On November 7, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported encouraging preclinical data on GDA-501, a genetically modified NAM (nicotinamide) Natural Killer (NK) pre-clinical cell therapy candidate from Gamida Cell’s expanding pipeline of cell therapy candidates (Press release, Gamida Cell, NOV 7, 2022, View Source [SID1234623301]). The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting taking place in Boston, MA from November 10-12, 2022.

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NK cells have generated significant interest as potential new treatment options for patients with cancers. In pre-clinical and clinical studies, Gamida Cell’s proprietary NAM technology has demonstrated successful expansion of NK cells, enhanced functionality, increased cytotoxic activity as well as creating a protective effect against oxidative stress and improved homing to targeted blood and solid tumor cancers.

"Our proprietary NAM technology enhances desirable cancer fighting qualities across a broad range of innate and adaptive cell types, including NK cells. As shown in our SITC (Free SITC Whitepaper) poster, by optimizing downstream signaling we were able to directly enhance NK cell activity resulting in potent cytotoxicity against HER2-expressing cells. These results suggest that GDA-501 represents a unique allogeneic cell therapy candidate potentially targeting HER2+ solid tumors," said Yona Geffen, Ph.D., Vice President, Research and Development at Gamida Cell. "These data further validate our NAM technology and our pipeline of genetically modified NK cell therapy candidates that offer the potential to improve clinical outcomes for patients with cancers, including cancers that express HER2."

The success of immune cell therapies has been limited in solid tumors due to multiple barriers, including immunosuppressive tumor microenvironment, inefficient trafficking, and heterogeneity of tumor antigens. In a poster presentation titled, "Engineered NAM-NK cells with HER2-CAR expression demonstrate increased cytotoxicity against HER2-expressing solid tumors", GDA-501, a genetically modified HER2-CAR NAM-NK cell, displayed significantly enhanced and persistent in vitro cytotoxicity and potency when cultured with HER2+ targeted cancer cells. Cryopreserved GDA-501 significantly inhibited tumor growth of a HER2+ solid tumor model in vivo. These preclinical data demonstrate potent antitumor activity and suggest that GDA-501 represents a unique potential treatment option using an allogeneic NAM-enabled cell therapy candidate for this poor prognostic group of patients with cancers that express HER2.

The GDA-501 poster (abstract #273) will be presented in Hall C on Thursday, November 10, 2022, from 9:00 AM EST to 9:00 PM EST. The poster presentation is publicly available at www.sitcancer.org.

About NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About GDA-501
Gamida Cell expanded the use of its NAM-enabled technology to create GDA-501, an allogeneic innate NK cell therapy candidate for the potential treatment of HER2+ solid tumors. Human epidermal growth factor receptor 2 (HER2) is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers.1 GDA-501 is genetically modified with a chimeric antigen receptor (CAR) to target HER2 by optimizing downstream signaling which directly enhances GDA-501 cytotoxicity. In vitro data demonstrated potent cytotoxicity against HER2-expressing cells. As a result, HER2-CAR may be used to target multiple HER2+ solid tumors. For more information about GDA-501, please visit View Source

On November 7, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, reported that the company will host a conference call and live audio webcast on Monday, November 14, 2022, at 8:00 AM EST to review its third quarter 2022 financial results and provide an update on the company (Press release, Gamida Cell, NOV 7, 2022, View Source [SID1234623300]).

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To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

On November 7, 2022 Pionyr Immunotherapeutics, Inc., a company developing first-in-class Myeloid TuningTM antibody therapeutics that enhance the body’s anti-tumor immunity by altering, or "tuning," immune cells within the tumor microenvironment, reported that it will present pre-clinical data showing the potential for its PY265 program to treat solid tumors, as a single agent and in combination with checkpoint inhibitor (CPI) therapy (Press release, Pionyr Immunotherapeutics, NOV 7, 2022, View Source [SID1234623299]). The data will be presented in a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th annual meeting November 10th to the 11th in Boston, Massachusetts.

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PY265 is a monoclonal antibody targeting macrophage receptor with a collagenous structure (MARCO), a protein expressed on the surfaces of immuno-suppressive myeloid cells including tumor-associated macrophages (TAMs) and monocytic myeloid-derived suppressor cells (MDSCs). In experiments with human monocyte-derived macrophages, PY265 bound MARCO and stimulated myeloid cell reprogramming through induction of rapid phosphorylation events, transcriptional activation of pro-inflammatory pathways, production of cytokines and chemokines, and upregulation of cell surface activation receptors. By reprogramming myeloid cells, PY265 remodels the TME to unleash anti-tumor immunity and converts CPI-resistant tumors into treatment-responsive tumors.

In mice, a murine version of PY265 demonstrated significant anti-tumor activity—as a single agent in CPI-sensitive tumor models and in combination with anti-PD-1 in CPI-resistant tumor models. In a non-human primate toxicokinetic study, PY265 was generally well tolerated at all dose levels tested.

"MARCO is an attractive target for Myeloid Tuning representing a novel mechanism of action distinct from other myeloid-directed therapies currently in development," said Kevin Baker, Ph.D., Pionyr Senior Vice President and Chief Development Officer. "Inside the tumor microenvironment, MARCO is highly expressed on immunosuppressive myeloid cells, and blocking MARCO has been shown in earlier studies to reprogram those immunosuppressive cells into pro-inflammatory myeloid cells. The data we present at SITC (Free SITC Whitepaper) is consistent with the body of research in myeloid tuning we’ve assembled, adds to our confidence in the powerful therapeutic potential for this approach, and supports clinical development of PY265."

Poster Presentation at SITC (Free SITC Whitepaper) 2022

Abstract 1342
Title: Therapeutic targeting of MARCO with PY265 antibody promotes myeloid cell reprogramming and unleashes anti-tumor immunity
Location: Poster Hall
Date/Time: November 10-11, 9:00 AM to 9:00 PM ET
The poster will be available on the Pionyr company website after the completion of the SITC (Free SITC Whitepaper) poster session.

About Myeloid TuningTM

Pionyr has developed a therapeutic platform called Myeloid TuningTM, a process that rebalances the tumor microenvironment (TME) to promote anti-tumor immunity. Myeloid cells are a type of immune cell and are part of a family of cell types that regulate both the activation and suppression of the immune response to cancer.

One such critical type of myeloid cell, tumor-associated macrophages (TAMs), are a key component of the TME. TAMs are generally categorized into two functionally contrasting subtypes, called M1-like and M2-like macrophages. M1-like macrophages are inflammatory and have anti-tumor functions, including directly mediating antibody-dependent cell-mediated cytotoxicity (ADCC) to kill tumor cells. Alternatively, M2-like macrophages are immune suppressive, and thereby inhibit T-cell-mediated anti-tumor responses, allowing for tumor angiogenesis, growth, and progression.

Myeloid Tuning describes the process of introducing agents that shift the balance of inhibitory myeloid cells—including M2-like TAMs—toward a more inflammatory, M1-like phenotype, to promote anti-tumor immune responses in the TME that destroy solid tumors.

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.

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]).

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"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.