Hematological Cancer Research Investment and Education Act

CD19-Targeting Therapies Show Remarkable Growth, Revolutionizing Cancer Treatment with High Response Rates - ResearchAndMarkets.com

Retrieved on: 
Wednesday, November 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, FDA, Antibody, Tisagenlecleucel, IND, Acute leukemia, Fast Track, CD19, B-cell lymphoma, Hematological Cancer Research Investment and Education Act, Research, Neurotoxicity, Quality of life, Novartis, Indication, Immune system, Cytokine release syndrome, USD, NHL, CRS, Lymphoid leukemia, Therapy, Patient, Non-Hodgkin lymphoma, ALL, Monoclonal antibody, Vaccine, Pharmaceutical industry, Amgen

Market Opportunity: The global CD19 antibody market is projected to exceed USD 10 billion by 2028, showcasing its remarkable growth potential.

Key Points: 
  • Market Opportunity: The global CD19 antibody market is projected to exceed USD 10 billion by 2028, showcasing its remarkable growth potential.
  • Commercially Approved CD19 Antibodies: Currently, there are 10 approved CD19 antibodies available in the market, indicating a diverse range of treatment options for patients.
  • These therapies, including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and chimeric antigen receptor T-cell (CAR-T) therapies, have made a significant impact on cancer treatment.
  • To date, nine CD19-targeting therapies have received approval from regulatory bodies, including bispecific antibodies, monoclonal antibodies, antibody-drug conjugates, and CAR-T therapies.

Salarius Completes FDA Type B Meeting for Seclidemstat Ewing Sarcoma Development Program

Retrieved on: 
Tuesday, November 7, 2023
Survival, FDA, Trial of the century, TC, Salinicola salarius, Cyclophosphamide, Hematological Cancer Research Investment and Education Act, Food, Progression-free survival, DCR, Canaccord Genuity, Disclosure, Acquisition, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ewing sarcoma, Clinical trial, Cancer, ORR, LSD1, MD Anderson Cancer Center, Patient, Pharmaceutical industry, Topotecan

HOUSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that it participated in a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma. The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting.

Key Points: 
  • FDA briefing included new Ewing sarcoma clinical data from ongoing investigation where 60% of first-relapse patients achieved disease control and have not progressed after at least 14.5, 19.7 and 22.8 months
    Future development activities were identified; Salarius intends to submit an amended Ewing sarcoma clinical trial protocol
    HOUSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that it participated in a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma.
  • The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting.
  • Salarius is currently evaluating strategic options to advance the clinical development of seclidemstat with a third party.
  • The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with topotecan and cyclophosphamide (TC) chemotherapy as a treatment for relapsed and refractory Ewing sarcoma.

Umoja Biopharma Announces Oral Presentation at the 65th American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Hematology, CAR, Hematological Cancer Research Investment and Education Act, NHP, Society, Vaccine, Medical imaging

SEATTLE, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers, today announced that its abstract, VivoVec™ Surface-Engineered Lentiviral Particles Mediate In Vivo CAR T Generation with Potent and Highly Durable Activity in Non-Human Primates and Tumor-Bearing Humanized Mice, has been selected for an oral presentation at the 65th American Society of Hematology Annual Meeting to be held December 9-12, 2023, in San Diego, California.

Key Points: 
  • SEATTLE, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers, today announced that its abstract, VivoVec™ Surface-Engineered Lentiviral Particles Mediate In Vivo CAR T Generation with Potent and Highly Durable Activity in Non-Human Primates and Tumor-Bearing Humanized Mice, has been selected for an oral presentation at the 65th American Society of Hematology Annual Meeting to be held December 9-12, 2023, in San Diego, California.
  • Umoja’s presentation will discuss the development of the Company’s novel lentiviral in vivo delivery platform, VivoVec™, and additional data from ongoing NHP studies demonstrating best-in-class in vivo CAR T cell generation will be provided at the time of presentation.

Prelude Announces Strategic Pipeline Progress and Updates, including its Partnership with AbCellera, and Reports Third Quarter Financial Results

Retrieved on: 
Wednesday, November 1, 2023
Survival, Research, Standard of care, Research and development, Plasma, AACR, IV, Antigen, MCL1, SMARCA4, MD, G&A, SMARCA2, Conference, Hematological Cancer Research Investment and Education Act, Chromatin, CDK9, MYC, Protein, AbCellera, R, Growth, Cell death, Antibody, Partnership, Spacecraft, Cancer, Hepatotoxicity, Security (finance), Brain, Bone marrow, Toxicity, Safety, Lymphoid leukemia, Patient, EU, Administration, Neutropenia, AML, Mutation, Prelude, Pharmaceutical industry, Vaccine, Fine chemical, IND, PRB

WILMINGTON, Del., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today provides strategic pipeline updates and reports third quarter financial results.

