Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation

This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.

Start Date08 Jan 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06405087

/ Not yet recruitingPhase 3

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.
In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 [NCT06100289]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.
During the study, participants will visit their study clinic several times.

Start Date11 Jul 2025

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT06880744

/ Not yet recruitingPhase 3

Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

Start Date26 Jun 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Vedolizumab

100 Translational Medicine associated with Vedolizumab

100 Patents (Medical) associated with Vedolizumab

2,079

Literatures (Medical) associated with Vedolizumab

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

X-linked Deficiency in ELF4 in Females with Skewed X Chromosome Inactivation

Article

Author: Zhou, Lina ; Du, Hongqiang ; Liu, Zhifeng ; Sun, Gan ; Zhang, Zhuo ; An, Yunfei ; Zhang, Qianlu ; Zhao, Rongtao ; Mei, Shiyue ; Zhao, Xiaodong ; Tang, Xuemei ; Lv, Qianying ; Zhou, Fang ; Sun, Li

Deficiency in ELF4, X-linked (DEX) is a newly identified monogenic autoinflammatory disease. Most reported cases are male, leading to the recognition of DEX being primarily limited to male patients. Here we described 3 pediatric female patients with DEX from 3 unrelated families, who are all heterozygous for ELF4 mutations (c.320_c.321insA, c.329delA and c.685 A > G). Similar to reported male DEX patients, the main clinical features include recurring oral ulcers, abdominal pain and diarrhea with colonoscopy showing ulcers in the colon. Meanwhile, novel and effective treatment strategies, such as the use of the biologic vedolizumab and exclusive enteral nutrition (EEN), have provided additional options for the treatment of DEX. Finally, we observed skewed X chromosome inactivation patterns in all three female patients, with over-inactivation of the X chromosome carrying the wild-type allele confirmed in two of them.

01 Apr 2025·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Obesity Is Associated With Worsened Outcomes in Patients With Ulcerative Colitis on Advanced Therapies: A Propensity Matched Cohort Study From the U.S.

Article

Author: Farraye, Francis A. ; Sehgal, Priya ; Lichtenstein, Gary R. ; Lewis, James D. ; Desai, Aakash ; Khataniar, Himsikhar ; Kochhar, Gursimran S.

ABSTRACT:

Background:

Obesity has been linked to a more severe phenotype in patients with ulcerative colitis (UC).

Aim:

To evaluate the impact of obesity on outcomes of advanced therapies in UC.

Methods:

We conducted a retrospective cohort study utilising the TriNetX database comparing the composite score of corticosteroid use, change in advanced therapy or colectomy within two years between two cohorts of patients with UC—those with obesity (BMI ≥ 30 kg/m2) and those without (BMI 18.5–24.9). The risk assessment was stratified to specific advanced therapies, including tumour necrosis factor α inhibitors (TNFi), vedolizumab, ustekinumab and Janus kinase inhibitors (JAKi). We performed 1:1 propensity score matching (PSM) for demographics, co‐morbid conditions, laboratory values and IBD medications including corticosteroids.

Results:

There were 3904, 2025, 1150 and 477 patients on TNFi, vedolizumab, ustekinumab and JAKi, respectively, in the UC obesity cohort. After PSM, the UC obesity cohort was at an increased risk of the composite outcome of corticosteroid use, change in therapy and colectomy compared to the UC control cohort in patients on TNFi (aHR 1.37, 95% CI 1.29–1.49), vedolizumab (aHR 1.29, 95% CI 1.16–1.43), ustekinumab (aHR 1.1.26, 95% CI 1.10–1.44) and JAKi (aHR 1.38, 95% CI 1.13–1.69). Sub‐group analysis based on the specific TNFi also showed an increased risk of composite outcome for infliximab (aHR 1.36, 95% CI 1.22–1.52) and adalimumab (aHR 1.26, 95% CI 1.11–1.42) within 2 years.

Conclusions:

Obesity is associated with lower efficacy of several advanced therapies in patients with UC.

01 Apr 2025·Clinical Journal of Gastroenterology

Achievement of duodenal ulcer remission by vedolizumab in children with eosinophilic gastroenteritis

Article

Author: Taniguchi, Riki ; Yoshida, Masashi ; Iwama, Itaru ; Ichimura, Kayoko ; Hara, Tomoko ; Nambu, Ryusuke

Eosinophilic gastrointestinal disorders (EGIDs) are treated with corticosteroids and food allergen elimination. However, treatment for refractory cases is not standardized. We demonstrate the efficacy of vedolizumab, an anti-α4β7 integrin agent, in 2 children with duodenal ulcers developed by non-eosinophilic esophagitis EGIDs. In both, vedolizumab was used continuously without side effects, and long-term remission has been durable. Duodenal ulcers associated with EGIDs are increasing. Vedolizumab has potential as a treatment for even upper gastrointestinal lesions in refractory EGIDs.

