MAIA Biotechnology, Inc.’s Post

The evolution continues...one of, if not the first report, of a phase I clinical trial with a bispecific ADC (HER3-EGFR directed) https://lnkd.in/e_DquMPZ

Zevra Therapeutics announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial evaluating the safety and tolerability of KP1077 in patients with idiopathic hypersomnia (IH). This proof-of-concept study was not powered to demonstrate statistical significance.  The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design. “Zevra’s Phase 2 trial evaluating KP1077 as a treatment for IH demonstrated clinically meaningful impact and encouraging outcomes on both clinical safety and efficacy,” stated Christopher Drake, PhD, FAASM, DBSM, Principal Investigator of the study. Read more here - https://lnkd.in/gPSzkbdG

This Friday an FDA advisory committee will meet to discuss the results of a new meta-analysis on the use of minimal residual disease (MRD) as an endpoint to support the accelerated approval of new drugs in multiple myeloma (MM). Currently, drugs in MM are approved based on clinical benefit endpoints, leading to lengthy clinical trials and drug approval timelines and ultimately delays in offering patients potentially beneficial treatments. MRD testing can measure a patients response to treatment by the use of sensitive technologies which measure the level of tumor cells in a patient’s blood. The use of MRD results as an endpoint for drug approval would allow MRD testing to be used to demonstrate drug efficacy instead of clinical response thus shortening clinical trial and drug development times. A recent Diaceutics report on the use and perceptions of MRD found the majority of hematoncologists were comfortable with the use of MRD as a surrogate endpoint in clinical trials. If implemented, this would represent a paradigm shift in the approval of novel therapies. While this discussion is currently limited to MM, the scope for using MRD in drug development and the management of patients is currently being investigated in multiple haematological and solid tumor indications. MRD has the potential to become routine clinical practice in the management of oncology indications and would enable the early detection of disease relapse and allow patient treatments to be adapted accordingly. View the Diaceutics report on MRD at https://lnkd.in/eKu4imxW

Breakthrough approach on MRD which could significantly impact timelines on getting new treatments to patients. If you have not accessed the Diaceutics report on MRD read more at the link below and get in touch. Dr Bob Holt #precisionmedicine #patients #FDA #MRD #cancer

We published a review paper in Clinical Trials. In this paper we examine several innovative phase I–II clinical trial designs that utilize accumulated efficacy and toxicity outcomes to adaptively determine doses for subsequent patients and identify the optimal biological dose, maximizing the overall therapeutic effect. Specifically, we highlight three categories of phase I–II designs: efficacy-driven, utility-based, and designs incorporating multiple efficacy endpoints. For each design, we review the dose–outcome model, the definition of the optimal biological dose, the dose-finding algorithm, and the software for trial implementation.

WEBINAR - UPDATE ON CLINICAL TRIALS IN OI OIFE supports and encourages the advancement into research to find new treatments, improve diagnosis and aid a better understanding of OI. We strive to keep the OI community informed of what clinical trials are ongoing. As part of this we are hosting our 2nd clinical trial update webinar on October the 22nd. The event is free and open for anyone to register: https://lnkd.in/dRBir8xg The goal of the webinar is to update the OI-community about ongoing clinical trials – both those who are recruiting and others. This include the following trials: * The Cosmic and the Orbit trials (setrusumab) * The BoostB4 trial (stem cells) * The Topaz trial (teriparatide and zolendronate) * The MOI-A trial (Losartan) * Osteoanabolic treatment in OI caused by WNT mutations (Germany) More clinical trials might be added later. #osteogenesisimperfecta

Endeavor BioMedicines’ ENV-101 is a hedgehog pathway inhibitor for adults with idiopathic pulmonary fibrosis (#IPF). Investigator Toby Maher, M.D., Ph.D. from the Keck School of Medicine of the University of Southern California recently discussed new data from the ENV-101 Phase 2a clinical trial with Isabella Hornick at Healio. "The placebo group acted as a placebo group should in this type of trial, which is to say that they lost lung function over the course of the 12 weeks.” Dr. Maher also commented, “What was exciting is that the treatment arm demonstrated a continuous and statistically significant improvement in lung function. This really distinguishes the data generated in this trial vs. what we’ve seen with other studies in the past, where we might only see a slowing of disease progression." Learn more about ENV-101 and what's next for the Phase 2b clinical trial: https://lnkd.in/eB6ZeqV2 #biotech #clinicaltrial

Imugene Limited has made significant progress in multiple candidates, has a strong balance sheet and numerous upcoming potential clinical catalysts, says #DiamondEquityResearch. The research group has provided a valuation on #IMU of $0.49 per share, contingent on the successful execution of upcoming clinical milestones. This presents significant upside potential to the company’s current share price of around $0.053. It recognised IMU’s “significant strides” made in advancing its pipeline toward late-stage clinical trials, with several major milestones potentially expected in the second half of 2024 and into 2025. More at #Proactive #ProactiveInvestors #IMU #IUGNF http://ow.ly/VV2v105F7vn

🧪 #FIPO: launch of the 3rd cohort in the clinical trial The scientific council has given the green light for the third dose in the ascending phase of our FIPO clinical trial. This Phase I/II trial tests the safety and efficacy of XON7 in patients with solid tumors. Key updates: ✅ Safety validated: after cohorts at 1.5 mg/kg and 3 mg/kg, the safety of XON7 has been confirmed. 👩⚕️ New cohort: 3 patients with solid tumors are now being treated at 6 mg/kg across our Foch, Lyon, and Toulouse centers. 📈 Ascending phase: we are progressively increasing doses to ensure safety and assess the benefit/risk ratio of XON7. 💫 Hope for patients: XON7 represents a new hope for patients who have not responded to current treatments. 🔍 More information in our carousel. #ClinicalTrial #XON7 #Biotech #Innovation #PatientCare

Great to see this published today: American Society of Clinical Oncology (ASCO) research statement with four key solutions to address the regulatory and administrative barriers for decentralizing trials to improve patient access: (1) #FDA should engage the research community in a public-private partnership to #modernize standards and enable local #access to #trials (2) #sponsors and #CROs should develop standards and protocols that accommodate flexible approaches, enable local participation, provide clarity around roles and requirements, and promote consistency (3) research centers, networks, and #sites should update policies and procedures to implement #decentralized trial elements (4) research community should develop a streamlined, uniform mechanism to simplify #regulatory #data collection and #documentation and use it consistently across trials. Link to the paper here: https://lnkd.in/gSz2CheM