Acepodia to Present Preclinical Data on its Gamma Delta T cell Therapy Candidate, ACE1831, at 2022 SITC Annual Meeting

On November 3, 2022 Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique antibody-cell conjugation (ACC) technology to address gaps in cancer care, reported the upcoming poster presentation of new preclinical data for ACE1831, a gamma delta 2 T cell therapy being developed as a treatment for non-Hodgkin’s lymphoma (Press release, Acepodia, NOV 3, 2022, View Source [SID1234623062]). The company will present this data at the 37th annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held in Boston, MA, from November 8 to 12, 2022.

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The poster presentation will showcase data demonstrating that ACE1831 is able to target cancer cells, overcome tumor defenses, and deliver a potent, cancer-killing cellular payload.

Details on the presentation and session information are provided below:

Presentation details

The poster presentation will be accessible in person and virtually. All accepted abstracts will be published in a Supplement to the Journal for ImmunoTherapy of Cancer (JITC).

"Acepodia’s unique Antibody-Cell Conjugation (ACC) technology platform is inherited from the lab of Dr. Carolyn Bertozzi, 2022 Nobel Prize laureate in Chemistry, where she pioneers work in the development of biorthogonal chemistry and moves click chemistry into living organisms. Antibody-Cell Conjugation technology uses this live-cell compatible chemistry to link any tumor-targeting antibody to the surface of human immune cells. This powerful, new approach to cell therapy development has the potential to enhance the ability of γδ2 T cells to recognize and engage the tumor by unlocking multiple receptor signaling pathways. This could potentially allow ACC-γδ2 T therapies to overcome the challenges that have prevented cell therapies from effectively targeting solid tumors," said Sonny Hsiao, Ph.D., chief executive officer and co-founder of Acepodia. "We plan to continue developing novel off-the-shelf cell therapy that leverage our unique ACC technology platform, which can be applied to a variety of immune effector cells, and we look forward to advancing our ACE1831 into phase 1 clinical study in 2022."

About Gamma-Delta T Cells
Acepodia’s gamma delta T cell program harnesses the unique properties of gamma delta T cells to develop a new class of off-the-shelf cell therapies for the treatment of cancer. Gamma delta T cells have characteristics of both the innate and adaptive immune systems that make them an ideal chassis for the development of cell therapies. This cell type can recognize and attack cancerous cells as well as coordinate a broad antitumor immune response by recruiting other immune factors and cells to the site of disease. Gamma delta T cells have also been shown to preferentially traffic to distinct tissues and could be ideally suited for more targeted treatment of certain types of cancers.

Pathios Therapeutics to Present Preclinical Data Highlighting Potential of GPR65 Inhibition as a Powerful Anti-Tumor Immunotherapy Strategy at SITC 2022

On November 3, 2022 Pathios Therapeutics Limited ("Pathios"), a biotech company focused on the development of first-in-class therapies for cancer, reported that new preclinical data highlighting the therapeutic potential of the company’s novel GPR65 inhibition platform will be the focus of a poster presentation at the upcoming 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2022) (Press release, Pathios Therapeutics, NOV 3, 2022, View Source [SID1234623061]). Presented results will showcase the company’s unique approach to "macrophage conditioning" with novel GPR65 inhibitors as a means to reversing the immunosuppression that results from an acidic tumor microenvironment, and, in turn, driving anti-tumor activity. SITC (Free SITC Whitepaper) 2022 is being held November 8-12, 2022, in Boston, Massachusetts.

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Details of the company’s presentation at SITC (Free SITC Whitepaper) 2022 are as follows:

About Acidity in the Tumor Microenvironment
The acidic tumor microenvironment, inherent to many cancers, causes a profound immunosuppression of infiltrating immune cells. This environment disarms the anti-cancer immune response and negates the effectiveness of current immunotherapies. This is particularly evident in tumor associated macrophages (TAM), where acidity is sensed by the cell-surface receptor GPR65, leading to the widespread suppression of a host of pro-inflammatory mediators and anti-tumorigenic genes, as well as the upregulation of several tissue repair genes and angiogenic factors.

ImmunoGenesis to Present Pre-Clinical Data from Lead Program at Society for Immunotherapy of Cancer Conference

On November 3, 2022 ImmunoGenesis, a clinical-stage biotechnology company developing science-driven immune therapies, reported that two poster presentations on its lead development program, IMGS-001, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting (SITC 2022), November 8-12, 2022, in Boston, MA (Press release, ImmunoGenesis, NOV 3, 2022, View Source [SID1234623060]). The posters will be available on the ImmunoGenesis website following the conference.

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About IMGS-001, a PD-L1/PD-L2 Dual-Specific Inhibitor
ImmunoGenesis’ lead program is IMGS-001, a PD-L1/PD-L2 dual-specific inhibitor with an engineered cytotoxic effector function. As the first molecule to target PD-L2 in addition to PD-L1, IMGS-001 has the potential to shut down the entire PD-1 pathway, potentially providing superior blockade compared to other PD-1 or PD-L1 inhibitors. The built-in engineered effector function allows IMGS-001 to kill immunosuppressive cells that express PD-L1 and/or PD-L2. Preclinical data showed that IMGS-001 offered five times the response rate in cold tumors than currently available immunotherapies. Additionally, IMGS-001 can provide a foundation for add-on therapies.

Regulus Therapeutics Announces Timing for Third Quarter 2022 Financial Results Webcast and Conference Call

On November 3, 2022 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that it will report its third quarter 2022 financial results on Thursday, November 10, 2022, after the U.S. financial markets close (Press release, Regulus, NOV 3, 2022, View Source [SID1234623059]).

