Allogene said the clinical hold was placed after it notified the FDA of a chromosomal abnormality detected in a bone marrow biopsy undertaken to assess pancytopenia in a patient who was treated with the company’s ALLO-501A CAR T cells in the Phase I/II ALPHA2 trial (NCT04416984).
Establishing comparability in manufacturing cell therapies is a significant challenge for the field due to the complexity of the products, limited material availability, and inherent donor-to-donor variability. As products progress through their lifecycles, organizations need to focus on their ultimate manufacturing end goal. In addition, commercialization and application of cell therapy products to larger patient populations drive the need to switch from small-scale, manual, or semi-automated single function-based production models to more robust and efficient commercial-scale manufacturing using closed and automated end-to-end platforms.
Pairing a newly developed gel with immunotherapy that was delivered to post-surgical mouse brains with glioblastoma, a highly malignant and deadly cancer, improved the immunotherapy’s effectiveness, report researchers from the University of North Carolina Lineberger Comprehensive Cancer Center and colleagues.
Immunotherapy, which harnesses the power of the body's immune system to fight disease, is gaining huge traction in treating cancer. Chief among cancer immunotherapies is a treatment known as CAR-T, or chimeric antigen receptor T cell therapy. CAR-T therapy has had great success in treating blood cancers such as leukemia, especially in children and young adults. But using the therapy to combat solid tumors, including skin cancer, has proven much more difficult.
The FDA has sent shockwaves through the off-the-shelf CAR-T space, slapping a clinical hold on all of Allogene Therapeutics’ AlloCAR T clinical trials in response to an abnormality that could theoretically cause cancer.
The main components of cancer vaccines are (a) a tumor antigen, (b) an immunological adjuvant, and (c) a vehicle or carrier. Cancer vaccine success depends on a number of factors, including choosing the appropriate target antigen, formulation, adjuvant, and delivery route. Each of these components must be selected from a variety of choices, which makes the process of vaccine optimization a complex problem.
C'est une promesse qui fait rêver médecins et associations de patients. Avec ses ciseaux moléculaires, la BioTech française Cellectis ambitionne de soigner les leucémies et cancers récalcitrants. Les experts veulent croire qu'une révolution est en marche.
Chimeric antigen receptor T-cell (CAR-T) therapies have been changing the cancer treatment landscape. These one-time customized treatments created from an individual’s own T cells represent a significant advancement in treatment. Expanding their use across care settings is essential to improving patient outcomes and quality of life.The economic viability of CAR-T, however, could be constrained by proposals to limit Medicare reimbursement when it is administered in outpatient settings, such as hospital outpatient and specialty cancer centers, to the average sales price (ASP) of the therapy plus an amount capped at $1,000 for most drugs and up to $2,000 for immunotherapies like CAR-T.
Medical devices developer Biocorp has entered into an agreement with science and technology firm Merck to develop a specific version of Mallya, a Bluetooth enabled clip-on device. Under the deal, the companies will develop and supply the specific version of Mallya device for the monitoring of treatment adherence in the field of human growth hormone (HGH).
TreeFrog Therapeutics, a privately held French-based biotech startup focused on developing safe and affordable stem cell-derived cell therapies for millions of patients, today announced the successful closing of a $75 million (€64M) Series B financing round, bringing the total funding to date to $83 million (€70M). The financing round was led by Bpifrance Large Venture, part of the French Public Investment Bank, joined by U.S. investment firm Leonard Green & Partners L.P., global pharmaceutical company Bristol Myers Squibb, and European venture capital team XAnge. In conjunction with the financing, independent board member Frederic Desdouits, PhD, has been appointed chief executive officer. It was also announced that Kevin Alessandri, PhD, co-founder, will relocate in early 2022 to Boston, MA, to lead the newly created U.S. subsidiary, TreeFrog Therapeutics Inc.
The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and the sixth approved CAR-T product globally. Currently the only approved CAR-T product that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designation. May provide a best-in-class CAR-T therapy in China given its demonstration of high rates of durable disease response and low rates of CAR-T associated
The burden of non-communicable diseases (NCDs) has risen rapidly in Africa, with these diseases typically affecting younger working populations than seen in developed countries. Diabetes and hypertension alone lead to about two million deaths a year on the continent. Africa also has a continuing high burden of HIV-infection. The achievements of the high-quality HIV programmes are impressive, with over 60% of people living with HIV infection in East and Southern Africa in regular care. In contrast, health care services for diabetes and hypertension, which are also often organised separately, are patchy with only about 10-20% of people with these conditions estimated to be in care.
Le cannabis médical, que l’on appelle aussi parfois cannabis thérapeutique, fait référence à l’utilisation du cannabis pour soigner des maladies ou des symptômes de certaines maladies. Cela est lié à la découverte de certaines propriétés du cannabis, notamment au travers de ses cannabinoïdes, comme le THC ou le CBD (ces deux derniers étant les principales molécules), pouvant contribuer à soigner, voire guérir, les maux de certains patients. Par exemple, les propriétés anti-inflammatoires du CBD sont désormais reconnues : le CBD est alors recommandé pour lutter contre des maladies comme l’arthrose ou les rhumatismes, qui se caractérisent par des douleurs chroniques.
