LONDON – A follow-up study of participants in the phase II/III U.K. trial of Astrazeneca plc’s COVID-19 vaccine has shown it remains effective against the new B.1.1.7 variant of SARS-CoV-2. Between Oct. 1 – Jan. 14, the researchers at Oxford University who co-developed the vaccine, used swabs taken from volunteers with both symptomatic and asymptomatic infections to work out which variant of the virus had infected them after receiving either the vaccine or control. They found the level of protection against symptomatic infection was similar for both variants. That is despite lower neutralizing antibody titers in people infected with B.1.1.7, compared to those infected with the original variant against which the vaccine was designed.
Filing plans intact after DMD miss by PTC’s Translarna in Study 405
PTC Therapeutics Inc. continued down its long U.S. regulatory road with Translarna (ataluren) for patients with nonsense mutation Duchenne muscular dystrophy. The South Plainfield, N.J.-based firm said Study 045 fell short of statistical significance on the primary endpoint of change in dystrophin expression (6.56% increase as measured by electrochemiluminescence in the intent to treat population; p=0.24). The company said it plans to file for approval based on the totality of data collected with the compound so far. The ongoing Study 401 – not due to report until the third quarter of 2022 – could provide a “backstop” for full FDA clearance. CEO Stuart Peltz outlined during a conference call with investors the argument that PTC will make with regulators, based on the drug’s biological and clinical effects, as well as real-world evidence. Translarna is believed to interact with the ribosome, enabling it to read through premature nonsense stop signals on mRNA and thereby allow the cell to produce a full-length, functional protein.
Lucky seven: Biotech IPOs set a single-day record
The week finishes with flurry of biotech IPOs, seven of them, a record number in a single day, according to BioWorld stats. The companies are anticipating total gross proceeds of about $1.06 billion. Eyeing gross proceeds of $258 million, T-cell receptor developer Immunocore Holdings plc is the biggest of the bunch, and its stock (NASDAQ:IMCR) had rocketed 54% upward at midday to about $40 per share. The second largest IPO comes from Bolt Biotherapeutics Inc., a clinical-stage immune-oncology company, which anticipates gross proceeds of $230 million. The company’s stock had bolted 26% upward at midday. Last year was a record year for IPOs as 106 new offerings were completed and raised $22.5 billion, more than double the previous record of $10.7 billion set in 2018.
Feverish financings: The frenzy continues in 2021
Biopharma financings have done it again. Breaking all kinds of records in January, the year appears to be off to an extraordinary start. The industry raised $10.15 billion during the month through a total of 158 financings. This represents a significant climb above the previous records. The first four days of February have already added another 33 financings worth $3.75 billion. If the momentum continues, the year could raise as much or even surpass the $134.5 billion top amount raised for all of 2020.
Newco news: Covicept lands Forbion backing for mission to tackle RNA viruses
Covicept Therapeutics Inc., a new San Diego-based company focused on developing a small molecule to inhibit the replication and spread of SARS-CoV-2 and other RNA viruses, has launched with $2.3 million in seed funding from European VC firm Forbion. The company, spun out of research at the University of California, San Diego, aims to initiate a first clinical study in the second half of 2021.
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Achilles, Actinogen, AIM Immunotech, Alexion, Alphageneron, Assertio, Astrazeneca, Biovaxys, Celltrion, Covaxx, Curevac, Diamond, Eyepoint, GHP Noetic Science-Psychedelic, Gilead, Hyloris, I-Mab, Inmed, Innocare, Johnson & Johnson, Multimmune, Neurocrine, Novavax, Oncocyte, Onxeo, Orchard, Pfizer, Pharnext, PTC, Purna Female Healthcare, Regeneron, Silence, Spark, Spero, Tryp, Veracyte