This is an open-label study of andecaliximab in participants at risk of developing bone where bone should not be, such as in muscle, tendons, and other soft tissues following traumatic spinal cord injury. The goal of this study is to assess the safety of andecaliximab, how much drug is in the body over time (pharmacokinetics/PK), and how it affects the body (pharmacodynamics/PD) in participants who have had a recent traumatic spinal cord injury.

Start Date14 May 2025

Sponsor / Collaborator

ashibio, Inc.

NCT06508021

/ Active, not recruitingPhase 2/3

A Phase 2/3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study With Open-Label Extension (OLE) to Assess the Efficacy and Safety of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)

This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva (FOP). The study will evaluate how safe and effective andecaliximab is in patients with FOP.
The study is looking at several research questions, including:
* Safety of andecaliximab in participants with FOP
* Whether andecaliximab reduces the number of new heterotopic bone lesions (Heterotopic Ossification; HO)
* Whether andecaliximab reduces the number or severity of flare-ups
* Pharmacokinetics/pharmacodynamics (PK/PD): How much study drug is in your blood at different times and its impact on blood biomarker(s)
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Start Date25 Oct 2024

Sponsor / Collaborator

ashibio, Inc.

NCT02862574

/ TerminatedPhase 2

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid Arthritis

The primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745) versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and methotrexate in adults with moderate to severe rheumatoid arthritis (RA).

Start Date15 Dec 2016

Sponsor / Collaborator

Gilead Sciences, Inc.

100 Clinical Results associated with Andecaliximab

100 Translational Medicine associated with Andecaliximab

100 Patents (Medical) associated with Andecaliximab

Literatures (Medical) associated with Andecaliximab

01 Sep 2025·PHARMACOTHERAPY

Biological Therapy and Small Molecules for Adults With Crohn's Disease: Systematic Review and Network Meta‐Analysis

Review

Author: Gorski, Daniela ; Pontarolo, Roberto ; Tonin, Fernanda Stumpf ; Lazo, Raul Edison Luna ; de Souza, Dalton de Assis ; Borba, Helena Hiemisch Lobo

ABSTRACT:

First‐line therapeutic approaches for Crohn's disease include immunosuppressants, aminosalicylates, and corticosteroids. However, more than one‐third of patients are resistant to these treatments and require second‐line therapies. Our goal was to synthesize the evidence on the efficacy and safety of biologics and small molecules for inducing remission in patients with moderate‐to‐severe Crohn's disease. A systematic review was conducted by searching for randomized controlled trials on the target population in PubMed, Scopus, and Web of Science (March 2025). Data synthesis for the outcomes of remission, health‐related quality of life (HRQoL), and safety was performed using network meta‐analyses and surface under the cumulative rating curve (SUCRA) analyses. The results were presented as risk ratios with 95% credible intervals. We included 55 trials ( n = 16,113 patients) evaluating 26 biological drugs across 83 doses and six small molecules across 15 doses. Similar results were obtained in the sensitivity analyses conducted across different measurement time points. Alongside infliximab 5 mg/kg (SUCRA 98.6%), 10 mg/kg (92%), and 20 mg/kg intravenous (91.8%), the recently approved drugs guselkumab 1200 mg (83.2%), 600 mg (89.2%), and 200 mg intravenous (90.1%), as well as mirikizumab 600 mg (91.5%) and 1000 mg intravenous (82.4%) presented higher probabilities of disease remission and were associated with increased HRQoL. Drugs such as certolizumab, andecaliximab, fontolizumab, abatacept, and etanercept ranked low for remission (SUCRA < 40%) and presented high probabilities of serious adverse events (over 60%). Small molecules presented an intermediate profile. Inhibitors of interleukin‐23 appear to be promising alternatives for the treatment of moderate‐to‐severe Crohn's disease. Given their safety profile, some anti‐TNF drugs should be avoided in practice. Trial Registration: PROSPERO: CRD42024519150

04 Jun 2025·Journal of Crohns & Colitis

Metabolism and response to stress gene signatures reveal ulcerative colitis heterogeneity and identify patients with increased response to therapy

Article

Author: Linggi, Bryan ; Vande Casteele, Niels ; Ma, Christopher ; Sangiorgi, Bruno ; Jairath, Vipul ; Smith, Michelle I ; Teft, Wendy ; Filice, Melissa

Abstract:

Background and Aims:

Ulcerative colitis (UC) therapies lead to variable remission and response rates in patients participating in clinical trials, likely due to interindividual target variability, differences in active biological pathways, feedback, and/or resistance mechanisms. Here, we stratified patients into subtypes by characterizing heterogeneity using mucosal biopsy transcriptomics data.

