A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).

Start Date17 Mar 2021

Sponsor / Collaborator

Bristol Myers Squibb Co.

JPRN-jRCT2080223369

Phase 1

A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer

Start Date01 Jan 2017

Sponsor / Collaborator

Bristol-Myers Squibb KK

NCT02949895

/ CompletedPhase 1

A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer

A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer

Start Date29 Nov 2016

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Atigotatug

100 Translational Medicine associated with Atigotatug

100 Patents (Medical) associated with Atigotatug

Literatures (Medical) associated with Atigotatug

01 Mar 2026·Clinical Lung Cancer

TIGOS Trial: A Randomized, Double-Blind, Phase III Trial of Atigotatug and Nivolumab Fixed-Dose Combination With Chemotherapy Versus Atezolizumab With Chemotherapy as First-Line Therapy in Patients With Extensive-Stage Small Cell Lung Cancer

Article

Author: Zhou, Caicun ; Paz-Ares, Luis G ; Hayashi, Hidetoshi ; Girard, Nicolas ; Pisupati, Radhika ; Pacius, Misena ; Reck, Martin ; O'Byrne, Kenneth John ; Gharpure, Vishwanath Suresh ; Johnson, Melissa L ; Ready, Neal E

INTRODUCTION:

Extensive-stage small cell lung cancer (ES-SCLC) is an aggressive malignancy with limited treatment options and poor outcomes. Despite the addition of antiprogrammed death ligand 1 inhibitors to platinum-etoposide chemotherapy, median overall survival (OS) remains < 1 year.

PATIENTS AND METHODS:

TIGOS (CA245-0001; NCT06646276) is an ongoing randomized, double-blind, multicenter phase III study evaluating a fixed-dose combination (FDC) of atigotatug and nivolumab (BMS-986489) plus carboplatin-etoposide chemotherapy compared with atezolizumab plus carboplatin-etoposide chemotherapy as first-line treatment for patients with ES-SCLC. Atigotatug is a monoclonal antibody acting as a tumor-targeted innate immune inducer that binds fucosyl-monosialoganglioside-1, which is expressed on ≤ 90% of SCLC tumor cells and minimally in normal tissues. Nivolumab, an antiprogrammed death-1 antibody, restores T-cell activity and promotes adaptive antitumor immunity. Together, these agents act through distinct but complementary immune mechanisms to enhance tumor cell killing. Approximately 530 adults (age ≥ 18 years) with histologically or cytologically confirmed ES-SCLC, ≥ 1 measurable extracranial lesion per RECIST v1.1, and an Eastern Cooperative Oncology Group performance status of 0-1 will be randomized 1:1 to receive either atigotatug and nivolumab FDC or atezolizumab in combination with carboplatin plus etoposide until progression, toxicity, or withdrawal. The primary endpoint is OS. The key secondary endpoint (statistically analyzed) is time to definitive deterioration; other secondary endpoints include progression-free survival, objective response, duration of response, and safety.

CONCLUSION:

Recruitment is ongoing at 182 sites across 26 countries with an estimated primary completion date of April 2028, with study completion in September 2031.

01 Nov 2022·JTO clinical and research reports

BMS-986012, an Anti–Fucosyl-GM1 Monoclonal Antibody as Monotherapy or in Combination With Nivolumab in Relapsed/Refractory SCLC: Results From a First-in-Human Phase 1/2 Study

Article

Author: Lathers, Deanne ; Surmont, Veerle ; Sanghavi, Kinjal ; Lin, Hongxia ; He, Chunsheng ; Liu, Yu ; Andelkovic, Vladimir ; Kollia, Georgia ; Rudin, Charles M ; Sanatani, Michael ; Snow, Stephanie ; Kim, Dong-Wan ; Basciano, Paul ; Rivera, Mirelis Acosta ; Urbanska, Katarzyna ; Clarke, Stephen ; Ready, Neal ; Tannenbaum-Dvir, Sarah ; Juergens, Rosalyn A ; Sibille, Anne ; van Herpen, Carla ; Markman, Ben ; DiPiero, Andrew ; Chu, Quincy ; Leighl, Natasha B

Introduction:

Fucosyl-GM1 is a monosialoganglioside with limited expression in healthy tissues and high expression on SCLC cells. BMS-986012 is a nonfucosylated, first-in-class, fully human immunoglobulin G1 monoclonal antibody that binds to fucosyl-GM1.

