Elraglusib

CHICAGO, IL and FORT WORTH, TX, USA I December 17, 2024 I Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced new positive data from its ongoing and fully enrolled randomized Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) (Actuate-1801 Part 3B). A pre-specified analysis was triggered by reaching >70% death events in the GnP control arm (data cut off November 15, 2024). The analysis of interim data demonstrated treatment with elraglusib in combination with GnP resulted in statistically significant increases in 1-year survival rate (p value of 0.002) and median overall survival (p value of 0.016, hazard ratio of 0.63) versus treatment with GnP alone. The combination treatment also resulted in increased Objective Response Rates (ORR) and Disease Control Rates (DCR) in the elraglusib/GnP combination arm versus the GnP control arm. “These interim results are highly encouraging and underscore the transformative potential of elraglusib in the treatment of metastatic pancreatic cancer,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “The improvement in median and overall long-term survival, disease control rate and overall response rate compared to GnP alone, combined with elraglusib’s favorable risk-benefit profile, offers the possibility of improved outcomes for patients with limited treatment alternatives. We are excited to continue evaluating the potential of elraglusib, a novel immune-oncology GSK-3 targeted approach for mPDAC, and look forward to engaging with the FDA in 1H 2025 to share topline data and discuss next steps, including a proposed phase 3 registration trial.” Inhibition of GSK-3β may inhibit tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, activation of innate anti-tumor immunity and regulation of gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT). Study highlights include: “Pancreatic cancer is one of the most aggressive and lethal cancers with less than 5% survival rate in the US at 5 years. We are encouraged by consistent evidence of significant clinical benefit and anti-tumor activity in the elraglusib combination arm across multiple endpoints in this study,” said Dr. Andrew Mazar, Actuate’s Scientific Co-Founder and Chief Operating Officer. “Further, the favorable risk-benefit profile observed to date may provide a treatment option for many patients with metastatic pancreatic cancer that may not tolerate more aggressive and less tolerable chemotherapy approaches.” The ongoing Actuate-1801 Part 3B study (NCT04239092) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first line mPDAC. The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. The primary endpoint is 1-year survival rate, with mOS the primary parameter for summarization of survival data at the end of the study. Secondary endpoints are DCR, ORR, PFS and AE. About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug product, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy including several DNA Damage Response (DDR) pathways. Elraglusib is designed to act as a mediator of anti-tumor immunity through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and regulates multiple immune checkpoints and immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com. SOURCE : Actuate Therapeutics

Plus, news about Akamis Bio, Tenaya Therapeutics, Reviva, Actuate Therapeutics, CG Oncology and Candel Therapeutics: Affimed shares early lung cancer data: In a Phase 1/2a trial, its bispecific innate cell engager, called AFM24, plus Roche’s Tecentriq reached a 21% overall response rate in 33 people with pretreated EGFR wild-type non-small cell lung cancer. The ORR was 24% in 17 EGFR-mutant patients. Affimed said it has selected the 720 mg dose for further development. Affimed’s shares $AFMD were down about 22% on Tuesday morning after it announced the data. — Ayisha Sharma Indapta Therapeutics gets $22.5M: The Houston and Seattle biotech raised the new round to fund clinical development of its allogeneic natural killer cell therapy. The biotech emerged with a $50 million Series A in February 2022. — Kyle LaHucik Oncolytic virus biotech has new funding and a deal in China: Akamis Bio announced that it raised new funding plus inked an out-licensing deal with Xuanzhu Biopharma for its lead candidate for up to $60 million. That figure includes private funding, the upfront for the outlicensing deal and biobucks, though CEO Howard Davis declined to disclose how much each portion is. Akamis, which rebranded from PsiOxus in 2023, is developing a gene therapy called NG-350A that is designed to target tumor cells and drive expression of CD40 agonist antibodies. The hope is that by engaging these key immune proteins, the therapy can trigger the immune system to attack the cancer. The company plans to use the funds to study the therapy in a Phase 1b rectal cancer trial. — Lei Lei Wu Tenaya’s shares slide: The company reported early results for an AAV therapy for three patients with a genetic heart condition called MYBPC3-associated hypertrophic cardiomyopathy. It pointed to biomarkers that suggested the therapy was having an initial effect, though it said “longer-term data are needed to characterize TN-201’s activity.” Tenaya said longer follow-up data as well as results from a higher dose cohort are expected next year. The company’s shares $TNYA fell 47% on Tuesday morning. — Lei Lei Wu Reviva’s long-term results for its schizophrenia drug: The Cupertino, CA-based biotech said brilaroxazine administered once daily showed sustained efficacy over one year in the open-label extension portion of a Phase 3 trial. There were no side effects with an incidence of more than 5%, but there was a 35% treatment discontinuation rate. Its stock $RVPH fell about 44% in trading on Tuesday morning. — Ayisha Sharma Actuate’s pancreatic cancer asset boosts survival: The drugmaker’s elraglusib in combination with gemcitabine and nab-paclitaxel (GnP) almost doubled the one-year survival rate versus GnP alone in a Phase 2 trial, good for a p-value of 0.002. Actuate said that 38% of treated patients were still alive at the cutoff date in November, compared with 19% of the control cohort. The company’s share price $ACTU was up 14% at market open on Tuesday. — Ayisha Sharma CG Oncology raised $238 million in its public offering, up from the $204 million it planned to bring in. — Jaimy Lee Candel ended up raising $92 million in its public offering. — Jaimy Lee