Methods:

Transcriptomics data from an andecaliximab phase 2/3 study in patients with UC were scored for gene signature enrichment. Eleven Reactome gene sets, moderately correlated with histological disease activity using Robarts Histopathology Index with low correlation to each other, were selected and evaluated in baseline gene expression data of ustekinumab, infliximab, and adalimumab clinical trials in patients with UC.

Results:

Of 11 gene sets, referred to as “Metabolism and Response to Stress” (MARS) signatures, 5 correlated with “non-disease” mucosa and 6 with “disease-related” mucosa. Clustering baseline andecaliximab samples scored with MARS revealed 3 clusters with low non-disease/high disease-related, high non-disease/low disease-related, or a mixture. Importantly, these clusters did not correlate with patient demographics, clinical characteristics, or disease activity metrics. Clustering baseline data from other clinical trials (anti-interleukin-12/23 and anti-tumor necrosis factor) in patients with UC scored with MARS showed that patients in low non-disease/high disease-related baseline score clusters less likely to achieve treatment response.

Conclusions:

We identified and evaluated a novel, multi-dimensional signature gene set to characterize previously undefined heterogeneity in patients with UC and identify patients less likely to respond to therapy. This approach offers potential utility to define clinical trial populations, enrich for clinical responders, and identify difficult-to-treat populations for therapeutic development.

01 Jan 2024·International journal of medical sciences

Text Mining and Drug Discovery Analysis: A Comprehensive Approach to Investigate Diabetes-Induced Osteoporosis

Article

Author: Hu, Yihe ; Liang, Feng ; Wang, Chenfeng

Purpose: Osteoporosis (OP) and diabetes are prevalent diseases in orthopedic and endocrinology departments, with OP potentially arising as a complication of diabetes. However, the mechanism underlying diabetes-induced osteoporosis (DOP) remains enigmatic, and drug discovery in this domain is restricted, hindering research into the DOP's etiology and treatment. With the ultimate goal of preventing OP in diabetic patients, the objective of this study is to mine the genes and pathways linked to DOP using bioinformatics and databases. Method: The present study employed text mining as the initial approach to retrieve genes commonly associated with diabetes and OP. Subsequently, functional annotation was conducted to investigate the roles and functionalities. In order to explore the interactions between proteins relevant to DOP, we constructed protein-protein interaction (PPI) networks. Furthermore, to obtain key genes and candidate drugs for DOP treatment, we conducted drug-gene interaction (DGI) analysis, complemented by a thorough examination of transcriptional factors (TFs)-miRNA co-regulation. Results: The results through text mining revealed 110 genes that are commonly associated with both diabetes and OP. Subsequent enrichment analysis narrowed down the list to 95 symbols that were involved in PPI analysis. After DGI analysis, we identified 7 genes targeted by 11 drugs, which represent candidates for treating DOP. Conclusion: This study unveils ANDECALIXIMAB, SILTUXIMAB, OLOKIZUMAB, SECUKINUMAB, and IXEKIZUMAB as promising potential drugs for DOP treatment, demonstrating the significance of utilizing text mining and pathway analysis to investigate disease mechanisms and explore existing therapeutic options.

News (Medical) associated with Andecaliximab

20 Aug 2025

·pipelinereview.com

āshibio Expands Clinical Pipeline with Vantictumab, a First-In-Class Antibody for Autosomal Dominant Osteopetrosis Type 2

