On September 10, 2024 CEL-SCI Corporation (NYSE American: CVM) reported that it will report new data from its Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress which takes place from September 13 – 17, 2024 in Barcelona, Spain (Press release, Cel-Sci, SEP 10, 2024, View Source [SID1234646495]). A poster titled "Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy" will be presented by the study’s co-author József Tímár MD, PhD, DSc, a prominent and highly respected pathologist.

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"Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy"

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CEL-SCI has received the go-ahead from the U.S. Food and Drug Administration (FDA) to commence a confirmatory Registration Study of Multikine in the treatment of head and neck cancer based on strong safety and efficacy data from its IT-MATTERS completed Phase 3 study.

Dr. Timar is Professor Department of Pathology, Forensic and Insurance Medicine at Semmelweis University in Budapest, Hungary, and served as the Director of the Central Pathology Laboratory for the IT-MATTERS study. With 174 peer reviewed studies published, Dr. Timar is a founding editor, editor in chief, or a member of the editorial board of four oncology journals. He is the recipient of a dozen honors and awards for excellence in cancer research and teaching.

On September 10, 2024 GC Cell, a leading innovator in cell therapy, has officially reported the execution of a landmark ‘Technology Transfer and License Agreement’ with PT Bifarma Adiluhung (Bifarma), a premier stem cell therapy company in Indonesia (Press release, GC Cell, SEP 10, 2024, View Source [SID1234646480]). This strategic partnership, which began in June, solidifies approximately three months later with the signing of the final license agreement.

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Under the terms of the agreement, Bifarma will be granted the exclusive rights to develop, manufacture, and commercialize Immuncell-LC for 15 years.

GC Cell and PT Bifarma Adiluhung sign a licensing agreement for Immuncell-LC to expand access in Indonesia (PRNewsfoto/GC Cell)
GC Cell and PT Bifarma Adiluhung sign a licensing agreement for Immuncell-LC to expand access in Indonesia (PRNewsfoto/GC Cell)
Bifarma is recognized for operating Indonesia’s first GMP-certified cell therapy production facility and possesses a comprehensive sales and marketing infrastructure focused on oncology, specializing in a cold chain distribution network that spans across Indonesia. This infrastructure is expected to maximize the accessibility and commercial success of Immuncell-LC.

James Park, CEO of GC Cell, expressed his enthusiasm about the partnership’s potential, stating, "The initiation of technology transfer concurrent with the signing of the license agreement sets us on a path to introduce Immuncell-LC in Indonesia by next year, leveraging both our expertise and a firm partnership with Bifarma. This milestone is pivotal as we work to introduce Immuncell-LC, South Korea’s first anticancer drug cell therapy, to a global audience, offering new treatment avenues to a broader patient demographic."

The Indonesian pharmaceutical market, the largest in Southeast Asia, is rapidly expanding with an average growth rate exceeding 8% annually, representing a significant opportunity for innovative treatments like Immuncell-LC. The introduction of the product is expected to mark a significant advancement in Indonesia’s cancer treatment landscape, particularly for Hepatocellular Carcinoma (HCC), which affects approximately 23,000 new patients annually in the country.

Dr. Sandy Qlintang, MBiomed., President Director of PT Bifarma Adiluhung said, "We are excited to announce our collaboration in Immuncell-LC with GC Cell, focusing on innovative treatments for hepatocellular carcinoma (HCC) in Indonesia. By combining our expertise, we aim to enhance therapeutic strategies and bring groundbreaking advancements to liver cancer treatment through cutting-edge immune cell therapies. Together, we are committed to make a significant impact in the fight against HCC."

Immuncell-LC, an anti-cancer immune cell therapy, has demonstrated significant efficacy in solid tumors, particularly liver cancer, and has been recognized as an FDA-designated orphan drug. It consists primarily of autologous blood-derived T lymphocytes enhanced to improve cancer cell killing capabilities. The therapy has proven its effectiveness in large-scale Phase 3 clinical trials for early-stage Hepatocellular Carcinoma (HCC) patients, significantly reducing recurrence risk and mortality with a favorable safety profile.

As GC Cell continues to engage with major pharmaceutical entities across emerging markets, the partnership with Bifarma is poised to set a precedent for the introduction of innovative therapies in underserved regions, promising enhanced clinical outcomes and increased accessibility to cutting-edge treatments.

