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Data From Incyte’s Oncology Portfolio to Be Presented at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

On November 7, 2022 Incyte (Nasdaq:INCY) reported that abstracts featuring data from its oncology portfolio will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, held November 8-12, 2022, in Boston and virtually (Press release, Incyte, NOV 7, 2022, View Source [SID1234623298]).

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"We are proud of the progress being made across our earlier-stage clinical programs, spanning small molecules, monoclonal and bispecific antibodies"

"We are proud of the progress being made across our earlier-stage clinical programs, spanning small molecules, monoclonal and bispecific antibodies," said Lance Leopold, M.D., Group Vice President, Clinical Development Hematology and Oncology at Incyte. "We look forward to presenting data at the SITC (Free SITC Whitepaper) Annual Meeting from our immuno-oncology pipeline, including our oral PD-L1 program, as we make progress toward our goal of identifying new solutions for patients with cancer who need additional options."

Key abstracts include:

Poster Presentations

All accepted odd-numbered posters are available from 9:00 a.m. – 9:00 p.m. EST on Thursday, November 10. All accepted even-numbered posters are available Friday, November 11, from 9:00 a.m.–8:30 p.m. EST.

INCB099280 (PD-L1)

A Phase 1 Study Exploring the Safety and Tolerability of the PD-L1 Small Molecule Inhibitor INCB099280 in Patients with Select Advanced Solid Tumors (Abstract #734)

INCB099318 (PD-L1)

A Phase 1 Study Exploring the Safety and Tolerability of the Small Molecule PD-L1 Inhibitor, INCB099318, in Patients with Select Advanced Solid Tumors (Abstract #662)

INCB086550 (PD-L1)

A Phase 1 Study Exploring the Safety and Tolerability of the Small Molecule PD-L1 Inhibitor, INCB086550, in Patients with Select Advanced Tumors (Abstract #774)

INCA32459 (LAG3xPD-1)

Phase 1 First-in-Human, Open-Label, Multicenter Study of INCA32459, a Bispecific Anti–PD1 and Anti–LAG-3 Antibody, in Patients with Select Advanced Malignancies (Abstract #723)

A Human Bispecific Antibody Targeting LAG-3 and PD-1 (INCA32459) Potently Activates Exhausted T Cells (Abstract #1210)

INCAGN01876 (GITR)

A Phase 2, Open-Label, Multicenter Study of INCAGN01876 (anti-GITR agonist) in Combination with Retifanlimab (anti–PD-1) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Abstract #677)

Bispecific Antibody Research

Comparison of Four in Vitro Cytotoxicity Assays for Assessing the Potency of Bispecific Antibodies Redirecting T Cells to Kill Tumor Target Cells (Abstract #1199)

More information regarding the congress is available on the SITC (Free SITC Whitepaper) website: View Source The virtual meeting platform will be available following the conclusion of the meeting for registered attendees until Monday, Jan. 9, 2023.

Adicet Bio Showcases Preclinical Data for Four New Pipeline Programs at The Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

On November 7, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported that positive preclinical data from four new pipeline programs will be featured at poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting on November 10-11, 2022 (Press release, Adicet Bio, NOV 7, 2022, View Source [SID1234623297]).

"The emerging pipeline to be presented at SITC (Free SITC Whitepaper) represents Adicet’s concerted efforts to design and deliver best-in-class gamma delta T cell therapies," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "The new programs represent an exciting step in our evolution as a company, and we look forward to initiating additional preclinical studies designed to support the submission of investigational new drug applications to advance our first-in-class allogeneic CAR and CAd gamma delta T cell therapy product candidates for a variety of cancer indications, including solid tumors."

"The new pipeline programs have been carefully selected by integrating aspects of gamma delta 1 tissue homing, differentiated mechanisms of action, targeting enhancement and engineered armoring. Our innovative CAd and de novo CAR programs have illustrated increased proliferative potential, cytotoxicity, tumor homing, and inhibition of tumor growth in preclinical models," commented Blake T. Aftab, Ph.D., Chief Scientific Officer at Adicet Bio. "We are motivated by these encouraging results and look forward to advancing therapeutic options for patients with hematologic and solid tumor malignancies."

