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GV20 Therapeutics Announces Publication in Cell Highlighting the Discovery of IGSF8 as an Innate Immune Checkpoint and Cancer Immunotherapy Target

On April 24, 2024 GV20 Therapeutics, a clinical-stage biotechnology company integrating AI, genomics, and cancer biology to create next-generation antibody therapeutics, reported the publication of a peer-reviewed article titled, "IGSF8 is an innate immune checkpoint and cancer immunotherapy target" in the journal Cell (Press release, GV20 Therapeutics, APR 24, 2024, View Source [SID1234642314]).

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Antigen presentation defects in tumors are prevalent mechanisms of adaptive immune evasion and resistance to cancer immunotherapy, whereas how tumors evade innate immunity is less clear. In this study, the authors discovered that tumors with antigen presentation defects over express IGSF8 which interacts with NK receptors to suppress NK cell cytotoxicity. A monoclonal antibody against IGSF8 increases NK cell killing of cancer cells in vitro. In multiple syngenetic tumor models, anti-IGSF8 alone or in combination with anti-PD1 potently inhibit tumor growth in vivo. These results support IGSF8 as a novel innate immune checkpoint that could be exploited as a therapeutic target, and led to the nomination of GV20’s lead program, GV20-0251.

"This publication in Cell builds on our recent oral presentation at AACR (Free AACR Whitepaper) 2024 outlining the immune function of IGSF8 and the advancement of GV20-0251 into combination studies with KEYTRUDA under our clinical collaboration with Merck," said Shirley Liu, CEO of GV20 Therapeutics. "The ongoing GV20-0251 Phase 1 study is advancing well, and we are pleased with the clinical profile seen thus far. We look forward to advancing GV20-0251 into monotherapy cohort expansion and combination studies later this year."

IDEAYA Biosciences Announces ASCO 2024 Oral Presentation for Darovasertib in Neoadjuvant Uveal Melanoma Phase 2 Investigator Sponsored Study

On April 24, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that interim results from the investigator-sponsored Phase 2 trial evaluating darovasertib safety and efficacy as neoadjuvant/adjuvant treatment in uveal melanoma (UM) have been selected for an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31-June 4, 2024 in Chicago, Illinois (Press release, Ideaya Biosciences, APR 24, 2024, View Source [SID1234642313]).

Details for the oral presentation are as follows:

Session: Melanoma/ Skin Cancers

Title: A Phase 2 Safety and Efficacy Study of Neoadjuvant/Adjuvant Darovasertib for Localized Ocular Melanoma

Presenter: Anthony Joshua, M.B.B.S, Ph.D., FRACP

Abstract number: 9510

Date and Time: June 3, 2024, at 9:51 AM CDT

ASCO will publish the abstract summary on Thursday, May 23, 2024, at approximately 5:00 pm ET.

Breakthrough in Lung Cancer Treatment: Dizal to Unveil Groundbreaking Results of Sunvozertinib for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations at 2024 ASCO Annual Meeting

On April 24, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing groundbreaking new medicines for the treatment of cancer and immunological diseases, reported that two abstracts featuring the latest data on sunvozertinib in non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31 through June 4 in Chicago (Press release, Dizal Pharma, APR 24, 2024, View Source [SID1234642312]).

In a featured oral presentation, Dizal will highlight topline results from its WU-KONG1 Part B study. This multinational pivotal phase II trial, conducted across ten countries and regions, including the U.S., the EU, and China, investigates the efficacy and safety of sunvozertinib in patients with relapsed or refractory non-small cell lung cancer (NSCLC) harboring EGFR exon20ins mutations.

"We are very pleased that the inaugural global pivotal study of sunvozertinib is selected for oral presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting again" said Xiaolin Zhang, PhD, CEO of Dizal.

He added, "Last year, sunvozertinib was selected for oral presentation based on the results from WU-KONG6 study, a pivotal study in China. It was subsequently approved in China, making sunvozertinib the world first and only oral drug for the treatment of lung cancer patients with EGFR exon20ins mutations. WU-KONG1 Part B is the equivalent study with patients from Asia, Europe, North America, and South America. Preliminary analysis showed similar results to the WU-KONG6 study. With Breakthrough Therapy Designation, we are working closely with the US FDA, EMA and other regulatory agencies to accelerate its NDA submission."

Multiple clinical trials have consistently demonstrated the transformative potential of sunvozertinib as a single, oral agent to treat NSCLC patients with EGFR exon20ins mutations. A randomized, global phase III study (WU-KONG28), comparing sunvozertinib vs. platinum containing doublets, is ongoing in the first-line setting.

In addition to the oral presentation, one other abstract has been selected for a poster presentation. This poster will focus on plasma ctDNA biomarker analysis in patients with EGFR exon20ins NSCLC who have undergone treatment with sunvozertinib. The aim is to investigate the correlation between baseline EGFR exon20ins mutations and the anti-tumor effectiveness of sunvozertinib, along with potential strategies to address resistance to the drug.

