On May 24, 2024 Agendia, Inc., reported that new data on its comprehensive genomic tests will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place May 31st – June 4th, 2024, in Chicago, Illinois (Press release, Agendia, MAY 24, 2024, View Source [SID1234643701]).

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The presented data underscores Agendia’s commitment to advancing individualized management of breast cancer and to providing support throughout a patient’s treatment journey. These studies add to the already robust library of clinical studies demonstrating Agendia’s MammaPrint and BluePrint effectiveness in providing reliable guidance for therapeutic considerations in early-stage breast cancer.

The two abstracts that have been selected by ASCO (Free ASCO Whitepaper) for oral discussion will 1) feature an investigation of underlying biology that mediates immune therapy response and, 2) will provide an evaluation of the MammaPrint Index and 3-year recurrence-free interval in patients treated with CT, with and without anthracycline. Both presentations utilize whole transcriptome data from the prospective, observational real-word evidence FLEX Study (NCT03053193).

The following are details of the abstracts that have been accepted at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting:

Oral Discussion

Association of MammaPrint index and 3-year outcome of patients with HR+HER2- early-stage breast cancer treated with chemotherapy with or without anthracycline
Authors: O’Shaughnessy, J., et al.
Presenter: Joyce O’Shaughnessy, MD | Baylor-Sammons Cancer Center, Texas Oncology
Session: Rapid Oral Abstract – Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Friday, May 31, 2024 | 2:45 PM – 4:15 PM CDT
Abstract #: 511
Elucidating the immune active state of HR+HER2- MammaPrint High 2 early breast cancer
Authors: Cobain, E., et al.
Presenter: Erin Cobain, MD | University of Michigan Rogel Cancer Center
Session: Oral Abstract Session – Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Monday, June 3, 2024 | 3:00 PM – 6:00 PM CDT
Abstract #: 506
Poster sessions

Cost consequence model of the MammaPrint (70-gene signature) and 21-gene signature in patients with primary HR+ HER2-, N1 early-stage breast cancer in Germany
Authors: Lux M.P., Sandor M. F., Hofmann V., Pronin D., Klinkhamer J.C., Müller-Huesmann H.
Presenter: Harald Müller-Huesmann | St. Josef Brothers Hospital Paderborn, Germany
Session Date & Time: Sunday, June 2, 2024 | 9:00 AM – 12:00 PM CDT
Abstract #: 534
Other Investigator Initiated Abstracts Utilizing MammaPrint + BluePrint:

Correlation of hormone receptor positive HER2-negative/MammaPrint high-2 breast cancer with triple negative breast cancer: Results from gene expression data from the ISPY2 trial.
Authors: Alejandro Rios-Hoyo; Lajos Pusztai
Session Date & Time: Sunday, 2, 2024 | 9:00AM-12:00PM CDT
Abstract #: 573
Genomic profile in Mexican women with early-stage breast cancer using Mammaprint + Blueprint assay: A retrospective study.
Authors: Valdez, et al.
Abstract #: e12541
More information about the program can be found at the ASCO (Free ASCO Whitepaper) 2024 website.

On May 24, 2024 Fulgent Pharma, a subsidiary of Fulgent Genetics, Inc. (NASDAQ: FLGT) and a leading nanobiotechnology company specializing in innovative cancer therapeutics, reported that Phase 1 clinical data on its lead therapeutic development candidate, FID-007, to treat Head and Neck cancer, will be presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2024 in Chicago, Illinois (Press release, Fulgent Pharma, MAY 24, 2024, View Source [SID1234643700]).

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Details of the presentation are as follows:

Abstract Title: Efficacy from the phase 1 study of FID-007, a novel nanoparticle paclitaxel formulation, in patients with head and neck squamous cell carcinoma
Session: Head and Neck Cancer
Presentation Date and Time: June 2, 2024, from 9:00 a.m. to 12:00 p.m. Central Time
Presentation Type: Poster Session
Abstract #6042, Poster Board #345

About FID-007

FID-007 consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability. In addition to allowing the drug to remain in solution until it can enter a cancer cell, the PEOX nanoparticle is designed to preferentially deliver paclitaxel to the tumor through the leaky hyperpermeable vasculature.

On May 24, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing groundbreaking new medicines for the treatment of cancer and immunological diseases, reported new findings from a biomarker study in non-small cell lung cancer (NSCLC) patients with exon 20 insertion (exon20ins) mutations, highlighting sunvozertinib as an effective treatment for this patient population (Press release, Dizal Pharma, MAY 24, 2024, View Source [SID1234643699]). The findings have been published in an abstract (#8563) available on the official website of the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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A total of 121 patients with EGFR exon20ins mutations treated with sunvozertinib were included in this biomarker study. Serial plasma ctDNA samples were collected from baseline until disease progression (PD). The key findings of the analysis were as follows:

Anittumor efficacy of sunvozertinib was observed in patients regardless of baseline EGFR exon20ins status in plasma ctDNA.

There was a positive correlation between detectable EGFR exon20ins in baseline plasma ctDNA and higher number of metastasis sites.
Higher abundance of EGFR exon20ins in baseline plasma ctDNA was positively correlated with more metastasis sites and brain metastasis (BM).
Patients with baseline negative EGFR exon20ins in plasma ctDNA achieved a higher objective response rate (ORR) (68.0% vs. 45.8%) and longer median progression free survival (PFS) (7.4 months vs. 5.5 months) than those with positive EGFR exon20ins.
Sunvozertinib could effectively clear EGFR exon20ins in plasma ctDNA, confirming its direct effect on EGFR pathway.

