Antibody

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant Treatment of haemophilia B, 26/10/2018 Withdrawn

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星期四, 四月 18, 2024
Eurostat, Diagnosis, Civil service commission, Brain, Disease, Coagulation, Patient, Committee, Knowledge, Internal, Regulation, Haemophilia, EMA, IRIS, Joint, Human, Wound healing, Clinical trial, European, Therapy, COMP, Bleeding, Spinal cord, Sponsor, European Commission, Immune system, Antibody, Safety, Factor IX, Blood, Marketing, Limited, Haemophilia B, Medicine, Pharmaceutical industry

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant Treatment of haemophilia B, 26/10/2018 Withdrawn

Key Points: 


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant Treatment of haemophilia B, 26/10/2018 Withdrawn

Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positive

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星期四, 四月 18, 2024
Community, Eurostat, Civil service commission, Diagnosis, CD7, Graft-versus-host disease, Cell, Bone marrow, Disease, Patient, Committee, Extrapyramidal system, Tissue, Knowledge, Antibody, Regulation, EMA, IRIS, Protein, CD3, BV, European, Skin, WT1, COMP, Oxygen, Immune system, European Commission, Safety, Hematopoietic stem cell transplantation, Stomach, Liver, Pharmaceutical industry

Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positive

Key Points: 


Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positive

EQS-News: Heidelberg Pharma granted orphan drug designation by FDA for its proprietary ATAC candidate HDP-101

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星期三, 四月 10, 2024
ODD, Diagnosis, RRMM, BCMA, Patient, Multiple myeloma, Spacecraft, Amanitin, AACR, Antibody, Safety, HPHA, FDA, B-cell maturation antigen, ATAC, Food, Pharmaceutical industry

Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.

Key Points: 
  • Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.
  • Heidelberg Pharma is investigating the candidate in a clinical Phase I/IIa study for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted that our proprietary ATAC candidate HDP-101 has been granted Orphan Drug Designation by the FDA, providing further validation of its potential benefit as a therapeutic for patients with multiple myeloma.
  • The designation provides significant incentives to promote the development of the drug including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.

EQS-News: Heidelberg Pharma announces progress into Cohort 6 with its proprietary ATAC candidate HDP-101 in Phase I/IIa multiple myeloma study

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星期三, 四月 10, 2024
Multiple myeloma, Bone marrow, Cohort, Infection, Incidence, BCMA, Patient, Plasma cell, Mortality, B cell, Spacecraft, AACR, Annual report, Antibody, The Annual Report, Safety, Pharmacokinetics, HPHA, FDA, ATAC, Food, Pharmaceutical industry

Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body.

Key Points: 
  • Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body.
  • Plasma cells are a type of blood cell that makes antibodies to fight infection, created by bone marrow.
  • Heidelberg Pharma’s Phase I/IIa clinical study is an ongoing, non-randomised, open label study which is actively enrolling patients with relapsed or refractory multiple myeloma or other plasma cell disorders expressing BCMA.
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, said: “Our proprietary ATAC candidate HDP-101 is showing exciting potential for treating multiple myeloma.

ProMIS Neurosciences Publishes in the Journal of Biological Chemistry on the Interaction Between Pathogenic Proteins as a Treatment Target for ALS

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星期二, 四月 9, 2024
Toxicity, PMN, MSA, Bioorganic chemistry, ALS, Multiple system atrophy, Zebrafish, SOD1, Neuroscience, Journal, Brain cell, TAR, Protein, Biochemistry, PROMIS, Antibody, Therapy, Vaccine

ProMIS is developing antibodies selectively targeting misfolded forms of TDP-43 and SOD1.

Key Points: 
  • ProMIS is developing antibodies selectively targeting misfolded forms of TDP-43 and SOD1.
  • ALS is a fatal neurodegenerative disease of motor neurons.
  • “Publication of these data underscores the connection of misfolded proteins and ALS and supports targeting our TDP-43-specific epitope with PMN267 as a potential therapeutic approach,” stated Neil Warma, Chief Executive Officer of ProMIS Neurosciences.
  • “PMN267 is advancing through preclinical development and is showing promise as a potential treatment for ALS.

Compass Therapeutics Presents Data Demonstrating Elimination of MHC Class I Negative Tumors in In Vivo Models at the 2024 American Association for Cancer Research (AACR) Annual Meeting

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星期二, 四月 9, 2024
Major histocompatibility complex, CPI, Cell, Entrepreneurship, Oncology, Immunotherapy, DLL4, Patient, Neoplasm, Data, Tumor microenvironment, VEGF, Checkpoint, Doctor of Philosophy, MD, Natural killer T cell, News, AACR, MHC, Research and development, Therapy, MHC-I, Antibody, Immune system, PD-L1, San Diego Convention Center, NK, PD-1, Vaccine

Immune responses were generated toward the MHC-I negative tumors by combining CTX-009 with CTX-471.

Key Points: 
  • Immune responses were generated toward the MHC-I negative tumors by combining CTX-009 with CTX-471.
  • The proposed mechanism for this effect suggests the involvement of NK-cells, which can generate potent cell killing independent of MHC-I.
  • Following mCTX-009 and mCTX-471 combination treatment, superior efficacy was observed in MHC Class I negative tumors.
  • A copy of the presentation materials can be accessed on the News & Events section under “ Presentations ” of the Company’s website at www.compasstherapeutics.com once the presentation has concluded.

