iTeos Therapeutics - Clinical Trial Updates & Milestones, Jul 8, 2024
iTeos Therapeutics announced the dosing of the first patient in the Phase 3 GALAXIES Lung-301 trial, evaluating belrestotug + dostarlimab versus placebo + pembrolizumab in advanced NSCLC patients. This milestone triggers $35 million in payments from GSK. The trial is part of iTeos' collaboration with GSK, which includes up to $2.075 billion in milestone payments and profit-sharing in the US. CEO Michel Detheux highlighted this as a significant step in advancing therapeutic options for patients.
Full Article: iTeos announces first patient dosed in GALAXIES Lung-301 Phase 3 study, earning $35 million in milestones from GSK
Ideaya Biosciences - Positive Trial Data, Jul 8, 2024
IDEAYA Biosciences announced promising Phase 2 trial results for IDE397, a MAT2A inhibitor, in MTAP-deletion urothelial cancer and NSCLC, showing a 39% response rate and 94% disease control rate. The drug demonstrated a favorable safety profile, with minimal severe adverse events. IDEAYA is also collaborating with Amgen on a combination trial and plans further combination studies, addressing significant unmet needs for MTAP-deletion cancer therapies.
Full Article: IDEAYA reports promising clinical data for cancer treatment IDE397
Phio Pharmaceuticals - Company Expansion, Jul 8, 2024
Phio Pharmaceuticals announced the addition of the University of Pittsburgh Medical Center as a site for its Phase 1b trial of PH-762, an INTASYL siRNA compound targeting PD-1 in skin cancer. The trial, now at five sites, received a safety recommendation to escalate the dose and is enrolling for the second cohort. PH-762 aims to enhance T cell cancer-killing ability, and the study will evaluate its safety and tumor response in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.
Full Article: Phio Pharmaceuticals announces addition of clinical trial site for its Phase 1b study of PH-762
Myricx Bio - Series A Investment, Jul 8, 2024
Myricx Bio, a UK biotech firm, has closed a £90m ($114m) Series A financing round led by Novo Holdings and Abingworth. The funds will advance their novel NMTi ADC platform for antibody-drug conjugates, targeting cancer-associated antigens with promising preclinical efficacy, including complete tumor regressions in refractory cancer models.
Full Article: Myricx Bio announces £90m ($114m) Series A financing to advance its novel NMTi ADC therapeutics into clinical development
Curve Therapeutics - C-Suite Changes, Jul 9, 2024
Curve Therapeutics appointed Simon Jones as CFO and COO. Jones, with over 20 years of experience, previously led finance and operations at SpyBiotech and Karus Therapeutics. CEO Simon Kerry emphasized Jones's expertise in advancing Curve's Microcycle® discovery platform and expanding its pipeline of first-in-class assets.
Full Article: Curve Therapeutics strengthens leadership team with appointment of experienced biotech executive Simon Jones
IDEAYA Biosciences - Positive Trial Data, Jul 9, 2024
In the study of 18 evaluable patients, including those with urothelial cancer and NSCLC, a 30mg once-daily dose of IDE397 demonstrated an overall response rate of 39% and a disease control rate of 94%. Additionally, 78% of patients showed tumor shrinkage. These preliminary findings are based on data as of June 21 and include one complete response and six partial responses according to RECIST 1.1 criteria.
CARGO Therapeutics - Clinical Trial Updates, Jul 10, 2024
CARGO Therapeutics announced favorable Phase 1 data in The Lancet for firi-cel, a CD22 CAR T-cell therapy for LBCL patients refractory to CD19 CAR T-cell therapy, showing a 68% overall response rate and a 53% complete response rate. The study supports the design of CARGO's Phase 2 trial, with interim analysis expected in early 2025. Firi-cel received FDA Breakthrough Therapy Designation.
Full Article: CARGO Therapeutics announces Phase 1 clinical study of firi-cel CAR T-cell therapy published in The Lancet
Kazia Therapeutics - Positive Trial Data, Jul 10, 2024
Kazia Therapeutics' GBM-AGILE Phase II/III study showed paxalisib improved overall survival by 3.8 months for newly diagnosed glioblastoma patients with unmethylated MGMT promoter compared to standard care. Paxalisib was well tolerated with no new safety issues. Kazia plans to discuss accelerated approval with the FDA. Full study data will be presented later this year.
Full Article: Kazia Therapeutics announces Phase II/III clinical trial results for paxalisib in glioblastoma
Intensity Therapeutics - Clinical Trial Updates, Jul 10, 2024
The Phase 3 INVINCIBLE-3 study has dosed its first US patient with INT230-6 for metastatic sarcoma. INT230-6, combining cisplatin, vinblastine, and a penetration enhancer, is being tested against standard chemotherapy in 333 patients. The primary endpoint is overall survival. Previous trials showed promising results with a median overall survival of 21.3 months.
Full Article: Phase 3 study of INT230-6 doses first US patient with metastatic sarcoma
Kazia Therapeutics - Positive Trial Data, Jul 10, 2024
Kazia Therapeutics reported promising results from the GBM-AGILE study, demonstrating a 3.8-month improvement in overall survival with paxalisib compared to standard care for newly diagnosed glioblastoma patients with unmethylated MGMT promoter status. Paxalisib showed good tolerability with no new safety concerns identified. Discussions with the FDA for accelerated approval are planned based on these findings, with detailed data to follow at a scientific meeting.
Full Article: Kazia Therapeutics announces Phase II/III clinical trial results for paxalisib in glioblastoma
Enhertu - Company Updates, Jul 12, 2024
Enhertu, approved in September 2022, achieved reimbursement in Korea by April, offering hope to HER2-positive metastatic breast cancer patients. This milestone enables potential complete remission and better management of side effects through collaboration between Korean medical experts and Daiichi Sankyo.
Full Article: Enhertu achieves reimbursement in Korea
