News
Our Client Adial Pharmaceuticals Partners with Genomind for Precision Medicine Testing Solution
Partnership has successfully completed analytical validation of a cheek swab collection solution for testing and identifying patients with the genotypes important for AD04 development.
The objective of the partnership was to develop an analytically validated gene test in a CLIA-certified laboratory that would identify the important SNPs (single nucleotide polymorphisms) of the serotonergic system used for identifying patients for the upcoming Phase 3 program for AD04. This would serve as the starting point for development of a commercial companion diagnostic test for which a cheek swab specimen can be easily collected in a physician’s office or at home.
Our Client Adial Pharmaceuticals Completes a Successful EOP2 FDA Meeting
The FDA has provided input into the AD04 Phase 3 adaptive design clinical trial and the overall clinical program.
Following the meeting, Adial is now prepared to advance AD04- its lead investigational drug and a serotonin-3 receptor antagonist- into its Phase 3 clinical development program for the treatment of Alcohol Use Disorder (AUD) in individuals with heavy drinking and select genotypes and, most importantly, the AG+ genotype.
The objective for the EOP2M was to align with the FDA on the design of the Phase 3 clinical development program for AD04. This included key elements of the planned adaptive study design elements, such as population, endpoints, inclusion/exclusion criteria, dose regime, and affirmation of the biomarker positive and biomarker negative groups.
Inotrem publishes on the pivotal role of the soluble TREM-1 biomarker in identifying high-risk septic shock patients and guiding targeted treatment with nangibotide. High levels of this marker identify the most critically ill patients developing severe organ failure and with the highest risk of dying. When administered on top of standard of care, nangibotide significantly improves clinical outcome in this patient population.
Our Client Proteotype Diagnostics Publishes Seminal Paper in Nature Communication
This work introduces a novel, minimally invasive platform that harnesses the body’s own immune response to spot cancer at its earliest stages and forecast how patients will respond to therapy. Instead of hunting for tiny fragments of circulating tumour DNA, the platform measures fluctuations in specific amino acid residues – building blocks of immune proteins – in a simple blood sample.
Early-stage tumours often provoke a robust immune response before they shed enough DNA to be detected by existing liquid-biopsy methods. By tapping into this stronger immunological signal, the new assay – termed the Amino Acid Concentration Signature (AACS) – detects cancers with unprecedented sensitivity, while also predicting which patients will benefit from targeted therapies.
Our Client Nuvation Bio Receives FDA Approval for Ibtrozi, a kinase inhibitor to treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
FDA approves taletrectinib for ROS1-positive non-small cell lung cancer
Fore Bio is focused on resetting the standard in BRAF driven tumors with a potential first in class paradox breaker with compelling early clinical data that support the potential of plixorafenib monotherapy to address the well-known treatment gaps oncologists face with first- and second-generation BRAF inhibitors. We are impressed with the team’s progress to date, excited about the multiple near term data readouts, and are proud to support the continued advancement of plixorafenib.
Boudicca DX a global precision medicine consulting firm will support Vizgen, Inc. in advancing its clinical, regulatory and technical strategies for its spatial biology and multiomics tissue-based assays.
Boudicca DX Partners with Boutique CRO GBC
Boudicca DX will work in tandem with Global BioClinical to provide comprehensive and seamless support to global medical device and IVD clients, reducing both time and financial burden for clients setting up clinical feasibility, validation, and utility studies to generate the data needed to get their precision medicine products to the market and to support reimbursement.
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with endometrial cancer and other tumor types. Drug-tailored, proprietary OncoSignature biomarker assays are developed using the generative AI-driven Acrivon Predictive Precision Proteomics (AP3) platform, which is also used for streamlined, biologically rational drug design and indication finding.
From Data to Recovery: Transforming AUD Treatment with Precision Medicine
Our genetic diagnostic test is transforming AUD treatment by identifying patients who are most likely to benefit from treatment with AD04, paving the way for a new era of targeted care. Through a collaborative partnership with Boudicca Dx and Eurofins US, Adial is developing a genetic diagnostic test to pinpoint individuals who are most likely to respond to AD04 treatment.
