ADC

Telix Announces Positive rPFS Data from ProstACT SELECT Trial of TLX591 rADC Therapy Candidate in Prostate Cancer

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torsdag, maj 30, 2024
ASX, PET, Patient, Phase, Docetaxel, PSMA, Safety, Radiation, TLX, ADC, Clutch (eggs), Prostate cancer, RLT, Physician, Quality of life, Pharmaceutical industry

TLX591 is an investigational anti-PSMA1 radio-antibody-drug conjugate (rADC) therapy being developed for the treatment of mCRPC, differentiated by a short two-week dosing regimen.

Key Points: 
  • TLX591 is an investigational anti-PSMA1 radio-antibody-drug conjugate (rADC) therapy being developed for the treatment of mCRPC, differentiated by a short two-week dosing regimen.
  • Builds on prior data from the ProstACT SELECT2 trial, demonstrating favourable safety profile and biodistribution3.
  • MELBOURNE, Australia, May 31, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces additional positive data from the ProstACT SELECT trial (“SELECT”) of TLX591 (177Lu rosopatamab tetraxetan), a lutetium-labelled rADC therapy for the treatment of adult patients with PSMA-positive metastatic castrate-resistant prostate cancer (mCRPC).
  • SELECT is a radiogenomics study intended to evaluate lesion concordance between 68Ga (gallium)-based PSMA-PET4 imaging and TLX591 dosimetry for the purpose of validating PET imaging for patient selection for rADC therapy.

ADC Therapeutics to Participate in the Jefferies Global Healthcare Conference

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torsdag, maj 30, 2024
Conference, Event, Webcast, ADC

LAUSANNE, Switzerland, May 30, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced that Ameet Mallik, Chief Executive Officer, will present a company overview at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 11:30 a.m.

Key Points: 
  • LAUSANNE, Switzerland, May 30, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced that Ameet Mallik, Chief Executive Officer, will present a company overview at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 11:30 a.m.
  • ET.
  • A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website at ir.adctherapeutics.com .
  • A replay of the webcast will be available for approximately 30 days.

EVOKE-01 Study Results in Metastatic NSCLC to Be Presented at an Oral Session at ASCO 2024

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fredag, maj 31, 2024
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Merck & Co., Patient, Progression-free survival, Diarrhea, Doctor of Philosophy, Survival, Pembrolizumab, Neutropenia, Docetaxel, Lung cancer, PFS, Histology, Safety, NSCLC, ADC, MD, Gilead Sciences, Science, Death, Abstract, Neoplasm, Incidence, ASCO, Merck, Journal, Hospital, OS, Fatigue, Society, Aes, Standard of care, Annual general meeting, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract #LBA8500) today (2:45-5:45pm CT) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract #LBA8500) today (2:45-5:45pm CT) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • The company previously announced that the study did not meet the primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC).
  • “Treating patients with metastatic NSCLC who have progressed on available treatments continues to be a challenge.
  • Longer-term results from Cohort A of the Phase 2 EVOKE-02 study of Trodelvy in combination with KEYTRUDA® (pembrolizumab) in first-line metastatic PD-L1 ≥50% NSCLC will also be presented in a poster session (Abstract #8592) on June 3, 2024.

Gilead Provides Update on Phase 3 TROPiCS-04 Study

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torsdag, maj 30, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Hospitals, Clinical Trials, Patient, Progression-free survival, Survival, TPC, UC, Bladder cancer, G-CSF, Diagnosis, FDA, PFS, Breast cancer, ADC, Ageing, ITT, Death, Metastasis, OS, Physician, MUC, Infection, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC).

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC).
  • The study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population.
  • Gilead is continuing to analyze the data and will discuss the results and next steps with the FDA.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, including the TROPiCS-04 study.

Frost & Sullivan Released Report: "The Fourth Revolutionary Wave of Biologics Manufacturing: CDMOs Empower Large-Scale Production of Biologics"

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onsdag, maj 29, 2024
Bioprocess, Stainless steel, Fourth, Bioreactor, CGT, ADC, Frost, Research, Biopharmaceutical, CDMO, Fine chemical

Shanghai, China--(Newsfile Corp. - May 29, 2024) - Frost & Sullivan released a report, titled "The Fourth Revolutionary Wave of Biologics Manufacturing: CDMOs Empower Large-Scale Production of Biologics".

Key Points: 
  • Shanghai, China--(Newsfile Corp. - May 29, 2024) - Frost & Sullivan released a report, titled "The Fourth Revolutionary Wave of Biologics Manufacturing: CDMOs Empower Large-Scale Production of Biologics".
  • The global market size of biologics CDMOs has grown significantly from US$13.3 billion in 2018 to US$29.3 billion in 2022.
  • Given the challenges in process development and production for different biologics types, specialized CDMO services for each type have emerged.
  • In the fourth revolutionary wave of biologics manufacturing, leading companies invest heavily in production capacity to remain competitive
    The world's leading CDMOs are ramping up capacities for the large-scale commercial production of biologics.

