This week: SNIPR Biome (Copenhagen, Denmark) reported positive interim results for its CRISPR-based microbial gene therapy targeting E. coli; the US FDA accepted Iovance Biotherapeutics’ (CA, USA) Biologics License Application for their advanced melanoma tumor-infiltrating lymphocyte therapy; and AVROBIO (MA, USA) has sold its cystinosis gene therapy program to Novartis (Basel, Switzerland) for US$87.5 million.
The news highlights:
- SNIPR Biome reports positive clinical interim results for CRISPR-based microbial gene therapy
- US FDA accepts Iovance’s Biologics License Application for advanced melanoma cell therapy
- AVROBIO sells cystinosis gene therapy program to Novartis for US$87.5 million
SNIPR Biome reports positive clinical interim results for CRISPR-based microbial gene therapy
SNIPR Biome, the company pioneering CRISPR-based microbial gene therapy, has announced positive interim results from its Phase I clinical trial of SNIPR001. SNIPR001 is a novel CRISPR-Cas therapeutic that targets antibiotic-resistant E. coli in the gastrointestinal tract, which can cause life-threatening infections in vulnerable patients. The study of 36 healthy individuals found that the drug was well tolerated and successfully lowered E. coli levels in the gut.
"We are thrilled with these positive interim results from our Phase 1 clinical trial of SNIPR001, which provide clinical validation for this innovative treatment. This is a significant milestone in our mission to develop groundbreaking solutions in the fight against antimicrobial resistance, and we look forward to advancing SNIPR001 through further clinical studies to learn more and ultimately, we hope, to improve patient outcomes," commented Christian Grøndahl, CEO and co-founder of SNIPR Biome.
US FDA accepts Iovance’s Biologics License Application for advanced melanoma cell therapy
Iovance Biotherapeutics , a company that develops tumor-infiltrating lymphocyte (TIL) therapies, has announced that the US FDA has accepted their Biologics License Application for lifileucel, a TIL therapy for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The FDA granted lifileucel Priority Review, a program that expedites the review process for drugs that would significantly improve the safety or effectiveness of treatments for a serious condition. They have assigned 25 November 2023 as the target action date for a decision under the Prescription Drug User Fee Act.
Frederick Vogt, Interim President and CEO of Iovance, commented, “The BLA acceptance is a significant milestone in our mission to deliver lifileucel as the first individualized, one-time cell therapy for a solid tumor. The FDA’s commitment to a six-month Priority Review validates the unmet need and urgency for new treatment options for patients with advanced melanoma who have progressed on or after standard of care therapies.”
AVROBIO sells cystinosis gene therapy program to Novartis for US$87.5 million
Leading clinical-stage gene therapy company AVROBIO, whose main focus is lysosomal disorders, has announced an agreement to sell its investigational hematopoietic stem cell gene therapy program for the treatment of cystinosis to Novartis for US$87.5 million in cash.
“This transaction strengthens AVROBIO’s balance sheet, focuses our pipeline strategy and is a strong endorsement of our HSC gene therapy approach and plato® gene therapy platform,” commented Erik Ostrowski, AVROBIO’s interim CEO and current CFO.
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