Shots:
Ipsen has entered into an exclusive licensing agreement with Simcere Zaiming for SIM0613 to treat solid tumors with the highest unmet needs
Ipsen will secure global rights to SIM0613 outside Greater China, gain manufacturing rights after technology transfer, & assume responsibility for all development activities beyond Greater China, incl. P-I preparation & IND/CTA submissions
As…
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The US FDA has granted ODD to GSK’s risvutatug rezetecan (GSK5764227) for the treatment of small-cell lung cancer (SCLC)
Designation was supported by preliminary P-I (ARTEMIS-001) trial data showing durable responses in pts with extensive-stage SCLC treated with risvutatug rezetecan
GSK’227 is a B7-H3-targeted ADC developed by Hansoh Pharma for various solid tumors. GSK…
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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…
Shots:
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…

