NEWS

Agenus Highlights Data from Five Studies of Botensilimab/Balstilimab (BOT/BAL) Regimen as Multiple lines of Therapy in Colorectal Cancer at ASCO GI 2025

Shots: P-II neoadj. studies were UNICORN (n=56) & NEST (n=24) in resectable CRC. UNICORN: 93% & 29% pCR with 100% & 36% pMR in dMMR/MSI-H & pMMR/MSS tumors, respectively; NEST: At 18 (NEST-1) & 9mos. (NEST-2) follow-up, all were ctDNA-ve w/o recurrences; pMR improved to 47% in MSS tumors in NEST-2 P-I/II study of BOT/BAL…

January 23, 2025

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Shots: The US FDA has granted Orphan Drug Designation to Zai Lab’s ZL-1310 for treating small cell lung cancer (SCLC) The designation is based on promising P-Ia/Ib trial data of ZL-1310 as monotherapy and with atezolizumab in treatment-experienced ES-SCLC patients, presented at the ENA Symposium 2024 ZL-1310 is a novel ADC targeting DLL3…

January 23, 2025

Holon Health Reports Development of Holon Vibe App for the People with Substance Use Disorders (SUD)

Shots: Holon Health reported the development of Holon Vibe, a multi-modal therapeutic app to provide health evaluations & care plan management for people with SUD in Indiana & Arizona, with more states to be added in 2025 Primary data for the app showed a 65%+ appointment show rate for users, a 61-day increase in…

January 23, 2025

Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots: The P-III (ALLEVIATE-1) study assessed analgesic efficacy of cebranopadol (400µg, QD) vs PBO for treating moderate-to-severe acute pain post abdominoplasty surgery Study depicted significantly reduced pain intensity as evaluated by Pain Numeric Rating Scale (NRS) AUC4-48 (1.34 mean hourly difference) and a well-tolerated safety with nausea being the common AE Tris will…

January 23, 2025

Coherus to Highlight Final P-II Study Data of Casdozokitug Regimen to Treat Metastatic Hepatocellular Carcinoma at ASCO-GI 2025

Shots: Coherus will present the P-II trial data of casdozokitug (10mg/kg; IV; Q3W) + Tecentriq (1200mg) + Avastin (15mg/kg) vs PBO for 1L LA/M HCC patients (n=30), in both viral & non-viral diseases, at ASCO GI 2025 Study (as of Sep 2024) met its 1EP of safety & all 2EPs depicting 38% ORR (5…

January 23, 2025

Antennova to Highlight P-I/II (CLINCH) Trial Data of ATN-022 to Treat Advanced/Metastatic Gastric Cancer at ASCO GI 2025

Shots: The company will highlight data from P-I/II (CLINCH) trial of ATN-022 to treat advanced/metastatic gastric cancer in Australia & China at ASCO GI 2025 under the title, ‘Safety and Preliminary Efficacy of ATG-022 in Patients with Advanced/Metastatic Gastric Cancer (CLINCH)’ In the dose expansion phase (as of Nov 2024), 21 patients with CLDN18.2…

January 22, 2025

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

Shots: The US FDA has granted FTD to SGT-212 for treating Friedreich’s ataxia (FA) and previously approved its IND on Jan 07, 2025 The P-Ib study will assess safety & tolerability of contemporaneous systemic IV and bilateral IDN administration of SGT-212 in non-ambulatory and ambulatory FA patients for 5yrs., with dosing anticipated during H2’25…

January 22, 2025

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM patients, following the CHMP’s positive opinion. Regulatory findings are under review in Japan & China Approval was based on a P-III (IMROZ) study assessing Sarclisa + VRd vs VRd, which showed improved PFS of 40% (1EP) with findings reported…

January 22, 2025

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

Shots: The US FDA has granted 510(k) clearance & CLIA waiver for Cobas liat STI multiplex assay panels (CT/NG & CT/NG/MG), commercially available under the CE mark in upcoming months The CT/NG (chlamydia & gonorrhea) & CT/NG/MG (chlamydia, gonorrhea & Mycoplasma genitalium) assays compliment the existing portfolio of singleplex & multiplex tests of Cobas liat…

January 22, 2025

ArriVent Biopharma Collaborates with Lepu BioPharma to Develop and Commercialize MRG007 for the Treatment of Gastrointestinal Cancers

Shots: ArriVent & Lepu Biopharma entered into an exclusive license agreement for MRG007, where ArriVent will get rights to develop & market MRG007 (ADC) globally excl. Greater China (mainland China, Hong Kong, Macau & Taiwan) As per the terms, Lepu Biopharma will receive upfront, near-term milestones ($47M cash) & development, regulatory & sales milestones…

January 22, 2025

NEWS

Agenus Highlights Data from Five Studies of Botensilimab/Balstilimab (BOT/BAL) Regimen as Multiple lines of Therapy in Colorectal Cancer at ASCO GI 2025

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Holon Health Reports Development of Holon Vibe App for the People with Substance Use Disorders (SUD)

Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Coherus to Highlight Final P-II Study Data of Casdozokitug Regimen to Treat Metastatic Hepatocellular Carcinoma at ASCO-GI 2025

Antennova to Highlight P-I/II (CLINCH) Trial Data of ATN-022 to Treat Advanced/Metastatic Gastric Cancer at ASCO GI 2025

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

ArriVent Biopharma Collaborates with Lepu BioPharma to Develop and Commercialize MRG007 for the Treatment of Gastrointestinal Cancers

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