– Company’s second clinical-stage asset licensed from Mereo Biopharma based on novel insights generated in a mouse model of osteopetrosis – – āshibio has exclusive license to develop and commercialize vantictumab globally, excluding Europe, where Mereo retains commercial rights – – Vantictumab development program is supported by safety and biomarker data generated in previous clinical trials – BURLINGAME, CA, USA I August 19, 2025 I āshibio , a privately held, clinical-stage biotechnology company developing novel therapeutics for the treatment of bone and connective tissue disorders, today announced an exclusive licensing agreement with Mereo BioPharma (NASDAQ: MREO) for vantictumab for the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare, debilitating bone disorder with no approved therapies. The licensing of vantictumab represents a strategic expansion of āshibio’s pipeline of clinical-stage assets that address high unmet needs and carry significant clinical and commercial potential. ADO2, also known as Albers-Schönberg disease, is a genetic disorder caused by reduced function of osteoclasts. Impaired osteoclast function results in dense, brittle bone and leads to complications such as multiple fractures, poor bone healing, low blood counts (due to bone marrow sequestration), and painful nerve compression. The most common form of osteopetrosis, ADO2 results from a mutation in the chloride channel 7 (CLCN7) gene and has a reported incidence of 1 in 20,000 births. 1 “People living with autosomal dominant osteopetrosis type 2 face a lifetime of bone-related complications resulting in significant morbidity, multiple surgical procedures, chronic pain, and impaired quality of life – yet patients have no approved therapy to address the disease,” said āshibio Chief Executive Officer Pankaj Bhargava, MD. “Bringing vantictumab into our pipeline reflects our commitment to advancing therapies for rare skeletal conditions and improving the lives of those affected by serious bone disorders.” Vantictumab is a monoclonal antibody that selectively binds to certain frizzled (Fzd) receptors and inhibits Wnt signaling pathways. 2 Originally intended for the treatment of cancer, vantictumab has been previously evaluated in oncology clinical trials, demonstrating a favorable safety and pharmacokinetic profile. Previous clinical trials have provided biomarker data that directly support the activity of vantictumab on osteoclast function. These data significantly derisk the clinical program and allow āshibio to rapidly advance vantictumab into clinical development for ADO2. Preclinical data supporting the development of vantictumab in ADO2 will be presented at the upcoming American Society for Bone and Mineral Research (ASBMR) annual meeting, which takes place September 5-8, 2025 in Seattle, Wash. Under the terms of the agreement, āshibio will lead global clinical development for vantictumab in adult and pediatric patients. Mereo has granted āshibio an exclusive license to develop and commercialize vantictumab in the US and the rest of the world, excluding Europe, where Mereo retains commercial rights. About āshibio āshibio is a privately held, clinical-stage biotechnology company developing a pipeline of novel therapeutics for the treatment of bone disorders. Founded in 2022, āshibio exited stealth mode in June 2024 with $40 million in seed and Series A financing. The company has initiated a Phase 2/3 trial of its lead asset, andecaliximab, in patients with fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder characterized by progressive heterotopic ossification (HO), a pathological condition characterized by abnormal bone formation in muscle and soft tissues. āshibio has also initiated a development program in non-hereditary heterotopic ossification (NHHO), a severely disabling condition for which there are no approved therapies. The first study in the NHHO program is a Phase 1b trial of andecaliximab in patients with spinal cord injury at risk of HO. For more information, visit www.ashibio.com . About Mereo BioPharma Mereo BioPharma is a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. The Company has two rare disease product candidates: setrusumab for the treatment of osteogenesis imperfecta (OI); and alvelestat for the treatment of severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD). Mereo’s partner, Ultragenyx Pharmaceutical, Inc., has completed enrollment in the Phase 3 portion of a pivotal Phase 2/3 study in pediatric patients and young adults (5 to 25 years old) for setrusumab in OI and in the Phase 3 study in pediatric patients (2 to <7 years old). The partnership with Ultragenyx includes potential additional milestone payments of up to $245 million and royalties to Mereo on commercial sales in Ultragenyx territories. Mereo has retained EU and UK commercial rights and will pay Ultragenyx royalties on commercial sales in those territories. Setrusumab has received Orphan Designation for osteogenesis imperfecta from the European Commission (“EC”) and the U.S. Food and Drug Administration (FDA), PRIME designation from the European Medicines Agency (EMA), and Breakthrough Therapy and Rare Pediatric Disease Designations from the FDA. Alvelestat has received Orphan Designation for AATD from the EC and the FDA, and Fast Track designation from the FDA for AATD-LD. Mereo has also entered into an exclusive global license agreement with ReproNovo SA, a reproductive medicine company, for the development and commercialization of leflutrozole, a non-steroidal aromatase inhibitor. In addition to the rare disease programs, Mereo has two oncology product candidates, etigilimab, an anti-TIGIT; and navicixizumab for the potential treatment of late-line ovarian cancer. Navicixizumab has been partnered with Feng Biosciences, Inc. in a global licensing agreement that includes milestone payments and royalties. For more information, visit www.mereobiopharma.com . 1 Wu CC, Econs MJ, DiMeglio LA, et al. Diagnosis and management of osteopetrosis: consensus guidelines from the Osteopetrosis Working Group. J Clin Endocrinol Metab . 2017 Sep 1;102(9):3111-3123. doi: 10.1210/jc.2017-01127 2 Diamond JR, Becerra C, Richards D, et al. Phase Ib clinical trial of the anti-frizzled antibody vantictumab (OMP-18R5) plus paclitaxel in patients with locally advanced or metastatic HER2-negative breast cancer. Breast Cancer Res Treat . 2020 Aug 14;184(1):53–62. doi: 10.1007/s10549-020-05817-w SOURCE: āshibio