Dizal presentation details during ASCO (Free ASCO Whitepaper) 2024

Lead Author

Abstract Title

Presentation Details

Prof. James Chih-Hsin Yang

A multinational pivotal study of sunvozertinib
in platinum pretreated non-small cell lung
cancer with EGFR exon 20 insertion mutations:
Primary analysis of WU-KONG1 study

Abstract #8513

Rapid Oral Abstract Session

Lung Cancer – Non-Small Cell Metastatic

June 1, 2024, 4:30 PM-6:00 PM CDT

S406

Prof. Mengzhao Wang

Plasma ctDNA biomarker study in patients with
non-small cell lung cancer with EGFR exon 20
insertion mutation treated with sunvozertinib

Abstract #8563

Poster Session

Lung Cancer – Non-Small Cell Metastatic

June 3, 2024, 1:30 PM-4:30 PM CDT

Hall A

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins mutations after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins mutations. The primary endpoint of the study was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins mutations.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR Exon20ins mutations.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).

Sapience Therapeutics Announces Oral Presentation at the Upcoming 2024 ASCO Annual Meeting Featuring ST101 Phase 2 Results in GBM

On April 24, 2024 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that data from its Phase 2 study of ST101 will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31-June 4, 2024, in Chicago, IL and online (Press release, Sapience Therapeutics, APR 24, 2024, View Source [SID1234642311]).

ST101 is a first-in-class antagonist of C/EBPβ, currently being evaluated in patients with recurrent and newly diagnosed GBM in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279).

Presentation details:

Abstract Title: "Efficacy and biomarker analysis of phase 2 (P2) and window-of-opportunity (WoO) cohorts of patients with glioblastoma (GBM) treated with ST101, an inhibitor of the transcription factor C/EBPβ"

Abstract Number for Publication: 2011

Session Type and Title: Clinical Science Symposium – Advancing Trial Design: Illuminating Tumor Evolution in Central Nervous System Cancer

Date and Time: 6/1/2024, 3:00 PM-4:30 PM CDT

Presenting Author: Fabio M. Iwamoto, MD, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center

More information can be found on the 2024 ASCO (Free ASCO Whitepaper) website. The presentation described here will be made available on the Sapience Therapeutics website following the conference.

About ST101

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in patients with newly diagnosed and recurrent GBM (ndGBM and rGBM) in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279). In an ongoing window-of-opportunity sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in ndGBM, with patients receiving ST101 before and after surgical resection. ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and orphan designations for glioma from the U.S. FDA and the European Commission.

Mercy BioAnalytics to Present Results from a Large Ovarian Cancer Screening Study at the ASCO Annual Meeting

On April 24, 2024 Mercy BioAnalytics, Inc., a pioneer in extracellular vesicle-based liquid biopsy for the early detection of cancer, reported that it will present data at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showing the performance of its Mercy Halo Ovarian Cancer screening test in a large cohort of asymptomatic, postmenopausal women (Press release, Mercy BioAnalytics, APR 24, 2024, View Source [SID1234642310]). The results of the study, which included more than 1,300 women, will be shared in a poster presentation on June 3rd, 2024.

Ovarian cancer is one of the leading causes of cancer death among women. More than 70% of ovarian cancer is diagnosed in women over 50 years of age, and nearly 80% of ovarian cancer is diagnosed at an advanced stage of disease, when survival is poor. Today, there are no guideline-recommended screening tests for ovarian cancer, which kills nearly 13,000 women each year in the US alone.

"Legacy technologies such as CA125 serum biomarker testing and transvaginal ultrasound imaging have not proven accurate enough to justify their use for population ovarian cancer screening. Unfortunately, no alternative technology has demonstrated superior clinical performance in a screening population since CA125 and transvaginal ultrasound were introduced nearly four decades ago," said Dawn Mattoon, PhD, Mercy’s CEO.

Mercy is developing a highly sensitive and specific screening test designed to help detect ovarian cancer earlier in asymptomatic, postmenopausal women. Mercy analyzed samples from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) in which 200,000 women were enrolled, randomized to no screening or annual screening, and followed for up to 20 years. All trial participants donated a blood sample at the time of enrollment. Mercy analyzed the blood of more than 1,300 trial participants to assess the sensitivity and specificity of the Mercy Halo test for detecting ovarian cancer up to three years prior to clinical diagnosis.

"This study allowed us to see how far in advance of the presentation of clinical disease our test can detect early-stage ovarian cancer, and at what sensitivity and specificity," Mattoon said. "We’re excited to share the outstanding performance of the Mercy Halo test in this large patient cohort that is representative of our intended patient population."

The Mercy Halo test achieves high sensitivity and specificity through the simultaneous detection of multiple cancer-related biomarkers co-localized on the surface of individual tumor-associated extracellular vesicles. The high abundance of extracellular vesicles in circulation enables the Mercy Halo test to be run on a very small volume of serum or plasma with a simple qPCR-based read-out, unlike cell-free DNA-based tests which typically require a larger volume of blood and next-generation sequencing to generate results.

The Mercy ovarian cancer data will be shared on June 3rd in a poster titled "Evaluation of a novel extracellular vesicle (EV) based ovarian cancer (OC) screening test in asymptomatic postmenopausal women."