On September 26, 2023 Beactica Therapeutics AB, the Swedish precision oncology company, reported that it has entered into a research collaboration agreement with the National Center for Advancing Translational Sciences (NCATS), one of 27 institutes and centers at the U.S. National Institutes of Health (NIH) (Press release, Beactica, SEP 26, 2023, View Source [SID1234635430]). The collaboration will focus on the translation of novel proteolysis-targeting degraders of TEAD under development by Beactica for treatment of cancer.

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Under the agreement, NCATS will gain access to proprietary targeted degraders of TEAD from Beactica to evaluate their efficacy in disease-relevant preclinical models. NCATS will also map systematically the drug-combination landscape for selected preclinical candidates by performing a high-throughput drug-combination screen using a collection of about 3,000 oncology-focused, mechanistically annotated drugs.

Pharmacological modulation of the Hippo signalling pathway has translational potential in both regenerative and oncology indications. Small-molecule modulators of the TEAD transcription factors have recently emerged as a novel anti-cancer drug-class, to specifically target Hippo-pathway-deficient cancers.

"We are very pleased to be selected by NCATS and look forward to collaborating with them to maximize the therapeutic potential of our targeted degraders of TEAD." said Dr Per Källblad, CEO of Beactica Therapeutics. "Their extensive expertise and capabilities will accelerate our project’s progress, enhancing its potential to positively impact patients".

About YAP–TEAD

YAP1 (Yes-associated protein 1) is a coactivator that together with TEAD 1–4 (TEA Domain) transcription factors play key roles in the Hippo signalling pathway that regulate cell proliferation, apoptosis, and stemness. Dysregulation of the Hippo pathway and subsequent activation of TEAD has been reported in a wide range of cancers such as squamous cell carcinoma, head and neck, gynaecological, and gastrointestinal cancers. The first clinical proof-of-concept for drugging the Hippo–YAP–TEAD pathway was recently achieved with the TEAD inhibitor VT3989, which was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.

On September 26, 2023 Mission Bio, a leader in single-cell multi-omic solutions for precision medicine, reported the commercial launch of the Tapestri Single-cell MRD (scMRD) AML Multiomics Assay (Press release, Mission Bio, SEP 26, 2023, View Source [SID1234635429]). The company designed the scMRD AML Multiomics Assay to bring unprecedented resolution to disease relapse and recurrence in acute myeloid leukemia (AML), demonstrating the potential of single-cell DNA and protein multiomics to identify therapeutic targets in recurrent AML.

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"Through our early access program, world-leading clinicians and scientists within academia and the biopharma industry have provided robust validation showing that our scMRD AML Multiomics Assay can provide impactful insights into AML evolution and patient relapse," said Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio. "By simultaneously interrogating DNA and protein targets at single-cell resolution and characterizing genotypic and immunophenotypic drifts over disease course, our assay not only identifies patients with recurrent AML, but potentially offers clinicians actionable treatment targets. Tapestri could transform care with comprehensive MRD detection for potentially guiding targeted treatments in AML, multiple myeloma (MM), and other blood cancers."

As the only solution to integrate genotypic and immunophenotypic assessment, the scMRD AML Multiomics Assay targets 40 genes for single-cell DNA sequencing based on current international AML MRD guidelines, such as European LeukemiaNet, and 17-plex antibody-oligonucleotide conjugate (AOC) panel curated for key biomarkers associated with AML MRD.

Through a seamlessly integrated workflow, the assay allows clinician-researchers to:

Distinguish true MRD from pre-leukemic or precursor clones with a limit of detection of 0.01%,
Reveal clonal architecture (co-occurrence and zygosity of mutation) and uncover the order of acquisition of mutations (phylogeny),
Track clonal dynamics and immunophenotypic drifts through disease course to identify therapeutic targets and therapy-resistance subclones.
"Relapse continues to be a major challenge in cancer care, especially in the treatment of patients with AML. The problem is that current tools, like bulk NGS and flow cytometry, lack the clonal resolution and specificity to detect the treatment-resistant cancer cells still hiding in the shadows," said P.J.M. (Peter) Valk, PhD, Principal Investigator at Erasmus MC in Rotterdam, Netherlands. "Mission Bio’s unique approach to characterizing MRD could dramatically change how we stratify patients in clinical trials and create personalized care strategies in the future."

A recent study published in Science Advances and led by Wenbin Xiao, MD, PhD from the lab of world-leading leukemia specialist & physician-scientist Ross Levine, MD, Deputy Physician in Chief for Translational Research at MSK demonstrated the potential of the scMRD AML Multiomics Assay to better predict AML recurrence. The researchers found that the assay could detect clinically relevant variants missed by bulk next-generation sequencing with 0.01% limit of detection. Additionally, the researchers tapped the multiomic capabilities of the assay to illustrate the clonal architecture distinguishing leukemic clones from preleukemic clones and hematopoietic clones.

Taken together, the data suggest that the scMRD AML Multiomics Assay could help identify AML relapse and has the potential to provide data-driven guidance to healthcare professionals regarding personalized treatment strategies, disease monitoring, and clinical trial stratification.

