SIRP

Electra Therapeutics presents first clinical data from ongoing Phase 1b study of ELA026 for treatment of secondary hemophagocytic lymphohistiocytosis (sHLH)

Retrieved on: 
Monday, December 11, 2023
Biotechnology, Health, Oncology, Clinical Trials, Assistant, IL2RA, CRP, Safety, C-reactive protein, Therapy, University, ASH, Disease, Patient, Peripheral T-cell lymphoma, Monoclonal antibody, Trial of the century, Prognosis, ORR, MD, HLH, Cancer, SIRP, Doctor of Philosophy, Biomarker, MD Anderson Cancer Center, Society, Pharmaceutical industry, Vaccine, Nursing

Data from ten sHLH patients in the ongoing Phase 1b clinical study showed favorable safety results and overall response rate (ORR) of 70% in all patients dosed with ELA026.

Key Points: 
  • Data from ten sHLH patients in the ongoing Phase 1b clinical study showed favorable safety results and overall response rate (ORR) of 70% in all patients dosed with ELA026.
  • The majority of enrolled patients were difficult-to-treat, malignancy-associated HLH and displayed poor prognostic clinical and biomarker features at baseline.
  • The Phase 1b study is an ongoing open-label, multi-dose, single-arm, multicenter study designed to evaluate the safety and efficacy of ELA026, assess biomarkers and identify a dose for Phase 2/3 testing (ClinicalTrials.gov identifier: NCT05416307 ).
  • “We are extremely encouraged by the data from the first two cohorts, and we look forward to continuing enrollment for this study as we advance the ELA026 clinical program.”

Electra Therapeutics to Present Clinical Data for ELA026 at the American Society of Hematology (ASH) 2023 Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, ASH, Patient, SIRP, Society, Therapy, Monoclonal antibody, Poster, Vaccine

Electra Therapeutics, Inc ., a clinical stage biotechnology company developing antibody therapies against novel targets, announced today that the company will present the initial clinical data for its lead drug candidate, ELA026, in a poster at the American Society of Hematology (ASH) annual meeting being held in San Diego, California, December 9-12, 2023.

Key Points: 
  • Electra Therapeutics, Inc ., a clinical stage biotechnology company developing antibody therapies against novel targets, announced today that the company will present the initial clinical data for its lead drug candidate, ELA026, in a poster at the American Society of Hematology (ASH) annual meeting being held in San Diego, California, December 9-12, 2023.
  • ELA026 is a monoclonal antibody that targets signal regulatory protein-α/β1/γ (SIRP) to enable precise depletion of pathological immune cells.
  • ELA026 is currently in a Phase 1b clinical study in patients with secondary hemophagocytic lymphohistiocytosis (sHLH), a life-threatening inflammatory disease.
  • Details of the poster presentation are as follows:
    Title: A Phase 1b Study of ELA026, a Monoclonal Antibody Targeting Signal Regulatory Protein-α/β1/γ, in Patients with Newly Diagnosed and Previously Treated Secondary Hemophagocytic Lymphohistiocytosis

HanchorBio Announces First Patient Dosed in the Phase 1 Multi-Regional Clinical Trial of HCB101

Retrieved on: 
Tuesday, October 3, 2023
RBC, Macrophage, Cancer, SIRP, Immunotherapy, Patient, SAN, IND, FC, Safety, Bone marrow, Pharmaceutical industry

The trial aims to evaluate the safety, tolerability, pharmacodynamics, and anti-tumor activity of HCB101 in patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.

Key Points: 
  • The trial aims to evaluate the safety, tolerability, pharmacodynamics, and anti-tumor activity of HCB101 in patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.
  • "The dosing of the first patient with HCB101 marks another major milestone in evaluating the potential benefit of HCB101 for these patient populations," said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio.
  • HanchorBio is dedicated to discovering and developing immunotherapies to overcome the inadequacies of PD-1/L1 therapies with our proprietary FBDB(TM) technology platform."
  • Preclinical studies have shown that HCB101 has anti-tumor activity across a wide range of solid tumors and hematological malignancies.

FocalPointK12 Earns SOC 2 Type II Certification, Demonstrating Commitment to Data Security

Retrieved on: 
Tuesday, August 1, 2023
Educational technology, SDLC, System and Organization Controls, SOC, SIRP, Privacy, Confidentiality, AICPA, Certification, SOC 2, System, American Institute, Medical device, Risk management

ATLANTA, August 1, 2023 /PRNewswire-PRWeb/ -- The SOC 2 framework encompasses five essential "trust service principles" - security, availability, processing integrity, confidentiality, and privacy. Developed by the AICPA, this certification defines stringent criteria for managing customer data, making it the industry standard for data security among digital companies in the United States.

