TLR9

InDex Pharmaceuticals to exhibit at United European Gastroenterology Week

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Mercoledì, Ottobre 5, 2022
EMA, TLR9, The Lancet, Patient, Nasdaq, III, IIB, Index, DIMS, Certification, Hepatology, Patent, Safety, Ulcerative colitis, DNA, FDA, JAK, Immunotherapy, Pharmaceutical industry

The study has been designed in consultation with both the US and European regulatory authorities, the FDA and EMA respectively.

Key Points: 
  • The study has been designed in consultation with both the US and European regulatory authorities, the FDA and EMA respectively.
  • The induction study will include approximately 440 patients, and the primary endpoint will be clinical remission at week 6, which is the same primary endpoint as used in the successful phase IIb study CONDUCT.
  • Cobitolimod is being evaluated in the phase III study CONCLUDE as a novel treatment of moderate to severe ulcerative colitis.
  • InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options.

Tallac Therapeutics Announces First Patient Dosed with TAC-001, a First-in-Class Toll-like Receptor 9 Agonist Antibody Conjugate, in a Phase 1/2 Study for Patients with Advanced Solid Tumors

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Giovedì, Luglio 28, 2022
Oncology, Health, Health Technology, General Health, Clinical Trials, Pharmaceutical, Biotechnology, TLR9, Immunity, CEO, Melanoma, Partnership, TRAAC, Therapy, Immune system, Safety, Tumor microenvironment, Multimedia, Immunology, Cancer, Immunotherapy, B cell, Patient, Nasdaq, CD22, Pharmacokinetics, Doctor of Philosophy, TLS, IND, Pharmaceutical industry, Vaccine, Mount Tallac

TAC-001 is the companys lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform and the first to enter the clinic.

Key Points: 
  • TAC-001 is the companys lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform and the first to enter the clinic.
  • This therapeutic candidate is a systemically delivered toll-like receptor 9 (TLR9) agonist targeting dendritic cells via SIRP-alpha receptors.
  • The Phase 1/2 trial, known as INCLINE-101 ( NCT05399654 ), is an open label, multicenter, dose escalation and expansion study of TAC-001 in patients with select advanced or metastatic solid tumors.
  • Tallac Therapeutics TRAAC platform is designed to deliver a potent and differentiated TLR9 agonist (T-CpG) for targeted immune activation via systemic administration.

TriSalus Life Sciences Provides Update on Development of Immunotherapy Platform Approach for Liver and Pancreatic Tumors

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Mercoledì, Giugno 22, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Medical Devices, Clinical Trials, MD Anderson Cancer Center, Population, FDA, Therapy, Uveal melanoma, Liver, Columbia University Irving Medical Center, Hope, Safety, Science, Society, Pancreatic tumor, Tumor microenvironment, TLR9, Drug, University of Pittsburgh Medical Center, SIR, Immunosuppression, Liver cancer, Research, Blood, LinkedIn, Cohort study, Engineering, Pressure, Massachusetts General Hospital, Congress, MDSC, Society of Interventional Radiology, Clinical trial, FACS, Immune system, University, Nivolumab, International Society, Hepatocellular carcinoma, Liver disease, Immunotherapy, Associate, Twitter, Patient, Columbia University, Academic health science centre, Neoplasm, Principal investigator, Pancreas, Cholangiocarcinoma, Interventional radiology, Thomas Jefferson University Hospital, Medical imaging, Pharmaceutical industry, MD

TriSalus Life Sciences , an immunotherapy company on a mission to extend and improve the lives of patients with liver and pancreatic tumors, today highlighted a series of updates from clinical and pre-clinical studies that help support the companys immunotherapy platform approach for treating liver and pancreatic tumors.

Key Points: 
  • TriSalus Life Sciences , an immunotherapy company on a mission to extend and improve the lives of patients with liver and pancreatic tumors, today highlighted a series of updates from clinical and pre-clinical studies that help support the companys immunotherapy platform approach for treating liver and pancreatic tumors.
  • Dr. Katz continued, The TriSalus immunotherapy platform combines the well-studied, investigational immunotherapy, SD-101, administered via PEDD, an innovative vascular delivery method leveraged by FDA-cleared devices.
  • In a second abstract presentation at SIR 2022 , TriSalus highlighted new data on the development of a trans-venous approach for the regional treatment of pancreatic tumors, called pancreatic retrograde venous infusion (PRVI).
  • TriSalus Life Sciences is an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors.

Statera Biopharma Announces BF Borgers CPA PC as Independent Registered Public Accounting Firm

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Martedì, Giugno 14, 2022
Certified Public Accountant, Fibromyalgia, Company, Income, Cancer, Pancreatic cancer, Autoimmunity, Budget, GLOBE, Patient, TLR9, COVID-19, Antibody, NASDAQ, SEC, TLR5, Virus, Multiple sclerosis, Homeostasis, TLR, Entolimod, TLR4, Bookkeeping, Vaccine

Statera Biopharma, Inc. (formerly Cytocom, Inc.) is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the bodys immune system and restore homeostasis.

