REDIRECT

Affimed Announces Acceptance of Abstracts at the 17th International Conference on Malignant Lymphoma (17-ICML)

Retrieved on: 
Friday, June 9, 2023
PTCL, Hodgkin lymphoma, Abstract, Peripheral T-cell lymphoma, ASH, REDIRECT, Affimer, Bacterial conjugation, Lymphoma, Cancer, Food and Drug Administration, NK, International Conference on Creationism, Poster, Patient, Samsung Medical Center, FDA, IND, Nanakaly Hospital for Hematology & Oncology, Conference, Food, Safety, Pharmaceutical industry, Medical imaging, Book

An additional encore oral presentation will show the final results of the phase 2 REDIRECT study with AFM13 monotherapy in a r/r PTCL patient population.

Key Points: 
  • An additional encore oral presentation will show the final results of the phase 2 REDIRECT study with AFM13 monotherapy in a r/r PTCL patient population.
  • Associated with the AFM13-induced cytotoxic activity was an increased functional activation status of AB-101 demonstrated through degranulation and IFN-γ production.
  • Importantly, in a mouse xenograft model, adoptive transfer of AB-101 in combination with AFM13 conferred tumor growth control.
  • The data of AFM13 in combination with the allogeneic, cryopreserved, off-the-shelf, cord blood-derived AB-101 NK cells demonstrate synergistic anti-tumor activity in vivo.

Fluid Biomed Inc. Announces World's First Implantation of Polymer-based Neurovascular Stent in Human Patients

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Thursday, June 1, 2023
Science, Creativity, Stroke, Clinical trial, AB, Physician, Medicine, Patient, REDIRECT, Engineering, Biomedical engineering, Medical imaging

CALGARY, AB, June 1, 2023 /PRNewswire/ - Fluid Biomed Inc., a medical device company developing ReSolv™, the world's first hybrid polymer-metal flow-diverting stent to treat brain aneurysms, announces the international launch of REDIRECT, its first-in-human clinical trial.

Key Points: 
  • CALGARY, AB, June 1, 2023 /PRNewswire/ - Fluid Biomed Inc., a medical device company developing ReSolv™, the world's first hybrid polymer-metal flow-diverting stent to treat brain aneurysms, announces the international launch of REDIRECT, its first-in-human clinical trial.
  • Phase 1 of this technical feasibility and safety study has begun with successful device implantation without adverse effect in human subjects at the pre-determined 30-day time point and recruitment is on-going.
  • Dr. John Wong, neurosurgeon, company co-founder and Chief Executive Officer, said "We view this first clinical demonstration in multiple patients of our revolutionary stent, as the next leap in brain aneurysm treatment that combines science, engineering, and medicine.
  • Fluid Biomed also announces new company advisors: Professor Ajay Wakhloo, renowned neuroradiologist and stent pioneer; and Michael Wallace, serial entrepreneur and medical industry leader.

Affimed Announces Abstracts at the Annual Meeting of the European Hematology Association

Retrieved on: 
Thursday, May 11, 2023
PTCL, Abstract, Index, Angioimmunoblastic T-cell lymphoma, AE, European Hematology Association, REDIRECT, ADCC, Progression-free survival, Bone marrow, Grade 3, Cancer, FDG-PET, NK, Cell, IRR, Redirect, AML, CD123, EHA, MTD, ORR, Safety, Pharmaceutical industry, Vaccine, Patient

HEIDELBERG, Germany, May 11, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that two abstracts have been accepted to EHA2023, the annual meeting of the European Hematology Association (EHA) taking place in Frankfurt, Germany on June 8-11, 2023.

Key Points: 
  • HEIDELBERG, Germany, May 11, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that two abstracts have been accepted to EHA2023, the annual meeting of the European Hematology Association (EHA) taking place in Frankfurt, Germany on June 8-11, 2023.
  • In the REDIRECT study, the AFM13 innate cell engager (ICE®) exhibited clinical efficacy in a heavily pre-treated CD30-positive r/r PTCL population.
  • Overall, the objective response rate (ORR) based on FDG-PET assessed by an independent review committee was 32.4%, thus comparable to therapies approved for this indication.
  • The median duration of response, progression-free survival, and overall survival were 2.3, 3.5, and 13.8 months, respectively.

Affimed Presents Final Data Demonstrating Safety and Efficacy of AFM13 Phase 2 REDIRECT Study in Patients with Heavily Pretreated Relapsed or Refractory Peripheral T Cell Lymphoma at the American Association for Cancer Research Annual Meeting 2023

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Sunday, April 16, 2023
Neutropenia, AACR, REDIRECT, Affimer, OS, Cancer, American Association for Cancer Research, PFS, ORR, Dor, Patient, CR, Samsung Medical Center, Fever, Nanakaly Hospital for Hematology & Oncology, Lymphoma, IRR, Safety, Disease, Pharmaceutical industry, PTCL

Primary efficacy measures include an ORR of 32.4% and a CR rate of 10.2%.