Key Points: 
  • Developed by the AICPA, this certification defines stringent criteria for managing customer data, making it the industry standard for data security among digital companies in the United States.
  • The SOC 2 examination involved a thorough assessment of FocalPointK12's internal controls, ensuring the protection of customer data and sensitive information.
  • Insight Assurance , an independent auditor, conducted the comprehensive examination, validating FocalPointK12's data security, availability, and confidentiality standards in alignment with AICPA guidelines.
  • By upholding stringent security measures, FocalPointK12 not only safeguards its customers' data today but also ensures it remains at the forefront of data protection in the ever-evolving landscape of educational technology.

Exelixis and Sairopa Announce US FDA Clears Investigational New Drug Application for ADU-1805 in Patients with Advanced Solid Tumors

Retrieved on: 
Monday, February 13, 2023
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Allele, EXEL, Safety, Patient, Food, Tumor microenvironment, SIRP, Medical Affairs Bureau, Immune system, Antibody, Partnership, Learning, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmacokinetics, IND, Pharmaceutical industry, Exelixis

Exelixis, Inc. (Nasdaq: EXEL) and Sairopa B.V. (Sairopa) today announced that the U.S. Food and Drug Administration (FDA) has cleared Sairopa’s Investigational New Drug (IND) Application to evaluate the safety and pharmacokinetics of ADU-1805 in adults with advanced solid tumors.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) and Sairopa B.V. (Sairopa) today announced that the U.S. Food and Drug Administration (FDA) has cleared Sairopa’s Investigational New Drug (IND) Application to evaluate the safety and pharmacokinetics of ADU-1805 in adults with advanced solid tumors.
  • As a monoclonal antibody active against all human alleles of SIRPα, ADU-1805 has the potential to address a broader patient population than other SIRPα-directed therapies.
  • This IND clearance triggers a $35 million milestone payment to Sairopa which will be paid in the first quarter of 2023.
  • “Given the robust preclinical data generated, we are thrilled that ADU-1805 is now able to advance to the clinic,” said Laura Lassouw-Polman, Chief Operating Officer, Sairopa.

Exelixis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 7, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Orange, Neoplasm, Bristol Myers Squibb, Calendar, ADC, District court, News, 1836 U.S. Patent Office fire, Clinical trial, Absorption, United States District Court for the Eastern District of Texas, Partnership, Orange Book, Relatlimab, IMDC, Toxicity, Patent, Checkmate, Trial of the century, Acceleration, Breast, Potential, RECIST, Catalent, Software, Tumor microenvironment, SIRP, Antibody, FDA, Progression-free survival, DC, MSN, Douglas v. U.S. District Court ex rel Talk America, Society, Ipilimumab, T helper cell, PDC, RCC, ASCO, OS, CDK7, BMS, Webcast, Investigational New Drug, Royalty payment, ANDA, Initial, ENA, Allele, Cabozantinib, Blinded, LAG-3, Conjugation, Conference, IND, Online shopping, Pharmaceutical industry, Communications satellite, Nivolumab, Exelixis, Patient, Exatecan

In 2022, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $1.9 billion.

Key Points: 
  • In 2022, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $1.9 billion.
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2022, Exelixis earned $33.9 million and $121.4 million, respectively, in royalty revenues.
  • Exelixis expects its partner Sairopa to file an Investigational New Drug application (IND) for ADU-1805 in the first quarter of 2023.
  • Exelixis management will discuss the company’s financial results for the fourth quarter and full year of 2022 and provide a general business update during a conference call beginning at 5:00 p.m.

Exelixis Announces Preliminary Fourth Quarter and Full Year 2022 Financial Results, Provides 2023 Financial Guidance, and Outlines Key Priorities and Milestones for 2023

Retrieved on: 
Sunday, January 8, 2023
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Cancer, District court, Colorectal cancer, Growth, Large-cell lung carcinoma, Renal cell carcinoma, Catalent, Roche, Nivolumab, Calendar, Therapeutic index, Arm, Head, 5T4, FDA, Antibody, IO, Neck, DC, SIRP, ANDA, Prostate, CD47, Absorption, Ipilimumab, Safety, Webcast, Control, Software, Investigational New Drug, Thyroid cancer, Pharmacokinetics, RCC, Survival analysis, News, Biomarker, CDK7, Breast, Patient, CRC, Tumor microenvironment, ADC, Allele, Conference, Pivotal, Liver, Health insurance, Insurance, Pharmaceutical industry, Vaccine, Exelixis, IND

The preliminary 2022 financial information presented in this press release has not been audited and is subject to change.

Key Points: 
  • The preliminary 2022 financial information presented in this press release has not been audited and is subject to change.
  • The complete Exelixis Fourth Quarter and Full Year 2022 Financial Results are planned for release after market on Tuesday, February 7, 2023.
  • Exelixis President and Chief Executive Officer Michael M. Morrissey, Ph.D., will provide a corporate overview and discuss the company’s preliminary fourth quarter and full year 2022 financial results, 2023 financial guidance, and key priorities and milestones for 2023 during the company’s presentation at the J.P. Morgan Healthcare Conference beginning at 8:15 p.m.
  • To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading.

