TP53

Gilead To Discontinue Phase 3 ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS

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Venerdì, Luglio 21, 2023
Biotechnology, Hospitals, Health, Pharmaceutical, Clinical Trials, Gilead Sciences, TP53, Research, Immunotherapy, Doctor of Philosophy, Acute myeloid leukemia, MDS, AML, MD, Patient, Science, News, Safety, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis.
  • The safety data seen in this study is consistent with the known magrolimab profile and adverse events that are typical in this patient population.
  • Gilead recommends discontinuing treatment with magrolimab in patients with MDS.
  • “Gilead is deeply grateful to the patients, families, investigators, and the advocacy community who contributed to this research as we learn more about magrolimab and explore its potential in treating other cancers.”
    Gilead is working with study investigators on appropriate next steps for patients enrolled in the ENHANCE study.

Ryvu Therapeutics Presents Updated Clinical and Preclinical Data on RVU120 at the 2023 European Hematology Association Congress

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Venerdì, Giugno 9, 2023
Memorial Sloan Kettering Cancer Center, Disulfiram-like drug, Abstract, Nausea, TP53, WSE, Glycophorin A, Neutropenia, Bone marrow, Mutation, Toxicity, Acute myeloid leukemia, Vomiting, Congress, Pancreatic serous cystadenoma, Fibrosis, AML, Erythropoiesis, Anemia, Flow cytometry, EHA, Hematology, CD71, Infrared spectroscopy correlation table, Therapy, Splenomegaly, Safety, Disease, Pharmaceutical industry, Medical imaging, Patient, Myeloproliferative neoplasm

We anticipate the clinical benefit will even further increase as dose-escalation progresses in patients with AML and HR-MDS.

Key Points: 
  • We anticipate the clinical benefit will even further increase as dose-escalation progresses in patients with AML and HR-MDS.
  • Importantly, we observed that treatment with RVU120 induces erythropoiesis, which supports further testing in patients with anemia.
  • We are also encouraged to see that the monotherapy continues to be generally well-tolerated across all dose levels.
  • These data warrant further clinical development of RVU120 in combination with JAK1/2 inhibition as a potential novel therapeutic strategy in myeloproliferative neoplasms.

Repare Therapeutics Reports Proof of Concept for Lunresertib (RP-6306) in Clinic, Initial Monotherapy Data from Phase 1 MYTHIC Clinical Trial and Early Insights from Ongoing Combination Trials

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Mercoledì, Giugno 7, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Pharmacodynamics, PPP2R1A, DNA, Cholangiocarcinoma, TP53, IST, Diarrhea, Princess Margaret Cancer Centre, FOLFIRI, STEP2, RECIST, Pharmacokinetics, Paclitaxel, Toxicity, Carboplatin, Doctor of Philosophy, Rash, Vomiting, DNA repair, MD, Patient, BID, Colorectal cancer, Anemia, Medicine, CCNE1, Nausea, Uterine cancer, FBXW7, Therapy, Safety, ATR, Aplastic anemia, Pharmaceutical industry, Vaccine, Dietary supplement, Medical imaging, PKMYT1, Reparenting

“The data demonstrate that lunresertib effectively inhibits PKMYT1 and offers a synthetic lethal combination with CCNE1 amplification or inactivating mutations in FBXW7 and PPP2R1a.

Key Points: 
  • “The data demonstrate that lunresertib effectively inhibits PKMYT1 and offers a synthetic lethal combination with CCNE1 amplification or inactivating mutations in FBXW7 and PPP2R1a.
  • As of the data cutoff date of April 28, 2023, 63 patients were enrolled in lunresertib monotherapy Module 1 of the MYTHIC study, which is ongoing and accruing patients.
  • Early clinical combination insights demonstrated greater anti-tumor activity in patients treated with the combination of lunresertib and camonsertib than lunresertib alone, based on higher molecular response rates and RECIST 1.1 responses.
  • Repare is also currently evaluating lunresertib in combination with gemcitabine in the Phase 1 MAGNETIC study and in combination with FOLFIRI in the Phase 1 MINOTAUR study.

Puma Biotechnology Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel versus Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer at the 2023 ASCO Annual Meeting

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Domenica, Giugno 4, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Puma Biotechnology, Translational Genomics Research Institute, MYC, City of Hope, TP53, Texas Oncology, Unfolded protein response, Progression-free survival, Metastasis, HER2, Neoplasm, Paclitaxel, Biomarker, RNA, PFS, Trial of the century, AKT1, ASCO, HR, City, American Society of Clinical Oncology, Patient, Breast cancer, MBC, Baylor University Medical Center, Annual general meeting, Puma, Cancer, UPR, AURKA, Poster, CDT, Research, Phase, Abstract, Woman, Gene, Society, JAMA Network Open, CDH1, Disease, Pharmaceutical industry, Vaccine, Medical imaging, PIK3CA

(Jama Network Open, April 2021) and showed that the addition of alisertib to paclitaxel improved progression-free survival (PFS) among enrolled patients compared with paclitaxel alone (HR, 0.56; 95%CI, 0.37-0.84; P = .005).