178

News (Medical) associated with Vedolizumab

10 Mar 2025

·pipelinereview.com

Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients

Topline results also show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to 30.2% at Week 12 and a favorable safety profile in Phase 2b ANTHEM-UC study Clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program Icotrokinra demonstrates potential to offer therapeutic benefit and tolerability with a once daily oral treatment SPRING HOUSE, PA, USA I March 10, 2025 I Johnson & Johnson (NYSE: JNJ ) today announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). The study met its primary endpoint of clinical response a in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission b , symptomatic remission and endoscopic improvement at Week 12. In the ANTHEM-UC study (n=252), three doses of once daily icotrokinra were tested with all meeting the primary endpoint of clinical response at Week 12. A response rate of 63.5% for patients treated with the highest dose of icotrokinra was achieved at Week 12 versus 27% for placebo (p<0.001). Further, 30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at Week 12 versus 11.1% of patients who received placebo (p<0.001). Remission and response rates continued to improve through Week 28. 1 Icotrokinra was well tolerated with proportions of participants reporting one or more adverse events (AEs) being similar between the icotrokinra dose groups and the placebo group. 1 “These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment,” said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. “With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases.” Comprehensive results from the ANTHEM-UC study are being prepared for presentation at upcoming medical congresses. Editor’s notes: a. Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. b. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. About ANTHEM-UC ANTHEM-UC ( NCT06049017 ) is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally. 2 About Ulcerative Colitis Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system’s overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue. 3 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor, 4 which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases. 5,6 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signalling in human T cells. 7 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra. 8 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications. 9,10,11 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis and active psoriatic arthritis and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com . Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. 1 Data on file. 2 Clinicaltrials.gov. A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017. https://clinicaltrials.gov/study/NCT06049017?term=ANTHEM-UC&rank=1 . Accessed February 2025. 3 Crohn’s & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis . Accessed April 2024. 4 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8. 5 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol . 2018 Feb; 48(2): 220–229. 6 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology . 2012 Feb; 135(2): 112–124. 7 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14. 8 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: https://www.jnj.com/media-center/press-releases/janssen-enters-into-worldwide-exclusive-license-and-collaboration-agreement-with-protagonist-therapeutics-inc-for-the-oral-interlukin-23-receptor-antagonist-drug-candidate-for-the-treatment-of-inflammatory-bowel-disease . Accessed November 2024. 9 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html . Accessed November 2024. 10 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html . Accessed November 2024. 11 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html . Accessed November 2024. SOURCE: Johnson & Johnson

Phase 2Clinical ResultLicense out/inPhase 3Phase 1

10 Mar 2025

·www.prnewswire.com

Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients

Topline results also show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to 30.2% at Week 12 and a favorable safety profile in Phase 2b ANTHEM-UC study Clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program Icotrokinra demonstrates potential to offer therapeutic benefit and tolerability with a once daily oral treatment SPRING HOUSE, Pa., March 10, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). The study met its primary endpoint of clinical responsea in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remissionb, symptomatic remission and endoscopic improvement at Week 12. In the ANTHEM-UC study (n=252), three doses of once daily icotrokinra were tested with all meeting the primary endpoint of clinical response at Week 12. A response rate of 63.5% for patients treated with the highest dose of icotrokinra was achieved at Week 12 versus 27% for placebo (p<0.001). Further, 30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at Week 12 versus 11.1% of patients who received placebo (p<0.001). Remission and response rates continued to improve through Week 28.1 Icotrokinra was well tolerated with proportions of participants reporting one or more adverse events (AEs) being similar between the icotrokinra dose groups and the placebo group.1 "These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment," said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases." Comprehensive results from the ANTHEM-UC study are being prepared for presentation at upcoming medical congresses. Editor's notes: a. Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. b. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. About ANTHEM-UC ANTHEM-UC (NCT06049017) is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally.2 About Ulcerative Colitis Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.3 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,4 which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.5,6 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signalling in human T cells.7 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.8 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.9,10,11 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis and active psoriatic arthritis and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1Data on file. 2Clinicaltrials.gov. A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017. . Accessed February 2025. 3Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed April 2024. 4Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8. 5Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229. 6Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. 7Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14. 8Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: . Accessed November 2024. 9Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: . Accessed November 2024. 10Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: . Accessed November 2024. 11Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: . Accessed November 2024. Media contact: Craig Stoltz [email protected] Investor contact: Lauren Johnson [email protected] SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultLicense out/inPhase 3Phase 1

