Serology

Candel Therapeutics Announces Oral Presentation During the 5th Glioblastoma Drug Development Summit with Update on Phase 1b Clinical Trial of CAN-3110 in Recurrent High-Grade Glioma

Retrieved on: 
Thursday, March 28, 2024
SOC, Survival, Fast track (FDA), Safety, Patient, Food and Drug Administration, Standard of care, Doctor of Philosophy, MD, Clinical trial, Therapy, Injection, FDA, Drug development, CADL, Food, Serology, Pharmaceutical industry

“Dosing patients with multiple injections represents the next step forward in the development of CAN-3110 for rHGG,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “The observed data suggest that repeated injections of CAN-3110 are well tolerated, supporting the design of a future phase 2 clinical trial in this indication. We’re excited by our recent progress -- as illustrated by the publication in Nature, CAN-3110’s recent FDA Fast Track designation, and the collaboration with Batavia Biosciences -- to accelerate the development and production of CAN-3110, along with our update presented today. Together, we hope this will help to accelerate the development of a better treatment for patients with high unmet need.”

Key Points: 
  • The first cohort of patients were treated with multiple injections of CAN-3110 in the ongoing phase 1b clinical trial.
  • A second cohort is being planned for enrollment in the ongoing phase 1b clinical trial of CAN-3110.
  • The data were presented today during the 5th Glioblastoma Drug Development Summit in Boston, Massachusetts.
  • Results from the ongoing phase 1b clinical trial were published in Nature in Q4 2023.

argenx Advances Clinical Development of Efgartigimod in Primary Sjogren’s Disease

Retrieved on: 
Wednesday, March 27, 2024
Disease, Patient, Biomarker, STAR, Euronext, Woman, EULAR, Safety, Composite, Immunoglobulin G, RHO, Serology

“We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.

Key Points: 
  • “We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.
  • “Consistent with our indication selection strategy, we confirmed our IgG biology hypothesis with these data, and now have a demonstrated clinical effect across multiple efficacy scales to support proof-of-concept.
  • Sjogren’s disease can be debilitating, predominantly affects women, and given its heterogeneous nature, is often misdiagnosed with its symptoms poorly understood.
  • Efficacy assessments showed a treatment effect across multiple clinical endpoints, which were also consistent with biomarker data.

First Wave BioPharma Announces Two Abstracts on Celiac Disease Research Accepted for Presentation at the 2024 Digestive Disease Week (DDW) Conference

Retrieved on: 
Monday, March 18, 2024
Inflammation, Health, Conference, Database, Patient, Serology, Research, Lymphocyte, Gastrointestinal disease, Doctor of Philosophy, CED, First wave, Abstract, Gastroenterology, DDW, Coeliac disease, IEL

BOCA RATON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that two abstracts have been accepted for presentation at the 2024 Digestive Disease Week Conference (DDW 2024) taking place May 18-21, 2024, in Washington, D.C.

Key Points: 
  • “The abstracts accepted for presentation at DDW 2024 showcase significant advancements in the field of gastroenterology, particularly in the precision diagnosis and management of celiac disease through the innovative VCIEL scale that our team has developed,” stated James Sapirstein, Chairman and CEO of First Wave BioPharma.
  • Details on the presentations are as follows:
    Jack Syage, PhD.
  • President & Chief Operating Officer, First Wave BioPharma
    Jack Syage, PhD.
  • President & Chief Operating Officer, First Wave BioPharma

Vaxcyte Completes Enrollment of Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease (IPD) in Infants

Retrieved on: 
Monday, March 4, 2024
SAN, Immunization, PCV, Serology, Life, Vaccine, Safety, Meningitis, Genetically modified bacteria, IPD, Tolerability, Infant, Disease, Streptococcus pneumoniae, Fungal infection

SAN CARLOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced the completion of enrollment in its Phase 2 study evaluating VAX-24, a broad-spectrum, carrier-sparing 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in healthy infants. Vaxcyte expects to announce topline safety, tolerability and immunogenicity data from the Phase 2 study primary three-dose immunization series by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025.

