Author: Juliet Preston

Reinventing tissue regeneration, one layer at a time

There are some fancy tools out there for repairing skin, from 3D bioprinting, scaffolds and matrices to spray guns that rain stem cells directly onto a wound. Doctors in Brazil are even experimenting with sterilized Tilapia fish skin as a novel dressing for burns. Creativity is nice, but that alone won’t save patients battling through the most critical hours of their lives. Denver Lough, an M.D./Ph.D., saw this first hand while working at the Johns Hopkins Plastic and Reconstructive Surgery Program. Nothing was truly getting the job done. “Name one regenerative medicine product or company that’s out there that actually truly regenerates anything,” Lough challenged in a recent phone interview. “Not, ‘we grow keratinocytes,’ or ‘we can turn a cell into an osteogenic lineage’ but really; does this grow full thickness tissue? There’s really not one out there and there’s certainly not one that’s being used clinically right now for skin regeneration.” Now CEO and CSO of PolarityTE, Lough believes the fundamental approach to tissue regeneration is taught wrong. And that’s why, after all these years, skin healing remains imperfect. Biotechs working in this field have zoomed in on individual cells, he said, working to culture and manipulate stem cells or to find the right recipe for growth factors that can guide differentiation. That’s not how biology works, Lough contests. “[Biology] works through cells interacting with each other, having...

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It’s not a competition but… Kite’s CAR-T therapy just claimed a first in Europe

As Novartis awaits a final FDA ruling on its CAR-T therapy, Santa Monica, California-based Kite Pharma has jumped the Atlantic to file the first Marketing Authorization Application (MAA) with the European Medicines Agency (EMA). Announced Monday, the MAA centers around axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy that targets CD19, a protein expressed on the surface of the B-cells that drive lymphomas and leukemias. Axi-cel is being pitched as a potential treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for autologous stem cell transplants. It also has a biologics submission filed with FDA, though it is several months behind Novartis. While it seems inevitable that one of the CAR-T therapies will soon reach the market, many question marks remain around the post-marking logistics — domestically and internationally. Kite unveiled an early outline for manufacturing and distribution of the therapy at the J.P. Morgan Healthcare Conference in January. The company has reportedly constructed a manufacturing facility in El Segundo, California, in close proximity to the Los Angeles International Airport (LAX). T-cells harvested from patients throughout the U.S. would be flown there for engineering, before being sent back to the patient’s local clinic for reinfusion. According to E.P. Vantage’s Jacob Plieth, the El Segundo facility would also service Europe. $KITE just confirmed to me that KTE-C19 manufacturing under...

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Why the immune system is our best bet to battle cancer

It’s a big week for oncology and immunotherapy, as an FDA panel convenes on Wednesday to interrogate the first CAR-T therapy vying for approval. Developed by Novartis, the five-step approach seeks to harness and weaponize the patient’s own immune system to fight off late-stage blood cancers. Kite Pharma has its own version awaiting FDA review and several others are moving through clinical trials. With their almost science fiction-like complexity and remarkable effects, Chimeric Antigen Receptor-engineered T-cells (CAR-Ts) have understandably captured the field’s attention. But underneath the hype and excitement, all the different programs rely on a much more basic and familiar aspect of cell biology: the protein/receptor target. Whether it’s a cancer vaccine, an antibody-drug conjugate (ADC), or an entirely new platform; there has to be a way for the therapy and/or the immune system to differentiate between cancerous and healthy cells. It’s a common denominator throughout all immuno-oncology programs and as a result, it can be a window into the evolution and expansion of the field. All or nothingAccording to a recent report by the trade group PhRMA, there are 240 cancer immunotherapies in the pipeline. For each candidate, R&D teams have to ask the same fundamental question: How can we drive or enable an immune response? The lead programs of both Novartis and Kite are actively programming T-cells to seek out CD19, a protein found on the surface of...

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Bluebird is pretty chirpy about its anti-BCMA CAR-T therapy outcomes

The walkway during the 2017 ASCO annual meeting You know you’ re onto something worthwhile when your study leader can’ t very hold back the tears when presented with the final data. That was the case with Bluebird Bio’ t first major  clinical trial for its experimental anti-BCMA CAR-T cell therapy in patients with  relapsed and/or refractory multiple myeloma. In an open-label  Phase one study, 100 percent of patients taking an active dose acquired some sort of response to the therapy. Of those, 73 percent achieved an excellent partial response or better, the company reported. The results furthermore appear...

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May Patrick Soon-Shiong silence his many critics?

On the phone, Patrick Soon-Shiong speaks gradually and deliberately. He clearly trusts himself, but he or she doesn’ t trust journalists anymore. A number of scathing articles by STAT News and Politico delivered stocks in his publicly-traded companies tumbling earlier this year. On Mon, he has an opportunity to change that narrative somewhat, with the introduction of data from human trials of his malignancy vaccine at a major oncology conference. The particular stories allege that despite his bold claims, Soon-Shiong’ s NantWorks subsidiaries are underperforming and reliant upon contracts from other companies in the group. Reporters have also stated...

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