Eisai Showcases Oncology Portfolio and Pipeline at ASCO 2024

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torsdag, maj 23, 2024
MSD, Pembrolizumab, Merck & Co., Patient, Oxidative stress, TPS, Trastuzumab, Science, HER2, Proteostasis, Tumor microenvironment, FDA, Endometrial cancer, Safety, Breast cancer, ADC, Senior, Headquarters, LEAP, Research, Deep, Cancer, Drug discovery, ASCO, Merck, PRISM, Society, Apoptosis, Hepatocellular carcinoma, Differentiable function, Inflammation, Hypoxia, Annual general meeting, Pharmaceutical industry

TOKYO, May 23, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of research across multiple types of cancer from its oncology portfolio and pipeline during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO24), which is taking place virtually and in-person in Chicago, Illinois from May 31 to June 4.

Key Points: 
  • TOKYO, May 23, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of research across multiple types of cancer from its oncology portfolio and pipeline during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO24), which is taking place virtually and in-person in Chicago, Illinois from May 31 to June 4.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains with the aim of contributing to the cure of cancers.
  • (1) KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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.

MEDSIR & Debiopharm Initiate Clinical Collaboration to Explore Potential Synergy of Debio 0123 & Sacituzumab Govitecan in Advanced Breast Cancer

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tisdag, maj 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Infectious Diseases, Clinical Trials, Patient, Infection, Prognosis, WEE1, HER2, Clinical trial, University, Diagnosis, AACR, Safety, Breast cancer, Sacituzumab govitecan, ADC, Gilead Sciences, HR, Breast, Metastasis, Cell, Mortality, IST, PR, University of Bristol, TNBC, Pharmaceutical industry

Hormone receptor-positive (HR+)/HER2- is the most common type of breast cancer and it accounts for 70% of all breast cancers.

Key Points: 
  • Hormone receptor-positive (HR+)/HER2- is the most common type of breast cancer and it accounts for 70% of all breast cancers.
  • “It’s great to see companies like Debiopharm that are open to investigating novel combination strategies to support breast cancer patients.
  • “We are honored to develop this Investigator Sponsor Trial (IST) in collaboration with Debiopharm and Gilead to explore new approaches to breast cancer treatment.
  • The foundations for this clinical trial were set by the promising preclinical data suggesting an existing synergy between Debiopharm’s Debio 0123 and Gilead’s sacituzumab govitecan.

Datopotamab deruxtecan showed clinically meaningful overall survival improvement vs. chemotherapy in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial

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måndag, maj 27, 2024
Science, Cardiology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Biopharmaceutical, Docetaxel, Congress, Lung, Lung cancer, World Health Organization, DXD, Survival, ADC, MD, Cleavage, PD-1, Medicine, OS, Immunotherapy, Statistics, Immunology, Safety, NSCLC, Cancer, Patient, Incidence, Sapporo Medical University, Metabolism, AstraZeneca, Gefitinib, Observational study, Progression-free survival, Immunoglobulin G, Treatment, PFS, Pircher, Death, Triple-negative breast cancer, Pharmacotherapy, Social media, Daiichi Sankyo, ESMO, Pemetrexed, American Cancer Society, Oncology, Pharmaceutical industry

In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy.

Key Points: 
  • In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy.
  • Patients without known actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
  • Datopotamab deruxtecan (Dato-DXd) vs doxetaxel in previously treated advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC): results of the randomized phase 3 study TROPION-Lung01.
  • Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC: protocol-specified final analysis from KEYNOTE-189.

The EBA consults on draft guidelines on acquisition, development and construction exposures to residential property under the standardised approach of credit risk

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tisdag, maj 28, 2024
Risk, GLS, Sale, Capital Requirements Regulation 2013, ADC, Public housing, Acquisition, Comment, EBA, CRR, European, Medical device

The European Banking Authority (EBA) today launched a public consultation on its draft Guidelines (GLs) under the Capital Requirements Regulation (CRR3) regarding acquisition, development and construction (ADC) exposures to residential property. These Guidelines specify the credit risk-mitigating conditions that allow institutions to assign a risk weight of 100% instead of 150% for ADC exposures to residential property. Furthermore, the Guidelines also address the specificities of institutions’ lending to public housing or not-for profit entities. The consultation runs until 19 August 2024.

Key Points: 
  • The EBA consults on draft guidelines on acquisition, development and construction exposures to residential property under the standardised approach of credit risk
    - The EBA plays an important role in the implementation of the EU Banking Package.
  • - These draft guidelines will contribute to a more a robust regulatory framework, efficient supervision, and enhanced risk control by credit institutions.
  • The European Banking Authority (EBA) today launched a public consultation on its draft Guidelines (GLs) under the Capital Requirements Regulation (CRR3) regarding acquisition, development and construction (ADC) exposures to residential property.
  • These Guidelines specify the credit risk-mitigating conditions that allow institutions to assign a risk weight of 100% instead of 150% for ADC exposures to residential property.