CLINICAL AND REGULATORY
Trodelvy offered modest OS benefit over chemo, but worked in patients not eligible for Enhertu
The three-plus months of OS benefit from Gilead’s Trodelvy in HR-positive, HER2-negative breast cancer in the closely watched TROPiCS-02 study represents a modest benefit relative to competing ADC Enhertu in a similar population, but it could secure a market in a subset of patients not eligible for the Enhertu. In a late-breaking abstract released ahead of ESMO, Gilead reported that the TROP2-targeted ADC led to a median OS of 14.4 months versus 11.2 months with chemotherapy.
Though Trodelvy hasn’t matched the survival data achieved by Enhertu, the TROPiCS-02 study included a subset of patients that wasn’t included in the Enhertu study. The company confirmed a PFS benefit in both subpopulations, carving out HR-positive, HER2-negative breast cancers as a potential market for Trodelvy that’s not yet addressed by Enhertu. The company confirmed a PFS benefit in both subpopulations, carving out HR-positive, HER2-negative breast cancers as a potential market for Trodelvy that’s not yet addressed by Enhertu.
EMA’s CHMP recommended Zynlonta for treatment of DLBCL
Zynlonta loncastuximab tesirine, a CD19 directed antibody drug conjugate ADC Therapeutics and Swedish Orphan Biovitrum, was recommended by EMA’s CHMP for diffuse large B cell lymphoma and high grade B cell lymphoma. SOBI received rights to commercialize the therapy in the EU in July. Under the terms of the agreement, ADC is eligible for $50 million upon the first approval by the EC.
DEALS AND FINANCING
Zai Lab gained rights to Tivdak from Seagen in Greater China
Zai Lab announced a deal with Seagen, under which it gains rights to Tivdak tisotumab vedotin-tftv in mainland China, Hong Kong, Macau and Taiwan. Tivdak became the first ADC for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy after it gained accelerated approval from FDA last year. Tivdak comprises a human mAb directed to tissue factor and Seagen’s ADC technology, which uses a protease-cleavable linker that covalently attaches microtubule-disrupting agent monomethyl auristatin E to the antibody. Seagen will receive $30 million up front and is eligible to receive $263 million in milestones, plus tiered royalties.
Startup Pheon banks $68 million series A to design new ADC payloads
Months after CEO Bertrand Damour steered NBE to a sale to Boehringer Ingelheim, he has assumed leadership of Pheon, a start-up seeking to advance an ADC as well as a payload technology platform the company hopes it can improve from a prior attempt. Pheon Therapeutics revealed a $68 million series A round, with Brandon Capital, Forbion and Atlas Venture as co-leaders. Seed investor Research Corporation Technologies also participated. Pheon is advancing a PDD dimer conjugation platform that belonged to Femtogenix. The platform was “not doing well” in Femtogenix’s hands, but Pheon believes it can enhance its safety profile through improved chemistry. He declined to say exactly how, but the company believes it can optimize for “the right balance” of safety and efficacy. Along with the platform, Pheon has in-licensed an antibody from undisclosed company with which it intends to create a first-in-class ADC. The company is aiming to submit its first IND within 18 months.