Epitope

ExeVir Bio Announces Positive Virus Neutralization Data for XVR012 Against Emerging COVID-19 Omicron Variants

Retrieved on: 
Montag, Januar 15, 2024
Patient, Epitope, Omicron, Risk, Public, Infection, Immunodeficiency, IC50, WHO, COVID-19, Antibody, Virus, Vaccine, SARS-CoV-2

All authorized SARS-CoV-2 therapeutic antibodies that have been used in the clinic show severe to complete loss of virus neutralization potency against the currently circulating variants.

Key Points: 
  • All authorized SARS-CoV-2 therapeutic antibodies that have been used in the clinic show severe to complete loss of virus neutralization potency against the currently circulating variants.
  • ExeVir’s XVR012, a cocktail of XVR013m and XVR014, targets three distinct epitopes highly conserved across the broad sarbecovirus subgenus of Coronaviridae to minimize the risk for viral escape.
  • XVR013m is a heavy chain-only antibody targeting a unique membrane-proximal epitope in the S2 subunit of the spike protein.
  • ExeVir is currently gearing up to start the clinical development of both the combination XVR012, as well as its individual components XVR013m and XVR014.

Prothena Provides Updates on PRX012, PRX123, Birtamimab and Portfolio Programs

Retrieved on: 
Montag, Januar 8, 2024
Biotechnology, Health, Clinical Trials, Biology, Failure, Food, Risk, Hand, FDA, Acquisition, Amyloidosis, Roche, Mortality, Organ dysfunction, Orphan, ATTR, VITAL, Novo Nordisk, Epitope, PD, European Medicines Agency, Fast track (FDA), TTR, Amyloid, Alpha-synuclein, Patient, Bristol Myers Squibb, Therapy, Vaccine

Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, provided a business update on portfolio programs.

Key Points: 
  • Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, provided a business update on portfolio programs.
  • The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for PRX012 for the treatment of AD.
  • Update on Financial Position for December 31, 2023
    At December 31, 2023, Prothena had cash, cash equivalents, and restricted cash of approximately $621 million.
  • Cash on hand provides sufficient capital which takes Prothena beyond the completion of its ongoing clinical trials.

ProMIS Neurosciences Issues Letter to Shareholders

Retrieved on: 
Montag, Januar 8, 2024
PROMIS, Intellectual property, ALS, MSA, Multiple system atrophy, Antibody, Letter, Frontotemporal lobar degeneration, Trial of the century, Brain, MD, RACK1, Epitope, PMN, Artificial intelligence, SAD, FTLD, Growth, Safety, Patient, Dementia, Therapy, Pharmaceutical industry

TORONTO, Ontario and CAMBRIDGE, Massachusetts, Jan. 08, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Issues Letter to ShareholderProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that its Chief Executive Officer, Neil Warma, issued the following letter to the Company’s shareholders.

Key Points: 
  • TORONTO, Ontario and CAMBRIDGE, Massachusetts, Jan. 08, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Issues Letter to ShareholderProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that its Chief Executive Officer, Neil Warma, issued the following letter to the Company’s shareholders.
  • Our ultimate goal is to get these potential new drugs to patients who are in desperate need of safe and effective treatment options.
  • This specificity is expected to improve efficacy outcomes and prevent any off-target safety issues, which are common with other AD therapies currently marketed or in development.
  • As we navigate this transformative period, I am confident that ProMIS will emerge stronger, more resilient, and better positioned to make significant contributions to healthcare.

Invivyd Submits Request for Emergency Use Authorization (EUA) to U.S. FDA for VYD222 for the Pre-exposure Prevention of COVID-19 in Immunocompromised Adults and Adolescents

Retrieved on: 
Mittwoch, Januar 3, 2024
Immunodeficiency, Entrepreneurship, Food, FDA, Vaccine, Half-life, Epitope, COVID-19, SARS-CoV-2, Safety

Many immunocompromised people do not achieve full benefit from COVID-19 vaccines as their immune systems are unable to provide sufficient defense against SARS-CoV-2.

Key Points: 
  • Many immunocompromised people do not achieve full benefit from COVID-19 vaccines as their immune systems are unable to provide sufficient defense against SARS-CoV-2.
  • On December 18, 2023, Invivyd announced positive initial results from the ongoing CANOPY pivotal clinical trial.
  • VYD222 produced high serum virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in the immunocompromised cohort.
  • If authorized, Invivyd aims to have VYD222 commercially available rapidly thereafter.

