Associated tags: Lupus, Inflammation, Therapy, Chronic myelomonocytic leukemia, CD3, ILT3, LAIR1, White blood cell, LILRB2, LILRB4, Acute myeloid leukemia, CMML, AML, ILT4, Vaccine, Health, Pharmaceutical, Oncology, Biotechnology, Pharmaceutical industry, Clinical Trials, Patient, Immunotherapy, Research
Locations: CALIFORNIA, UNITED STATES, NORTH AMERICA, SAN FRANCISCO, CHINA
Retrieved on:
Wednesday, February 21, 2024
Oncology,
Health,
FDA,
General Health,
Clinical Trials,
Pharmaceutical,
Biotechnology,
AZA,
AML,
LILRB4,
Azacitidine,
Marketing,
Food,
Inflammation,
HMA,
Therapy,
Bone marrow,
CMML,
Patient,
Autoimmunity,
Chronic myelomonocytic leukemia,
Diagnosis,
Acute myeloid leukemia,
Pharmaceutical industry Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IO-202 for the treatment of chronic myelomonocytic leukemia (CMML).
Key Points:
- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IO-202 for the treatment of chronic myelomonocytic leukemia (CMML).
- IO-202 received Fast Track Designation for treatment of relapsed or refractory CMML in 2023.
- In addition, Fast Track and Orphan Drug Designations for IO-202 were granted by the FDA for the treatment of acute myeloid leukemia (AML) in 2022 and 2020, respectively.
- “We are very proud that the FDA has granted IO-202 Orphan Drug Designation for the treatment of CMML.
Retrieved on:
Tuesday, February 20, 2024
Oncology,
FDA,
Health,
Clinical Trials,
Pharmaceutical,
Biotechnology,
Bevacizumab,
National Comprehensive Cancer Network,
Food,
Safety,
LILRB2,
Hepatocellular carcinoma,
Therapy,
HCC,
ILT4,
Roche,
Patient,
Immunotherapy,
Cancer,
Pharmaceutical industry Atezolizumab and bevacizumab is the first cancer immunotherapy combination regimen approved by the U.S. Food and Drug Administration for this setting and is the recommended standard of care by the National Comprehensive Cancer Network.
Key Points:
- Atezolizumab and bevacizumab is the first cancer immunotherapy combination regimen approved by the U.S. Food and Drug Administration for this setting and is the recommended standard of care by the National Comprehensive Cancer Network.
- “We are excited to work with Roche to accelerate the development of IO-108,” said Charlene Liao, Ph.D., chief executive officer and board chair of Immune-Onc.
- “IO-108 has demonstrated clinical activity and an acceptable safety profile across multiple solid tumors as monotherapy and in combination with T cell checkpoint inhibitors.
- The collaboration marks a significant milestone in establishing IO-108 as the preferred myeloid checkpoint inhibitor for combination with standard of care immunotherapy regimens in solid tumors.”
Under the collaboration, Roche will sponsor and conduct the global, randomized Phase 1b/2 trial to evaluate the safety, efficacy and pharmacodynamics of IO-108 in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab, the standard of care treatment regimen for advanced liver cancer.
Oncology,
Health,
FDA,
General Health,
Clinical Trials,
Pharmaceutical,
Biotechnology,
CMML,
AZA,
Myelocyte,
PD,
European Hematology Association,
LILRB4,
Associate professor,
ILT3,
Acute leukemia,
Chronic myelomonocytic leukemia,
Bone marrow,
Pharmacokinetics,
Fast track (FDA),
Acute myeloid leukemia,
MD Anderson Cancer Center,
MSCE,
AML,
Azacitidine,
Monocyte,
Pancreatic serous cystadenoma,
MD,
Patient,
Immunoglobulin G,
Division,
University,
Cure,
Blood,
EHA,
Toxic leukoencephalopathy,
Leukemia,
Therapy,
Safety,
Vaccine,
Pharmaceutical industry,
Rare-earth element Data from the dose escalation part of the Phase 1 study evaluating patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) will be presented during a poster session at the European Hematology Association (EHA) Annual Meeting in Frankfurt, Germany on June 9, 2023.
Key Points:
- Data from the dose escalation part of the Phase 1 study evaluating patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) will be presented during a poster session at the European Hematology Association (EHA) Annual Meeting in Frankfurt, Germany on June 9, 2023.
- “AML is the most common form of acute leukemia in adults in the U.S. and is characterized by high rates of relapsed and refractory disease.
- Monocytic AML is especially in need of break-through medicine as it is often resistant to standard-of-care treatment.
- Poster presentation details are as follows:
Title: A first-in-human Phase 1 study of IO-202 (anti-LILRB4 mAb) in Acute Myeloid Leukemia (AML) with monocytic differentiations and Chronic Myelomonocytic Leukemia (CMML) patients.
Health,
Clinical Trials,
General Health,
Research,
Pharmaceutical,
Science,
Myelocyte,
AACR,
PD,
LILRB2,
LILRB4,
CD3,
ILT3,
Merkel-cell carcinoma,
Pharmacokinetics,
American Association for Cancer Research,
Biomarker,
Immunotherapy,
ILT4,
Patient,
Pembrolizumab,
Therapy,
Disease,
Safety,
Tislelizumab,
Vaccine,
Pharmaceutical industry,
Angela Merkel The data will be presented in an oral session at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida, April 18.
Key Points:
- The data will be presented in an oral session at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida, April 18.
- Preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will also be presented on April 18 as a late-breaking poster at AACR 2023.
- Treatment with IO-108 was well-tolerated to the maximum administered dose (1800 mg Q3W); the maximum tolerated dose was not reached.
- These findings suggest that LILRB2 is a critically important immunotherapy target.”