27 Feb 2025

·www.prnewswire.com

Spyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

Reported positive interim pharmacokinetic ("PK") and safety data in Phase 1 trial of SPY001 in November 2024 and strengthened the balance sheet with a $230 million public offering Continued execution towards expected milestones across portfolio, with interim Phase 1 data readouts for SPY002 and SPY003 on-track for the second quarter and second half of 2025, respectively Remain on track for initiation of Phase 2 platform trial in ulcerative colitis ("UC") in mid-2025 with SPY001 (α4β7), followed by SPY002 (TL1A), SPY003 (IL-23), and combinations thereof, with initial monotherapy results expected in 2026 Announced indication expansion into rheumatoid arthritis ("RA") with SPY002, with expected Phase 2 trial initiation in mid-2025 and top-line results in 2026 $603 million of cash, cash equivalents, and marketable securities as of December 31, 2024, with expected runway into the second half of 2028 WALTHAM, Mass., Feb. 27, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. ("Spyre" or the "Company") (NASDAQ:SYRE), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, dose optimization, and rational therapeutic combinations to target improved efficacy and convenience in the treatment of inflammatory bowel disease ("IBD") and other immune-mediated diseases, today announced its fourth quarter and full year 2024 financial results and provided program and corporate updates. "In 2024, we initiated first-in-human studies for three of our next-generation antibodies and delivered outstanding interim Phase 1 results for SPY001, which underscore our portfolio's potential to revolutionize the treatment of IBD. Looking ahead, we are progressing our suite of therapeutics into a groundbreaking Phase 2 platform study in ulcerative colitis, which is designed to test both monotherapies and combination therapies with the potential for unified quarterly subcutaneous dosing in maintenance," said Cameron Turtle, DPhil., Chief Executive Officer. "Additionally, the expansion of SPY002 into a Phase 2 rheumatoid arthritis trial this year represents a key step in addressing a pressing unmet need in a disease that affects millions across the globe. We are well-positioned and well-capitalized to deliver a series of value-inflecting catalysts, including three Phase 1 readouts expected in 2025 and four Phase 2 proof-of-concept readouts expected in 2026." Development Pipeline Overview and Update The Company's approach combines best-in-class antibody engineering, dose optimization, and rational therapeutic combinations with the goal of maximizing efficacy, safety, and convenience in the treatment of IBD and other immune-mediated diseases. IBD is a chronic condition characterized by inflammation within the gastrointestinal tract, including two main disorders: UC and Crohn's disease ("CD"). In the United States, it is estimated that approximately 2.4 million individuals are diagnosed with IBD. RA is a chronic inflammatory autoimmune condition that primarily affects the joints but also other parts of the body. It is characterized by pain, stiffness, and swelling of one or more joints and can progress from mild swelling of the joints in early stages to severe deformations of the feet, ankles, and hands in late/severe stages. RA affects more than 1.5 million individuals in the United States. The Company has four programs in nonclinical and clinical development, three of which are targets in IBD validated by third parties. The fourth program is an undisclosed target. All three validated targets offer the potential for safe and effective treatment of UC and CD, with infrequent, subcutaneous maintenance dosing as a monotherapy or in rational combinations. The Company is also planning to study its anti-TL1A program in additional indications outside IBD, beginning with RA. SPY001 – a highly potent and selective investigational monoclonal antibody targeting α4β7, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing. In November 2024, interim healthy volunteer data from a Phase 1 trial were presented, demonstrating a favorable safety profile, a meaningfully differentiated PK profile relative to vedolizumab with half-life estimates greater than 90 days supporting potential Q6M maintenance dosing, and complete occupancy of α4β7 receptors out to 12 weeks at a single dose of 300mg. Longer-term data from this Phase 1 trial will be presented at a medical meeting later this year. Based on these interim results, Spyre plans to advance SPY001 to a Phase 2 clinical trial in UC patients in mid-2025. SPY002 – a program with two