Methods:

CA001-030 is a phase 1/2, first-in-human study of BMS-986012 as monotherapy or in combination with nivolumab for adults with relapsed or refractory SCLC. Safety is the primary end point. Additional end points include objective response rate, duration of response, progression-free survival, pharmacokinetics, and overall survival.

Results:

Patients (BMS-986012 monotherapy, n = 77; BMS-986012 + nivolumab, n = 29) were predominantly of male sex (58%), 63 years old (mean), current or past tobacco users (97%), and treated previously with first-line systemic therapy (99%). The most common treatment-related adverse event was pruritus (n = 95 [90%]). Grade 4 treatment-related adverse events were reported in 2% (n = 2) of patients. The objective response rate (95% confidence interval [CI]) was higher with BMS-986012 plus nivolumab (38% [20.7%-57.7%]) than with monotherapy (4% [0.8%-11.0%]). Median (95% CI) duration of response with BMS-986012 plus nivolumab was 26.4 (4.4-not reached) months. Progression-free survival (95% CI) at 24 weeks with monotherapy and BMS-986012 plus nivolumab was 12.2% (6.0%-20.7%) and 39.3% (21.7%-56.5%), respectively. The pharmacokinetics profile of monotherapy and BMS-986012 plus nivolumab suggested dose proportionality across the tested dose range. Median overall survival (95% CI) with monotherapy and BMS-986012 plus nivolumab was 5.4 (4.0-7.3) and 18.7 (8.2-37.3) months, respectively.

Conclusions:

BMS-986012 in combination with nivolumab represents a well-tolerated, potential new therapy for relapsed or refractory SCLC. BMS-986012 is currently being explored in combination with carboplatin, etoposide, and nivolumab as a first-line therapy in extensive-stage SCLC (NCT04702880).

15 Oct 2018·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

A Novel, Fully Human Anti–fucosyl-GM1 Antibody Demonstrates Potent In Vitro and In Vivo Antitumor Activity in Preclinical Models of Small Cell Lung Cancer

Q1 · MEDICINE

Article

Author: Chen, Bing ; Cristea, Sandra ; Cardarelli, Pina M. ; Menezes, Daniel ; Oyasu, Miho ; Rangan, Vangipuram S. ; Sun, Huadong ; Pan, Chin ; LeBlanc, Heidi ; Deshpande, Shrikant ; Sage, Julien ; Strachan, Debbie ; Park, Kwon-Sik ; Wang, Xi-Tao ; Ponath, Paul

Abstract:

Purpose: The ganglioside fucosyl-GM1 (FucGM1) is a tumor-associated antigen expressed in a large percentage of human small cell lung cancer (SCLC) tumors, but absent in most normal adult tissues, making it a promising target in immuno-oncology. This study was undertaken to evaluate the preclinical efficacy of BMS-986012, a novel, nonfucosylated, fully human IgG1 antibody that binds specifically to FucGM1.Experimental Design: The antitumor activity of BMS-986012 was evaluated in in vitro assays using SCLC cells and in mouse xenograft and syngeneic tumor models, with and without chemotherapeutic agents and checkpoint inhibitors.Results: BMS-986012 showed a high binding affinity for FcγRIIIa (CD16), which resulted in enhanced antibody-dependent cellular cytotoxicity (ADCC) against FucGM1-expressing tumor cell lines. BMS-986012–mediated tumor cell killing was also observed in complement-dependent cytotoxicity (CDC) and antibody-dependent cellular phagocytosis (ADCP) assays. In several mouse SCLC models, BMS-986012 demonstrated efficacy and was well tolerated. In the DMS79 xenograft model, tumor regression was achieved with BMS-986012 doses of 0.3 mg/kg and greater; antitumor activity was enhanced when BMS-986012 was combined with standard-of-care cisplatin or etoposide. In a syngeneic model, tumors derived from a genetically engineered model of SCLC were treated with BMS-986012 or anti-FucGM1 with a mouse IgG2a Fc and their responses evaluated; when BMS-986012 was combined with anti–PD-1 or anti-CD137 antibody, therapeutic responses significantly improved.Conclusions: Single-agent BMS-986012 demonstrated robust antitumor activity, with the addition of chemotherapeutic or immunomodulatory agents further inhibiting SCLC growth in the same models. These preclinical data supported evaluation of BMS-986012 in a phase I clinical trial of patients with relapsed, refractory SCLC. Clin Cancer Res; 24(20); 5178–89. ©2018 AACR.

