Incyte - Positive Trial Data, Sep 15, 2024
Incyte’s INCB123667, a CDK2 inhibitor, showed early promise in treating advanced solid tumors, especially ovarian cancer, in Phase 1b data presented at ESMO 2024. The drug achieved a 24.3% overall response rate in ovarian cancer patients. It had a manageable safety profile with common side effects like nausea and thrombocytopenia. A pivotal ovarian cancer study is planned.
Full Article: Incyte’s CDK2 Inhibitor INCB123667 Shows Promising Evidence of Clinical Activity in Patients with Advanced Solid Tumors, Notably Ovarian Cancer
Daiichi Sankyo - Positive Trial Data, Sep 15, 2024
Initial results from the Phase 1 trial of DS-9606, a Claudin-6 (CLDN6)-targeted antibody-drug conjugate, show early promise in advanced solid tumors. Presented at ESMO 2024, the data from 53 heavily pretreated patients indicate no dose-limiting toxicities and suggest preliminary efficacy, especially in germ cell tumors. DS-9606 achieved four confirmed responses and showed tumor marker reductions in GCT patients. Further studies are needed to refine dosing and evaluate efficacy across various tumor types.
Full Article: DS-9606 Shows Promising Preliminary Clinical Activity in Patients with Advanced Solid Tumors
Kyverna Therapeutics - C-Suite Changes, Sep 16, 2024
Kyverna Therapeutics has announced a leadership change, with CEO Peter Maag stepping down and Warner Biddle, a former Genentech and Kite Pharma executive, taking over immediately. This follows Kyverna’s $319 million IPO earlier this year. Maag had led the company’s pivot towards developing KYV-101, a CD19-targeting cell therapy for autoimmune diseases like lupus and multiple sclerosis. Kyverna is advancing KYV-101 into later-stage trials as part of its growth strategy. Christi Shaw, former Kite CEO, has also joined Kyverna’s board.
Full Article: Kyverna CEO Resigns, Warner Biddle Takes Over as Leadership Changes at Kyverna
Celyad Oncology - C-Suite Changes, Sep 17, 2024
Celyad Oncology has appointed Matt Kane as its new CEO, effective October 1. Kane brings over 20 years of experience in leadership roles, including pioneering genome editing and developing multiple allogeneic CAR T-cell therapies. He was previously CEO of Tune Therapeutics and co-founded Precision BioSciences, where he led the company’s IPO.
Full Article: Matt Kane to Take Up CEO Role at Celyad Oncology in October
ImmunOs Therapeutics - Series C Investment, Sep 17, 2024
ImmunOs Therapeutics has secured $11 million in a Series C funding round led by existing investors Gimv, Pfizer Ventures, and others, with new support from Double Point Ventures. The funds will advance the clinical trial of IOS-1002, a multifunctional immunotherapy for advanced solid tumors, through its Phase Ia dose escalation trial, both as a monotherapy and in combination with KEYTRUDA® (pembrolizumab). IOS-1002 targets several immune checkpoints and aims to enhance both innate and adaptive immune responses, potentially improving outcomes for patients with limited treatment options.
Full Article: ImmunOs Therapeutics Raises $11 Million and Further Strengthens Investor Base
Brenus Pharma - Series A Investment, Sep 18, 2024
Brenus Pharma has raised $25 million in a Series A round led by French and Belgian investors to fund the first Phase I/IIA clinical trial of its STC-1010 cancer vaccine for metastatic colorectal cancer and to develop a second candidate, STC-1020, targeting another solid tumor. The company’s innovative STC platform aims to create next-generation immunotherapies by stimulating patients' immune systems to combat evolving cancer cells. With regulatory reviews underway and positive preclinical results, Brenus plans to launch trials in Europe and the U.S. starting in late 2024.
Full Article: Brenus Pharma Raises $25 Million to Accelerate Clinical Trials of Its Precision Cancer Vaccines
Sonnet BioTherapeutics - Clinical Trial Updates, Sep 18, 2024
Sonnet BioTherapeutics has completed enrollment and begun dosing in its Phase 1 SB101 clinical trial for SON-1010 (IL12-FHAB), targeting advanced solid tumors. With 24 subjects enrolled, the trial focuses on assessing the safety, tolerability, and pharmacokinetics of SON-1010, which uses a proprietary platform to enhance the half-life and activity of interleukin-12. Early data show the treatment is safe and well-tolerated, with no dose-limiting toxicities reported. Topline safety data is expected in Q4 2024, with promising initial results, including stable disease in one patient for nearly two years.