highly potent and selective, investigational anti-TL1A monoclonal antibodies, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing. The Company believes TL1A has emerged as one of the most promising targets in IBD and broader immunology indications. In January 2025, the Company announced its intent to study one of its anti-TL1A antibodies in RA, with Phase 2 trial initiation expected in mid-2025 and topline results in 2026. With class-leading potency and half-life established in preclinical studies, SPY002 has the potential to become the first-in-class and best-in-class anti-TL1A treatment for RA. In December 2024, the Company initiated first-in-human ("FIH") trials of both SPY002 candidates, with healthy volunteer interim data expected in the second quarter of 2025. If successful, the Company expects one or more SPY002 candidates would then advance to Phase 2 clinical trials. In October 2024, preclinical data for both SPY002 development candidates were presented at the United European Gastroenterology Week ("UEGW") Congress demonstrating superior or comparable in vitro potency to first-generation anti-TL1As, as well as a pharmacokinetic half-life of 24 days in non-human primates ("NHPs"), which represents a two to three-fold increase compared to these same first-generation anti-TL1As. SPY003 – a highly potent and selective investigational monoclonal antibody targeting the p19 subunit of IL-23, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing. In October 2024, preclinical data for SPY003 were presented for the first time at UEGW, demonstrating comparable potency to risankizumab, as well as a pharmacokinetic half-life of 30 days in NHPs, greater than three-fold compared to risankizumab. These data also demonstrated that SPY003 exhibits high selectivity and affinity for IL-23 and potently inhibits downstream cellular signaling. SPY003 remains on track to initiate a FIH trial in the first quarter of 2025, with healthy volunteer interim data expected in the second half of 2025. Rational Combinations – the Company plans to investigate combinations of our proprietary antibodies in nonclinical studies and clinical trials in order to evaluate whether combination therapy can potentially lead to best-in-class efficacy in IBD, with less frequent dosing. In February 2025, new preclinical data for SPY120 were presented at the 20th Congress of the European Crohn's and Colitis Organisation, demonstrating that the combined inhibition of TL1A and α4β7 is superior to either monotherapy in mouse models of colitis and that coadministration of SPY001 and SPY002 demonstrated no drug effects on PK in NHPs. In October 2024, preclinical data for SPY130 and SPY230 were presented at UEGW, demonstrating enhanced efficacy and pharmacodynamics with SPY003 in combination with SPY001 and with SPY002. The Company expects to initiate a Phase 2 clinical trial in 2025 that is intended to include each of its rational combinations, as well as all three of its lead monotherapy programs. Recent Corporate Updates In December 2024, Spyre was added to the Nasdaq Biotechnology Index. In November 2024, the Company raised $230 million in gross proceeds from a public offering of common stock with broad participation from both new and existing investors, extending cash runway into the second half of 2028. In October 2024, the Company announced the appointment of Sheldon Sloan, M.D., M. Bioethics, as Chief Medical Officer. Dr. Sloan's 25+ years of experience in both large pharmaceutical and small biotech companies, featuring an extensive track record of program leadership in the field of Inflammation and Immunology, will be invaluable to guide the Company as it advances its potentially best-in-class IBD portfolio. Fourth Quarter 2024 Financial Results Cash Position: As of December 31, 2024, Spyre had cash, cash equivalents, and marketable securities of $603.1 million. Net cash used in operating activities was $37.2 million for the fourth quarter of 2024. In November 2024, the Company raised $230 million in gross proceeds, before deducting $14.2 million in underwriting discounts, commissions, and other offering expenses, from a public offering of common stock. Research and Development (R&D) expenses: R&D expenses totaled $50.5 million for the fourth quarter of 2024 and $33.7 million for the fourth quarter of 2023. The increase was primarily driven by nonclinical and clinical development, as well as manufacturing expenses, for the Company's pipeline candidates. General and Administrative (G&A) expenses: G&A expenses totaled $10.8 million for the fourth quarter of 2024 and $14.1 million for the fourth