German biotech, Vivoryon Therapeutics and the Chinese pharma group have entered into a strategic regional licensing deal, with Simcere securing a regional license to develop and commercialize Vivoryon’s small molecule candidate, varoglutamstat, which targets a subtype of amyloid known as N3pE or pGlu-Abeta.
The Chinese player will be responsible for clinical development locally of varoglutamstat in patients with early onset AD.
N3pE amyloid triggers a number of pathological processes in AD, including the formation of toxic soluble Abeta oligomers, tau pathology, neuroinflammation, and impairment of synaptic function. By preventing formation of this toxic molecule, Varoglutamstat is said to act very early in disease pathogenesis and, thus, is flagged as having the potential to prevent neuronal damage.
Simcere has also acquired an option to advance Vivoryon’s PBD-C06, a preclinical monoclonal antibody specifically designed to bind to and remove neurotoxic N3pE amyloid from the brain. The antibody is reportedly optimized with respect to low immunogenicity and low potency to induce amyloid-related imaging abnormalities (ARIAs), which represent the major severe side effects of antibody-based AD therapies.
Under the terms of the agreement, the German company will receive an undisclosed upfront payment and will also be eligible for payments upon achievement of certain development and sales milestones, with all components amounting to a total of over US$565m. In addition, Vivoryon will receive double-digit royalties on sales.
Multiple amyloid and tau targeting drugs have failed in Alzheimer’s trials over the years.
The US Food and Drug Administration (FDA), of course, approved Biogen’s monoclonal antibody, Aduhelm (aducanumab), earlier this month, on the basis that it reduces the levels of amyloid beta plaques in the brain. But the approval has proved contentious, with many researchers questioning whether the drug is effective.
Worldwide, around 35 million people are affected by AD, according to the WHO, while the Chinese Geriatrics Society says the number of Alzheimer's patients in China will exceed 40 million by 2050.
Novel treatment backed in China
Interestingly, it was the Chinese regulatory agency, the National Medical Products Administration (NMPA), that, in late 2019, that became the first national regulator to approve a drug for the treatment of mild to moderate Alzheimer’s disease and improving cognitive function.
Oligomannate, developed by Shanghai Green Valley Pharmaceuticals, is derived from marine brown algae, a type of seaweed; it was the first novel treatment to be approved globally since 2003.
Last year saw the US FDA also clear the drug to start US trials.
Oligomannate works to alter bacteria in the gut microbiome to affect changes in the brain, a novel mechanism of action for an Alzheimer’s drug. Traditional Alzheimer’s drugs, such as cholinesterase inhibitors, target parts of the brain alone.