FDA approved Adcetris for treatment of patients with large B-cell lymphoma

DEALS AND FINANCING

Corbus’ ADC targeting nectin-4 demonstrated encouraging safety and broader efficacy in Phase 1 

Corbus Pharmaceuticals presented data from its US and UK conducted first-in-human dose escalation clinical study of CRB-701 (SYS6002) at the ASCO GU. No dose limiting toxicities were encountered during the dose escalation phase of both studies. CRB-701 was well tolerated with majority of treatment emergent adverse events being grade 1 or 2 in both studies. Clinical responses were seen in urothelial and cervical cancer participants in both studies. First time targeting of head and neck squamous cell carcinoma with CRB-701 yields multiple responses.

Pfizer discontinued its B7-H4 ADC triggering $1 billion impairment charge 

Pfizer terminated the development of a B7-H4-directed ADC felmetatug vedotin (FV), triggering a $1 billion impairment charge. Pfizer announced the discontinuation alongside a $200 million charge linked to another ADC. The $1 billion charge is tied to B7-H4, an ADC that Pfizer acquired in its takeover of Seagen. Seagen was running Phase 1 in people with advanced solid tumors, the recruitment was twice stopped and resumed, but now Pfizer announced the program will be terminated based on clinical data generated to date. The data indicate that FV is unlikely to achieve a meaningful improvement over SOC chemotherapy in patients with advanced solid tumors, including triple-negative breast cancer. There have been no new safety signals observed in patients taking FV. Pfizer reported the discontinuation of FV as part of $2.9 billion in intangible asset impairment charges in its fourth-quarter results. Another ADC, disitamab vedotin (DV), accounted for $200 million of the charges. DV is a HER2 ADC that Seagen acquired under a deal with Remegen. The impairment charge reflects the reality of “emerging competition,” Pfizer said in its financial filing. RemeGen won approval for DV in China in 2021.   

Summit announces clinical trial collaboration with Pfizer to combine Ivonescimab with ADCs

Summit Therapeutics announced a clinical trial collaboration with Pfizer to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with several of Pfizer’s ADCs across multiple solid tumor settings. Each study intends to evaluate ivonescimab plus one of Pfizer’s vedotin ADCs in individual, distinct solid tumor settings to determine the safety profile and potential anti-tumor activity of the combinations. Summit will provide ivonescimab for use in the proposed studies, and Pfizer will be responsible for conducting the operations of the studies. The studies will be overseen by both Summit and Pfizer. Both parties retain their respective rights to their products. The studies combining ivonescimab with Pfizer’s vedotin ADCs are planned to begin in the middle of this year.

Bolt provided update on immunotherapy co-Development with Toray

Bolt Biotherapeutics announced that the target of their worldwide co-development collaboration with Toray Industries is Caprin-1, a novel cancer target discovered by Toray. The collaborators are developing a Boltbody Immune-Stimulating Antibody Conjugate (ISAC) targeting Caprin-1, which is applicable to multiple solid tumor types. Toray supplies its proprietary antibodies targeting Caprin-1, such as the antibody TRK-950, and Bolt contributes proprietary linker-payloads from its Boltbody ISAC platform technology. Bolt plans to co-develop and jointly commercialize the resulting ISAC product candidate with Toray. Caprin-1 is a tumor-specific antigen that is strongly expressed on the cell membrane surface of most solid tumors, with minimal expression on the surface of normal tissues. Caprin-1 has also been shown to contribute to tumor growth and metastases. Toray’s asset TRK-950 is a monoclonal antibody targeting Caprin-1 that is in Phase 2 development for Gastric cancer, providing validation for this antigen as a promising ISAC target.