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Kernal Biologics to Present at Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting

On October 31, 2023 Kernal Biologics, Inc. (Kernal Bio) — a development-stage mRNA-technology company developing cancer therapeutics designed to improve patients’ survival rate and quality of life — reported that it is presenting a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting on Friday, November 3, 2023 in San Diego, CA (Press release, Kernal Biologics, OCT 31, 2023, View Source [SID1234636579]).

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The poster presentation features preclinical insights into KR-336, an onco-selective mRNA LNP therapeutic that Kernal Bio has rationally designed using their mRNA2.0 platform to be selectively translated into therapeutic protein within the tumor microenvironment. These data support the feasibility of systemically administering Kernal’s onco-selective mRNA LNP to achieve tumor-localized immunomodulation as a highly efficacious and well tolerated treatment option for patients with otherwise immunosuppressive tumors.

"Previously, we have shown that local onco-selective mRNA LNP therapy via intratumoral injections can result in complete responses in various pre-clinical murine tumor models, including those that are resistant to checkpoint inhibitors," said Kernal Bio Co-founder and Chief Executive Officer Yusuf Erkul, M.D. "At SITC (Free SITC Whitepaper), we look forward to reporting the outcome of in vivo proof-of-concept studies for systemic mRNA LNP administration, which resulted in robust anti-tumor effectiveness."

Details for the Kernal Bio presentation are as follows:

Poster Presentation: Systemically Administered Onco-Selective mRNA LNP Achieves Tumor Regression and Improves Overall Survival, As Monotherapy
Abstract #: 1339
Presenter: Matthew Strout, MD, PhD, Vice President of Business Development, Kernal Biologics
Time: Friday, November 3, 2023, 9:00 AM – 7:00 PM PDT

Replicate Bioscience to Present Progress on Two srRNA Oncology Programs at Society for Immunotherapy of Cancer 2023 Meeting

On October 31, 2023 Replicate Bioscience, a clinical-stage company pioneering novel self-replicating RNA (srRNA) technology for use in infectious disease, oncology, autoimmune disease, and more, reported a poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 38th Annual Meeting November 3-5, 2023 in San Diego, CA (Press release, Replicate Bioscience, OCT 31, 2023, View Source [SID1234636578]).

Precision immuno-oncology (PIO) is Replicate’s novel approach to targeting predictable resistance mutations, which arise when cancer cells evolve to evade therapies. RBI–1000 is an srRNA precision immunotherapy candidate targeting acquired resistance mutations (ARM) in estrogen receptor positive (ER+) firstline, metastatic breast cancer, which is the most common type of metastatic breast cancer. RBI-1000 leads to tumor control with the elimination of tumor cells expressing ARM in preclinical models. RBI-3000 is an srRNA PIO program targeting acquired resistance to current tyrosine kinase inhibitor standard of care therapy for metastatic EGFRm+ non-small cell lung cancer.

"When combined with standard of care, RBI-1000 induces synthetic immune lethality: a lose-lose scenario in which the tumor is forced to either remain the same and be eliminated by the targeted therapeutic or mutate and be destroyed by srRNA-trained immune cells," said Zelanna Goldberg, M.D., Chief Medical Officer at Replicate and poster presenter. "Our srRNA oncology programs are being developed to harness the power of the body’s own cells to train the immune system to destroy the treatment resistant tumor clones and produce durable therapeutic benefit. We are pleased to share the latest progress on our oncology programs with the SITC (Free SITC Whitepaper) community."

Details for the poster presentation is as follows:

Title: Self-replicating RNA therapeutics for Off-the-Shelf Precision Immunotherapy targeting acquired resistance mutations in low TMB tumors

Abstract Number: 876

Type of Presentation: Poster Presentation

Date & Time: Saturday, November 4; 9 a.m. – 8:30 p.m.

The abstract can be found on the SITC (Free SITC Whitepaper) Annual Meeting website and the poster will be available on the Replicate website following presentation.

