Tevimbra is a humanised IgG4 anti-PD-1 monoclonal antibody designed to lower binding to Fc-gamma (Fcγ) receptors on macrophages, supporting the body’s immune cells to detect and fight tumours
Novartis campus in Basel, Switzerland. (Credit: Silesia711 from Wikimedia Commons)
Biotechnology company BeiGene has signed an agreement with Switzerland-based Novartis to regain worldwide rights to develop, manufacture, and commercialise Tevimbra (tislelizumab).
Tevimbra is a humanised IgG4 anti-PD-1 monoclonal antibody. It is specifically designed to lower binding to Fc-gamma (Fcγ) receptors on macrophages, supporting the body’s immune cells to detect and fight tumours.
BeiGene has introduced over 20 potentially registration-enabling trials with Tevimbra. It has shown positive results in 10 late-stage randomised trials and four Phase 2 trials.
The prior partnership and licence agreement, signed in January 2021, was mutually agreed to be terminated.
According to the new agreement, BeiGene regained complete global rights to Tevimbra with no royalty payments due to Novartis.
The Swiss firm will also offer BeiGene transition services and support to ensure that crucial Tevimbra development and commercialisation plan elements, including manufacturing, regulatory, safety, and clinical assistance, can proceed without interruption.
The biotechnology firm has agreed to provide Novartis with the ongoing clinical supply of monoclonal antibodies to support its clinical trials.
In accordance with the prior agreement, Novartis oversaw regulatory submissions and, after receiving regulatory approval, had the right to market in the licensed countries.
BeiGene co-founder, chairman and CEO John Oyler said: “We are excited to regain the global rights to Tevimbra, which enables us to build out our in-house solid tumour commercial capabilities and complements our deep pipeline presented at our recent R&D Day.
“With more than 12,000 patients enrolled in our Tevimbra global clinical trial programme, we plan to rapidly accelerate our regulatory and development plans across a wider range of tumour types.”
In a separate development for Tevimbra, BeiGene secured European Commission (EC) approval for the anti-PD-1 antibody in oesophagal squamous cell carcinoma (ESCC) treatment.
EC has approved Tevimbra as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy.
The biotechnology company also announced that the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.