A2 Bio to Highlight Progress of CAR T Clinical Programs in Three Poster Presentations at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 24, 2024 A2 Biotherapeutics, Inc. (A2 Bio) a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies to selectively target tumor cells and protect normal cells, reported the acceptance of three posters for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting May 31-June 4, 2024, in Chicago, Ill (Press release, A2 Biotherapeutics, APR 24, 2024, View Source [SID1234642316]). A2 Bio will present two Trials in Progress on its first-in-human Phase 1/2 studies EVEREST-1 and EVEREST-2, and one poster highlighting the BASECAMP-1 master prescreening study protocol’s impact on increasing trial diversity.

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Poster presentations on Saturday, June 1, 9:00 am – 12:00 pm CT

EVEREST-1: A seamless phase 1/2 study of A2B530, a carcinoembryonic antigen (CEA) logic-gated Tmod CAR T-cell therapy, in patients with solid tumors associated with CEA expression also exhibiting human leukocyte antigen (HLA)-A*02 loss of heterozygosity (LOH)

Session: Developmental Therapeutics – Immunotherapy
Presenting Author: Julian Molina, MD, PhD, Mayo Clinic
Abstract #: TPS2698
Poster Bd #: 162b

EVEREST-2: A seamless phase 1/2 study of A2B694, a mesothelin (MSLN) logic-gated Tmod CAR T-cell therapy, in patients with solid tumors that show MSLN expression and human leukocyte antigen (HLA)-A*02 loss of heterozygosity (LOH)

Session: Developmental Therapeutics – Immunotherapy
Presenting Author: Salman Punekar, MD, NYU Langone Health
Abstract #: TPS2699
Poster Bd #: 163a

Improving ethnic and racial diversity in biomarker-driven clinical trials: A proof of concept with the BASECAMP-1 master prescreening study of patients with high-risk solid tumors with human leukocyte antigen-A*02 (HLA-A*02) loss of heterozygosity (LOH)

Session: Care Delivery/Models of Care
Presenting Author: Caleb Smith, MD, Mayo Clinic
Abstract #: 1604
Poster Bd #: 475

About EVEREST-1

EVEREST-1 (NCT05736731) is a seamless Phase 1/2 study for A2B530, an autologous logic-gated investigational cell therapy developed from A2 Bio’s proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B530 consists of an activator that targets carcinoembryonic antigen (CEA) and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting patients with lung, colorectal and pancreatic cancers.

About EVEREST-2

EVEREST-2 (NCT06051695) is a seamless Phase 1/2 study for A2B694, an autologous logic-gated investigational cell therapy developed from A2 Bio’s proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets mesothelin (MSLN) and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting patients with lung, colorectal, pancreatic, ovarian and mesothelioma cancers.

Arcus Biosciences to Present New Data from Phase 2 Studies of Novel Immuno-Oncology Combinations at the 2024 ASCO Annual Meeting

On April 24, 2024 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported three accepted abstracts at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held May 31 – June 4, 2024 (Press release, Arcus Biosciences, APR 24, 2024, View Source [SID1234642315]). The selected abstracts presented in partnership with Gilead Sciences provide strong support for the companies’ portfolio of investigational medicines across multiple types of cancer, including lung, upper GI and colorectal cancer.

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"We will have two oral presentations for Phase 2 studies that highlight the potential for novel immuno-oncology mechanisms and combinations in gastrointestinal cancers," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The EDGE-Gastric presentation will include the median progression-free survival (PFS) data for our Fc-silent anti-TIGIT antibody in combination with zimberelimab and chemotherapy in upper GI cancers, the same setting as our STAR-221 Phase 3 study. The ARC-9 presentation will include randomized PFS and overall survival data for an etrumadenant (our adenosine receptor antagonist)-based combination therapy versus regorafenib, an approved standard of care in third-line colorectal cancer."

Three Accepted Abstracts Will Be Presented

Study

Title

Abstract Number

Session Type &
Title

Session Date
& Time

Domvanalimab (Fc-silent anti-TIGIT monoclonal antibody) plus Zimberelimab (anti-PD-1 antibody)

EDGE-Gastric

Updates on Abstract 433248: EDGE-Gastric Arm A1: Phase 2 study of domvanalimab, zimberelimab, and FOLFOX in first-line (1L) advanced gastroesophageal cancer.

433248

ASCO Plenary Series: Rapid Abstract Updates

6/01/2024,
12:30 PM –
1:30 PM CT

VELOCITY-Lung Substudy-03 TIP

VELOCITY-Lung substudy-03: A phase 2 study of neoadjuvant domvanalimab (dom)+zimberelimab (zim)+chemotherapy (chemo) or zim+chemo followed by adjuvant dom+zim or zim in patients with resectable stage II-III non-small cell lung cancer (NSCLC).

TPS8121

Poster Session – Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

6/3/2024,
1:30 PM –
4:30 PM CT

Etrumadenant (A2a/A2b receptor antagonist)

ARC-9

ARC-9: A Randomized Study to Evaluate Etrumadenant-Based Treatment Combinations in Previously Treated Metastatic Colorectal Cancer (mCRC)

3508

Gastrointestinal Cancer—Colorectal and Anal: Oral Abstract Session

6/2/2024,
8:00 AM –
11:00 AM CT

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]).

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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]).

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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).