Cell therapy

BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval

Retrieved on: 
Wednesday, November 29, 2023
Cell therapy, Physician, Heart, Element, BCDA, Patient, Therapy, Heart failure, BNP, Medical device

Japan’s PMDA asked for further details on a number of elements included in BioCardia’s CardiAMP preclinical and clinical packages in order to gain approval.

Key Points: 
  • Japan’s PMDA asked for further details on a number of elements included in BioCardia’s CardiAMP preclinical and clinical packages in order to gain approval.
  • For the points raised with respect to the pre-clinical package, BioCardia management believes that these can be readily addressed.
  • Formal minutes from the PMDA meeting are expected in four weeks and a follow-up consultation is being planned.
  • PMDA approval would enable physicians and patients to consider the CardiAMP cell therapy option alongside other cell therapy approaches for the treatment of heart failure already in clinical use in Japan requiring open heart surgical administration of the cells.”

Abecma Delivers Sustained Progression-Free Survival Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Longer-Term Follow-up from KarMMa-3

Retrieved on: 
Tuesday, December 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Multiple myeloma, Bristol Myers Squibb, Oncology Drug Advisory Committee, NYSE, Safety, Research, Food, Bone marrow, European Medicines Agency, Progression-free survival, ASH, CRS, Cohort, Risk, Disease, Cytopenia, Patient, PFS, BMY, Doctor of Philosophy, Division, FDA, Cell therapy, ORR, ASCT, Death, Survival, Grade, Neurotoxicity, Society, BCMA, HIV disease progression rates, Cytokine release syndrome, Boxed warning, Pharmaceutical industry, Hematology, Swissmedic, Idecabtagene vicleucel, OS

With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.

Key Points: 
  • With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.
  • Due to the median PFS observed with standard regimens, more than half (56%) of patients in the standard regimens arm crossed over to receive Abecma as a subsequent therapy.
  • Historically, based on real-world evidence, median OS for patients with triple-class exposed relapsed and refractory multiple myeloma is approximately 13 months.
  • Regulatory applications for Abecma in earlier lines of therapy for triple-class exposed relapsed and refractory multiple myeloma are also under review with the European Medicines Agency and Swissmedic.

Virtual twin to improve treatment with cancer immunotherapies

Retrieved on: 
Wednesday, December 13, 2023
Multiple myeloma, Research, Business development, Fraunhofer Society, Investment, Disease, Collection, Clinical trial, Hematology, Oncology, Patient, Radiation, Immunology, European, Malignancy, Science, Machine learning, Cell therapy, Diagnosis, Cancer, MRNA vaccine, Doctor of Philosophy, Bone marrow, Pharmaceutical industry, Medical imaging

Together with partners from science, industry and the healthcare sector, the project team led by the Fraunhofer Institute for Cell Therapy and Immunology IZI aims to develop a virtual twin that will improve treatment with personalized cancer immunotherapies in the future.

Key Points: 
  • Together with partners from science, industry and the healthcare sector, the project team led by the Fraunhofer Institute for Cell Therapy and Immunology IZI aims to develop a virtual twin that will improve treatment with personalized cancer immunotherapies in the future.
  • In recent years, cancer immunotherapies have established themselves as a further pillar of medical oncology alongside traditional treatment options (surgery, radiotherapy and chemotherapy).
  • In the EU project CERTAINTY, modules are now to be developed for a corresponding virtual twin for the treatment of cancer patients with CAR-T cell therapies.
  • The EU consortium "CERTAINTY - A cellular immunotherapy virtual twin for personalized cancer treatment" is being funded by the European Union with almost EUR 10 million over the next 4.5 years.

Immatics Reports Interim Clinical Data from ACTengine® IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRAME in an Ongoing Phase 1 Trial

Retrieved on: 
Wednesday, November 8, 2023
Patient, FDA, Research, Pharmacology, Uveal melanoma, Regenerative Medicine Advanced Therapy, Uterine cancer, NSCLC, International Congress on Tuberculosis, Corr, Cmax, Ovarian cancer, Nivolumab, Infrared spectroscopy correlation table, TCR, Appendix, CMC, Neurotoxicity, Lung, SD, DLT, Cytokine release syndrome, Melanoma, ORR, Cell therapy, Triple-negative breast cancer, CET, PRAME, Safety, CRS, Society, Melanoma Research, Diagnosis, Today, Cytopenia, BRAF, Pharmaceutical industry, Vaccine, Medical imaging, MD

The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2.

