Rapport Therapeutics Appoints Dr. Jeffrey Sevigny as Chief Medical Officer, Mar. 3, 2025
Rapport Therapeutics has appointed Dr. Jeffrey Sevigny as Chief Medical Officer, bringing over 15 years of leadership in translational and clinical drug development across neuroscience and rare diseases. Previously CMO at Prevail Therapeutics, a subsidiary of Eli Lilly, Dr. Sevigny played a key role in the company’s growth, including its IPO and acquisition. At Rapport, he will oversee clinical strategy and pipeline advancement, including the RAP-219 program. His expertise in regulatory interactions and team building will support Rapport’s mission to develop precision medicines for neurological disorders.
Full Article: Rapport Therapeutics Appoints Dr. Jeffrey Sevigny as Chief Medical Officer
Innovent Biologics Doses First Patient in Pivotal Study of IBI363 for Melanoma, Mar. 3, 2025
Innovent Biologics has dosed the first patient in a pivotal study evaluating IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, in patients with advanced mucosal or acral melanoma. The study, comparing IBI363 monotherapy with pembrolizumab, aims to validate IBI363’s potential to offer superior treatment outcomes. Early clinical trials have shown promising results, including a 61.5% objective response rate and 84.6% disease control rate, suggesting it may outperform current therapies. Innovent continues to advance IBI363 globally, aiming to provide effective treatment options for melanoma patients worldwide.
Full Article: Innovent Biologics Doses First Patient in Pivotal Study of IBI363 for Melanoma
CStone Pharmaceuticals Doses First Patient in Global Phase I Trial of CS2009, Mar. 3, 2025
CStone Pharmaceuticals has dosed the first patient in a global Phase I clinical trial for CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody targeting a range of advanced solid tumors, including non-small cell lung cancer and hepatocellular carcinoma. CS2009 combines three clinically validated targets to reverse T cell exhaustion, promote T cell activation, and block tumor angiogenesis, potentially offering enhanced efficacy with lower systemic toxicity. Early preclinical data showed superior anti-tumor activity, positioning CS2009 as a promising next-generation immunotherapy. The trial is currently being conducted in Australia, with plans for expansion into China and the U.S.
Full Article: CStone Pharmaceuticals Doses First Patient in Global Phase I Trial of CS2009
Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 Phase 1 Study, Mar. 3, 2025
Acadia Pharmaceuticals and Saniona have successfully completed two cohorts in their Phase 1 multiple-ascending-dose (MAD) study of ACP-711 in healthy volunteers. The drug was safe and well tolerated, with no serious adverse events or safety concerns. With essential tremor as the lead indication, the companies are seeking regulatory approval to extend the study to elderly volunteers and higher repeated doses. The trial is temporarily paused pending approval.
Full Article: Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 Phase 1 Study
Jeito Capital Announces Significant Participation in $187 Million Series A Financing for Callio Therapeutics, Mar. 3, 2025
Jeito Capital announced its significant participation in the $187 million Series A financing round for Callio Therapeutics, a biotechnology company focused on advancing multi-payload antibody-drug conjugates (ADCs) to enhance cancer therapy. Founded by Frazier Life Sciences, Callio is developing innovative HER2-targeted dual-payload ADCs and other programs to overcome the limitations of single-payload therapies. The funding round was led by Frazier Life Sciences, with Jeito and other prominent investors, including Novo Holdings and Omega Funds, joining in. Jeito's Rachel Mears will join Callio's Board, reaffirming Jeito's commitment to supporting transformative oncology innovations.
Full Article: Jeito Capital Announces Significant Participation in $187 Million Series A Financing for Callio Therapeutics
Centauri Therapeutics Selects First ABX-01 Clinical Candidate for Serious Lung Infections, Mar. 4, 2025
Centauri Therapeutics has selected its first clinical candidate for the ABX-01 program, targeting serious Gram-negative bacterial lung infections. Based on the Alphamer platform, the broad-spectrum antimicrobial peptide combines immunotherapeutic effects with antibacterial properties. Preclinical studies have shown strong activity against multidrug-resistant bacteria. Centauri is now conducting regulatory preclinical activities to advance ABX-01 into a Phase 1 clinical trial.
Full Article: Centauri Therapeutics Selects First ABX-01 Clinical Candidate for Serious Lung Infections
Clarity Pharmaceuticals Announces Progression to Dose Expansion Phase in SECuRE Trial, Mar. 5, 2025
Clarity Pharmaceuticals announced that the Phase 1/2 SECuRE trial (NCT04868604) has completed its dose escalation phase and is progressing to the dose expansion phase. The study evaluates 64Cu/67Cu-SAR-bisPSMA in metastatic castration-resistant prostate cancer (mCRPC). Based on Phase 1 data, the trial will proceed with an 8 GBq dose, increasing treatment cycles from 4 to 6. Across cohorts, 68% of patients achieved a PSA reduction, and 78% had disease control. The trial protocol has been amended to include pre-chemotherapy patients, with some receiving treatment in combination with enzalutamide. Final results are expected in September 2026.
Full Article: Clarity Pharmaceuticals Announces Progression to Dose Expansion Phase in SECuRE Trial
NorthSea Therapeutics Announces Publication of Positive Phase 2b ICONA Trial Results, Mar. 6, 2025
NorthSea Therapeutics announced promising Phase 2b ICONA trial results for icosabutate in MASH, published in the Journal of Hepatology. The study showed significant fibrosis improvement in both AI-assisted and conventional histology assessments, along with glycemic and inflammatory benefits. Icosabutate was well tolerated with no cases of drug-induced liver injury, making it a potential monotherapy or combination therapy for advanced MASH patients.
Full Article: NorthSea Therapeutics Announces Publication of Positive Phase 2b ICONA Trial Results
ITM Isotope Technologies Prepares for U.S. Approval of ITM-11 After Phase III Results, Mar. 6, 2025
ITM Isotope Technologies Munich SE is preparing to enter the U.S. market with its radiopharmaceutical therapy ITM-11 (177Lu-edotreotide) after Phase III COMPETE trial results showed a significant progression-free survival (PFS) advantage over Novartis’s Afinitor in GEP-NETs. With a median PFS of 23.9 months vs. 14.1 months for Afinitor, ITM plans to seek regulatory approval in 2025. The company leverages in-house manufacturing and a robust supply chain, positioning itself as a key player in the radiopharmaceutical industry.
Full Article: ITM Isotope Technologies Prepares for U.S. Approval of ITM-11 After Phase III Results
Avacta Therapeutics Announces Promising Early Efficacy and Safety Data for AVA6000, Mar. 7, 2025
Avacta Therapeutics has successfully completed Phase 1a dose escalation for AVA6000, a pre|CISION®-enabled form of doxorubicin, showing encouraging PFS data in salivary gland cancers with a 91% disease control rate. The Phase 1b expansion has begun, enrolling patients across three indications: salivary gland cancer, triple-negative breast cancer, and high-grade soft tissue sarcoma. Further Phase 1a data is expected in Q2 2025, with Phase 1b updates by year-end.
Full Article: Avacta Therapeutics Announces Promising Early Efficacy and Safety Data for AVA6000
Trimtech Therapeutics Raises £25 Million in Seed Funding to Advance Bispecifics, Mar. 7, 2025
Trimtech Therapeutics closed a £25 million (US$31 million) oversubscribed seed funding round to advance its targeted protein degradation treatments for neurodegenerative and inflammatory diseases.
Full Article: Trimtech Therapeutics Raises £25 Million in Seed Funding to Advance Bispecifics