Chimeric antigen receptor (CAR) T cell therapy, which uses engineered T cells to treat certain types of cancers, has often been a challenging approach to treating solid tumors. CAR T cells need to recognize a specific target on cancer cells to kill them. However, cancer cells do not always have the target, or they find ways to hide the target and stay invisible to CAR T cell attack. A new study from Penn Medicine, published online in Cell, demonstrates that RN7SL1, a naturally occurring RNA, can activate the body's own natural T cells to seek out the cancer cells that have escaped recognition by CAR T cells. This may help improve efforts to treat solid tumors, which represent most human cancers.
JW Therapeutics, a joint venture between Bristol Myers’ Juno Therapeutics and WuXi AppTec, has won approval in China for CD19 CAR-T cell therapy relmacabtagene autoleucel (relma-cel) to treat large B-cell lymphoma after at least two prior lines of systemic therapy. Relma-cel marks China’s second approved CAR-T therapy. Fosun Kite Biotechnology, a joint venture between Fosun Pharma and Gilead Sciences’ Kite Pharma, claimed the first-to-market title in June with their approval for Yescarta in the same disease setting.
The report collected publicly available recall information from the FDA and European regulators. The report then identified 59 instances where drugs were recalled due to glass-related issues between January 2014 and July 2021. The causes identified include recalls for delamination, particulate matter, breakage, ethylene oxide residuals and adhesive issues.
Les ARN (pour Acides RiboNucléique) sont des molécules dont la structure est proche de celle des molécules d’ADN (Acide DésoxyriboNucléique). Beaucoup moins stables que ces dernières, ce qui signifie qu’elles sont plus facilement détruites, les molécules d’ARN jouent toutefois de nombreux rôles dans les cellules. Ceux-ci varient selon la classe d’ARN considérée : ARN de transfert ou ARN ribosomique qui interviennent dans l’assemblage des protéines, ARN guides qui aident à positionner certaines enzymes au bon endroit… Aujourd’hui encore, de nouvelles classes d’ARN possédant diverses fonctions biologiques sont découvertes.
Emerging evidence indicates a central role for the microbiome in immunity. However, causal evidence in humans is sparse. Here, we administered broad-spectrum antibiotics to healthy adults prior and subsequent to seasonal influenza vaccination. Despite a 10,000-fold reduction in gut bacterial load and long-lasting diminution in bacterial diversity, antibody responses were not significantly affected. However, in a second trial of subjects with low pre-existing antibody titers, there was significant impairment in H1N1-specific neutralization and binding IgG1 and IgA responses.
Too many "exhausted" T cells left in the wake of aggressive chemotherapy regimens for patients with advanced chronic lymphocytic leukemia (CLL) make it more challenging for chimeric antigen receptor (CAR) T cell therapy to do its job. Now, a new study from researchers in the Perelman School of Medicine at the University of Pennsylvania shows how to overcome this type of resistance and reinvigorate these T cells with an experimental small molecule inhibitor.
Eight of 11 lymphoma patients who received one Fate NK cell therapy, FT516, have shown evidence of a response, as have 10 of 14 given another known as FT596. No serious neurological side effects were reported, and only two Grade 1 or Grade 2 cases of the immune-related adverse events typically associated with other forms of engineered cell therapy were observed.
Pancreatic cancer is the third leading cause of cancer deaths in the United States, in part because it is very difficult for chemotherapy drugs to reach the pancreas, which is located deep within the abdomen. To help overcome that obstacle, researchers from MIT and Massachusetts General Hospital have now developed a small, implantable device that delivers chemotherapy drugs directly to pancreatic tumors. In a study of mice, they found that this approach was up to 12 times more effective than giving chemotherapy drugs by intravenous injection, which is how most pancreatic cancer patients are treated.
In most industries, the superlatives “breakthrough” and “disruptive” are sizzling marketing claims designed to incite customer interest in a product that is unlike any other; it does something that has never been done before or advances the state of the art in a dramatic way. But when it comes to medical devices and other products used in medicine, these terms induce almost as much fear—on the part of developers and their customers—as excitement.
Technology advancement and the digitization of information has played a large role in the disruption of industries and markets. However, it would be a mistake to attribute disruption solely to technology. There are several other factors underpinning disruptive innovation regardless of industry. An industry ripe for disruption typically exhibits one or more of the following dynamics.
According to McKinsey & Company, more than 60% of patients want more information before making healthcare decisions, and yet only a fraction say they have access to it, so nearly 49% follow the recommendation of their doctor, clinician or insurer without considering better, lower-cost or more convenient care options.Simply put, providing consumers with better and more accessible information about their healthcare and treatment options has a profound impact on their overall healthcare decisions.
“We will be much more effective at improving health behavior if we work with the irrational parts of our nature… instead of ignoring them or fighting against them. The good news is that we are irrational in a rather predictable way! When it comes to health care, understanding our irrationality is just another tool in our tool box. And harnessing that irrationality, that maybe the most rational move of all.”
The only thing worse than a Monday morning is having your periods start suddenly on a Monday morning! Dragging yourself to work, while your cramps are at an all-time high and your mood at an all-time low is literally hell on Earth. You can pop in a painkiller, but the effect only lasts for a few hours, and it isn’t my preferred means of relief, to be honest. And a proper heating pad is almost impossible to carry around with you! Hence, Sofia Papenova and Lidia Grits designed WIM, a smart heating pad that you can actually wear!
New mRNA technology is a biotechnological leap in progress but our ability to scale (Uber for vaccines) and mandate (Regulatory or media capture) mRNA medicines opens the world up to self-inflicted medical crises. We can limit the risks of a “biological Chernobyl” by being thoughtful about the business models used to develop and deploy mRNA medicines.