The acquisition will give BioNTech full ownership of an investigational bispecific antibody targeting the PD-L1/VEGF-A pathways, a hot area in oncology that could potentially replace standard checkpoint inhibitors for cancer treatment.
BioNTech on Wednesday announced it will acquire development partner Biotheus, gaining full control of an investigational bispecific antibody that some say could dethrone checkpoint inhibitors as the standard treatment for solid tumors.
As per the agreement, BioNTech will make an $800 million upfront payment, mostly in cash, along with the promise of up to $150 million in certain milestones. The partners expect to complete the transaction in the first quarter of 2025, pending antitrust clearances and other customary closing conditions.
At the heart of the buyout is BNT327/PM8002, a bispecific antibody that combines the inhibition of PD-L1 with the neutralization of VEGF-A. This dual targeting allows BNT327/PM8002 to restore the immune system’s ability to detect and destroy cancer cells while suppressing the tumor’s ability to form new blood vessels to sustain itself, the companies claim.
In an investor note on Wednesday, BMO Capital Markets analyst Etzer Darout noted that the acquisition is a “good deal” for BioNTech, given that the firm projects $2 billion in sales for BNT327/PM8002 by 2032, “based on indications we believe BNTX could develop.”
“We view the deal as a positive for BNTX with the potential for a good [return on investment] if the company can realize BNT327’s clinical potential,” Darout added.
This mechanism of action—targeting both the PD-1 and VEGF pathways—has quickly become one of the hottest developments in oncology since September 2024, when Akeso and Summit Therapeutics revealed that their PD-1/VEGF-A bispecific ivonescimab beat Merck’s blockbuster cancer therapy Keytruda (pembrolizumab) in a Phase III non-small cell lung cancer study.
Ivonescimab’s advantage was substantial: compared with Keytruda, the investigational bispecific reduced the risk of disease progression or death by 50%, an effect that was highly statistically significant with a p-value less than 0.0001, the companies noted at the time.
BioNTech is hoping to carve out a similar niche for BNT327/PM8002, which CEO Ugur Sahin said in Wednesday’s statement “has the potential to set a new standard of care in multiple oncology indications, surpassing traditional checkpoint inhibitors.”
The German biotech first recognized the potential of BNT327/PM8002 in November 2023, when it paid Biotheus $55 million for the right to develop, manufacture and commercialize the bispecific outside the Greater China region. That deal included potential development, regulatory and sales milestones exceeding $1 billion in value, plus tiered royalties.
According to Wednesday’s news release, BNT327/PM8002 has so far been administered to 700 patients across different trials and has demonstrated “encouraging efficacy and tolerability” in several tumor types. BioNTech plans to launch “multiple” registrational trials for BNT327/PM8002 in 2024 and 2025, assessing its combination with chemotherapy for different solid tumor indications, such as non-small cell lung cancer and triple-negative breast cancer.
BioNTech is also looking to test BNT327/PM8002 with its proprietary antibody-drug conjugates (ADCs). The company in June 2024 kicked off a Phase I/II study of the bispecific with BNT325/DB-1305, an anti-TROP2 ADC being developed in partnership with Duality Biologics, for advanced or metastatic solid tumors.
Aside from BNT327/PM8002, Wednesday’s acquisition will also grant BioNTech ownership over all of Biotheus’ other pipeline candidates and its in-house platform for developing bispecific ADCs. The deal will also expand BioNTech’s China footprint, giving it a local R&D presence for conducting clinical trials.
