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.
Photys Therapeutics Inc. raised a $75 million series A financing to develop phosphorylation-inducing chimeric small-molecule medicines to fix dysfunctional proteins. Photys, of Cambridge, Mass., was founded by the Longwood Fund and Amit Choudhary of Brigham and Women’s Hospital and the Broad Institute of MIT and Harvard University.
Akston Biosciences Corp. emerged from a successful small company that was sold to a pharma major. For Todd Zion, that’s a back-to-basics move that suits him just fine. Zion co-founded Smartcells Inc. in 2003 with technology developed at the Massachusetts Institute of Technology. The company went on to develop the once-daily injectable self-regulating insulin product, Smartinsulin, and sold it to Merck & Co. in what was at the time one of the largest preclinical pharmaceutical acquisitions ever.
Arsenal Biosciences Inc. closed on an oversubscribed $220 million series B financing so it could continue developing its programmable cell therapy research programs and its candidates for treating solid tumor malignancies. Arsenal’s lead program is AB-1015 for treating ovarian cancer.
Ocean Biomedical Inc., a company with preclinical programs in oncology, fibrosis, infectious disease treatments and vaccines, is poised to go public via a merger with Aesther Healthcare Acquisition Corp., a special purpose acquisition company (SPAC).
It’s another setback for Jounce Therapeutics Inc. Top-line data from the phase II Select study of vopratelimab, the company’s lead candidate, combined with pimivalimab vs. pimivalimab alone in 69 patients missed its primary endpoint of mean tumor change when averaged over nine and 18 weeks. The clinical trial participants were immunotherapy naïve, immunotherapy TISvopra biomarker-selected, second-line non-small-cell lung cancer (NSCLC) patients.
Sirnaomics Ltd. went five for five in its study of treating cutaneous basal cell carcinoma. Five of five patients in a cohort of the open-label, dose-escalation phase II study of STP-705, composed of two sIRNA oligonucleotides targeting transforming growth factor beta 1 and cyclooxygenase-2, had a 100% complete response.
Having initiated its first two clinical trials in non-small-cell lung cancer since January, Nuvalent Inc. said it expects to unveil preliminary dose-escalation data before year-end. Ahead of the data, Nuvalent's phase I/II Arros-1 trial evaluating NVL-520, a kinase inhibitor, in patients with advanced ROS1-positive NSCLC and other solid tumors, continues to enroll participants.
Three of the biggest COVID-19 vaccine developers are heading into a legal battle. Moderna Inc. said it has filed lawsuits alleging the Pfizer Inc.-Biontech SE Comirnaty vaccine infringes patents Moderna filed between 2010 and 2016 that cover its mRNA technology. Pfizer and Biontech “unlawfully” copied the technology without permission, according to Moderna.
As Novartis AG works to streamline the company and finalized a long-considered plan to separate its Sandoz Inc. business by creating a standalone company, it temporarily stopped dosing in a study of branaplam for treating Huntington’s disease. Several findings from the phase IIb study suggested the presence of peripheral neuropathy in some participants. An independent data monitoring committee recommended the dosing halt but fell short of recommending the study be terminated. The VIBRANT-HD steering committee agreed with the committee’s recommendation.
