Bellicum have just announced that the FDA placed a clinical hold on BPX–501 clinical trials in the United States following three cases of encephalopathy “deemed as possibly related to” treatment with their new product in development, BPX–501.
The FDA clinical hold does not affect the ongoing BP–004 registration trial in Europe.
Here we take a look at some of the issues underlying the unfortunate news.
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Yesterday, Juno Therapeutics announced a new deal for a collaboration with Editas Medicine that is:
“Focused on creating chimeric antigen receptor (CAR T) and high-affinity T cell receptor (TCR) therapies to treat cancer. The companies will pursue three research programs together utilizing Editas’ genome editing technologies, including CRISPR/Cas9, with Juno’s CAR and TCR technologies.”
This follows on from their recent deals with Fate Therapeutics and Stage Cell Therapeutics and bluebird bio’s licensing deal with Five Prime for novel antibodies to develop CAR T cell therapy.
One of the most interesting questions in CAR T cell development, is whether you need to incorporate a suicide gene or suicide switch into them that allows you to turn off the response, force the T cells to self-destruct, in the event of severe Cytokine Release Syndrome (CRS) or other serious adverse events.
This review article is another example that straddles data from conferences earlier this month at Immunology 2015 (AAI) and American Society of Gene and Cell Therapy (ASGCT) with the American Society of Clinical Oncology (ASCO) this coming weekend.
At ASGCT we spoke with Dr Carl June and also heard the latest update on what Cellectis are doing from Dr Julianne Smith.
Companies mentioned: Juno Therapeutics, Novartis/U Penn, Cellectis, Bellicum, bluebird bio, Formula, Molmed.
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Several subscribers have written to ask what we think of Houston based Bellicum Pharmaceuticals?
Bellicum is a company that along with Novartis, Kite, Juno and Cellectis has a Chimeric Antigen Receptor (CAR) T cell therapy in development, amongst other things.
Readers already know the company had a successful IPO in December (NASDAQ: BLCM) and were reported to have raised $140M to fund future development.
This morning, the company announced enrollment of the first cohort of pediatric patients in a phase 1/2 dose escalation trial of BPX-501 (link to press release). This T cell therapy aims to mitigate the risk of graft versus host disease (GvHD) after an allogeneic haploid hematopoietic stem cell transplant.
BSB spoke with Bellicum CEO Tom Farrell and COO Dr Annemarie Moseley to answer some of the questions we think subscribers would like to know more about such as:
- Market opportunity for BPX-501
- Mechanism of action of BPX-501
- Strategic direction the company is taking
- Vision with regards to its CAR-T development
- Milestones expected in 2015
We’ve provided some additional commentary on the challenges and opportunities Bellicum may face in the GvHD market and how we think the company stacks up against the competition in the CAR-T space. Be warned this piece is a long read: 6,000+ words!
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