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Myriad Genetics and SOPHiA GENETICS to Develop an Innovative Companion Diagnostic Offering in Liquid Biopsy

On September 23, 2025 Myriad Genetics (Nasdaq: MYGN), a leader in molecular diagnostic testing and precision medicine, and SOPHiA GENETICS (Nasdaq: SOPH), an AI technology company transforming precision medicine, reported a strategic collaboration to develop and provide pharmaceutical companies with an innovative global liquid biopsy companion diagnostic (CDx) test (Press release, Myriad Genetics, SEP 23, 2025, View Source [SID1234656177]). This partnership will leverage Myriad’s advanced laboratory capabilities in the U.S. to support global testing for clinical trials and SOPHiA GENETICS’ broad, decentralized network of more than 800 connected institutions in more than 70 countries for global test deployment.

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"Serving patients and healthcare providers along the cancer care continuum is a strategic focus for Myriad Genetics," said Sam Raha, President and CEO, Myriad Genetics. "We expect this collaboration with SOPHiA GENETICS to support the development and global commercialization of comprehensive CDx solutions for our BioPharma partners with the potential to positively impact patient lives, add an important product offering to the Myriad menu and support the growth of our CDx programs."

SOPHiA GENETICS and Myriad will initially focus on the liquid biopsy application, MSK-ACCESS powered with SOPHiA DDM. Developed in collaboration with Memorial Sloan Kettering Cancer Center, MSK-ACCESS powered with SOPHiA DDM is an innovative liquid biopsy test that detects actionable genomic alterations from a single blood draw using proprietary, state-of-the-art algorithms which analyze circulating tumor DNA (ctDNA). By developing the application into a CDx, more patients can gain access to the benefits of this high-quality tumor profiling test, advancing personalized healthcare at scale.

Myriad will pursue regulatory submissions in the U.S., and SOPHiA GENETICS will manage regulatory submissions outside of the U.S. Both companies will collaborate across development activities. This innovative, hybrid approach is expected to provide pharmaceutical partners with access to key regulated markets globally.

"This collaboration represents a pivotal moment for the industry," said Jurgi Camblong, Co-founder and CEO of SOPHiA GENETICS. "By combining the complementary strengths of a specialty lab leader and a global testing network, we are not only expanding access to innovative oncology testing but also laying the foundation for a new hybrid model in companion diagnostics. This collaboration will allow us to serve both clinical and pharmaceutical partners better, while accelerating the adoption of liquid biopsy solutions across key markets."

SOPHiA GENETICS and Myriad will participate in a panel discussion at the World CB and CDx Summit in Boston and provide additional details on the collaboration.

GRAIL to Present New Galleri® Data From More Than 32,000 Participants Across the PATHFINDER 2, SYMPLIFY and REFLECTION Studies at ESMO Congress 2025 and EDCC

On September 23, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported it will present new data highlighting the Galleri multi-cancer early detection (MCED) test performance and safety from its registrational PATHFINDER 2 study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Oct. 17-21, 2025 (Press release, Grail, SEP 23, 2025, View Source;symplify-and-reflection-studies-at-esmo-congress-2025-and-edcc-302563434.html [SID1234656176]). The PATHFINDER 2 study, conducted under an FDA-approved investigational device exemption application, is the largest MCED interventional study conducted in the U.S. in an intended use population with no clinical suspicion of cancer.

As previously reported, top-line results from evaluable PATHFINDER 2 study participants with 12 months of follow-up showed that adding the Galleri test to standard of care screening demonstrated substantially greater additional cancer detection, as well as a substantially higher positive predictive value (PPV), than observed in the first PATHFINDER study. Cancer signal of origin (CSO) accuracy and specificity were consistent with the PATHFINDER study.

In addition, the company will present new Galleri data from the follow-up of symptomatic participants enrolled in SYMPLIFY, a prospective observational study, and real world experience of veterans tested with Galleri from the REFLECTION study at the Early Detection of Cancer Conference (EDCC) 2025 in Portland, Ore., Oct. 21-23, 2025.