License out/inOrphan DrugPhase 1Phase 3Fast Track

25 Jun 2025

·pipelinereview.com

āshibio Doses First Patient in Phase 1b Trial of Andecaliximab in Patients with Spinal Cord Injury (SCI) at Risk of Heterotopic Ossification (HO)

– Company expands lead program into non-hereditary heterotopic ossification (NHHO), a condition with no approved treatments – – Initial NHHO study targets patients with traumatic SCI who have high rates of HO, which causes abnormal bone growth in soft tissues – BRISBANE, CA, USA I June 24, 2025 I āshibio , a privately held, clinical-stage biotechnology company developing novel therapeutics for the treatment of severe bone and connective tissue disorders, today announced that the first participant has been dosed in its Phase 1b clinical trial of andecaliximab in patients with spinal cord injury (SCI). The study, called ANDECA-HO, is evaluating patients who are at risk of developing heterotopic ossification (HO), a condition that causes abnormal bone formation in muscles, tendons, ligaments, and other soft tissues. The trial signals a strategic expansion of the andecaliximab clinical development program into non-hereditary heterotopic ossification (NHHO). NHHO is a severely debilitating condition that can occur in people who have experienced SCI, traumatic brain injury, hip arthroplasty, burns, blast injuries, and other forms of trauma. āshibio is conducting its first NHHO study in patients with SCI and plans to expand to other NHHO conditions in the future. Researchers estimate that clinically significant HO affects approximately 20% of SCI patients in the United States each year, an estimated 15,000 patients per year. The ANDECA-HO study is āshibio’s second clinical trial for andecaliximab, the company’s lead product candidate for the potential treatment of HO. On January 23, 2025, the company announced the dosing of the first patient in the ANDECAL trial, a Phase 2/3 study of andecaliximab in patients with fibrodysplasia ossificans progressiva (FOP), a genetic disease characterized by severe HO starting in early childhood. āshibio is investigating andecaliximab in patients with FOP and NHHO, due to the common pathology of HO in both conditions. “Heterotopic ossification can prevent individuals with spinal cord injury from being in a sitting position, fitting into a wheelchair, or transferring from a bed. HO increases the risk of complications such as bed sores and infections, and increases the SCI survivor’s reliance on others for activities of daily living, negatively impacting their quality of life,” said āshibio Chief Medical Officer Deborah Wenkert, MD. “Abnormal bone formation compresses nerves and blood vessels, leading to loss of function and poorer health outcomes. We hope the ANDECA-HO study brings us a step closer to delivering new options to patients living with or at risk of HO.” Andecaliximab is a humanized antibody that specifically inhibits the matrix metalloproteinase-9 (MMP9) enzyme. Researchers have demonstrated MMP9 expression in human and rodent NHHO lesions, and believe that MMP9 promotes HO in patients with SCI due to its greater expression in areas of inflammation and its role in degrading certain matrix proteins. Previous clinical trials of andecaliximab, involving more than 1,000 patients, have characterized its safety and tolerability profile. “MMP9 was discovered as a novel target based on clinical observations in a unique patient with FOP and preclinical research demonstrating the critical role of MMP9 in heterotopic ossification,” 1 said Pankaj Bhargava, MD, Chief Executive Officer of āshibio. “Preclinical studies conducted by our team have further demonstrated that MMP9 is essential for the development of NHHO, a condition with no approved therapies that is often cited as an area of high unmet need by physiatrists specializing in spinal cord injury medicine,” added Dr. Bhargava. “Inhibiting MMP9 in individuals with spinal cord injury may help reduce heterotopic ossification that can severely limit mobility, hinder recovery, and reduce quality of life,” noted ANDECA-HO Principal Investigator Andrew Park, MD, Physician Scientist at Craig Hospital in Englewood, Colo., who dosed the first patient in the SCI study. “We are excited to initiate dosing in this trial, which gives us an important opportunity to assess the safety and activity of andecaliximab in a patient population that has long awaited a safe and effective treatment option.” The Phase 1b trial is an open-label study assessing the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of andecaliximab in up to 10 adults (aged 18-89 years) with a history of traumatic SCI. This study will support a future randomized trial in patients with HO related to SCI and other conditions. For additional trial details, visit the study page on clinicaltrials.gov. About āshibio āshibio is a privately held, clinical-stage biotechnology company developing a pipeline of novel therapeutics for the treatment of bone and connective tissue disorders. Founded in 2022, āshibio exited stealth mode in June 2024 with $40 million in seed and Series A financing. The company has initiated a Phase 2/3 trial of its lead asset, andecaliximab, in patients with fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder characterized by progressive heterotopic ossification (HO), a pathological condition characterized by abnormal bone formation in muscle and soft tissues. āshibio has also initiated a development program in non-hereditary heterotopic ossification (NHHO), a severely disabling condition for which there are no approved therapies. The first study in the NHHO program is a Phase 1b trial of andecaliximab in patients with spinal cord injury at risk of HO. For more information, visit www.ashibio.com . References: SOURCE: āshibio

