Opna Bio - Clinical Trial Updates, Aug 26, 2024
Opna Bio has dosed the first patient with OPN-6602, a selective EP300/CBP bromodomain inhibitor, in a Phase 1 study for relapsed or refractory multiple myeloma. The trial, enrolling up to 130 patients in the U.S., aims to assess OPN-6602’s safety, tolerability, and anti-tumor activity. Preclinical data showed significant tumor growth inhibition, and the study will explore OPN-6602 both alone and with dexamethasone, with results expected by late 2026.
Full Article: Opna Bio Initiates Phase 1 Study of OPN-6602 in Relapsed or Refractory Multiple Myeloma
Opna Bio - Executive Changes, Aug 26, 2024
Opna Bio has appointed Axel Bolte, MBA, MSc, as a board director and Stephanie Oestreich, PhD, MPA, as a board observer following an investment from the Myeloma Investment Fund. Bolte, former CEO of Inozyme Pharma, and Oestreich, managing director of the Myeloma Investment Fund, bring extensive experience in industry operations, financing, and business development. Their appointments are expected to enhance Opna’s strategic and operational capabilities.
Full Article: Opna Bio Announces New Board Appointments
Mabwell - Clinical Trial Updates, Aug 26, 2024
Mabwell has launched a Phase 3 trial (NCT06196736) to test the ADC 9MW2821 with toripalimab versus standard chemotherapy for advanced urothelial cancer. The trial, which received breakthrough designation from China's NMPA, will enroll 420 patients and aims to complete by December 2026. A Phase 1b/2 trial of the combination is also underway.
Full Article: Mabwell Launches Phase 3 Trial of 9MW2821 with Toripalimab for Advanced Urothelial Cancer
LIXTE Biotechnology - Clinical Trial Updates, Aug 26, 2024
LIXTE Biotechnology has dosed the first patient in a clinical trial (NCT06012734) for unresponsive metastatic colorectal cancer, using its compound LB-100 and Roche's atezolizumab. This study aims to make immunotherapy effective for the 85% of colorectal cancer patients who don't respond to current treatments. This trial is supported by Roche and follows a similar recent trial with GSK for ovarian cancer.
Full Article: LIXTE Biotechnology Doses First Patient in New Clinical Trial for Colorectal Cancer
Diakonos Oncology - Seed Funding, Aug 27, 2024
Diakonos Oncology has secured $11.4 million in an oversubscribed seed financing round, led by Restem Group. The funds will support the company's manufacturing operations, leadership expansions, and the completion of a Phase 1 study of its dendritic cell vaccine, DOC1021, for glioblastoma. Diakonos plans to advance into a Phase 2 trial by late 2025 and is also running trials for pancreatic cancer and angiosarcoma. The FDA has granted Fast Track designations for the GBM and pancreatic cancer programs, and Orphan Drug Designation for GBM.
Full Article: Diakonos Oncology Raises $11.4 Million in Seed Funding to Advance Dendritic Cell Vaccine
Sermonix Pharmaceuticals - Clinical Trial Updates, Aug 27, 2024
Sermonix Pharmaceuticals has completed enrollment for its Phase 2 trial evaluating lasofoxifene, a selective estrogen receptor modulator, as a neoadjuvant endocrine therapy in HR+/HER2- locally advanced breast cancer. This study is part of the Endocrine Optimization Pilot Protocol within the I-SPY 2 TRIAL and aims to explore lasofoxifene's efficacy and tolerability compared to standard aromatase inhibitors. The trial enrolled 20 patients and will assess outcomes such as safety, efficacy, and patient-reported quality of life, with the goal of enhancing breast cancer treatment while reducing toxicity.
Full Article: Sermonix Pharmaceuticals Completes Enrollment of Phase 2 I-SPY 2 Arm Evaluating Lasofoxifene
Medicus Pharma - Clinical Trial Updates, Aug 27, 2024
Medicus Pharma has begun its Phase 2 trial of D-MNA for nodular basal cell carcinoma (BCC), enrolling the first patient. The study will test two dose levels across 60 patients in the U.S., following a successful Phase 1 trial. CEO Dr. Raza Bokhari highlighted the goal of developing a non-invasive treatment for BCC, the world's most common cancer.
Full Article: Medicus Pharma Enrolls First Patient in Phase 2 Skin Cancer Trial
Astellas Pharma - Clinical Trial Updates, Aug 27, 2024
Astellas Pharma has initiated the HIGHLIGHT 1™ Phase 3 study, dosing the first patient with fezolinetant, an investigational nonhormonal oral treatment for moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy. VMS, including hot flashes and night sweats, are common side effects of these therapies, affecting up to 97% of patients. Breast cancer, the most prevalent cancer among women globally, saw approximately 2.3 million new cases in 2022.
