In one of the largest private rounds raised by an Italian biotech, Genespire Srl has closed a €46.6 million (US$51.88 million) series B, enabling it to lay the ground for a phase I/II clinical trial of its lead program, Gene-202, and to further develop its proprietary lentiviral vectors. The vectors are designed to be applicable to a range of liver-related metabolic disorders and, as its first indication, the company intends to treat methylmalonic acidemia, a serious genetic condition that results in impaired metabolism of certain amino acids and lipids.
Vicebio Ltd. is funded to take two of its molecular clamp respiratory infection vaccines through phase II development, after raising $100 million in a series B.
For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.
Imcheck Therapeutics SAS’s gamma-delta T-cell activating antibody has become a poster child for the French government’s plan to reduce dependence on imports of biopharmaceuticals by directly supporting domestic development and manufacture of 20 novel products by 2030. The Marseille-based company has been awarded nondilutive public funding of €20.18 million (US$22.4 million) as part of the €54 billion France 2030 strategy, which aims to restore the country’s industrial competitiveness.
Advanz Pharma Ltd. has won a stay on the withdrawal of its primary biliary cholangitis (PBC) drug, Ocaliva (obeticholic acid), after the European Commission (EC) said on Sept. 3 that the conditional marketing approval should be revoked. Following that, London-based Advanz launched a legal challenge, announcing on Sept 5 that the General Court of the EU has temporarily suspended the EC’s decision. As a result, the conditional marketing authorization for Ocaliva remains in place until further notice from the court, and the 7,000 existing patients – and new ones – will still have access to the farnesoid X receptor agonist.
The dark matter of long non-coding RNA (lncRNA) is shades brighter, after the signing of two major deals between biotech pioneers and big pharma in the past week. Haya Therapeutics SA announced Sept. 4 that it has sealed a multiyear agreement with Eli Lilly and Co. to apply its lncRNA platform technology to identify targets in obesity and related metabolic disorders.
The dark matter of long non-coding RNA (lncRNA) is shades brighter, after the signing of two major deals between biotech pioneers and big pharma in the past week. Haya Therapeutics SA announced Sept. 4 that it has sealed a multiyear agreement with Eli Lilly and Co. to apply its lncRNA platform technology to identify targets in obesity and related metabolic disorders.
George Medicines Ltd. has published positive data from two phase III studies showing GMRx2, a low-dose triple-drug combination treatment for hypertension, is superior to dual combinations of its components.
Cumulus Oncology Ltd. is in the thick of raising a $50 million series A round as its model of sourcing novel drug targets emerging from academia, shaping them up for clinical development, and spinning them into startups, gathers pace. At the same time, Nodus Oncology Ltd., the first spinout created around an acquired asset, has just reached in vivo proof of concept with its lead DNA damage response inhibitor, and it, too, is looking to raise a series A to take the program through to the end of phase I.
Microbiotica Ltd. is poised to advance two of its microbiome-derived products into the clinic after securing regulatory approval and fresh finance. The first live bacterial therapeutic, MB-097, will be tested in combination with Keytruda (pembrolizumab) in patients with advanced melanoma who have not responded to treatment with immune checkpoint inhibitors. The second product, MB-310, is a once-daily oral therapy for treating the inflammatory bowel disease, ulcerative colitis.