Coeptis Therapeutics Announces Research Demonstrating the Potential of SNAP-CAR T-cells to Reduce Tumor Burden and Growth in HER2 and CD20 Expressing Cancers Will be Presented at SITC 2023

On October 31, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that research demonstrating the potential of the SNAP-CAR T-cell platform to target multiple antigens, including HER2 and CD20, through combinatorial use of different adaptors will be the subject of a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (SITC 2023) (Press release, Coeptis Therapeutics, OCT 31, 2023, View Source [SID1234636577]). SITC (Free SITC Whitepaper) 2023 is being held Nov. 1–5, 2023, at San Diego Convention Center in San Diego.

The poster presentation titled, "SNAP CAR T cells for programmable antigen targeting," describes research involving SNAP-CAR, a "universal" CAR T cell therapy platform, that demonstrates the technology’s versatile antigen targeting abilities both in vitro and in vivo in human tumor xenograft models. In vitro experiments showed potent and specific SNAP-CAR function with co-administered adaptors targeting HER2, EGFR, and CD20 on cancer cell lines including activation of CD69 and CD107a markers, specific target cell lysis, and IFN-gamma production. Additionally, the researchers tested SNAP-CAR T cells in vivo in a human leukemia tumor xenograft NSG mouse model targeting HER2, observing that SNAP-CAR T cells were able to significantly reduce tumor burden, leading to a lack of detectable tumors in the majority of mice. Further, in another leukemia model targeting the CD20 antigen, SNAP-CAR T cells showed significant inhibition of tumor growth. Finally, evaluating two anti-HER2 adaptors with distinct binding epitopes in a human ovarian cancer xenograft model, the researchers observed a significant tumor reduction with both adaptors compared to adaptor only and SNAP-CAR T cell only controls.

"These findings suggest SNAP-CAR can potentially enable the development of T-cell therapies that can be tuned by adaptor dose and targeted toward multiple antigens through combinatorial use of different adaptors, potentially avoiding toxicities and relapse due to antigen loss," commented Jason Lohmueller, Ph.D., Assistant Professor of Surgery and Immunology in the Division of Surgical Oncology Research, University of Pittsburgh. "While still early in its development, we continue to see vast potential for the SNAP-CAR platform for treating both liquid and solid tumor malignancies."

"The data being presented at SITC (Free SITC Whitepaper) 2023 encapsulates the groundbreaking research being conducted at the University of Pittsburgh, which demonstrates the potential of SNAP-CAR T-cells to reduce tumor burden and tumor growth in numerous cancers, including HER2-expressing and CD20-expressing cancers," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Coeptis is energized more than ever to forge the path forward with the powerful SNAP-CAR platform to develop T-cell and NK-cell technologies for various undertreated cancer indications."

Alkermes Announces Effectiveness of Mural Oncology Form 10 Registration Statement

On October 31, 2023 Alkermes plc (Nasdaq: ALKS) reported that the Registration Statement on Form 10, as amended (Form 10), filed by Mural Oncology plc (Mural Oncology) was declared effective by the U.S. Securities and Exchange Commission (SEC) (Press release, Alkermes, OCT 31, 2023, View Source [SID1234636575]). This Form 10 describes Alkermes’ planned separation of its oncology business into Mural Oncology, which, upon completion of the separation, will be a new, independent, publicly traded company.

The completion of the separation is set to occur on Nov. 15, 2023 through a distribution to Alkermes shareholders of one ordinary share of Mural Oncology for every 10 ordinary shares of Alkermes held as of the close of business on Nov. 6, 2023, the record date for the distribution. No action is required by Alkermes shareholders in order to receive ordinary shares of Mural Oncology in the distribution.

Nasdaq has approved the listing of Mural Oncology’s ordinary shares on the Nasdaq Global Market under the stock ticker symbol "MURA" beginning on Nov. 16, 2023. While there is no current trading market for Mural Oncology’s ordinary shares, a limited "when-issued" public trading market for Mural Oncology’s ordinary shares is expected to commence prior to the distribution under the stock ticker symbol "MURAV" and will continue up to and through the date of the distribution. A limited "ex-distribution" public trading market for Alkermes’ ordinary shares under the stock ticker symbol "ALKSV" is expected for the same period. This "ex-distribution" market will be in addition to the existing trading market for Alkermes ordinary shares. A description of these expected trading markets is included in the Form 10.

