Company News

Hansoh Pharmaceutical Group Co Ltd announced a second antibody-drug conjugate (ADC) deal with the Roche Group on 19 October, giving the Chinese company an upfront payment of $400 million. The two companies did not disclose the specific cancers that they will be investigating. They did however say that Hansoh will lead early development of the programmes up to the completion of global Phase 1a clinical trials. After this, Roche will be responsible for further development worldwide – excluding the Chinese mainland, Hong Kong, Macau and Taiwan.

The European Medicines Agency has taken steps to innovate its regulatory procedures with two pilot programmes that will, on the one hand, align with the US Food and Drug Administration’s plans to reduce animal studies in drug development and on the other, to conduct structured dialogues with companies on the requirements for marketing authorisation applications. In the first case, the goal is to modernise pre-clinical tests for new drugs. In the second, it is to create space for more interactions between the agency and companies prior to the submission of formal applications.

OMass Therapeutics Ltd, a 2016 spin-out from the University of Oxford, has raised $310 million in a Series C financing to support development of its lead programme for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome. The funding was announced on 15 October.

AstraZeneca Plc is to explore the use of artificial intelligence in drug development and expand its oncology portfolio under two new collaborations with US companies. The first, announced on 28 September, is an equity investment and clinical collaboration with Summit Therapeutics Inc under which the companies will investigate combination therapies of a bispecific antibody from Summit with antibody-drug conjugates (ADCs) from AstraZeneca. 

A new platform company focused on the delivery of small interfering RNA (siRNA) to cells was launched on 13 October with the goal of addressing one of the main limitations of genetic medicines – reaching tissues beyond the liver. Undecimal Bio Ltd is a spin-out of Eleven Therapeutics (UK) Ltd, a synthetic medicines company. It has raised $18 million in seed financing from a syndicate co-led by 4BIO Capital and IQ Capital of the UK. Its initial therapeutic focus is renovascular disease.

In the US and elsewhere, programmes financed by governments for national defense can take many forms – including to support basic science. The Defense Advanced Research Projects Agency (DARPA) of the US, originally founded in the late 1950s to develop satellite technology, has in recent years branched out into computers and vaccines. On 23 September, DARPA stepped deeper into biology with the award of a research grant of up to $14 million to a consortium led by Scarlet Therapeutics Ltd of the UK to develop engineered, laboratory-produced red blood cells for defense.

A syndicate of venture capitalists, with support from the European Regional Development Fund, has raised seed financing of €40 million for Aptadir Therapeutics Srl of Italy to support development of a new RNA therapeutic for difficult genetic disorders. The preclinical compound is being investigated for Fragile X syndrome, an inherited generic, neurological disorder.

The US Food and Drug Administration has approved a new small molecule drug for a rare genetic disease that can impair the supply of thyroid hormone to the brain whilst also leaving excessive levels of the hormone in the bloodstream. The drug, Emcitate (tiratricol), was developed by Egetis Therapeutics US Inc, and received multiple designations in the run-up to  its approval on 28 September, including a Priority Review designation in March.

Sofinnova Partners SAS has created a new fund to build and support companies developing  medical technologies with plans to launch six to eight new companies over the next five years. This is being enabled by an over-subscribed €82 million financing round announced on 28 September. While the target technologies haven’t been identified, the broad approach is to create companies from the ground up. Explaining this strategy, Antoine Papiernik, managing partner, said the investment group builds and supports “every company from day one.” These assets are then scaled up.

The US Food and Drug Administration has approved a new gene therapy for a rare neurological disorder that manifests at an early age – Sanfilippo syndrome type A. Until the approval, treatment was limited to managing symptoms. The therapy, Fayuvi (rebisufligene etisparvovec), is an adeno-associated serotype 9 virus therapy (AAV9) that delivers a working copy of a gene enabling the body to produce sulfamidase, an enzyme which is missing in patients with the disease. Children with deficient supplies of the enzyme cannot beak down a sugar chain known as heparan sulfate.