On November 2, 2023 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies, reported new highlights from the BASECAMP-1 (NCT04981119) master pre-screening protocol in an oral presentation Friday, November 3, at the 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting November 1-5, 2023, in San Diego (Press release, A2 Biotherapeutics, NOV 2, 2023, View Source [SID1234636842]). Additionally, A2 Bio is presenting two posters on November 4, 2023, detailing the BASECAMP-1 master pre-screening trial and EVEREST-1 CAR T interventional trial.

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"There is a high unmet need for solid tumor cancer treatments. I am excited to be an Investigator with the BASECAMP-1 pre-screening study, which identifies patients early in their clinical course for treatment with A2 Bio’s novel cell therapy platform," said Diane Simeone, M.D., Laura and Isaac Perlmutter Professor of Surgery at NYU.

"BASECAMP-1 provides patients an early opportunity to be identified and triaged to the appropriate EVEREST logic-gate Tmod CAR T trial. BASECAMP-1 is an innovative approach to preserve T cells for subsequent CAR-T manufacturing, in a patient’s clinical course before they are exposed to extensive chemotherapy," said William Go, M.D., Ph.D., Chief Medical Officer of A2 Bio.

BASECAMP-1 is a novel pre-screening protocol to identify a diverse set of patients with the genetic loss of HLA-A*02 in solid tumors, which is required to enroll in A2 Bio interventional trials.

A2 Bio has partnered with Tempus, a leader in precision medicine, to bring the latest technology to patient screening. In BASECAMP-1, tumor tissue of patients at A2 clinical sites is tested through Tempus’ xT NGS diagnostic to identify patients with permanent genetic loss of HLA-A*02 in their tumors. In addition, Tempus connects patients with HLA loss screened through standard of care to A2 clinical investigators through the AWARE program.

Once eligibility is met, patients from BASECAMP-1 can be leukapheresed with their cells stored for future manufacturing for a current or future A2 Bio interventional trial. BASECAMP-1 is open at 13 sites across the United States.

EVEREST-1 (NCT05736731) is a seamless Phase 1/2 study for A2B530, the first autologous logic-gated cell therapy developed from A2 Bio’s proprietary Tmod platform. The Tmod platform utilizes 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.

The EVEREST-1 poster will highlight the study design for A2B530, which is actively dosing patients with pancreatic, colorectal and lung cancers. If a patient is ready for treatment, A2B530 can be manufactured for a patient from their apheresis that has already been collected and stored at A2 Bio via the BASECAMP-1 study. EVEREST-1 is open at 8 sites across the United States.

EVEREST-2 (NCT06051695), A2 Bio’s second clinical program, is a seamless Phase 1/2 study for A2B694, which targets mesothelin (MSLN) with a blocker that targets HLA-A*02. Patients with pancreatic, lung, colorectal, ovarian and mesothelioma are currently being pre-screened through the BASECAMP-1 study.

Details of the presentations are below:

Oral presentation

BASECAMP-1: A master prescreening study to identify patients with high-risk or metastatic solid tumors with HLA loss of heterozygosity (LOH) in preparation for Tmod CAR T-cell therapy trials
Presenter: Diane Simeone, M.D. – NYU
Session: Rapid Oral Abstract-Clinical | Session 105b
Date and time: Friday, November 3; 12:15pm – 1:15pm PT
Location: Ground Level – Exhibit Hall C – San Diego Convention Center

Poster presentations

EVEREST-1: A seamless phase 1/2 study of CEA logic-gated Tmod CAR T-cell therapy (A2B530) in patients with solid tumors associated with CEA expression also exhibiting HLA loss of heterozygosity (LOH)
Abstract: 634
Presenter: Salman Punekar, M.D. – NYU
Date and time: Saturday, November 4, 2023; 9am – 8:30pm PT
Location: Exhibit Halls A and B1 – San Diego Convention Center

BASECAMP-1: A master prescreening study to identify patients with high-risk or metastatic solid tumors with HLA loss of heterozygosity (LOH) in preparation for Tmod CAR T-cell therapy trials
Abstract: 636
Presenter: Diane Simeone, M.D. – NYU
Date and time: Saturday, November 4, 2023; 9am – 8:30pm PT
Location: Exhibit Halls A and B1 – San Diego Convention Center

The two posters will be available on the A2 Bio website after November 4, 2023.

About A2B530

A2B530 consists of an activator that targets carcinoembryonic antigen (CEA) and a blocker that targets HLA-A*02. CEA is a tumor-associated antigen expressed at high levels in colorectal, pancreatic and non-small cell lung cancers, but also in healthy gut tissues. HLA-A*02 is expressed in normal tissues and permanently lost via genetic deletion in tumor tissues in the patient population eligible for EVEREST-1. A2B530’s dual-receptor design is intended to provide selective killing of tumor tissues that express CEA and have lost the HLA-A*02 gene permanently.

About A2B694

A2B694 consists of an activator that targets mesothelin (MSLN) and a blocker that targets HLA-A*02. MSLN is a tumor-associated antigen expressed at high levels in mesothelioma, ovarian, colorectal, pancreatic, and non-small cell lung cancers, but also in healthy tissue such as the lining of the heart and lung. HLA-A*02 is expressed in normal tissues and permanently lost via genetic deletion in tumor tissues in the patient population eligible for EVEREST-2. A2B694’s dual-receptor design is intended to provide selective killing of tumor tissues that express MSLN and have lost the HLA-A*02 gene permanently.