Prostate cancer is the most-commonly diagnosed malignancy and the second leading cause of cancer death among men in the United States. In its ever-indelicate world, the stubborn disease can continue to grow even when the amount of testosterone in the body is reduced to very low levels, thus earning the clumsy name: castrate-resistant prostate cancer (CRPC). It poses a major clinical challenge as a protein called the androgen receptor (AR) remains behind as a critical player in cancer, changing its behavior in CRPCs. Androgen-deprivation therapy, which is a treatment that reduces the levels of male hormones, is the first-line treatment for locally advanced or metastatic prostate cancer. Despite initial responses to the therapy, nearly all patients eventually develop CRPC within a few years. It is now well recognized that CRPC continues to be dependent on AR signaling. “Understanding the triggers that cause changes in AR’s activity is important for developing ...
With two cell therapies approved and three more in its pipeline, Bristol Myers Squibb is working to beef up its manufacturing capabilities for the complex, personalized, one-and-done medicines.On Thursday, BMS took a positive step in that direction as the FDA gave the go-ahead for the company to begin commercial cell therapy manufacturing at its sprawling facility in Devens, Mass. The cell therapy portion of the Devens site includes 244,000 square feet and has been under construction since 2021. It becomes BMS’ third commercial CAR-T manufacturing facility in the U.S. and adds more than 500 new cell therapy jobs. It is the second significant expansion of the Devens complex, which sits on 89 acres of land and covers 700,000 square feet and has been operational for more than a decade. BMS’ cell therapies, Abecma and Breyanzi—both for blood cancers—were approved a month apart in early 2021. Abecma pulled in sales of ...
Researchers at the Francis Crick Institute and King’s College London have revealed the complex interactions between cancer and the immune cells that surround a tumor, with the potential to inform how patients will respond to immunotherapy.In the study, published in the journal Genome Medicine, the researchers analyzed thousands of samples across 32 types of cancer to examine the way that cancer dynamically interacts with the tumor immune microenvironment (TIME), allowing the disease to flourish. Cancer evolves within the TIME, which is sculpted by cancer cells and, in turn, sculpts the cancer genome. These dynamic interactions have a significant impact on how the cancer develops and responds to treatments such as immunotherapy. Gaining a greater understanding of cancer-immune system interaction is therefore crucial to understanding cancer biology. The researchers focused on a class of genes called cancer drivers because, when altered, they help drive cancer. They identified 477 of these cancer ...
Researchers in the Hermelin Brain Tumor Center at Henry Ford Health are leading a Phase I clinical trial studying the maximum tolerated dose of an oncolytic adenovirus, a mutated virus engineered to selectively replicate in and destroy cancer tissue, in combination with fractionated stereotactic radiosurgery among patients who are undergoing resection of a recurrent high-grade astrocytoma brain tumor. Tobias Walbert (M.D., Ph.D., principal investigator of the study and co-director of the Hermelin Brain Tumor Center at Henry Ford Health) said, “The participants in this study have progressive high-grade astrocytoma as well as glioblastoma, and are scheduled to undergo repeat surgery. After the removal of as much tumor tissue as possible, a modified oncolytic adenovirus is injected into the wall of the resection cavity and any residual tumor tissue. The goal of this study is to determine the maximum tolerated dose of the injected adenovirus, which is engineered to selectively replicate ...
A Ludwig Cancer Research study has shown that some molecules previously used to treat hypertension might also help the immune system to better target cancer cells. Reported in the current issue of Nature, these findings could, in time, be applied to significantly improve the effectiveness and applicability of cancer immunotherapy. “Immunotherapy today can effectively fight only 30% to 40% of cancers,” said Benoît Van den Eynde, who is a member of the Ludwig Institute for Cancer Research, co-director of the de Duve Institute and professor of Tumor Immunology at the University of Oxford. “Many cancers are resistant, largely because their T lymphocytes are not reactive enough. We discovered that drugs once used to treat hypertension could have a very interesting effect in combating these forms of immunotherapy-resistant cancers.” The immune system protects against disease by destroying foreign substances and pathogens, such as bacteria and viruses. T lymphocytes, a type of ...
Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.In the phase 3 THOR trial, Balversa cut the risk of death by 36% to accomplish its primary objective. It helped extend lives by an average of 12.1 months versus a 7.8-month average for patients on chemotherapy. The interim results were from cohort 1 of the confirmatory study and were presented Monday at the American Society of Clinical Oncology’s (ASCO’s) annual meeting in Chicago. “The use of Balversa in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer,” Yohann Loriot, M.D., Ph.D., of the University of Paris-Saclay in France and the principal study investigator, said in a release. Balversa was approved on an accelerated basis in 2019, becoming the first ...
Announcing a new article publication for Zoonoses journal. Pasteurella multocida, a Gram-negative, penicillin-sensitive coccobacillus that is frequently a member of the normal respiratory microbiota of different animals, remains a clinically important pathogen with the ability to cause severe disease. Few case reports have involved P. multocida infections without animal bites. Moreover, few reports have identified P. multocida as the causative agent of septic shock, which usually occurs in patients with cirrhosis and/or immunocompromised patients. To our knowledge, a human submandibular salivary gland abscess caused by P. multocida has not been reported. Pasteurella spp. are resistant to benzylpenicillin, and human isolates of beta-lactamase-producing resistant strains of P. multocida resistant have also been documented. The noteworthy findings of the current study were as follows: (i) the combination of ceftriaxone and ciprofloxacin successfully treated two patients infected with P. multocida; (ii) the first reported case of a septicemic patient with no history of ...
Sacituzumab govitecan, a novel antibody drug-conjugate therapy was granted accelerated approval on February 3, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic HR+, HER2- breast cancer. The FDA action was based on the results of TROPICS-02, a study in which Dana-Farber Cancer Institute’s Sara Tolaney, MD, MPH, helped lead and which was presented at the European Society of Medical Oncology annual meeting in September 2022 as well as the American Society of Clinical Oncology meeting in June 2022. Researchers reported that the sacituzumab govitecan produced a statistically significant improvement in overall survival rates compared to chemotherapy. The overall survival rate for patients taking part in the global phase 3 study was 14.4 months for those who received sacituzumab govitecan and 11.2 for those given chemotherapy. The sacituzumab arm of the study also showed superior response rates as well as prolonged median progression free survival ...
The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Rocket Pharmaceuticals’ adeno-associated virus (AAV)-based gene therapy, RP-A501, for the treatment of Danon Disease, a rare X-linked inherited disorder. The designation for the investigational gene therapy was granted based on positive safety and efficacy data from the Phase I study in patients with Danon Disease. A favourable safety profile of RP-A501 was observed with improvements in multiple clinical and highly relevant laboratory parameters including LAMP-2 protein expression. The study also observed reduced autophagic vacuoles, high sensitivity troponin I, brain natriuretic peptide (BNP) and left ventricular mass and wall thickness. In addition, improvement was observed in symptoms and quality of life as measured by New York Heart Association and the Kansas City Cardiomyopathy Questionnaire, respectively. Improvements and normalisation across several quantifiable parameters used by cardiologists in clinical practice to enable risk assessment and treatment decisions were also demonstrated in ...
eXmoor pharma has received an investment of around $35m in its Series A round to support the expansion of its cell and gene therapy production capability. The fundraise saw the participation of new and existing investors Kineticos Ventures and MVM Partners, respectively. Kineticos Ventures president and CEO Frank Lis is joining eXmoor board as a result of the financing. The investment will allow eXmoor to launch its Cell and Gene Therapy Centre, a 65,000ft2 good manufacturing practice (GMP) facility. The purpose-built facility will help the firm to develop and produce autologous and allogeneic cell therapies in addition to viral vectors. It will see eXmoor leveraging around two decades of in-house facilities design, strategic cell and gene therapy (CGT) process development and transformation of its consultancy experience to become a comprehensive CGT contract development and manufacturing organisation (CDMO). Planned to be opened in Bristol, UK in this July, the facility will ...
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