Decrease of EGFR exon20ins mutant allele was observed in 85.7% of patients with sunvozertinib treatment.
The earliest clearance of EGFR exon20ins occurred after one week of sunvozertinib treatment.
The resistance to sunvozertinib could be through EGFR-dependent and EGFR-independent mechanisms and combination of golidocitinib, a JAK1 inhibitor, with chemotherapy could be a potential approach to overcome sunvozertinib resistance.

Acquired EGFR C797S and other genetic aberrations in EGFR downstream signaling pathway may be associated with resistance to sunvozertinib.
In vitro and in vivo experiments suggested that combination of golidocitinib, a JAK1 inhibitor, with chemotherapy could be a potential approach to overcome sunvozertinib resistance.
"This biomarker study selected for poster presentation at 2024 ASCO (Free ASCO Whitepaper) Annual Meeting helps us further optimize treatment options for NSCLC patients with EGFR exon20ins mutations, and at the same time validates sunvozertinib’s efficiency of clearance of EGFR exon20ins mutations." said Xiaolin Zhang, PhD, CEO of Dizal, "Supported by positive findings from the WU-KONG6 study, a pivotal study with patients from China, sunvozertinib was approved in China in relapsed or refractory setting, making it the world’s first and only oral drug for the treatment of NSCLC patients with EGFR exon20ins mutations. The latest data from WU-KONG1 Part B, the equivalent study with patients worldwide, will be unveiled at the upcoming ASCO (Free ASCO Whitepaper) meeting. The study met its predefined primary end point and was statistically significant, providing substantial evidence for successful NDA submissions of sunvozertinib in the US, the EU and other overseas markets."

WU-KONG1 Part B is a multinational pivotal study, currently being conducted across ten countries and regions in Asia, Europe, North America, and South America. The primary analysis showed that sunvozertinib demonstrated promising antitumor efficacy in relapsed or refractory NSCLC with EGFR exon20ins, with a tolerable safety profile. The updated data will be presented orally at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract #8513).

On May 24, 2024 Tyligand Bioscience, a clinical-stage biotechnology company focused on the discovery and development of innovative cancer therapies, reported that the first patient had been dosed in the Phase 1/2 trial of TSN1611 for the treatment of KRAS G12D mutant solid tumors in the United States (Press release, Tyligand Bioscience, MAY 24, 2024, View Source [SID1234643698]). The program has been cleared for IND by U.S. FDA and China NMPA in Feb and April 2024, respectively.

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TSN1611 is a highly selective and orally bioavailable small molecule targeting the G12D mutant of KRAS oncogene, with excellent enzymatic and cellular activities. It effectively engages both the ON-state (GTP-bound) and OFF-state (GDP-bound) of KRAS G12D. TSN1611 has demonstrated superior in vivo anti-tumor activity with a durable response across multiple animal models. TSN1611 features favorable physicochemical properties, oral pharmacokinetic profiles, and notable brain penetration potential to address a large unmet medical need.

The ongoing first-in-human, multi-center clinical trial (NCT06385925) is designed to assess the safety, tolerability, pharmacokinetic profile, and preliminary anti-tumor activity in patients with advanced solid tumors harboring the KRAS G12D mutation. Patient recruitment is currently underway in the United States, with plans to initiate in China in the coming months.

"Preclinical profile indicated the potential of TSN1611 as a best-in-class molecule for treating cancers driven by KRAS G12D," said Dr. Tony Zhang, PhD., CEO of Tyligand Bioscience, "We are proud of our teams for the creativity, quality and speed in the discovery and early development efforts, and grateful for the support from our partners and investors in advancing TSN1611 one step closer toward the patients in need."

On May 24, 2024 STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, reported that it will be presenting interim clinical data on its first-in-class lead product, STC-15 at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, US from May 31 to June 4, 2024 (Press release, STORM Therapeutics, MAY 24, 2024, View Source [SID1234643697]).

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The poster presentation, entitled ‘Phase 1 Dose Escalation and Cohort Expansion Study Evaluating Safety, PK, PD and Clinical Activity of STC-15, a METTL3 Inhibitor, in Patients with Advanced Malignancies’, describes findings from STORM’s ongoing dose escalation and expansion Phase 1 clinical study to evaluate STC-15, an oral and highly selective small molecule inhibitor of METTL3, in advanced cancer patients. These interim results will focus on safety, pharmacokinetics, target modulation and tumor assessments to support future clinical studies. STC-15 is the first molecule specifically targeting an RNA methyltransferase enzyme to enter clinical development.

Preclinical data has demonstrated that METTL3 inhibition stimulates immune cells and activates interferon pathways, leading to the destruction of tumor cells. The poster presentation will detail the study design, patient demographics, safety data, pharmacokinetics, METTL3 target engagement, mechanistic biomarker data, and assessments of clinical activity.

Details of the poster presentation are as follow:

Poster Title: Phase 1 dose escalation and cohort expansion study evaluating safety, PK, PD and clinical activity of STC-15, a METTL3 inhibitor, in patients with advanced malignancies
Presenter: Justin Moser at HonorHealth Research Institute
Authors: Justin Moser[1], Kyriakos Papadopoulos[2], Jordi Rodon Ahnert[3], Yaara Ofir-Rosenfeld[4], Josefin-Beate Holz[4]
Organizations: [1]HonorHealth Research Institute, [2]START San Antonio, [3]The University of Texas MD Anderson Cancer Center, [4]Storm Therapeutics Ltd
Poster Session: Developmental Therapeutics—Immunotherapy
Session Date and Time: Saturday June 1, 2024, 9:00 AM – 12:00 PM CDT
Poster Board Number: 65
Abstract Presentation Number: 2586

The Abstract is available on the ASCO (Free ASCO Whitepaper) online itinerary planner here, and on the STORM website here.