BeiGene ends Shoreline partnership in step back from cell therapy

26 Feb 2024
firstwordpharma.com
Cell TherapyDrug ApprovalAccelerated ApprovalImmunotherapy
BeiGene’s first foray into cell therapy has ended without bearing any fruit. The cancer drugmaker disclosed in a securities filing Monday that it has parted ways with Shoreline Biosciences more than three years after first agreeing to develop NK cell therapies together.
Under the 2021 deal, BeiGene paid $45 million upfront to collaborate with Shoreline on anti-cancer cell therapies against four targets using the latter’s iPSC NK cell technology.
The terminated partnership leaves BeiGene’s pipeline bereft of cell therapies to treat cancer, though investors don’t seem to mind. Stellar sales of Brukinsa (zanubrutinib) and Tevimbra (tislelizumab) – to which Novartis recently handed back its rights – pushed the firm’s 2023 revenues to an all-time high, and its stock gained more than 3% Monday.
The Chinese firm reported 2023 revenues of $2.2 billion, up 75% from its 2022 product sales of $1.4 billion, roughly in-line with analyst expectations.
Bullish on BTK
Brukinsa continued to collect approvals last year, most notably for relapsed/refractory chronic lymphocytic leukaemia (CLL) in both the US and Europe, where the BTK inhibitor is also approved to treat mantle cell lymphoma, Waldenström's macroglobulinemia and marginal zone lymphoma (MZL). For more, see ViewPoints: Safety makes Brukinsa first choice in chronic lymphocytic leukaemia.
Full-year global sales of Brukinsa reached $1.3 billion last year, more than double its 2022 revenues of $564.7 million, with that figure expected to only increase as US sales continue to grow.
Revenue could receive a bump if the FDA approves Brukinsa in combination with obinutuzumab to treat relapsed/refractory follicular lymphoma in adults who have received at least two prior lines of systemic therapy; the drug received European approval of the indication in November. A decision is expected in March, and if positive, would grant the BTK inhibitor the broadest label in the class.
PD-1 progress
Despite facing turmoil from a terminated agreement with Novartis, anti-PD-1 antibody Tevimbra brought in $536.6 million last year, up from its 2022 sales of $422.9 million.
In September, European regulators approved the drug to treat adults with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. That same day, Novartis returned all rights for Tevimbra to BeiGene.
The drug also saw a ray of bright news on Monday, as a committee for the European Medicines Agency (EMA) recommended approval of Tevimbra for a trio of non-small-cell lung cancer (NSCLC) indications as both a monotherapy treatment and as part of two different combinations with chemotherapy.
Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC, with a decision expected next half.
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