Author: Josh Baxt

Is TapImmune’s cancer vaccine the real deal?

Like stem cells and gene therapy, cancer vaccines have been long on hope but short on results. Gene therapies have had a couple of recent breakthroughs, but where are we with vaccines? Jacksonville, Florida-based TapImmune released some interesting results this week from a Phase I trial conducted at the Mayo Clinic that will add some spice to that discussion. Published in Clinical Cancer Research, the study assessed 22 women with breast and ovarian cancer and found their T-cell vaccine, TPIV200, was safe and induced an immune response against the antigens being targeted. The study also hinted at efficacy, though...

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The FDA weighs in on 3D printing, offering guidance on pathways for manufacturers

3D printed brain model for surgical simulation by Stratasys Direct Manufacturing. The FDA just released new guidance for 3D-printed devices, seeking to clarify the pathway manufacturers must follow to get their products approved. This is the FDA’s latest attempt to keep pace with a fast-moving technology. A few weeks ago, the agency shared their emerging approach to molecular diagnostics. But 3D printing, or additive manufacturing in agency nomenclature, offers its own unique regulatory challenges. The technology has long been a boon in the design process, driving rapid, iterative prototyping and evaluation. But with these approaches moving into the clinic,...

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Kymriah and the CAR-T roller coaster

Last week, Novartis’ CAR-T immunotherapy, Kymriah (tisagenlecleucel), was approved for children and young adults with relapsed B-cell acute lymphoblastic leukemia (ALL). The excitement was palpable as this first gene therapy and next generation immunotherapy got the FDA nod. But this week, the FDA held up two Cellectis phase 1, CAR-T trials for UCART123 after one patient died from adverse effects associated with the treatment and another had a severe reaction. These contrasts highlight the bumpy ride CAR-T therapies may face on their way to approval. UCART123 is by no means dead – the trial protocols can be redesigned to ease side effects. But CAR-T represents a high-risk/high-reward strategy to take on cancer. Advertisement “These are very potent drugs, good and bad,” said Sandip Patel, medical oncologist and assistant professor of medicine at the UC San Diego Moores Cancer Center, in a phone interview. “Good in terms of their effects on the cancer but bad if the side effects get out of control. Unfortunately, people can die from these side effects.” Kymriah made it through trials with no such complications and benefits from being a late-stage treatment aimed mostly at children. Though the $475,000 price tag has raised some eyebrows, it is not inconsistent with what bone marrow transplants cost. “It’s actually lower than some of us anticipated, given the earlier estimates,” said Madelyn Hanson, manager, Oncology Consulting Services, Clinical...

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Harvard University spinout raises $10M to advance platelet bioreactor technologies

Platelet BioGenesis’ bioreactor Boston-based Platelet BioGenesis provides received $10 million in Series A financing to relocate their platelet manufacturing technology forward. The financing circular for the Harvard University spinout was led by Qiming U. S. Healthcare Fund and included Vivo Funds, eCoast Angels and other investors. The new funding will support preclinical studies for Platelet BioGenesis’ come cell-based bioreactors. The company hopes to begin clinical trials within around three years. By removing human donations from the platelet equation, Platelet Biogenesis hopes to create a more reliable provide. “ We can only store platelets pertaining to five days, so we...

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