Merck KGaA and its partner Pfizer Inc have stopped a Phase 3 trial of a new drug combination for treatment-naïve patients with locally advanced or metastatic ovarian cancer. The trial was evaluating the immunotherapy avelumab in combination with chemotherapy, followed by maintenance therapy consisting of avelumab in combination with talazoparib, a poly ADP-ribose-polymerase (PARP) inhibitor.
The German biotech Probiodrug AG and a US-based cooperative have received a $15 million grant from the US National Institutes of Health (NIH) to test Probiodrug’s small molecule drug in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
The grant will help finance a Phase 2b study of the drug PQ912 which inhibits glutaminyl cyclase, an enzyme that triggers the production of a peptide which is a constituent of Alzheimer’s disease plaques. The grant is expected to be dispersed over four years.
The London-based investment group, Arix Bioscience Plc, has co-led a $63 million investment round in Imara Inc, a US company developing a small molecule drug to treat sickle cell disease, a rare genetic blood disorder that can lead to organ injury. Joining Arix as co-leader of the Series B round was Orbimed Advisors.
The European Commission is to allocate more than €2 billion for the final two years of an experimental programme intended to nurture entrepreneurs and start-up companies across Europe.
MorphoSys ended 2018 with cash of €454.7 million, higher royalty income from its partnered drug for plaque psoriasis, Tremfya, and plans for a US regulatory filing for MOR208, its first wholly-owned cancer drug. MOR208 is being developed to treat diffuse large B cell lymphoma, an aggressive lymphoma.
Brussels has decided that this is the time when Britain’s biotech and pharmaceutical companies might be enticed into moving to Europe’s capital.
Following the British Parliament’s rejection an agreed plan for withdrawal from the European Union, UK legislators have also rejected leaving the Union without any agreement. What this means is that Parliament will continue to muddle on. No one knows for how long or whether the Europe will put up with another lengthy dither.
The checkpoint antibody Tecentriq (atezolizumab) received its fifth approval from the US Food and Drug Administration on 8 March – this time for triple-negative breast cancer. The approval is for the use of Tecentriq in combination with chemotherapy for patients with breast cancer whose tumours express the PD-L1 protein. Patients will be identified using a new FDA-approved assay.
A young Danish company, SNIPR BIOME, that is using CRISPR/Cas technology to fight bacteria has raised $50 million in a Series A financing round co-led by Life Sciences Partners (LSP) and existing investor Lundbeckfonden Emerge. The North-East Family Office of Copenhagen, Denmark and Wellington Partners of Munich, Germany also participated in the round.
The US Centers for Medicare and Medicaid Services (CMS) has proposed to reimburse cancer treatments with chimeric antigen receptor (CAR) T cell therapies under a policy called ‘Coverage with Evidence Development.” Currently there is no national Medicare policy for covering CAR T cell therapy so local Medicare contractors will have discretion over whether to pay for it. The proposed coverage would require Medicare to cover the therapy when it is offered in a CMS-approved registry or clinical study in which patients are monitored for at least two years after treatment.
Genmab A/S ended 2018 with a cash balance of DKK 6.1 billion ($920 million), up by 13% from a year earlier as royalty revenue from its lead cancer product Darzalex (daratumumab), developed with Janssen Biotech Inc, continued to roll in. Darzalex is a monoclonal antibody that binds to the protein CD38 on multiple myeloma cells for the treatment of multiple myeloma. It is now approved for six indications in the US including, most recently, as a split dose regimen.