Adicet R&D Webcast Event Information

Adicet is hosting an R&D webcast event on Thursday, November 10, 2022, at 9:00 a.m. ET to provide additional preclinical data from its newly disclosed pipeline and upcoming milestones. Marco Davila, M.D., Ph.D., from the Roswell Park Comprehensive Cancer Center will participate in the event. The live webcast can be accessed under "Presentations & Events" in the investors section of the Company’s website at www.adicetbio.com or by dialing 1-888-660-6513 (toll-free) or 1-929-203-0876 (toll) and referencing the conference ID 9936249. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

Calidi Biotherapeutics Presents Promising Pre-Clinical Data from SuperNova-1 (SNV1), a Novel Oncolytic-Cell Based Platform, at the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022)

On November 7, 2022 Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, reported the presentation of new pre-clinical data from the company’s SuperNova-1 (SNV1) platform at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, taking place in Boston, Massachusetts and virtually, November 8-12, 2022 (Press release, Calidi Biotherapeutics, NOV 7, 2022, View Source [SID1234623296]).

SNV1 is composed of adipose tissue-derived allogeneic stem cells (AD-MSC) loaded with tumor selective CAL1 oncolytic vaccinia virus that is designed to overcome multiple innate and adaptive immune barriers that restrict traditional oncolytic virotherapies. Early Calidi research has shown the potential ability of the SNV1 platform to shield the viral payload from the immune system, supporting efficient delivery to tumor sites and effectively potentiating oncolytic viruses’ therapeutic efficacy.

The poster presentation details the evaluation of SNV1 in multiple tumor-bearing mouse models, where SNV1 was tested for its ability to resist humoral immune-mediated inactivation in cell culture. Additionally, following either single or three dose regimens, tumor growth inhibition of multiple human xenografts and murine syngeneic models was examined. The study also investiagted the molecular signature associated with the infection of mesenchymal stem cells (MSC) with the oncolytic virus CAL1 by RNA sequencing.

"These incremental data validate our belief in the potential of SNV1 and the use of stem cells as a delivery and potentiation platform for oncolytic viruses," said Antonio F. Santidrian, Ph.D., SVP, Global Head of R&D of Calidi Biotherapeutics. "Through the demonstration of tumor growth inhibition across multiple pre-clinical models as well as the ability to overcome rapid inactivation by the immune system, we believe SNV1 can revolutionize the use of oncolytic virotherapy to treat a broad range of cancers and look forward to advancing this promising asset into the clinic."

Key highlights from the poster presentation are below:

The SNV1 stem cell-based platform protects and potentiates oncolytic vaccinia virus by circumventing humoral innate and adaptive immune barriers, resulting in enhanced anticancer effects in tumor-bearing mouse models.
SNV1 provided instantly active viral particles for immediate infection in the injected tumors, transforming the tumor environment from "cold" to "hot" locally and systemically, and leading to significant tumor growth inhibitions in multiple human and mouse tumor models.
Repeated intratumoral administrations of SNV1 inhibited treated as well as distant untreated tumors. These effects were also associated with a significant increase of tumor infiltrating lymphocytes in both treated and untreated tumors.
RNA sequenced genome wide analysis provided insights into the valuable role of stem cells in the immuno therapeutic MOA of SNV1.

Affini-T Therapeutics to Present Preclinical Data from its Lead Programs Targeting KRAS G12V at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

On November 7, 2022 Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported that data from its oncogenic driver programs targeting KRAS G12V will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting (Press release, Affini-T Therapeutics, NOV 7, 2022, View Source [SID1234623295]).

"Patients are the central motivation for all of our work at Affini-T, and now is an exciting time to be in the KRAS drug development space – tackling hard-to-treat solid tumors for patients with high unmet needs," said Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics. "We have observed encouraging preclinical potency and selectivity data for our KRAS G12V TCR-T cell therapy candidates that support further clinical translation and development. We look forward to presenting our findings at the SITC (Free SITC Whitepaper) Conference in Boston."

