On May 30, 2024 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) reported they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status (Press release, Qiagen, MAY 30, 2024, View Source [SID1234643866]). This next-generation sequencing (NGS) test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer and is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners. The project builds on the recently announced master collaboration agreement between the two companies.

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The test will be based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digital Insight solutions, which creates a sample to insight HRD solutions, and Myriad’s proprietary FDA-approved MyChoice CDx, a single-site PMA-approved centralized testing service for analyzing HRD in certain tumors. MyChoice CDx assesses the HRD status by examining a tumor’s DNA repair capabilities, particularly focusing on BRCA1 and BRCA2 gene mutations and calculating a Genome Instability Score (GIS). The GIS aids in pinpointing ovarian cancer patients who are most likely to benefit from targeted treatments, such as LYNPARZA (olaparib) by AstraZeneca.

"Our partnership with Myriad Genetics underscores a shared commitment to advancing cancer diagnostics. Together, we aim to broaden the accessibility of HRD tests, allowing an increasing number of cancer patients to benefit from tailored treatments," said Fernando Beils, Senior Vice President and head of the Molecular Diagnostics Business Area. "By introducing a distributable HRD test, we anticipate a reduction in the time required for therapy decisions, a decrease in associated costs, and shorter turnaround times compared to outsourced testing, ultimately benefitting the patients."

The MyChoice CDx assay can identify 34% more tumors with HRD using the GIS score compared to other methods only using percent loss of heterozygosity (%LOH)[1]. Given that approximately 48% of ovarian cancer tumors exhibit HRD[2], often due to specific mutations within the tumor, expanding access to this assay is vital for advancing personalized medicine and ensuring that patients receive the most appropriate treatments.

We’re excited to share this milestone in our partnership with QIAGEN as we work collectively to advance cancer care worldwide," said Patrick Burke, Executive Vice President of Strategy and Innovation, Myriad Genetics. "By extending the global reach and ease of access to Myriad’s gold-standard HRD-testing technology we aim to help drive wide-spread and broader clinical adoption of HRD testing. This milestone demonstrates what the QIAGEN and Myriad partnership is uniquely able to deliver to pharmaceutical partners – propriety content, cutting edge assay platforms, clinical trial execution, and world-wide CDx product distribution."

QIAGEN will manage the development and distribution of the kit-based HRD test outside of the United States. The IP license grants QIAGEN the capability to collaborate with pharmaceutical partners to create an IVD-validated test, intended for use as a companion diagnostic outside of the United States. The combined regulatory expertise of QIAGEN and Myriad enables seamless compliance and integration in clinical and companion diagnostic applications.

QIAGEN’s QIAseq panels enable efficient and accurate NGS library preparation. Over 4 million samples have been processed with QIAseq panels for cancer testing applications.[3]

QIAGEN has master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global pharma and biotech companies – a deep pipeline that helps advance precision medicine in diverse disease indications, tailoring a patient’s treatment to the genetic profile identified by companion diagnostics testing. Myriad has provided testing support for hundreds of clinical trials, has obtained 10 companion diagnostic approvals from the FDA and PMDA, and anticipates that the QIAGEN partnership will drive the expansion of the Myriad’s oncology products portfolio.

On May 30, 2024 Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, reported that members of management will participate in the following upcoming investor conferences in June (Press release, Precision Biosciences, MAY 30, 2024, View Source [SID1234643865]):

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Jefferies Global Healthcare Conference
Date: Wednesday, June 5, 2024
Time: 1:30 pm – 1:55 pm ET
Format: Fireside Chat
Webcast Registration: Link

Goldman Sachs 45th Annual Global Healthcare Conference 2024
Date: Wednesday, June 12, 2024
Time: 10:00 am – 10:35 am ET
Format: Fireside Chat
Webcast Registration: Link

A live webcast of each presentation will also be accessible on Precision’s website in the Investors section under Events & Presentations at investor.precisionbiosciences.com. An archived replay of the webcasts will be available for approximately 30 days following each event.

On May 30, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that enrollment has been completed and dosing initiated for the fifth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI) (Press release, Oncternal Therapeutics, MAY 30, 2024, https://investor.oncternal.com/news-releases/news-release-details/oncternal-announces-enrollment-completed-and-dosing-initiated [SID1234643864]). Patients in the fifth cohort are receiving ONCT-534, the company’s dual-action androgen receptor inhibitor (DAARI), at a dose of 600 mg taken orally once each day. The decision to proceed to this higher dose level was made by the study’s Safety Review Committee (SRC) after reviewing data from the fourth dose level of 300 mg ONCT-534 daily. An initial update on ONCT-534 safety and efficacy based on prostate-specific antigen (PSA) levels from this study is expected in the third quarter of 2024 and will include data from this 600 mg dose cohort.

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"We are encouraged by the rapid enrollment in the dose escalation portion of our Phase 1/2 study with ONCT-534. The drug has been well tolerated, with no dose limiting toxicities observed to date. We continue to open new sites and patient demand continues to be strong," said Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics. "We are looking forward to sharing initial safety and efficacy data soon, which will include a larger, more robust set of clinical and biomarker results, as well as longer follow-up from the initial dosing cohorts."