"Galleri is the only available MCED test with demonstrated performance in an intended use population being screened for cancer. These new data build on the results from our first clinical implementation study, PATHFINDER, which was published in the Lancet in 2023, and showed that Galleri approximately doubled the number of cancers identified when added to standard of care screening," said Josh Ofman, MD, MSHS, President of GRAIL. "We’re witnessing the beginning of a transformative era for cancer screening, with these results demonstrating Galleri’s ability to detect cancers earlier, when they can be easier to treat and are potentially curable."

ESMO Data Presentations

Title: Safety and Performance of a Multi-Cancer Early Detection (MCED) Test in an Intended-Use Population: Initial Results from the Registrational PATHFINDER 2 Study

Abstract Number: 7528
Session Title: Proffered Paper session 1: Basic science & Translational research
Date/Time: Saturday, Oct. 18, 2025 at 10:15-10:25 a.m. CEST
Location: Nuremberg Auditorium – Hall 5.2

Title: Clinical Performance of a Blood-only, Targeted Methylation Circulating Tumor DNA (ctDNA) Assay for Minimal Residual Disease (MRD) Detection in Colorectal Cancer (CRC)

Abstract Number: 6215
Presentation Type: e-Poster

EDCC Data Presentations

Title: Long-term cancer registry follow-up of false positive multi-cancer early detection (MCED) test results from the SYMPLIFY study.

Presentation Type: Poster

Title: REFLECTION: Real-World Evidence Study of Multi-Cancer Early Detection (MCED) Among Veterans in the Veterans Affairs Healthcare System (VA)

Presentation Type: Lightning Talk
Date/Time: Thursday, Oct. 23, 10:35-10:50 AM PT

Title: NHS-Galleri trial: approaches to retain a diverse participant cohort across multiple trial appointments

Presentation Type: Poster

Title: Baseline participant characteristics from PATHFINDER 2, a prospective interventional study of a multi-cancer early detection test in a population setting

Presentation Type: Poster

Title: Molecular Cancer Signal Localization in Multi-Cancer Early Detection (MCED) Testing Minimizes Radiation and Imaging Burden Compared to Whole Body Imaging Approaches

Presentation Type: Poster

Illumina advances personalized cancer care with new pharma development partnerships

On September 23, 2025 Illumina Inc. (NASDAQ: ILMN) reported it will partner with multiple global pharmaceutical companies to develop companion diagnostics (CDx) enabled on the TruSight Oncology (TSO) Comprehensive genomic profiling test (Press release, Illumina, SEP 23, 2025, View Source [SID1234656175]). The continued expansion of tumor-agnostic CDx claims underscores Illumina’s commitment to advance access for patients to precision oncology care by generating standardized, globally distributable tests. The new companion diagnostic partnerships will focus on KRAS alterations, which are known to cause uncontrolled cell growth, leading to cancer.

"Developing companion diagnostic claims for the historically important KRAS biomarker will enable broader identification of patients who may benefit from targeted therapies, regardless of tumor origin," said Traci Pawlowski, vice president and head of Clinical Solutions at Illumina. "This marks a critical step forward as we build our clinical offerings to support clinicians and pharmaceutical partners in delivering more personalized, effective, and broadly accessible precision cancer care."

Genomic profiling with CDx helps match patients to precision therapies

CDx built on TSO Comprehensive help clinicians match patients with approved targeted therapies based on the genetic mutations underlying their cancer. TSO Comprehensive does this by generating a molecular tumor profile that can identify the genetic mutations driving cancer growth. To target those underlying mutations, clinicians use the CDx to confirm whether a patient is a candidate for a targeted therapy or clinical trial.