Key Points: 
  • (Jama Network Open, April 2021) and showed that the addition of alisertib to paclitaxel improved progression-free survival (PFS) among enrolled patients compared with paclitaxel alone (HR, 0.56; 95%CI, 0.37-0.84; P = .005).
  • No mutations were significantly associated with response or resistance to alisertib plus paclitaxel, including those in PIK3CA, TP53, AKT1, HER2, and CDH1.
  • Increased MYC RNA expression was not observed in patients who did not appear to benefit from alisertib plus paclitaxel.
  • This biomarker analysis will be very helpful to the design of the future trials of alisertib that we are planning in hormone receptor positive HER2-negative breast cancer.”

Lilly Highlights Verzenio® (abemaciclib) and Jaypirca™ (pirtobrutinib) Data at 2023 ASCO® Annual Meeting

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Venerdì, Giugno 2, 2023
Breast Cancer Research, Monarch butterfly migration, TP53, Diarrhea, American Journal of Clinical Oncology, Progression-free survival, Hematology, Lymphoid leukemia, Atrial fibrillation, Grade 3, DOR, Aes, COVID-19, Survival, Clinical trial, Quality of life, BTK, PFS, Rated R, Cough, Fatigue, Back pain, LLY, RDI, Bruise, ET, Journal, EBC, Patient, Breast cancer, Risk, Data, Breast, Annual general meeting, Triple-negative breast cancer, Periodic breathing, Eli Lilly and Company, MCL, Chronic lymphocytic leukemia, Research, Recurrence, Abstract, Society, NYSE, ORR, Safety, Sarah Cannon Research Institute, Pharmaceutical industry, Pirtobrutinib, Abemaciclib

INDIANAPOLIS, June 2, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced Verzenio® (abemaciclib; CDK4/6 inhibitor) and Jaypirca™ (pirtobrutinib; non-covalent (reversible) BTK inhibitor) data to be presented at the 2023 ASCO® Annual Meeting in Chicago, June 2 – 6, 2023. Presentations include new analyses from the Phase 3 monarchE trial of two years of Verzenio treatment in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high risk early breast cancer (EBC) and updated data from the Phase 1/2 BRUIN trial for an approved use of Jaypirca in patients with covalent BTK inhibitor pre-treated relapsed or refractory mantle cell lymphoma (MCL).

Key Points: 
  • In this analysis, patients were classified into three equal-sized subgroups according to their relative dose intensity (RDI) of Verzenio.
  • The dataset includes the first 90 MCL patients enrolled who had received a prior covalent Bruton's tyrosine kinase (BTK) inhibitor.
  • These safety data, based on longer-term Jaypirca therapy, are consistent with the overall safety profile, without evidence of new or worsening toxicity signals.
  • Both Jaypirca data presentations will be discussed on June 5 from 1:15 – 2:45 p.m. CT during the Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia poster discussion session.

Alaunos Therapeutics to Present Early Data from TCR-T Library Phase 1/2 Trial at 2023 American Society of Clinical Oncology Annual Meeting

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Giovedì, Maggio 25, 2023
KRAS, CT, Therapy, TP53, Progression-free survival, NSCLC, Lung cancer, TCR, ASCO, MD Anderson Cancer Center, Assistant professor, American Society of Clinical Oncology, Cytokine release syndrome, Patient, Sleeping Beauty, Colorectal cancer, University, Immune system, Annual general meeting, Poster, Society, DL2, Safety, Vaccine, Medical imaging, Pharmaceutical industry

“We believe our innovative non-viral approach targeting high-frequency driver mutations is the most promising approach for treating solid tumors.

Key Points: 
  • “We believe our innovative non-viral approach targeting high-frequency driver mutations is the most promising approach for treating solid tumors.
  • We are encouraged by our ability to manufacture cell products with high viability, purity and TCR positivity that have exhibited persistence and tumor infiltration in patients.
  • There remains a significant unmet medical need for new, patient-specific therapies for people living with difficult-to-treat solid tumor cancers.
  • Alaunos expects to provide an interim data update on multiple new patients in the third quarter of 2023 and anticipates establishing a recommended Phase 2 dose by year-end 2023.

