GSK and Wave Life Sciences to Collaborate on Oligonucleotide Therapeutics

GSK and Wave Life Sciences, a US-based clinical-stage genetic medicines company, have entered into a strategic collaboration to advance oligonucleotide therapeutics focusing on novel genetic targets. Oligonucleotides are short strands of DNA or RNA that can reduce, restore, or modulate RNA through several different mechanisms. The collaboration includes Wave’s preclinical RNA editing program that targets alpha-1 antitrypsin deficiency (AATD), WVE-006.

According to a Dec. 13, 2022 company press release, the collaboration comprises two main components: a discovery collaboration and a late-phase development collaboration. In the discovery collaboration component, GSK can advance up to eight programs and Wave can advance up to three programs. In addition to these programs, GSK receives the exclusive global license for Wave’s preclinical program WVE-006. The discovery collaboration has an initial four-year research term and combines GSK’s insights from human genetics and its global development and commercial capabilities with Wave’s proprietary discovery and drug development platform, PRISM.

The second component of the collaboration involves bepirovirsen, an investigational antisense oligonucleotide for the potential treatment of chronic hepatitis B infection, and GSK4532990, a small interfering RNA (siRNA) oligonucleotide. Bepirovirsen is now entering Phase III trials, and GSK4532990 is moving toward Phase II trials for non-alcoholic steatohepatitis (NASH).

Under the agreement, Wave will receive an upfront payment of $170 million, including a cash payment of $120 million and a $50 million equity investment. Additionally, for the WVE-006 program, Wave is eligible to receive up to $225 million in development and launch milestone payments as well as up to $300 million in sales-related milestone payments. The company is also eligible to receive tiered sales royalties. After Wave completes the first-in-patient study, development and commercialization responsibilities will transfer to GSK.

Furthermore, for each of GSK’s eight collaboration programs, Wave will be eligible to receive up to $130 million–$175 million in development and launch milestones and $200 million in sales-related milestones as well as tiered sales royalties. Wave will be responsible for leading all preclinical research for GSK and Wave programs up to investigational new drug (IND)-enabling studies. Meanwhile, GSK collaboration programs will transfer to GSK for IND-enabling studies, clinical development, and commercialization.

“Oligonucleotide therapeutics are becoming a mainstream modality, and this collaboration will enable us to use our leading position in human genetics and genomics to advance novel oligonucleotide therapies. Pairing GSK's genetic expertise with the best-in-class PRISM platform enables us to accelerate drug discovery for newly-identified targets, by matching target to modality. The addition of WVE-006 complements more advanced, clinical-phase oligonucleotides in our pipeline, including bepirovirsen for chronic hepatitis B and GSK4532990 for [NASH],” said Tony Wood, president and chief scientific officer, GSK, in the press release.

“For the past decade, Wave has been building a unique oligonucleotide platform that combines novel chemistry with the means to optimally address disease biology through multiple therapeutic modalities. In 2022, we started to deliver on the promise of our platform with the first data showing translation in the clinic for our next-generation stereopure PN-chemistry containing candidates. Now, with our GSK collaboration, we are excited to leverage their expertise in genetics to continue building a differentiated oligonucleotide pipeline, with a focus on our … RNA editing and upregulation capability,” said Paul Bolno, president and CEO, Wave Life Sciences, in the release.

Source: GSK