Key Points: 
  • The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2.
  • In line with previous results, IMA203 GEN1 monotherapy was well tolerated at total doses up to 10x109 TCR-T cells infused.
  • The presentation is available on Immatics’ website – covering the complete data set including Phase 1a, Phase 1b Cohort A and the deprioritized Cohort B (IMA203 GEN1 combined with nivolumab).
  • Discussions with FDA to align on patient populations, trial design and CMC aspects concerning the planned Phase 2 trial are ongoing.

Affimed Presents Preclinical Data Showing that Addition of an Innate Cell Engager to NK and CAR-NK Cells Improves Tumor Cytotoxicity of Both Cell Types at the 38th Annual Meeting of the Society for Immunotherapy of Cancer

Retrieved on: 
Friday, November 3, 2023
IZI, Society for Immunotherapy of Cancer, Affimer, Engineering, Poster, SITC, Immunotherapy, ADCC, NK, Cell therapy, Society, Cancer, Patient, Fraunhofer Society, Fertilizer, Vaccine

“This is the first direct comparison of NK cells redirected by Affimed’s ICE® with CAR-NK cells,” said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed.

Key Points: 
  • “This is the first direct comparison of NK cells redirected by Affimed’s ICE® with CAR-NK cells,” said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed.
  • The combination of allogeneic NK cells with ICE® molecules represents the most straightforward way to generate potent and targeted NK cells.
  • The combination of the ICE® molecule with NK cells or CAR-NK cells enhanced antibody-dependent cellular cytotoxicity (ADCC) against tumor cells and mediated elevated levels of degranulation when compared to NK cells or CAR-NK cells alone.
  • In conclusion, the combination of NK cells with ICE® represents a straight-forward way to potently target and activate NK cells.

Wugen to Present New Clinical Data for WU-CART-007 and Preclinical Data for WU-NK-101, Two Investigational Allogeneic Cell Therapies for Challenging Hematologic Cancers, at American Society of Hematology Annual Meeting & Exposition

Retrieved on: 
Thursday, November 2, 2023
Marriott Marquis, Patient, University of Nottingham, Washington University in St. Louis, Lymphoma, Intel Extreme Masters, Society, ASH, LBL, San Diego Marriott Marquis & Marina, NK, Abstract, Cell therapy, Exposition, Safety, American Society for Investigative Pathology, AML, SAN, Pharmaceutical industry, Vaccine, Mobile phone, Leukemia

ST. LOUIS and SAN DIEGO, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, will be presenting four abstracts, now available online, at the American Society of Hematology (ASH) Annual Meeting and Exposition Dec. 9-12.

Key Points: 
  • The Wugen oral and poster presentation schedule at ASH is below.
  • The meeting will take place at the Marriott Marquis in San Diego and virtually.
  • Access the full schedule here .
  • Session: #704, Cellular Immunotherapies: Early Phase and Investigational Therapies: Novel Approaches to Enhance Cellular Therapies and Immune Responses in Leukemias and Lymphomas, 10:30 a.m.- 12 p.m. PT
    Session: #703, Cellular Immunotherapies: Basic and Translational: Novel Approaches for Next Generation Cellular Immunotherapies, 9:30-11 a.m. PT

OBiO Announces Strategic Partnership with Refreshgene to Realize Commercialization of Gene Therapy Product

Retrieved on: 
Tuesday, October 24, 2023
CGMP, IND, AAV, European Society of Gene and Cell Therapy, Therapy, Genetics, Congress, CMC, CDMO, Research, Huber loss, Gene, Partnership, Cell therapy, GMP, CMO, Patient, Retina, Fine chemical, Pharmaceutical industry

SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. (OBiO, 688238.SH), a world leading contract development and manufacturing organization for cell and gene therapy, officially announced an agreement with Refreshgene Therapeutics (Refreshgene). Under the agreement, OBiO leverages its capabilities of process development, large-scale cGMP commercial production and global business development to provide high-quality CDMO/CMO services and authorized cooperation services for Refreshgene's RRG-001 pipeline, and jointly promote the development of advanced therapies to benefit patients around the world.

