GSK is also enriching its siRNA hold by paying $40 million upfront to two oligonucleotide therapies of Frontier Biotechnologies.
The companies did not provide much information about the candidates and their targets, but revealed that Frontier has already put one of them in a phase 1 study in China. According to a Feb. 24 release, the biotech is undertaking IND-enabling activities for the other preclinical drug.
Upon the completion of phase 1 and IND activities, GSK shall assume responsibility for clinical development, regulatory submissions, and commercialization activities worldwide.
In addition to the initial cash outlay of $40 million, GSK has to pay a maximum of 963 million in milestones and tiered royalties on the possible net sales all over the world.
In an announcement, the Frontier CEO, Dong Xie, said that the present morning agreement is a sign of increased appreciation of our research and development potential.
The CEO added that this deal will establish a strong base upon which Frontier Biotech will build by enhancing strong international partnerships, speeding up the value transformation in its pipeline, and, possibly, hitting the commercialization stage.
In September, Frontier presented results of animal trials on two of its siRNA candidates, dubbed FB7011 and FB7013, that both target MASP-2 as a possible therapy in a chronic immune kidney disease known as IgA nephropathy. The company is most famously recognized in Aikening, which is the first anti-HIV drug in China.
GSK does not have a license for oligonucleotides, which are short strands of artificial DNA or RNA, that can lessen, heal, or change RNA by use of a variety of mechanisms. Bepirovirsen, an oligonucleotide pipeline that is championed by the British pharma, a partner with Ionis Pharmaceuticals, has recently passed two phase 3 trials as a possible functional cure against the hepatitis B virus infection.
Other oligo portfolio holdings are a partnership with Arrowhead Pharmaceuticals on fatty liver disease, multiple properties of Wave Life Sciences, and the platform of Elsie Biotechnologies. Most recently, GSK has reportedly paid to cover upfront rights to a siRNA oligonucleotide in phase 1 development of chronic obstructive pulmonary disease, but acquired these rights through Empirico.
Kaivan Khavandi, the head of respiratory, immunology, and inflammation R&D at GSK, stated that Frontier as adding two potential first-in-class oligonucleotide therapies, both with substantial potential to positively impact patient outcomes across a range of kidney diseases.
GSK Expands siRNA Pipeline Through Major Licensing Agreement
Pharmaceutical giant GSK has struck a significant licensing agreement valued at up to $1 billion to acquire exclusive global rights to two siRNA (small interfering RNA) therapeutic candidates from a Chinese biotech partner. The deal marks a strategic move for the company to deepen its involvement in gene silencing therapies and broaden its portfolio in cutting-edge medicine.
What the Deal Includes
Under the terms of the agreement, GSK will obtain worldwide development, manufacturing, and commercialisation rights to both siRNA drug candidates. One of the assets is already at the Investigational New Drug (IND) stage, while the other is still a preclinical candidate.
The Chinese biotech will continue to advance the two programmes initially — conducting a Phase I clinical trial for the IND-stage asset and completing IND-enabling studies for the preclinical drug — before handing over global responsibilities to GSK.
GSK will pay an upfront fee as part of the agreement, with additional milestone payments tied to development, regulatory approvals, and commercial achievements. The total deal value could reach up to $1 billion, including tiered royalty payments after product launches.