Oral Presentation and Poster details are as follows:

Abstract #244 Oral presentation: Clinical Session 206 Nov 11th 12:10-1:10 pm ET (and poster presentation Nov 11th 11:55 am-1:25 pm and 7:00-8:30 pm ET): AFNT-111, a preclinically safe and effective TCR-engineered T cell therapy targeting the oncogenic driver KRAS G12V mutation – Presenting Author: Hubert Lam, Ph.D., Vice President, Preclinical Development, Affini-T Therapeutics
Abstract #342 Poster presentation: Nov 11th 11:55 am-1:25 pm and 7:00-8:30 pm ET: KRAS G12V T cell receptor-engineered T cells expressing the durability FAS-41BB switch receptor exhibit a potent, persistent, coordinated CD4/CD8 anti-tumor response in vitro and in vivo – Presenting Author: Gary Shapiro, Ph.D., Vice President, Discovery Biology, Affini-T Therapeutics

A2 Bio Identifying Solid Tumor Patients for Possible Inclusion in Phase 1 Studies Targeting CEA and Mesothelin Expected to Begin in 2023: Update at SITC 2022

On November 7, 2022 A2 Biotherapeutics, Inc., "A2 Bio", is a biotechnology company focused on the development of first-in-class T cell therapeutics to tackle the fundamental challenge in solid tumor treatment—the ability of cancer medicines to selectively kill tumor cells while protecting normal cells (Press release, A2 Biotherapeutics, NOV 7, 2022, View Source [SID1234623294]).

A2 Bio reported four poster presentations showcasing: (1) BASECAMP-1, a master pre-screening trial to identify patients whose tumors have permanently lost HLA-A*02 (NCT04981119); (2) use of the Tempus xT Next Generation Sequencing (NGS) diagnostic to identify such patients; (3) data for A2 Bio’s lead program, A2B530, targeting CEA Cell Adhesion Molecule 5 (CEA); and (4) data for A2 Bio’s second program, A2B694, targeting mesothelin (MSLN).

A2 Bio’s logic‑gated cell therapy utilizes dual receptors (an activator and blocker) and has demonstrated in vitro and in vivo the ability to kill tumor cells via the activator while protecting healthy cells via the blocker. Patients who may benefit from this therapy can be identified by using the Tempus diagnostic to pre-screen patients whose tumors have lost HLA-A*02. Once patients are identified, their T cells may be banked early in their disease course for potential utilization in a Phase 1 study in the event of relapse.

"The unmet medical need in lung, colorectal and particularly pancreatic cancer remains extremely high. BASECAMP-1 is a non-interventional pre-screening trial that identifies eligible patients and banks their T cells. If the patients have the misfortune to relapse or progress, A2 Bio will have their cells ready to be manufactured and dosed in our upcoming Phase 1 studies targeting CEA and MSLN," said William Go, MD, PhD, Chief Medical Officer of A2 Bio.

Diane Simeone, MD, Director of the Pancreatic Cancer Center, Perlmutter Professor of Surgery at NYU and Principal Investigator on the study, stated, "BASECAMP-1 is an exciting trial that identifies patients with limited treatment options for a new and unique logic-gated CAR-T immunotherapy approach. We are thrilled to enroll patients at BASECAMP-1 and get them prepped for potential inclusion in Phase 1 studies in 2023."

The four poster presentations will be given on November 10, 2022 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston, MA.

Details of the posters being presented on November 10, 2022 from 9am-9pm EST at the Poster Hall:

Title: BASECAMP-1: Leveraging HLA loss of heterozygosity in solid tumors by NGS to identify patients with relapsed solid tumors for future CEA and MSLN logic-gated Tmod CAR T-cell therapy
Poster Number: 639
Presenter: Diane Simeone, MD, Director of the Pancreatic Cancer Center, Perlmutter Professor of Surgery at NYU and Chair of the Pancreatic Cancer Action Network’s (PanCAN) National Scientific and Medical Advisory Board

Title: An NGS assay to identify HLA loss of heterozygosity for future CEA and MSLN logic-gated CAR-T solid tumor protocols designed for reduced on-target, off-tumor toxicity
Poster Number: 77
Presenter: Scott Kopetz, MD, PhD – Deputy Chair and Professor, Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center

Title: A2B530, an autologous CEA-directed Tmod T-cell therapy with an inhibitory receptor gated by HLA-A*02 to target colorectal, pancreatic, and lung cancer
Poster Number: 229
Presenter: J. Randolph Hecht, MD, Carol and Saul Rosenzweig Chair for Cancer Therapies Development, the Director of the UCLA Gastrointestinal Oncology Program and Professor of Clinical Medicine in the David Geffen School of Medicine at UCLA

Title: A2B694, an autologous logic-gated cell therapy targeting mesothelin
Poster Number: 263
Presenter: Julian Molina, MD, PhD – Professor of Oncology and Consultant, Division of Medical Oncology at Mayo Clinic, Rochester

ePosters will be released for viewing on November 10 at 7:00 am ET and can be viewed from the A2 Bio website (View Source)