News

Pfizer Inc and BioNTech SE are seeking regulatory approval to expand the enrolment of their Phase 3 Covid-19 vaccine trial to include 44,000 participants, up from 30,000 at present. An application to amend the trial protocol has been submitted to the US Food and Drug Administration, the companies announced on 12 September.

The prospective vaccine, BNT162b2, is a single nucleoside-modified messenger RNA that encodes an optimised SARS-CoV-2 full length spike glycoprotein which is the target of virus neutralising antibodies.

MiNA Therapeutics Ltd, which is developing drugs based on small activating RNA molecules, has raised £23 million in a Series A financing round to advance the clinical development of its lead product as a combination treatment for cancer. The financing was led by the Israeli venture capital fund aMoon, with participation from existing investors.

Nestle Health Science is to take full ownership of the food allergy company Aimmune Therapeutics Inc in an all-cash transaction that values the company at $2.6 billion. Nestle already owns 25.6% of Aimmune and will acquire the remaining equity for $34.50 per share, representing a 174% premium to the company’s closing share price on Nasdaq on 28 August.

ABX464, a small molecule drug being investigated for ulcerative colitis, generated positive data in patients who completed a second year of treatment, the developer Abivax SA announced on 2 September. The Phase 2a maintenance study showed that 69% of patients were in clinical remission and 94% benefited from a clinical response at the end of the second year. Twenty-two patients were initially enrolled in the study in which ABX464 was administered once daily at a dose of 50 mg.

A Phase 3 trial of Farxiga (dapagliflozin) has shown a reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease, according to the developer AstraZeneca Plc.  The trial results were presented on 30 August at a virtual meeting of the European Society of Cardiology. Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor which has been approved to treat Type 2 diabetes and heart failure.

A Phase 3 trial of a prospective triple combination therapy for advanced melanoma failed to meet its primary endpoint of progression free survival, Novartis announced on 22 August. The trial was testing the experimental checkpoint antibody spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib), both approved products, in patients with melanoma with a BRAF V600 mutation.

BioMarin Pharmaceutical Plc has received a complete response letter (CRL) from the US Food and Drug Administration saying it can’t approve the company’s gene therapy for haemophilia A without further data on its durable effect. The therapy, valoctocogene roxaparvovec, is intended as a one-time treatment for the blood clotting disorder.

Johnson & Johnson Inc is to significantly expand its presence in drugs for autoimmune diseases with the acquisition of Momenta Pharmaceuticals Inc in an all cash transaction valued at approximately $6.5 billion. Momenta’s lead product, nipocalimab, is in Phase 3 for the treatment of a rare autoimmune disorder called warm autoimmune haemolytic anaemia.

An application from Gilead Sciences Inc to market filgotinib, a candidate treatment for rheumatoid arthritis, has been turned back by US Food and Drug Administration with a request for further safety data, the company announced on 19 August. Filgotinib, a JAK1 inhibitor, was discovered by Galapagos NV and is being jointly developed with Gilead.

Germany-based CureVac NV, which is developing a messenger RNA (mRNA) vaccine against Covid-19, has closed its initial public offering of shares on the US Nasdaq market, raising a gross $245.3 million, including the full exercise of the underwriters’ share options. The stock was priced at $16 per share.