ONO

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.

ONO PHARMA USA Announces 2023 Golden Ticket Competition in Partnership with LabCentral and MBC BioLabs

Retrieved on: 
Tuesday, April 18, 2023
Golden Ticket, ONO, Organization, MBC, LabCentral, The Golden Ticket, Neurology, Pharmaceutical industry, Film industry

CAMBRIDGE, Mass., April 18, 2023 /PRNewswire/ -- ONO PHARMA USA today announced partnerships with LabCentral in Cambridge, Mass., and MBC BioLabs in San Francisco, to award each organization one Golden Ticket for an innovative life sciences startup company.

Key Points: 
  • CAMBRIDGE, Mass., April 18, 2023 /PRNewswire/ -- ONO PHARMA USA today announced partnerships with LabCentral in Cambridge, Mass., and MBC BioLabs in San Francisco, to award each organization one Golden Ticket for an innovative life sciences startup company.
  • The competition is sponsored by ONO PHARMA USA's parent company, Ono Pharmaceutical Co., Ltd. (ONO), and applications will be received through May 2023.
  • The Golden Ticket awards provide promising early-stage R&D companies lab space and mentorship, two components vital to the success of nascent life science businesses.
  • "As longtime believers in open innovation and the power of partnerships, we are excited once again to offer this Golden Ticket competition in collaboration with LabCentral and MBC BioLabs," said Kunihiko Ito, President and CEO of ONO PHARMA USA.

ONO PHARMA USA's Tirabrutinib Receives Orphan Drug Designation from the FDA for the Treatment of Primary Central Nervous System Lymphoma

Retrieved on: 
Thursday, March 23, 2023
Lymphoma, Seizure, PCNSL, Spinal cord, Eye, Brain, Trial of the century, ONO, Vomiting, Incidence, Patient, Nausea, Orphan, Diagnosis, Neoplasm, Rare, FDA, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Primary central nervous system lymphoma, Food, Pharmaceutical industry

CAMBRIDGE, Mass., March 23, 2023 /PRNewswire/ -- ONO PHARMA USA, INC., announced that its candidate, tirabrutinib (ONO-4059), a Bruton's tyrosine kinase inhibitor, was granted Orphan Drug Designation on March 21, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with primary central nervous system lymphoma (PCNSL).

Key Points: 
  • CAMBRIDGE, Mass., March 23, 2023 /PRNewswire/ -- ONO PHARMA USA, INC., announced that its candidate, tirabrutinib (ONO-4059), a Bruton's tyrosine kinase inhibitor, was granted Orphan Drug Designation on March 21, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with primary central nervous system lymphoma (PCNSL).
  • The FDA's Orphan Drug Designation program supports the development and evaluation of investigational drugs and biologics that show promise for the diagnosis, treatment, or prevention of rare diseases or disorders, affecting fewer than 200,000 people in the United States (U.S.).
  • ONO is currently recruiting newly diagnosed and relapsed or refractory adult PCNSL patients in the U.S. for the PROSPECT clinical study ( www.theprospectstudy.com ; NCT04947319).
  • "We are extremely pleased that tirabrutinib has been granted orphan drug status for the treatment of PCNSL," said Kunihiko Ito, President and CEO of ONO PHARMA USA.

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.

KSQ Therapeutics Announces Ono Pharmaceutical Co., Ltd. is Acquiring Multiple Research-Stage Oncology Programs Identified with KSQ’s CRISPRomics® Platform Technology

Retrieved on: 
Wednesday, January 25, 2023
Biotechnology, Technology, Health, Pharmaceutical, Oncology, Neurology, Research, Software, Genetics, Science, Clinical Trials, DNA, Senior, Therapy, ONO, KSQ, DDR, Acquisition, Discovery, Cancer, Pharmaceutical industry

KSQ Therapeutics, a clinical-stage biotechnology company developing therapies to treat cancer and autoimmune diseases using its proprietary, integrated discovery CRISPRomics platform, announced today that Ono Pharmaceutical Co., Ltd. (“ONO”), has acquired multiple research-stage DNA damage response (DDR) programs identified using KSQ’s CRISPRomics platform technology.

Key Points: 
  • KSQ Therapeutics, a clinical-stage biotechnology company developing therapies to treat cancer and autoimmune diseases using its proprietary, integrated discovery CRISPRomics platform, announced today that Ono Pharmaceutical Co., Ltd. (“ONO”), has acquired multiple research-stage DNA damage response (DDR) programs identified using KSQ’s CRISPRomics platform technology.
  • All the programs are novel and have the potential to become first-in-class therapies.
  • “This acquisition of multiple research-stage oncology programs by ONO is further validation of the power of our platform to identify novel oncology targets and develop potential first-in-class programs,” said Qasim Rizvi, Chief Executive Officer of KSQ.
  • "This is an important transaction for KSQ, enabling us to focus on our other programs.

Repare Therapeutics Receives $1.5 Million (¥200 million) Payment from Ono Pharmaceuticals

Retrieved on: 
Thursday, January 19, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Therapy, U.S.–Afghanistan Strategic Partnership Agreement, ASEAN, Partnership, Ono Pharmaceutical, ONO, Pharmaceutical industry, IND, War reparations, EU

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced that the Company has received an approximately $1.5 million (¥200 million) research service payment from Ono Pharmaceutical Co., Ltd. (“Ono”).

Key Points: 
  • Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced that the Company has received an approximately $1.5 million (¥200 million) research service payment from Ono Pharmaceutical Co., Ltd. (“Ono”).
  • The payment reflects achievement of a specified research trigger, under the companies’ 2019 Strategic Partnership Agreement (“Ono Agreement”).
  • Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and EU.
  • In October 2021, upon the occurrence of a specified research trigger, Repare became eligible to receive a portion, amounting to ¥100 million ($0.9 million), of the research service payments.

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.

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.