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AstraZeneca acquires Dogma Therapeutics’ PCSK9 inhibitor programme

AstraZeneca has signed an agreement to purchase a preclinical oral PCSK9 inhibitor programme from Dogma Therapeutics for an undisclosed amount.

PCSK9 is a protein that modulates the low-density lipoprotein (LDL) or ‘bad’ cholesterol levels in the blood. Increased PCSK9 activity results in high LDL cholesterol.

The PCSK9 inhibitors covered under this agreement are small molecules designed to attach to a new part of PCSK9. In preclinical models, these PCSK9 inhibitors blocked its activity and lower LDL cholesterol.

Speaking of the development with AstraZeneca, Dogma Therapeutics CEO Brian Hubbard said: “We have built a robust data package that highlights the cholesterol-lowering and safety potential of our oral PCSK9 programme.

“This agreement with AstraZeneca meets our strategic goal to accelerate access to patients unable to meet target LDL cholesterol.”

AstraZeneca plans to advance the acquired programme into clinical development for dyslipidaemia, characterised by an abnormal amount of lipids in the blood. Furthermore, the company will focus on development in familial hypercholesterolemia, a common genetic condition that leads to high cholesterol.

Currently, there are no oral PCSK9 inhibitors approved for patient use or in clinical development.

AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Whilst PCSK9 is a well-validated target for lowering LDL cholesterol, it has been a hugely challenging target to inhibit with small molecules.

“This agreement with Dogma Therapeutics offers us the opportunity to develop the first small molecule, orally bioavailable PCSK9 inhibitor, for patients at risk of cardiovascular disease.”

Pangalos added that increased LDL cholesterol is a significant risk factor for cardiovascular disease. Statistics show that the condition is responsible for 2.6 million deaths per year, globally.

AstraZeneca expects to begin clinical development of the PCSK9 inhibitors next year.

Roche acquires biotech firm Inflazome for $449m

Lilly partners with Amgen to manufacture Covid-19 antibody therapies

Eli Lilly has formed a global antibody manufacturing partnership with Amgen to boost the supply capacity for its therapy candidates against Covid-19.

Under the collaboration, Lilly and Amgen can quickly scale-up manufacturing, as well as boost global access, if one or more of Lilly’s antibody therapies succeed in clinical trials and obtain regulatory approval.

Palleon Pharmaceuticals secures $100m in Series B funding

Palleon Pharmaceuticals has raised $100m in a Series B financing round to develop drugs targeting glycan-mediated immune regulation to treat cancer and inflammatory diseases.

The financing round, led by Matrix Capital Management, was joined by Series A investors SR One, Pfizer Ventures, Vertex Ventures HC, Takeda Ventures and AbbVie Ventures, along with new investor Surveyor Capital.

India’s Dr Reddy’s signs deal for Russia’s Sputnik V Covid-19 vaccine

India-based pharmaceutical company Dr Reddy’s Laboratories has partnered with the Russian Direct Investment Fund (RDIF) for clinical trials and supply of Sputnik V Covid-19 vaccine.

After obtaining regulatory approval in India, RDIF will supply 100 million doses of the vaccine to Dr Reddy’s for distribution in the country. Deliveries should start in the coming months, subject to completion of trials and regulatory registration of the vaccine in India.

BioNTech to acquire Novartis site for Covid-19 vaccine production

BioNTech has signed a share purchase agreement with Novartis to acquire a manufacturing site to boost its messenger RNA (mRNA)-based BNT162 Covid-19 vaccine candidate production capacity.

Expected to be fully operational by the first half of next year, the facility located in Marburg city of Germany will increase BioNTech’s Covid-19 vaccine production capacity by up to 750 million doses annually.

Moderna and Vertex partner on gene-editing therapies for cystic fibrosis

Moderna has teamed up with Vertex Pharmaceuticals to identify and develop lipid nanoparticles (LNPs) and messenger RNAs (mRNAs) for the delivery of gene-editing therapies to treat cystic fibrosis (CF).

Under the three-year research partnership and licensing deal, Moderna will receive a $75m upfront payment from Vertex and be qualified for milestones of up to $380m.

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