Electra Therapeutics highlights ELA026 Phase 1b study in sHLH and presents preclinical data at ASH Annual Meeting

Retrieved on: 
Monday, December 12, 2022
Oncology, Health, Stem Cells, Clinical Trials, Pharmaceutical, Biotechnology, ADCP, Therapy, Histiocytosis, Lymphocyte, Primate, MD, Monocyte, Immunotherapy, Infection, Poster, PK, Pharmacology, Protein, Society, SIRP, Biomarker, Patient, Trial of the century, Cancer, Multiple organ dysfunction syndrome, Splenomegaly, Myelocyte, Death, Incidence, Autoimmune disease, Roger Hawkins (drummer), Clinical trial, Safety, Hepatomegaly, ADCC, Immunosuppression, ASH, PD, Cytopenia, Pharmaceutical industry, Vaccine, Medical device

Electra also announced today that a Phase 1b global study of ELA026 in sHLH patients has been initiated and is ongoing (ClinicalTrials.gov identifier: NCT05416307 ).

Key Points: 
  • Electra also announced today that a Phase 1b global study of ELA026 in sHLH patients has been initiated and is ongoing (ClinicalTrials.gov identifier: NCT05416307 ).
  • The Phase 1b study is highlighted as a clinical trial in progress poster at ASH, titled A Phase 1b study of ELA026 in patients with secondary hemophagocytic lymphohistiocytosis.
  • The Phase 1b study is an open-label, single-arm, multicenter study which will evaluate the safety and efficacy of ELA026, assess biomarkers and identify a dose for Phase 2/3 testing.
  • We have created a robust design for this Phase 1b study with the aim of progressing rapidly toward a Phase 2/3 study so we can accelerate ELA026 as a potential treatment option for sHLH patients in need.

Electra Therapeutics to Highlight ELA026 in Three Presentations at the American Society of Hematology (ASH) 2022 Annual Meeting

Retrieved on: 
Thursday, November 3, 2022
Biotechnology, Pharmaceutical, Health, Infection, Cytopenia, Multiple organ dysfunction syndrome, Society, Death, Hepatomegaly, Electra, ASH, Therapy, Splenomegaly, Autoimmune disease, SIRP, Toxicity, Immunotherapy, Patient, Cancer, Program, Vaccine

With ELA026, Electra is taking a first-in-class approach to targeting SIRP to enable precise depletion of pathological immune cells.

Key Points: 
  • With ELA026, Electra is taking a first-in-class approach to targeting SIRP to enable precise depletion of pathological immune cells.
  • ELA026 is currently in Phase 1 clinical studies, including a Phase 1b trial in patients with secondary hemophagocytic lymphohistiocytosis (sHLH), a life-threatening inflammatory disease.
  • Details of the poster presentations are as follows:
    Secondary hemophagocytic lymphohistiocytosis (sHLH) is a life-threatening hyperinflammatory condition for which there is no approved treatment.
  • ELA026 is in clinical development for secondary hemophagocytic lymphohistiocytosis (sHLH), a life-threatening hyperinflammatory condition for which there is no approved treatment.

Exelixis and Sairopa Establish Exclusive Clinical Development Collaboration and Option Agreement to Develop ADU-1805, a Potentially Best-in-Class Monoclonal Antibody Targeting SIRPα

Retrieved on: 
Tuesday, November 1, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Security (finance), SIRP, S&P, Population, Radiation, Acquisition, Toxic epidermal necrolysis, U.S. Securities and Exchange Commission, Pembrolizumab, News, SEC, Daiichi Sankyo, Cancer, Research, Antibody, IND, Nasdaq, COVID-19, Macrophage, Allele, Intellectual property, EXEL, Immune system, Myelocyte, Phagocytosis, Anemia, Thrombocytopenia, Standard, Midcap, ADCP, Compliance, Genentech, Genetics, Therapy, CD47, Antigen presentation, Patient, Multimedia, Esaxerenone, Drug discovery, Forward-looking statement, Tumor microenvironment, Achievement, Vaccine, Pharmaceutical industry, Kerosene, Facebook, Limited, Exelixis

Exelixis, Inc. (Nasdaq: EXEL) and Sairopa B.V. (Sairopa) today announced that the companies have entered into an exclusive clinical development and option agreement for ADU-1805, a potentially best-in-class monoclonal antibody that targets SIRP.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) and Sairopa B.V. (Sairopa) today announced that the companies have entered into an exclusive clinical development and option agreement for ADU-1805, a potentially best-in-class monoclonal antibody that targets SIRP.
  • With an Investigational New Drug filing anticipated in the first quarter of 2023, this agreement provides an exciting opportunity to expand our clinical pipeline.
  • Sairopa was founded to develop a portfolio of therapeutic antibodies that modulate immune system activity to provide benefit to cancer patients.
  • Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered U.S. trademarks of Exelixis.