Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC

Shots: The NMPA has approved IND application to initiate P-Ib/II trial of opamtistomig (LBL-024) in combination therapy for metastatic colorectal cancer (mCRC) Trial will evaluate the safety & efficacy of opamtistomig combination regimens in pts with mCRC & explore potential predictive biomarkers. Opamtistomig mechanism was already validated across EP-NEC, NSCLC, SCLC, & biliary tract cancer…

ByRidhi RastogiAugust 3, 2026

NEWS

Akeso Reports First Patient Dosing in P-Ib/II Study of AK138D1 + Ivonescimab in NSCLC

Shots: Akeso has dosed the first patient in the P-Ib/II (AK138D1-201) trial assessing AK138D1, as monotx. or in combination with ivonescimab for advanced NSCLC The study will evaluate the regimen across multiple settings in advanced NSCLC, incl. 1L treatment, treatment after EGFR-TKI resistance, & treatment after immuno-CT resistance AK138D1 is a HER3-targeted ADC comprising a…

ByRidhi RastogiJuly 28, 2026

NEWS

Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Shots: The US FDA has granted Fast Track designation to Lu AH69593 for the treatment of patients with narcolepsy Lu AH69593 is a small-molecule orexin 2 receptor agonist being developed by Lundbeck for narcolepsy to regulate arousal, wakefulness, & sleep-wake stability Lu AH69593 is being evaluated in a P-Ib clinical program, with Lundbeck continuing to…

ByRidhi RastogiJuly 24, 2026

NEWS

Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Shots: 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…

ByRidhi RastogiJune 15, 2026

NEWS

Eli Lilly Reports the P-Ib (Heart-2) Trial Data on VERVE-102 as a One-Time Treatment for Hypercholesterolemia

Shots: 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…

ByRidhi RastogiMay 26, 2026

NEWS

Sensei Biotherapeutics Reports First Patient Dosing in P-Ib/II Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer

Shots: 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%…

ByRidhi RastogiMay 5, 2026

NEWS

Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Shots: 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…

ByRidhi RastogiApril 7, 2026

NEWS

Adagene Reports P-Ib/II Trial Data on Muzastotug + Keytruda for Microsatellite Stable Colorectal Cancer (MSS CRC)

Shots: 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…

ByRidhi RastogiApril 6, 2026

NEWS

J&J Presents the P-Ib/II (OrigAMI-1) Trial Data on Rybrevant for Metastatic Colorectal Cancer at ASCO GI 2026

Shots: 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.,…

ByRidhi RastogiJanuary 12, 2026

NEWS

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Shots: 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…

ByPrince GiriDecember 8, 2025

Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC

Akeso Reports First Patient Dosing in P-Ib/II Study of AK138D1 + Ivonescimab in NSCLC

Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Eli Lilly Reports the P-Ib (Heart-2) Trial Data on VERVE-102 as a One-Time Treatment for Hypercholesterolemia

Sensei Biotherapeutics Reports First Patient Dosing in P-Ib/II Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer

Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Adagene Reports P-Ib/II Trial Data on Muzastotug + Keytruda for Microsatellite Stable Colorectal Cancer (MSS CRC)

J&J Presents the P-Ib/II (OrigAMI-1) Trial Data on Rybrevant for Metastatic Colorectal Cancer at ASCO GI 2026

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Contact US

FOLLOW US