CLINICAL AND REGULATORY
European Commission approves BMS’s LAG3 blocker
Six months after approval by FDA, the EC approved Opdualag nivolumab/relatlimab from BMS to treat unresectable or metastatic melanoma with tumor cell PD-L1 expression <1%. Opdualag, a fixed dose combination of relatlimab and the pharma’s marketed PD-1 inhibitor Opdivo nivolumab, is the first drug targeting LAG3 to have received regulatory approval. The EC’s decision is based upon an exploratory analysis of results from the Phase 2/3 RELATIVITY-047 trial in patients with tumor cell expression < 1%, which demonstrated that treatment with the fixed-dose combination of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab more than doubled the median progression-free survival (PFS) compared to nivolumab monotherapy – an established standard of care. No new safety events were identified with the combination when compared to nivolumab monotherapy. The EC decision allows for the use of Opdualag for the first-line treatment of adults and adolescents 12 years of age and older with advanced melanoma and tumor cell PD-L1 expression < 1% in all European Union member states*, as well as Iceland, Liechtenstein, and Norway.
DEALS AND FINANCING
Exelixis and Ryvu to develop STING agonist-based therapies
Exelixis and Poland-based Ryvu Therapeutics will develop targeted therapies using Ryvu’s STimulator of INterferon Gene technology. Exelixis will pay $3 million up front for rights to Ryvu’s small molecule STING agonists, which it will use for targeted therapies including antibody-drug conjugates. Ryvu, which is eligible for milestones and tiered royalties, retains full rights to its STING agonists as stand-alone small molecules.
RNA play RIGImmune debuts with F-Prime’s backing
Founded by Yale University’s Akiko Iwasaki and Anna Marie Pyle, RIGImmune debuted by announcing the acquisition of antiviral company Subintro and an investment from F-Prime Capital. The biotech is developing stemloop RNA therapeutics that selectively activate the innate immune sensor retinoic acid inducible gene I (RIG-I), a cytosolic sensor protein and host surveillance pathway essential to the innate immune response to RNA viruses and tumor DNA. F-Prime’s Nihal Sinha will join RIGImmune’s board; neither the size of F-Prime’s investment nor any amounts paid to Subintro were disclosed. Subintro co-founder Garth Rapeport is a partner at F-Prime.
RayzeBio raises $160 million series D for radiopharmaceuticals
Targeted radiopharmaceuticals company RayzeBio raised $160 million in a series D round co-led by Viking Global Investors, Sofinnova Investments and Wellington Management to advance targeted radiopharmaceuticals for cancers, raising $418 million since beginning operations in August 2020. Fellow new investors Ally Bridge Group, Sands Capital, Laurion Capital Management and Soleus Capital, and an undisclosed global investor participated along with RayzeBio’s existing investors. RayzeBio also hired Abhi Bhat as SVP, discovery; Bhat was SVP and head of R&D at Design Therapeutics.