News (Medical) associated with Atigotatug

28 May 2026

·www.prnewswire.com

Florida Cancer Specialists & Research Institute Advances the Future of Cancer Care

32 Abstracts and Presentations Showcase Cutting-Edge Research at the 2026 ASCO® Annual Meeting 2026 ASCO® Annual Meeting abstracts featuring FCS research: 1073, 1094, 1530, 2629, 3013, 3078, 3088, 3146, 4213, 5511, 5565, 5580, 6062, 7023, 7029, 7532, 7565, 9564, e13044, e16400, TPS11202, TPS2668, TPS2680, TPS3155, TPS3160, TPS3167, TPS3179, TPS5139, TPS5628, TPS5647, TPS8134, TPS8136 FORT MYERS, Fla., May 28, 2026 /PRNewswire/ -- Findings from 32 abstracts and presentations conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) are among the groundbreaking scientific advances in cancer care that will be featured as oncology professionals from around the world gather this week at the 2026 American Society of Clinical Oncology (ASCO®) Annual Meeting in Chicago. Continue Reading Florida Cancer Specialists & Research Institute (FCS) will present findings from 32 abstracts and presentations at the 2026 ASCO® Annual Meeting, showcasing innovative clinical trials, targeted therapies and precision oncology research led by FCS physicians and researchers across Florida. Thirteen physicians and leaders from the statewide practice will present the outcomes of early and late-phase clinical trials performed at FCS Phase 1 Drug Development Units and clinics throughout Florida. Research conducted at FCS is made possible through valuable relationships with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, Paradigm Health, an AI-enabled clinical trial matching and recruitment platform, and other independent clinical trial programs. FCS Assistant Managing Physician, David Wenk, MD, said, "Our extensive research program is a defining strength of FCS and a vital part of our mission to provide patients with convenient access to world-class cancer care close to home." "The research being presented highlights both innovative treatment strategies and cutting-edge targeted therapies," said FCS Director of Drug Development Manish R. Patel, MD. "Through our ongoing clinical research efforts, we are generating new scientific insights that are advancing precision oncology for patients with a wide range of cancers, including rare and advanced disease." The following FCS principal investigators are first authors on ten abstracts that will be presented throughout the meeting: Lucio Gordan, MD, FCS president & managing physician, Ashley Hernandez, Amanda Warner and Christian Okitondo Patient characteristics, treatment patterns, social determinants of health, and safety in patients prescribed nivolumab and hyaluronidase-nvhy by early adopters. Lowell Hart, MD (Retired) (RW) post-progression outcomes after first-line (1L) treatment with ribociclib + an aromatase inhibitor (AI) vs AI alone in US patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC). Maen Hussein, MD, FCS director of value-based care and Kristin Boykin, FCS senior director, pharmacy operations Evaluating the impact of a statewide intervention on multiple myeloma bispecific T-cell engaging antibody (BsAb) therapy uptake in Florida (FL). Management of chemotherapy-induced adverse events in patients with metastatic pancreatic ductal adenocarcinoma: A US-based modified Delphi consensus. Bradley Monk, MD, FACOG, FACS A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors: DESTINY-PanTumor04. Efficacy prediction for progression-free survival (PFS) and overall survival (OS) by genomic instability score (GIS) cutoffs in patients (pts) with advanced ovarian cancer (aOC): Post hoc results from the phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial. Manish R. Patel, MD A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as monotherapy and in combination for patients with advanced solid tumors, including hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) breast cancer (BC) and cyclin E1 (CCNE1)–amplified solid tumors: Updated safety and efficacy results. A phase 1, first-in-human study of DS9051, a novel targeted protein degradation molecule, in patients with advanced/metastatic adrenocortical carcinoma (ACC) or metastatic castration-resistant prostate cancer (mCRPC). Judy Wang, MD, FCS associate director of drug development, Sarasota Drug Development Unit A first-in-human study of ATX-295, an oral inhibitor of KIF18A, in patients with advanced or metastatic solid tumors, including ovarian cancer. Judy Wang, MD and Cesar Augusto Perez, MD, FCS director of drug development, SCRI at Lake Nona Drug Development Unit Phase 1 dose escalation of CTX-8371, a novel PD-1×PD-L1 bispecific antibody, in patients with advanced malignancies post checkpoint inhibition. The following FCS principal investigators have co-authored 22 additional abstracts and publications of research results and other clinical findings featured throughout the annual meeting: Lucio N. Gordan, MD Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma (LBCL).