quarter of 2023. The decrease was driven by higher stock compensation expense related to the Spyre acquisition in the fourth quarter of 2023. Other income (expense): Other income totaled $5.0 million for the fourth quarter of 2024 primarily driven by interest earned on the Company's cash and marketable securities. For the fourth quarter of 2023, other expense totaled $17.3 million, primarily driven by an increase in the Company's CVR liability related to the increased likelihood of certain milestone payments related to pegzilarginase reimbursement in European markets, partially offset by interest earned on the Company's cash and marketable securities. Net Loss: Net loss totaled $56.3 million and $63.2 million for the fourth quarters of 2024 and 2023, respectively, which includes non-cash stock compensation expense of $9.2 million and $17.3 million for the fourth quarters of 2024 and 2023, respectively. About Spyre Therapeutics Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. For more information, please visit . Safe Harbor / Forward Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical fact are forward-looking statements. These forward-looking statements include statements regarding the Company's future results of operations and financial position; its business strategy, including the Company's ability to successfully develop best-in-class and/or first-in-class therapeutics for IBD, RA, or other immune-mediated diseases that meaningfully improve both efficacy and convenience compared to today's standard of care; the SPY001 Phase 1 trial final data readouts not being consistent with or being different than the interim Phase 1 results; the sufficiency of the Company's funding to support the development of its assets, including expectations of cash runway extending into the second half of 2028; the length of time that the Company believes its existing cash resources will fund its operations; estimated market sizes and potential growth opportunities; its nonclinical and future clinical development activities; clinical trial designs and related regulatory feedback; further clinical evaluation of therapeutic combinations; the potential efficacy, tolerability, convenience, commercial viability and safety profile of its product candidates, including in combinations; the planned dosing regimen for SPY001 and our other product candidates, including the potential for a Q6M dosing profile; the potential therapeutic benefits and economic value of its product candidates as monotherapies or in combinations and their extended half-life; the timing for initiation of nonclinical studies and clinical trials, including the commencement of FIH and Phase 2 trials; and the planned expansion of SPY002 into RA, including timing thereof. The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "predict," "target," "intend," "could," "would," "should," "project," "plan," "expect," the negatives of these terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the expected or potential impact of macroeconomic conditions, including U.S. elections inflationary pressures, rising interest rates, general economic slowdown or a recession, changes in monetary policy, the prospect of a shutdown of the U.S. federal government, volatile market conditions, financial institution instability, as well as geopolitical instability, including the ongoing military conflict in Ukraine, conflict in Israel and surrounding areas, and geopolitical tensions in China on the Company's operations, the potential impacts of the BIOSECURE Act bill if passed into law and those risks described in the Company's Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, as well as in other filings and reports that the Company makes from time to time with the Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for the Company's management to predict all risks, nor can the Company assess the impact of all factors on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. The Company undertakes no obligation to update publicly any forward-looking statement for any reason after the date of this press release to conform these statements to actual results, to reflect changes in the Company's expectations, or otherwise, except as required by law. You should read press release with the understanding that the Company's actual results, levels of activity, performance, events, outcomes, and the timing of results and outcomes, and other circumstances may be materially different from what the Company expects. SOURCE Spyre Therapeutics, Inc. 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Phase 1Financial StatementExecutive ChangePhase 2

