Immunoglobulin G

Kineta Reports Initial Clinical Response Data at AACR 2024 of its Ongoing Phase 1/2 VISTA-101 Clinical Trial

Retrieved on: 
Monday, April 8, 2024
Combination, CPI, Immunosuppression, Patient, Tumor microenvironment, Immunoglobulin G, Merck, Cancer, Pembrolizumab, Lung cancer, AACR, DLT, Clinical trial, Merck & Co., Kineta, NK, VISTA, Pharmaceutical industry

SEATTLE, April 08, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today at the American Association for Cancer Research (AACR) in San Diego, CA an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123, an anti-VISTA monoclonal antibody, as monotherapy and in combination with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors.

Key Points: 
  • KVA12123 cleared the fifth of six monotherapy dose levels and the second of four cohorts in combination with pembrolizumab.
  • KVA12123 was well tolerated with no dose limiting toxicities (DLT) or cytokine related adverse events at any dose level.
  • Patients currently enrolled in the trial will be permitted to continue to participate.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

ProMIS Neurosciences Announces Full Year 2023 Financial Results and Recent Highlights

Retrieved on: 
Monday, April 1, 2024
Research, PMN, FTLD, Biotechnology, MSA, ALS, Multiple system atrophy, CSF, Patient, Neuroscience, Epitope, Immunoglobulin G, RACK1, Cerebrospinal fluid, Activated, Synucleinopathy, Clinical trial, PROMIS, Antibody, Vaccination, Safety, Pharmacokinetics, Interim, Therapy, Blood, SAD, Frontotemporal lobar degeneration, Pharmaceutical industry

This is a very exciting opportunity for both ProMIS and the AD patients we aim to serve.

Key Points: 
  • This is a very exciting opportunity for both ProMIS and the AD patients we aim to serve.
  • ProMIS dosed the first participants in a first-in-human Phase 1a clinical trial of PMN310 as a potential treatment for AD in November 2023 (Study NCT06105528 ).
  • Using a proprietary computational platform, ProMIS identified potential conformational epitopes (misfolded portions) unique to toxic alpha-synuclein involved in synucleinopathies.
  • Cash and cash equivalents were $12.6 million as of December 31, 2023, compared to $5.9 million as of December 31, 2022.

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, March 29, 2024
Head, Immunotherapy, HNSCC, Patient, Roche, Lead, Immunoglobulin G, Neoplasm, CRC, Audit committee, PD-1, Observation, Bioinformatics, Colorectal cancer, SAN, Information technology, Pembrolizumab, PRS, Safety, PD-L1, Compensated emancipation, Annual report, Apoptosis, Cervical cancer, Part, Merck, Senior, Bevacizumab, MSS, GAAP, ASCO, PFS, MTD, Liver disease, HCC, Therapeutic index, Endometrial cancer, Progression-free survival, ADS, Net, Regulatory T cell, Research and development, Liver, Pharmaceutical industry

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

Key Points: 
  • Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
  • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
  • Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

IMUNON Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024
Transfer, Ovarian cancer, Immunotherapy, Patient, Lung, Vaccine, Good manufacturing practice, Sale, CMC, IND, Bangladesh Technical Education Board, IPR, Investment, Clinical trial, Neoplasm, Research, Primate, DNA, NOL, MD Anderson Cancer Center, Trial of the century, ITT, Safety, MRD, Interim, Silicon Valley Bank, Vaccination, Food, CMOS, Elsevier, CD8, Drug discovery, SVB, CRS, University, Death, SARS-CoV-2, Earnings call, Lassa mammarenavirus, PFS, Immunoglobulin G, FDA, OS, CD4, Temperature, Progression-free survival, COVID-19, Mouse, Messenger, Human, Wistar Institute, Hospital

LAWRENCEVILLE, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.

Key Points: 
  • “We remain on track to report topline results mid-year from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer.
  • In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study.
  • The Company is hosting a conference call to provide a business update, discuss 2023 financial results and answer questions at 10:00 a.m. Eastern time today.
  • To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON 2023 Earnings Call.

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.

Intravacc announces positive data of first in human intranasal OMV based vaccine for SARS-CoV-2

Retrieved on: 
Tuesday, March 26, 2024
Conference, Immunoglobulin A, Female, Aes, FIH, SARS-CoV-2, Volunteering, Trial of the century, Male, OMV, Vaccination, Safety, Vaccine, Immunoglobulin G, Administration

The phase I clinical trial, which was conducted in Australia, assessed the tolerability, safety and immunogenicity of the Avacc 10® vaccine.

Key Points: 
  • The phase I clinical trial, which was conducted in Australia, assessed the tolerability, safety and immunogenicity of the Avacc 10® vaccine.
  • In a randomized, double-blinded, placebo and OMV controlled study, 36 healthy 18-55 year-old, male and female volunteers, received two intranasal doses, 3 weeks apart.
  • Dr. Dinja Oosterhoff, Intravacc’s VP of Research & Development, stated:
    “This FIH intranasal vaccine study marks a significant milestone for Intravacc’s flagship OMV based vaccine platform.
  • Now Intravacc is also developing an intranasal vaccine for Gonorrhea targeting the FIH in Q4 2025.

