CXCR2

Fate Therapeutics Announces Initiation of Phase 1 Clinical Trial for FT825 / ONO-8250 in Patients with HER2-expressing Advanced Solid Tumors

Retrieved on: 
Monday, January 8, 2024
Partnership, Tumor microenvironment, Immunotherapy, HER2, Trastuzumab, CD8, CXCR2, IPSC, SAN, Therapy, Pharmacokinetics, Destiny, CD16, Patient, Safety, Vaccine

SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today announced the initiation of enrollment for its Phase 1 clinical trial of FT825 / ONO-8250, a multiplexed-engineered, chimeric antigen receptor (CAR) T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2). The iPSC-derived CAR T-cell product candidate incorporates a novel HER2-targeted antigen binding domain and is designed to overcome unique challenges in treating solid tumors. The Phase 1 study of FT825 / ONO-8250 is being conducted under a strategic collaboration with Ono Pharmaceutical Co., Ltd. (Ono).

Key Points: 
  • The iPSC-derived CAR T-cell product candidate incorporates a novel HER2-targeted antigen binding domain and is designed to overcome unique challenges in treating solid tumors.
  • The Phase 1 study of FT825 / ONO-8250 is being conducted under a strategic collaboration with Ono Pharmaceutical Co., Ltd. (Ono).
  • The Phase 1 study is designed to investigate a single dose of FT825 / ONO-8250 as monotherapy and in combination with monoclonal antibody therapy in previously-treated patients with advanced solid tumors.
  • The parties are currently conducting preclinical development of an additional solid tumor program targeting an undisclosed tumor-associated antigen.

Fate Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Wednesday, November 8, 2023
Food, Multiple myeloma, CXCR2, Enrollment, B-cell lymphoma, Lupus, SITC, Cetuximab, Annual general meeting, Rituximab, SLE, CAR, Hyperbaric treatment schedules, GAAP, Graft-versus-host disease, Safety, Cancer, Therapy, Ono Pharmaceutical, Investment, Patient, IPSC, Society for Immunotherapy of Cancer, Chronic lymphocytic leukemia, Research, Immunotherapy, TRAC, CD16, NK, Clinical trial, Multiplexing, BCL, Acute leukemia, CRS, Cell, FDA, Trastuzumab, IND, ONO, ADR, HER2, Neoplasm, Protocol, Lupus Research Alliance, Destiny, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmacokinetics, Tumor microenvironment, BCMA, Vaccine, Pharmaceutical industry, Autoimmunity

SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • FT522 is the Company’s off-the-shelf, multiplexed-engineered natural killer (NK) cell product candidate that incorporates five synthetic controls of cell function.
  • In addition, as of September 30, 2023, cash receivables from the Company’s collaboration with ONO were $1.5 million.
  • Shares Outstanding: Common shares outstanding were 98.6 million, and preferred shares outstanding were 2.8 million, as of September 30, 2023.
  • ET to review financial and operating results for the quarter ended September 30, 2023.

Fate Therapeutics Reports Second Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Tuesday, August 8, 2023
GMP, Graft-versus-host disease, TRAC, Neoplasm, ADR, Investment, Chronic lymphocytic leukemia, IPSC, Multiple myeloma, Cancer, Hyperbaric treatment schedules, NK, GAAP, Research, B-cell lymphoma, ONO, CXCR2, CAR, Destiny, Patient, SAN, B cell, Mab, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Tumor microenvironment, Acute leukemia, Ono Pharmaceutical, Food, BCMA, Safety, Vaccine, Pharmaceutical industry, Cryptocurrency

SAN DIEGO, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today reported business highlights and financial results for the second quarter ended June 30, 2023.

Key Points: 
  • In addition, as of June 30, 2023, cash receivables from the Company’s collaboration with ONO were $2.8 million.
  • Total Operating Expenses: For the second quarter of 2023, GAAP operating expenses were $63.5 million, including research and development expenses of $40.9 million and general and administrative expenses of $22.6 million.
  • Shares Outstanding: Common shares outstanding were 98.5 million, and preferred shares outstanding were 2.8 million, as of June 30, 2023.
  • ET to review financial and operating results for the quarter ended June 30, 2023.