The initial data from dose escalation supports further development of IO-108.
Biotechnology,
Health,
Pharmaceutical,
Clinical Trials,
Oncology,
AACR,
CD3,
Drug development,
Therapy,
LILRB2,
ILT4,
American Association for Cancer Research,
Patient,
Immunotherapy,
LILRB4,
ILT3,
Vaccine,
Pharmaceutical industry In addition, preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will be presented as a late-breaking poster at AACR 2023.
Key Points:
- In addition, preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will be presented as a late-breaking poster at AACR 2023.
- “We are very excited that our interim clinical data of IO-108 is selected for oral presentation at AACR 2023.
- This reflects the clinical significance and broad market potential of IO-108 as monotherapy and in combination with an anti-PD-1 for treatment in a variety of solid tumors.
- Presenter: Charlene Liao, Ph.D., chief executive officer of Immune-Onc Therapeutics, Inc
Science,
Biotechnology,
Research,
Pharmaceutical,
Oncology,
Health,
Genetics,
Clinical Trials,
UC,
Bone marrow,
Morton,
University of California,
Medicine,
Myeloid tissue,
SAB,
University,
Biomedical Research,
Therapy,
United States Air Force Scientific Advisory Board,
Communication,
UC San Diego School of Medicine,
Pharmacology,
Symposia,
Pathology,
Biomedicine,
Translational research,
Immunotherapy,
Vaccine,
Communications satellite,
Pharmaceutical industry Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, announced today its plans to present on the company’s myeloid biology research and clinical stage programs at three upcoming scientific and investor conferences in March.
Key Points:
- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, announced today its plans to present on the company’s myeloid biology research and clinical stage programs at three upcoming scientific and investor conferences in March.
- The presentations will highlight the potential of Immune-Onc’s pipeline of first-in-class myeloid checkpoint inhibitors to transform current treatment approaches for blood cancers and solid tumors.
- The Myeloid Network seeks to connect researchers worldwide to promote communication and advancement of research and medicine in the field of myeloid cell biology.
- Dr. Liao will present a corporate overview on Tuesday, March 14 at 4:00 - 4:30 p.m.
Retrieved on:
Thursday, January 5, 2023
Biotechnology,
Health,
Pharmaceutical,
Clinical Trials,
Oncology,
Cancer,
LILRB2,
ILT3,
Food,
Therapy,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
LLS,
Biomarker,
Leukemia,
Immunotherapy,
ILT4,
Leukemia & Lymphoma Society,
LILRB4,
Growth,
Patient,
Regeneron Pharmaceuticals,
Conference,
Tislelizumab,
Pharmaceutical industry Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints today announced the close of an additional $25 million through a Series B extension, for a total of $131 million in Series B financing.
Key Points:
- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints today announced the close of an additional $25 million through a Series B extension, for a total of $131 million in Series B financing.
- This extension was led by existing investor Triwise Capital and with participation from new investors including Proxima Ventures, among others.
- In addition, the company has received continued strategic capital investments from The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (LLS TAP) and Wuxi Biologics HealthCare Venture.
- Immune-Onc will provide additional corporate and clinical progress updates during 1:1 investor and prospective partner meetings at the upcoming J.P. Morgan 41st Annual Healthcare Conference.
Retrieved on:
Thursday, November 10, 2022
In addition, we are able to study IO-202 at a higher starting dose in solid tumors by leveraging safety data from our Phase 1 trial of IO-202 in AML and CMML.
Key Points:
- In addition, we are able to study IO-202 at a higher starting dose in solid tumors by leveraging safety data from our Phase 1 trial of IO-202 in AML and CMML.
- This study may also provide an opportunity to identify preliminary efficacy signals for IO-202 as a monotherapy and as a combination with a PD-1 inhibitor in patients with advanced solid tumors.
- The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 ( NCT05309187 ).
- Immune-Onc Therapeutics Inc. (Immune-Onc) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients.
Retrieved on:
Tuesday, November 8, 2022
Biotechnology,
Pharmaceutical,
Health,
Oncology,
National,
LILRB4,
LAIR1,
LILRB2,
White blood cell,
Industry,
Onyx Pharmaceuticals,
Case Western Reserve University,
Patient,
Lymphatic system,
Doctor of Philosophy,
ILT4,
GSK,
NCI,
Board,
Leukemia & Lymphoma Society,
Cancer,
Immunotherapy,
California Institute for Quantitative Biosciences,
Chronic myelomonocytic leukemia,
Regenerative medicine,
University of California, Davis,
UCSF,
California Institute for Regenerative Medicine,
Drug development,
University,
CIRM,
National Cancer Institute,
NIH,
Board of directors,
University of California, San Francisco,
OncoMed,
Leadership,
Genentech,
Medicine,
Amgen,
Record,
Leukemia,
Biology,
Acute myeloid leukemia,
BeiGene,
LLS,
Research,
Therapy,
Tumor microenvironment,
AML,
CMML,
ILT3,
Regeneron Pharmaceuticals,
Cytokine,
Vaccine,
Pharmaceutical industry "Austin and Barbara have a deep understanding of the discovery and development process for breakthrough cancer therapies, experience that both complements and expands the expertise of our Board.
Key Points:
- "Austin and Barbara have a deep understanding of the discovery and development process for breakthrough cancer therapies, experience that both complements and expands the expertise of our Board.
- Immune-Oncs pioneering role in developing myeloid checkpoint inhibitors as next generation immunotherapies has impressed me, said Dr. Gurney.
- Austin Gurney, Ph.D. is a biotech industry veteran with over two decades of experience in the discovery and development of novel therapeutics.
- Immune-Oncs focused platform approach has led to the development of several promising therapeutics across various stages of development.
