FDA lifts hold on CAR-T therapy P-PSMA-101 and gene signature predicts whether localized PCa will spread

[NPfisherman]

Greetings FPC members,

The FDA had previously put a hold on Poseida's P-PSMA-101 candidate but has now lifted the hold for it to continue Phase 1 testing. The hold was placed after a patient died of Macrophage Activation Syndrome. The death was not determined to be definitively related to P-PSMA-101 and the patient missed several follow up visits after infusion.

Designed to target prostate-specific membrane antigen, P-PSMA-101 was developed using Poseida’s piggyBac DNA Modification System, which produces agents with a high percentage of stem cell memory cells. These cells are able to reconstruct T-cell subsets, such as effecter T cells, which play a key role in eliminating cancer cells. Additionally, the higher composition of stem cell memory cells is hypothesized to be able to potentially overcome challenges associated with earlier-generation CAR T-cell therapies, according to the company.

onclive.com/view/fda-lifts-...

Some information from the company's website:

P-PSMA-101

This is our first solid tumor autologous CAR-T product candidate targeting prostate-specific membrane antigen, or PSMA, being developed to treat patients with mCRPC. In preclinical studies, P-PSMA-101 has demonstrated elimination of tumor cells to undetectable levels in 100% of animals, with only one incidence of relapse in the lower dose. To our knowledge based on published literature, no other product candidate has shown complete solid tumor elimination in this preclinical model. We initiated a Phase 1 clinical trial with patient dosing in May of 2020.

poseida.com/pipeline/#carts...

and finally, the clinical trial information--STILL RECRUITING:

clinicaltrials.gov/ct2/show...

Lastly, the discovery of a gene signature that indicates whether localized prostate cancer will metastasize. Sixteen genes known as META-16 have been identified as the cause for metastasis, and will be evaluated for targeted therapy.

sciencedaily.com/releases/2...

The Science is Coming !!! There are 301 clinical trials listed at NCI and there are more than that, so everyone keep your eyes peeled and please report. Adios Amigos...

Don Pescado

[cesces]

"Lastly, the discovery of a gene signature that indicates whether localized prostate cancer will metastasize. Sixteen genes known as META-16 have been identified as the cause for metastasis, and will be evaluated for targeted therapy."

Very very very interesting.

It will be interesting when such tests become generally available.

[Fanger1]

Thank you for the info "complete solid tumor elimination in this preclinical model"!!! 🐟🤙

[NPfisherman in reply to Fanger1]

Indeed, I know some disregard "mouse studies" but 100% elimination at the higher dose of ALL solid tumors to an "undetectable" level with only one relapse at a lower dose is impressive. If someone were in trouble, this is one trial I would take a serious look at for help...

Fish