Immunocompetence

selectION, Inc. to Present Update on Clinical Progress at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA, on January 11, 2024

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星期五, 一月 5, 2024
Selection, Immunocompetence, Conference, Atopic dermatitis, Safety, Patient, KCNA3, Disease, Pharmaceutical industry

San Diego, CA, USA, and Munich, Germany – January 5, 2024 - selectION, Inc., a clinical-stage biopharmaceutical company developing novel treatments for T cell mediated autoimmune diseases, today announced that management will present at the 42nd Annual J.P. Morgan Healthcare Conference.

Key Points: 
  • San Diego, CA, USA, and Munich, Germany – January 5, 2024 - selectION, Inc., a clinical-stage biopharmaceutical company developing novel treatments for T cell mediated autoimmune diseases, today announced that management will present at the 42nd Annual J.P. Morgan Healthcare Conference.
  • The presentation will be held Thursday, January 11, 2024, 08:00 AM - 08:25 AM PST at Golden Gate (32nd Floor), The Westin.
  • Blocking the target with a high-affinity molecule results in specific deactivation of the disease associated cell clone and induction of immunoregulatory processes.
  • As such, si-544 presents a compelling pipeline opportunity in the treatment of T cell mediated autoimmune diseases.

Corvus Pharmaceuticals Presents New Interim Soquelitinib Data from its Phase 1/1b T Cell Lymphoma Trial

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星期六, 十二月 9, 2023
Patient, Peripheral, Eligibility, Survival, Clinical trial, Lymphoma, Overalls, OS, Data, PFS, Pralatrexate, Immunocompetence, Pharmaceutical industry

BURLINGAME, Calif., Dec. 09, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from its Phase 1/1b clinical trial of soquelitinib in patients with relapsed PTCL. Soquelitinib demonstrated durable anti-tumor activity, evidenced by progression free survival, duration of response and overall survival rates that exceed current standard of care therapies for patients with relapsed PTCL. The data continues to support the advancement of soquelitinib into a Phase 3 registrational clinical trial in PTCL.

Key Points: 
  • The data continues to support the advancement of soquelitinib into a Phase 3 registrational clinical trial in PTCL.
  • Figure 1: Waterfall Plot for Patients in the 200 mg Dose Cohort of the Soquelitinib Phase 1/1b Clinical Trial for Peripheral T Cell Lymphoma.
  • Figure 3: Table Comparing Soquelitinib Data from Phase 1 (Eligible and Ineligible) to Data Reported for Pralatrexate and Belinostat.
  • Soquelitinib data are shown for both the eligible and ineligible patient populations from the Phase 1/1b trial reported above.

ChemDiv Presented Non-Clinical Summary Data for The Best-in-Class Selective FLT3 Clinical Candidate at the 65th ASH Annual Meeting and Exposition with Its Partners and Sponsors

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星期二, 十二月 12, 2023
Immunocompetence, Safety, SAN, Expert system, Chemical Diversity, Eilean Donan, Pharmacology, FLT3, University, Survival, AML, University of Cincinnati, Pharmaceutical industry

SAN DIEGO, Dec. 12, 2023 /PRNewswire/ -- ChemDiv Inc., dedicated to partnering in discovery and development of breakthrough therapies based on its unique chem-bio platforms, announces the presentation of non-clinical summary data for the best-in-class selective FLT3 clinical candidate at the 65th ASH Annual Meeting and Exposition in San Diego, CA.

Key Points: 
  • SAN DIEGO, Dec. 12, 2023 /PRNewswire/ -- ChemDiv Inc., dedicated to partnering in discovery and development of breakthrough therapies based on its unique chem-bio platforms, announces the presentation of non-clinical summary data for the best-in-class selective FLT3 clinical candidate at the 65th ASH Annual Meeting and Exposition in San Diego, CA.
  • "Therapeutic Targeting of FLT3 gatekeeper mutation with E2082-0047 in traditional and a novel Immunocompetent murine adoptive transfer model of AML" was presented by collaborators from University of Cincinnati, Ohio, Molsoft LLC and Expert Systems Inc of San Diego, California, and Eilean Therapeutics LLC from Dover, Delaware.
  • The presentation highlighted best-in-class potency and selectivity against gatekeeper resistant FLT-mutant AML and compelling survival benefit superior to gilteritinib in a fully immunocompetent Nmp1CAFLT3ITD-F692L AML adoptive transfer model, supporting the clinical candidate's ongoing clinical development.
  • In collaboration with rational design groups of Molsoft and Expert Systems, John Byrd's lab at University of Cincinnati, ChemDiv deployed a muti-targeting/multi-property optimization approach to achieve a 400-1000x selectivity of the resulting clinical candidate, which translated in best-in-class efficacy, safety, tolerability and developable pharmacology advantages delivered to partners at Eilean Therapeutics LLC.