Key Points: 
  • Given the overlap with the CDK9 program, Prelude does not plan to advance PRT1419 further at this time.
  • Given the focus of the Company on SMARCA2 and CDK9, Prelude will not advance the program further and is actively pursuing further clinical development with external partners.
  • “We made significant progress in the third quarter with our four clinical stage molecules and, as planned, conducted a rigorous assessment of each program.
  • We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

INmune Bio Inc. Patent Claims Covering INB16 Cell Line and INKmune™ Therapeutic Composition given Favorable Patentability Opinion by International Search Authority

Retrieved on: 
Tuesday, October 31, 2023
Patient, IND, PSA, Patent, Leukemia, Progression-free survival, Biomarker, Art, Ligand, World Intellectual Property Organization, CD15, Invention, CELL, Hematological Cancer Research Investment and Education Act, Patent Cooperation Treaty, Cell, EPO, Administration, China International Search and Rescue Team, Disease, ATCC (company), NK, Cancer, WIPO, CT, Blood, TME, General counsel, CD2, Immunosuppression, Hypoxia, Insurance, Vaccine, Pharmaceutical industry

Boca Raton, Florida, Oct. 31, 2023 (GLOBE NEWSWIRE) --  INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announced an update regarding the company’s patent covering its proprietary cell line, “INB16”, as well as the therapeutic composition comprising replication-incompetent INB16 cells known as “INKmune™” and methods of treating cancer by administering INKmune™, with a goal of achieving in vivo priming of natural killer (NK) cells to enhance the ability of a patient’s own NK-cells to effect cancer surveillance, recognition, and killing.

Key Points: 
  • INmune Bio receives International Search Report and Written Opinion communicating possession of novelty, inventive step, and industrial applicability in all claims pending in an international patent application covering, among other things, its proprietary cell line, INB16, and the INKmune™ therapeutic composition.
  • The application discloses and claims the novel INB16 cell line on deposit with the American Type Culture Collection, as well as compositions comprising replication incompetent INB16 cells (“INKmune™”) and methods of treating cancer in patients by administering INKmune™.
  • “Patents covering novel cell lines are somewhat rare in practice and form a very small number of total patents issued,” said Joshua Schoonover, Esq., in-house General Counsel for the Company.
  • INB16 is a tumor cell line which is relatively insensitive to killing by natural killer (NK) cells from healthy donors and from patients.

Oncoclínicas opens first Cancer Center in Brazil as an International Collaborative Member of Dana-Farber Cancer Institute

Retrieved on: 
Wednesday, November 1, 2023
Gibbs Cancer Center & Research Institute, Harvard Medical School, Patient, Dana–Farber Cancer Institute, MD, Oncology, Organization, Hematological Cancer Research Investment and Education Act, Health, International Collaboration for the Care of the Elderly, Instituto Nacional de Medicina Genómica, Dana, Disease, Medicine, INCA, Partnership, Instituto Oncológico Nacional, Ferrari, Cancer, Pharmacist, Nursing, Patient safety, Pharmaceutical industry

The estimated investment by Oncoclinicas in the new Cancer Center is BRL 93 million, including infrastructure, technology, and operations.

Key Points: 
  • The estimated investment by Oncoclinicas in the new Cancer Center is BRL 93 million, including infrastructure, technology, and operations.
  • These facilities will be expanded to accommodate the new Oncoclínicas Cancer Center in Belo Horizonte e Nova Lima, an International Collaborative Member of Dana-Farber Cancer Institute.
  • "The Oncoclínicas cancer center in Belo Horizonte is the first outside the United States to receive the designation of international collaborating member of the Dana Farber Cancer Institute.
  • "Among other collaborative efforts, our multidisciplinary discussions contribute to democratizing cancer care for every patient across our operations in Brazil.

GPCR Therapeutics Announces Publication on Improving Hematopoietic Stem Cell Mobilization Using Propranolol with GPC-100

Retrieved on: 
Thursday, October 26, 2023
Stem cell, Survival, Bone pain, Gq alpha subunit, Google Store, GPCR, Multiple myeloma, Propranolol, Therapy, Hope, Health, Hematological Cancer Research Investment and Education Act, CXCR4, Sickle cell disease, Research, Cell, ASCT, Mouse, Clinical trial, Risk, Cancer, HSC, G-CSF, G protein-coupled receptor, Transplant, Bone marrow, PLOS, Tumors of the hematopoietic and lymphoid tissues, Biology, Patient, B cell, Seoul National University, Pharmaceutical industry, Microbiology

These findings strongly support the use of this combination for peripheral blood HSC harvest in autologous stem cell transplant treatment in hematological cancers.

Key Points: 
  • These findings strongly support the use of this combination for peripheral blood HSC harvest in autologous stem cell transplant treatment in hematological cancers.
  • The paper, authored in collaboration with Seoul National University’s School of Biological Sciences and Institute of Microbiology, is entitled, “GPC-100, a novel CXCR4 antagonist, improves in vivo hematopoietic cell mobilization when combined with propranolol” (1).
  • The authors highlight that GPC-100 alone shows greater mobilization efficacy than a drug already approved for stem cell mobilization.
  • Increasingly, clinicians are using Autologous Stem Cell Transplant (ASCT) to treat patients, which has improved the anti-cancer response and survival compared to conventional chemotherapy.

Umoja Biopharma Announces Opening of Development and Manufacturing Facility in Louisville, Colorado

Retrieved on: 
Thursday, October 19, 2023
Senior, Growth, Hematological Cancer Research Investment and Education Act, Patient, Doctor of Philosophy, Interface (computing), Pharmaceutical industry, Umoja

SEATTLE, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers, announced today the opening of its new development and manufacturing facility, The Colorado Laboratory & Innovative Manufacturing Building (The CLIMB) in Louisville, Colo.

Key Points: 
  • SEATTLE, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers, announced today the opening of its new development and manufacturing facility, The Colorado Laboratory & Innovative Manufacturing Building (The CLIMB) in Louisville, Colo.
  • The facility is designed to accelerate the development of Umoja’s therapeutic candidates.
  • The Company anticipates its first manufacturing run of clinical material in the first quarter of 2024.
  • We are thrilled to be a part of this vibrant and dynamic community in Colorado as we work together to bring life-changing therapies to patients and their families.”

AI Diagnostic Platform Company Noul, unveils the result of Malaria study in Ethiopia and Ghana

Retrieved on: 
Monday, October 23, 2023
Plasmodium falciparum, Research, Real-time, Trial of the century, Global health, Exhibition, Incidence, University of Notre Dame, Parasitism, Korea Human Rights Foundation, History, Prevalence, Infection, Malaria, UNITAID, RDT, R, Society, Artificial intelligence, Plasmodium vivax, Tropical medicine, Hematological Cancer Research Investment and Education Act, Clinical trial, Diagnosis, Risk, Annual report, Partnership, University of Science and Technology, Annual general meeting, Blood, University, Public, American Society of Tropical Medicine and Hygiene, Patient, University of Gondar, Pharmaceutical industry, Medical imaging, Medical device, Typhoon Noul (2015), Plasmodium, Hygiene

In the study, the scientists compared the sensitivity and specificity of the qPCR with those of miLab™, field microscopy, and Rapid Diagnostic Test (RDT) respectively.

Key Points: 
  • In the study, the scientists compared the sensitivity and specificity of the qPCR with those of miLab™, field microscopy, and Rapid Diagnostic Test (RDT) respectively.
  • Diagnosis of P. falciparum infections included cases with hrp2/hrp3 gene deletion with renders parasites 'invisible' to common rapid diagnostic tests.
  • Also, the diagnostic results of miLab™ in P. falciparum infected patients with hrp2/hrp3 gene deletion have been released.
  • This new study in Ethiopia and Ghana confirmed the clinical performance of miLab™ as a reliable new tool in the diagnosis of P. falciparum and P. vivax malaria.

ImCheck to Present New Positive Data on ICT01 Monotherapy in Hematological Cancers at ESMO 2023

Retrieved on: 
Wednesday, October 18, 2023
Olive, Congress, Incidence, Acute myeloid leukemia, Pembrolizumab, Standard of care, AE, Safety, AML, Hematological Cancer Research Investment and Education Act, Cancer, Oncology, ESMO, Therapy, SD, B-cell lymphoma, DCR, CRi, Bone marrow, CET, European Society for Medical Oncology, Blood, Follicular lymphoma, Patient, CR, Pharmaceutical industry, Medical device

“The positive safety profile, consistent with previous data in solid tumor patients, together with the promising clinical activity underscores the potential of ICT01 in hematological malignancies.

Key Points: 
  • “The positive safety profile, consistent with previous data in solid tumor patients, together with the promising clinical activity underscores the potential of ICT01 in hematological malignancies.
  • “We continue to generate highly encouraging clinical signals in both solid and hematological tumors.
  • The reported data did not reveal any dose-limiting toxicities and demonstrated a DCR of 30% among the 10 evaluable patients at week 8.
  • Based on these results, the company has started evaluating ICT01 in combination with Venetoclax/azacitidine in a Phase IIa expansion cohort in first-line AML patients.