Pharmaceutical Market Europe • December 2024 • 6-7
NEWS
Roche and Flare Therapeutics have entered into an agreement worth over $1.8bn to discover small molecule treatments aimed at previously undrugged transcription factor (TF) targets in oncology.
The strategic discovery collaboration centres around Flare’s proteomic and mass spectrometry platform powered by its proprietary library of electrophilic compounds.
TFs have long been aspirational targets of drug developers due to their central role in cancer and other diseases. However, less than 1% have been successfully targeted for therapeutics.
Flare’s integrated discovery engine brings together genetic, biochemical and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential.
Flare will lead discovery and preclinical activities, while Roche will take on further preclinical and clinical development and commercialisation of potential products. In exchange, Flare will receive an upfront cash payment of $70m and will be eligible for discovery, development and commercialisation milestone payments potentially exceeding $1.8bn, as well as royalties.
Flare will also have the right to co-fund development for one target under the collaboration in exchange for increased royalties in the US for the product.
Novartis and Schrödinger have entered into a research collaboration and licence agreement worth over $2.4bn to advance multiple drug candidates for Novartis to develop and commercialise.
The alliance will see the companies combine their existing research efforts to identify and advance drug candidates for undisclosed targets in Novartis’ core therapeutic areas.
Though details of the programmes have not been disclosed, Novartis’ areas of focus include cardiovascular, renal and metabolic diseases, immunology, neuroscience and oncology.
Schrödinger and Novartis will both be responsible for the discovery of development candidates under the collaboration, while Novartis will take on clinical development, manufacturing and global commercialisation.
In exchange, Schrödinger will receive $150m upfront and will be eligible for up to $892m in research, development and regulatory milestone payments. Schrödinger will also be in line for up to $1.38bn in commercial milestones and tiered mid single-digit to low double-digit royalties on net sales of each product commercialised by Novartis.
The partners also announced an expanded three-year software agreement that “substantially increases” Novartis’ access to Schrödinger’s computational predictive modelling technology and enterprise informatics platform.
Merck & Co – known as MSD outside the US and Canada – has entered into a global licensing agreement worth over $3.2bn to advance LaNova Medicines’ investigational PD-1/VEGF bispecific antibody.
The company will expand its oncology pipeline by gaining an exclusive global licence to develop, manufacture and commercialise LM-299.
A phase 1 clinical trial of the candidate in advanced solid tumours is enrolling patients in China following promising preclinical results demonstrating strong inhibition of tumour growth and a well-tolerated safety profile.
LM-299 can be used in combination with a range of treatment modalities, including immuno-oncology drugs, small molecule targeted therapies, antibody-drug conjugates and T-cell activators, according to LaNova, which described the drug as a “promising cornerstone therapy for the next generation of tumour immunotherapy”.
LaNova will receive an upfront payment of $588m and will be eligible for up to $2.7bn in milestone payments associated with the technology transfer, development, regulatory approval and commercialisation of LM-299 across multiple indications.
Dean Li, president of Merck Research Laboratories, said the company “[looks] forward to advancing LM-299 with speed and rigour for patients in need”.
AbbVie has announced that it will be acquiring Aliada Therapeutics for $1.4bn, marking a notable boost to its neuroscience pipeline.
The deal gives AbbVie access to Aliada’s therapies that use a novel blood-brain barrier (BBB)-crossing technology to address challenging central nervous system (CNS) diseases. This includes lead candidate ALIA-1758, an anti-pyroglutamate amyloid beta antibody in phase 1 development for Alzheimer’s disease (AD).
An estimated 982,000 people are living with dementia in the UK, with AD accounting for up to 75% of cases. The neurodegenerative disease slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Aliada’s Modular Delivery (MODEL) platform is designed to deliver different types of biological cargoes into the brain, including therapeutic antibodies and genetic medicines such as small interfering RNA.
ALIA-1758 utilises the transferrin protein to transport an anti-pyroglutamate amyloid beta antibody across the BBB to enable degradation and elimination of amyloid beta plaques, a hallmark of AD.
The announcement came less than three months after AbbVie completed its $8.7bn acquisition of Cerevel Therapeutics, giving it access to multiple candidates targeting neurological and psychiatric disorders.
GSK and Vesalius Therapeutics have entered into a strategic partnership worth $650m to discover and develop new treatments for Parkinson’s disease (PD) and one additional neurodegeneration indication.
The alliance will see Vesalius use its platform to identify new intervention points that GSK may then advance. GSK will also receive global development and commercial rights from Vesalius to a preclinical small molecule programme with an initial focus in PD.
More than ten million people worldwide are living with PD, a progressive neurological disorder characterised by symptoms such as tremor, muscle rigidity, slowness of movement and difficulty with balance.
Founded in 2019 by Flagship Pioneering, Vesalius is focused on identifying previously unrecognised groups of patients who are likely to respond favourably to treatments by targeting novel points of intervention.
Vesalius will receive $80m in upfront and equity payments, and will be eligible for preclinical, development and commercial milestone payments of up to $570m, plus tiered royalties for the preclinical small molecule programme.
Vesalius will also be in line for milestone payments and tiered royalties for each of the intervention points resulting from the deal.
Biogen and Eisai’s Alzheimer’s disease (AD) drug has been recommended by the European Medicines Agency’s human medicines committee to treat patients with early stages of the neurodegenerative disorder.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that lecanemab be used in adults with a clinical diagnosis of mild cognitive impairment and mild dementia due to AD who have one or no copies of the apolipoprotein E4 gene.
The decision comes after Eisai, which serves as the lead for the drug’s development and regulatory submissions globally, requested a re-examination of the negative opinion adopted by the CHMP in July.
The new recommendation was supported by results from the late-stage Clarity AD, in which lecanemab reduced clinical decline by 31% at 18 months compared to placebo in the recommended indicated population.
This was measured using the global cognitive and functional scale, CDR-S, which looks at six domains of functioning, including memory, orientation, judgement and problem-solving, community affairs, home and hobbies, and personal care.
The European Commission will now consider the recommendation as it makes a final decision on lecanemab.