On October 11, 2024 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy (Press release, Foundation Medicine, OCT 11, 2024, View Source [SID1234647160]).

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Approximately 70% of all breast cancers are hormone-receptor positive, HER2-negative.1 PIK3CA is the most commonly mutated gene in hormone-receptor positive, HER2-negative breast cancer, with approximately 40% of patients harboring this mutation.2

"This approval reinforces the importance of testing for PIK3CA mutations at the time of diagnosis to help guide decision-making in the first-line setting for metastatic breast cancer patients," said Mia Levy, Ph.D., M.D., chief medical officer at Foundation Medicine. "Our high-quality liquid biopsy companion diagnostic relies on a routine blood draw to identify patients with PIK3CA mutations, enhancing broader access to genomic testing while allowing more patients to benefit from this new best-in-class first-line treatment regimen."

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. From a routine blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights.

With this approval, Foundation Medicine has seven companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company.3 Foundation Medicine is the global leader in approved companion diagnostic indications with more than 60% of all approved U.S. companion diagnostic indications for next-generation sequencing (NGS) testing.

"Given the high prevalence of PIK3CA mutations in hormone receptor-positive, HER2-negative breast cancer, the introduction of a new targeted treatment regimen in the first-line setting will have a profound impact on this patient population," said Jean A. Sachs, MSS, MLSP, chief executive officer at Living Beyond Breast Cancer. "Biomarker testing plays an important role in helping patients and their families make personalized treatment decisions based on their individual cancer, and we’re encouraged to see Foundation Medicine continue to expand its approved companion diagnostic indications in breast cancer."

On October 11, 2024 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases reported that new clinical data on the efficacy of its Merlin test will be presented at the 21st International Congress of the Society for Melanoma Research (SMR) Annual Meeting 2024 in New Orleans (Press release, SkylineDx, OCT 11, 2024, View Source [SID1234647158]).

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The study, which assessed the clinical utility and performance of Merlin test in T1a melanoma patients, showed that it dramatically improves the ability to differentiate between low- and high-risk T1a patients. Merlin test identified 88% of patients as Low Risk, resulting in a post-test SLN positivity rate of only 1.5% among those classified as Merlin Low Risk. Conversely, 12% of patients were classified as High Risk, with a significantly higher SLN positivity rate of 15.8% among those identified as Merlin test High Risk. These findings highlight the test’s potential to reduce unnecessary SLNB surgeries, preventing overtreatment in the vast majority of patients while ensuring high-risk individuals receive appropriate care.

Alexander Meves, M.D., MBA, dermatologist at Mayo Clinic and principal inventor of the CP-GEP model, shared: "The intent is to help prevent undertreatment in seemingly low-risk early-stage melanoma patients who are actually at risk for nodal metastasis. By accurately identifying these at-risk individuals, we ensure that they receive the necessary interventions, even in the absence of traditional clinical risk factors."

For patients with at least one traditional adverse feature, such as age under 40, lymph vascular invasion, or a high mitotic rate, Merlin test identified 37 patients as Low Risk, all with a post-test SLN positivity rate of 0%. Additionally, among 104 patients without any adverse features, the Merlin test still identified 7 patients as High Risk, with a post-test SLN positivity rate of 14.3%. These results demonstrate that Merlin test effectively pinpoints high-risk individuals who might otherwise go untreated under traditional guidelines.

This latest data highlights the importance of Merlin test in transforming early-stage melanoma treatment. Merlin test provides clinicians with a robust, evidence-based tool to tailor SLNB surgery decisions, minimizing unnecessary surgeries while ensuring that high-risk patients receive appropriate care. With the ongoing advancements in genomic testing and personalized medicine, the Merlin test offers a new standard of care that has the potential to improve outcomes for countless melanoma patients.

About CP-GEP (Merlin test)

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to stratify patients based on being high or low risk for metastasis and thereby categorize them in the appropriate surgical action categories listed in evidence-based cancer treatment, prevention and screening guidelines. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase access. In the United States, Tempus is commercializing the Tempus Merlin test.
Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict.