* Lowell Hart, MD (Retired) (RW) post-progression outcomes following first-line (1L) ribociclib (RIB) + aromatase inhibitor (AI) versus AI alone in African American and low socio-economic status (SES) patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC) in US. Maen Hussein, MD, FCS medical director, value-based care TIGOS-LS, an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in limited-stage small-cell lung cancer. Bradley Monk, MD TroFuse-036/GOG-3123/ENGOT-cx22: A 2-part, phase 3, randomized study of sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) ± bevacizumab (bev) vs standard of care (SoC) as first-line maintenance therapy for PD-L1–positive cervical cancer. Overall survival for patients with pre-treated platinum-resistant ovarian cancer receiving gotistobart in combination with pembrolizumab. Puxitatug samrotecan (AZD8205) vs chemotherapy in patients with B7‑H4–selected advanced/metastatic endometrial cancer: The phase 3 randomized Bluestar‑Endometrial01 (BE01)/GOG-3110/ENGOT-EN28 trial. Manish R. Patel, MD A phase 1, first-in-human study of OP-3136, a novel oral selective KAT6A/B inhibitor, as monotherapy in advanced solid tumors and in combination with endocrine therapy in ER+, HER2− advanced breast cancer (ABC): Preliminary results. A randomized, open-label, phase 3 study of ZL-1310, a DLL3 antibody-drug conjugate (ADC), compared to investigator's choice therapy in participants with relapsed small cell lung cancer (DLLEVATE). BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumors. Farnesyl transferase inhibitor (FTI) darlifarnib (KO-2806) in combination with adagrasib in KRAS G12C mutated (mut) advanced solid tumors: Preliminary results from the FIT-001 phase 1 first-in-human trial. A phase 3 randomized, open-label study of pasritamig (JNJ-78278343), a T-cell engager targeting human kallikrein-2, with docetaxel versus docetaxel for metastatic castration-resistant prostate cancer. Intismeran autogene to induce de novo neoantigen-specific T cells as adjuvant therapy in melanoma. Shachar Peles, MD, FCS director of cell therapy Fixed-duration subcutaneous (SC) mosunetuzumab (Mosun) in elderly/unfit patients with previously untreated diffuse large B-cell lymphoma (DLBCL): Interim analysis and patient-reported outcomes (PROs) from the phase 2 MorningSun study Ivor Percent, MD Post-hoc efficacy and biomarker analysis of elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone in metastatic pancreatic ductal adenocarcinoma. Cesar Augusto Perez, MD First-in-human study of BG-C9074 (B7-H4–targeting ADC) in advanced solid tumors: Dose escalation and safety expansion. BMS-986504 in patients (pts) with advanced solid tumors with homozygous MTAP deletion (MTAP-del): Exploratory pharmacodynamic (PD) and biomarker analyses from CA240-0007. A phase 1/2, first-in-human, open-label, dose-escalation and -expansion study of TAK-188, a novel antibody-drug conjugate (ADC) targeting CCR8+ regulatory T cells, in adult patients with locally advanced or metastatic solid tumors. A phase 1/2 study of the next-generation nectin-4–targeting antibody-drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma. Phase I, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug conjugate (ADC) in patients with advanced solid tumors. First-in-human phase 1a/1b study of LB-LR1109, an anti-LILRB1 monoclonal antibody, as monotherapy in advanced solid tumors and in combination with atezolizumab in advanced NSCLC. Judy Wang, MD A phase 1, first-in-human study of DS5361, a small-molecule, nonsense-mediated mRNA decay (NMD) inhibitor in patients with advanced/metastatic solid tumors (parts 1 and 2). Syed Zafar, MD Durable clinical benefit with B-cell maturation antigen (BCMA)–directed therapy, belantamab mafodotin plus pomalidomide and dexamethasone (BPd) in relapsed/refractory multiple myeloma (RRMM): DREAMM‑8 long‑term responder (LTR) analysis. FCS Chief Executive Officer Ryan Ciarrocchi said, "The ASCO® Annual Meeting highlights the most significant cancer research from around the world, and FCS is proud to once again be recognized among the leaders helping to shape the future of cancer care." All abstracts and presentations are available to view at ASCO® 2026 Annual Meeting. The American Society of Clinical Oncology (ASCO®) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO® works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care. About Florida Cancer Specialists & Research Institute, LLC: ( FLCancer.com ) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. Through its robust clinical research program with Sarah Cannon Research Institute (SCRI) and a suite of independent site management programs, with advanced clinical trial matching technology, FCS offers patients innovative therapies close to home. Each year, FCS conducts more than 180 active clinical trials that directly elevate patient care and accelerate progress in oncology. Many of the cancer drugs approved by the FDA in the U.S over the past decade were accessible to patients at FCS through clinical trial participation before receiving approval. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. SOURCE Florida Cancer Specialists & Research Institute 21% more press release views with Request a Demo

