Modex Therapeutics Inc., owned by Opko Health Inc., signed an exclusive worldwide license and collaboration agreement with Merck & Co. Inc. outside the U.S. for work with MDX-2201, Modex’s preclinical nanoparticle vaccine candidate targeting Epstein-Barr virus. Opko bags an up-front payment of $50 million and is eligible for milestone rewards associated with progress in the development and commercialization of up to $872.5 million, plus royalties on global sales. Based on Modex’s ferritin platform, the vaccine presents antigens from four viral proteins involved in viral entry into host cells. After spiking to $1.28, shares of Opko (NASDAQ:OPK) were trading midday at $1.13, down 4 cents.
Redx halts biliary tract cancer treatment monotherapy program
Top-line results of a phase II study of RXC-004, a porcupine inhibitor for treating Wnt ligand-dependent cancers, are not good enough to continue development as a monotherapy for biliary tract cancer, according to Redx Pharma plc. Despite the monotherapy arm not hitting progression-free survival at six months, the study continues with its other treatment arm, using Keytruda (pembrolizumab, Merck & Co. Inc.). Data from that arm are set for the second half of 2023. In late February, Redx and Jounce Therapeutics Inc. agreed to merge in an all-share transaction of $425 million. The merged company, Redx Inc., will take up Jounce’s Nasdaq listing but will have its headquarters in the U.K., where the majority of operations will be based. In the meantime, Redx closed out March 8 on the London exchange 18% lower at £33.50 (US$39.66) per share.
Covis makes second offer to withdraw Makena
Noting that the FDA had rejected its previous proposal last year to voluntarily withdraw Makena from the U.S. market, Covis Pharma BV again this week offered to voluntarily withdraw the drug, which is prescribed to reduce the risk of preterm birth. However, the company asked the agency “to allow for an orderly wind-down that would best serve the interests of the patients,” according to a letter from Covis’ attorney to FDA Commissioner Robert Califf and Namandjé Bumpus, the agency’s chief scientist. The FDA recommended withdrawing Makena (hydroxyprogesterone caproate) and its generics in 2020 because of a failed confirmatory trial, but following a protracted hearing process, Califf has yet to issue a final decision on the withdrawal.
CFIUS finally clears merger with F-star and Invox
After placing a temporary hold on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd., citing “unresolved national security risks,” the Committee on Foreign Investment in the United States (CFIUS) has finally cleared the merger to proceed. Invox announced its plans to acquire F-star in June 2022 for $161 million to build up the presence of its parent company, Sino Biopharm Ltd., outside of China. Established in 2021 in the U.K., Invox is Sino Biopharm’s international expansion platform and is focused on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics.
Prenatal gene-editing treatment offers curative potential for serious inherited disease
The researcher who pioneered prenatal surgery to correct neural tube defects has turned her attention to using CRISPR-edited gene therapies to correct severe monogenic diseases in utero. The availability of prenatal genetic diagnosis and advances in treating fetuses, and also in gene therapy/gene editing, make it possible to repair almost any defect in the genetic code. At the same time, there is a clear rationale for intervening before birth, Tippi MacKenzie, professor of surgery at UCSF’s School of Medicine, told attendees of the third International Human Genome Editing Conference in London on March 7.