TNBC

Beyond Cancer Presents First-in-Class Clinical Data Showing an Immunogenic Response in Subjects with r/r Unresectable Solid Tumors Treated with Ultra-High Concentration Nitric Oxide (UNO)

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月曜日, 6月 3, 2024
MD, Biomarker, PD-1, TNBC, Toxicity, Malignancy, Annual general meeting, Cancer, Society, B cell, UNO, Immune system, Triple-negative breast cancer, Ministry, Vaccine

HAMILTON, Bermuda, June 03, 2024 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd., a clinical-stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, announced encouraging first-in-class clinical data demonstrating evidence of immune system activation via biomarker response in a heavily pretreated population in the ongoing Phase 1a trial. The single agent treatment in relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous malignancies represents an unprecedented use of UNO as an immunotherapeutic up to 50,000 parts per million. These data were presented at the American Society of Clinical Oncology Key Opinion Leader Event held in conjunction with the 2024 Annual Meeting in Chicago, Illinois.

Key Points: 
  • The single agent treatment in relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous malignancies represents an unprecedented use of UNO as an immunotherapeutic up to 50,000 parts per million.
  • These data were presented at the American Society of Clinical Oncology Key Opinion Leader Event held in conjunction with the 2024 Annual Meeting in Chicago, Illinois.
  • Subjects enrolled in the Phase 1b trial will be treated with the UNO + anti-PD-1 combination upon completion of the Phase 1a trial.
  • “We look forward to future results of the planned Phase 1b trial in combination with PD-1 inhibitor therapy and potentially expand its application to other cancer types.”

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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月曜日, 6月 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.

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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火曜日, 5月 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.

Merck Announces Phase 3 KEYNOTE-522 Trial Met its Overall Survival (OS) Endpoint in Patients With High-Risk Early-Stage Triple Negative Breast Cancer (TNBC)

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火曜日, 5月 28, 2024
Research, Diabetes, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, Patient, Survival, Merck & Co., Lung cancer, FDA, Cervical cancer, Breast cancer, PCR, Cancer, CPS, OS, MRK, Data monitoring committee, PD-L1, TNBC, Pharmaceutical industry

At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in OS compared to pre-operative chemotherapy.

Key Points: 
  • At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in OS compared to pre-operative chemotherapy.
  • The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were observed.
  • Results will be presented at an upcoming medical meeting and shared with regulatory authorities.
  • Merck has a comprehensive clinical development program in various subtypes of breast cancer.

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

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火曜日, 5月 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.

Cartography Announces Strategic Collaboration with Gilead to Develop Oncology Therapies Against Novel Targets and Target Pairs

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火曜日, 5月 28, 2024
Oncology, Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Genomics, Antigen, Patient, Algorithm, Lung cancer, Drug development, NSCLC, Adenocarcinoma, Gilead Sciences, Triple-negative breast cancer, ATLAS, Cartography, TNBC, Pharmaceutical industry

Under the multi-year collaboration, Cartography’s proprietary computational and genomics platform will be utilized to discover and validate novel tumor-selective target antigens and pairs of antigens.

Key Points: 
  • Under the multi-year collaboration, Cartography’s proprietary computational and genomics platform will be utilized to discover and validate novel tumor-selective target antigens and pairs of antigens.
  • Gilead can opt in on multiple targets identified through this collaboration and will undertake all further research, development, and commercialization of programs against those targets.
  • “We are excited to partner with Gilead to identify novel and compelling antigen targets using our ATLAS and SUMMIT platforms,” said Kevin Parker, Ph.D., CEO of Cartography Biosciences.
  • Cartography is also eligible to receive development, regulatory and commercial milestones, and tiered royalties on net sales for Gilead programs against each optioned target.

Theratechnologies’ Sudocetaxel Zendusortide ASCO 2024 Presentation Demonstrates Signs of Long-Term Efficacy and Manageable Safety Profile in Patients with Solid Tumors

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木曜日, 5月 23, 2024
Patient, Pharmacokinetics, Gynecologic Oncology (journal), Female, Ovarian cancer, Toxicity, Ovary, Docetaxel, Cmax, Recurrence, Endometrial cancer, Safety, Disease, Wayne State University, AUC, RECIST, Senior, Triple-negative breast cancer, Part, Cancer, Melanoma, Incidence, ASCO, PDC, Associate, FACOG, Neoplasm, Society, Aes, Therapy, TNBC, TSX, Pharmaceutical industry

The poster presentation, which constitutes the first report of long-term efficacy, safety, and pharmacokinetic (PK) data from the Phase 1 study, also suggests that sudocetaxel zendusortide has a manageable safety profile when dosed at 300mg/m2, with few Grade 3 adverse events (AEs).