Seismic Therapeutic Announces Participation at Multiple Upcoming Scientific Conferences in April and May 2024

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, Pharmaceutical, Health, Pharmacology, Drug discovery, The Next Mutation, Patient, Impact, Doctor of Philosophy, IND, Autoimmunity, Therapy, Machine learning, Immunoglobulin G, IMPACT, Pharmaceutical industry

Seismic Therapeutic, Inc ., the machine learning immunology company, today announced that the company will participate in four upcoming scientific conferences, presenting the company’s emerging pipeline of novel therapeutics to treat rare and prevalent autoimmune diseases, as well as its proprietary IMPACT platform that applies machine learning to biologics drug discovery.

Key Points: 
  • Seismic Therapeutic, Inc ., the machine learning immunology company, today announced that the company will participate in four upcoming scientific conferences, presenting the company’s emerging pipeline of novel therapeutics to treat rare and prevalent autoimmune diseases, as well as its proprietary IMPACT platform that applies machine learning to biologics drug discovery.
  • "The bolus of preclinical data we are presenting in the coming months highlights the immense potential of Seismic’s pipeline in autoimmune diseases,” said Jo Viney, PhD, Founder, President and CEO of Seismic Therapeutic.
  • “In just two years since the company’s founding, we have internally developed two potentially best-in-class development candidates as well as a number of discovery-stage programs, and these presentations from Seismic’s expert team of scientists underscore the productivity of our IMPACT platform in drug discovery.
  • Session Category: Exploring the Impact of Treg Biology on Development of Treg Directed Therapies to Drive Precise Therapeutic Interventions.

Tubulis Presents Preclinical Data for Solid Tumor Targeting ADC Candidates TUB-030 and TUB-040 Demonstrating Superior Efficacy Profile and a Wide Therapeutic Window at the AACR Annual Meeting 2024

Retrieved on: 
Monday, April 8, 2024
Oncology, Health, Clinical Trials, Research, Science, Biotechnology, Ovarian cancer, Translocase, 5T4, Cell, NSCLC, Adenocarcinoma, Patient, Neoplasm, Immunoglobulin G, Cancer, Cancer research, Spacecraft, Translation, Abstract, AACR, ADC, Non-small-cell lung cancer, Vaccine

Tubulis today presented comprehensive preclinical data on its two lead antibody-drug conjugate (ADC) candidates TUB-030 and TUB-040 at this year’s Annual Meeting of the American Association for Cancer Research (AACR) in San Diego.

Key Points: 
  • Tubulis today presented comprehensive preclinical data on its two lead antibody-drug conjugate (ADC) candidates TUB-030 and TUB-040 at this year’s Annual Meeting of the American Association for Cancer Research (AACR) in San Diego.
  • The poster presentations contained preclinical data, highlighting the ability of the two next-generation Tubutecan ADCs to create effective and durable responses even in low target-expressing tumor mouse models.
  • Tubulis is leveraging a proprietary suite of platform technologies to build a pipeline of uniquely matched ADC candidates that combine the right targeting molecule, conjugation chemistry and payload to deliver the true therapeutic value of the ADC approach.
  • The company’s lead candidates, both targeting solid tumor indications, are in late-stage preclinical testing, with TUB-040 ready for clinical evaluation.

SAB Biotherapeutics Announces Clinical Partnership with Naval Medical Research Center to Advance Potential Influenza Treatment

Retrieved on: 
Monday, March 25, 2024
Disease, Development, Immunotherapy, Partnership, T1D, Patient, NMRC, Research, Mortality, Death, Breakthrough therapy, Infection, CDC, Vaccination, Safety, SAB, Therapy, Vaccine, Immunoglobulin G, Food

The NMRC Clinical Trials Center, located in Bethesda, Maryland, will be conducting this PK study under the leadership of Cmdr.

Key Points: 
  • The NMRC Clinical Trials Center, located in Bethesda, Maryland, will be conducting this PK study under the leadership of Cmdr.
  • SAB has utilized its proprietary DiversitAb™ platform to manufacture SAB-176, fully human polyclonal antibodies targeting influenza from Transchromosomic (Tc) Bovine™.
  • SAB-176 is a novel multi-target biologic that has shown sustained neutralization activity across multiple virus strains of Influenza A and B.
  • Influenza is responsible for approximately 226,000 excess hospitalizations and 30,000 to 50,000 deaths each year in the United States alone.

Bluejay Announces Receipt of PRIME Designation from European Medicines Agency (EMA) for BJT-778 for the Treatment of Chronic Hepatitis Delta Virus Infection

Retrieved on: 
Monday, March 25, 2024
Therapy, Patient, SAN, HDV, European Medicines Agency, PRIME, Hepatology, Immunoglobulin G, Blue jay, Disease, EMA

SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc., a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection.

Key Points: 
  • SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc., a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection.
  • BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) mAb that acts as an anti-viral to HDV by neutralizing and facilitating the clearance of HDV virions.
  • The application for PRIME designation was bolstered by compelling data from non-clinical studies, along with interim results from the company's Phase 1/2 study that included subjects with chronic HDV.
  • “We eagerly anticipate our continued collaboration with the EMA and other regulatory agencies to expedite the availability of this promising treatment for patients.”