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.

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"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.

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]).

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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.

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]).

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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.

On September 23, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or refractory multiple myeloma (RRMM) demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim analysis of the MRD endpoint (Press release, Bristol-Myers Squibb, SEP 23, 2025, View Source [SID1234656170]). In accordance with the trial design and based on the recommendation from the Data Monitoring Committee, the trial will continue without changes to evaluate the other dual-primary endpoint of progression-free survival (PFS), and the key secondary endpoint of overall survival and safety. The safety profile of iberdomide in combination with daratumumab and dexamethasone in this study is generally consistent with previous studies.

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"This result builds on our significant experience in both targeted protein degradation and developing new treatment options for patients living with multiple myeloma," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology and Cell Therapy. "Iberdomide represents the first of a novel class of medicines, called CELMoDs, which has the potential to create a new foundation for multiple myeloma treatment that may be combined with other therapies."

The company plans to discuss these results with health authorities.

About EXCALIBER-RRMM
EXCALIBER-RRMM (NCT04975997) is a Phase 3, multicenter, two-stage, randomized, open-label study evaluating the efficacy and safety of iberdomide in combination with daratumumab and dexamethasone (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma (RRMM). The study is designed to assess dual-primary endpoints of minimal residual disease (MRD) negativity and progression-free survival (PFS), with additional secondary endpoints including overall survival (OS), overall response rate (ORR), duration of response (DoR), time to progression (TTP), time to next treatment (TTNT), and health-related quality of life (HR-QoL). Stage 1 of the study identified 1.0 mg iberdomide as the optimal dose based on safety, pharmacokinetics, and efficacy data. In Stage 2, approximately 664 patients were randomized to receive either IberDd or DVd.

About Minimal Residual Disease (MRD)
Minimal residual disease (MRD) refers to the small number of cancer cells that may remain in a patient’s body after treatment and are undetectable using conventional diagnostic methods. In multiple myeloma, MRD assessment has emerged as a highly sensitive and clinically meaningful tool for evaluating treatment response. MRD negativity does not necessarily mean all cancer cells are gone, but it may predict improved clinical outcomes, including longer remission and survival.

Modern MRD detection methods, such as next-generation sequencing (NGS) and next-generation flow cytometry (NGF), can identify one malignant cell among 100,000 (threshold for MRD) to 1,000,000 normal cells, offering unprecedented precision in measuring disease burden. MRD is increasingly being used in clinical trials as a surrogate endpoint for progression-free survival (PFS) and is gaining recognition from regulatory authorities for its role in accelerating therapeutic development.

About Targeted Protein Degradation and Novel CELMoD Agents
Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered "undruggable." We are the only company that has successfully developed and commercialized protein degrader agents – immunomodulatory drugs (IMiD) which helped establish the current standard of care in the treatment of multiple myeloma. We are building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD agents, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach allows us to match the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb.

On September 23, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech"), alongside its artificial intelligence ("AI") company InstaDeep Ltd. ("InstaDeep"), reported it will host its second AI Day, an edition of BioNTech’s "Innovation Series", at 09:00 a.m. EDT (3:00 p.m. CEST) on Wednesday, October 1, 2025, in London, United Kingdom (Press release, BioNTech, SEP 23, 2025, View Source [SID1234656169]). The event will provide an overview of BioNTech’s AI strategy and capabilities, and the application of AI in BioNTech’s pipeline and internal processes.

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The live webcast of the event will be available via this link.

Participants may also access the slides and a recording of the event via the "Events & Presentations" page in the Investor Relations section of BioNTech’s website at www.BioNTech.com. The recording will be available shortly after the event’s conclusion and archived on BioNTech’s website for one year thereafter.