Phase 1Phase 2

23 Jan 2025

·pipelinereview.com

āshibio Doses First Patient in ANDECAL study, a Phase 2/3 Trial of Andecaliximab for Treatment of Fibrodysplasia Ossificans Progressiva (FOP)

– āshibio advances lead program into safety and efficacy trials – – Andecaliximab is the first in a planned pipeline of investigational therapies for patients with bone and connective tissue disorders – – Milestone follows Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA) – BRISBANE, CA, USA I January 23, 2025 I āshibio , a privately held, clinical-stage biotechnology company developing novel therapeutics for the treatment of severe bone and connective tissue disorders, today announced the dosing of the first participant in its ANDECAL study, a Phase 2/3 clinical trial evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of andecaliximab in patients with fibrodysplasia ossificans progressiva (FOP). The dosing milestone for andecaliximab, āshibio’s lead product candidate, marks advancement of the company’s first clinical trial in a set of indications characterized by heterotopic ossification (HO), a pathological condition that causes abnormal bone formation in soft tissues such as muscles, tendons and ligaments. “Heterotopic ossification, or HO, is a devastating condition with significant unmet need. We are initiating development in fibrodysplasia ossificans progressiva, a rare genetic disease characterized by severe and progressive HO leading to profound disability and shortened life span,” said āshibio Chief Executive Officer Pankaj Bhargava, MD. “People living with FOP lack adequate treatment options, and dosing of the first participant in the ANDECAL trial is a significant milestone in our mission to address their needs. Andecaliximab has extensive prior human clinical experience and safety data. Our team is dedicated to advancing this potential first-in-class treatment for HO, starting with FOP and expanding to other forms of non-genetic HO.” Andecaliximab is a humanized antibody that specifically inhibits the matrix metalloproteinase-9 (MMP-9) enzyme, which researchers have identified as a potentially novel therapeutic target for FOP. The discovery that the MMP-9 enzyme could serve as a novel target for FOP was first published in the Journal of Bone and Mineral Research (JBMR) in February 2024. The researchers evaluated a unique patient who harbors the classic mutation of FOP yet has minimal symptoms of the disease. The patient, who is now 36 years old, carries two mutations in the MMP-9 gene, which likely protect him from the devastating heterotopic ossification that most individuals living with FOP face. The effect of blocking MMP-9 was confirmed in mouse models of FOP in which knockout experiments and pharmacological treatments targeting MMP-9 showed substantial reduction of HO. “This unique person revealed something that could significantly change the lives of people with FOP,” said Frederick S. Kaplan, MD, one of the study’s senior authors and the Isaac and Rose Nassau Professor of Orthopaedic Molecular Medicine at the University of Pennsylvania. “We hope that ongoing efforts will validate what we found and provide a path toward quality treatment for individuals with FOP.” Edward Hsiao, MD, PhD, Professor in the Division of Endocrinology and Metabolism and Director of the Metabolic Bone Clinic at the University of California, San Francisco, enrolled the first participant dosed in the ANDECAL study. “We are excited to initiate enrollment in the ANDECAL trial. I am grateful to the UCSF team and my colleague Dr. Kelly Wentworth for all their efforts in making this study available to our patients with FOP,” said Dr. Hsiao. “The advancement of andecaliximab into the clinic is a significant milestone in our mission to improve the lives of those living with FOP and other forms of HO,” said āshibio Chief Medical Officer, Deborah Wenkert, MD. “We are deeply grateful to the participants for taking part in this important study, and to the investigators for their partnership in helping to advance this potential treatment to address the unmet needs of individuals living with FOP.” The U.S. Food and Drug Administration (FDA) has granted andecaliximab a Rare Pediatric Disease Designation (RPDD) for the treatment of FOP. An RPDD designation is granted to potential treatments for serious or life-threatening rare diseases with fewer than 200,000 patients in the U.S., and which primarily affect individuals under 18 years of age. For additional trial details, visit the study page on clinicaltrials.gov. About āshibio āshibio is a privately held, clinical-stage biotechnology company developing a pipeline of novel therapeutics for the treatment of bone and connective tissue disorders. Founded in 2022 by the team at MPM BioImpact, āshibio exited stealth mode in June 2024 with $40 million in seed and Series A financing. The company has initiated a Phase 2/3 trial of its lead asset, andecaliximab, in patients with fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder characterized by progressive heterotopic ossification (HO), a pathological condition characterized by abnormal bone formation in muscle and soft tissues. For more information, visit www.ashibio.com . About the ANDECAL trial The ANDECAL study is a Phase 2/3 trial consisting of two parts. Part 1, now underway at sites in the United States, is a randomized study evaluating the safety, PK, and PD of two different doses of andecaliximab, along with a preliminary efficacy assessment, in individuals living with FOP. Part 1 consists of two cohorts: Cohort 1a is being conducted in individuals with FOP aged 15 years and older who will undergo a NaF PET scan. Cohort 1b is being conducted in individuals with FOP who are aged 12 years and older and experiencing flare-ups. Following completion of Part 1, āshibio plans to initiate Part 2, a double-blind, placebo-controlled registration study, at sites in the U.S. and selected countries globally. SOURCE: āshibio