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In connection with the earnings release, Regulus’ management team will host a live conference call and webcast on the same day at 5:00 PM ET, to discuss the Company’s financial results and provide a corporate update. To access the call, please dial (866) 652-5200 (domestic) or (412) 317-6060 and use the conference ID 10171026. To access the telephone replay of the call, dial (877) 344-7529 (domestic) or (412) 317-0088 and refer to the entry replay code 5033234 The webcast and telephone replay will be archived on the Company’s website at www.regulusrx.com following the call.

Loxo@Lilly Announces Details of Presentations at the 2022 American Society of Hematology Annual Meeting

On November 3, 2022 Loxo@Lilly, the oncology unit of Eli Lilly and Company (NYSE: LLY), reported that study investigators will present data from the BRUIN Phase 1/2 trial of pirtobrutinib at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 10-13, 2022, in New Orleans, Louisiana, and virtually (Press release, Eli Lilly, NOV 3, 2022, View Source [SID1234623058]). Pirtobrutinib is an investigational, highly selective, potent, reversible inhibitor of the Bruton’s tyrosine kinase (BTK).

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The pirtobrutinib oral and poster presentations will provide updated clinical data from the ongoing BRUIN Phase 1/2 study in previously treated chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Richter transformation, and Waldenström macroglobulinemia. In addition, an analysis of the safety and tolerability of pirtobrutinib monotherapy in patients with relapsed or refractory B-cell malignancies who were intolerant to a prior covalent BTK inhibitor will be presented in a poster presentation. Submitted abstracts on CLL/SLL, Richter transformation, Waldenström macroglobulinemia, and intolerance to prior covalent BTK therapy utilized a January 2022 data cut-off date, and the presentations will utilize a July 2022 data cut-off date.

A list of the presentations, along with their viewing details, is shared below.

Presentation Title

Details

Efficacy of Pirtobrutinib, a Highly Selective,

Non-Covalent (Reversible) BTK Inhibitor in
Relapsed / Refractory Waldenström
Macroglobulinemia: Results from the Phase 1/2
BRUIN Study

Abstract #229

Oral Session: 623. Mantle Cell, Follicular, and
Other Indolent B Cell Lymphomas:

Clinical and Epidemiological III

Date: Saturday, December 10, 2022

Presentation Time: 2:00 PM CT

Location: Theater C

Presenter: M. Lia Palomba, M.D.

Efficacy of Pirtobrutinib, a Highly Selective,

Non-Covalent (Reversible) BTK Inhibitor in
Richter Transformation: Results from the Phase
1/2 BRUIN Study

Abstract #347

Oral Session: 642. Chronic Lymphocytic

Leukemia: Clinical and Epidemiological:

Targeted Triplet Combinations and Richter’s
Transformation

Date: Saturday, December 10, 2022

Presentation Time: 5:00 PM CT

Location: R06-R09

Presenter: William G. Wierda, M.D., Ph.D.

Efficacy of Pirtobrutinib in Covalent BTK-
inhibitor Pre-treated Relapsed / Refractory
CLL/SLL: Additional Patients and Extended
Follow-up from the Phase 1/2 BRUIN Study

Abstract #961

Oral Session: 642. Chronic Lymphocytic

Leukemia: Clinical and Epidemiological: Drugs

in Development and COVID-19

Date: Monday, December 12, 2022

Presentation Time: 4:30 PM CT

Location: 243-245

Presenter: Anthony R. Mato, M.D.

Safety and Tolerability of Pirtobrutinib
Monotherapy in Patients with B-Cell

Malignancies Who Were Previously Intolerant

to a Covalent BTK Inhibitor: Results from the
Phase 1/2 BRUIN Study

Abstract #1797

Poster Session: 642. Chronic Lymphocytic
Leukemia: Clinical and Epidemiological:

Poster I

Date: Saturday, December 10, 2022

Time: 5:30 PM – 7:30 PM CT

Location: Hall D

Presenter: Nirav N. Shah, M.D.

Efficacy of Pirtobrutinib in Covalent BTK-
inhibitor Pre-treated Relapsed / Refractory

Mantle Cell Lymphoma: Additional Patients and
Extended Follow-up from the Phase 1/2

BRUIN Study

Abstract #4218

Poster Session: 623. Mantle Cell, Follicular, and
Other Indolent B Cell Lymphomas:

Clinical and Epidemiological: Poster III

Date: Monday, December 12, 2022

Time: 6:00 PM – 8:00 PM CT

Location: Hall D

Presenter: Michael L. Wang, M.D.

About Pirtobrutinib (LOXO-305)
Pirtobrutinib is an investigational, highly selective, reversible (non-covalent) Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia. Pirtobrutinib was developed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate, and preserve activity in the presence of the C481 acquired resistance mutations. Interested patients and physicians can contact the Loxo@Lilly Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email [email protected].

About the BRUIN Phase 1/2 Trial
The BRUIN Phase 1/2 clinical trial is the ongoing first-in-human, global, multi-center evaluation of pirtobrutinib in patients previously treated for mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or other non-Hodgkin lymphomas (NHL).

The trial includes a Phase 1 dose-escalation phase, a Phase 1b combination arm, and a Phase 2 dose-expansion phase. The primary endpoint of the Phase 1/1b study is safety, and secondary endpoints include pharmacokinetics and preliminary efficacy of the drug combinations. The primary endpoint for Phase 2 is overall response rate. Secondary endpoints include duration of response, overall survival, safety, and pharmacokinetics.