EpiVax Licenses ISPRI Toolkit to Eisai for Preclinical in silico Immunogenicity Screening

Retrieved on: 
Mittwoch, Dezember 20, 2023
Antibody, Epitope, EpiVax, CSCO, Partnership, Risk assessment, Phenotype, Dementia, Risk, Neurology, Vaccine

PROVIDENCE, R.I., Dec. 20, 2023 /PRNewswire/ -- EpiVax, Inc. ("EpiVax"), an internationally recognized leader in the field of immunogenicity, today announced that Eisai Co. Ltd. ("Eisai") has licensed EpiVax's ISPRI toolkit for preclinical immunogenicity risk assessment of Eisai's robust biologics pipeline.

Key Points: 
  • PROVIDENCE, R.I., Dec. 20, 2023 /PRNewswire/ -- EpiVax, Inc. ("EpiVax"), an internationally recognized leader in the field of immunogenicity, today announced that Eisai Co. Ltd. ("Eisai") has licensed EpiVax's ISPRI toolkit for preclinical immunogenicity risk assessment of Eisai's robust biologics pipeline.
  • "We're eager to enable Eisai with incorporation of rapid, secure, and advanced immunogenicity risk assessment"
    The ISPRI toolkit is a secure web-based platform that allows researchers to rapidly assess the immunogenic risk of biologic candidates.
  • Eisai's R&D organization plans to utilize the ISPRI toolkit to screen a wide range of therapeutic modalities, including antibodies, antibody-drug conjugates, and non-antibody protein therapeutics.
  • "We're eager to enable Eisai with incorporation of rapid, secure, and advanced immunogenicity risk assessment into their drug discovery process," said EpiVax CEO/CSO, Annie De Groot, MD.

EQS-News: CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2023 and Provides Business Update

Retrieved on: 
Dienstag, Dezember 26, 2023
Survival, Research and development, BioNTech, CureVac, Workforce, Operating cost, GSK, Epitope, Webcast, Safety, Business development, RNA, CVAC, Conference, Sąd rejonowy, Astrocytoma, Neoplasm, Pfizer–BioNTech COVID-19 vaccine, Development, Vaccine, Commercial, LNP, Phase II, Acquisition, Immortalised cell line, Animal, GMP, Interim, Palatine Higher Regional Court, Patent, SARS-CoV-2, Tumor microenvironment, Toxicity, Glioblastoma, Antigen, Therapy, Research, Messenger, Mouse, COVID-19, Infection, Clinical trial, District court, Cancer, Patient, CMO, CD8

ET / 3 p.m. CET

Key Points: 
  • ET / 3 p.m. CET
    TÜBINGEN, Germany/BOSTON, USA – November 14, 2023 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced financial results for the third quarter and first nine months of 2023 and provided a business update.
  • Positive preliminary data reported in early 2023 in COVID-19 and flu provided strong validation of CureVac’s mRNA technology platform.
  • All jointly tested candidates are based on CureVac’s proprietary second-generation mRNA backbone, targeting improved intracellular mRNA translation for early and strong immune responses.
  • The first nine months of 2022 were positively impacted by €36.8 million related to the reversal of an outstanding CRO provision.

Emergex Signs Contract of £1.79M with the UK Department of Health and Social Care’s UK Vaccine Network (“UKVN”) to Advance Its Novel Synthetic T Cell-Priming Set-Point Candidate Against Chikungunya Virus

Retrieved on: 
Freitag, November 17, 2023
UK Research and Innovation, Orthornavirae, Low, Good manufacturing practice, CHIKV, MHRA, Disease, DHSC, Government, Epitope, Epidemic, Research, Swiss Medical Students' Association, UKRI, Arthritis, Vaccine, AMR, CD8, Infection, CGMP, Pacific Ocean, News, RNA, Social work, Chikungunya, Dengue fever

In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact.

Key Points: 
  • In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact.
  • The programme is intended to position Emergex for entry to the clinic by its completion, ready to begin a Phase-1 clinical trial.
  • Subsequently, Emergex achieved all milestones priming the CHIKV candidate for progression to the next stage of its preclinical development.
  • A Phase-2 trial for CoronaTcP and a Phase-1 trial for a Universal Influenza vaccine candidate are planned in H1 2024.

