Iovance Biotherapeutics Inc.’s faith in tumor-infiltrating lymphocyte (TIL) therapy lifileucel was further proven by the Jan. 23 acquisition of worldwide rights from Clinigen Ltd. to Proleukin (aldesleukin), an IL-2 product used to promote T-cell activity after infusion of TILs. Terms call for San Carlos, Calif.-based Iovance to pay Clinigen, of Burton Upon Kent, U.K., £166.7 million (US$$206.1 million) right away and a £41.7 million milestone payment upon first approval of lifileucel in advanced melanoma, plus double-digit global royalties for Clinigen.
Albeit with complaints and provisos, the U.S. FDA’s Antimicrobial Drugs Advisory Committee (ADAC) rubber-stamped Cidara Therapeutics Inc.’s rezafungin, an injectable treatment for candidemia and invasive candidiasis (IC) in adults. Panelists were asked to vote on a single question: “Is the overall benefit-risk assessment favorable for the use of rezafungin for treatment of candidemia/IC in adults with limited or no alternative treatment options?” The balloting turned out 14 yes, one no.
Eli Lilly and Co.’s complete response letter (CRL) from the U.S. FDA relating to accelerated approval of Alzheimer’s disease (AD) candidate donanemab set off a round of speculation regarding not only what the move might mean for the pharma giant but also for others in the embattled therapeutic space and beyond. The answer, if you believe analysts: not much.
Upcoming catalysts from Annexon Biosciences Inc. put some joy into shares as the firm talked up its prospects during the recent J.P. Morgan Healthcare Conference, where attendees heard Jan. 8 about the news ahead with C1q protein complex inhibitor ANX-005 in Huntington’s disease (HD) as well as progress in Guillain-Barre syndrome (GBS), and more. The stock (NASDAQ:ANNX) enjoyed a 43% stock boost in the days after JPM, rising from $4.79 on Jan 8 to $6.84 on Jan. 13.
Irlab Therapeutics AB’s phase IIb exploration of the dopamine D3-receptor with the Ipsen SA-partnered oral antagonist mesdopetam in Parkinson’s disease (PD) levodopa-induced dyskinesia (LID) fell short in terms of the primary endpoint, but the company is holding out hope. Mesdopetam missed the primary endpoint of change in daily hours of “on” time – periods of adequate PD control – without troublesome dyskinesia as shown in patient diaries, the company said.
An already-intrigued Wall Street appreciated Relay Therapeutics Inc.’s Jan. 10 update during the J.P. Morgan Healthcare Conference (JPM), where the company detailed progress across its development efforts, including those with RLY-4008, an oral small-molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2), in the works for patients with FGFR2-altered cholangiocarcinoma (CCA) and other cancers. Shares of the Cambridge, Mass.-based firm (NASDAQ:RLAY) ran up by about 38%, or $6, in the five days ahead of Jan. 13. The stock closed Jan. 17 at $20.45, down 32 cents.
The accelerated approval by the U.S. FDA of Immunogen Inc.’s landmark antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx) injected further oomph into the NaPi2b space, where a handful of developers are due to yield important data shortly. In play are such names as Mersana Therapeutics Inc. and Zymeworks Inc., encouraged by historical – if not entirely successful – efforts by giant Roche Holding AG.
Although strides have been made in the space, biopharma’s hunt for a wider net to cast in vaccines for pneumococcal disease has recruited the likes of Vaxcyte Inc., GSK plc and Merck & Co. Inc., each racing for a candidate with improved valence.
Alpine Immune Science Inc.’s update in its earnings report Nov. 14 on its ALPN-303 program added more intrigue to the notion of targeting B cell cytokines B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) together in lupus, as other players are trying the dual approach as well, including China’s Remegen Co. Ltd. and Vera Therapeutics Inc.<
Since the advent of COVID-19 mRNA vaccines, the space has steadily grown hotter, a situation on which Anima Biotech Inc. has capitalized by way of a potential $580 million-plus deal with Abbvie Inc. to deploy mRNA biology modulators for three targets across oncology and Immunology.
