Larimar Therapeutics has completed its rolling BLA for nomlabofusp, a frataxin replacement fusion protein, seeking accelerated approval based on skin frataxin as a novel surrogate endpoint. The company expects a potential US approval in mid-2027.
|Articles|April 1, 2020
FibroGenesis Announces Provisional Patent for a Fibroblast Therapy for COVID-19 Treatment
Author(s)BioPharm International Editors
The patent includes the use of fibroblast cells and adjuvants such as peptides and hydroxychloroquine, which fuels the assembly of natural interferon to overpower the virus.
Advertisement
FibroGenesis, a regenerative medicine company located in Houston, TX, announced on April 1, 2020 that it has filed a provisional patent for peptides and adjuvants for augmentation of fibroblast therapy for COVID-19 treatment.
According to a company press release, the patent includes the use of fibroblast cells and adjuvants such as peptides and hydroxychloroquine, which fuel the assembly of natural interferon to overpower the virus. The patent also features methods for preventing infection, propagation, and pathology as a result of COVID-19.
"As we continue our accelerated preclinical program, we are discovering the superiority of fibroblasts over mesenchymal stem cells and the data is leading us toward multiple treatment options for the patient," said Tom Ichim, PhD, chief scientific officer of FibroGenesis, in the press release. "By including adjuvants such as peptides and hydroxychloroquine in our treatment we've seen added potency."
"We are working to expand our discoveries in the lab and accelerate the clinical development into a cure for COVID-19 using our advanced fibroblast cell therapy," added Pete O'Heeron, CEO, FibroGenesis, in the press release. "The war we are fighting, with this invisible enemy, will likely require a cocktail-based approach for victory. At FibroGenesis we are following the lead of Thomas Edison when he discovered the filament for the lightbulb; we are testing as many therapeutic combinations as possible, in search of the most efficient and effective cure. Enhancing the natural production of interferon combined with our previous work can be seen as a possible advancement toward a cure."
Source:
Advertisement
Related to this article
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
Detalimogene voraplasmid produced a 56% complete response rate in BCG-unresponsive bladder cancer, with an estimated 43% of responses lasting a year.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
4
Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial
5