KRAS is one of the most commonly mutated oncogenes in cancer, driving tumor proliferation, survival, and progression. Given its prominence in cellular transformation, previous research has demonstrated that identifying KRAS variants is critical for proper therapy selection and improving patient outcomes.1,2

Genomics paves the way in precision oncology

Recent advances using genomics to detect KRAS variants have been successfully demonstrated across cancer types despite historical challenges in targeting KRAS. This includes traditionally difficult-to-treat diseases like pancreatic ductal adenocarcinoma, leading to opportunities for improved prognostication and treatment decisions.1,2 Genomics insights into KRAS both enhance our understanding of KRAS-driven tumor biology and pave the way for more personalized therapeutic strategies.

"KRAS mutations are common across cancer types but have historically been difficult to address," said Kashif Firozvi, MD, Maryland Oncology Hematology. "The field is evolving rapidly, with new therapies better suited to patients with mutations in this once ‘undruggable’ gene. As the treatment landscape expands, including drugs that target the KRAS pathway, knowing a patient’s KRAS status becomes essential to guiding effective treatment protocols and improving outcomes."

Illumina maintains a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will continue to support groundbreaking targeted therapies and immunotherapies to make a difference in the lives of patients with cancer.

Sensei Biotherapeutics to Host Virtual KOL Event to Discuss Full Dose Expansion Data for Solnerstotug in PD-(L)1 Resistant Tumors on October 20, 2025

On September 23, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that it will host a virtual key opinion leader (KOL) event on Monday, October 20, 2025 at 8:00 AM ET featuring company leadership and Kyriakos Papadopoulos, MD (Co-Director of Clinical Research at START, San Antonio), who will discuss the unmet need and current treatment landscape for immunotherapy-resistant solid tumors (Press release, Sensei Biotherapeutics, SEP 23, 2025, View Source [SID1234656172]).

The event will provide an update on the Company’s plans for Phase 2 studies and data from the full Phase 1/2 dose expansion cohort, including from the ESMO (Free ESMO Whitepaper) oral presentation on Friday, October 17th. Solnerstotug (formerly SNS-101), is a conditionally active monoclonal antibody targeting VISTA (V-domain Ig suppressor of T cell activation) in PD-(L)1 resistant tumors.

A live question and answer session will follow the formal presentations.

Monopar Therapeutics Inc. Announces Pricing of $135 Million Underwritten Offering of Common Stock and Pre-Funded Warrants

On September 23, 2025 Monopar Therapeutics Inc. (Nasdaq: MNPR) ("Monopar Therapeutics", "Monopar", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, reported the pricing of an underwritten registered offering of 1,034,433 shares of its common stock at an offering price of $67.67 per share and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase 960,542 shares of common stock at the purchase price of $67.669 per pre-funded warrant, which represents the offering price per share for the common stock less a $0.001 per share exercise price (Press release, Monopar Therapeutics, SEP 23, 2025, View Source [SID1234656171]).

The gross proceeds to Monopar from the offering net of the anticipated Stock Repurchase (as defined below), but before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $100 million. Monopar intends to use such remaining net proceeds from the offering for general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

Monopar Therapeutics intends to use up to $35 million of the proceeds from the offering to purchase shares of its common stock held by Tactic Pharma, LLC in a privately negotiated transaction at $63.6098 per share, which is the same price per share as the price at which the shares are being sold to investors in the offering, less underwriting discounts and commissions (the "Stock Repurchase").

The offering is expected to close on or about September 25, 2025, subject to customary closing conditions.

Morgan Stanley, Leerink Partners and Barclays are acting as the lead book-running managers for the offering.

The securities in the registered offering are being offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-289947), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on August 29, 2025, and declared effective on September 9, 2025. A prospectus supplement and accompanying prospectus describing the terms of the registered offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the registered offering, when available, may also be obtained by contacting Morgan Stanley & Co. LLC at Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email: [email protected]; Leerink Partners LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Barclays Capital Inc., Attn: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.