National Cancer Institute

ORYZON Announces U.S. FDA Clearance of CTEP-CRADA Phase I/II Clinical Trial Sponsored by NCI for Iadademstat Plus Immune Checkpoint Inhibitors in 1L Extensive Stage Small Cell Lung Cancer

Retrieved on: 
Monday, April 8, 2024
JHU, NCI, Development, Carcinoma, CRADA, National Cancer Institute, MSKCC, IND, Investigational New Drug, Genomics, Immune system, Bangladesh Technical Education Board, FDA, SCLC, Food, Pharmaceutical industry

This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.

Key Points: 
  • This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.
  • The trial ( NCT06287775 ) is entitled “A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer”.
  • “We are very pleased that NCI has received the regulatory approval from the FDA to initiate this first-in-human Phase I/II combination trial with iadademstat plus immune check point inhibitors” stated Dr. Carlos Buesa, Chief Executive Officer of Oryzon.
  • “The molecular mechanisms underlying the ability of iadademstat to render small cell lung cancer cells visible to the immune system while simultaneously enhancing immune activity to aggressively target these malignant cells have been clearly elucidated.

TELA Bio Welcomes Acclaimed Surgeon as Vice President of Medical Affairs and Surgeon Strategy

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Monday, April 8, 2024
Surgeon, Plastic, Associate, Education, Matrix, National Cancer Institute, Bellevue Hospital, MD Anderson Cancer Center, NYU, University, General surgery, Surgical oncology, Health, FACS, Dentistry

MALVERN, Pa., April 08, 2024 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced Howard N. Langstein, MD, FACS, as Vice President of Medical Affairs and Surgeon Strategy.

Key Points: 
  • MALVERN, Pa., April 08, 2024 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced Howard N. Langstein, MD, FACS, as Vice President of Medical Affairs and Surgeon Strategy.
  • Dr. Langstein is the former Chief of Plastic and Reconstructive Surgery at the University of Rochester Medical Center, known for his extensive expertise, especially in microvascular reconstruction and innovative approaches to complex surgical problems.
  • “With more than 30 years of experience in plastic and reconstructive surgery, I understand the needs and challenges in this space,” said Dr. Langstein.
  • "We are thrilled to welcome Dr. Langstein to our team," said Paul Talmo, Chief Technology Officer of TELA Bio.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

PDS Biotech Announces Clinical Strategy Update and Reports Full Year 2023 Financial Results

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Wednesday, March 27, 2024
Principal, PDSB, NCI, Head, Survival, Associate, Incidence, Patient, National Cancer Institute, Cancer, Doctor of Philosophy, Biotechnology, Overalls, Oncology, Neck, ICI, Clinical trial, Immune system, IL-12, ICIS, FDA, Physician, PDS, Food, Pharmaceutical industry

This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.

Key Points: 
  • This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.
  • “We have had several discussions with key opinion leaders in HNSCC regarding the use of the triple combination in HNSCC.
  • The NCI clinical trial data show significant promise in the use of PDS01ADC in combination with Versamune® HPV,” said Katharine A.
  • The event will be archived on the Investor Relations section of PDS Biotech’s website for six months.

City of Hope Scientists Present Leading-Edge Research at American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Monday, April 8, 2024
Science, Biotechnology, Research, Oncology, Health, Health Technology, Genetics, Clinical Trials, Breast cancer, Survival, Immunotherapy, Health equity, Patient, Lung, City, National Cancer Institute, AGAF, Breast, MicroRNA, Pancreatic cancer, Lymphocyte, Clinical trial, Neoplasm, Therapy, Cancer, Exosome, Plasma, Colorectal cancer, Risk, Experiment, DNA, Virus, Translational Genomics Research Institute, Memory, Treatment, Cholangiocarcinoma, Pathology, Liquid biopsy, Microbiome, Recurrence, Irell & Manella, Disease, Intelligence, Molecular diagnostics, Overalls, AACR, TILS, Pancreas, Prognosis, Beckman Research Institute, Biomarker, Abdomen, Biology, Abstract, Bangladesh Technical Education Board, Data, Blood, Medical imaging

“City of Hope’s research presented at AACR’s conference this year reinforces our focus on early detection, smarter and more precise treatments, and achieving health equity.

Key Points: 
  • “City of Hope’s research presented at AACR’s conference this year reinforces our focus on early detection, smarter and more precise treatments, and achieving health equity.
  • “Cancer is complex and the breadth and diversity of research this year further underscores the talent, scientific rigor and curiosity at City of Hope,” Van den Brink added.
  • But those diagnosed when the cancer is contained to the pancreas have a 44.3% relative survival rate after five years.
  • Scientists with Translational Genomics Research Institute, part of City of Hope, also contributed to the study.

