Oncolytic virus specialist Theolytics Ltd. has raised £19 million (US$23.7 million) in its latest financing round, as it prepares to start phase I development of the lead product, THEO-260, later this year.
“The development of psychedelic medicines should adhere to the current European regulatory framework, at both the pan-European and member state level. It is imperative that developers understand and thoroughly apply the regulatory guidance and requirements that are in place.” That was the somewhat discouraging opening statement at the stakeholder workshop convened by the EMA to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health.
Essential Pharma Ltd. is paying up to £70 million (US$88.7 million) to acquire Renaissance Pharma Ltd., taking ownership of Hu14.18, a treatment for high-risk neuroblastoma. The antibody has completed a 64-patient phase II trial conducted by St Jude’s Children’s Research Hospital, in which it showed an improvement in overall survival of around 50% compared to currently available therapies.
Medicxi has made its first ever investment in China – and its biggest single commitment to date – putting $40 million into D3 Bio Inc. The investment by the London-based venture capital firm will accelerate development of D3’s lead program D3S-001, a second generation KRAS G12C inhibitor, which is in phase II development in advanced solid tumors.
Medicxi has made its first ever investment in China – and its biggest single commitment to date – putting $40 million into D3 Bio Inc. The investment by the London-based venture capital firm will accelerate development of D3’s lead program D3S-001, a second generation KRAS G12C inhibitor, which is in phase II development in advanced solid tumors.
With nine months to go before their introduction, the industry is flagging many uncertainties around the proposed guidelines for implementing joint clinical assessments.
Microbiome specialist Enterobiotix Ltd. has raised £27 million (US$34.2 million) in a series B round as it starts a phase II trial of EBX-102-02 in the treatment of irritable bowel syndrome.
Addex Therapeutics has offloaded its portfolio of preclinical allosteric modulation drugs into Neurosterix, a new company that arrives on the scene with a $63 million series A round.
Analysis of the immune signatures of blood samples from patients with early-stage multiple sclerosis (MS) who were treatment naive has identified three distinct subtypes that have different disease trajectories and which respond differently to therapy.
Europe may still await its first disease-modifying Alzheimer’s drug after the EMA postponed its decision on Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd) on March 22, but leading members of the World Dementia Council were in an optimistic mood when they convened in London four days later. “We are working to make the inevitable happen earlier,” said Lenny Shallcross, executive director of WDC. “The inevitable will be rollout of medicines, rollout of better diagnostics and the improvement of care. All of those things over the next 10 years are inevitably going to happen.”