A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs

Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).

Start Date01 Aug 2012

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with PRT-2607

100 Translational Medicine associated with PRT-2607

100 Patents (Medical) associated with PRT-2607

353

Literatures (Medical) associated with PRT-2607

01 Jun 2025·FISH & SHELLFISH IMMUNOLOGY

The role of SYK phosphorylation in LPS-induced immunoglobulin responses of B cells in large yellow croaker (Larimichthys crocea)

Article

Author: Chen, Xinhua ; Cao, Shuangshuang ; Wang, Zhiqiang ; Chen, Yueming ; Cui, Zhengwei ; Xie, Hongjun

Spleen tyrosine kinase (SYK), a non-receptor protein tyrosine kinase, is a key component of B cell receptor signaling and can regulate multiple physiological functions of B cells in mammals. In this study, a SYK gene was cloned and characterized from large yellow croaker (Larimichthys crocea) (LcSYK), whose open reading frame consists of 1851 base pairs and encodes 616 amino acid residues. The predicted LcSYK protein contains two N-terminal tandem Src homology 2 domains and a C-terminal tyrosine kinase catalytic domain, and shares a high amino acid sequence identity with SYK sequences in other vertebrate species. LcSYK was mainly expressed in immune tissues, such as head kidney, trunk kidney, spleen, and gill. The mRNA expression of LcSYK in primary head kidney leukocytes was not changed at 12, 24, and 48 h after lipopolysaccharide (LPS) stimulation. LPS stimulation upregulated the mRNA expression and protein production of IgM in IgM⁺ B cells, accompanied by an increase in the phosphorylation level, but not the total protein level, of LcSYK. Moreover, when we used PRT062607 HCl to inhibit the phosphorylation of LcSYK, both mRNA expression and protein production of IgM in IgM⁺ B cells were significantly suppressed. These results suggest that SYK phosphorylation may play a role in LPS-induced IgM production by IgM⁺ B cells, improving our understanding of the role of SYK in immunoglobulin responses of B cells in fish.

01 Dec 2024·Innere Medizin (Heidelberg, Germany)

Review

Author: Uzun, Günalp ; Bakchoul, Tamam ; Moyses, Margarete ; Lengerke, Claudia

Immune thrombocytopenia (ITP) is an acquired thrombocytopenia caused by an autoimmune reaction against platelets in the blood and against megakaryocytes in the bone marrow. The indication for treatment is based on the bleeding symptoms and patient-specific factors. This article presents the current 2023 expert report that also forms the basis for the updated version of the Onkopedia guideline, which is expected in the course of 2024. In addition to the background to pathogenesis and pathophysiology, the article discusses clinical manifestations and diagnostics, as well as first-, second- and third-line therapy, including the management of emergency situations. Practice-relevant recommendations are given on the use and side effects of glucocorticoids, as well as on therapy with thrombopoietin receptor agonists (TRA), including the withdrawal regimen, and on treatment with a syk inhibitor.

01 Nov 2024·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

CpG oligonucleotides induce acute murine thrombocytopenia dependent on toll-like receptor 9 and spleen tyrosine kinase pathways

Article

Author: Henry, Scott ; Semple, John W ; Italiano, Joseph E ; Shen, Lijiang ; Marcoux, Geneviève ; Rebetz, Johan ; Johansson, Karl ; Narayanan, Padma ; Shannon, Oonagh ; Maouia, Amal

BACKGROUND:

CpG oligonucleotides (ODNs) are synthetic single-stranded DNA sequences that act as immunostimulants. They have been increasingly used to treat several cancers; however, thrombocytopenia is a potential recognized side effect of some sequences.

OBJECTIVES:

We tested the ability of 2 CpG ODNs (ODN 2395 and ISIS 120704) to induce thrombocytopenia when administered to BALB/c mice and determined mechanisms associated with thrombocytopenia.

METHODS:

BALB/c mice were prebled and then injected with titrated doses of CpG ODNs, and platelet counts were determined. The mice were treated with intravenous immunoglobulin (IVIg) or various inhibitors and antagonists of toll-like receptor 9 (TLR9) and spleen tyrosine kinase (Syk) to determine their effects on thrombocytopenia.

RESULTS:

Compared with saline-treated mice or mice treated with 2'-O-methoxyethyl-modified antisense ODN, both ODN 2395 and ISIS 120704 induced acute dose-dependent thrombocytopenia within 3 and 24 hours, respectively. The thrombocytopenia was associated with significant increases in plasma monocyte chemoattractant protein 1. IVIg administration significantly rescued the CpG ODN-induced thrombocytopenia, as did treatment with either a Syk inhibitor or TLR9 antagonists. In vitro, CpG ODN could activate human platelets and this correlated significantly with enhanced IVIg- and Syk-dependent phagocytosis by THP-1 monocytes.

CONCLUSION:

These results suggest that CpG ODNs induce acute inflammatory-associated (IVIg-sensitive) thrombocytopenia that can be alleviated by Syk- or TLR9-blockade, and an IVIg- and Syk-dependent platelet clearance pathway appears primarily responsible for the thrombocytopenia.

