Pharmaceutical Market Europe • November 2022 • 6-7

NEWS

Amgen completes $3.7bn acquisition of ChemoCentryx

Image

Amgen has successfully completed its previously announced acquisition of ChemoCentryx in an agreement valued at approximately $3.7bn in cash. ChemoCentryx is a biopharmaceutical company focused on orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer.

Through the acquisition of all outstanding shares of ChemoCentryx common stock for $52 per share in cash, Amgen gains access to the biopharma’s autoimmune disease treatment Tavneos (avacopan), an orally administered selective complement component 5a receptor inhibitor.

The drug was approved by the US Food and Drug Administration (FDA) in October 2021 as an adjunctive treatment for adult patients with severe active antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis – an umbrella term for a group of multi-system autoimmune diseases with small vessel inflammation – in combination with standard therapy.

The treatment is also approved in major markets outside the US, including the EU and Japan.

In patients with ANCA-associated vasculitis, inflamed vessels may rupture or become blocked, giving rise to a range of clinical symptoms and signs related to a systemic inflammatory response, which may result in severe injury and dysfunction in the kidneys, lungs and other organs.

Prior to the approval of Tavneos, treatment for ANCA-associated vasculitis was limited to courses of non-specific immunosuppressants, combined with the administration of daily glucocorticoids – steroids – for prolonged periods of time, associated with significant clinical risk, including death from infection.


Gilead completes acquisition of MiroBio in $405m cash deal

Image

Gilead Sciences (Gilead) has announced the completion of the previously announced transaction to acquire UK-based biotechnology company MiroBio, for approximately $405m in cash.

The deal includes MiroBio’s proprietary discovery platform and its entire portfolio of immune inhibitory receptor agonists.

MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA), which is currently in phase 1 clinical trials, with the first patient dosed in early August 2022. The antibody targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

MiroBio’s REceptor Selection and Targeting to Reinstate immune Equilibrium – I-ReSToRE platform – has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases.

The platform supports the identification and development of therapeutics that utilise inhibitory signalling networks to restore immune homeostasis for patients.
Gilead said it anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programmes, over the ‘next several years’.

MiroBio was spun-out of Oxford University in 2019, with the privately owned biotech based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall.


Novo Nordisk acquires Forma Therapeutics in $1.1bn deal

Novo Nordisk has announced that its acquisition of Forma Therapeutics (Forma) has been completed in a deal worth $1.1bn, expanding the company’s blood disorders portfolio.

Through the acquisition of all outstanding shares of Forma common stock at a price of $20 per share in cash, Novo Nordisk gains access to Forma’s lead development candidate – etavopivat – an investigational oral, once-daily, selective pyruvate kinase-R (PKR) activator, being developed to improve anaemia and red blood cell health in people with sickle cell disease (SCD).

Around 17 million people worldwide live with SCD, a lifelong, incurable genetic illness causing red blood cells to take a distinct crescent shape, which can block blood vessels and affect the movement of oxygen around the body.

SCD can cause serious health problems, including anaemia, fatigue, episodes of pain known as vaso-occlusive crises (VOCs) and chronic end-organ damage. Despite recent advances in treatment, most patients with SCD still suffer from pain crises, lifelong disability, reduced quality of life and shortened life expectancy, Novo Nordisk reports.

Employing a multimodal approach, etavopivat activates the red blood cell’s natural PKR activity to decrease levels of the metabolite 2,3-DPG, allowing sickle haemoglobin to retain oxygen longer, resulting in decreased polymerisation, haemolysis and sickling.

Image

AbbVie to acquire DJS Antibodies in $255m cash deal

Image

AbbVie has announced the acquisition of DJS Antibodies (DJS), a privately held UK-based biotechnology company focused on discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins, including G protein-coupled receptors (GPCRs).

The acquisition will give AbbVie access to DJS’ lead programme, DJS-002, a potential first-in-class lysophosphatidic acid receptor 1 antagonist antibody currently in investigational preclinical studies for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases.

IPF is an aggressive, high mortality disease caused by fibrotic scarring in the lungs and remains an area of high unmet medical need, AbbVie reports.

Under the terms of the agreement, AbbVie will pay approximately $255m in cash to DJS shareholders, who will remain eligible for additional payments upon achievement of certain development milestones related to the success of the DJS-002 programme. The company also outlined its plans to retain all current DJS employees and its facility in Oxford.

In addition to DJS-002, the biotech’s proprietary HEPTAD platform, a novel approach to antibody discovery with specific capabilities targeting transmembrane protein targets, will be a key benefit to AbbVie and complement the company’s current capabilities in biotherapeutics research.

Specifically, DJS will leverage AbbVie’s extensive drug discovery knowledge to continue generating antibody therapeutics and novel biology insights against targets like GPCRs, which have previously been intractable to biologics approaches.


Merck and Moderna agree on $250m cancer vaccine deal

Image

Merck & Co – known as MSD outside the US and Canada – has exercised its option to jointly develop and commercialise personalised cancer vaccine (PCV), mRNA-4157/V940, with Moderna in accordance with the terms of its existing collaboration and licence agreement.

Moderna will receive an upfront payment of $250m from Merck, with the two companies sharing the costs and any profits equally under this worldwide collaboration.

PCVs are designed to prime the immune system so that patients can generate a tailored antitumour response to their tumour mutation signature to treat their cancer.
mRNA-4157/V940 is currently being evaluated in combination with Keytruda, Merck’s anti-PD-1 therapy, in a phase 2 clinical trial being conducted by Moderna for the adjuvant treatment of patients with high-risk melanoma. Keytruda was selected as the comparator in the trial because it is considered a standard-of-care for high-risk melanoma patients, the companies outlined.

In the trial, following complete surgical resection, patients were randomised to receive mRNA-4157/V940 (nine doses every three weeks) and Keytruda (200mg every three weeks) versus Keytruda alone for approximately one year until disease recurrence or unacceptable toxicity.

The primary endpoint of the trial is recurrence-free survival, with secondary endpoints including distant metastasis-free survival and overall survival. The trial is fully enrolled and primary data is expected in the fourth quarter of 2022.


Gates Foundation commits $1.2bn towards eradicating polio

Image

The Bill & Melinda Gates Foundation (the Foundation) will commit $1.2bn to bolster efforts to end all forms of polio worldwide.

The announcement was made at the World Health Summit, ahead of a pledge that was co-hosted by Germany and the Global Polio Eradication Initiative (GPEI).

The contribution made by the Foundation will aid in the implementation of the GPEI’s Polio Eradication Strategy 2022-2026, an initiative aiming to end wild poliovirus in the last two endemic countries, Pakistan and Afghanistan, and halt outbreaks of new variants of the virus. To date, the Foundation has invested almost $5bn in GPEI.

The GPEI is focused on further integrating polio campaigns, with a wider scope of health services and essential immunisation programmes as part of its strategy.

The GPEI has helped reduce polio cases worldwide by more than 99% and has helped to prevent an estimated 20 million cases of polio paralysis since 1988. Vaccine misinformation, interruptions in routine immunisation, political unrest and the 2022 floods in Pakistan have further highlighted the need to end polio.

Recently, new detections of the virus were reported in countries such as the UK and the US, confirming a poliovirus variant outbreak. As a result, in September 2022, these countries were added to the World Health Organization’s outbreak list.