Full Article: Astellas Pharma Doses First Patient in HIGHLIGHT 1™ Phase 3 Study of Fezolinetant for VMS
Verrica Pharmaceuticals - Positive Trial Data, Aug 28, 2024
VP-315, an investigational oncolytic peptide developed by Verrica Pharmaceuticals, demonstrated significant tumor reduction and complete histological clearance in over 50% of patients with basal cell carcinoma (BCC) in a Phase 2 trial. Preliminary results showed an average tumor reduction of 86% across all patients, with no dose-limiting toxicities or serious treatment-related adverse events observed. This promising data suggests that VP-315 could potentially improve outcomes and offer a less invasive treatment alternative for BCC compared to current therapies and surgical procedures.
Full Article: Encouraging Tumor Shrinkage Observed in VP-315 for Basal Cell Carcinoma
Oncoinvent - C-Suite Changes, Aug 28, 2024
Oncoinvent, a clinical-stage radiopharmaceutical company, announced the appointment of Oystein Soug as CEO, effective September 1, 2024. Soug, with over a decade of experience in radiopharmaceutical development, will lead the company as it advances its Phase 2 study of Radspherin® for treating peritoneal carcinomatosis in ovarian cancer. He succeeds Anders Månsson, who resigned for personal reasons.
Full Article: Oncoinvent Names Øystein Soug as New CEO
Merck - Fail Trial Results, Aug 29, 2024
Merck announced the discontinuation of two late-stage studies of Keytruda, its anti-PD-1 therapy, in non-small cell lung cancer (NSCLC) and cutaneous squamous cell carcinoma (cSCC) due to poor outcomes. The Phase III trials failed to demonstrate significant survival benefits, with higher adverse event rates leading to the decision. This continues a series of recent clinical setbacks for Keytruda, including halted trials in small cell lung cancer, high-risk melanoma, and endometrial cancer, all due to either lack of efficacy or safety concerns.
Full Article: Merck Discontinues Two Keytruda Phase III Trials Due to Disappointing Data
Repare Therapeutics - Workforce Reduction/Layoffs, Aug 29, 2024
Repare Therapeutics is laying off 25% of its workforce as it shifts focus from preclinical research to more advanced oncology programs, including a synthetic lethal drug returned by Roche. The layoffs, mainly affecting the preclinical team, aim to cut costs and extend the company's cash runway into 2026. Despite the challenges, Repare plans to advance its most promising programs, including a Phase 1 trial of a combination therapy for ovarian and endometrial cancers, and is preparing for a potential registrational trial next year.
Full Article: Repare Therapeutics Reduces Workforce to Focus on Advanced Oncology Programs
Bayer and NextRNA Therapeutics - Collaboration, Aug 29, 2024
Bayer and NextRNA Therapeutics have partnered in a $547 million deal to develop small molecule therapies targeting long non-coding RNA (lncRNA) in oncology. The collaboration will advance two lncRNA-targeting programs, with Bayer gaining access to NextRNA's platform and expertise.
Full Article: Bayer and NextRNA Therapeutics Enter $547M Oncology Partnership
Orgenesis - Positive Trial Data, Aug 30, 2024
Orgenesis' CAR-T therapy ORG-101 has demonstrated efficacy and safety in treating acute lymphoblastic leukemia (ALL) in 233 patients in China, with complete response rates of 82% in adults and 93% in children. The therapy also showed low rates of severe cytokine release syndrome (CRS). ORG-101 is produced using a cost-effective decentralized manufacturing approach, and Orgenesis plans to begin a multicenter Phase 1/2 clinical trial in Greece.
Full Article: Orgenesis CAR-T ORG-101 Shows Efficacy in Acute Lymphoblastic Leukemia
Bayer - Clinical Trial Updates, Aug 30, 2024
Bayer has enrolled the first patient in the global Phase III SOHO-02 trial, which evaluates the efficacy and safety of BAY 2927088 as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with HER2 mutations. BAY 2927088 is also being studied as a second-line therapy for the same patient group. This investigational agent, developed in collaboration with the Broad Institute, has received Breakthrough Therapy designation from the FDA and China’s CDE. Bayer emphasizes its commitment to precision medicine and improving outcomes for patients with HER2-mutant NSCLC.
Full Article: Bayer Starts Phase III Trial of BAY 2927088 for HER2-Mutant NSCLC
