Cytokine release syndrome

Principal Investigator from City of Hope National Medical Center Invited to Present Clinical Data from Marker Therapeutics APOLLO Study at 11th Global Summit on Hematologic Malignancies 

Retrieved on: 
Monday, April 8, 2024
Principal, Malignancy, Risk, Patient, Food and Drug Administration, City, CRS, NHL, Mutagenesis, Therapy, Hematology, Bone marrow, B-cell lymphoma, APOLLO, Neurotoxicity, DLBCL, Cytokine release syndrome, Lymphoma, Press release

HOUSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today reported that Geoffrey Shouse, D.O., Ph.D., the Principal Investigator at City of Hope National Medical Center in Duarte, CA, was invited to present his clinical experience from the APOLLO study at the 11th Global Summit on Hematologic Malignancies in Whistler, BC, Canada (April 2-7, 2024). Dr. Shouse provided an overview on the clinical observations obtained at City of Hope on Saturday, April 6, 2024.

Key Points: 
  • Dr. Shouse provided an overview on the clinical observations obtained at City of Hope on Saturday, April 6, 2024.
  • During the presentation, Dr. Shouse showed that this study participant remains in CR nine months following initial treatment with MT-601.
  • This APOLLO participant had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy.
  • Dr. Shouse’s presentation included data from two additional study participants that have been treated at City of Hope.

Sensei Biotherapeutics Announces Nature Communications Publication Describing Mechanism of Action of SNS-101 Selectively Targeting the Active Form of VISTA within the Tumor Microenvironment

Retrieved on: 
Thursday, April 4, 2024
Risk, Sensei, Patient, Research, Tumor microenvironment, Manuscript, CRS, Cancer, Trial of the century, Cytokine release syndrome, Myelocyte, Antibody, Safety, Therapy, VISTA, Nature Communications, PD-1, Vaccine

The research was conducted by scientists at Sensei Biotherapeutics in collaboration with genOway and the laboratory of Dr. Robert Schreiber at the Washington University, St. Louis School of Medicine.

Key Points: 
  • The research was conducted by scientists at Sensei Biotherapeutics in collaboration with genOway and the laboratory of Dr. Robert Schreiber at the Washington University, St. Louis School of Medicine.
  • The paper describes Sensei Biotherapeutics’ approach to the discovery and development of SNS-101, which was designed to potently and selectively target the active protonated form of VISTA, a protein that plays a significant role in suppressing T-cell activation.
  • SNS-101 is designed to block VISTA by inhibiting its interaction with PSGL-1 on T-cells resulting in T-cell activation.
  • The manuscript published in Nature Communications is entitled “VISTA checkpoint inhibition by pH-selective antibody SNS-101 with optimized safety and pharmacokinetic profiles enhances PD-1 response,” and can be found here: https://rdcu.be/dDF8x

ADC Therapeutics Announces Updates on LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Glofitamab or Mosunetuzumab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Retrieved on: 
Thursday, April 4, 2024
B-cell lymphoma, Toxicity, Associate, Part, Patient, CRS, University, Doctor of Philosophy, Therapy, Diffuse large B-cell lymphoma, Infrared spectroscopy correlation table, Division, ADC, Hematology, Cytokine release syndrome, Lymphoma, Follicular lymphoma, Pharmaceutical industry

LAUSANNE, Switzerland, April 04, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced the completion of dose escalation in LOTIS-7, a Phase 1b open-label clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with bispecific antibodies glofitamab or mosunetuzumab in heavily pre-treated patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL).

Key Points: 
  • Additionally, after the first investigator assessment, evidence of anti-tumor activity was observed among the majority of patients, with mixed histologies including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL).
  • “The early data from Part 1 of our LOTIS-7 trial highlight the potential combinability of ZYNLONTA with bispecifics in lymphoma patients,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics.
  • The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (BsAbs).
  • For more information about the LOTIS-7 trial, visit clinicaltrials.gov (NCT04970901).

Affimed Reports 2023 Financial Results and Operational Progress

Retrieved on: 
Thursday, March 28, 2024
Research, EGFR, GVHD, NSCLC, Genentech, ASH, AML, PD, Disease, International, International Financial Reporting Standards, Patient, Webcast, EFS, EDT, CRS, Cancer, Record, Insurance, Trial of the century, Bank statement, Investment, Safety, Workforce, Roivant Sciences, PFS, IASB, Hodgkin lymphoma, Book, NK, HL, Cytokine release syndrome

MANNHEIM, Germany, March 28, 2024 (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 reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.

Key Points: 
  • MANNHEIM, Germany, March 28, 2024 (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 reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.
  • Based on the promising results, Affimed expanded enrollment in this cohort to 40 patients.
  • Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB.
  • Affimed will host a conference call and webcast on March 28, 2024, at 8:30 a.m. EDT / 13:30 CET to discuss full year 2023 financial results and corporate developments.

Obsidian Therapeutics Presents Positive 25-Week Median Study Follow-Up Safety and Efficacy Data from First-in-Human Study of OBX-115 in Advanced Melanoma at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Toxicity, NSCLC, TIL, Disease, Patient, University, MD Anderson Cancer Center, AACR, IL2, ICI, Therapy, Safety, Poster, PFS, Capillary leak syndrome, Cytokine release syndrome, Pharmaceutical industry

, professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study.