Key Points: 
  • Vaxcyte expects to announce topline safety, tolerability and immunogenicity data from the Phase 2 study primary three-dose immunization series by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025.
  • “Completing enrollment of the VAX-24 study with more than 800 healthy infants demonstrates yet another significant milestone in the development of our VAX-24 and VAX-31 PCV candidates,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte.
  • “We believe VAX-24 has a potential best-in-class profile for this vital population and is designed to cover more serotypes than any infant pneumococcal vaccine on-market or in U.S. clinics today.
  • “Given the significant burden of disease in young children, there remains a need for broader-spectrum vaccines like VAX-24 and VAX-31, our next-generation 31-valent PCV candidate, that are designed to provide greater protection than the current standard-of-care.”

Cancer Immunotherapy Stocks - Tapping into Immune Systems for Next Generation Treatments

Retrieved on: 
Thursday, February 15, 2024
Neoplasm, Doctor of Philosophy, Immunotherapy, SCCA, News, Pharmaceutics, Destiny, PR, Optimism, Poster, Anal cancer, Pancreatic cancer, Anal, CEACAM6, Brigham and Women's Hospital, Bristol Myers Squibb, Therapy, Immune system, Pelareorep, International, Breast cancer, Fast track (FDA), Serology, AIO, Hospital, Hope, Principal investigator, HGG, Conference, Safety, Biomarker, Tumor microenvironment, Patent, Clinical trial, Survival, Harvard Medical School, Acute lymphoblastic leukemia, Injection, MSI, MD, BioNTech, FDA, TSX, Cancer, Entrepreneurship, Prevalence, American depositary receipt, Anal canal, Patient, Cone Health Women's Hospital, ONC, Pharmaceutical industry

According to the American Association for Cancer Research "Cancer immunotherapeutics work by unleashing the power of a patient's immune system to fight cancer and, over the last decade, have emerged as one of the most exciting new approaches to cancer treatment."

Key Points: 
  • According to the American Association for Cancer Research "Cancer immunotherapeutics work by unleashing the power of a patient's immune system to fight cancer and, over the last decade, have emerged as one of the most exciting new approaches to cancer treatment."
  • Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) is developing pelareorep, a unique immunotherapy with the power to awaken the immune system and unlock its antitumor potential.
  • It is committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
  • Bristol-Myers Squibb and Fate Therapeutics are some of the other key patent filers in cancer immunotherapy."

CAN-3110 Receives FDA Fast Track Designation for Treatment of Recurrent High-Grade Glioma

Retrieved on: 
Tuesday, February 13, 2024
Injection, Doctor of Philosophy, Fast track (FDA), MD, Serology, FDA, Food, Hospital, CADL, Hope, Principal investigator, HGG, Therapy, Tumor microenvironment, Patient, Clinical trial, Survival, Harvard Medical School, Pharmaceutical industry

“Receiving FDA Fast Track Designation for CAN-3110 reinforces the critical need to find effective treatment options for patients with recurrent HGG and further supports the potential of CAN-3110 to address the challenges that the standard of care and conventional therapies have failed to meet,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel.

Key Points: 
  • “Receiving FDA Fast Track Designation for CAN-3110 reinforces the critical need to find effective treatment options for patients with recurrent HGG and further supports the potential of CAN-3110 to address the challenges that the standard of care and conventional therapies have failed to meet,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel.
  • “As recently published in Nature, a strong local and systemic anti-tumoral response and improved survival in patients with recurrent HGG was observed following a single injection of CAN-3110.
  • Positive HSV-1 serology was a predictor of response and was associated with improved survival (mOS in this population reached 14 months).
  • “With Fast Track Designation, I look forward to the potential of accelerating the development of CAN-3110 and the possibility of bringing this differentiated therapy to patients with recurrent high-grade glioma as we strive to improve outcomes and provide hope for patients and their families.”

Candel Therapeutics Sets Path to Success: Recent Achievements Pave the Way for a Promising 2024 Propelled by Key Value Drivers and Catalysts

Retrieved on: 
Monday, February 5, 2024
Injection, Serology, OS, Tumor microenvironment, Survival, Prostate cancer, Breast cancer, Immunotherapy, Pancreatic cancer, MD, PDAC, SITC, Enlightenment, Food and Drug Administration, Lung cancer, Society, Clinical trial, Therapy, Patient, Brain, Cancer, FDA, Biomarker, Trial of the century, Food, CADL, Fast track (FDA), CSO, Disease, Biology, Pancreatitis, Doctor of Philosophy, Valaciclovir, Conference, Pharmaceutical industry

“Candel is focused on delivering key value drivers to maximize the impact of its assets and to create substantial value to patients and other stakeholders.

