Jan. 10 Company Quick Takes: Nektar gains on expanded BMS deal; plus Nurix-Sanofi, Amunix-Roche, Sorrento, Alderaan, Keytruda, Akari, Moderna
BMS, Nektar adding more combo trials to bempeg/Opdivo deal
Bristol-Myers Squibb Co. (NYSE:BMY) and Nektar Therapeutics (NASDAQ:NKTR) will start two new registrational trials under an expanded partnership in which they are developing Nektar's bempegaldesleukin (NKTR-214) in combination with BMS's PD-1 inhibitor Opdivo nivolumab. The partners will conduct pivotal studies of the doublet to treat adjuvant melanoma and muscle-invasive bladder cancer, as well as a Phase I/II trial of the pair plus axitinib as first-line therapy for renal cell carcinoma (RCC). Under the companies' prior deal, they are studying the bempeg/Opdivo combination in registrational studies to treat melanoma, metastatic bladder cancer and RCC in first-line settings. Nektar rose $5.33 (25%) to $26.92 Friday.
Nurix, Sanofi in protein degradation deal
Nurix Therapeutics Inc. and Sanofi (Euronext:SAN; NASDAQ:SNY) partnered to develop protein degradation therapies for three targets and multiple diseases. Sanofi, which has an option to license compounds for two additional targets, has exclusive rights to the candidates and is responsible for clinical development and commercialization. Nurix, which has a co-development and co-promotion option to up to two products in the U.S., will receive an upfront payment of $55 million and is eligible for $2.5 billion in milestones, plus royalties (see “Nurix: Two Sides of Protein Degradation”).
Roche to use Amunix’s peptide tech in drug development
Amunix Pharmaceuticals Inc. licensed use of XTEN, its unstructured polypeptide technology platform, to Roche (SIX:ROG; OTCQX:RHHBY) to discover and develop non-oncology therapies against undisclosed targets. Amunix will receive $40 million up front and is eligible for $1.5 billion in milestones, plus royalties.
Sorrento rises after disclosing takeout bid
Immuno-oncology company Sorrento Therapeutics Inc. (NASDAQ:SRNE) said Friday that a private equity firm has proposed to acquire a majority or all of its outstanding shares for up to $7 each. Its board is reviewing the non-binding proposal. Sorrento shares gained $1.35 (40%) to $4.76 Friday.
French biotech Alderaan Biotechnology debuted with €18.5 million ($20.7 million) in a series A round led by Advent France Biotechnology and new investor Medicxi. Alderaan is developing mAbs against CD25 to deplete T regulatory cells for cancer, as well as a program targeted at activation of natural killer cell receptor CD160, both of which are in preclinical testing.
Keytruda approved for non-muscle invasive bladder cancer
Merck & Co. Inc. (NYSE:MRK) said FDA approved an sBLA for Keytruda pembrolizumab to treat Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) in patients with carcinoma in situ who are ineligible for or have not undergone cystectomy. Merck said the antibody is the first anti-PD-1 drug approved for the indication.
Akari gains on nomacopan data
Akari Therapeutics plc (NASDAQ:AKTX) gained $0.44 (25%) to $2.17 after reporting interim data from the Phase III CAPSTONE study showing nomacopan met the primary endpoint of hemoglobin stabilization and avoidance of blood transfusion in all four evaluable paroxysmal nocturnal hemoglobinuria patients.
Moderna discloses more Phase I data, launches Phase II study of CMV vaccine
Moderna Inc. (NASDAQ:MRNA) announced additional Phase I data showing its cytomegalovirus vaccine mRNA-1647 boosted neutralizing antibody titers in both seronegative and seropositive participants, and said it dosed the first patient in its Phase II study of the vaccine with three month interim data expected 2H20; a pivotal Phase III study is planned to start in 2021. Viral vaccines have become a key focus for the mRNA platform company (see "Moderna's Focus on mRNA Vaccines").
Targets: CD25 (IL2RA) - Interleukin-2 receptor α chain; PD-1 (PDCD1; CD279) - Programmed cell death 1