Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.Bayer on Tuesday opened its first Cell Therapy Launch Facility in Berkeley, California, which is expected to create capacity to bring cell therapies to patients worldwide. Bayer has invested $250 million to build the plant, which will initially crank out materials for late-stage clinical trials across 100,000 square feet of space, the drugmaker said in a release. The plant is also equipped to support the potential commercial launch of BlueRock’s experimental cell therapy for Parkinson’s disease, bemdaneprocel. At the moment, BlueRock says planning is underway for its phase 2 study of bemdaneprocel, which is expected to start enrolling patients in the first half of 2024. The plant features flexible, modular space ...
BeiGene will utilise Nona’s Harbour Mice platform as part of the agreement BeiGene and Nona Biosciences have announced an agreement to expand their strategic collaboration for antibody discovery. The collaboration will allow BeiGene to utilise Nona’s Harbour Mice platform – a fully human transgenic mouse platform – to further improve therapeutic antibody discovery efficiency and flexibility. BeiGene first obtained the rights to use the proprietary Harbour Mice H2L2 platform for multiple antibody programmes in 2018 as part of the now expanded collaboration. Harbour Mice works to generate fully human monoclonal antibodies in classical two light and two heavy chain (H2L) formats and heavy chain only (HCAb) formats. The H2L platform allows mice to bear fully human immunoglobulin genes with robust B cell development and antibody maturation. The HCAb platform is the world’s first human HCAb transgenic mouse platform that works to generate fully human heavy chain-only antibodies. It allows the ...
Depicting the plight of patients with chronic and potentially fatal diseases is always a challenge for pharma companies, but Gilead Sciences has quite literally found a novel way forward.Teaming up with British historian, presenter and writer Professor David Olusoga, OBE, Gilead is launching “From the Margins,” (PDF) in what is intended to be one of the most difficult books to read. That’s because the book has every word printed entirely in the margins of the pages in what Gilead and Prof. Olusoga see as a direct inversion of a normal book. The idea is simple: “To tell the profoundly moving personal stories of marginalized people living with HIV, Hepatitis C and cancer,” according to a statement sent to Fierce Pharma Marketing. Gilead markets drugs for all three diseases. The book is specific to Britain and being run to “to raise awareness of the issue of marginalization and health inequality in ...
2seventy bio will be reducing its workforce by 40% and firing 176 employees in an effort to cut costs. One of the main reasons cited for restructuring was the decreased 2023 sales forecasts of Abecma (idecabtagene vicleucel), the company’s only approved therapy. The chimeric antigen receptor (CAR) T-cell therapy, developed in partnership with Bristol Myers Squibb, is expected to generate $470m-$570m less in sales than previously projected, as per 2seventy bio. Still, the company was quick to note that it remains hopeful Abecma sales may improve, considering the expected label expansion for a third indication. The therapy is currently under review with the US Food and Drug Administration (FDA) for the treatment of triple-class exposed relapsed and/or refractory multiple myeloma, with the Prescription Drug User Fee Act (PDUFA) date set for 16 December. Multiple pharma companies have announced staff layoffs this year following FDA rejections and as a general cash ...
University of Pennsylvania spinout BlueWhale Bio has surfaced on a mission to smash bottlenecks in cell and gene therapy manufacturing.The new company uncloaked Thursday with news it has raised $18 million in seed financing. The funding round was led by the ventures arm of Danaher Corporation with contributions from the likes of Novalis LifeSciences and Marshall Wace as well. Concerned that demand for cell therapy products is outstripping supply, BlueWhale aims to develop a technology platform and product portfolio that could bring the benefits of cell therapy to more patients “faster and at lower costs,” the company said in a press release. BlueWhale will be based in Philadelphia and led by CEO Peter Keller. The company’s scientific team is spearheaded by immunotherapy pioneers Carl June, M.D., the Richard W. Vague professor in immunotherapy at Penn’s Perelman School of Medicine, and James Riley, Ph.D., a professor of microbiology at Penn. “With ...
Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed or refractory multiple myeloma (RRMM). The authorisation for Talvey (talquetamab-tgvs) specifically applies to adult RRMM patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Multiple myeloma is a difficult-to-treat blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Despite recent advances, Janssen has reported that an unmet need remains for more therapeutic options with different modes of action, including for those treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs. Talvey, which is administered as a weekly or bi-weekly subcutaneous injection after an initial step-up phase, ...
Astellas Pharma and Poseida Therapeutics have announced a strategic investment to support Poseida’s commitment to redefining cancer cell therapy. Under the terms of the agreement, Astellas will invest a total of $50m, including $25m to acquire 8,333,333 in shares of the common stock of Poseida, as well as a one-time $25m payment for a right of exclusive negotiation and the first refusal to licence one of Poseida’s clinical stage programmes. In oncology, Poseida’s research and development of cell and gene therapies for cancer and rare genetic diseases provides a broad pipeline of allogeneic CAR-T cell therapy product candidates for solid and liquid tumours. This includes P-MUC1C-ALL01, an allogeneic CAR-T cell therapy that is currently in phase 1 development for multiple solid tumour indications. The company has provided Astellas with a board observer seat to allow it to attend scientific advisory board meetings, as well as certain notice rights related to ...
Pfizer has invested $25m in the clinical-stage, clustered, regularly interspaced, short palindromic repeats, genome-editing biopharmaceutical firm, Caribou Biosciences. Pfizer purchased 4,690,431 common shares of Caribou at $5.33 per share. Pfizer global product development multiple myeloma vice-president and development head Sriram Krishnaswami will now join the scientific advisory board of Caribou. The investment will be used to progress an immune-cloaked allogeneic CAR-T cell therapy, CB-011. The company is currently evaluating the cell therapy in a Phase I CaMMouflage clinical trial for relapsed or refractory multiple myeloma. The US Food and Drug Administration granted fast track designation for CB-011 in April 2023. The complete ownership and control of the pipeline comprising allogeneic CAR-T and CAR-NK cell therapies will be retained by Caribou. Caribou president and CEO Rachel Haurwitz stated: “We believe Pfizer’s investment in Caribou highlights the potential of our clinical programmes and we are excited to establish this partnership with one ...
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 ...
Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti.Two days after presenting remarkable data from a phase 3 trial in multiple myeloma at the American Society of Clinical Oncology annual meeting, the companies have filed with the FDA for expanded use of the cell therapy. After gaining approval 16 months ago for Carvykti to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment. Specifically, Legend and J&J submitted an application seeking an approval to treat patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a protease inhibitor, such as Takeda’s Velclade, and an immunomodulatory agent, such as Bristol Myers Squibb’s Revlimid. With such an approval, Carvytki could leapfrog BMS’ multiple ...
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