Key Points: 
  • Driven by human genetics and translational medicine, Refreshgene develops new gene therapy and drugs to satisfy unmet clinical needs via highly druggable and tissue-specific gene delivery technology.
  • Refreshgene owns well-established research and technology system of AAV gene therapy and built up clinic-stage pipeline in the field of retinal diseases and congenital deafness.
  • Moreover, Refreshgene is the first gene therapy company in the world to apply dual AAV vector technology into clinical trials in congenital deafness.
  • And this time, OBiO and Refreshgene intend to establish a comprehensive strategic partnership for clinical application, clinical & commercial production and global commercial cooperation of RRG-001 gene therapy product.

OBiO Announces Strategic Partnership with Refreshgene to Realize Commercialization of Gene Therapy Product

Retrieved on: 
Tuesday, October 24, 2023
CGMP, IND, AAV, European Society of Gene and Cell Therapy, Therapy, Genetics, Congress, CMC, CDMO, Research, Huber loss, Gene, Partnership, Cell therapy, GMP, CMO, Patient, Retina, Fine chemical, Pharmaceutical industry

SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. (OBiO, 688238.SH), a world leading contract development and manufacturing organization for cell and gene therapy, officially announced an agreement with Refreshgene Therapeutics (Refreshgene). Under the agreement, OBiO leverages its capabilities of process development, large-scale cGMP commercial production and global business development to provide high-quality CDMO/CMO services and authorized cooperation services for Refreshgene's RRG-001 pipeline, and jointly promote the development of advanced therapies to benefit patients around the world.

Key Points: 
  • Driven by human genetics and translational medicine, Refreshgene develops new gene therapy and drugs to satisfy unmet clinical needs via highly druggable and tissue-specific gene delivery technology.
  • Refreshgene owns well-established research and technology system of AAV gene therapy and built up clinic-stage pipeline in the field of retinal diseases and congenital deafness.
  • Moreover, Refreshgene is the first gene therapy company in the world to apply dual AAV vector technology into clinical trials in congenital deafness.
  • And this time, OBiO and Refreshgene intend to establish a comprehensive strategic partnership for clinical application, clinical & commercial production and global commercial cooperation of RRG-001 gene therapy product.

Vivoryon Therapeutics N.V. Shares Highlights from Virtual R&D Event with Key Opinion Leaders

Retrieved on: 
Tuesday, October 17, 2023
Identification, UMC, Cognition, Deficit spending, Research, Caregiver, Toxicity, Data, Cell therapy, Safety, Cogstate Brief Battery, Memory, Amsterdam, EEG, DSMB, Data monitoring committee, Fraunhofer Society, MCI, Immunology, QPCT, CBB, Pathology, AD, NTB, Patient, Euronext Amsterdam, Medical imaging, Pharmaceutical industry, Medical device, Amyloid beta

AD is a disorder of cognition, not just memory and MCI and early AD are characterized by a variety of cognitive deficits.

Key Points: 
  • AD is a disorder of cognition, not just memory and MCI and early AD are characterized by a variety of cognitive deficits.
  • It has the advantage of investigating a broad range of cognitive domains acknowledged to be clinically meaningful measures of function.
  • reliability and validity, support its use as an outcome measure in treatment evaluation studies and for use in clinical practice.
  • Based on the results in the SAPHIR study in early AD patients, theta power has been selected as a key secondary endpoint in the VIVIAD study.

BioCardia Announces Completion of Enrollment in Phase III CardiAMP HF Trial and Plans for CardiAMP HF Trial II

Retrieved on: 
Wednesday, October 11, 2023
Probability, Doctor of Philosophy, BCDA, Trial of the century, Risk, Therapy, N-terminal prohormone of brain natriuretic peptide, Cell therapy, Heart, Mortality, Safety, Survival, FDA, DSMB, Data monitoring committee, Medicare, Phase, Heart failure, Marketing, Clinical trial, LVAD, Arrest, Patient, Pharmaceutical industry

The proposed CardiAMP Heart Failure II study includes the requirement that all patients have an NT-proBNP at baseline greater than 500 pg/ml and has a modified primary endpoint.

Key Points: 
  • The proposed CardiAMP Heart Failure II study includes the requirement that all patients have an NT-proBNP at baseline greater than 500 pg/ml and has a modified primary endpoint.
  • Statistical calculations for this clinical study design support that a modestly sized clinical trial, based on the interim results, would achieve high power (probability of success).
  • Additional modifications to the trial design proposed include elements to simplify clinical logistics and reduce the cost of performing the study.
  • “Our world-class clinical leadership is supportive of pursuing the compelling and consistent interim results for patients with elevated NT-proBNP at baseline.