Data from the FORESEE clinical feasibility study with previous client Biocept (clinical data acquired by Plus Therapeutics) was presented at the SNO Annual Meeting on November 24, 2024.
Priya Kumthekar 1, Michael Youssef 2, Jonathan Yang 3, David Piccioni 4, Sue Beruti 5, Laura Gillis 5, Kelly Gordon 6, Barbara Blouw 7, Melissa Moore 7, Norman LaFrance 7, Marc Hedrick 7, Seema Nagpal 8
1 Northwestern, Chicago/IL, USA, 2 UT Southwestern.edu, Dallas/TX, USA, 3 New York University, New York/NY, USA, 4 University of San Diego Health, San Diego/ CA, USA, 5 Independent Consultant, Winchester/VA, USA, 6 Independent Consultant, Brentwood/TN, USA, 7 Plus Therapeutics, Austin/TX, USA, 8 Stanford Medicine, Stanford/CA, USA
Leptomeningeal metastases (LM) in solid tumors is difficult to diagnose and treat, and occurs when there are cancer cells in the cerebrospinal fluid (CSF)/pia and arachnoid. Current standard of care methods to diagnose or assess treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. The FORESEE Study was a multi-center, prospective clinical trial evaluating a novel diagnostic platform, CNSide, that aimed to overcome these challenges. The FORESEE study enrolled patients with breast or non-Small Cell Lung Cancer (NSCLC) with suspicion of or confirmed LM. CNSide can detect and quantify tumor cells in the CSF from patients with breast cancer or NSCLC having a suspicious or confirmed LM as well as identify actionable mutations in the CSF via Fluorescent In Situ Hybridization (FISH) and next-generation sequencing. The primary end point was to determine the impact of CNSide on physician treatment decisions. Secondary endpoints included evaluating the clinical performance of CNSide vs. cytology in tumor cell detection (sensitivity, specificity, PPV and NPV). The study enrolled 40 patients (22 breast cancer and 19 NSCLC). Each patient underwent standard of care diagnostic evaluations at baseline and at three follow up timepoints through their treatment. CNSide aided clinical decision making in 93% (50/54) of the clinical decisions. At baseline, 39 patients were assessed, showing that CNSide confirmed a positive LM diagnosis in 15% (6/39), a negative LM diagnosis in 8% (3/39), progression in 15% (6/39), resolution in 15% (6/39) and no progression, or resolution in 36% (14/39) of the patients. CNSide informed the specific drug selected for treatment in 26% (10/39) patients at baseline and demonstrated clinical high utility.
Presentation here:
Adial Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update
WBENC Certification is the most widely recognized and respected national certification for women-owned businesses in the United States. To become certified, business owners undergo a rigorous vetting process, including review of business documentation and a site visit. Boudicca Dx is proud to have received this certification.
1. Summarize Technical & Regulatory requirements for each phaseout step
2. Review the parallel FDA IVD Reclassification Process
3. Discuss Biopharma Clinical Trial Testing & Companion Diagnostic Opportunities for Laboratories
Earn CME credit: 1 hour.
Dr. Gordon will present on the Final FDA LDT Rule at an Open Scientific Discussion sponsored by AAPS Gene and Cell Therapy Products (GCTPs) and Biomarkers and Precision Medicine (BPM) Communities: “The Impact of the Latest FDA Regulations on Laboratory Developed Tests (LDTs) for Patient Management.”
Events
Boudicca DX™ will be @
Invited Speaker: The Society for Functional Precision Medicine
Inspire your team with a dynamic & relevant presentation from our CEO Dr. Gordon that gets people excited & ready to tackle complex precision medicine product development challenges.
Reach out to courtney@boudiccadx.com to book Dr. Gordon for your next virtual or live event.