Syros Presents Data from Phase 1/1b Clinical Trial of SY-5609 in Advanced Solid Tumors at ASCO Annual Meeting

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Giovedì, Maggio 25, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, PDAC, American Society of Clinical Oncology, Partnership, Index, Liver disease, TP53, Tactical data link, DCR, Fulvestrant, CDK7, Cancer, ASCO, Patient, Annual general meeting, MTD, Bone marrow, Abstract, Gemcitabine, Society, SD, Breast cancer, Pharmaceutical industry, Medical imaging, Syros

The data will be presented in two posters at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, in Chicago, Illinois.

Key Points: 
  • The data will be presented in two posters at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, in Chicago, Illinois.
  • “We are pleased to share data from our Phase 1/1b clinical trial of SY-5609, which further reinforce the potential of selective CDK7 inhibition as a potentially transformative approach for difficult-to-treat solid tumors,” said David A. Roth, M.D., Chief Medical Officer of Syros.
  • Syros will present updated data from the single agent dose escalation portion and the gemcitabine/nab-paclitaxel combination safety lead-in portion of the Phase 1/1b trial.
  • The data show that the combination of SY-5609 and fulvestrant demonstrated an acceptable safety profile across a variety of dosing schedules.

Ryvu Therapeutics to Present Clinical and Preclinical Data on RVU120 at the 2023 European Hematology Association Congress

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Giovedì, Maggio 11, 2023
Abstract, Ruxolitinib, TP53, WSE, Bone marrow, MDS, Congress, Pancreatic serous cystadenoma, AML, Patient, Memorial Sloan Kettering Cancer Center, EHA, CR, WBC, Infrared spectroscopy correlation table, Therapy, MPN, Splenomegaly, Safety, Pharmaceutical industry

These data reinforce the potential emerging role of targeting both CDK8/19 and JAK1/2 in myeloproliferative neoplasms.

Key Points: 
  • These data reinforce the potential emerging role of targeting both CDK8/19 and JAK1/2 in myeloproliferative neoplasms.
  • Results from patients dosed up to 110 mg have shown a favorable safety profile of RVU120.
  • At the data cut-off of February 28, 2023, 22 pts have been enrolled, and 10 out of 19 evaluable patients showed clinical benefit: 1 pt.
  • The data warrant further exploration of RVU120 in AML and HR-MDS, and enrollment is ongoing at 135 mg.

Alaunos Therapeutics Reports First Quarter 2023 Financial Results

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Mercoledì, Maggio 10, 2023
KRAS, Precigen, Therapy, TP53, Telephone, Silicon Valley Bank, Research, ID, TCR, MS, ASCO, Silicon, Development, State Administrative Expenses, American Society of Clinical Oncology, SVB, Patient, Physician, EGFR, Sleeping Beauty, Administration, Annual general meeting, Poster, Society, Pharmaceutical industry, Doctor of Philosophy

ET

Key Points: 
  • ET
    HOUSTON, May 10, 2023 (GLOBE NEWSWIRE) -- Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq: TCRT), a leading T-cell receptor (TCR) cell therapy company advancing a clinical-stage pipeline of therapeutics for solid tumors, today announced financial results for the first quarter ended March 31, 2023, and provided a corporate update.
  • Manufactured multiple cryopreserved products: In the first quarter of 2023, Alaunos enhanced its manufacturing process to move from fresh to cryopreserved cell product enabling greater flexibility for patient scheduling and treatment.
  • Amended exclusive license agreement with Precigen, Inc.; Alaunos maintains exclusive rights to TCRs using Sleeping Beauty targeting driver mutations: In April 2023, Alaunos amended its exclusive license agreement with Precigen.
  • First Quarter Ended March 31, 2023, Financial Results
    Research and Development Expenses: Research and development expenses were $6.5 million for the first quarter of 2023, compared to $5.6 million for the first quarter of 2022, an increase of approximately 17%.

Shattuck Labs Reports First Quarter 2023 Financial Results and Recent Business Highlights

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Martedì, Maggio 9, 2023
Mirvetuximab soravtansine, Completeness, TP53, Macrophage, Neoplasm, Clinical trial, Cancer, Pharmacokinetics, Acute myeloid leukemia, ASCO, AML, Azacitidine, Patient, Autoimmune disease, Safety, Pharmaceutical industry, PROC

AUSTIN, TX and DURHAM, NC, May 09, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today reported financial results for the quarter ended March 31, 2023, and provided recent business highlights.

Key Points: 
  • Both expansion cohorts are expected to begin enrollment in the third quarter of 2023, and we now expect to complete enrollment in both expansion cohorts during the second half of 2023.
  • Research and Development (R&D) Expenses: R&D expenses were $16.7 million for the quarter ended March 31, 2023, as compared to $19.2 million for the quarter ended March 31, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses were $5.1 million for the quarter ended March 31, 2023, as compared to $5.0 million for the quarter ended March 31, 2022.
  • Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations through year-end 2024, beyond results from its Phase 1 clinical trials of SL-172154.