On October 11, 2024 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported the selection of three abstracts for presentation, including a late-breaking oral presentation, at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024), taking place October 23-25, 2024, in Barcelona, Spain (Press release, Tyra Biosciences, OCT 11, 2024, View Source [SID1234647157]).

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Details of the presentations are below:

Title: "Preliminary safety and anti-tumor activity of TYRA-300, a highly selective FGFR3 inhibitor, in participants with advanced solid tumors with activating FGFR3 mutations/fusions (SURF301)"

Session: Late Breaking Abstracts and Proffered Papers: Novel discoveries in drug development
Date: Friday, October 25, 2024
Time: 15:36 – 15:48 hrs CEST
Abstract #: LBA500

Title: "TYRA-300, an oral, FGFR3-selective inhibitor: Preliminary pharmacokinetic and pharmacodynamic analysis from SURF301, the multicenter open-label phase 1/2 study of TYRA-300 in advanced urothelial carcinoma and other solid tumors with activating FGFR3 alterations"

Abstract #: 72
Poster #: PB060

Title: "A Multicenter, Open-label Phase 1/2 Study of TYRA 300 in Advanced Urothelial Carcinoma and Other Solid Tumors with Activating FGFR3 Gene Alterations (SURF301)"

Abstract #: 35
Poster #: PB023

The abstracts related to the presentations are under embargo until 00.01 hrs CEST on Friday, October 25, 2024.

On October 11, 2024 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, reported financial results for the third quarter ended August 31, 2024, and provided a corporate update (Press release, Nurix Therapeutics, OCT 11, 2024, View Source [SID1234647156]).

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"We continue to make great progress and remain focused on execution as we advance our pipeline of wholly owned and partnered programs in oncology, inflammation and immunology," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "As we approach the end of the year, we are well capitalized and look forward to building further momentum as we head into clinical data readouts in the fourth quarter of 2024 and the initiation of pivotal studies of NX-5948 in 2025."

Recent Business Highlights

•Expanded clinical development of NX-5948: In the third quarter of 2024, Nurix initiated the Phase 1b portion of its ongoing Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies. The Phase 1b expansion includes a randomization to a low dose (200mg QD) or a high dose (600mg QD) of NX-5948 in patients with chronic lymphocytic leukemia (CLL) who have been treated with at least two prior regimens including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL2 inhibitor. This is the patient population for which the FDA granted Nurix Fast Track designation in January 2024. Cohorts were also initiated to evaluate NX-5948 in patients with Waldenstrom’s macroglobulinemia (WM), marginal zone lymphoma and follicular lymphoma.

•Re-initiated enrollment in NX-2127 Phase 1a/b trial: Nurix recently reinitiated enrollment with its new chirally controlled drug product in a standard dose escalation study within the current Phase 1a/1b trial. As previously announced, in March 2024, the U.S. Food and Drug Administration (FDA) lifted a manufacturing-related, partial clinical hold on the NX-2127 clinical trial. Patients enrolled prior to the partial clinical hold who are deriving clinical benefit continue to receive uninterrupted treatment with the original drug product.

•Presented early preclinical data from ongoing collaboration with Pfizer to develop Degrader-Antibody Conjugates, a new class of therapeutics: On September 10, 2024, at the ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit, Nurix’s chief scientific officer, Gwenn M. Hansen, Ph.D., presented an outline of the advantages of DACs, Nurix’s matrixed approach to the generation and optimization of DACs using its DELigase platform, and early preclinical data demonstrating cell-type selective degradation of targeted proteins by DACs. Nurix believes that DACs may represent a next generation of antibody drug conjugate (ADC) technology that could broaden its use in oncology and potentially other indications. DACs combine the catalytic activity of a targeted protein degrader with the tissue specificity of an antibody which has the potential to provide improved therapeutic index and broader applicability than standard ADCs and which can potentially be applied to any protein target in any tissue.

