Clinical Cancer Research

AIM ImmunoTech Announces Publication of Positive Findings from a Study Evaluating Ampligen® in the Treatment of Pancreatic Cancer in the Journal Clinical Cancer Research

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월요일, 3월 25, 2024
Ovarian cancer, Gene, Clinical Cancer Research, Erasmus MC, Data analysis, Colorectal cancer, Progression-free survival, Patient, Neoplasm, Triple-negative breast cancer, Tumor microenvironment, Manuscript, Pancreatic cancer, Cancer, Doctor of Philosophy, MD, Epithelium, PD-L1, AIM, Liver, RNA, Vaccine

The manuscript titled “ Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses ,” appears in the journal Clinical Cancer Research, one of oncology’s most prestigious journals.

Key Points: 
  • The manuscript titled “ Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses ,” appears in the journal Clinical Cancer Research, one of oncology’s most prestigious journals.
  • Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and tumors.
  • Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes.
  • Additionally, the changes in the tumor microenvironment we see in pancreatic cancer are similar to those we have seen in triple-negative breast cancer, ovarian cancer and colorectal cancer metastatic to the liver.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

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화요일, 4월 2, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Breast cancer, Goserelin, Patient, Lung, Social media, Immunoglobulin G, National Cancer Institute, Neoplasm, Merck & Co., TNBC, Capecitabine, DXD, BRCA, Clinical Cancer Research, Metabolism, Immunology, Biopharmaceutical, World Health Organization, Cancer, Safety, ADC, BLA, Daiichi Sankyo, Vinorelbine, IHC, Mutation, NSCLC, Disease, Merck, AKT, Death, MD, AstraZeneca, PARP, Oncotarget, PFS, FDA, OS, HER2, Eribulin, Cleavage, Progression-free survival, Triple-negative breast cancer, Female, Emerging, Olaparib, Biology, Sapporo Medical University, Medicine, Pharmaceutical industry

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

Lunit SCOPE IO Reveals Promising Results in Neoadjuvant Immunotherapy Study for Head and Neck Cancer Patients

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화요일, 3월 26, 2024
Research, Head, Clinical Cancer Research, Immunotherapy, Patient, Tumor microenvironment, Durvalumab, Cancer, AI, CCR, AACR, Phenotype, Yonsei University, Immune system, Therapy

SEOUL, South Korea, March 26, 2024 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the publication of a new study featuring Lunit SCOPE IO, Lunit's AI-powered analyzer for quantitative immune phenotyping from H&E. The study was recently published in Clinical Cancer Research (CCR), an international journal by the American Association for Cancer Research (AACR).

Key Points: 
  • The study was recently published in Clinical Cancer Research (CCR), an international journal by the American Association for Cancer Research (AACR).
  • This investigation addresses the current lack of exploration into the clinical implications of neoadjuvant immunotherapy in HNSCC patients with resectable tumors, utilizing Lunit SCOPE IO to examine the changes in tumor microenvironment when treated with durvalumab and tremelimumab.
  • "Through this prospective clinical study, we have confirmed the clinical utility of preoperative immunotherapy for treating locally advanced head and neck cancer," said Professor Kim Hye Ryun, head of the research.
  • "In this study, Lunit SCOPE IO provides deeper insights into the tumor microenvironment and immune response, empowering healthcare professionals with invaluable information to make more informed treatment decisions.

Cardiff Oncology Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update

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목요일, 2월 29, 2024
CRDF, SAN, Research, Investment, Cancer, Bev, FOLFIRI, PLK1, Bevacizumab, Standard of care, Clinical Cancer Research, Interim, Safety, Patient, SOC, Pharmaceutical industry

New clinical data from discontinued second-line randomized ONSEMBLE trial provides further evidence of onvansertib’s improvement of the efficacy for standard of care therapy in bev naïve patients.