Key Points: 
  • The poster presentation, which constitutes the first report of long-term efficacy, safety, and pharmacokinetic (PK) data from the Phase 1 study, also suggests that sudocetaxel zendusortide has a manageable safety profile when dosed at 300mg/m2, with few Grade 3 adverse events (AEs).
  • “It is highly unusual to see such long-lasting disease stabilization even after treatment cessation in patients with advanced disease.
  • Sudocetaxel zendusortide has a manageable safety profile, with most treatment-related AEs rated as mild to moderate in severity and managed with standard supportive care or dose reductions.
  • The maximum concentration (Cmax) of sudocetaxel zendusortide was 30.4 micromolar (μM), compared to 0.58 μM for free docetaxel.

Immutep Presents Data from Safety Lead-in Phase of AIPAC-003 at ESMO Breast 2024

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水曜日, 5月 15, 2024
ASX, Patient, CD4, Plasma, MBC, Pharmacodynamics, Safety, Autoimmune disease, RECIST, IMM, Poster, Congress, Blood, CDK, Cancer, Eftilagimod alpha, MHC, Paclitaxel, ESMO, Oncology, CD8, TNBC, Gamma ray, MHC class II, Pharmaceutical industry

SYDNEY, AUSTRALIA, May 15, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces encouraging efficacy, safety, and pharmacodynamic data from the safety lead-in of the AIPAC-003 Phase II/III trial presented at the European Society for Medical Oncology (ESMO) Breast Cancer 2024 Congress. This lead-in represents the first ever 90mg dosing of eftilagimod alpha (“efti”), a soluble LAG-3 protein and MHC Class II agonist, given in combination with weekly paclitaxel.

Key Points: 
  • During the immuno-oncology (IO)-chemotherapy treatment of efti and paclitaxel, this patient achieved a partial response (PR) that subsequently turned into a CR.
  • As of the data cut-off (April 3), no dose-limiting toxicities and no treatment-emergent adverse events of grade 3 or higher severity were recorded.
  • Further data updates in terms of safety and efficacy from AIPAC-003 are expected in CY2024.
  • The ESMO Breast 2024 poster will be available on the Posters & Publications section of Immutep’s website.

Merck to Present New Data at 2024 ASCO Annual Meeting Demonstrating Advancements in Novel Oncology Treatment Approaches Across Broad Portfolio and Diverse Pipeline

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水曜日, 5月 15, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, HER2, BTC, Cisplatin, PBC, Brentuximab vedotin, HCC, INT, Merck & Co., Pros, Endometrial cancer, ADC, Abstract, Melanoma, Hepatocellular carcinoma, Physician, PD-L1, Quality of life (healthcare), TNBC, Pembrolizumab, Safety, NSCLC, Cancer, Carcinoma, ASCO, Society, Patient, AHCC, Lung cancer, Therapy, Radiation, Daiichi Sankyo, MRK, Conjugation, Webcast, Quality of life, Annual general meeting, Georgetown University, Pharmaceutical industry

New data being shared at the meeting showcase the company’s continued progress to advance clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates.

Key Points: 
  • New data being shared at the meeting showcase the company’s continued progress to advance clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates.
  • “This year’s ASCO is also particularly meaningful as we approach 10 years since KEYTRUDA was first approved in the U.S.
  • As Merck continues to build its broad oncology portfolio, the company will also present data at ASCO from its diverse pipeline of investigational candidates, many being evaluated in combination with KEYTRUDA.
  • Merck will hold an Oncology Investor Event to coincide with the 2024 ASCO Annual Meeting on Monday, June 3, 2024, 6 p.m. CT, at which senior management will provide an update on the company’s oncology strategy and program.

Pheast Unveils First Preclinical Data for PHST001, an Anti-CD24 Macrophage Checkpoint Inhibitor

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月曜日, 5月 13, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Patient, Therapy, Neoplasm, Cancer, Macrophage, Protein engineering, CD24, Protein Sciences, TNBC, Monoclonal antibody, Ovary, Vaccine

Pheast Therapeutics (“Pheast”), a biotech developing novel macrophage checkpoint therapies to defy cancer, today announced the first presentation of preclinical data for PHST001, an anti-CD24 antibody drug candidate that is designed to block a key macrophage “don’t eat me” signal on cancer cells.

Key Points: 
  • Pheast Therapeutics (“Pheast”), a biotech developing novel macrophage checkpoint therapies to defy cancer, today announced the first presentation of preclinical data for PHST001, an anti-CD24 antibody drug candidate that is designed to block a key macrophage “don’t eat me” signal on cancer cells.
  • “Pheast’s lead drug candidate, PHST001, is an exceptionally well-engineered, well-expressed antibody against an exciting new target, CD24,” said Roy Maute, Ph.D., Cofounder and CEO, Pheast Therapeutics.
  • Pheast has engineered PHST001 to bind recombinant CD24 and cell surface CD24 with high affinity and specificity and to block Siglec-10 binding.
  • Pheast scientists have demonstrated that blocking CD24 with PHST001 induces macrophage phagocytosis of multiple cancer subtypes in vitro, and have shown potent efficacy for PHST001 in vivo.