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Grünenthal to Acquire Bayer’s Stivarga for ~€375M

Shots: Grünenthal has entered into an agreement with Bayer to acquire Stivarga for ~€375M (~$430.67M), subject to customary closing conditions incl. regulatory approval, with the transaction expected to close by the end of 2026 or early 2027 Stivarga (regorafenib) is an oral multikinase inhibitor indicated for metastatic colorectal cancer, hepatocellular carcinoma, & gastrointestinal stromal tumours…

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Acepodia Reports the US FDA IND Clearance to Initiate P-I Trial of ACE723 in HCC

Shots: The US FDA has granted IND clearance to ACE723 for the initiation of P-I trial to treat patients with unresectable or metastatic hepatocellular carcinoma (HCC) The P-I study will assess ACE723’s safety, tolerability, dose-limiting toxicities, PK & preliminary antitumor activity in above-mentioned pts, with dose-escalation portion of establishing recommended dose for further development &…

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Astrazeneca

AstraZeneca Reports the P-III (EMERALD-3) Trial Data on Imfinzi Combination + TACE in Unresectable Hepatocellular Carcinoma

Shots: The P-III (EMERALD-3) trial assessed single priming dose of Imjudo (300mg) + Imfinzi (1500mg) followed by Imfinzi (Q4W) + transarterial chemoembolisation (TACE) ± lenvatinib vs TACE alone in 760 pts unresectable HCC eligible for embolization Imjudo + Imfinzi + Lenvatinib & TACE showed improved PFS (1EP) vs TACE alone, with OS (2EP) demonstrating a favorable trend in the…

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Akesobio

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

Shots: Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & China Cadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…

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Pilatus Biosciences Collaborates with Roche to Evaluate PLT012 & Tecentriq Combination for Hepatocellular Carcinoma (HCC)

Shots: Pilatus Biosciences & Roche have entered into a clinical trial collaboration to evaluate PLT012 + atezolizumab for HCC pts Under the collaboration, Roche will supply atezolizumab (Tecentriq) for Pilatus' P-I study of PLT012 in combination therapy for HCC, with plans to expand to other cancers PLT012 is a humanized mAb that blocks CD36-driven lipid uptake, targeting…

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PharmaShots Interview Mahesh Karande, CEO of Omega Therapeutics Shares Insights from the Preclinical Data Presented at the AACR 2022

PharmaShots Interview: Mahesh Karande, CEO of Omega Therapeutics Shares Insights from the Preclinical Data Presented at the AACR 2022

Shots: Mahesh talked about the data presented on its lead candidate in hepatocellular carcinoma at the AACR 2022 Mahesh also spoke about Omega’s drug-development platform that identifies and targets specific and unique DNA sequences of regulatory elements  The interview gives a profound grip on Omega’s development strategies to use mRNA therapeutics as a new class…

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