Padcev plus Keytruda received positive CHMP opinion for first-line bladder cancer tretment

CLINICAL AND REGULATORY 

Padcev plus Keytruda received positive CHMP opinion for first-line bladder cancer treatment

The positive CHMP opinion is based on data from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed the combination significantly extends OS and PFS compared to platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer. Treatment with the combination resulted in a median OS of 31.5 months compared to 16.1 months with chemotherapy. The median PFS of 12.5 months with the combination compared to 6.3 months with chemotherapy represents a 55% reduction in the risk of cancer progression or death. 

Mabwell received NMPA approval for clinical trial of novel nectin-4 ADC in breast cancer 

Mabwell announced its novel nectin-4 targeting ADC has been approved by the NMPA to enter Phase 2 trial as monotherapy or in combination with a PD-1 inhibitor for the treatment of triple-negative breast cancer (TNBC). The trial aims to evaluate the efficacy and safety of the compound as monotherapy or in combination with a PD-1 inhibitor in patients with locally advanced or metastatic TNBC. Clinical results previously presented at the 2024 ASCO meeting showed that among the 20 patients with locally advanced or metastatic TNBC treated by the ADC and evaluable for efficacy assessment, the ORR and DCR were 50% and 80% respectively. The mPFS was 5.9 months, and the mOS was not yet reached, with one patient achieved complete response. 

AC Immune unveiled novel therapeutic ADC technology in neurodegenerative diseases 

AC Immune unveiled a novel class of neurodegenerative disease-fighting drug-candidates called morADC (Morphomer Antibody Drug Conjugate) in an oral presentation at the annual Alzheimer’s Association International Conference. While in oncology ADCs are designed to selectively kill tumor cells in a targeted manner, morADC combine the high brain penetrance of Morphomer small molecules with the target specificity of monoclonal antibodies, to reduce pathological, aggregating proteins in the central nervous system. The technology demonstrated significant synergies, substantially increasing blood brain barrier penetration and potency to inhibit protein aggregation compared to the antibody or small molecule alone. 

DEALS AND FINANCING 

BMS axed Eisai ADC collaboration three years after paying $650 million upfront 

Eisai announced that it has agreed to end its global strategic collaboration with BMS for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC), formerly known as MORAb-202, a FRα-targeting ADC due to ongoing portfolio prioritization efforts within BMS. Based on the agreement, Eisai now owns all rights to FZEC and will solely conduct the global development and commercialization of the agent. Eisai will accelerate the development of the agent as a high priority with the hope of delivering it to patients as early as possible. Eisai plans to refund a part of the unused portion of the $200 million payment it received towards research and development expenses from BMS under the collaboration agreement and record the remaining as other income. FZEC is Eisai’s first ADC and is composed of Eisai’s in-house developed farletuzumab, a humanized IgG1 monoclonal antibody that binds to the FRα, and Eisai’s in-house developed anticancer agent eribulin, using an enzymatically cleavable linker. Currently, three clinical studies are ongoing: Eisai’s Phase 1/2 study for solid tumors, and Bristol Myers Squibb’s Phase 2 studies for ovarian, peritoneal and fallopian tube cancers and non-small cell lung cancer. 

Myricx raised $115 million to advance its novel NMTi-ADC therapeutics into clinical development 

Myricx Bio, a UK biotech company focusing on the discovery and development of a completely novel class of payloads for ADCs, announced the closing of its series A financing raising £90m ($114m). The round was co-led by new leading life science investors Novo Holdings and Abingworth. Additional new investors British Patient Capital, Cancer Research Horizons and Eli Lilly and Company also participated alongside founding investors Brandon Capital and Sofinnova Partners. In connection with the financing, Michael Bauer from Novo Holdings and Lucille Conroy from Abingworth will join Myricx’s Board of Directors. The funds will be used to build out Myricx’s proprietary N-Myristoyltransferase inhibitor (NMTi) ADC payload platform and to advance its pipeline of NMTi-ADCs through clinical proof of concept targeting clinically validated tumour-associated antigens.