Key Points: 
  • Statera Biopharma, Inc. (formerly Cytocom, Inc.) is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the bodys immune system and restore homeostasis.
  • Statera Biopharma has clinicalprograms for Crohns disease (STAT-201),hematology (Entolimod), pancreatic cancer (STAT-401) andCOVID-19 (STAT-205) in addition to potential expansion into fibromyalgia and multiple sclerosis.To learn more about Statera Biopharma, please visit www.staterabiopharma.com .
  • We have based these forward-looking statements on the current expectations about future events held by management.
  • The forward-looking statements included in this press release are made only as of the date hereof.

Kuros Biosciences: Completion of the Acquisition of Checkmate Pharmaceuticals by Regeneron Pharmaceuticals Triggers a $5 Million Milestone Payment

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Giovedì, Giugno 2, 2022
Regeneron Pharmaceuticals, Melanoma, TLR9, GLOBE, Technology, Acquisition, NASDAQ, Kuros, CpG, Pharmaceutical industry, Checkmate

SCHLIEREN (ZURICH), Switzerland, June 02, 2022 (GLOBE NEWSWIRE) -- Kuros Biosciences AG (“Kuros” or the “Company”), a leader in next generation bone graft technologies, notes the completion of the acquisition of Checkmate Pharmaceuticals (NASDAQ: CMPI) by Regeneron Pharmaceuticals (NASDAQ: REGN). The completion triggers a $5 million milestone payment under a license agreement entered into by Kuros and Checkmate in 2015.

Key Points: 
  • SCHLIEREN (ZURICH), Switzerland, June 02, 2022 (GLOBE NEWSWIRE) -- Kuros Biosciences AG (Kuros or the Company), a leader in next generation bone graft technologies, notes the completion of the acquisition of Checkmate Pharmaceuticals (NASDAQ: CMPI) by Regeneron Pharmaceuticals (NASDAQ: REGN).
  • The completion triggers a $5 million milestone payment under a license agreement entered into by Kuros and Checkmate in 2015.
  • Under a royalty purchase agreement entered into by Kuros and XOMA Corporation (NASDAQ: XOMA) in 2021, XOMA is entitled to receive 50% of the milestone payment paid to Kuros as a result of a change of control of Checkmate Pharmaceuticals.
  • Therefore, $2.5 million of the $5 million milestone due to Kuros under the 2015 license agreement will be paid to XOMA.

University of Iowa Holden Comprehensive Cancer Center Presents Preliminary Data from Clinical Trial of Vidutolimod at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

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Giovedì, Maggio 26, 2022
CpG, Lymphoma, U.S. Securities and Exchange Commission, Private Securities Litigation Reform Act, VLP, Abstract, Patient, Acceleration, File, Financial condition report, NASDAQ, Result, NCI, Review, SC, COVID-19, Research, Securities Act of 1933, Toll, Pembrolizumab, CMPI, Immunization, Toxicity, Internal medicine, Forward-looking statement, Regeneron Pharmaceuticals, TLR9, University, Justice and Security Act 2013, Immune system, Security (finance), Analysis, Annual report, GLOBE, Pharmaceutical industry, Vaccine, Checkmate

The early phase trial is investigating intratumoral vidutolimod therapy in combination with intravenous pembrolizumab in patients with relapsed lymphoma.

Key Points: 
  • The early phase trial is investigating intratumoral vidutolimod therapy in combination with intravenous pembrolizumab in patients with relapsed lymphoma.
  • In addition to the funding provided by Checkmate, the ongoing study is supported by NCI grant P50 CA97274 to the University of Iowa/Mayo Clinic (UI/MC) Lymphoma SPORE (specialized program of research excellence).
  • Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer.
  • The information that Checkmate Pharmaceuticals posts on these channels and websites could be deemed to be material information.

Statera Biopharma Receives Notification Letter from Nasdaq Regarding Form 10-Q Filing

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Lunedì, Maggio 23, 2022
Cancer, Company, Autoimmunity, Cleveland BioLabs, TLR, Exercise, Patient, Homeostasis, Cleveland, Antibody, Coronavirus, TLR5, Therapy, COVID-19, Fibromyalgia, Research, Entolimod, TLR4, Compliance, Virus, Multiple sclerosis, Budget, Union, Risk, Calendar, Pancreatic cancer, SEC, Growth, TLR9, Letter, Annual report, GLOBE, Online gambling, Nasdaq

In addition, the Company has the potential to reinvirogate its pipeline with certain assets from Lay Sciences, Inc. as previously announced.

