Autolus will apply the capital to its CAR T-cell therapy currently under FDA review in cancer and in early clinical development in lupus. Meanwhile, BioNTech will gain access to Autolus’s cell therapy manufacturing assets as well as technologies that could support the R&D of in vivo therapies and antibody drug conjugates.
Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.
Cargo Therapeutics will use most of the IPO proceeds for clinical testing of a cell therapy engineered to overcome a common way cancers develop resistance. This program is based on research from the National Cancer Institute.
Johnson & Johnson is acquiring rights to two next-generation cell therapies from Cellular Biomedicines, both potential treatments for diffuse large B-cell lymphoma. One therapy is already in the clinic while the other is on track to begin human testing this year.
Cargo Therapeutics is developing CAR T-cell therapies that overcome ways cancers evade currently available treatments. True to its name, the startup’s approach involves putting more cargo and more complex cargo onto engineered T cells.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Cell therapy offers a treatment option for some advanced blood cancers, but the manufacturing process is lengthy and complex. The biopharmaceutical industry is working on various technologies that could make manufacturing faster and more efficient, or perhaps supplant the current process altogether.
CAR-T has become increasingly recognized as an exciting and potentially paradigm-shifting treatment in the past five years. In fact, more than 10,000 patients have undergone this new treatment for certain types of leukemia, lymphoma and multiple myeloma.
After settling in rural New Mexico, a cancer patient had to move 750 miles east and live in a trailer to access CAR-T treatment at the MD Anderson Cancer Center.
The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to improve the pharma giant’s first generation of cell therapies while also building a pipeline of next-generation treatments with better features and properties.
CAR T cell therapies for cancer still pose challenges in manufacturing, safety, and the ability to address solid tumors. A panel at the World Medical Innovation Forum discussed efforts to improve CAR T as well as new approaches for the next generation of cell therapies.
Approval of the Johnson & Johnson and Legend Biotech cell therapy, Carvykti, marks the second CAR T-cell therapy to clear the regulatory bar for multiple myeloma. The FDA approved Bristol Myers Squibb's cell therapy Abecma last year.
Clinical-stage Arcellx raised $123.8 million from its IPO, which the company will use to advance to a pivotal test for its lead program, a CAR T-cell therapy for multiple myeloma. Though Arcellx trails its large pharmaceutical rivals, the biotech contends its technology produces cell therapies with key advantages.
Despite the targeted approach of some cancer treatments, tumors can find ways to escape, leading patients to relapse. ImmPACT Bio will apply its Series B financing toward the development of cell therapies designed to prevent tumor escape.