Key Points: 
  • “Candel is focused on delivering key value drivers to maximize the impact of its assets and to create substantial value to patients and other stakeholders.
  • In 2023, we received Fast Track Designation from the FDA for CAN-2409, our most advanced product candidate, for both NSCLC and pancreatic cancer.
  • This platform is open for collaborations with external partners.”
    The Company's strategic prioritization of programs highlights Candel Therapeutics' commitment to operational excellence and efficiency.
  • This approach positions the Company for sustained success in the current dynamic market for new cancer therapeutics.

QPS Holdings, LLC Expands Operations in Springfield, Missouri

Retrieved on: 
Monday, December 4, 2023
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Pharmacist, Administration, Contract research organization, Clinical trial, Hematology, QPS, Safety, Urinalysis, Multimedia, Pharmacy, Physician, Pharmaceutical industry, Chemistry, Serology

QPS Holdings, LLC, a global contract research organization has expanded operations in Springfield, Missouri.

Key Points: 
  • QPS Holdings, LLC, a global contract research organization has expanded operations in Springfield, Missouri.
  • The 2,750-square-foot facility is fully operational as of the fall of 2023 and will give QPS significant flexibility in clinical research study operations.
  • View the full release here: https://www.businesswire.com/news/home/20231204471818/en/
    QPS Missouri is a division of QPS Holdings, LLC, a global Contract Research Organization.
  • QPS Missouri conducts Phase I-IV clinical trials in Springfield, Missouri, and has recently added a new safety laboratory, updated pharmacy, and clinical trial kit production facility.

EQS-News: EVOMEDIS Announces Strategic Partnership with Medical University of Graz and COREMED Graz to Foster Wound Healing Innovation

Retrieved on: 
Thursday, December 7, 2023
Burns, Medical school, Regenerative medicine, Orphan, Atakent (business cooperation center), Partnership, European Medicines Agency, Transfusion medicine, ATMP, RESEARCH, Serology, Wound healing, GMP, Pharmaceutical industry, Nursing, Austria, Germany

Investing in the future of burn medicine: Alliance to develop new cell-based therapy

Key Points: 
  • Investing in the future of burn medicine: Alliance to develop new cell-based therapy
    Graz, Austria, 23 November 2023 – EVOMEDIS GmbH (EVOMEDIS), an R&D stage life science company developing next-generation wound healing solutions, today announced the initiation of a strategic partnership with the Medical University of Graz (MedUni) and COREMED (Cooperative Center for Regenerative Medicine / JOANNEUM RESEARCH Forschungsgesellschaft mbH) to propel the shift from wound care to wound healing through innovative solutions.
  • EVOMEDIS has pledged an investment of €1.5 million over a span of two years for a collaborative project.
  • We have set up our operations at MedUni, which is part of the Medical Science City Graz (MSCG).
  • This perfectly aligns with our strategy of working closely with local partners to develop new innovations for wound healing up to clinical proof-of-concept.

Accelecom Increases Equine Diagnostic Solutions (EDS) Horsepower with High-Speed Network and Voice Solutions

Retrieved on: 
Tuesday, November 7, 2023
Serology, EDS, Veterinarian, UCAA, Partnership, Communication, Commonwealth, Horse

LOUISVILLE, Ky., Nov. 7, 2023 /PRNewswire/ -- Accelecom , a leading provider of next-generation fiber solutions announced today that it has been selected by Equine Diagnostic Solutions (EDS), a Lexington, Kentucky headquartered company to serve as its preferred network and voice provider.

Key Points: 
  • LOUISVILLE, Ky., Nov. 7, 2023 /PRNewswire/ -- Accelecom , a leading provider of next-generation fiber solutions announced today that it has been selected by Equine Diagnostic Solutions (EDS), a Lexington, Kentucky headquartered company to serve as its preferred network and voice provider.
  • Established in 2009, EDS has been dedicated to delivering relevant, accurate, expedient, high-quality, and accessible testing services for equine veterinarians across the globe.
  • Brad Kilbey, CEO of Accelecom, said, "The Equine industry is pivotal to the Commonwealth, and we are thrilled to work with Equine Diagnostic Solutions to provide them with the high-speed network and voice solutions they require.
  • EDS's mission to support equine veterinarians worldwide aligns perfectly with our commitment to delivering reliable and innovative communication solutions.