Key Points: 
  • New clinical data from discontinued second-line randomized ONSEMBLE trial provides further evidence of onvansertib’s improvement of the efficacy for standard of care therapy in bev naïve patients.
  • Contingent upon the results, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent.
  • Full Year 2023 Financial Results:
    As of December 31, 2023, Cardiff Oncology had approximately $75 million in cash, cash equivalents, and short-term investments.
  • Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024.

CERo Therapeutics, Inc. Announces Publication of Preclinical Research Supporting the Use of Its Clinical Candidate CER-1236 to Treat AML Patients

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목요일, 3월 7, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Therapy, NSCLC, Investigational New Drug, Bone marrow, AML, RUNX1, Cancer, B-cell lymphoma, ASXL1, Clinical Cancer Research, Classification, Patient, CERO, IND, Cero, Vaccine

The results in the paper found that the target for CER-1236 is found in the large majority (83%) of leukemic cells extracted from the bone marrow from patients, and that more importantly CER-1236 effectively eliminated leukemic cells in the company’s experiments.

Key Points: 
  • The results in the paper found that the target for CER-1236 is found in the large majority (83%) of leukemic cells extracted from the bone marrow from patients, and that more importantly CER-1236 effectively eliminated leukemic cells in the company’s experiments.
  • Finally, the target for CER-1236 was found by CERo to be highly expressed and detectable across common AML genetic classification subtypes, including patient samples with adverse risk mutations in TP53, ASXL1 and RUNX1.
  • “We’re very pleased with this publication in Clinical Cancer Research supporting our near term plans to advance CER-1236 into the clinic.
  • As we have previously reported, CERo plans to file an Investigational New Drug (IND) application in the first half of 2024, and is targeting initial treatment of AML patients as well as B Cell lymphoma patients before the end of the year,” said Brian G Atwood, CERo’s Chairman and Chief Executive Officer.

Jennifer Rider Appointed ConcertAI Head of Real-World Evidence Services

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화요일, 1월 30, 2024
Real-World Evidence, Abstract, Interview, Oncology, Research, AI, Clinical Cancer Research, Public, Flexner Report, FDA, Publication, Public health, Aetion, RCT, RWE, Harvard University, Epidemiology, MPH, Doctor of Science, Harvard Medical School, Drug development, Health, Doctor of Philosophy, University, University of Wisconsin–Madison, RWD

CAMBRIDGE, Mass., Jan. 30, 2024 /PRNewswire/ -- ConcertAI, the leader in oncology Real-World Data (RWD) and AI SaaS Solutions and for healthcare and life sciences, today announced Jennifer Rider, ScD, MPH, as the leader of the company's Real-World Evidence Services, focusing on regulatory applications of RWD as part of registration trials, breakthrough designation solutions post-approval studies, and regulatory registries. 

Key Points: 
  • Dr. Rider has over 20 years of experience in cancer epidemiology and real-world evidence research.
  • She first joined ConcertAI in 2020, moving from there to lead Aetion's Oncology Center of Excellence.
  • "Real-world evidence has taken on a more formal role in regulatory decision-making with the FDA's formalization of their guidance late last year ," said Jeff Elton, PhD, CEO of ConcertAI.
  • To hear more from Jennifer directly, listen to her interview on the latest episode of The ConcertAI Podcast here .

LUNGevity and Rising Tide Foundation Partner to Issue RFA for $1.5M to Improve Outcomes for People Living with Lung Cancer

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목요일, 1월 25, 2024
Clinical Cancer Research, Neoplasm, Patient, Research, Drug resistance, Partnership, Cancer research, Request, Lung cancer, Rising Tide, Doctor of Philosophy, MPH

WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- LUNGevity Foundation is honored to announce its partnership with the Rising Tide Foundation to issue an RFA (Request for Application) for the Rising Tide/LUNGevity Team Award to Target Mechanisms of Resistance.

