Silicon Valley-based Social Capital and New York investor Suvretta Capital have priced upsized IPOs for four new special purpose acquisition companies (SPACs), each intended to address what founders Chamath Palihapitiya and Kishen Mehta described as "suboptimal" outcomes for biotech IPOs of late. Each blank check company, Biotech SPAC Social Capital Suvretta Holdings Corp. I, II, III, and IV, will be funded by a $220 million offering, selling shares at $10 each. They intend to invest in neurology, oncology, immunology, as well as diseases of the heart, kidney, endocrine system and blood.
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans.
Shares of Sensei Biotherapeutics Inc. (NASADQ:SNSE) fell 16% to $9.10 on June 29 after an announcement by President and CEO John Celebi that the antigen display technology used in its prior lead candidate, SNS-301, "is suboptimal for use in an active cancer vaccine." A phase I/II trial evaluating it will be discontinued, he said. Now, work on a next-generation vaccine, SNS-401-NG, and the monoclonal antibody SNS-VISTA will take precedence in a portfolio reprioritization at the company, with IND-enabling studies for the anti-VISTA program planned to start by the end of 2021 and for the next-gen vaccine in second half of 2022.
Top-line data from a phase II trial of Italfarmaco SpA's givinostat in men with Becker muscular dystrophy found it failed to affect a significant change in total muscle fibrosis vs. placebo, the study's primary endpoint. But whether the outcome reflected a shortcoming of the drug or a function of the rare condition's clinical profile remained uncertain, with the company placing its bets on the latter.
Maintaining momentum for a rush of 2021 IPOs already on pace to beat 2020's record number, new offerings from Graphite Bio Inc., GH Research plc and Elevation Oncology Inc. raised nearly $500 million altogether on Friday. While shares of the first two fared well, climbing in their debuts, Elevation's shares (NASDAQ:ELEV) fell from $16 debut to $11.44 at the close, a 28.5% decline.
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans.
Tvardi Therapeutics Inc., a company targeting a protein essential to cancer cells' survival and immune evasion, closed a $74 million series B financing. The round will help it advance candidates through multiple midstage trial readouts in cancer and fibrosis, the Houston-based company said.
Just days after Hifibio Therapeutics Inc. closed a $75 million series D financing, Fibrogen Inc. has agreed to pay the antibody specialist $25 million up front and as much as $1.1 billion in milestones for rights to multiple preclinical programs for autoimmune diseases and cancer. The deal includes exclusive rights to Galectin-9 programs, in which the lead asset is expected to enter clinical development in the first quarter of 2023, and options to license all assets in Hifibio's CXCR5 and CCR8 programs.
Gene therapy specialist Uniqure N.V. said Tuesday that, with confidence inspired by new 52-week data on its investigational hemophilia B therapy, etranacogene dezaparvovec, it plans to submit a BLA for the program with partner CSL Behring LLC in first quarter of 2022. Uniqure meanwhile has moved to acquire Corlieve Therapeutics SAS and its lead program to treat temporal lobe epilepsy, the most common form of focal epilepsy. The acquisition, worth up to €250 million (US$297.3 million) for Corlieve, includes €46.3 million cash up front.
Shares of Vir Biotechnology Inc. (NASDAQ:VIR) and Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) each rose modestly on June 21 as both delivered positive updates on their COVID-19 programs. Vir and its partner, Glaxosmithkline plc, shared final clinical data confirming the efficacy of their monoclonal antibody therapy, sotrovimab, following an FDA emergency use authorization for the therapy last month. Cumberland announced five case studies in which its antibiotic, Vibativ (telavancin), successfully treated hospital-acquired and ventilator-associated bacterial pneumonia in COVID-19 patients.
