BioNTech has entered into an exclusive licensing and collaboration agreement with Biotheus to develop and commercialise its bispecific antibody candidate outside of China, with the deal potentially worth over $1bn.

PM8002, which simultaneously targets PD-L1 and VEGF, is currently being evaluated in mid-stage studies in China as both a monotherapy and in combination with chemotherapy in patients with advanced solid tumours.

The asset has already demonstrated a positive safety profile and encouraging anti-tumour activity "presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumour microenvironment," the Chinese biotech said.

Under the terms of the agreement, Biotheus will receive an upfront payment of $55m and will be eligible to receive additional development, regulatory and sales milestone payments potentially totalling over $1bn, as well as tiered royalties on potential future product sales.

The transaction is expected to close in the fourth-quarter of this year subject to customary closing conditions.

Xiaolin Liu, co-founder, chairman and chief executive officer of Biotheus, said: "Biotheus' innovative platform has the capability to expedite preclinical research, bolstering our impressive innovative pipeline of products with encouraging efficacy and safety including PM8002.

"Collaborating with… BioNTech, we hope to advance PM8002 through multi-regional clinical trials with the aim to be able to provide it to patients worldwide."

The deal comes just a few days after BioNTech entered into an agreement to acquire small start-up AexeRNA and its novel lipid nanoparticles for mRNA medicines.

The German biotech also expanded its existing partnership with Duality Biologics in August by adding a third antibody-drug conjugate (ADC) to the deal.

Under the terms of the original agreement, which was announced in April this year, DualityBio would receive upfront payments totalling $170m and be eligible to receive development, regulatory and commercial milestone payments of potentially more than $1.5bn.

The latest candidate to be included in the contract is DB-1305, a third generation Trop2 ADC molecule that has also shown "potent anti-tumour activity" in preclinical tumour models and “robust" clinical efficacy in non-small cell lung cancer and other solid tumours, the companies said.

https://www.pmlive.com/pharma_news/biontech_acquires_right_to_biotheus_bispecific_antibody_candidate_in_deal_worth_over_$1bn_1503517