Shots:
Day One has entered into a definitive merger agreement to acquire Mersana, delisting Mersana from the public market & making it a wholly owned subsidiary upon deal completion
As per the deal, Day One will acquire Mersana for $25/share plus a CVR of ~$30.25/share tied to certain clinical development, regulatory, & commercial milestones for…
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Daiichi Sankyo has dosed the first patient with DS3610 in P-I trial for the treatment of advanced, metastatic or unresectable solid tumors
The P-I trial will evaluate DS-3610 in advanced or metastatic solid tumors to determine the recommended dose, assessing PK & immunogenicity endpoints plus safety endpoints incl. DLTs & AEs. Exploratory endpoints like…
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Syndivia has granted GSK exclusive global rights to develop and commercialize a preclinical ADC for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
As per the deal, GSK will handle global development, manufacturing, & commercialization of the ADC in exchange for an upfront payment, along with development & commercial milestone payments up to a total of…
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Daiichi Sankyo and Merck reported efficacy results for raludotatug deruxtecan (R-DXd) in patients with recurrent Pt.-resistant ovarian, primary peritoneal, or fallopian tube cancer from the P-II (dose-optimization) part of the REJOICE-Ovarian01 P-II/III study
Across all doses (4.8 mg/kg, 5.6 mg/kg, and 6.4 mg/kg), ORR was 50.5% (n=107) as assessed by BICR, with 3 complete…
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BI has entered into a global collaboration & licensing agreement with AimedBio to develop a novel ADC for a broad range of cancers, expanding NBE Therapeutics’ portfolio (BI subsidiary)
As per the deal, AimedBio will receive ~$991M, incl. an upfront, development & regulatory milestones, plus commercial milestones, as well as net sales-based royalties
AimedBio’s…
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The US FDA has granted FTD to ADCE-D01 for the treatment of soft tissue sarcoma (STS)
ADCE-D01 is being evaluated in P-I/II (ADCElerate1/EUCT) dose escalation & expansion study as a monotx. for metastatic &/or unresectable STS, with enrolment ongoing in the US & EU
ADCE-D01 is an ADC targeting uPARAP & conjugated to the…
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The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with Avastin
Designation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…
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Novatim has entered into an exclusive global licensing agreement (excl. China) with RADIANCE Biopharma for KY-0301 to treat cancer
As per the deal, RADIANCE Biopharma will receive rights to develop, register, & commercialize KY-0301 globally (excl. China) in exchange for $15M upfront, ~$150M in R&D & registration milestones & ~$1B in commercial milestone, with progressive…
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The US FDA has granted BTD to izalontamab brengitecan (iza-bren) for LA/M NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations progressing on or after EGFR TKI & Pt-based CT
Designation was backed by data from 3 ongoing trials: BL-B01D1-101 & BL-B01D1-203 in China led by Sichuan Biokin, & the global BL-B01D1-LUNG-101…
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Mabwell has dosed its first patient with Bulumtatug Fuvedotin (BFv or 9MW2821) in P-I trial for the treatment of TNBC pts
Trial will assess safety & efficacy of BFv in TNBC pts previously treated with a taxane & an ADC with a topoisomerase inhibitor payload, measuring ORR as the 1EP
Bulumtatug Fuvedotin, a Nectin-4–targeting…