Phase 1ASCOPhase 3Clinical ResultCell Therapy

06 Oct 2025

·www.globenewswire.com

Exicure Highlights Recent Achievements and Near-term Strategic Priorities

Burixafor (GPC-100) Phase 2 Trial in Multiple Myeloma Nears Key Readout Preparing for Expansion into Sickle Cell Disease and Acute Myeloid Leukemia New Leadership Appointments Bring Deep Drug Development Expertise REDWOOD CITY, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Exicure, Inc. (Nasdaq: XCUR), a clinical-stage biotechnology company developing therapeutics for hematologic diseases, today shared recent progress for its lead program, burixafor (GPC-100), outlined upcoming strategic priorities, and introduced new members of its leadership team who will help drive the company’s next phase of growth. “The progress we’ve achieved since integrating GPCR Therapeutics earlier this year reflects both the strength and potential of the burixafor program and the dedication of our team,” said Andy Yoo, Chief Executive Officer of Exicure. “As we look ahead to our upcoming Phase 2 data readout and plan for expansion into new indications, I am energized by the opportunity to advance a program that could transform treatment approaches across multiple diseases.” Burixafor Phase 2 Trial in Multiple Myeloma Nears Key Clinical Readout Exicure’s ongoing Phase 2 study (NCT05561751) is a randomized, open-label, multicenter trial evaluating burixafor, a small molecule CXCR4 antagonist, in autologous stem cell transplant (ASCT) for multiple myeloma. By blocking CXCR4, burixafor is designed to mobilize hematopoietic stem cells out of the bone marrow and into the bloodstream, where they can be collected for use in transplant procedures. Interim results to date have been highly encouraging, with 100% of patients (10/10) achieving the primary endpoint of successful CD34+ stem cell mobilization, including patients previously treated with daratumumab. Burixafor has a faster kinetics of mobilization with a well-tolerated safety profile, enabling same-day administration of the mobilizing agent and leukapheresis. This differentiates burixafor from FDA-approved agents such as plerixafor and motixafortide, which require overnight pre-treatment. In August, the company announced that the final patient had completed their last study visit. The clinical database has since been locked, and Exicure remains on track to report topline data in Q4 2025. Preparations are also underway for a potential Phase 3 trial. A full data publication from the ongoing Phase 2 trial (NCT05561751) is anticipated in 2026. In addition, a publication from a previous Phase 2 study (NCT02104427) evaluating burixafor in combination with G-CSF in patients with multiple myeloma, non-Hodgkin lymphoma, and Hodgkin disease, is currently under peer review. Expanding Development Opportunities Building on progress in multiple myeloma, Exicure is preparing to expand burixafor into additional indications: Sickle Cell Disease: Exicure is in discussions with key clinicians at leading institutions to initiate an investigator-sponsored trial evaluating burixafor for improving stem cell mobilization in patients undergoing gene editing and autologous transplant.Acute Myeloid Leukemia (AML): The company is also planning a Phase 1 chemosensitization study in AML. Preclinical data suggest that burixafor may mobilize tumor cells from protective bone marrow niches, potentially enhancing the efficacy of chemotherapy. New Leadership Strengthen Scientific and Clinical Capabilities Following its acquisition of GPCR Therapeutics USA earlier this year, Exicure has been advancing the Phase 2 trial with dedicated internal drug development experts. These scientific leaders bring broad experience spanning from basic research to regulatory approval and have decades of proven track records in developing innovative medicines. Josephine (Pina) Cardarelli, Ph.D. joined as President and Chief Scientific Officer. Dr. Cardarelli is a seasoned drug development executive whose career spans oncology, immunology, pharmacology, and translational medicine. She most recently served as Vice President of Cell Biology & Pharmacology at Bristol-Myers Squibb, where she played a key role in the approvals of Yervoy® and Opdivo® and Fucosyl GM-1 antibody program that is currently in Phase 3. Earlier in her career at Medarex, she advanced multiple programs into clinical development, including CXCR4 (Ulocuplumab), CXCL10, CD30, and CD19 antibodies and multiple ADCs. She also identified the lead antibody for the IFNα receptor program that ultimately became AstraZeneca’s FDA-approved Saphnelo™. With more than 100 global patents and over 50 peer-reviewed publications, Dr. Cardarelli brings extensive expertise in biologics, antibody-drug conjugates, IND strategy, and regulatory affairs. She received her Ph.D. in physiology from Albany Medical College. Niña Caculitan, Ph.D. has been appointed Head of Clinical, overseeing activities spanning manufacturing, regulatory affairs, clinical development, clinical operations and data analysis. She brings over 15 years of experience from both academia and industry, with a strong background in antibody and small molecule chemistry for therapeutics in oncology and immune-mediated disorders. Previously, she was a key contributor to understanding cellular mechanisms of antibody drug conjugate processing at Genentech. Dr. Caculitan earned her Ph.D. in chemistry from the University of California, Berkeley. Devki Sukhtankar, Ph.D. has joined as Head of Preclinical Research and Translational Medicine, guiding cross-functional translational research efforts with a focus on integrating clinical data and advancing the pipeline into new indications. She brings over 15 years of experience in oncology, neurology and inflammatory diseases, where she has led preclinical programs with a focus on pharmacology and contributed to 20 peer-reviewed publications. Dr. Sukhtankar earned her Ph.D. in cancer biology from the University of Arizona and has extensive experience collaborating with partner organizations to expand therapeutic opportunities. About Burixafor (GPC-100)Burixafor (GPC-100) is a highly selective small molecule antagonist of CXCR4, a chemokine receptor that plays a central role in retaining hematopoietic stem cells in the bone marrow niche. By blocking CXCR4, burixafor may enhance the mobilization of these cells into the peripheral blood for collection and use in autologous stem cell transplant (ASCT) procedures. Originally developed by GPCR Therapeutics, Inc., burixafor became part of Exicure’s pipeline following the company’s acquisition in January 2025. In addition to multiple myeloma, burixafor is also being considered in other diseases where improved stem cell mobilization could help enable more efficient and effective treatment approaches, such as sickle cell disease, rare diseases requiring autologous transplant, and cell and gene therapy settings. A chemosensitization trial in AML is also being planned, leveraging burixafor’s mechanism of mobilizing malignant cells from protective bone marrow niches into the peripheral blood, where they may be more effectively targeted by chemotherapy. About Exicure Exicure, Inc. (Nasdaq: XCUR) is a clinical-stage biotechnology company developing therapies to address key challenges in hematologic diseases. The company’s lead program, burixafor (GPC-100), is being evaluated for its ability to improve stem cell mobilization in multiple myeloma, sickle cell disease, and in support of cell and gene therapy. It is also being studied as a potential chemosensitizing agent in acute myeloid leukemia (AML). For more information, visit www.exicuretx.com. Contact:Exicure, Inc.847.673.1700 (Tel)847.556.6411 (Fax)

