Active	01/15/2020	—	11/30/2021	Mucopolysaccharidosis Type II	Metabolic disorders	AO GENERIUM	None	NCT05208281 Phase 2/3 started in Nov 2021 NCT04539340 Phase 1 started in Feb 2020	None	—	—	—	None	123112 Moscow, Testovskaya str., 10, entrance 2	Russia	Europe	https://www.generium.ru/en/contacts/
Clinical	YABS2905	11/26/2024	Vecantoxatug	GR2001	None	mAb - source TBD	TBD	TBD	None	Tetanus toxin	TBD	TBD	None	None	None	Listed as mAbs in company pipeline (http://www.genrixbio.com/#/science?classId=class3)	None	None	Phase 3	Active	08/27/2022	03/15/2023	09/03/2024	Tetanus prophylaxis	Infectious diseases	Genrix (Shanghai) Biopharmaceutical Co., Ltd.	None	Breakthrough Therapy designation in China. NCT06635798 CTR20243076 Phase 3 started in Sep 2024. NCT06302374 Phase 1/2 started in Mar 2023. CXSL2200485 has event date of Sep 27, 2022.	None	—	—	—	None	Shanghai, China	China	Asia	https://synapse.patsnap.com/organization/575cf201cc223eac2f65ac65cddb2931