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

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星期二, 八月 22, 2023
EUA, SARS-CoV-2, Centers for Disease Control and Prevention, Allergy, Medicine, Completeness, Arthralgia, Vaccination, Hospital, COVID-19, Chills, Section, Fever, Immunodeficiency, Coronavirus, Myocarditis, Pericarditis, COVID, History, Person, Immunocompetence, Messenger, CDC, Emergency Use Authorization, Myalgia, Research and development, Development, Hypoesthesia, Anaphylaxis, XBB, VAERS, NVAX, FDA, Headache, Death, Paresthesia, MIS, FD, Pharmaceutical industry, Vaccine, Novavax COVID-19 vaccine, Adjuvant, Novavax, Research

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

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星期二, 八月 22, 2023
EUA, SARS-CoV-2, Centers for Disease Control and Prevention, Allergy, Medicine, Completeness, Arthralgia, Vaccination, Hospital, COVID-19, Chills, Section, Fever, Immunodeficiency, Coronavirus, Myocarditis, Pericarditis, COVID, History, Person, Immunocompetence, Messenger, CDC, Emergency Use Authorization, Myalgia, Research and development, Development, Hypoesthesia, Anaphylaxis, XBB, VAERS, NVAX, FDA, Headache, Death, Paresthesia, MIS, FD, Pharmaceutical industry, Vaccine, Novavax COVID-19 vaccine, Adjuvant, Novavax, Research

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

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星期四, 七月 6, 2023
EUA, Autumn, Use, Centers for Disease Control and Prevention, Allergy, Medicine, Civil service commission, Arthralgia, Vaccination, Hospital, Completeness, Chills, Section, Fever, COVID-19, Immunodeficiency, European Directive on Traditional Herbal Medicinal Products, Coronavirus, Myocarditis, Pericarditis, COVID, History, Marketing, Person, Immunocompetence, CDC, Committee, Myalgia, Messenger, Hypoesthesia, Emergency Use Authorization, Anaphylaxis, European, VAERS, NVAX, European Medicines Agency, Ageing, FDA, Headache, Death, Regulation of tobacco by the U.S. Food and Drug Administration, Paresthesia, MIS, FD, Multisystem inflammatory syndrome, Food, European Commission, Safety, Financial Services and Markets Authority (Belgium), Vaccine, Pharmaceutical industry, EU, Novavax COVID-19 vaccine, Adjuvant, Novavax

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

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星期四, 七月 6, 2023
EUA, Autumn, Use, Centers for Disease Control and Prevention, Allergy, Medicine, Civil service commission, Arthralgia, Vaccination, Hospital, Completeness, Chills, Section, Fever, COVID-19, Immunodeficiency, European Directive on Traditional Herbal Medicinal Products, Coronavirus, Myocarditis, Pericarditis, COVID, History, Marketing, Person, Immunocompetence, CDC, Committee, Myalgia, Messenger, Hypoesthesia, Emergency Use Authorization, Anaphylaxis, European, VAERS, NVAX, European Medicines Agency, Ageing, FDA, Headache, Death, Regulation of tobacco by the U.S. Food and Drug Administration, Paresthesia, MIS, FD, Multisystem inflammatory syndrome, Food, European Commission, Safety, Financial Services and Markets Authority (Belgium), Vaccine, Pharmaceutical industry, EU, Novavax COVID-19 vaccine, Adjuvant, Novavax

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

CDC’s ACIP Unanimously Votes to Provisionally Recommend Use of Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) as an Option for Pneumococcal Vaccination in Infants and Children

