GERMANY — BioNTech has entered into a partnership with DualityBio, a move that will enable both companies to delve into next-generation antibody-drug conjugate (ADC) therapeutics for cancer and autoimmune diseases.

ADCs are antibodies linked to cancer-killing molecules that are designed to target tumour cells more effectively, so they have fewer harmful effects on healthy tissues.

Under the terms of the agreement, BioNTech will have access to two ADC candidates, which the companies will develop and commercialize globally.

This includes DualityBio’s lead candidate, DB-1303, and DB-1311, which is less advanced than DB-1303.

In exchange for access to these ADC candidates, BioNTech will pay US$170 million upfront, with milestone payments that could add up to US$1.5 billion.

This deal marks a major foray into ADC therapeutics by BioNTech as it seeks to expand beyond its COVID-19 vaccines and bring an additional class of drug to the company’s oncology portfolio.

In fact, this move comes at a crucial time for BioNTech, which reported a profit drop in Q4 2022 due to the decreased demand for its COVID-19 vaccines and projected a decline in vaccine sales this year.

Notably, BioNTech’s interest in oncology was also reflected earlier this year when the company made its biggest acquisition to date, with the purchase of InstaDeep for a staggering US$440 million in initial cash.

The rise of ADCs in oncology has garnered significant attention in recent years, with researchers exploring their potential in offering alternative treatment options for diseases that currently lack viable therapies.

A paper published in Cancer Cell International last year further highlighted the potential of ADCs, noting that these therapeutic agents could represent a promising therapy option where specific targeting by antibodies is possible and the therapeutic goal is to induce cell death in the target cells.

Given the increasing interest and research being dedicated to ADCs in oncology, BioNTech’s partnership with DualityBio comes as no surprise, and highlights the company’s continued commitment to advancing innovative and effective therapies for cancer patients.

Going forward, the company has indicated that it will be focusing more of its efforts on its oncology pipeline.

According to BioNTech CEO Ugur Sahin, the ADC field has made significant progress over the last few years, overcoming several limitations and demonstrating its potential as a broadly applicable precision medicine drug class that might be an alternative to standard chemotherapy.

Indeed, DB-1303, which is a third-generation ADC molecule that targets HER2-positive and HER2 low-tumor cancers, aims to address unmet medical needs in various HER2-expressing cancers.

By leveraging the strengths of both companies, the partnership hopes to accelerate the development and commercialization of these promising ADC therapeutics for the benefit of cancer patients worldwide.

BioNTech’s pipeline currently lists a total of 38 programs, of which 24 are dedicated to cancer indications.

One of the ways in which BioNTech has applied its mRNA technology to cancer treatment is through the development of personalized cancer vaccines.

In addition, the company has made significant strides in the field of chimeric antigen receptor T-cell therapy (CAR-T) with its wholly-owned novel candidate, BNT211.

Despite reporting positive follow-up Phase I/II data for BNT211 in patients with relapsed or refractory advanced solid tumors, the company did not see a corresponding rise in its stock as a result.

BNT211 is being studied both alone and in combination with a CAR-T cell Amplifying RNA Vaccine (CARVac) encoding Claudin 6 (CLDN6).

The CARVac is designed to enhance the in vivo expansion of transferred CAR-T cells, thereby increasing their persistence and efficacy.

Later this year, BioNTech has stated that it expects to provide a data update on an ongoing Phase I/II dose escalation and expansion study evaluating CLDN6 CAR-T cells with or without CLDN6 CARVac in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Looking ahead, BioNTech has ambitious plans for BNT211, with a Phase II study in patients with second-line plus platinum-resistant testicular cancer expected to commence in 2024.

Meanwhile, Japanese drugmaker Takeda is paying US$5 million upfront to Innate Pharma of the US in a deal that is seeking to extend the use of ADCs beyond their main use in oncology.

This move comes on the heels of another ADC licensing deal by Takeda, as well as Pfizer’s massive US$43 billion acquisition of ADC trailblazer Seagen.

Seagen’s technology has been instrumental in the development of four out of the twelve ADCs currently available in the US market.

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