100 Deals associated with Vedolizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D08083	Vedolizumab	L04AA33	DB09033

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ileal Diseases	South Korea	Takeda Pharmaceuticals Korea Co., Ltd.	19 Jun 2015
Crohn's disease, active moderate	European Union	Takeda Pharma A/S	22 May 2014
Crohn's disease, active moderate	Iceland	Takeda Pharma A/S	22 May 2014
Crohn's disease, active moderate	Liechtenstein	Takeda Pharma A/S	22 May 2014
Crohn's disease, active moderate	Norway	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	European Union	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	Iceland	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	Liechtenstein	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	Norway	Takeda Pharma A/S	22 May 2014
Pouchitis	European Union	Takeda Pharma A/S	22 May 2014
Pouchitis	Iceland	Takeda Pharma A/S	22 May 2014
Pouchitis	Liechtenstein	Takeda Pharma A/S	22 May 2014
Pouchitis	Norway	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	European Union	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	Iceland	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	Liechtenstein	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	Norway	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active severe	European Union	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active severe	Iceland	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active severe	Liechtenstein	Takeda Pharma A/S	22 May 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pediatric Crohn's Disease	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022
Pediatric Crohn's Disease	Phase 3	China	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022
Pediatric Crohn's Disease	Phase 3	Japan	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022
Pediatric Crohn's Disease	Phase 3	Australia	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022
Pediatric Crohn's Disease	Phase 3	Belgium	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022
Pediatric Crohn's Disease	Phase 3	Canada	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022
Pediatric Crohn's Disease	Phase 3	Croatia	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022
Pediatric Crohn's Disease	Phase 3	Czechia	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022
Pediatric Crohn's Disease	Phase 3	Greece	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022
Pediatric Crohn's Disease	Phase 3	Hungary	Takeda Pharmaceutical Co., Ltd.	30 Apr 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04804540 (CTgov)	Phase 4	Crohn Disease \| Colitis, Ulcerative	150	Vedolizumab (UC Participants: Vedolizumab 300 mg)	xbisarmlij = kxfrzovnmz jkqstqscrw (ridgtknjgn, vygjbphwux - asenbfpjfq) View more	-	25 Mar 2025
				Vedolizumab (CD Participants: Vedolizumab 300 mg)	xbisarmlij = zudgbrypiv jkqstqscrw (ridgtknjgn, qmmtsdkmjk - lddwrocrec) View more
ChiCTR2200063233 (Early CD, PRNewswire) Manual	Phase 4	Crohn Disease	172	维得利珠单抗	ekmnmkimkw(xbiepozhjn) = melcngczvx ryzgekmrig (eollwzghzw ) View more	Positive	21 Feb 2025
ESMO_IO2024	Not Applicable	Colitis	74	Vedolizumab	rodffzfzje(poohajjdws) = kzzcwfklrp ebjhlnjlka (nwabhiigvt )	-	12 Dec 2024
UEGW2024	Not Applicable	Colitis, Ulcerative	-	Vedolizumab IV infusion every 8 weeks (Q8W)	hiesddsydl(gporszpcny) = ogpdwkstzg qupwjatkvw (ttwnylfnwj ) View more	-	13 Oct 2024
				Vedolizumab IV infusion every 4 weeks (Q4W)	hiesddsydl(gporszpcny) = gciondfqgz qupwjatkvw (ttwnylfnwj ) View more
UEGW2024	Not Applicable	Colitis, Ulcerative	-	Vedolizumab	qpoewiohyc(anjdtdbhcg) = In the first study, safety outcomes were followed from treatment initiation up to five half-lives after treatment discontinuation; 6.8% treated with Vedolizumab experienced SAEs compared with 19.2% with anti-tumour necrosis factor-alpha treatment. In the second study, the rate of SAEs was similar between patients treated with Vedolizumab (4.5%) and anti-tumour necrosis factor-alpha treatment (5.0%). In the third study that reported SAEs within the first year of treatment; the rates of SAEs were 14.3% and 10.9% among patients who received Vedolizumab and anti-tumour necrosis factor-alpha treatment, respectively. ltnnvizqwk (efqramlpix )	-	13 Oct 2024
				Anti-tumour necrosis factor-alpha treatment
UEGW2024	Not Applicable	Colitis, Ulcerative	-	Vedolizumab	fsfphjrhad(pvrjnlodft) = ssydvdmkab wxzcjwuhdb (pspkgunwbn, 37.0–48.3)	-	13 Oct 2024
NCT02790138 (EARNEST, Pubmed)	Phase 3	Pouchitis	-	Vedolizumab	aijfbzkifb(hnfbsdghey) = wfnmdpkppk wbqrpkytvu (ywrxplgnne ) View more	Positive	16 Jul 2024
				Placebo	aijfbzkifb(hnfbsdghey) = aukwyvaxiq wbqrpkytvu (ywrxplgnne ) View more
NCT02764762 (EXPLORER, Pubmed \| Clin Gastroenterol Hepatol) Manual	Phase 4	Crohn Disease	55	Vedolizumabadalimumabmethotrexate	stwuqpkvfk(tlrhjylesx) = zmhvoblchb hvdeswadar (pwobskahrk ) View more	Positive	01 Jul 2024
NCT03657160 (Pubmed)	Phase 3	Hematopoietic stem cell transplantation	343	Vedolizumab	rlfsocwqym(ggfggduiix) = umhnexqwua ancyevnvgq (idvdrikfrz, 79.2 - 90.1)	Positive	06 Jun 2024
				Placebo	rlfsocwqym(ggfggduiix) = mebckhzwlx ancyevnvgq (idvdrikfrz, 63.2 - 77.2)
DDW2024	Not Applicable	Colitis, Ulcerative	-	Ustekinumab	ernrgijrql(zwxkqsbjkr) = ivhibsnpkq zkpmbwvfnu (rpmgbhcgwc ) View more	-	21 May 2024
				Vedolizumab	ernrgijrql(zwxkqsbjkr) = ftasyolbsb zkpmbwvfnu (rpmgbhcgwc ) View more

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