GSK Plc has received US approval for Ojjaara (momelotinib), a Janus kinase inhibitor for the treatment of myelofibrosis patients with anaemia. The authorisation is based on positive results from two Phase 3 trials both of which were designed to show a reduction in manifestations of the disease. Myelofibrosis is a rare blood cancer that can lead to severely low blood counts, including anaemia and thrombocytopaenia.
Yescarta, a chimeric antigen receptor (CAR) T cell therapy, has delivered positive results in a Phase 2 study of patients with relapsed or refractory large B cell lymphoma after one prior therapy. The patients were all ineligible for chemotherapy and autologous stem cell transplantation. Yescarta (axicabtagene ciloleucel) is already approved for several lymphoma indications in the US and Europe.
A Phase 2 trial of a gene therapy for geographic atrophy secondary to dry age-related macular degeneration has been stopped for lack of efficacy, Syncona Ltd, the UK developer, announced on 11 September. This followed a recommendation by the trial’s independent data monitoring committee which concluded that the overall benefit/risk assessment of the therapy didn’t support continuation.
ROME Therapeutics Inc, a US company developing therapies based on the dark genome, has secured $72 million from a Series B round extension bringing the total amount raised up to $149 million. Strategic investors Johnson & Johnson Innovation-JJDC Inc and Bristol Myers Squibb Inc joined the funding syndicate alongside new and existing investors.
In an article published on www.mednous.com on 21 August 2023 entitled SSI Strategy buys NDA Group, the leadership of the new group has been corrected to show that Douglas Locke, Chief Executive Officer of SSI Strategy, has been named CEO of the combined group. A corrected version follows.
Forbion, the European life sciences venture fund, has announced the close of a Series B financing round for Mariana Oncology, a US radiopharmaceutical company with a lead drug candidate targeting small cell lung cancer. In conjunction with the funding, Geert-Jan Mulder, a managing partner of Forbion, will join the board of directors alongside Rebecca Luse from Deep Track Capital which co-led the funding round.
The French start-up company Corteria Pharmaceuticals has raised €65 million in an oversubscibed Series A financing to progress its candidate therapies for heart failure. Announced on 7 September, the financing was co-led by Jeito Capital and Orbimed with participation from the existing investors Kurma Partners, Fountain Healthcare Partners, V-Bio Ventures, Invivo Capital, and Omnes Capital.
Sofinnova Investments has led a $90 million Series C financing round for Star Therapeutics Inc, the proceeds of which will support one of Star’s portfolio companies called Vega Therapeutics. Based in South San Francisco, US, Star is a biotechnology company consisting of subsidiary enterprises which are each focused on developing products based on specific areas of biology.
In addition to Sofinnova, investors in the oversubscribed round included the Qatar Investment Authority, Catalio Capital Management, Agent Capital, Soleus Capital and NYBC Ventures.
The first patient in a trial of a new radiopharmaceutical has been dosed – paving the way for a potentially new treatment for extensive stage small cell lung cancer, the developer Ariceum Therapeutics GmbH announced on 7 September. The Phase 1b study is taking place at the Murdoch University Health Center in Perth, Australia. It will investigate the safety and tolerability of a theranostic, or a diagnostic agent paired with the radiopharmaceutical product, 177Lu-satoreotide tetraxetan.
The private equity group Permira has made an offer to buy Ergomed Plc, a UK-based contract research organisation (CRO), for approximately £703 million. The offer represents a 32.4% premium to the three-month volume weighted average price per Ergomed share and will be executed through a newly incorporated company controlled by funds advised by Permira Advisors LLP. Ergomed has been listed on the AIM market of the London Stock Exchange since 2014 when it raised £11 million through an initial public offering.