Full Article: Sonnet BioTherapeutics Completes Enrollment in Phase 1 Study of SON-1010 (IL12-FHAB) as a Monotherapy (SB101) for the Treatment of Solid Tumors
Imugene - Clinical Trial Updates, Sep 18, 2024
Imugene's Phase 1b trial of azercabtagene zapreleucel (azer-cel), an allogeneic CD19 CAR T-cell therapy for diffuse large B-cell lymphoma (DLBCL), reported three complete responses (CRs) among a small cohort. In cohort B, two of three evaluable patients achieved CRs, yielding a 67% overall response rate. Cohort A showed a 33% response rate with one CR. The trial aims to enhance response durability, with further data expected for a potential registrational Phase 2/3 trial.
Full Article: Azer-cel Achieves Complete Responses in Relapsed/Refractory DLBCL
Innovent Biologics - Positive Trial Data, Sep 18, 2024
Innovent Biologics reported Phase 1 data on IBI363, a PD-1/IL-2α-bias bispecific antibody, combined with bevacizumab for advanced colorectal cancer at the 2024 ESMO Congress. Among 35 subjects, the overall response rate (ORR) was 21.9% with a disease control rate (DCR) of 65.6%. The median duration of response was 8.1 months, and the safety profile was consistent with prior studies. Ongoing trials are investigating IBI363 in other cancers, with updates expected at future conferences.
Full Article: Innovent Announces Clinical Data of IBI363, First-in-Class PD-1/IL-2 Bias Bispecific Antibody Fusion Protein Combined with Bevacizumab in Advanced Colorectal Cancer at the 2024 ESMO Congress
Kura Oncology - Executive Changes, Sep 18, 2024
Kura Oncology has appointed Dr. Michael Vasconcelles to its Board of Directors. With over 25 years in oncology drug development, Dr. Vasconcelles brings leadership experience from roles at ImmunoGen, Flatiron Health, and Takeda. CEO Troy Wilson emphasized his expertise will be vital as Kura advances its menin inhibitor and farnesyl transferase inhibitor programs, while Dr. Vasconcelles expressed enthusiasm for contributing to the company's precision oncology efforts.
Full Article: Kura Oncology Appoints Michael Vasconcelles, M.D., to Board of Directors
Oncolytics Biotech - Positive Trial Data, Sep 19, 2024
Oncolytics Biotech reported positive results from its BRACELET-1 Phase 2 study of pelareorep in HR+/HER2- advanced breast cancer, showing that median overall survival was not reached in the pelareorep + paclitaxel group, with over 64% of patients alive at two years compared to 33% for paclitaxel alone. Median progression-free survival was significantly improved at 12.1 months versus 6.4 months. The interim CEO noted the treatment's potential to extend patient lives and expressed confidence in further studies based on these findings.
Full Article: Oncolytics Biotech Reports Favorable Results for BRACELET-1 Breast Cancer Study, Reinforcing Path to Funding of a Registration-Enabling Study
Novartis - FDA Approval, Sep 19, 2024
The FDA has approved Novartis's Kisqali for early-stage metastatic breast cancer, which has been shown to reduce the risk of cancer recurrence by 25%. A Phase III trial demonstrated a significant reduction in risk, while an analysis presented at the European Society for Medical Oncology conference indicated a 28.5% reduction after four years. Dr. Dennis J. Slamon, a lead investigator, called this approval a pivotal moment for patient care, emphasizing the impact of breast cancer treatment on patients' mental and physical well-being.
Full Article: Breast Cancer Drug Kisqali Gets FDA Approval to Prevent Cancer Recurrence
Ryvu Therapeutics - Clinical Trial Updates, Sep 20, 2024
Ryvu Therapeutics has announced the dosing of the first patient in the REMARK Phase II trial, evaluating RVU120 as a monotherapy for lower-risk myelodysplastic syndromes (LR-MDS). Conducted through the EMSCO network with Prof. Uwe Platzbecker as Principal Investigator, the study aims to assess the safety and efficacy of RVU120 in treating anemia in LR-MDS patients. With approval across multiple European countries and a planned enrollment of 40 patients, the trial builds on encouraging results from earlier studies, focusing on reducing red blood cell transfusion dependence and improving patient outcomes.
Full Article: Ryvu Therapeutics Announces Dosing of the First Patient in the REMARK Phase II Study of RVU120 for the Treatment of Anemia in Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Brenus Pharma - Series A Investment, Sep 20, 2024
Brenus Pharma has raised $25 million in a Series A funding round to advance its cancer vaccine development, particularly for its lead candidate STC-1010. This funding will support the first-in-human trials for STC-1010, a vaccine designed for metastatic colorectal cancer patients resistant to immunotherapies. Based on Brenus Pharma's STC platform, which educates the immune system to detect and destroy tumor cells, the technology aims to reduce relapse rates in solid tumor patients. The Phase I/IIA "BreAK-CRC" trial is currently under regulatory review, with initial trials focusing on safety, efficacy, and immune response.
Full Article: Brenus Pharma Closes $25 Million Series A to Develop Cancer Vaccines
