GSK and Wave Life Sciences Collaborate on Oligonucleotide Therapeutics

GSK and Wave Life Sciences Collaborate on Oligonucleotide Therapeutics

GSK plc and Wave Life Sciences Ltd., a clinical-stage genetic drugs company, have entered into a strategic collaboration to advance oligonucleotide therapeutics, including the preclinical RNA editing program targeting alpha-1 antitrypsin deficiency (AATD), WVE-006. The four-year discovery collaboration combines GSK’s knowledge of human genetics, as well as its global development and commercial capabilities, with Wave’s drug discovery and development platform, PRISM.

Oligonucleotides are short strands of DNA or RNA that can reduce, restore, or modulate RNA by several different mechanisms. The unique ability of oligonucleotides to address a wide range of genomic targets across multiple therapeutic areas offers new opportunities to treat a range of human diseases, including diseases for which no drugs currently exist or which have historically been difficult to treat. with small molecules or biological products.

Wave’s PRISM platform is the only oligonucleotide platform offering three RNA targeting modalities (editing, splicing and silencing, including siRNA and antisense). Importantly, these modalities incorporate novel chemistry, including PN backbone chemistry and stereochemistry control, to optimize the pharmacological properties of therapeutic oligonucleotides.

The collaboration has two main components. The discovery collaboration that allows GSK to advance up to eight programs and Wave to advance up to three programs. In addition, GSK holds an exclusive worldwide license to Wave’s preclinical program for AATD called WVE-006, which uses Wave’s “AIMer” technology (A to I(G) RNA editing). AATD is an inherited genetic disease that affects both the lungs and the liver with limited treatment options. Wave’s WVE-006 is a first-in-class RNA editing therapy designed to treat the liver and lung manifestations of the disease.

Wave will receive $170 million upfront, which includes a cash payment of $120 million and an equity investment of $50 million.

For the WVE-006 program, Wave is eligible to receive up to $225 million in development and launch milestone payments and up to $300 million in milestone payments, plus royalties on sales . Development and commercialization responsibilities will transfer to GSK once Wave completes the first patient study.

For each of GSK’s eight collaboration programs, Wave will be eligible to receive up to $130-175 million in development and launch stages and $200 million in sales stages, plus royalties on sales. Wave will lead all preclinical research for the GSK and Wave programs through to enabling studies of investigational new drugs (INDs). GSK’s collaborative programs will be transferred to GSK for IND studies, clinical development and commercialization. The collaboration includes an option to extend the duration of the research for up to three additional years, thereby increasing the number of programs available to both parties.

Tony Wood, President and Chief Scientific Officer of GSK, said, “Oligonucleotide therapies are becoming a mainstream modality, and this collaboration will allow us to use our leadership position in human genetics and genomics to advance new oligonucleotide therapies. Combining GSK’s genetic expertise with the best-in-class PRISMTM platform allows us to accelerate drug discovery for newly identified targets, by matching target to modality. The addition of WVE-006 complements more advanced clinical-stage oligonucleotides in our pipeline, including bepirovirsen for chronic hepatitis B and GSK4532990 for non-alcoholic steatohepatitis (NASH).

Bepirovirsen, an investigational antisense oligonucleotide for the potential treatment of chronic hepatitis B infection, is now entering phase III trials, and GSK4532990, an siRNA oligonucleotide, is advancing to phase II for NASH. WVE-006 brings a third oligonucleotide to GSK’s portfolio that has the potential to be a first-in-class AATD therapy for lung and liver disease and is a well-understood genetic target, contributing to GSK’s pipeline which now represents over 70 % genetically validated.

Paul Bolno, MD, MBA, President and CEO of Wave Life Sciences, said, “Over the past decade, Wave has built a unique oligonucleotide platform that combines new chemistry with the means to treat optimal disease biology through multiple therapeutic modalities. Now, with our collaboration with GSK, we are excited to leverage their expertise in genetics to continue building a pipeline of differentiated oligonucleotides, with a focus on our enhanced RNA editing and upregulation capability. . Additionally, GSK is the ideal partner for our WVE-006 program, given its long history and global reach in respiratory disease. The collaboration significantly extends our cash trail to 2025 and provides the opportunity to achieve important future milestones, providing new resources to provide patients with life-changing medicines.

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