FluoGuide - Clinical Trial Updates, Oct 7, 2024
Copenhagen-based biotech company FluoGuide has submitted a Clinical Trial Application (CTA) for a phase II trial in head and neck cancer, specifically targeting oral squamous cell carcinoma. The trial will evaluate FG001, a product designed to improve surgical accuracy by illuminating cancer cells. Following promising results from a proof-of-concept trial and input from key opinion leaders, the study will enroll 25-30 patients, with the first expected in Q1 2025. Interim data are anticipated by H2 2025, aiming to enhance treatment options and outcomes for patients.
Full Article: FluoGuide submits clinical trial application for head and neck cancer treatment
CytoMed - Clinical Trial Updates, Oct 7, 2024
CytoMed Therapeutics has launched the ANGELICA Trial, a Phase I study using allogeneic CAR-T cells for advanced cancer treatment in collaboration with Singapore's National University Hospital. This approach aims to lower costs and improve therapy. The company also acquired a Malaysian cord blood bank to support its cell therapy research, emphasizing affordable, off-the-shelf cancer treatments.
Full Article: CytoMed begins clinical trial for innovative cancer therapy
Monopar Therapeutics - Clinical Trial Updates, Oct 7, 2024
Monopar Therapeutics has initiated a Phase 1a trial for its radiopharmaceutical MNPR-101-Lu, targeting patients with advanced solid tumors. The open-label, dose-escalation study is recruiting at the Melbourne Theranostic Innovation Centre in Australia. MNPR-101, Monopar’s proprietary antibody, selectively targets uPAR, aiming to kill cancer cells while sparing healthy tissue. The trial follows promising results from MNPR-101-Zr imaging studies, marking a significant step in uPAR-targeted radiopharma therapy.
Full Article: Monopar initiates clinical trial of novel uPAR targeted radiopharmaceutical therapy in advanced cancers
Cybrexa Therapeutics - Clinical Trial Updates, Oct 7, 2024
Cybrexa Therapeutics has dosed the first patient in a Phase 2 trial evaluating CBX-12 for platinum-resistant or refractory ovarian cancer. CBX-12, a peptide-drug conjugate using the alphalex™ technology, delivers the TOP1 inhibitor exatecan directly to tumors, sparing healthy tissue. Following promising Phase 1 results, this trial will assess safety and efficacy at two dose levels. Cybrexa also plans future Phase 2 studies of CBX-12 in colorectal cancer and other solid tumors, with additional pipeline assets, including CBX-15, expected to enter clinical trials in 2025.
Full Article: Cybrexa Therapeutics announces first patient dosed in Phase 2 trial of CBX-12
Vincerx Pharma - Positive Trial Data, Oct 7, 2024
Vincerx Pharma reported two complete responses in its ongoing Phase 1 dose-escalation study of VIP943, an antibody-drug conjugate (ADC) for relapsed/refractory AML, HR-MDS, and B-ALL. Of the 22 enrolled patients, two achieved complete remission, highlighting VIP943’s potential as a best-in-class therapy. Early data showed favorable safety, tolerability, and significant target engagement in CD123+ malignancies. The company also provided updates on VIP236, a small molecule drug conjugate (SMDC) in Phase 1 for advanced solid tumors, and enitociclib, a CDK9 inhibitor in Phase 1 for relapsed/refractory lymphomas.
Black Diamond Therapeutics - Workforce Reduction/Layoffs, Oct 8, 2024
Black Diamond Therapeutics has deprioritized its BDTX-4933 program for RAF/RAS-mutant solid tumors and is seeking partnerships for the asset, while focusing on its lead candidate, BDTX-1535, for EGFR-mutant NSCLC. To optimize operations, the company has laid off staff, including two executives, and appointed Erika Jones as principal financial officer. These restructuring efforts are expected to fund operations through mid-2026, with upcoming phase 2 data for BDTX-1535 in NSCLC and glioblastoma anticipated in early 2025.
