Reg Med - Utveckling - Nuläge

 Bloggen inleder med en reminder. Sen info om senaste relevanta nyheterna inom Reg Med.

Medical professionals and researchers have made significant strides in the relentless pursuit of innovative cancer treatments in recent years. One groundbreaking advancement that has captured the spotlight is Chimeric Antigen Receptor T-cell therapy, commonly known as CAR T cell therapy. This revolutionary approach harnesses the power of the immune system to target and eliminate cancer cells, offering new hope to patients with certain types of cancers.

Looking ahead, ongoing clinical trials are exploring the potential of CAR T cell therapy in various cancer types. Researchers are also investigating ways to enhance the therapy's safety and effectiveness, such as incorporating multiple CARs or combining CAR T cell therapy with other treatment modalities.

CAR T cell therapy stands at the forefront of cancer treatment innovation, offering a beacon of hope for patients facing limited options. As research continues to advance and more clinical trials unfold, the potential for CAR T cell therapy to transform the landscape of cancer care is both exciting and promising. The journey from laboratory discovery to widespread clinical application exemplifies the power of scientific ingenuity in the fight against cancer, marking CAR T cell therapy as a shining example of the relentless pursuit of a cure.

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February 16, 2024

Scientists at the UCLA Health Jonsson Comprehensive Cancer Center have built and demonstrated the potential efficacy of a new chimeric antigen receptor (CAR) T-cell-based immunotherapy specifically designed to treat patients with cutaneous and rare subtypes of melanoma.

CAR T-cell therapy uses genetically engineered versions of a patient’s immune cells to target and destroy cancer cells. This type of treatment has transformed the field of cancer, especially for people with challenging-to-treat cancers.

The new approach, described in the journal Nature Communications, uses an engineered CAR T-cell that is designed to recognize and attack cells with high levels of TYRP1, a protein found on the surface of melanoma cells. The team found these engineered CAR T-cells can effectively eliminate cancer cells in preclinical tests without causing severe side effects.

Fotnot. UCLA är bekanta med HoloMonitor via hudforskaren Robert L Judson-Torres. Robbie tillsammans med kollegor från UCLA har belyst tekniken Holomonitor bygger på, QPI (Quantitative Phase Imaging) i nedanstående studie från just UCLA. 

Quantitative Phase Imaging:Recent Advances and Expanding Potential in Biomedicine

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FDA godkände 16/2 för första gången T Cell behandling mot en annan typ av hudcancer än den UCLA berättar om härovan.

FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

For Immediate Release:

February 16, 2024

Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). 

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light, which can come from sunlight or indoor tanning. Although melanomas only represent approximately 1% of all skin cancers, they account for a significant number of cancer-related deaths. Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease. 

Treatment for unresectable or metastatic melanoma may include immunotherapy using PD-1 inhibitors, which are antibodies targeting certain proteins in the body to help the immune system fight off cancer cells. In addition, drugs targeting the BRAF gene, which helps with managing the growth and functioning of cells, may be used for treating melanoma associated with BRAF gene mutations. Those patients whose melanoma has progressed with these therapies have a high unmet medical need.

Amtagvi is a tumor-derived autologous T cell immunotherapy composed of a patient’s own T cells, a type of cell that helps the immune system fight cancer. A portion of the patient’s tumor tissue is removed during a surgical procedure prior to treatment. The patients’ T cells are separated from the tumor tissue, further manufactured and then returned to the same patient as a single dose for infusion. This is the first FDA-approved tumor-derived T cell immunotherapy.

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Brittiska forskare har upptäckt att T Cells metoden kan vara ett nytt starkare motmedel till kommande Covid19 utbrott.

Study reveals T cells could provide more protection against Omicron in future vaccines

Memory T cells were found to be more effective at fighting SARS-CoV-2 than antibodies

20th February 2024

Researchers from Imperial College London (ICL) have revealed that T cells could provide more protection in COVID-19 vaccines against Omicron, a SARS-CoV-2 virus strain, than antibodies do.

The new review, published in Cell Host and Microbe, offers new insights into the development of COVID-19 vaccines and how T cells could play a crucial role in protecting people from these emerging variants.

Since being first identified in 2019, the SARS-CoV-2 virus has evolved with several variants and subvariants, such as Omicron, Pirola and Juno, leading to new waves of infection.

Although neutralising antibodies were considered to be the primary defence mechanism against COVID-19 during the pandemic, the virus has since evolved to become better at evading them.

The new research reveals that memory T cells, which play a key role in the body’s adaptive immune response to recurring viral infections, are more effective at recognising and combating the virus’ in comparison to antibodies.

Fotnot. Imperial College London är kund till PHI och har x antal HoloMonitor till sin forskning.Länk

UK

• Imperial College, London

Stannar vi i England kan berättas att myndigheter öppnar upp för nytt regelverk beträffande instrumentering inom Reg Med. Ett underlättande för MedTech mao.

UK approved bodies launch Team-AB as MHRA gears up for new medtech legislation

19 February 2024

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Apropå regelverk har amerikanska FDA nu börjat accelerera sina regelverk och godkännanden inom Reg Med området.

FDA's CBER Issues Final Guidance For CAR T Cell Products 

February 15, 2024

The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29.1 The guidance document was well-received when it was first issued as a draft in March 2022, according to the majority of docket comments posted on the Federal Register.2 Comments were prepared by various professional societies, therapeutic developers, academic institutions, and other contributors. A few significant changes were made to the document since the draft, and points of additional clarity were added throughout each section, in line with many of the comments posted.  

På nedanstående sida från FDA kan man se alla Reg Med godkännanden. De är många !

Approved Cellular and Gene Therapy Products

Min kommentar
USA har börjat trycka lätt på gaspedalen beträffande Reg Med. Signalerna är många att loket USA nu börjar dra igång Reg Med på allvar. I texten ovan hoppas jag att ni noterar fotnötterna som är bifogade.

Dra er egen slutsats av dessa nötter. 😎

                                                     Mvh the99