News (Medical) associated with PRT-2607

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

21 Mar 2024

·www.prnewswire.com

FDA Grants Orphan Drug Designation to Cevidoplenib for ITP

PANGYO, South Korea, March 21, 2024 /PRNewswire/ -- Oscotec Inc. has secured orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its SYK inhibitor, Cevidoplenib, to treat immune thrombocytopenia (ITP). Oscotec has successfully completed phase 2 study in patients with chronic ITP last year and are currently seeking partners for further development and global commercialization. "Potential partners are drawing attention not only to the efficacy of cevidoplenib but also its exceptional safety profile and the convenience of oral dosing," said Dr. Taeyoung Yoon, CEO/CSO of Oscotec. "Obtaining ODD is an important milestone in the development of cevidoplenib and ultimately will benefit patients. We will explore every available option including partnership to deliver our drug as quickly as we can to those who suffers from the potentially crippling disease." The orphan drug designation is granted to agents that prevent, diagnose, or treat a rare disease. Drug sponsors are eligible for incentives including tax credits for clinical trials, exemption from user fees, and a potential of 7 years of market exclusivity after approval. About Immune Thrombocytopenia (ITP) Immune thrombocytopenia (ITP) is a disorder that can lead to easy or excessive bruising and bleeding. The bleeding results from unusually low levels of platelets. Formerly known as idiopathic thrombocytopenic purpura, ITP can cause purple bruises, as well as tiny reddish-purple dots that look like a rash. The prevalence (how many have ITP at any time) is 9.5 per 100,000. ITP patients experience chronic fatigue. The most concerning, but rare, form of bleeding due to ITP is an intracranial hemorrhage (bleeding in the brain). ITP treatment consists of the administration of corticosteroids, immunoglobulins, thrombopoietin receptor agonists, etc. However, sustained remission in the absence of treatment suggests the optimization of ITP management is necessary. About Oscotec Inc. Oscotec is a clinical stage drug discovery and development company pursuing translation of rigorous science into innovative medicine for clinically unmet needs.. The Company's clinical pipeline consists of targeted therapeutics in immunology and oncology. Oscotec is developing cevidoplenib (SYK inhibitor) for ITP (Phase 2, completed) and FLT3/AXL inhibitor for AML (Phase 1) as well as solid tumors (Phase 1). The company is also the originator of Lazertinib (LECLAZA®), a 3rd generation EGFR inhibitor being developed by Janssen Pharma and Yuhan Corp. for lung cancers. Contacts Jihyun Park, IR/PR [email protected] SOURCE Oscotec Inc.

Phase 2Orphan DrugPhase 1Immunotherapy

25 Aug 2023

·www.fiercepharma.com

Fierce Pharma Asia—Moderna's cancer combo plan; GSK's trial win; Glenmark's DOJ deal

Moderna and CARsgen's cancer deal, GSK's shingles trial in China and Glenmark's settlement with the U.S. Justice Department made our news this week. Moderna is considering pairing one of its mRNA cancer vaccine candidates with a CAR-T therapy from China's CARsgen. GSK's Shingrix showed 100% efficacy in a postmarketing trial in China. Glenmark and Teva have reached a settlement with U.S. prosecutors over price-fixing charges. 1. Moderna reveals Claudin18.2 ambitions via cancer vaccine, solid tumor CAR-T combo plans Chinese company CARsgen Therapeutics has reached a deal with Moderna for the two companies to “contemplate conducting preclinical studies and a phase 1 clinical trial” for a combination of Moderna’s Claudin18.2 mRNA cancer vaccine and CARsgen’s CAR-T therapy directed at the same target. Astellas, AstraZeneca, BioNTech and Legend Biotech are also working on Claudin18.2 therapies. 2. In GSK's trial of shingles vaccine in China, Shingrix keeps it 100 In a postmarketing study of GSK’s Shingrix in China, the shingles vaccine demonstrated 100% efficacy in nearly 6,000 people ages 50 and up. No Shingrix recipients got shingles, compared with 31 cases in the placebo group. GSK has attributed much of Shingrix’s recent sales growth to the shot's expansion in China. 3. Teva, Glenmark ⁠reach $255M price-fixing settlement with DOJ, agree to offload certain meds Teva and Glenmark have reached a settlement with the U.S. Department of Justice to resolve a price-fixing case. In the deferred prosecution agreement, Glenmark agreed to pay a fine of $30 million. Glenmark also admitted to participating in a conspiracy over the price of pravastatin. Teva will pay $225 million in the deal. 4. Hutchmed eyes Chinese approval for autoimmune disorder drug after phase 3 success Hutchmed said a phase 3 trial in China testing its Syk inhibitor sovleplenib as a primary immune thrombocytopenia treatment has met its goals. Compared with placebo, sovleplenib showed a significant increase in durable response rate compared with placebo in previously treated patients. The company plans to file for approval in China by the end of the year. 5. Alembic and Aurobindo issue US drug recalls, citing quality and production issues Two Indian companies, Alembic and Aurobindo, issued voluntary recalls in the U.S. Alembic pulled bottles of the antibiotic tobramycin because of quality issues. Aurobindo recalled some rufinamide tablets for treating seizure disorders because the products were distributed without being approved. 6. With health panel backing, Eisai one step away from Leqembi approval in Japan (Fierce Pharma regulatory tracker) A Japanese drug review panel has recommended approval of Eisai’s Alzheimer’s disease drug Leqembi. The decision sets up an official go-ahead from the local health ministry. A Jefferies analyst said he expected the Japanese government will reimburse the drug at around $13,700 per year, according to Bloomberg. Other News of Note: 7. Chinese CRO Tigermed debuts new HQ den in Hong Kong 8. Crown Bioscience, HanX pact shows promise of lymphoma drug

VaccineDrug ApprovalPhase 3Phase 1mRNA

100 Deals associated with PRT-2607

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	Canada	Biogen, Inc.	01 Aug 2012
Inflammation	Phase 1	United States	Portola Pharmaceuticals LLC	-
Inflammation	Phase 1	United Kingdom	Portola Pharmaceuticals LLC	-
Neoplasms	Phase 1	United States	Portola Pharmaceuticals LLC	-
Neoplasms	Phase 1	United Kingdom	Portola Pharmaceuticals LLC	-
Systemic Lupus Erythematosus	Phase 1	United States	-	-

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