Allterum Therapeutics receives $12 million product development grant from CPRIT to advance anti-CD127 therapeutic antibody into clinic

Retrieved on: 
Monday, April 8, 2024
NCI, Acute lymphoblastic leukemia, CLL, Immunotherapy, AML, TTC, Lung, Patient, ALL, NeXT, National Cancer Institute, Breast, Cancer, Pediatrics, Doctor of Philosophy, IND, GMP, Clinical trial, Investigational New Drug, Therapy, Immune system, Prognosis, Research institute, Cancer prevention, FDA, Lymphoma, CD127, Pharmaceutical industry

HOUSTON, April 8, 2024 /PRNewswire-PRWeb/ -- Allterum Therapeutics, Inc. has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT), which will support the clinical evaluation of Allterum's lead candidate, 4A10, a monoclonal antibody targeting CD127. CD127 is a receptor that is expressed in major subsets of multiple cancers including hematological cancers (ALL, AML, CLL, and lymphoma) and solid tumors (lung, breast, colorectal, H&N, esophageal cancers).

Key Points: 
  • Allterum Therapeutics, Inc. has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
  • HOUSTON, April 8, 2024 /PRNewswire-PRWeb/ -- Allterum Therapeutics, Inc. has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT), which will support the clinical evaluation of Allterum's lead candidate, 4A10, a monoclonal antibody targeting CD127.
  • An addition to the $12M Product Development Award, Allterum received a $2.9M CPRIT seed award in 2020, which supported early-stage development work for the 4A10 antibody and laid the foundation for the current grant.
  • "We are pleased to provide Allterum with this TTC product development award to advance their promising anti-cancer drug into clinic," said Dr. Kenneth Smith, CPRIT's Chief Product Development Officer.

LIXTE Provides Update on Progress with LB-100 as a PP2A Inhibitor to Enhance Chemotherapy and Immunotherapy Cancer Treatments

Retrieved on: 
Thursday, March 21, 2024
Stroke, Netherlands Cancer Institute, Conference, Development, Immunotherapy, GSK, Patient, Lung, DSM-IV codes, National Cancer Institute, MD Anderson Cancer Center, University, Doctor of Philosophy, NIH, Senior, Sarcoma, Clinical trial, Annual report, Bangladesh Technical Education Board, Squamous-cell carcinoma, OCCC, Pharmaceutical industry

PASADENA, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, today provided an update on the Company’s progress with its proprietary compound, LB-100.

Key Points: 
  • -- Three Clinical Trials Currently Underway for Treating Ovarian, Lung and Sarcoma Cancers --
    PASADENA, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc .
  • (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, today provided an update on the Company’s progress with its proprietary compound, LB-100.
  • The clinical trial was initiated by, and is being conducted at, the University of Texas MD Anderson Cancer Center.
  • Dr. Bernards is a member of the Board of Directors of LIXTE.

Tempest Reports Year End 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 19, 2024
Research, OS, NCI, Mutation, EP4, Gene expression, Immunotherapy, RECIST, Patient, National Cancer Institute, Pembrolizumab, Society, AACR, Bevacizumab, Therapy, Nivolumab, ASCO, EP2, SITC, PFS, Liver cancer, FDA, Pharmaceutical industry

“2023 was a transformative year for Tempest.

Key Points: 
  • “2023 was a transformative year for Tempest.
  • We announced strong positive randomized data showing the benefit of TPST-1120 combination therapy compared to standard-of-care in first-line liver cancer,” said Stephen Brady, president and chief executive officer of Tempest.
  • Tempest ended the year with $39.2 million in cash and cash equivalents, compared to $31.2 million on December 31, 2022.
  • Based on current cash and operating plan, Tempest expected to have sufficient resources to fund operations into the second quarter of 2025.

Arvinas Appoints Noah Berkowitz, M.D., Ph.D., as Chief Medical Officer

Retrieved on: 
Monday, March 18, 2024
Employment, Development, ARVN, PROTAC, Pfizer, Oncology, Partnership, Novartis, Executive, Patient, Knowledge, National Cancer Institute, Bristol Myers Squibb, BMS, Neuroscience, Columbia University, LRRK2, Pharmaceutical industry

Effective today, Dr. Berkowitz will lead the ongoing clinical development of Arvinas’ PROTAC® protein degrader programs in oncology and neuroscience.

Key Points: 
  • Effective today, Dr. Berkowitz will lead the ongoing clinical development of Arvinas’ PROTAC® protein degrader programs in oncology and neuroscience.
  • “We are thrilled to have Dr. Berkowitz join Arvinas as we continue advancing multiple programs with the goal of improving the lives of patients with serious diseases,” said John Houston, Ph.D., Chairperson, President and Chief Executive Officer at Arvinas.
  • Dr. Berkowitz joins Arvinas from Bristol-Myers Squibb (BMS), where he was Senior Vice President, Development Unit Head, Hematology.
  • The option and restricted stock units were granted in accordance with Nasdaq Listing Rule 5635(c)(4) and not pursuant to Arvinas’ stock incentive plan.

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

Retrieved on: 
Tuesday, April 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.