Upcoming Program Highlights*

NX-5948: NX-5948 is an investigational, orally bioavailable degrader of BTK that is currently being evaluated in the Phase 1b portion of a Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies. By year-end 2024, Nurix plans to present additional clinical data from this study for patients with CLL. Later this month, at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM 12), Nurix will present a clinical update from this study on patients with WM. Additional information on the Phase 1a/b clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).

Nurix is also conducting a Phase 1 healthy volunteer study to assess food effects and drug-drug interactions in anticipation of initiating pivotal development in 2025. Additional information on this Phase 1 clinical trial can be accessed at www.clinicaltrials.gov (NCT06593457).

Nurix continues to lay the groundwork for indication selection in autoimmune and inflammatory diseases and expects to complete ongoing preclinical studies in 2024 that can enable an investigational new drug (IND) application for NX-5948 in autoimmune indications. An abstract titled "NX-5948, a Clinical-Stage BTK Degrader, Achieves Deep Suppression of BCR, TLR, and FcR Signaling in Immune Cells and Demonstrates Efficacy in Preclinical Models of Arthritis and Other Inflammatory Diseases" was accepted for a poster presentation at the upcoming annual meeting of the American College of Rheumatology (ACR 2024), being held November 14–19, 2024, in Washington, D.C.

NX-2127: NX-2127 is an orally bioavailable BTK degrader that also degrades cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) for the treatment of relapsed or refractory B‑cell malignancies. Nurix is conducting a Phase 1a/b clinical trial of NX-2127, which includes Phase 1b expansion cohorts focused on patients with diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). Nurix recently introduced a new chirally controlled drug product, which is being evaluated in a dose escalation within this Phase 1a/b trial. Future clinical updates are anticipated in 2025. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).

NX-1607: NX-1607 is an orally bioavailable inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) for immuno-oncology indications, including a range of solid tumor types and lymphoma. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in monotherapy and in a combination cohort utilizing paclitaxel in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in Phase 1a. Nurix anticipates providing a program update by year-end 2024. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

GS-6791 (previously NX-0479): GS-6791 is a potent, selective, oral IRAK4 degrader. Degradation of IRAK4 by GS-6791 has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. Nurix’s partner, Gilead, is responsible for conducting IND-enabling studies and advancing this program to clinical development. An abstract titled "IRAK4 Degrader GS-6791 Inhibits TLR and IL-1R-Driven Inflammatory Signaling, and Ameliorates Disease in a Preclinical Arthritis Model" was accepted for a poster presentation at ACR 2024.
STAT6 degrader: In April 2024, Nurix announced an extension of the ongoing research program with Sanofi for STAT6 (signal transducer and activator of transcription 6), a key drug target in type 2 inflammation, with the goal of nominating a development candidate in the first year of the extended term. Nurix remains on track for this goal.
Continued pipeline advancement of strategic collaborations with Gilead, Sanofi and Pfizer: Nurix expects to continue to achieve substantial research collaboration milestones throughout the terms of its collaborations with Gilead, Sanofi and Pfizer.

*Expected timing of events throughout this press release is based on calendar year quarters.

Fiscal Third Quarter 2024 Financial Results

Collaboration revenue for the three months ended August 31, 2024, was $12.6 million compared with $18.5 million for the three months ended August 31, 2023. Revenue from the collaboration with Gilead decreased as the initial research term for certain drug targets ended. The decrease was offset by an increase in revenue from the collaboration agreement with Pfizer that was entered into in the fourth quarter of fiscal year 2023.
Research and development expenses for the three months ended August 31, 2024, were $55.5 million compared with $47.9 million for the three months ended August 31, 2023. The increase was primarily due to clinical and contract manufacturing costs as Nurix continued to accelerate the enrollment of NX-5948 and progress its other clinical trial programs for NX-2127 and NX-1607.

General and administrative expenses for the three months ended August 31, 2024, were $11.7 million compared with $10.6 million for the three months ended August 31, 2023. The increase was primarily due to an increase in professional service and consulting costs.

