On October 31, 2023 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported a novel computational model for predicting significant immune-related adverse events (irAEs) in patients with non-small cell lung cancer (NSCLC) based on proteomic profiling of pre-treatment blood samples (Press release, OncoHost, OCT 31, 2023, View Source [SID1234636580]). The study was conducted using OncoHost’s PROphet platform and will be presented as a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting.

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Activation of the immune system by immune checkpoint inhibitors (ICIs) can result in complications known as immune-related adverse events (irAEs), which commonly affect the skin, liver, gastrointestinal tract, and endocrine organs, ranging in severity from mild (in the majority of cases) to life threatening. IrAEs can manifest at any point during a patient’s treatment, with the highest incidence occurring within the first three months. While most resolve with the appropriate intervention, some may become chronic and require lifelong care.

"While ICIs have shown success in treating non-small cell lung cancer, immune-related adverse events pose a complex challenge, complicating and affecting treatment efficacy and patients’ quality of life," said Yehonatan Elon, Ph.D., Chief Technology Officer at OncoHost. "The ability to anticipate the risk of irAEs in these patients prior to commencing treatment is a game-changer, as it enables the development of personalized management plans and strategies for risk reduction. We are excited about these results and look forward to improving the overall quality of cancer care for patients worldwide."

OncoHost’s predictive model was developed on a cohort of 426 ICI-treated NSCLC patients taking part in the company’s ongoing, multicenter PROPHETIC clinical trial (NCT04056247). Plasma samples and clinical data, including irAE occurrence, were collected, and deep proteomic profiling was conducted using SomaLogic’s (NASDAQ: SLGC) SomaScan platform, measuring the expression levels of approximately 7,000 proteins.

"It brings me great pride to witness the growth of our company, and the vast pipeline of indications that are coming to fruition through our PROphet platform," said Ofer Sharon, MD, CEO of OncoHost. "Our mission is to transform the approach to precision medicine for improved patient outcomes, and our scientific achievements are a testament to this dedication. The pressing concern regarding the lack of dependable pre-treatment biomarkers for predicting irAE development underscores a critical clinical need, and we are proud to spearhead the efforts to address this issue."

The clinical study was conducted in collaboration with Beaumont RCSI Cancer Centre, Asklepios Lung Clinic, Roswell Park Comprehensive Cancer Center, Sheba Medical Center Institute of Oncology,

Rabin Medical Davidoff Cancer Centre, Thomas Jefferson University, Northwestern University, Massachusetts General Hospital Cancer Center, among other institutions.

Poster Presentation Details

Session: Poster Hall

Abstract #: 1229

Title: Pre-treatment plasma proteomics-based predictive biomarkers for immune related adverse events in non-small cell lung cancer

The abstract will be available in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC) supplement.

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

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]).

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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.

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.

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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."

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.

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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.