Fate Therapeutics Reports First Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Wednesday, May 3, 2023
ASH, Completeness, Chronic lymphocytic leukemia, Bone marrow, Janssen, GAAP, Investigational New Drug, Patient, Investment, Mab, Autoimmune disease, Graft-versus-host disease, Multiple myeloma, NK, Research, B-cell lymphoma, FDA, IND, Ono Pharmaceutical, Safety, TRAC, Neoplasm, IPSC, ADR, Lymphoid leukemia, HER2, Cancer, ONO, CAR, Destiny, SAN, B cell, Therapy, Escalation, CXCR2, Multi, Regulation of tobacco by the U.S. Food and Drug Administration, Tumor microenvironment, Society, Acute leukemia, Food, BCMA, Vaccine, Security (finance), Pharmaceutical industry

SAN DIEGO, May 03, 2023 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today reported business highlights and financial results for the first quarter ended March 31, 2023.

Key Points: 
  • Upon clearance of the current treatment cohorts, the Company plans to open and assess three-dose treatment cohorts starting at 1 billion cells per dose.
  • Shares Outstanding: Common shares outstanding were 98.2 million, and preferred shares outstanding were 2.8 million, as of March 31, 2023.
  • ET to review financial and operating results for the quarter ended March 31, 2023.
  • The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com.

Fate Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Updates

Retrieved on: 
Tuesday, February 28, 2023
Cancer, IPSC, IND, Collaboration, Chronic lymphocytic leukemia, Multiple myeloma, Safety, Society, Therapy, Acute leukemia, Investigational New Drug, Workforce, Mab, Destiny, Patient, Completeness, Tumor microenvironment, HER2, ADR, D, Food, B cell, TRAC, Ono Pharmaceutical, NK, Research, Investment, Society for Immunotherapy of Cancer, Graft-versus-host disease, Exercise, SITC, B-cell lymphoma, ONO, CAR, Annual general meeting, Risk, Immunotherapy, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ASH, BCMA, CR, CXCR2, Cryptocurrency, Vaccine, Pharmaceutical industry, Janssen

Total Revenue: Revenue was $44.4 million for the fourth quarter of 2022, which was derived from the Company’s collaborations with Janssen and ONO.

Key Points: 
  • Total Revenue: Revenue was $44.4 million for the fourth quarter of 2022, which was derived from the Company’s collaborations with Janssen and ONO.
  • R&D Expenses: Research and development expenses were $87.2 million for the fourth quarter of 2022, which includes $12.4 million of non-cash stock-based compensation expense.
  • G&A Expenses: General and administrative expenses were $21.6 million for the fourth quarter of 2022, which includes $7.0 million of non-cash stock-based compensation expense.
  • ET to review financial and operating results for the quarter and full year ended December 31, 2022.

Fate Therapeutics Announces Termination of Collaboration Agreement with Janssen, Pipeline Prioritization, Next-Generation Programs, and Key 2023 Initiatives

Retrieved on: 
Thursday, January 5, 2023
Cancer, ONO, IPSC, Annual general meeting, Society, SITC, Workforce, Mab, CD20, Patient, Lymphatic system, BCMA, CXCR2, Preclinical development, Treatment, Degenerative disease, Cichocki, FDA, IND, ADR, HER2, B-cell lymphoma, Ono Pharmaceutical, Pharmacokinetics, ASH, Society for Immunotherapy of Cancer, Nature Communications, Food, Therapy, Regulation of tobacco by the U.S. Food and Drug Administration, Destiny, NHL, Acute myeloid leukemia, NK, CD38, Immunotherapy, Investigational New Drug, MM, Risk, Disease, CAR, Tumor microenvironment, B cell, Multiple myeloma, Multiplexing, Vaccine, Pharmaceutical industry, Janssen, Safety

In addition, we look forward this year to the further emergence of our iPSC-derived CAR T-cell programs for the treatment of hematologic malignancies and solid tumors.

Key Points: 
  • In addition, we look forward this year to the further emergence of our iPSC-derived CAR T-cell programs for the treatment of hematologic malignancies and solid tumors.
  • Ongoing Phase 1 Study of FT576 BCMA-targeted CAR NK Cell Program to Accrue Higher-dose, Multi-dose Treatment Cohorts.
  • The Company ended the fourth quarter of 2022 with unaudited cash, cash equivalents, and receivables totaling approximately $475 million.
  • Based on its current operating plan, the Company expects to have sufficient financial resources to fund operations through 2025.