Key Points: 
  • Primary efficacy measures include an ORR of 32.4% and a CR rate of 10.2%.
  • Key secondary and exploratory outcome measures include safety, durability of response, progression free survival and overall survival.
  • The safety profile of AFM13 was well managed and consistent with previously reported data of prior and ongoing clinical studies with AFM13.
  • These data substantiate the next step towards further development of AFM13 in PTCL,” said Dr. Adi Hoess, Chief Executive Officer at Affimed.

Affimed Provides Updated Clinical Data from Phase 1/2 Study of AFM13 Precomplexed with Cord Blood-Derived NK Cells at the ASH 2022 Annual Meeting

Retrieved on: 
Saturday, December 10, 2022
Peripheral T-cell lymphoma, Investigational New Drug, Global Monitoring Plan, Cell, University, FDG-PET, NK, Patient, Anderson, Clinical trial, CST, Haematopoietic system, Aplastic anemia, Terrorism, Cytokine release syndrome, Hodgkin lymphoma, Macrophage, Lymphoma, Cancer, DOR, Biotechnology, Toxic epidermal necrolysis, ASH, CD30, Affimer, REDIRECT, CR, CFGB-FM, ORR, EST, Growth, Research, ID, NHL, MD Anderson Cancer Center, Cyclophosphamide, Society, COVID-19, Lead, Pharmaceutical industry, Vaccine, Hospital

Results from the study continue to demonstrate high objective and complete response rates with a well-tolerated safety profile.

Key Points: 
  • Results from the study continue to demonstrate high objective and complete response rates with a well-tolerated safety profile.
  • Across all 35 patients treated at the RP2D, a 94% ORR and a CR rate of 71% were observed.
  • “It’s impressive that we continue to see these response rates in a patient population that has exhausted all other treatment options.
  • Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Lymphoma
    Affimed will host an investor event to review AFM13 clinical data and development plans in CD30-expressing malignancies.

Affimed Reports Topline Data from AFM13 Monotherapy Phase 2 REDIRECT Study in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma

Retrieved on: 
Saturday, December 10, 2022
Lymphoma, Samsung Medical Center, Cell, University, FDG-PET, NK, CST, Clinical trial, Terrorism, Neoplasm, Hodgkin lymphoma, Macrophage, Safety, Peripheral T-cell lymphoma not otherwise specified, Probability, Cancer, DOR, Biotechnology, Pharmacokinetics, OS, CD30, Affimer, REDIRECT, Dor, EST, ORR, Growth, ID, MD Anderson Cancer Center, IRC, COVID-19, Patient, PFS, Hematology-Oncology and Stem Cell Transplantation Research Center, Pharmaceutical industry, Online shopping, Vaccine, PTCL

The safety profile of AFM13 was well managed and consistent with previously reported data of prior and ongoing clinical studies with AFM13.

Key Points: 
  • The safety profile of AFM13 was well managed and consistent with previously reported data of prior and ongoing clinical studies with AFM13.
  • “Our parallel study investigating AFM13 in combination with allogeneic NK cells shows that this combination can materially improve clinical outcomes for patients with CD30-postive lymphomas.
  • Secondary and exploratory outcome measures included DoR, PFS, OS, the safety of AFM13 as well as pharmacokinetics and immunogenicity of AFM13.
  • AFM13 is Affimed’s most advanced ICE® clinical program and is currently being evaluated as monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT).

Affimed to Host Investor Event Highlighting AFM13 Clinical Development at 2022 ASH Annual Meeting

Retrieved on: 
Thursday, December 1, 2022
EST, ORR, Partnership, Biotechnology, CD30, REDIRECT, Patient, T-cell lymphoma, CST, Affimer, Society, TCL, NK, Webcast, ID, Cancer, ASH, HL, Hodgkin lymphoma, Online shopping, Vaccine

Date and Time: Saturday, December 10 at 4:00 p.m. CST / 5:00 p.m. EST / 23:00 CET

Key Points: 
  • Date and Time: Saturday, December 10 at 4:00 p.m. CST / 5:00 p.m. EST / 23:00 CET
    Affimed will host an investor event to review AFM13 clinical data and development plans in CD30 expressing malignancies.
  • The investor event will take place in-person and virtually and a webcast of the event will be available in the Webcasts section on the Investors page of Affimeds website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/ .
  • To reserve your place in the live event, please contact Alex Fudukidis via e-mail at [email protected] .
  • AFM13 is a CD30/CD16A bispecific Innate Cell Engager (ICE) that is investigated in Hodgkin Lymphoma (HL) and T cell lymphoma (TCL).