About Study ONCT-534-101
Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide, and darolutamide. After the safety and tolerability and preliminary antitumor activity of ONCT-534 have been assessed in Phase 1, Phase 2 will commence to further evaluate the safety and antitumor activity of ONCT-534 to support selecting an optimal dose.

On May 30, 2024 NuCana plc (Nasdaq: NCNA) reported that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will present and host one-on-one meetings at the Jefferies Global Healthcare Conference (Press release, Nucana BioPharmaceuticals, MAY 30, 2024, View Source [SID1234643863]).

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Event: Jefferies Global Healthcare Conference
Date: Thursday, June 6, 2024
Time: 12:30 PM EDT
Location: New York, NY

The presentation will be webcast live and available for replay under "Events & Presentations" in the Investors section of the Company’s website at www.nucana.com.

On May 30, 2024 – NH TherAguix (NHT), a phase II clinical stage biotechnology company specializing in the development of novel nanomedicine solutions applicable to precision radiotherapy in oncology, reported that its lead drug candidate, AGuIX, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as a next-generation radio-enhancer for the treatment of malignant gliomas, and in particular glioblastoma (GBM), the most common and deadliest brain cancer globally (Press release, NH TherAguix, MAY 30, 2024, View Source [SID1234643862]).

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A nanodrug capable of improving the precision and effectiveness of radiotherapy without damaging surrounding tissues

The result of over 10 years of research, AGuIX is a nanodrug designed to meet the growing medical need in brain cancer, by significantly improving the efficacy and precision of radiotherapy directly within tumors.

Its structure mostly made of gadolinium provides it with strong contrast imaging properties, coupled with the potential to indirectly increase the delivered X ray dose. AGuIX thus enables precise tumor delineation via MRI and can significantly improve radiotherapy efficacy. AGuIX also boasts an excellent safety profile, as demonstrated by the results of the first In Human Phase Ib clinical trial NANORAD-1.

This new designation marks an important regulatory milestone for NH TherAguix, paving the way for accelerated development of its lead drug candidate, and is in line with the deployment of the company’s new development strategy, following the recent appointment of Vincent Carrère as CEO.

Vincent Carrère, a pharmaceutical industry expert, appointed as CEO to steer the late-stage clinical development of AGuIX

Last September, Vincent joined NH TherAguix to lead the final steps of AGuIX clinical developments through registration trials, until expected market approval. Formerly Vice President-Head of the Northern and Central Europe Region at Ipsen, he brings over 15 years of experience in thepharmaceutical and biotech industry. His deep knowledge of the processes and final stages of drug development and commercial launch will be instrumental in finalizing the upcoming developments of AGuIX.

"We are delighted to have received this FDA Fast Track designation for AGuIX in the treatment of malignant glioma. It demonstrates the strong interest of the US regulatory authorities in our nextgeneration radio-enhancer. We are convinced that AGuIX holds great potential to offer an effective clinical and therapeutic response to patients suffering from these deadly cancers, for whom existing treatments remain largely insufficient. 2024 should be a major turning point in the development of our promising nano-drug, and we look forward to sharing the first results from our clinical trials later this year," said Vincent Carrère, CEO of NH TherAguix.

Major clinical inflection points expected in H2 2024

AGuIX is currently being evaluated in four Phase II clinical trials, out of which three should provide major inflection points before the end of 2024:

• The Phase II NANORAD 2 study, conducted by Grenoble University Hospital (p.i. Pr. C. Verry) on 100 patients with multiple brain metastases, is evaluating AGuIX in combination with whole brain radiotherapy1. Recruitment has been finalized and results of the interim efficacy analysis are expected by the end of 2024 at the latest.

• The Phase II NANOBRAINMETS trial, conducted in collaboration with the Dana Farber Cancer Institute (p.i. Dr. A. Aizer), the world’s leading institute for adult and pediatric cancer research and treatment, is evaluating AGuIX in 134 patients with brain metastases in combination with stereotactic radiotherapy2. A futility analysis (50% of patients enrolled) is scheduled for August 2024 to assess the first potential effects of the treatment on patients. Validation of the continuation of the study would underline the strong therapeutic potential of AGuIX in the treatment of these patients. Initial results from an interim efficacy analysis are then expected in November 2024.

• The Phase I/II NANOGBM trial, conducted by Clermont Ferrand Centre Jean Perrin (p.i. Dr. J. Biau), is evaluating AGuIX in the treatment of glioblastoma in 62 patients. Results from the interim efficacy analysis are expected by the end of 2024.

"Glioblastoma are the most common type of malignant primary brain tumor and account for most deaths among patient with primary tumors. Although there has been progresses in understanding the biology of these tumors, the unmeet therapeutic need remains very important. This Fast Track designation will facilitate NH TherAguix more frequent interactions with the FDA as well as accelerated approval and priority review in glioblastoma indications. This program will be led in parallel to our ongoing clinical development program in brain metastases, where preliminary signal of efficacy of AGuIX has already been detected," concluded Olivier de Beaumont, CMO of NH TherAguix.