“Big genomics” specialist Replay Holdings LLC has unveiled the first of four satellite genomic medicine companies it is forming to apply its high capacity herpes simplex viral (HSV) vector to next generation gene therapies. Eudora Therapeutics will specialize in inherited retinal eye diseases. It arrives on the scene with programs targeted at retinitis pigmentosa, Stargardt disease and Usher syndrome type 1B.
With roughly a decade of work behind it, Valitor Inc. is ready to put its Multivalent Polymer (MVP) platform to the test, having recently announced its presence with a $28 million series B round and appointment of biopharma veteran Steven Lo as CEO. The next step is IND-enabling studies for its lead ophthalmology candidate, with clinical testing slated to start in 2024.
Eye diseases specialist Oculis SA is set to add $200 million to its balance sheet by merging with the European Biotech Acquisition Corp., a special purpose acquisition company (SPAC) formed to invest in the European life sciences industry.
Over the next two weeks, the team at NGM Biopharmaceuticals Inc. will be digging through the data from its phase II trial of complement 3 inhibitor NGM-621 in patients with geographic atrophy (GA) secondary to age-related macular degeneration, following reports of a top-line miss Oct. 17 and a severe reaction from investors, who sent shares (NASDAQ:NGM) plummeting 70.5% to close at $3.41.
Surrozen Inc.’s back-end-loaded deal with Boehringer Ingelheim GmbH for the preclinical frizzled class receptor 4 agonist SZN-413 takes aim at vascular function in retinal diseases. The arrangement brings an up-front payment to South San Francisco-based Surrozen of $12.5 million, plus up to $586.5 million in potential development, regulatory and commercial milestone rewards, along with mid-single-digit to low-double-digit royalties on sales. After an initial period of joint research, Boehringer, of Ingelheim, Germany, will take over development and commercial responsibilities.
Trefoil Therapeutics Inc. has reported promising data from a phase II trial suggesting its engineered version of fibroblast growth factor 1, TTHX-1114, may speed and improve recovery of patients with Fuchs endothelial corneal dystrophy who are undergoing a surgical procedure called Descemet stripping only.
The U.S. FDA approved Santen Pharmaceutical Co. Ltd.’s and UBE Industries Ltd.’s Omlonti (omidenepag isopropyl) ophthalmic solution for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. It is the second FDA-approved product from Japan-based Santen in the last 15 months for patients in the U.S. with vision conditions.
It took resolving issues from two complete response letters for Fennec Pharmaceuticals Inc. to finally land U.S. FDA approval of Pedmark. The injectable formulation of sodium thiosulfate is for reducing the risk of platinum-induced ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors. Approval of the NDA arrived Sept. 20, three days before its Sept. 23 PDUFA date.
Ocular gene therapy firm Sparingvision SA raised €75 million (US$75 million) in a series B round to fund its transition to clinical development. The company is about to move its lead program, the mutation-agnostic gene therapy SPVN-06, into a phase I trial in retinitis pigmentosa (RP). “We are in the middle of the regulatory submission process,” CEO Stéphane Boissel told BioWorld.
Success in two pivotal studies of high dose Eylea (aflibercept) has significantly strengthened Regeneron Pharmaceuticals Inc.’s market position. But the company will face stiff competition from biosimilars and Roche Holding Group’s recently approved Vabysmo. After struggling for much of the year, the Tarrytown, N.Y.-based company’s stock (NASDAQ: REGN) rose about 20% this week. It closed 2% upward on Sept. 9 at $724.32 per share.
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