Merck (MSD) has signed a deal to acquire Pandion Therapeutics for approximately $1.85bn, gaining access to a pipeline of immune modulators for the treatment of autoimmune diseases.

Leading Pandion’s pipeline is an engineered IL-2 mutein fused to a protein backbone – known as PT101 – that is designed to selectively activate and expand regulatory T cells (Tregs) for the potential treatment of ulcerative colitis and other autoimmune diseases.
Tregs can inhibit the activity of several different pro-inflammatory immune cell types, and are critical for self-tolerance of the immune system. The dysfunction of Tregs is associated with a number of autoimmune diseases.

The investigational candidate completed a phase 1a clinical trial earlier this year, achieving its primary objective of safety and tolerability.

In this study, PT101 expanded Tregs with a mean maximal increase of up to 3.6-fold over baseline, with no evidence of expansion of natural killer T (NK) cells and pro-inflammatory conventional T (Tconv) cells at any dose studied.

Aside from PT101, Pandion’s pipeline also includes PD-1 agonists in development for a range of autoimmune diseases.

A number of other pharma companies are also developing IL-2 therapies, including Eli Lilly with a Nektar Therapeutics-partnered candidate that is currently in phase 2 trials for the treatment of systemic lupus erythematosus and ulcerative colitis.

In addition, Amgen is testing its own IL-2 candidate – AMG-592 – in patients with systemic lupus erythematosus and chronic graft-versus-host disease.

Seagen’s oral HER2 drug Tukysa has been authorised by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of HER2-positive advanced breast cancer.

The MHRA has cleared Tukysa (tucatinib) as an add-on therapy to Roche’s anti-HER2 antibody Herceptin (trastuzumb) plus Xeloda (capecitabine) for adult patients with HER2-positive locally advanced or metastatic breast cancer who have previously received at least two anti-HER2 treatment regimens.

In the HER2CLIMB trial, which the MHRA approval is based on, Tukysa plus Herceptin and Xeloda achieved a 46% reduction in the risk of disease progression or death compared to the two Roche drugs given alone.

Tukysa also met two secondary objectives in the trial, with a 34% reduction in the risk of death, and a 52% fall in the risk of disease progression or death in patients whose cancer had metastasised into the brain at the time they were enrolled in the study.

The European Commission also recently approved Tukysa in the HER2-positive advanced breast cancer setting.

The EC approval for Tukysa is valid in Northern Ireland, while the MHRA authorisation covers England, Scotland and Wales.

The oral HER2 inhibitor is also approved in the US for the treatment of HER2-positive advanced cancer.

The AMR Action Fund, launched last year, has raised $140m from new investors to bolster its efforts to bring new antibiotics through the clinical pipeline to patients.

The new investments come from the Boehringer Ingelheim Foundation, the European Investment Bank and the Wellcome Trust, representing the first non-pharmaceutical industry investments made to the AMR Action Fund.

This new funding adds to the $1bn raised at the launch of the AMR Action Fund, with the initial investments made by over 20 biopharmaceutical companies that established the fund in July 2020.

The AMR Action Fund was launched by major pharma companies represented by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), in collaboration with the World Health Organization, the European Investment Bank and the Wellcome Trust.

It was created to bring two to four new antibiotics to patients by 2030 – treatments that are urgently needed to address the rapid rise of antibiotic resistance, part of the broader issue of antimicrobial resistance.

The Fund will invest in clinical research into new antibiotics to address the most resistant bacteria and life-threatening infections.

In a statement, the AMR Action Fund said it will “soon take its first steps” in assessing investment opportunities in biotech companies that are focused on developing new antibiotics.

Each year, 700,000 people die as a result of AMR, with some analysts estimating that by 2050 as many as ten million people could lose their lives annually because of the increasing prevalence of antibiotic-resistant infections.

AstraZeneca (AZ) and Amgen’s investigational medicine tezepelumab has hit statistically significant markers of superiority across all primary and key secondary endpoints in a phase 3 trial.

Tezepelumab is a potentially first-in-class thymic stromal lymphopoietin (TSLP) targeting antibody – TSLP is thought to play a pivotal role in causing asthma inflammation and is a novel target for an asthma drug.

Full data from the NAVIGATOR trial – presented at the virtual American Academy of Allergy, Asthma & Immunology (AAAAI) meeting – showed that tezepelumab achieved a 56% reduction in the annual asthma exacerbation (AAER) rate over 52 weeks in the overall patient population when added to standard of care (SoC), compared to placebo plus SoC.

In this trial, SoC was defined as medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication, with or without oral corticosteroids (OCS).
A pre-planned subgroup analysis also showed that tezepelumab achieved a 41% reduction in AAER in patients with baseline eosinophil counts of less than 300 cells per microlitre.

Clinically meaningful reductions in AAER were also observed in two additional subgroups – 39% in patients with baseline eosinophil counts of less than 150 cells per microlitre and 70% in patients with greater than or equal to 300 cells per microlitre.

For every key secondary endpoint, tezepelumab also demonstrated statistically significant improvements on each count, including lung function measurements, asthma control and health-related quality of life.