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Akeso has enrolled the first patient in the P-Ib/II (AK138D1-202) study assessing its AK138D1 monotx. or in combination with ivonescimab for the treatment of advanced breast cancer
The trial is evaluating AK138D1 in 2 breast cancer subtypes: HR+/HER2- & triple-negative breast cancer. The study incl. pts ranging from treatment-naïve to heavily pretreated & enrolls…
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Trial assessed Lilly's VERVE-102 (IV; 0.3, 0.45, 0.6, 0.7, 0.8 & 1mg/kg) in 35 adults with HeFH or premature coronary artery disease who required additional LDL-C lowering despite maximally tolerated oral lipid-lowering therapy
Single infusion of VERVE-102 led to dose-dependent PCSK9 reductions of 51% (0.3mg/kg) to 88% (1mg/kg), with corresponding mean LDL-C reductions of…
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Sensei Biotherapeutics has dosed the first patient in P-Ib/II (FTH-PIK-101) trial assessing PIKTOR (serabelisib & sapanisertib) + fulvestrant &/or other anticancer therapies in pts with HR+/HER2- advanced or metastatic breast cancer
PIKTOR was evaluated in the P-Ib study in heavily pretreated advanced breast, endometrial, & ovarian cancers, where PIKTOR + paclitaxel achieved a 47%…
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Akeso has reported P-Ib/II study data assessing cadonilimab + anlotinib & docetaxel in pts with locally advanced or metastatic NSCLC who progressed after prior PD-(L)1 inhibitor-based therapy
At mFU of 21.45mos., the trial showed 6mos. PFS rate of 55.7%, with an mPFS of 7mos. in the overall population, while in sq-NSCLC & PD-L1 TPS…
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The P-Ib/II trial randomized 67 MSS CRC pts (65 evaluable) with no liver metastases to muzastotug (10mg/kg; Q3W or Q6W) or muzastotug (20mg/kg) followed by 10mg/kg (Q3W), or 20 mg/kg (Q6W), all in combination with Keytruda; P-II data expected in H1’27
As of Jan 24, 2026, pts in 10mg/kg cohorts (N=39) showed ORR of…
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J&J has reported longer follow-up results from Cohorts D & E of the P-Ib/II (OrigAMI-1) trial assessing Rybrevant (amivantamab-vmjw; IV) ± FOLFOX/FOLFIRI in pts with RAS/BRAF wild-type mCRC
At mFU of 16mos., Rybrevant + FOLFOX (n=20) or FOLFIRI (n=23) achieved a cORR of 51%, with early responses & median time to first response of 8.3wks.,…
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Nurix reported updated P-Ia/I b data for bexobrutideg in which P-Ia (n=48) showed an ORR of 83% incl. 2 CRs & a median PFS of 22.1mos. across all doses (50 mg to 600 mg OD) in heavily pretreated relapsed/refractory CLL/SLL pts.; P-Ib data (n=42) indicated higher ORR i.e. 83.3% & longer PFS at the 600mg…
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Nanjing Leads Biolabs has enrolled the first patient in P-Ib/II trial assessing opatisumab as monotx. & in combination with toripalimab, for the treatment of 1L advanced melanoma in China
Additionally, Opatisumab is being evaluated as monotx. in a registrational study for EP-NEC that completed enrolment in Aug 2025, & is also under investigation in multiple P-II trials…
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Japan’s MHLW has granted ODD to mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)
Mosliciguat (dry powder inhaler) is being evaluated in an ongoing global P-II (PHocus) trial against PBO among ~120 PH-ILD adults, with trial design to be presented at ERS Congress 2025
Mosliciguat is an sGC activator that…
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Fosun Pharma has granted Expedition global rights to develop, manufacture, & commercialize XH-S004, excl. Mainland China, Hong Kong SAR, & Macau SAR, where Fosun will retain its rights
As per the deal, Fosun will receive $120M incl. upfront & development milestone payments, with ~$525M in sales milestones
XH-S004 (DPP-1 inhibitor, PO) is being investigated…