Full Article: Black Diamond reshuffles execs, drops Phase 1 lung cancer drug to extend cash
Mosaic Therapeutics - C-Suite Changes, Oct 8, 2024
Mosaic Therapeutics has appointed Dr. Barry Davies as Chief Scientific Officer (CSO) to lead its scientific strategy and Research and Development team. With over 25 years of drug discovery experience, including 19 years at AstraZeneca where he led projects in areas like cell signaling and DNA damage response, Davies brings extensive expertise in oncology. His role will be instrumental as Mosaic advances its pipeline of targeted drug combinations for cancer. CEO Magda Jonikas expressed confidence in his leadership to propel the company’s mission of delivering precision medicines to patients with limited options.
Full Article: Mosaic Therapeutics appoints Dr. Barry Davies as CSO
Verismo Therapeutics - Clinical Trial Updates, Oct 8, 2024
Verismo Therapeutics has initiated its CELESTIAL-301 Phase 1 clinical trial at the Colorado Blood Cancer Institute, part of the Sarah Cannon Research Institute. The trial will assess the safety and efficacy of SynKIR™-310, a CAR-T therapy using Verismo's KIR-CAR platform, in patients with relapsed/refractory B-cell Non-Hodgkin Lymphomas, including DLBCL, FL, MCL, and MZL. SynKIR™-310 aims to improve CAR-T cell persistence and reduce relapse rates in patients who previously relapsed after CAR-T therapy. Verismo received FDA clearance for this trial in May 2024.
Full Article: Verismo Therapeutics announces the activation of its CELESTIAL-301 clinical trial at Colorado Blood Cancer Institute
Kiromic BioPharma - Positive Trial Data, Oct 8, 2024
Kiromic BioPharma has reported promising results from its Deltacel-01 Phase 1 trial, which is testing Deltace (KB-GDT-01), an allogeneic Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC). Patient 4 showed a 5.3% reduction in tumor size at six months, while Patient 6 demonstrated stable disease at two months. The trial's median progression-free survival has increased to 6 months, indicating the potential of Deltacel to delay disease progression in advanced NSCLC patients. Kiromic remains encouraged by the therapy's emerging clinical benefits.
Full Article: Kiromic BioPharma reports favorable ongoing clinical results from fourth and sixth patients enrolled in Deltacel-01
Phanes Therapeutics - Clinical Trial Updates, Oct 8, 2024
Phanes Therapeutics has dosed the first patient in a clinical trial evaluating its bispecific antibody, PT886, in combination with Merck's KEYTRUDA® for gastric and gastroesophageal cancers. The Phase I/II TWINPEAK study is assessing the safety and efficacy of PT886, which targets claudin 18.2 and CD47, and has received orphan drug and Fast Track designations for pancreatic cancer. The trial also includes PT886 as monotherapy and in combination with pembrolizumab or chemotherapy.
Full Article: Phanes Therapeutics announces first patient dosed in clinical study of PT886 in combination with KEYTRUDA
Rgenta Therapeutics - Clinical Trial Updates, Oct 8, 2024
Rgenta Therapeutics has dosed the first patients in a Phase 1a/b clinical trial evaluating RGT-61159, an oral small molecule targeting RNA regulation for the treatment of adenoid cystic carcinoma (ACC), colorectal cancer (CRC), and other solid tumors, as well as acute myeloid leukemia (AML). This first-in-human study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of RGT-61159, a MYB inhibitor addressing the root cause of ACC, with expansion to CRC patients whose disease has failed initial therapy.
Full Article: Rgenta Therapeutics announces first patients dosed in Phase 1a/b clinical trial of RGT-61159
Abalos Therapeutics - C-Suite Changes, Oct 9, 2024
Abalos Therapeutics has appointed Gerben Moolhuizen, MBA, as its new CEO, bringing over three decades of drug development experience. Moolhuizen will lead the company as it advances ABX-001, a novel immunostimulatory product from its AdaptInnate platform, towards clinical evaluation. ABX-001, designed to trigger a tailored immune response within tumors, has shown promising preclinical results in multiple tumor models. Moolhuizen’s background includes leadership roles at ISA Pharmaceuticals and OctoPlus, and his expertise is expected to drive Abalos’ transition into a clinical-stage biotechnology company.