Net loss for the three months ended August 31, 2024, was $49.0 million, or ($0.67) per share, compared with $37.0 million, or ($0.68) per share, for the three months ended August 31, 2023.
Cash, cash equivalents and marketable securities was $457.5 million as of August 31, 2024, compared to $452.5 million as of May 31, 2024.

On October 10, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that it is hosting an investor webcast highlighting its proprietary cell-free platform and its use to design and develop next-generation ADC innovation, including a near-term pipeline of differentiated programs with potential across a broad range of tumor types (Press release, Sutro Biopharma, OCT 10, 2024, View Source [SID1234647684]). The presentation will include an overview of Sutro’s strategic approach with the goal of improving the therapeutic index of ADCs. It will also provide details on the Company’s early-stage ADC pipeline, including STRO-004 (tissue factor-targeting ADC), dual-payload ADCs (ADC2) and immunostimulatory ADCs (iADC).

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"The precise design enabled by Sutro’s cell-free platform has allowed us to develop ADCs with a wide range of features that are not currently possible with other cell-bound approaches," said Hans-Peter Gerber, Ph.D., Sutro’s Chief Scientific Officer. "This includes the ability to safely increase potency and combine different payloads to overcome specific limitations such as tumor resistance. Today we are highlighting key data supporting our advancements in these areas, along with the long-term potential of our platform to deliver new ADC innovation. This includes plans for three IND filings for wholly owned programs over the next three years and the advancement of additional differentiated preclinical programs for internal development or external partnering."

The event will feature presentations by members of Sutro’s senior management team, functional leaders and Peter Sandor, M.D., EVP and Head of Corporate Strategy at Astellas Pharma (previously SVP, Primary Focus Lead Immuno-Oncology at Astellas, with responsibility for the Sutro-Astellas strategic collaboration to advance iADCs). Sutro management will participate in a Q&A session at the end of the presentation.

Next-Generation ADC Innovation:

Making ADCs better outside the tumor: Sutro’s proprietary cell-free platform enables key elements of ADC design that are intended to reduce platform toxicities associated with current-generation ADCs, including interstitial lung disease; skin, eye, liver and kidney toxicities; and thrombocytopenia. This includes transformational technology across the design of antibodies, payloads, linker and conjugation chemistry that have been demonstrated in preclinical models to reduce toxicities and improve pharmacokinetics.
Making ADCs better inside the tumor: Sutro highlights three approaches enabled by its cell-free platform: 1) increasing potency safely with higher drug-antibody ratio (DAR) exatecan ADCs; 2) combining payloads to overcome tumor resistance with dual-payload ADCs (ADC2); and 3) delivering next-generation immuno-oncology therapeutics with immunostimulatory ADCs (iADC) that combine immune activation with cytotoxic payloads.
Data Highlights and Near-Term Pipeline Milestones:

STRO-004, a tissue factor-targeting ADC, which features a DAR8 exatecan payload and site-specific linker design, demonstrated greater anti-tumor activity and lower toxicities than a tissue factor benchmark ADC in preclinical models. Sutro anticipates filing an IND for STRO-004 with the U.S. Food & Drug Administration in the second half of 2025.
Dual-payload ADCs (ADC2) provide therapeutic benefits compared to standard ADCs, including overcoming tumor resistance mechanisms, showing increased anti-tumor activity and desirable properties in preclinical models.
iADCs provide a novel mechanism of action, bridging innate and adaptive immunity to enable broad protection in a single molecule, and show increased and durable anti-tumor activity in a preclinical model compared to standalone ADCs or immune-stimulating antibody conjugates.
Sutro’s proprietary and partnered preclinical ADC portfolio has potential across a broad range of tumor types and the Company plans to deliver three INDs over the next three years, including for STRO-004 in the second half of 2025. The Company also intends to advance a deep pipeline of preclinical programs, providing further potential for internal development and/or partnering.
Webcast Information:
To access the live audio webcast beginning at 1:30 p.m. PT / 4:30 p.m. ET, please go to

View Source An archived replay of the webcast will be available on the Company’s website following the event.