Johnson & Johnson (J&J) has received a positive recommendation from NICE for TALVEY (talquetamab), for use within the NHS in England and Wales as a treatment option for relapsed and refractory multiple myeloma (RRMM).

TALVEY is a bispecific antibody designed to bind to both myeloma cells and T cells. By redirecting T cells to the myeloma cells, the therapy activates an immune response that results in targeted tumour cell death.

Multiple myeloma is an incurable blood cancer affecting plasma cells in the bone marrow. When these cells become malignant, they proliferate rapidly and replace healthy cells, forming tumours. Approximately 6,200 new cases are diagnosed in the UK each year, and an estimated 33,000 people are currently living with the disease.

Symptoms may include bone pain, recurrent infections, fatigue, peripheral neuropathy, hypercalcaemia and renal impairment. There remains a significant unmet need, particularly for patients who are heavily pre-treated, as the risk of relapse increases with each successive line of therapy.

NICE’s recommendation is supported by data from the phase 1/2 MonumenTAL-1 study, which met both primary and secondary endpoints.

Novartis has reported positive top-line results from the phase 3 KALUMA trial evaluating KLU156 (ganaplacide/lumefantrine, or GanLum), its investigational malaria therapy.

KLU156 combines two compounds that target the malaria parasite by disrupting its internal protein-transport mechanisms, which are critical for its survival within infected red blood cells. The therapy is part of a new class of potential antimalarials, known as imidazolopiperazines, identified following a landmark high-throughput screen of 2.3 million molecules.

The therapy received Fast Track and Orphan Drug Designations from the US FDA in 2022. If approved, it would represent the first major advance in malaria treatment in more than 25 years, following the introduction of artemisinin-based combination therapies.

The KALUMA trial assessed the efficacy, safety and tolerability of KLU156 – a novel, non-artemisinin combination developed in partnership with Medicines for Malaria Venture (MMV) – against Coartem, the current standard of care for acute, uncomplicated malaria in adults and children caused by Plasmodium falciparum.

Novartis said it intends to submit KLU156 to regulatory and health authorities in the near future.

Boehringer Ingelheim and CDR-Life have entered into a global licensing agreement for CDR111, a trispecific T-cell engager developed by CDR-Life for the treatment of autoimmune diseases.

CDR111 is an antibody-based M-gager designed to selectively target and deplete B cells, whose dysregulation can play a central role in autoimmune and inflammatory disorders such as lupus, multiple sclerosis and certain forms of arthritis. According to the partners, CDR111 has the potential to be effective across multiple indications through its immune system reset mechanism of action.

The new licensing deal builds on a previous collaboration between the two companies, which centred on an investigational antibody fragment. Boehringer has continued to develop that molecule using CDR-Life’s licensed technology, and it is currently being evaluated in the VERDANT phase 2 trial in patients with GA.

Under the terms of the latest agreement, CDR-Life could receive up to $570m in total payments. This includes approximately $48m in upfront and near-term payments, plus tiered royalties on future sales.