Key Points: 
  • WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- LUNGevity Foundation is honored to announce its partnership with the Rising Tide Foundation to issue an RFA (Request for Application) for the Rising Tide/LUNGevity Team Award to Target Mechanisms of Resistance.
  • Approximately 45%-50% of lung adenocarcinomas are known to harbor oncogenic drivers that have been successfully targeted by treatments.
  • While many patients benefit from these targeted therapies, the tumors will eventually develop drug resistance and begin to grow again.
  • "Understanding these shared mechanisms of drug resistance is a major need in the lung cancer community," said Upal Basu Roy, PhD, MPH, executive director of LUNGevity Research.

European Commission Approves Pfizer’s TALZENNA® in Combination with XTANDI® for Adult Patients with Metastatic Castration-Resistant Prostate Cancer

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월요일, 1월 8, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, European Commission, Food, HRR, Risk, Movement, Prognosis, PFE, Confidence interval, Disease, Prostate cancer, Doctor of Philosophy, Civil service commission, Cancer, University, PARP, Death, Clinical Cancer Research, University of Glasgow, ADP, Talazoparib, Patient, Safety, Medicine, Inc., Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
  • With this approval, TALZENNA is now the first and only PARP inhibitor licensed in the European Union for use with XTANDI for patients with mCRPC, with or without gene mutations.
  • “The European Commission’s approval of talazoparib in combination with enzalutamide offers a meaningful advancement for the treatment of patients with metastatic castration-resistant prostate cancer, the most advanced and aggressive stage of the disease.”
    “After years of fighting prostate cancer, it can be devastating for a patient to learn that their cancer has stopped responding to testosterone-lowering treatments.
  • At this stage of the disease, the prognosis is generally poor,” said Erik Briers, MS, PhD, Vice Chairman, Europa UOMO, a European advocacy movement for people with prostate cancer.

HiberCell Announces Successful Completion and Interim Results of Phase 1 Study of Novel PERK Inhibitor, HC-5404, in Solid Tumors and Maps Forward Path as Monotherapy and in Combinations

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월요일, 11월 27, 2023
MTD, Metastasis, AACR, Survival, Index, VEGFR, CCR, Diarrhea, PDX, Fatigue, Nausea, Renal cell carcinoma, Research, TKI, PD, Medicine, Neoplasm, RCC, Clinical Cancer Research, Xerostomia, Publication, Patient, Safety, Pharmaceutical industry

“We are excited to announce the successful completion of our Phase 1 monotherapy study of HC-5404 along with the two publications in Clinical Cancer Research,” said Jonathan Lanfear, President and CEO.

Key Points: 
  • “We are excited to announce the successful completion of our Phase 1 monotherapy study of HC-5404 along with the two publications in Clinical Cancer Research,” said Jonathan Lanfear, President and CEO.
  • “We are encouraged by the safety profile, dose-dependent exposure, and pathway engagement, as well as the preliminary signals of efficacy observed in our Phase 1 trial.
  • This provides a forward path for Ph1b/Ph2 studies in multiple indications/combinations as outlined in our publications in Clinical Cancer Research.
  • HiberCell is seeking partners to advance HC-5404 in combination with an antiangiogenic VEGFR TKI in the solid tumor metastatic setting.

Immix Biopharma Announces FDA Approval of IND Application for CAR-T NXC-201, Enabling U.S. Patient Dosing

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화요일, 11월 21, 2023
Exposition, Food, IND, Autoimmunity, CCR, FDA, Cell, IMS, Multiple myeloma, BCMA, MD, Gene, Society, Amyloidosis, EBMT, Investigational New Drug, AL amyloidosis, ASH, LOS, Clinical Cancer Research, Patient, Publication, Pharmaceutical industry

With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.

Key Points: 
  • With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.
  • “Building on encouraging NXC-201 clinical data to-date, we are thrilled that multiple leading U.S. sites are currently planning to enroll patients in the coming months,” said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma.
  • “We credit our world-class cell-therapy expert team in achieving this IND clearance in-line with our previously communicated timelines,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma.
  • “NXC-201’s favorable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL Amyloidosis into autoimmune indications.”