Sanofi SA and Seagen Inc. have reported antibody-drug conjugates comprising antibodies targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5; CEA; CD66e) covalently linked to topoisomerase I inhibitors through a linker reported to be useful for the treatment of cancer.
The Hodgkin lymphoma space found itself in the spotlight late last year when Affimed NV rolled out updated data with lead innate cell engager acimtamig when combined with allogeneic natural killer cells. Findings from the investigator-initiated trial became the topic of talk at the American Society of Hematology meeting, when Yago Nieto, professor at the University of Texas MD Anderson Cancer Center – and principal investigator of the study – spoke.
The landscape of biopharma deals and M&As has seen a transformative shift, with a year-over-year drop in transaction numbers while value has increased. Overall, biopharma deals saw an uptick in value of nearly 6%, and biopharma M&As concurrently soared 80% higher in value than the previous year.
Pharma-biotech pairings continued apace in the antibody-drug conjugate (ADC) space, with 2023 capped by Legochem Biosciences Inc. signing a $1.7 billion licensure deal with Johnson & Johnson arm Janssen Biotech Inc. for the former’s Trop2-directed compound, the second-biggest Korean technology transfer agreement.
The BioWorld Cancer Index (BCI) saw its highest point of the year from April through July, when it had a run above 30%, before falling to 23.5% at the end of August. It closed Q3 up 22.96% for the year, a sharp divergence from the more extensive Nasdaq Biotechnology Index and Dow Jones Industrial Average, which are tracking down 6.16% and up 1.09%, respectively.
Antibody-drug conjugates (ADCs) are effective anti-cancer agents in a wide variety of solid and hematologic cancers. CD30 (TNFRSF8), a member of the TNF receptor superfamily is the target of antibody drug conjugate Adcetris (brentuximab vedotin/BV, Seagen Inc.) approved for use in multiple CD30-expressing lymphomas.
In a mammoth deal with a potentially huge payoff, Nurix Therapeutics Inc. and Seagen Inc. will collaborate to develop what they call a new class of medicines, Degrader-Antibody Conjugates, to create drugs with new mechanisms of action for treating cancer.
Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way.
As Seagen Inc. preps for a merger, the U.S. FDA awarded accelerated approval to the company’s big-selling Padcev (enfortumab vedotin). The approval is for a combination therapy with Merck & Co. Inc.’s Keytruda (pembrolizumab) as a first-line treatment for adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy.
The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
