Hangzhou Qihan Biotech Co. Ltd. has received clinical trial clearance from China’s National Medical Products Administration (NMPA) for QN-019a for CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.
Maxcyte Inc. and Vittoria Biotherapeutics Inc. have signed a strategic platform license agreement for use of Maxcyte’s Flow Electroporation technology and Expert platform by Vittoria Biotherapeutics. Under the agreement, Vittoria will obtain nonexclusive clinical and commercial rights to use Maxcyte’s Flow Electroporation technology and Expert platform, and will pay Maxcyte platform licensing fees and program-related revenue.
The loss of the dopaminergic neurons in the substantia nigra and their projections in the putamen cause motor disabilities, which are one of the main hallmarks in patients with Parkinson’s disease (PD).
Tolerogenixx GmbH raised €7 million (US$7.6 million) in an extension to its series A round, which will enable it to continue phase IIb development of a cell therapy that induces donor-specific immune tolerance in kidney transplant recipients. At the same time, the company disclosed five-year follow-up data from a phase Ib trial of the therapy, which demonstrated that recipients continue to have stable graft function and to avoid acute rejection and severe opportunistic infections while on a reduced regimen of immunosuppressive drugs.
Lion TCR Pte. Ltd. raised $40 million in series B funding that will see the company advance its clinical trial program for its hepatitis B virus (HBV)-specific T-cell receptor (TCR) cell therapy for HBV-related liver cancer.
Two years after a U.S. FDA advisory committee agreed that Celltrans Inc.’s pancreatic islet cellular therapy had a favorable risk-benefit profile, the agency has finally approved Lantidra (donislecel) for treating adults with type 1 diabetes.
Regulatory T-cell specialist Quell Therapeutics Ltd. has sealed a potential $2 billion agreement under which Astrazeneca plc is taking rights to two autologous Treg cell therapies for treating inflammatory bowel disease (IBD) and type 1 diabetes. Quell will receive $85 million up front, the majority of which is in cash, with a modest (undisclosed) equity investment. Reaching the $2 billion headline figure will involve a series of development and commercial milestones and royalties on sales.
For Jeff Galvin, the CEO and founder of newly launched Addimmune Inc., HIV is not a condition that’s in the rearview mirror. It needs a functional cure to save lives, make people healthier and save money that need not have been spent. People wonder why it’s worth bothering to cure HIV, Galvin told BioWorld, when they are taking their medications every day and they are feeling pretty close to normal. But it’s not close for Galvin, who noted that there are side effects from taking the pills that can cause headaches, fatigue, nausea and diarrhea.
Medigene AG has announced its pipeline expansion into neoantigens with KRAS as the first target in its MDG-10xx program, a T-cell receptor engineered T cell (TCR-T) therapy being developed in combination with the company's PD1-41BB switch receptor technology.
The targeted delivery of optimized stem cells directly into injured tissues has been used to maximize efficacy and minimize systemic exposure. Still, despite hundreds of clinical trials evaluating mesenchymal stem cell (MSC) therapy as a treatment, clinical efficacy remains highly variable. Investigators at Case Western Reserve University have developed an optimized combination of cytokines and growth factors applied to MSCs (HXB-319).
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