Mission Bio continues to provide its customers with innovative solutions for clonal profiling and surveillance, including single-cell multi-omic tools for studying other blood cancers such as MM. The new scMRD AML Multiomics Assay is now commercially available. For more information on the assay and the bioinformatics analysis and reporting capabilities, visit View Source

On September 26, 2023 Sirius Medical a global leader in Value-Based Healthcare and Surgical Marker Navigation, reported that GE HealthCare will showcase Pintuition at the upcoming Annual European Society of Breast Imaging (EUSOBI) Conference 2023 (Press release, GE Healthcare, SEP 26, 2023, View Source [SID1234635428]). The event will take place in Valencia, Spain, from September 28 to 30, 2023.

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Sirius Pintuition will join in a workshop GE HealthCare will host focused on Contrast Enhanced Mammography (CEM) in combination with Sirius Pintuition titled: ‘Improving biopsy accuracy & workflow: CEM guided biopsy for enhancing-only lesions & DCIS and non-wire probe-guided localization systems’.

Sirius Medical has previously participated in The One-Stop Clinic, a pioneering concept introduced by GE HealthCare. The One-Stop Clinic approach marks a paradigm shift towards the delivery of value-based care, redefining the full care pathway experience for patients facing breast cancer.

The educational collaboration between Sirius Medical and GE HealthCare demonstrates a shared commitment towards the delivery of value-based healthcare. The incorporation of Sirius Pintuition and CEM will help with improvement of the patient workflow to support and extend sustainable access to breast cancer care.

"We are excited to collaborate with GE HealthCare and to improve the patient workflow with Sirius Pintuition and CEM," said Bram Schermers, CEO of Sirius Medical. "This opportunity embodies our shared dedication to improving patient care and sustainable access through the use of innovative medical technology."

"Sirius Medical’s innovative surgical oncology approaches aligns perfectly with our vision at GE HealthCare," said Karima Santi, EMEA Product Marketing Leader Mammography, GE HealthCare. "Together, we aim to enhance the full delivery of value-based care and optimize educational and interactive experiences that will benefit medical professionals and ultimately enhance patient outcomes."

On September 26, 2023 ABM Therapeutics reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the investigation of ABM-1310 for the treatment of Glioblastoma (GBM) patients carrying BRAF V600E mutation, following the Orphan Drug Designation for ABM-1310 to treat malignant gliomas including GBM received in July (Press release, ABM Therapeutics, SEP 26, 2023, View Source [SID1234635427]).

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The FDA grants Fast Track Designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track Designation is intended to bring promising medicines to patients sooner.

ABM-1310 is an investigational therapeutic candidate currently undergoing clinical development for BRAF V600E mutant solid tumors. The Fast Track Designation paves the potential path of ABM-1310 to have a significant impact on patients with BRAF V600E mutant Glioblastoma. The Fast Track Designation also reinforces ABM’s commitment to advancing this target therapy for Glioblastoma patients. ABM is ready to work closely with the FDA to expedite its development.

"We are very grateful to the FDA for recognizing the potential of our novel next-generation investigational drug ABM-1310 to help patients with brain tumors," said Zane Yang, M.D., CMO of ABM Therapeutics. "This offers ABM an interactive collaboration with the FDA to ensure ABM-1310 clinical development expeditiously with the highest standards of safety and quality."

ABM Therapeutics acknowledges the contributions of our team, partners, and investors who have played a vital role in reaching this milestone. Our mission remains to focus on developing innovative therapies for patients.

On September 26, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IDEAYA’s development program investigating IDE161, a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG), for the treatment of adult patients having advanced or metastatic ovarian cancer with germline or somatic BRCA 1/2 mutations who are platinum resistant and have received prior antiangiogenic and poly (ADP-ribose) polymerase (PARP) inhibitor therapies (Press release, Ideaya Biosciences, SEP 26, 2023, View Source [SID1234635426]).

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"We are extremely pleased to receive the U.S. FDA Fast Track designation for IDE161 based on the FDA’s review of preclinical and emerging clinical efficacy and tolerability data. We recently reported preliminary clinical proof-of-concept with expansion into priority HRD+ solid tumor indications in our Phase 1 clinical trial. The Fast Track designation has been provided for platinum-resistant BRCA1/2 mutant advanced or metastatic ovarian cancer, which represents a serious condition, and acknowledges the potential for IDE161 to treat this indication," said Dr. Darrin Beaupre, Chief Medical Officer at IDEAYA Biosciences.

Fast Track is a U.S. FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Under the Fast Track designation, the IDE161 development program in BRCA1/2m ovarian cancer, as specified in the Fast Track designation, is eligible for various expedited regulatory review processes, including generally more frequent FDA interactions (e.g., meetings, written communications), potential eligibility for rolling review of a New Drug Application (NDA) and potential accelerated approval and priority review of an NDA.

IDEAYA’s Phase 1 first-in-human clinical trial is evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having solid tumors with homologous recombination deficiency (HRD). Early clinical data from the dose escalation cohorts showed preliminary tumor shrinkage in multiple patients having solid tumors with HRD, including a BRCA 1/2m endometrial cancer subject. These data supported expansion into priority tumor indications in parallel with continuing evaluation of the optimal move-forward dose for Phase 2 expansion.

The expansion portion of the Phase 1 trial will include patients having HRD+ associated breast cancer and ovarian cancer, as well as a basket of other selected solid tumors. The breast cancer focus is on estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (Her2-) tumors with HRD, which represent approximately 10% to 14% of breast cancer patients. Ovarian cancer tumors with HRD represent approximately 50% of ovarian cancer patients.

IDEAYA owns or controls all commercial rights in IDE161, subject to certain economic obligations under its exclusive, worldwide license with Cancer Research UK and University of Manchester.