Key Points: 
  • In addition, the Company has the potential to reinvirogate its pipeline with certain assets from Lay Sciences, Inc. as previously announced.
  • On April 19, 2022, the Company received notification from Nasdaq that it had failed to comply with Nasdaq Listing Rule 5250(c)(1) because it was delinquent in filing its Annual Report on Form 10-K for the period ending December 31, 2021.
  • In a subsequent letter dated May 18, 2022 the Company received further notification from Nasdaq that it had failed to comply with Nasdaq Listing Rule 5250(c)(1) because it was delinquent in filing its Quarterly Report on Form 10-Q for the three-month period ending March 31, 2022.
  • Statera has clinicalprograms for Crohns disease (STAT-201),hematology (Entolimod), pancreatic cancer (STAT-401) andCOVID-19 (STAT-205) in addition to potential expansion into fibromyalgia and multiple sclerosis.To learn more about Statera Biopharma, please visit www.staterabiopharma.com .

Tallac Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for TAC-001, a First-in-Class Toll-like Receptor 9 (TLR9) Agonist Antibody Conjugate for Patients with Advanced Solid Tumors

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Giovedì, Maggio 19, 2022
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, CD22, Immunotherapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Tumor microenvironment, Multimedia, Patient, Therapy, Immunology, FDA, IND, Syngenic, TLS, Immunity, TRAAC, TLR9, Immune system, Cancer, Investigational New Drug, Melanoma, CEO, Pharmaceutical industry, Vaccine

TAC-001 is the companys lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform.

Key Points: 
  • TAC-001 is the companys lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform.
  • This critical milestone for our TRAAC platform marks the beginning of an exciting new phase as we evolve into a clinical-stage company.
  • (Graphic: Business Wire)
    We are delighted that our IND for TAC-001 was cleared by FDA, said Dr. Hong I. Wan, president, CEO and co-founder of Tallac Therapeutics.
  • TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent Toll-like Receptor 9 agonist (T-CpG) conjugated to an antibody against CD22, a receptor restricted to B cells, including tumor-infiltrating B cells.

Idera Pharmaceuticals Shares Positive Results from Investigator-Sponsored Trial in Melanoma Patients at Amsterdam UMC

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Martedì, Maggio 17, 2022
Cancer, U.S. Securities and Exchange Commission, Risk, Fever, Company, Flow cytometry, Disease, Population, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, OS, Survival, Melanoma, Nasdaq, Patient, Coronavirus, Phase II, Sentinel lymph node, SLN, LNR, Clinical trial, Idera, Inc., Survival rate, COVID-19, UMC, Death, Antigen presentation, Hope, Recurrence, Securities Act of 1933, Securities Exchange Act of 1934, Intention, Partnership, TLR9, Vrije Universiteit Amsterdam, B cell, Justice and Security Act 2013, Biopsy, Skin, Acquisition, GLOBE, RFS, Melanocyte, Security (finance), Documentation, Pharmaceutical industry, Medical imaging, Vaccine

EXTON, Pa., May 17, 2022 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (Idera, we, and our) (Nasdaq: IDRA) today shared positive interim results from Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands, regarding its investigator-sponsored trial, INTRIM 1, involving tilsotolimod, Ideras synthetic Toll-like receptor 9 agonist.

Key Points: 
  • EXTON, Pa., May 17, 2022 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (Idera, we, and our) (Nasdaq: IDRA) today shared positive interim results from Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands, regarding its investigator-sponsored trial, INTRIM 1, involving tilsotolimod, Ideras synthetic Toll-like receptor 9 agonist.
  • The trial will continue to relapse-free survival (RFS) and overall survival (OS) at 5 and 10 years after SLN biopsy.
  • Currently, there are limited adjuvant treatments available to improve survival after surgical excision of a primary melanoma, said Prof. Tanja de Gruijl of Amsterdam UMC.
  • INTRIM 1 is a multi-center investigator-sponsored trial conducted by UMC Amsterdam among patients with pT3-4 cN0M0 melanoma.

Statera Biopharma and Lay Sciences Inc. Announce Intent to Enter Strategic Partnership to License the Manufacturing Rights to Certain Lay Sciences IgY Products

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Venerdì, Maggio 13, 2022
Cancer, Immunoglobulin Y, Company, Autoimmunity, Cleveland BioLabs, TLR, Exercise, Infection, Patient, Homeostasis, Cleveland, Antibody, Coronavirus, TLR5, COVID-19, Fibromyalgia, Research, Entolimod, TLR4, Partnership, Virus, Multiple sclerosis, Budget, Union, Risk, Pancreatic cancer, Science, GI, SEC, Growth, TLR9, GLOBE, Fine chemical, Bookkeeping, Vaccine

The strategic partnership with Lay Sciences has the potential to produce near term revenue, said Michael K. Handley, President and Chief Executive Officer of Statera Biopharma.

Key Points: 
  • The strategic partnership with Lay Sciences has the potential to produce near term revenue, said Michael K. Handley, President and Chief Executive Officer of Statera Biopharma.
  • Statera also receives the right to license and commercialize current and future products for other indications.
  • Using patent pending and proprietary technologies owned by Lay Sciences or licensed from its partnering companies, ReaGene Biosciences Pvt.
  • Ltd., Lay Sciences is dedicated to developing and providing innovative products and devices focused on treating and preventing diseases of the GI tract.