First-in-Class Investigational SX-682 Demonstrates Single-Agent Efficacy in Patients with Hypomethylating Agent Failure Myelodysplastic Syndromes

Retrieved on: 
Friday, December 9, 2022
NIH, ORR, Microdeletion syndrome, International Prognostic Scoring System, IWG, MD, Research institute, Doctor of Philosophy, Lenalidomide, MDSC, Society, IPSS, Lung, Patient, Cancer, Neutrophil, Myelodysplastic syndrome, Abstract, National Heart, Lung, and Blood Institute, CXCR2, Tumor microenvironment, Bone marrow, AML, Clinical trial, Risk, Multimedia, Safety, The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, NHLBI, Transfusion-dependent anemia, MDS, MCR, ASH, CXCR1, BID, Pharmaceutical industry, Dietary supplement, HMA

AUBURN, Wash., Dec. 9, 2022 /PRNewswire/ -- Syntrix Pharmaceuticals today announced results from a single-arm, open-label Phase 1 trial of single-agent SX-682, an investigational CXCR1/2 inhibitor, in patients with any-risk myelodysplastic syndromes (MDS) in whom front-line hypomethylating-agent (HMA) had failed, a high unmet need population.  Results support the clinical activity of SX-682.  The data will be presented by David Sallman, MD of the H. Lee Moffitt Cancer Center and Research Institute, an investigator for the clinical trial, during an afternoon oral session on December 12, 2022 at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #855).

Key Points: 
  • All patients were transfusion-dependent and all had failed prior HMA and 24% lenalidomide (range 1-4 failed prior therapies).
  • The median age was 76, and patients were low (n=1), intermediate-1 (n=10), intermediate-2 (n=5) and high (n=1) risk by the International Prognostic Scoring System (IPSS).
  • Myelodysplastic syndromes (MDS) are a type of cancer caused by poorly formed or dysfunctional blood cells in the bone marrow.
  • Patients are treated with BID doses of SX-682 in six continuous 28-day cycles with responding patients continuing treatment.

Fate Therapeutics Announces Exercise by ONO Pharmaceutical of Option to HER2-targeted CAR T-Cell Product Candidate for Solid Tumors

Retrieved on: 
Monday, November 7, 2022
Company, Neoplasm, Private Securities Litigation Reform Act, Exercise, Immunosuppression, Tumor microenvironment, Discovery, Maintenance, CA, Cancer, Patent, Canadian Aviation Regulations, GLOBE, CAR, FDA, Trade, IND, Senior, NK, IPSC, Abstract, Multiplexing, Therapy, Immunotherapy, ONO, Annual general meeting, CXCR2, U.S. Securities and Exchange Commission, Exclusive Rights, Ono Pharmaceutical, NASDAQ, Risk, Security (finance), Collaboration, Society, HER2, SITC, Patient, Society for Immunotherapy of Cancer, Program, Destiny, Vaccine, Pharmaceutical industry

SAN DIEGO, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today announced that ONO Pharmaceutical Co., Ltd. (ONO) has exercised its option to FT825/ONO-8250, a multiplexed-engineered, iPSC-derived, chimeric antigen receptor (CAR) T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors. The preclinical product candidate incorporates multiple functional elements to enhance the activity and overcome unique challenges in treating solid tumors with cell-based cancer immunotherapies.

Key Points: 
  • The preclinical product candidate incorporates multiple functional elements to enhance the activity and overcome unique challenges in treating solid tumors with cell-based cancer immunotherapies.
  • Under the terms of the Collaboration and Option Agreement, Fate will receive a milestone payment in connection with ONOs exercise of its option to FT825/ONO-8250.
  • The parties recently expanded their collaboration to initiate preclinical development of an additional program targeting a second solid tumor antigen.
  • Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

Arena Reports Third Quarter Financial Results and Key Program Updates

Retrieved on: 
Thursday, November 4, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Corporation, Coronavirus, Private Securities Litigation Reform Act, CXCR2, Therapy, Aristea, SG, Ulcerative colitis, R, Security (finance), CEO, Arena Pharmaceuticals, UC, COVID-19, Research, Medication, Program, Conference call, Judgement, Porokeratosis, Conference, U.S. Securities and Exchange Commission, Alopecia areata, Disagreement, SEC, PPP, Division of Acquired Immunodeficiency Syndrome, Time, Asian Development Research Institute, Marketing, Nasdaq, Patient, Risk, Pharmaceutical industry, Management

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the third quarter ended September 30, 2021.

Key Points: 
  • Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the third quarter ended September 30, 2021.
  • During the quarter, the team continued to make significant progress across all key programs, including reaching full enrollment for the ELEVATE UC 12 program, said Amit D. Munshi, President and CEO of Arena.
  • This increase was primarily driven by our advancing clinical studies, including the etrasimod Phase 3 program, as well as an increase in personnel expenses to support our clinical programs.
  • Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.