Clinical Study

100 Deals associated with Andecaliximab

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KEGG	Wiki	ATC	Drug Bank
D11262	Andecaliximab	-	DB12296

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myositis Ossificans	Phase 3	United States	ashibio, Inc.	25 Oct 2024
Gastroesophageal junction adenocarcinoma	Phase 3	United States	Gilead Sciences, Inc.	13 Oct 2015
Gastroesophageal junction adenocarcinoma	Phase 3	Australia	Gilead Sciences, Inc.	13 Oct 2015
Gastroesophageal junction adenocarcinoma	Phase 3	Belgium	Gilead Sciences, Inc.	13 Oct 2015
Gastroesophageal junction adenocarcinoma	Phase 3	Chile	Gilead Sciences, Inc.	13 Oct 2015
Gastroesophageal junction adenocarcinoma	Phase 3	Colombia	Gilead Sciences, Inc.	13 Oct 2015
Gastroesophageal junction adenocarcinoma	Phase 3	Czechia	Gilead Sciences, Inc.	13 Oct 2015
Gastroesophageal junction adenocarcinoma	Phase 3	France	Gilead Sciences, Inc.	13 Oct 2015
Gastroesophageal junction adenocarcinoma	Phase 3	Germany	Gilead Sciences, Inc.	13 Oct 2015
Gastroesophageal junction adenocarcinoma	Phase 3	Hungary	Gilead Sciences, Inc.	13 Oct 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02862535 (Pubmed) Manual	Phase 1	stomach adenocarcinoma First line	16	S-1+cisplatin+andecaliximab	jvkikomuxp(wfdnzsmrpa) = Peripheral sensory neuropathy (69%), anorexia (63%), nausea (56%), and decreased neutrophil counts (44%) were the most common adverse events (AEs). astkcalskb (fxknuojnpj ) View more	Positive	30 Jun 2022
				S-1+oxaliplatin+andecaliximab
DDW2022	Not Applicable	Crohn Disease	-	Infliximab	mebeuzyzbg(tplvgizrag) = no significant differences were observed between placebo, comparators or any biologic kbbnfwoskw (ibltewwpzj ) View more	-	22 May 2022
				Adalimumab
NCT02862535 (Pubmed \| J Immunother Cancer)	Phase 1	Gastroesophageal junction adenocarcinoma	36	Andecaliximab monotherapy	yhkiywfmcl(nxybdanboc) = PK of andecaliximab in Japanese patients with gastric or GEJ adenocarcinoma was similar to that reported in non-Japanese patients with advanced solid tumors ngikewbkgt (mmucgztsas ) View more	Positive	01 Jan 2022
				Andecaliximab + Nivolumab
NCT02864381 (GS-US-296--2013, Pubmed \| J Immunother Cancer)	Phase 2	Advanced gastric carcinoma	144	Andecaliximab plus Nivolumab	jyrhcjnmbz(bpunkqjdbv) = ojpflcmpwt dyfwocutdb (nonbgxfypb, 4 - 19)	Negative	01 Dec 2021