Zymeworks Presents New Data from Multiple Preclinical Development Programs at 2024 American Association for Cancer Research Annual Meeting

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星期一, 四月 8, 2024
Well, Small-cell carcinoma, Therapeutic index, Glomus tumor, Endometrial cancer, Survival, Environment, Service provider, Trichloroethylene, Patient, Primate, Triple-negative breast cancer, Lead, Zymeworks, 3D, Standard of care, Cancer, TAA, Spacecraft, Lung cancer, IND, CD3, DLL3, AACR, Workflow, Antibody, TCE, CD28, Therapy, Stomach, ADC, Vaccine

The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.

Key Points: 
  • The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.
  • An investigational new drug (IND) submission or foreign equivalent is planned for 2024.
  • Small cell lung cancer (SCLC) is an aggressive neuroendocrine cancer with a poor prognosis and high unmet medical need2.
  • Displays no cross-linking of T cells and exhibits obligate cis T cell binding of CD28, requiring co-engagement of CD3.

Vincerx Pharma Presents Positive Preliminary Phase 1 Data for VIP236 and Updates on Pipeline Progress at the American Association for Cancer Research (AACR) Annual Meeting 2024 

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星期一, 四月 8, 2024
Sarah Cannon Research Institute, B-cell leukemia, AML, B-ALL, Patient, Webcast, Neoplasm, Acute myeloid leukemia, Cancer, Syndrome, Spacecraft, Camptothecin, AACR, DLT, PALO, Antibody, Drug development, Safety, Infrared spectroscopy correlation table, MDS, Therapy, ADC, Drug resistance, Pharmaceutical industry

PALO ALTO, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today presented positive preliminary Phase 1 data for VIP236 and updates on pipeline progress at the American Association for Cancer Research (AACR) Annual Meeting 2024.

Key Points: 
  • We are still in dose escalation and are starting to see tumor reduction after only two doses.
  • The study's main objective is to determine a safe dose and schedule for VIP236 for further clinical development.
  • As the study progresses through the dose escalation, Vincerx will present additional Phase 1 data for VIP943 on or around the 2024 European Hematology Association Annual Meeting in June 2024.
  • An archived replay of the webcast will be available on the Vincerx Investor Page website following the conclusion of the live event.

Glycotope to present platform approach for development of anti-GlycoTarget antibodies at 2024 AACR Meeting

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星期一, 四月 8, 2024
Protein, Workflow, AACR, Data collection, Database, Antibody, Vaccine

Berlin, Germany, 08 April, 2024 – Glycotope GmbH, a biotechnology company utilizing a proprietary platform technology to developing antibodies against proteins carrying tumor-specific carbohydrate structures, today announces that it will present its platform approach and GlycoTarget database in a poster presentation at the 2024 American Association for Cancer Research (AACR) Meeting, being held in San Diego, California, United States, between 05-10 April 2024.

Key Points: 
  • Berlin, Germany, 08 April, 2024 – Glycotope GmbH, a biotechnology company utilizing a proprietary platform technology to developing antibodies against proteins carrying tumor-specific carbohydrate structures, today announces that it will present its platform approach and GlycoTarget database in a poster presentation at the 2024 American Association for Cancer Research (AACR) Meeting, being held in San Diego, California, United States, between 05-10 April 2024.
  • Patrik Kehler, Chief Scientific Officer of Glycotope GmbH commented: “At Glycotope, we have established a standardized process for the data collection and prioritization of potential protein/carbohydrate combined glycoepitopes (GlycoTargets).
  • We look forward to attending AACR to present our workflow and corresponding database to leading cancer research experts, illustrating how this information is subsequently used for the targeted discovery of antibodies that bind to our GlycoTargets, offering increased tumor-specificity compared to simple protein targets.”
    Poster details are as follows:

Akoya Biosciences Showcases Spatial Biology 2.0 Solutions at AACR Annual Meeting with Case Studies Demonstrating Unprecedented Speed and Scale

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星期五, 四月 5, 2024
Head, Algorithm, Immunotherapy, University, Neoplasm, PM, Vaccine, Analysis, Navigation, Mutation, Thermo Fisher Scientific, Cancer, Unprecedented, Glioblastoma, Result, Risk, Research, Tumor microenvironment, Antibody, Security (finance), Personalized medicine, PST, Proteomics, AACR, Pancreatic cancer, Ultrahigh, Conversation, Annual general meeting, AQUA, Lung cancer, University of Queensland, MIT, Titan Mare Explorer, Medical imaging

MARLBOROUGH, Mass., April 05, 2024 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company®, today announced it will highlight case studies featuring its Spatial Biology 2.0 Solutions that enable unprecedented speed and scale for spatial biology studies at the American Association for Cancer Research (AACR) 2024 Annual Meeting in San Diego, April 5 to 10.

Key Points: 
  • MARLBOROUGH, Mass., April 05, 2024 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company®, today announced it will highlight case studies featuring its Spatial Biology 2.0 Solutions that enable unprecedented speed and scale for spatial biology studies at the American Association for Cancer Research (AACR) 2024 Annual Meeting in San Diego, April 5 to 10.
  • Industry-leading capabilities of the company’s spatial biology platforms will be presented during Akoya’s Spotlight Theater, titled “Spatial Biology 2.0: Spatial Insights and Precision Medicine at Unprecedented Scale” on Monday, April 8 at 3 PM (PST).
  • Akoya Biosciences will demonstrate new uses of its PhenoCode Signature Panels for accelerating discovery and validation of spatial biomarkers using the PhenoImager HT 2.0 platform.
  • PhenoImager HT 2.0: Features targeted PhenoCode Signature Panels and onboard spectral unmixing, simplifying biomarker development and validation workflows for large scale studies.