The completion of the separation is subject to certain conditions described in the Form 10, including those conditions set forth in a separation agreement to be entered into between Alkermes and Mural Oncology, a form of which is filed as an exhibit to the Form 10.

For more information about the separation, the distribution and Mural Oncology’s ordinary shares, refer to the Form 10, which can be viewed at View Source and on the investors section of Alkermes’ website at www.alkermes.com.

Antengene Presents Results from Five Investigational Programs at 2023 SITC Annual Meeting

On October 31, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that it has presented results from five programs by poster presentation, including two clinical programs on the anti-CD24 monoclonal antibody ATG-031 and the PD-L1/4-1BB bispecific antibody ATG-101; two preclinical programs on the LILRB4 antagonist antibody ATG-034 and the GPRC5D/CD3 T-cell engager ATG-021; and the Company’s proprietary novel AnTenGagerTM platform, at the 2023 Society of Immunology in Cancer Annual Meeting (SITC 2023) (Press release, Antengene, OCT 31, 2023, View Source [SID1234636574]). The SITC (Free SITC Whitepaper) Annual Meeting is a widely recognized and respected international event that brings together cutting-edge presentations by multidisciplinary experts in basic and applied cancer immunotherapy with a goal of improving outcomes for cancer patients.

"Thanks to Antengene’s robust R&D capabilities and its proprietary technology platforms, we have released the exciting results from multiple studies at the SITC (Free SITC Whitepaper) Annual Meeting this year. Among them, preclinical results on the pharmacokinetics, pharmacodynamics, and toxicology of ATG-031, the world’s first anti-CD24 monoclonal antibody entering clinical development, deserve particular attention as they demonstrated ATG-031’s ability to systemically enhance antitumor immunity and its favorable safety profile. Moreover, CD24 is highly expressed in a variety of solid tumors and hematologic malignancies, thus indicating the drug’s broad therapeutic opportunity. The U.S. Food and Drug Administration (FDA) has already cleared an Investigational New Drug (IND) application for a Phase I study of ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin lymphoma (B-NHL). The study, led by the MD Anderson Cancer Center, along with three other clinical centers in the U.S., is currently ongoing," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "Also at the meeting, we released results on AnTenGagerTM, an inhouse-developed and fully-patented T cell engager (TCE) platform that offers target-dependent T cell activation and enhanced antitumor activity with reduced risk of cytokine release syndromes. Building on the progress, we will continue to accelerate our development of cutting-edge therapies and showcase our innovative prowess on the global stage."

Details of the Poster Presentations:

ATG-031(anti-CD24 monoclonal antibody)
Title: The preclinical characterization and translational research of ATG-031, a first-in-class humanized anti-CD24 antibody, for the treatment of solid tumors and hematological malignancies
Abstract: 1337

CD24 is a small, highly glycosylated cell adhesion protein that functions as a novel "don’t eat me" target in cancer, where it is the dominant innate immune checkpoint. CD24 is extensively expressed in a variety of tumor types, whereas its distribution in normal tissues is limited.
Therapeutic antibodies blocking "don’t eat me" signals exhibited potent preclinical and early clinical efficacy against solid tumors and hematological malignancies.
As the first-in-class anti-CD24 monoclonal antibody entering clinical development, ATG-031 has demonstrated potent anti-tumor activity as a single agent and in combination with chemotherapies and checkpoint inhibitors, as well as excellent safety and PK properties in pre-clinical studies. It induces macrophage mediated phagocytosis of tumor cells, and boosts T cell dependent anti-tumor immunity in the tumor microenvironment.
These pre-clinical data support the further development and evaluation of ATG-031 in the Phase I, multicenter, dose escalating clinical trial in patients with solid tumors and hematological malignancies. To date, the U.S. Food and Drug Administration (FDA) has already cleared an Investigational New Drug (IND) application for a Phase I study of ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin lymphoma (B-NHL). The study, led by the MD Anderson Cancer Center, along with three other clinical centers in the U.S., is currently ongoing.
ATG-101(PD-L1/4-1BB bispecific antibody)
Title: Single-cell RNA sequencing reveals the positive feedback activation loop between T and dendritic cells induced by PD-L1x4-1BB bispecific antibody
Abstract: 1112

