Gilead and EVOQ Therapeutics (EVOQ) have entered into a collaboration and licensing agreement to advance immunotherapies to treat rheumatoid arthritis (RA) and lupus.

Gilead will receive rights to exclusively license EVOG’s NanoDisc technology, which is designed to enable lymph-targeted delivery of disease-specific antigens and said to have the potential to ‘change the paradigm’ for the treatment of autoimmune diseases.

There are more than 100 chronic autoimmune diseases, many of which are severely debilitating, and some life-threatening. According to the National Institutes of Health, up to 23.5 million people are living with an autoimmune disease in the US alone, and the prevalence is rising.

Under the terms of the agreement, EVOQ could potentially receive up to $658.5m in upfront, option exercise and milestone payments across all programmes, as well as tiered royalties on product sales.

Preclinical development will be split between the two companies, with Gilead responsible for all clinical development and potential commercialisation activities relating to any resulting products.

The collaboration follows the announcement of EVOQ’s partnership with JDRF last month to develop its novel platform technology to treat type 1 diabetes.

EVOQ also partnered with Amgen in January 2021 to discover and develop novel drugs for autoimmune disorders.

Takeda has announced it will acquire Nimbus Therapeutics’ NDI-034858 in a deal worth $6bn. NDI-034858 is an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor that is currently being evaluated for the treatment of multiple autoimmune diseases.

Under the terms of the agreement, Takeda will make an upfront payment of $4bn to Nimbus, and Nimbus will also be eligible for two $1bn milestone payments upon achieving annual net sales of $4bn and $5bn.

Nimbus recently announced positive top-line results from a phase 2b study evaluating NDI-034858, which will be known as TAK-279 upon completion of the transaction, for patients with moderate-to-severe plaque psoriasis.

Data from the 259 patients participating in the study showed that NDI-034858 achieved the primary efficacy endpoint, with a statistically significant greater proportion of patients achieving a 75% improvement in skin lesions compared to placebo at 12 weeks.

Takeda said it intends to present results from the study early in 2023, with NDI-034858 also expected to move to a phase 3 study in psoriasis in 2023.

The drug candidate is also part of an ongoing phase 2b study in active psoriatic arthritis, and Takeda has outlined its plans to investigate it for the treatment of inflammatory bowel disease and other autoimmune diseases.

Novartis’ Pluvicto has been approved by the European Commission to treat adult patients with prostate cancer who have previously been treated with AR pathway inhibition and taxane-based chemotherapy.

The approval is specifically for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). It follows a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in October 2022.

The company’s application was supported by results from the pivotal phase 3 VISION trial in which these patients receiving Pluvicto plus best standard of care had a 38% reduction in the risk of death and a 60% reduction in the risk of radiographic disease progression or death compared to best standard of care alone.

Prostate cancer is the most frequently diagnosed cancer in 112 countries, with more than 1.4 million new cases and 375,000 deaths recorded in 2020 alone.

The majority of patients with CRPC already present with metastases at the time of their diagnosis. Despite recent advances, however, patients with metastatic prostate have approximately a three in ten chance of surviving for five years, emphasising the need for new targeted treatment options to help improve long-term outcomes.

Pfizer’s Biologics License Application for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and over has been accepted by the US Food and Drug Administration (FDA) for priority review.

RSV is a contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults.

In the US alone, it is estimated that RSV infections in older adults account for approximately 60,000 to 120,000 hospitalisations and 6,000 to 14,000 deaths each year.

Pfizer’s application was supported by results from the phase 3 RENOIR trial, a global, randomised, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity and safety of a single dose of RSVpreF in adults aged 60 years and over.

The study showed the vaccine was 85.7% effective among participants with three or more symptoms, and 66.7% for two or more symptoms, according to an interim analysis carried out by an external data monitoring panel in August 2022. During the study, the vaccine was also shown to be well tolerated and no safety concerns were observed.