				Nivolumab alone	jyrhcjnmbz(bpunkqjdbv) = bxvrrhrwah dyfwocutdb (nonbgxfypb, 2 - 16)
NCT02545504 (GAMMA-1, Pubmed) Manual	Phase 3	Gastroesophageal junction adenocarcinoma First line EGFR2 negative	432	Andecaliximab+fluorouracil	somyyedbon(ncgfkninmi) = stxalprgeg vojhnqrevg (htdszgygfh ) View more	Negative	20 Mar 2021
				Placebo+fluorouracil	somyyedbon(ncgfkninmi) = patfynnbsh vojhnqrevg (htdszgygfh ) View more
NCT02862535 (###DELETE \| phase 1b \| NCT02862535, CTgov)	Phase 1	Advanced Gastric Adenocarcinoma \| Recurrent Gastroesophageal Junction Adenocarcinoma \| stomach adenocarcinoma ... View more	36	Andecaliximab (Cohort 1: ADX)	cgieonlgjw = ydqifnymde tsdbhlsvmz (pjdsydhymj, ophtfcnbhy - ksvcubmads) View more	-	24 Dec 2020
				Andecaliximab+S-1+cisplatin (Cohort 2: ADX + S-1 + Cisplatin)	cgieonlgjw = xhnckbnomc tsdbhlsvmz (pjdsydhymj, hfqqvdcnpx - rcqvjqjhed) View more
NCT02864381 (GS-US-296--2013, CTgov)	Phase 2	Recurrent Gastroesophageal Junction Adenocarcinoma \| stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma	144	Nivolumab+Andecaliximab (Andecaliximab + Nivolumab)	lwvgmpxklq(snyqxqdrhg) = ogxrstkukx errjizfmfo (ufrroqqpdg, jiovvqefjd - pfqxakvlyj) View more	-	18 Sep 2020
				Nivolumab (Nivolumab)	lwvgmpxklq(snyqxqdrhg) = cpojcmiyob errjizfmfo (ufrroqqpdg, dxcjaotabm - hvfzgqiojt) View more
NCT02077465 (CTgov)	Phase 1	Pulmonary Disease, Chronic Obstructive	11	Andecaliximab	ftvnvlneul = wxsjebkqpp hforthluna (dqfmfxdmtr, bysxuwpnbg - iwdysmevay) View more	-	13 Aug 2020
NCT02545504 (GAMMA-1, CTgov)	Phase 3	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma	432	mFOLFOX6+Andecaliximab (Andecaliximab + mFOLFOX6)	cfvytehdzf(vdwsjatbnt) = dditskwahs qwxfelekup (ghrofwlcky, fnvglbkxfe - sdbouaifcq) View more	-	28 Apr 2020
				mFOLFOX6 (Placebo + mFOLFOX6)	cfvytehdzf(vdwsjatbnt) = izrvepgrte qwxfelekup (ghrofwlcky, dmnuvsqheo - dulrotpymx) View more
NCT02862535 (ASCO_GI2019)	Phase 1	Adenocarcinoma	36	Andecaliximab 800 mg IV Q2W	dthfpvybll(htjxupjbkr) = nfrjcvclss widzvjdusg (ftksjeagwn )	-	29 Jan 2019
				Nivolumab plus Andecaliximab	bhwfxlyaun(vipyxingbv) = ibtrxruedk wjvpckzdsa (pjiwoqngrh ) View more

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis