Thrombocytopenia

Kymera Therapeutics Presents New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting

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lördag, juni 1, 2024
MD, Aes, Șaeș, Biomarker, ASCO, Uveal melanoma, Fatigue, Toxicity, Carcinoma, Melanoma, Plasma, Patient, Diarrhea, Annual general meeting, ACC, Neutropenia, Acute leukemia, Safety, MD Anderson Cancer Center, Resource, Society, DL2, Therapy, ALL, Appetite, AML, Arm, Thrombocytopenia, MDM2, DL, Arthralgia, Messenger, Adenoid cystic carcinoma, Lymphoma, Blood, Acute myeloid leukemia, CDKN1A, PD, TPD, MPN, Grade 3, Merkel-cell carcinoma, MCC, University, Poster, Therapeutic index, Nausea, Pharmaceutical industry

WATERTOWN, Mass., June 01, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today shared new clinical data from its ongoing KT-253 Phase 1 trial. KT-253, a potent, selective heterobifunctional small molecule degrader of MDM2, demonstrated preliminary signs of efficacy across tumor types at doses that were generally well-tolerated. The data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 – June 4, 2024. Results released in an ASCO poster today include a data cut-off of April 9, 2024.

Key Points: 
  • The data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 – June 4, 2024.
  • Results released in an ASCO poster today include a data cut-off of April 9, 2024.
  • “We’re encouraged by the data emerging from the KT-253 Phase 1 dose escalation trial, showcasing the potential of TPD to address this clinically proven but inadequately drugged cancer mechanism.
  • Kymera is also developing a biomarker-based patient selection strategy for subsequent development beyond Phase 1a and is expected to present data at a medical meeting this year.

invoX Pharma Presents Positive Clinical Data from Phase 1 Study of FS222 in Patients with Advanced Solid Tumours at the 2024 American Society of Clinical Oncology Annual Meeting

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måndag, juni 3, 2024
Research, Finance, Clinical Trials, Professional Services, Biotechnology, Health, Pharmaceutical, Science, Oncology, Drug development, MD, Ovarian cancer, TNBC, CD137, Melanoma, PD-L1, Patient, Mucosal melanoma, Neutropenia, NSCLC, Teaching hospital, Safety, Society, Pharmacokinetics, Mesothelioma, Therapy, Febrile neutropenia, Thrombocytopenia, MSS, FIH, Vall, Clinical trial, Lung cancer, Master of Science, Medical imaging

These preliminary findings were presented today at the 2024 American Society of Clinical Oncology Annual Meeting in Chicago as an oral presentation during the Development Therapeutics – Immunology Session.

Key Points: 
  • These preliminary findings were presented today at the 2024 American Society of Clinical Oncology Annual Meeting in Chicago as an oral presentation during the Development Therapeutics – Immunology Session.
  • FS222 is a novel tetravalent bispecific antibody, using invoX's proprietary Fcab® platform technology, that drives PD-L1 dependent CD137 agonism.
  • The data presented today are from 100 subjects in the ongoing first-in-human (FIH) dose-escalation phase 1 clinical trial of FS222 (NCT04740424) in patients with advanced solid tumours.
  • The study is designed to evaluate safety and identify the maximum tolerated dose, with secondary objectives related to anti-tumour activity, pharmacokinetics, and pharmacodynamics.

ImmuneOncia Announces Biomarker Results from Phase 1 Clinical Trial of CD47 Antibody at ASCO

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måndag, juni 3, 2024
Biotechnology, Pharmaceutical, Oncology, Health, Artificial Intelligence, Health Technology, Technology, Clinical Trials, Therapy, Breast cancer, ASCO, DCR, CBR, Hepatocellular carcinoma, Multimedia, Toxicity, Prognosis, Patient, Annual general meeting, ESMO, Cancer, Neutropenia, Society, Thrombocytopenia, Clinical trial, Anemia, Samsung Medical Center, CD47, Infrared spectroscopy correlation table, Pharmaceutical industry

ImmuneOncia (CEO Heung Tae Kim) announced the results of its solid tumour Phase 1a clinical trial of IMC-002, an anti-CD47 mAb, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA on June 1, 2024 (local time).

Key Points: 
  • ImmuneOncia (CEO Heung Tae Kim) announced the results of its solid tumour Phase 1a clinical trial of IMC-002, an anti-CD47 mAb, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA on June 1, 2024 (local time).
  • These results include updates on the Phase 1a clinical trial outcomes, along with biomarker findings achieved through collaboration with Lunit (CEO; Brandon Suh), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics.
  • View the full release here: https://www.businesswire.com/news/home/20240603017832/en/
    ImmuneOncia Announces Biomarker Results from Phase 1 Clinical Trial of CD47 Antibody at ASCO (Graphic: ImmuneOncia Therapeutics, Inc.)
    The study, a dose escalation part of Phase 1, enrolled a total of 12 patients across four dose cohorts starting from May 2022.
  • He further stated, "With the Phase 1b trial for IMC-002 initiated last November, we anticipate additional efficacy confirmation for IMC-002 in specific solid tumours with high unmet needs."

Takeda Receives Positive CHMP Opinion for Recombinant ADAMTS13 (rADAMTS13) in Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

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fredag, maj 31, 2024
General Health, Other Health, Health, Genetics, Pharmaceutical, Patient, Thrombotic thrombocytopenic purpura, ADAMTS13, Thrombocytopenia, TTP, Safety, European, Stroke, Marketing, European Commission, EMA, Toll, Mortality, Enzyme replacement therapy, Microangiopathic hemolytic anemia, Committee, CHMP

Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval, under exceptional circumstances, of recombinant ADAMTS13 (rADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval, under exceptional circumstances, of recombinant ADAMTS13 (rADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP.
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for rADAMTS13 throughout the European Union (EU).
  • “With this positive opinion for recombinant ADAMTS13, we are one step closer to offering patients in the EU the first treatment specifically indicated for cTTP.
  • Data from this trial ( NCT03393975 ) were published in The New England Journal of Medicine in May 2024. rADAMTS13 is also being investigated in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP), the acquired form of TTP, in an ongoing Phase 2b trial ( NCT05714969 ).

Meaningful Improvement in Overall Survival (OS) and Tolerability Observed in Patients Receiving Trilaciclib in Combination with a TROP2 Antibody-Drug Conjugate (ADC)

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tisdag, maj 28, 2024
Patient, Diarrhea, Progression-free survival, Survival, Thrombocytopenia, Anemia, Neutropenia, Diagnosis, PFS, Therapy, Disease, Breast cancer, RECIST, ADC, Seneviratne, ITT, Trilaciclib, Aplastic anemia, Spacecraft, ASCO, Poster, OS, Society, SACT, ESMO, CBR, Immunotherapy, G1 Therapeutics, Oncology, TNBC, Pharmaceutical industry

(abstract number 1091) describes the mature results from a Phase 2 trial of trilaciclib in combination with SG in patients with mTNBC.

Key Points: 
  • (abstract number 1091) describes the mature results from a Phase 2 trial of trilaciclib in combination with SG in patients with mTNBC.
  • Prolonged OS was observed in patients receiving trilaciclib with the ADC who had an initial breast cancer diagnosis of TNBC, prior use of checkpoint inhibitors, and no prior oral CDK4/6 inhibitor use.
  • The poster also describes the significant on-target benefit of trilaciclib in reducing adverse events associated with this ADC, including diarrhea, neutropenia, anemia, and thrombocytopenia.
  • In this patient population, median OS among patients receiving trilaciclib was 17.9 months vs. 12.1 for SG alone.

Sobi to present new myelofibrosis data at the ASCO 2024 Annual Meeting

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fredag, maj 24, 2024
Patient, Survival, Thrombocytopenia, Anemia, Disorder, BAT, Swedish Orphan Biovitrum, JAK, ASCO, Abstract, Society, Ruxolitinib, Pharmaceutical industry

WALTHAM, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of three abstracts that highlights data from its myelofibrosis treatment option at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31 – June 4, 2024.

Key Points: 
  • WALTHAM, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of three abstracts that highlights data from its myelofibrosis treatment option at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31 – June 4, 2024.
  • Sobi’s commitment to delivering innovative treatments for people living with hematological diseases is seen in global studies spanning multiple rare disorders, including myelofibrosis.
  • The number of patients experiencing treatment emergent Grade 3 anaemia was similar between pacritinib and BAT groups.
  • For details on how to contact the Sobi Investor Relations Team, please click here .

Zentalis Pharmaceuticals to Present Promising Results from Phase 1 Trial of Azenosertib and Gemcitabine in Relapsed or Refractory Osteosarcoma at 2024 American Society of Clinical Oncology Annual Meeting

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torsdag, maj 23, 2024
Patient, Medication, MTD, Osteosarcoma, Thrombocytopenia, Hope, Index, Relapse, Febrile neutropenia, EFS, Safety, SAN, RECIST, Death, Cancer, Incidence, ASCO, Glomus tumor, Society, Therapy, Annual general meeting, Lymphocytopenia, Pharmaceutical industry

NEW YORK and SAN DIEGO, May 23, 2024 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced the presentation of final results from a Phase 1 trial of azenosertib and gemcitabine in relapsed or refractory (R/R) osteosarcoma at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Key Points: 
  • “We are pleased to report the final results from our Phase 1 trial evaluating azenosertib administered with gemcitabine in patients with relapsed or refractory osteosarcoma,” said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis.
  • These results support studying the combination in patients facing this aggressive cancer, which we expect will occur in an upcoming investigator-initiated Phase 2 trial.
  • Data support further investigation of azenosertib administered in combination with gemcitabine in patients with R/R osteosarcoma in an upcoming investigator-initiated Phase 2 trial.
  • Title: Phase 1 Results of the WEE1 Inhibitor, Azenosertib, in Combination With Gemcitabine in Adult and Pediatric Patients With Relapsed or Refractory Osteosarcoma.

Compass Therapeutics to Present Phase 1 Data for CTX-471, A Novel CD137 Agonist Antibody, Demonstrating Anti-Tumor Activity in Patients Who Have Progressed on Approved PD-1 or PD-L1 Inhibitors at the American Society of Clinical Oncology (ASCO) Annual Mee

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torsdag, maj 23, 2024
SCLC, R&D, PET, Patient, Mesothelioma, Pharmacokinetics, Thrombocytopenia, Liver, News, Male, Therapy, Malignancy, Safety, Carcinoma, PD-1, Melanoma, Incidence, PR, Aes, PD-L1, Combination therapy, Pharmaceutical industry

Five clinical responses were observed, all in patients who previously received checkpoint inhibitors.

Key Points: 
  • Five clinical responses were observed, all in patients who previously received checkpoint inhibitors.
  • A durable partial response (PR) in a patient with small-cell lung cancer (SCLC) converted to a complete response, as confirmed by PET scan.
  • Four additional PRs were also observed, 3 of 11 (27.3%) patients with melanoma (2 confirmed, one unconfirmed) and one of four (25%) patients with mesothelioma (PR confirmed).
  • CTX-471 monotherapy was observed to be generally well-tolerated, with the majority of adverse events (AEs) being Grade 1-2.

Kymera Therapeutics to Present New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting

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torsdag, maj 23, 2024
Uveal melanoma, Patient, Headache, DL2, Carcinoma, Plasma, Acute myeloid leukemia, PD, Thrombocytopenia, Toxicity, ACC, Nausea, Black Majesty, Messenger, Pharmacodynamics, Therapy, Grade 3, Safety, Acute lymphoblastic leukemia, Arm, CDKN1A, MD, Blood, AML, Efficacy, MPN, ALL, Biomarker, ASCO, Șaeș, MDM2, Fatigue, Poster, Society, TPD, Adenoid cystic carcinoma, Aes, Merkel-cell carcinoma, Resource, Vomiting, MCC, DLT, Annual general meeting, Pharmaceutical industry

WATERTOWN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced new clinical data for KT-253, a first-in-class MDM2 degrader, from its ongoing Phase 1 dose escalation trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 – June 4, 2024, in Chicago, Illinois. Results released in an ASCO abstract today include a data cut-off of January 26, 2024.

Key Points: 
  • Results released in an ASCO abstract today include a data cut-off of January 26, 2024.
  • “We continue to see encouraging data from the trial’s dose escalation phase demonstrating potent upregulation of p53 biomarkers and signs of antitumor activity in patients.
  • The Company expects to complete the study and share additional clinical data to inform the program’s next development steps in 2024 at an upcoming medical meeting.
  • Kymera is also developing a biomarker-based patient selection strategy for subsequent development beyond Phase 1a and is expected to present data at a medical meeting this year.

Recludix Pharma Presents Data Demonstrating Oral STAT3 Inhibitors Drive Differentiated Efficacy and Safety in Preclinical Models of Th17 Mediated Skin Inflammation in Oral Plenary Session at SID Annual Meeting

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fredag, maj 17, 2024
TYK2, Parasitism, Biology, Thrombocytopenia, Anemia, Risk, Rheumatoid arthritis, Neutropenia, Defecation, Skin, Bacteria, Safety, SAN, Psoriasis, Society, Research, Cancer, STAT3, JAK, Inflammation, Virus, Annual general meeting, T helper 17 cell, Pharmaceutical industry

“These exciting data on our oral STAT3 inhibitors demonstrate that deep STAT3 inhibition has the potential to drive potent efficacy -- such as that seen with clinically validated biologics but with improved convenience as an orally-administered medication, while high selectivity for the downstream STAT3 target may avoid some of the safety concerns observed with JAK and TYK2 inhibitors,” said Ajay Nirula, M.D., Ph.D., executive vice president and head of research and development. “Inhibiting STAT3 could be a favorable and effective approach to treating Th17- and Th1-mediated diseases, such as psoriasis, psoriatic arthritis, rheumatoid arthritis, and inflammatory bowel disease.”

Key Points: 
  • -- In a preclinical model of psoriasis, the efficacy of oral small molecule REX-7117 was comparable to an anti-IL-17A biologic
    SAN DIEGO, May 17, 2024 (GLOBE NEWSWIRE) -- Recludix Pharma, a leader in discovery of inhibitors of challenging targets for inflammatory disease and cancer, presented new data today in an oral plenary presentation at the Society for Investigative Dermatology (SID) Annual Meeting titled “Oral selective STAT3 inhibitors demonstrate differentiated efficacy and safety potential in preclinical models of Th17 mediated skin inflammation” (abstract #738).
  • Recludix’s senior vice president of biology, Paul Smith, Ph.D., reviewed preclinical data on the company’s potent, selective, and orally bioavailable small molecule STAT3 inhibitors, including REX-7117.
  • Data demonstrated that REX-7117 achieves deep, durable, and selective STAT3 inhibition and exhibits similar efficacy to biologics targeting IL-17 in in vivo models of plaque psoriasis.
  • Data was also presented that, unlike JAK1/2 and TYK2 inhibitors, REX-7117 does not impair broader immune responses, such as interferon-dependent anti-viral immunity or growth factor signaling critical for hematologic homeostasis.