Key Points: 
  • , professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study.
  • The single-center study ( NCT05470283 ) is evaluating the safety, tolerability, dosing, and efficacy of OBX-115 in patients with ICI-resistant metastatic melanoma.
  • All 6 patients had disease that was primary-resistant to anti–PD-1 therapy, with a median of 2.5 (range, 1–5) lines of prior therapy.
  • In addition to the first-in-human study, Obsidian is actively enrolling patients with metastatic melanoma and NSCLC at multiple sites in its ongoing Phase 1/2 multicenter study.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Saturday, April 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

Antengene Presents Four Preclinical Posters at AACR 2024

Retrieved on: 
Saturday, April 6, 2024
PRMT5, AML, CDX, Risk, Weight loss, LILRB4, MTAP, Acute myeloid leukemia, CRS, Cancer, IND, AACR, PDX, Antibody, DDI, TCE, Immunohistochemistry, San Diego Convention Center, Cytokine release syndrome, Vaccine

SHANGHAI and HONG KONG, April 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), taking place from April 5th to April 10th at the San Diego Convention Center in San Diego, California, the United States.

Key Points: 
  • SHANGHAI and HONG KONG, April 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), taking place from April 5th to April 10th at the San Diego Convention Center in San Diego, California, the United States.
  • Study results showed that ATG-042 has the potential to elegantly target tumor cells while sparing healthy cells, with an attractive developability profile.
  • 12:00 AM - 3:30 AM, April 10, 2024 (Beijing Time)
    This preclinical study was designed to test the in vitro/in vivo efficacy, and preclinical pharmacokinetic (PK) properties of ATG-042.
  • This poster presents the discovery and validation of a novel, highly sensitive immunohistochemistry (IHC) antibody that selectively identifies CLDN18.2.

Kineta Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Research, Combination, CPI, AML, Caregiver, Bone marrow, Insurance, Patient, Merck, Acute myeloid leukemia, Cancer, Public expenditure, Pembrolizumab, Lung cancer, Trial of the century, Cytokine release syndrome, AACR, Chemokine, Clinical trial, Annual report, Safety, Workforce, Infrared spectroscopy correlation table, NK, VISTA, Pharmaceutical industry

SEATTLE, March 21, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives, announced today financial results for the full year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • In February 2024, the Company announced a significant corporate restructuring to substantially reduce expenses and preserve cash.
  • We truly appreciate the efforts of the healthcare professionals, the patients and their caregivers, and the Kineta employees involved in this trial.
  • Announced positive KVA12123 monotherapy safety data from its ongoing Phase 1/2 VISTA-101 clinical trial in patients with advanced solid tumors.
  • Cash position: As of December 31, 2023, cash was $5.8 million, compared to $13.1 million as of December 31, 2022.

Cabaletta Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 21, 2024
Research, MPV, IIM, MuSK protein, Toxicity, Conference, Disease, Dermatomyositis, Juvenile dermatomyositis, Federation, Patient, NOL, Observation, CRS, SLE, Health Canada, IND, Immunoglobulin therapy, Pemphigus, Investment, Investigational New Drug, Myopathy, Systemic scleroderma, Marketing, FDA, Clinical trial, Cytokine release syndrome, Cyclophosphamide, CD19, Food, Autoimmune disease, Pharmaceutical industry

In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.

Key Points: 
  • In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.
  • In November 2023, Cabaletta announced that its IND application for CABA-201 was allowed to proceed by the FDA for the Phase 1/2 RESET-MG trial.
  • Cabaletta anticipates reporting initial clinical data from the Phase 1/2 RESET-MG trial in the second half of 2024.
  • As of December 31, 2023, Cabaletta had cash, cash equivalents and short-term investments of $241.2 million, compared to $106.5 million as of December 31, 2022.

LAVA Provides Business Updates and Reports Fourth Quarter and Year-End Financial Results

Retrieved on: 
Wednesday, March 20, 2024
Research, LAVA, AML, Risk, Patient, Acute myeloid leukemia, CRS, Syndrome, Cancer, Completeness, Pembrolizumab, IND, DLT, Investment, Bone marrow, Infrared spectroscopy correlation table, Premedication, CD123, MDS, Cytokine release syndrome

LAVA 1207 – In Phase 1/2a -- Next update expected H2 2024 targeting a medical conferenceDesigned to mediate potent killing of prostate-specific membrane antigen (PSMA)-positive prostate cancer cells

Key Points: 
  • LAVA-1207 has enrolled dose level 9 in our Phase 1/2a trial of patients with metastatic castration-resistant prostate cancer (mCRPC).
  • We continue to be encouraged by the favorable safety profile and preliminary signs of anti-tumor activity.
  • We plan to provide new data for LAVA-1207 at an upcoming medical conference in the second half of 2024,” said Stephen Hurly, President and Chief Executive Officer of LAVA.
  • “These advances represent important steps for our proprietary Gammabody® T-cell engagers as we evaluate their potential to treat cancer.