SELLAS Life Sciences Receives Favorable FDA Type C Meeting Feedback on Chemistry, Manufacturing, and Controls (CMC) Biologics License Application (BLA) Filing Strategy for Galinpepimut-S (GPS)

Retrieved on: 
Montag, November 13, 2023
Doctor of Science, GMP, Regulatory affairs, GPS, Food, SLS, Type, BLA, Acute myeloid leukemia, Leukemia, Epitope, Patient, FDA, CD4, CD8, MD, CMC, AML, Immunotherapy, WT1, Pharmaceutical industry

NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that it recently concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Company’s Chemistry, Manufacturing, and Controls (CMC) sections in a potential biologics license application (“BLA”) for SELLAS’ lead product candidate, galinpepimut-S (GPS). SELLAS submitted a CMC Briefing Package to the FDA which provided an up-to-date overview of the extensive work completed for the GPS CMC program and commercial manufacturing and regulatory plans. The FDA reviewed this package of data and accompanying questions to the agency and responded with favorable guidance.

Key Points: 
  • SELLAS submitted a CMC Briefing Package to the FDA which provided an up-to-date overview of the extensive work completed for the GPS CMC program and commercial manufacturing and regulatory plans.
  • The FDA reviewed this package of data and accompanying questions to the agency and responded with favorable guidance.
  • GPS is expected to be stored at 2-8 C (36 – 46 F) making it more accessible for end-users.
  • GPS has the potential to offer clinical benefit to this population of leukemia patients and the positive CMC regulatory feedback is a critical step in its development.”

Cue Biopharma Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Donnerstag, November 9, 2023
PD-L1, Research, A11, Ono Pharmaceutical, A24, Disease, WT1, Clinical trial, Epitope, Patient, Autoimmune disease, Allele, Pembrolizumab, Neoplasm, DCR, ORR, Ovarian cancer, SITC, Stomach, Cancer, Society, Vaccine, Pharmaceutical industry, Cryptocurrency

BOSTON, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of T cell engagers to selectively modulate tumor-specific T cells, provided a business and financial update for the third quarter of 2023.

Key Points: 
  • BOSTON, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of T cell engagers to selectively modulate tumor-specific T cells, provided a business and financial update for the third quarter of 2023.
  • Presented positive data from ongoing Phase 1 trials of CUE-101 and CUE-102 at the Society for Immunotherapy of Cancer’s 38th Anniversary Annual Meeting (SITC 2023) held November 1-5.
  • Completed enrollment of 20 patients for the ongoing Phase 1b study of CUE-101 in combination with pembrolizumab.
  • The Company reported collaboration revenue of approximately $3.7 million and $1.1 million for the nine months ended September 30, 2023 and 2022, respectively.

OmniAb Presents New Scientific Data on its OmnidAb™ Platform at the 2023 Antibody Engineering & Therapeutics Conference

Retrieved on: 
Donnerstag, Dezember 14, 2023
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Washington Marriott Marquis, ISCB Senior Scientist Award, Antibody, Senior, Therapy, Chicken, Hook effect, Epitope, Multimedia, Conference, Engineering, AI, Discovery system (AI research), Vaccine, Fine chemical

OmniAb, Inc. (Nasdaq: OABI) announces the presentation of new scientific data on its OmnidAb™ platform, the industry’s first and only transgenic chicken host system producing single domain antibodies (sdAbs), at the 2023 Antibody Engineering & Therapeutics Conference underway in San Diego and hosted by The Antibody Society .

Key Points: 
  • OmniAb, Inc. (Nasdaq: OABI) announces the presentation of new scientific data on its OmnidAb™ platform, the industry’s first and only transgenic chicken host system producing single domain antibodies (sdAbs), at the 2023 Antibody Engineering & Therapeutics Conference underway in San Diego and hosted by The Antibody Society .
  • This minimizes the need for downstream engineering and provides a functionally diverse immune repertoire that is unavailable from mammalian systems.
  • OmniAb is showcasing OmnidAb and its entire technology stack at the 2023 Antibody Engineering & Therapeutics Conference at booth #300 at the Marriott Marquis San Diego Marina.
  • OmniAb is leveraging its technology stack to offer partners new discovery workflows and optimization tools for existing discovery campaigns.