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星期三, 六月 22, 2022
Health, Consumer, Children, Baby, Maternity, Pharmaceutical, Biotechnology, MSD, Immunocompetence, Population, Department, Fever, Fatigue, Patent, Security (finance), COVID-19, Animal, Streptococcus, Conjugate vaccine, Vaccine, Streptococcus pneumoniae, Disease, 23F, MMWR, Irritability, PCV13, United States Department of Health and Human Services, Myalgia, U.S. Securities and Exchange Commission, MRK, ACIP, Research, LinkedIn, Private Securities Litigation Reform Act, Ageing, Vaccination, Merck & Co., YouTube, Allergy, News, SEC, Twitter, Anaphylaxis, Diphtheria, Apnea, Coronavirus, Instagram, CDC, Headache, NYSE, Vaccines for Children Program, Human services, Morbidity and Mortality Weekly Report, Somnolence, Pharmaceutical industry, Merck, Facebook

Additionally, the ACIP unanimously voted to include VAXNEUVANCE in the Vaccines for Children program.

Key Points: 
  • Additionally, the ACIP unanimously voted to include VAXNEUVANCE in the Vaccines for Children program.
  • VAXNEUVANCE is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
  • Serotypes 3, 22F and 33F are responsible for more than a quarter of all invasive pneumococcal disease cases in children.
  • Vaccination of premature infants should be based on the infants medical status and the potential benefits and possible risks.

Talaris Therapeutics Presents Data on COVID-19 Outcomes Among Kidney Transplant Patients Treated with FCR001

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星期三, 四月 6, 2022
Private Securities Litigation Reform Act, Company, Therapy, Risk, Vaccination, Degenerative disease, Kidney, American Society of Transplantation, Immunocompetence, Clinical trial, Patient, COVID-19, IND, Research, U.S. Securities and Exchange Commission, Poster, Genetic distance, Safety, Society, Nasdaq, GLOBE, FCR, Northwestern University, Security (finance), Antibody, Pharmaceutical industry, Vaccine, Talari Networks

BOSTON and LOUISVILLE, Ky., April 06, 2022 (GLOBE NEWSWIRE) -- Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today shared new data on COVID-19 outcomes among living donor kidney transplant (LDKT) patients treated in the Company’s Phase 2 trial of investigational cell therapy product FCR001 (NCT00497926). The data were presented in a poster at the 2022 Cutting Edge of Transplantation (CEoT) meeting organized by the American Society of Transplantation.

Key Points: 
  • Of the 28 patients for whom data were available, 23 were durably chimeric and all of these patients were able to discontinue chronic immunosuppression (IS).
  • Of the 23 durably chimeric patients off chronic IS, 18 were vaccinated, of whom 2 (11%) tested positive for COVID-19.
  • Among the remaining 5 patients who were off all chronic IS but were unvaccinated, 3 (60%) tested positive for COVID-19.
  • Among the 5 patients who remained on chronic IS, 4 of whom were vaccinated, 2 (40%) tested positive for COVID-19.

Merck Provides Update on FDA Review of Supplemental Biologics License Application for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children

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星期五, 四月 1, 2022
FDA, Health, Research, Pharmaceutical, Science, Biotechnology, MSD, Life, LinkedIn, Headache, Population, MRK, Anaphylaxis, Patent, 23F, Allergy, Immunocompetence, Merck & Co., Prescription Drug User Fee Act, NYSE, Conjugate vaccine, Medicine, Vaccine, Vaccination, Research, SEC, Myalgia, Cancer, Food, U.S. Securities and Exchange Commission, Private Securities Litigation Reform Act, Security (finance), Diphtheria, Twitter, Breakthrough therapy, Priority review, COVID-19, Regulation of tobacco by the U.S. Food and Drug Administration, CRM197, News, Animal, HIV, Coronavirus, PDUFA, YouTube, Arthralgia, Streptococcus pneumoniae, FDA, Instagram, Fatigue, Patient, Infection, Pharmaceutical industry, Birth control, Facebook, Merck, VAXNEUVANCE (PNEUMOCOCCAL 15-VALENT CONJUGATE VACCINE), MERCK

The FDA requested additional analyses of data from the pediatric studies, which Merck has submitted to the FDA.

Key Points: 
  • The FDA requested additional analyses of data from the pediatric studies, which Merck has submitted to the FDA.
  • In December 2021, Merck announced that the FDA accepted the companys application for VAXNEUVANCE for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age and it was granted Priority Review.
  • VAXNEUVANCE previously received Breakthrough Therapy designation and Priority Review from the FDA for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age.
  • Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.