Affimed Announces Presentation of Phase 1/2 Data from AFM13 in Combination with Allogeneic NK Cells and Preclinical AFM28 Data at ASH 2022 Annual Meeting

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Thursday, November 3, 2022
Haematopoietic system, Society, University, LSC, ADCC, Clinical trial, Macrophage, LSCS, SEC, Terrorism, Department, Program, Growth, 2021 Essex County Council election, CST, GLOBE, NK, ASH, CR, Affimer, Forward-looking statement, GVHD, Patient, CFGB-FM, Cancer, ORR, MDS, Research, Drug resistance, Biotechnology, Global Monitoring Plan, COVID-19, Heidelberg University, CD123, REDIRECT, Pharmacology, Exposition, DL2, Serum, Lead, Industry, Cell, Cytokine release syndrome, Poster, CRS, Acute myeloid leukemia, Myelodysplastic syndrome, MD Anderson Cancer Center, Investigator's brochure, Lymphoma, CD30, IRR, EFS, AML, Pharmaceutical industry, Vaccine, Hematology

Each cycle of treatment consists of a lymphodepletion, followed by single dose of AFM13 precomplexed with cbNK cells and three subsequent infusions of AFM13 monotherapy.

Key Points: 
  • Each cycle of treatment consists of a lymphodepletion, followed by single dose of AFM13 precomplexed with cbNK cells and three subsequent infusions of AFM13 monotherapy.
  • In a panel of AML cell lines, AFM28 successfully engaged allogeneic NK cells to destroy CD123-positive tumor cells through antibody-dependent cytotoxicity (ADCC).
  • AFM28 is currently being prepared for a first-in-human clinical investigation as monotherapy and in combination with allogeneic NK cells.
  • Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukemias.

Affimed and Artiva Biotherapeutics Announce Partnership to Advance Combination Therapy of Innate Cell Engager (ICE®) AFM13 and Off-the-Shelf Allogeneic NK Cell Therapy AB-101

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Thursday, November 3, 2022
Bladder cancer, HL, Hodgkin lymphoma, SAN, Element, Food, CD16, Biotechnology, GC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, EDT, GLOBE, Lymphoma, NHL, FDA, Breast, Population, Cytokine release syndrome, Safety, Webcast, IND, Cell, NK, Conference, Trial of the century, MD Anderson Cancer Center, REDIRECT, CEO, Conference call, ADCC, Macrophage, PTCL, Forward-looking statement, Rituximab, Engineering, Partnership, University, SEC, Patient, CFGB-FM, Cancer, Program, Pharmaceutical industry, Vaccine, Broadcasting, Risk management, Affimer

AFM13 is currently being investigated in combination with allogeneic cord blood-derived NK cells (cbNK) from The University of Texas MD Anderson Cancer Center.

Key Points: 
  • AFM13 is currently being investigated in combination with allogeneic cord blood-derived NK cells (cbNK) from The University of Texas MD Anderson Cancer Center.
  • Pursuant to the agreement, revenues from the combination will be shared, with Affimed receiving 67% of the combination therapy revenue and Artiva receiving 33%.
  • AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors.
  • AB-101 is a cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers.

Affimed Announces Clinical Update and Trial in Progress Posters at the Annual Meeting of the American Association for Cancer Research (ASCO)

Retrieved on: 
Wednesday, April 27, 2022
NK, Lymphoma, ASCO, Affimer, Safety, EGFR, Pharmacokinetics, Biotechnology, REDIRECT, Patient, GLOBE, Annual general meeting, Cell, American Society of Clinical Oncology, Cancer, University, 2021 Essex County Council election, Haematopoietic system, EDT, Trial of the century, Macrophage, Society, Immunotherapy, MD Anderson Cancer Center, CDT, Disease, Chronic lymphocytic leukemia, Pharmaceutical industry, Medical imaging, Vaccine

Title: AFM24 in combination with atezolizumab in patients with advanced EGFR-expressing solid tumors: Phase 1/2a study design and rationale.

Key Points: 
  • Title: AFM24 in combination with atezolizumab in patients with advanced EGFR-expressing solid tumors: Phase 1/2a study design and rationale.
  • Title: The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors.
  • AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors.
  • The ROCK platform predictably generates customized innate cell engager (ICE) molecules, which use patients immune cells to destroy tumor cells.