Single-cell RNA-sequencing (scRNAseq) was used to better understand the biology of immune responses induced by ATG-101.
Transcriptional profiling of the tumor microenvironment (TME) revealed that ATG-101 reversed T cell exhaustion, increased T cell cytotoxicity, and reduced tolerogenic dendritic cells (DCs).
Due to the increased gene expression of PD-L1 in DCs and 4-1BB in T cells following ATG-101 treatment, it is anticipated that ATG-101 will promote greater T cell-dentritic cell crosslinking over time, further activating 4-1BB signalling, strengthening T cell-DC interaction, and generating a positive feedback loop.
Currently, ATG-101 is being assessed in a dose-escalation study in the Mainland of China, Australia, and the U.S.
ATG-034 (LILRB4 antagonist antibody)
Title: Antibody targeting a specific epitope of LILRB4 induces potent ADCC/ADCP effect against leukemia cells
Abstract: 1391

Acute myeloid leukemia (AML) patients, especially those with monocytic AML subtypes have poor treatment outcomes. Existing therapies targeting CD33 and CD123 has demonstrated hematological toxicities. Moreover, the antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis (ADCC/ADCP) effect of current therapeutic mAbs targeting LILRB4 antigen on AML is relatively weak.
ATG-034-S3 potentiates NK-mediated ADCC, macrophage-mediated ADCP, cytotoxicity of CD8+ T cells and reverses AML-mediated T cell suppression, thus enhancing anti-tumor immunity and demonstrating potent in vivo anti-tumor efficacy.
ATG-034-S3 may be a promising strategy for the treatment of monocytic M4/M5 AML and other LILRB-positive hematological malignancies.
ATG-021 (GPRC5D/CD3 T-cell engager)
Title: ATG-021, a novel 2+1 CD3-based T-cell engager (TCE) targeting GPRC5D, demonstrates potent in vivo anti-tumor efficacy with low cytokine release
Abstract: 1191

GPRC5D is expressed on malignant bone marrow plasma cells, whereas normal tissue expression is limited to the hair follicle; Upregulation of GPRC5D expression has been associated with unfavorable prognosis.
As a novel 2+1 GPRC5DxCD3 T cell engager, ATG-021 has demonstrated optimum efficacy and safety through its GPRC5D-dependent CD3 binding. It has demonstrated potent in vivo anti-tumor efficacy with reduced cytokine release in pre-clinical studies.
These pre-clinical data warrant further clinical evaluation of ATG-021 against multiple myeloma.
AnTenGager Platform
Title: A novel "2+1" bispecific T cell engager platform, enables enhanced anti-tumor activity with reduced risk of CRS
Abstract: 1190

Multiple T-cell engaging bispecific antibodies have demonstrated promising therapeutic efficacy in the treatment of hematological malignancies. However, suboptimal efficacy in the treatment of solid tumors and the risk of cytokine release syndrome (CRS) continue to be major challenges.
AnTenGagerTM is a novel "2+1" T cell engager platform developed by Antengene, and molecules developed through this platform have exhibited limited binding to CD3-positive cells before tumor-associated-antigen (TAA) crosslinking, suggesting reduced risk of CRS caused by systemic CD3 activation.
Compared to clinical benchmarks targeting the same tumor associated antigen (TAA), molecules developed by the AnTenGagerTM platform demonstrated substantially lower binding capacity to CD3+ before TAA-crosslinking, while inducing increased cytotoxicity against target-positive tumor cells, less ex-vivo cytokine release by human peripheral blood mononuclear cells (PBMCs), and enhanced in vivo efficacy in a PBMC humanized mouse tumor model.
These results suggest that AnTenGagerTM is a promising platform to develop next generation T cell engagers, with improved efficacy and safety profiles.