Full Article: Abalos Therapeutics Appoints Gerben Moolhuizen as Chief Executive Officer
Harbour BioMed - Positive Trial Data, Oct 10, 2024
Harbour BioMed has published results from its Phase I trial of porustobart (HBM4003), a fully human anti-CTLA-4 antibody, in combination with the anti-PD-1 antibody toripalimab for treating advanced solid tumors, particularly melanoma. The trial showed manageable safety, with no new safety signals and promising antitumor activity, especially in PD-1 treatment-naïve mucosal melanoma patients. With an objective response rate of 33.3%, the combination therapy demonstrated potential in addressing efficacy and toxicity challenges in cancer immunotherapy. Further studies are planned to confirm these findings and explore porustobart's potential.
Full Article: Harbour BioMed Announces Publication of the Phase I Study Results for Porustobart in Combination with Toripalimab
Panavance Therapeutics - Clinical Trial Updates, Oct 10, 2024
Panavance Therapeutics presented interim data from its Phase 1 trial evaluating misetionamide (GP-2250) combined with gemcitabine for advanced pancreatic ductal adenocarcinoma (PDAC) at the 2024 Visceral Medicine Congress. The trial, involving 49 patients, aims to assess safety, tolerability, and preliminary efficacy. Results showed a favorable safety profile, with six partial responders and promising progression-free survival compared to gemcitabine alone. Lead investigator Dr. Anup Kasi highlighted the combination’s potential as a new treatment option for PDAC, with further updates expected in 2025.
Gritstone Bio - Company Updates, Oct 10, 2024
Gritstone bio has filed for Chapter 11 bankruptcy while securing a stalking horse bid from an unnamed party to potentially save its cancer and infectious disease vaccine programs. The company plans to continue operations during the restructuring and strategic alternatives process. With $61.7 million in cash as of June 30, Gritstone faced a financial shortfall, unable to fund operations for 12 months. Despite encouraging results from its Phase II colorectal cancer vaccine, further follow-up is needed. The biotech’s filing is part of a larger trend, as the sector faces increasing financial challenges.
Full Article: Gritstone Files for Bankruptcy in Effort to Save Clinical Research
TransCode Therapeutics - Clinical Trial Updates, Oct 10, 2024
TransCode Therapeutics announced that all patients in the first cohort of its Phase 1a dose-escalation trial for TTX-MC138, its lead RNA therapeutic candidate targeting microRNA-10b in metastatic cancer, have been dosed. No significant safety or dose-limiting toxicities have been reported, and the company will continue evaluating safety and tolerability. The rapid enrollment is promising, and the trial coincides with the recent Nobel Prize recognizing microRNA research, highlighting the potential of TTX-MC138 in cancer treatment.
Full Article: TransCode Therapeutics Completes Initial Dosing of First Cohort in Phase 1 Clinical Trial with TTX-MC138
Cantargia - Positive Trial Data, Oct 11, 2024
Nadunolimab (CAN04) plus gemcitabine/nab-paclitaxel (GN) showed promising results in advanced pancreatic cancer in the CANFOUR trial, with a median overall survival of 13.2 months and a 71% disease control rate. Patients with high IL1RAP expression saw even better outcomes. The treatment had manageable side effects, with neutropenia being the most common.
Full Article: Nadunolimab Combo Shows Promising Efficacy in Advanced Metastatic PDAC
Turnstone Biologics - Workforce Reduction/Layoffs, Oct 11, 2024
Turnstone Biologics is cutting its workforce by 60% and restructuring its leadership to extend its cash runway and focus on its sole clinical-stage program, TIDAL-01, targeting colorectal cancer, head and neck cancer, and uveal melanoma. The company has deprioritized work in cutaneous melanoma and breast cancer and aims to stretch its cash into Q2 2026. Several leadership roles are shifting, including the appointments of Ines Verdon as CMO and Michael Fitch as SVP of manufacturing. The changes aim to prioritize clinical development and optimize costs.
Full Article: Turnstone Lays Off 60% of Staff, Shakes C-Suite to Keep Cancer Cell Therapy Trials Going