Phase 2Phase 1Phase 3AcquisitionImmunotherapy

100 Deals associated with Atigotatug

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KEGG	Wiki	ATC	Drug Bank
D13072	-	-	DB14831

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	Phase 2	United States	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Japan	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Australia	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Belgium	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Canada	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Greece	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Italy	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Netherlands	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Poland	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Romania	Bristol Myers Squibb Co.	17 Mar 2021

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04702880 (CA001-030, CTgov)	Phase 2	Extensive stage Small Cell Lung Cancer	135	Nivolumab+Etoposide+Carboplatin+BMS-986012 (Arm A)	flicqpybzs = ozjqpidzvc euyadjfazj (tpoazxhzrp, xxukljtjcw - wcfoedyore) View more	-	17 Jun 2026
				Nivolumab+Etoposide+Carboplatin (Arm B)	flicqpybzs = guorfxnugd euyadjfazj (tpoazxhzrp, poyuzegonw - ejgnmbypjf) View more
NCT04702880 (ESMO2024)	Phase 2	Extensive stage Small Cell Lung Cancer First line Fuc-GM1	-	Arm A (BMS-986012)	etfjtwicyy(ujrhirtwuo) = aeolyzwllj gbytskkhak (ldzsqhuxaz, 78) View more	Negative	14 Sep 2024
				Arm B (Control)	hzznewafib(gejibxigyr) = rgqauuytjl ujbhmwiqlb (avjjezkpro )
NCT04702880 (ESMO2024)	Phase 2	Extensive stage Small Cell Lung Cancer First line fuc-GM1	132	BMS-986012 + CE/NIVO	beukzzwfmr(kyqyrklmnw) = dtmnrajldt ifnxczusrr (avdfcauhrm, 5.0 - 7.9) View more	Positive	13 Sep 2024
				CE/NIVO	beukzzwfmr(kyqyrklmnw) = lgkjoumguj ifnxczusrr (avdfcauhrm, 4.8 - 6.6) View more
Corporate Publications Manual	Not Applicable	Small Cell Lung Cancer	133	BMS-986012 + nivolumab + chemotherapy	bjgtwvhoon(ixpirftunc) = vwkmtjjryn bigfxdeqgg (dilqffpqaf, 12.5 - NA) View more	Positive	01 Sep 2024
				Nivolumab + chemotherapy	bjgtwvhoon(ixpirftunc) = eacrjyazdk bigfxdeqgg (dilqffpqaf, 9.3 - 16.6) View more
NCT04702880 (Pubmed) Manual	Phase 1/2	Small Cell Lung Cancer	106	Nivolumab+BMS 986012	mtfvmoumeo(imgqybnkfh) = cfsogjsuos xmazteawgw (vekloxgamq, 21.7 - 56.5) View more	Positive	27 Aug 2022
				BMS 986012	mtfvmoumeo(imgqybnkfh) = puvrpozlmv xmazteawgw (vekloxgamq, 6.0 - 20.7) View more
NCT02247349 (WCLC2021 \| WCLC2021) Manual	Phase 1/2	Small Cell Lung Cancer	29	BMS-986012+nivolumab	lcdqpdbpaq(uqriexcjzb) = pruritus 93%;fatigue 28%;dry skin 28% ;hypothyroidism 17% sjcmmpnwbm (hygsvxtvhn ) View more	Positive	28 Jan 2021

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