On September 10, 2024 Incendia Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), reported that the first patient has been enrolled in the Phase 1c study of PRTH-101 for the treatment of patients with advanced or metastatic solid tumors (Press release, Incendia Therapeutics, SEP 10, 2024, View Source [SID1234646496]).

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"In our Phase 1a and 1b studies, we were able to select an optimal dose and identify potential biomarkers to carry forward" said Irena Webster, SVP Development and Operations of Incendia. "The data from this study will inform the design of the Phase 2/3 program, for which planning and global feasibility are currently underway."

Dr. Joseph Paul Eder, CMO, added "Incendia, with its outstanding team of investigators and investigative sites, has determined a recommended Phase 2 dose of PRTH 101. PRTH 101 has shown consistent safety as a single agent and in combination with pembrolizumab. We will now focus on tumor types that have demonstrated signs of clinical activity and patient benefits."

The Phase 1c study will evaluate the safety, tolerability and anti-tumor activity of PRTH-101 as both a monotherapy and in combination with KEYTRUDA (pembrolizumab).

About PRTH-101
PRTH-101 is a therapeutic antibody that targets DDR1, a collagen binding protein and kinase present on epithelial cells. Some tumor cells are believed to co-opt DDR1 – collagen binding to build an impenetrable barrier around the tumor. By allosterically disabling DDR1, PRTH-101 disrupts tumor associated collagen alignment to permit immune cell access into the tumor core. In preclinical experiments, PRTH-101 mediated DDR1 blockade has demonstrated both single agent anti-tumor activity as well as marked augmentation of checkpoint inhibitor function. Tumor types that express high levels of DDR1-associated collagen barriers include thymic, colorectal, pancreatic, ovarian, glioma, and non-small cell lung cancer. Currently, there are no approved drugs that target DDR1.

About the Phase 1 Trial
The Phase 1 trial (NCT05753722) is a multi-center, open-label, dose escalation and dose expansion study that is expected to enroll up to 270 patients in the US with advanced or metastatic solid tumors. The goals of the study are to assess safety and tolerability of PRTH-101, evaluate anti-tumor activity in select indications alone and in combination with anti-PD-1 inhibitors, and determine dosing regimens for the Phase 2 clinical program. In addition to examining the clinical profile of PRTH-101, the trial will evaluate DDR1 and pathway-related proteins as predictive biomarkers for patients whose tumors respond to treatment.

On September 10, 2024 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that members of the Aclaris management team will participate in a fireside chat during the 2024 Cantor Global Healthcare Conference on Tuesday, September 17, 2024 at 8:00 AM ET in New York, New York (Press release, Aclaris Therapeutics, SEP 10, 2024, View Source [SID1234646465]).

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A webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On September 10, 2024 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported its selection to present a poster at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, which will take place from September 13 to 17, 2024, in Barcelona, Spain (Press release, OncoHost, SEP 10, 2024, View Source [SID1234646481]).

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The abstract, titled "A plasma proteomic based algorithm is associated with prognosis in renal cell carcinoma," highlights the extended application of OncoHost’s PROphet platform beyond non-small cell lung cancer (NSCLC) to renal cell carcinoma (RCC). This research represents a collaboration between OncoHost and Dana-Farber Cancer Institute, a world leader in adult and pediatric cancer treatment and research. The findings will be presented by Dr. Eddy Saad, MD, MSc, a Postdoctoral Research Fellow at Dana-Farber.

"In this work, we demonstrated that OncoHost’s plasma-based proteomic model, initially trained and validated in NSCLC, can also be applied to another tumor type, RCC, to risk stratify patients," said Dr. Eddy Saad, MD, MSc, Postdoctoral Research Fellow at Dana-Farber, and co-author of the abstract. "Moving forward, we aim to further develop and train an RCC-specific model and assess its predictive abilities to guide patient treatment."

The study explored the use of OncoHost’s PROphet platform in a cohort of 201 RCC patients treated with various therapies, including VEGFR tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), or a combination of both. The results demonstrated that patients identified as PROphet-POSITIVE had significantly improved overall survival (OS) and progression-free survival (PFS) compared to PROphet-NEGATIVE patients, indicating the platform’s potential to predict clinical outcomes across various cancer types.

Furthermore, the research uncovered distinct subsets of circulating proteins associated with clinical benefit among patients treated with different therapies, suggesting that the proteomic features leveraged by the PROphet platform may have broad predictive value. These findings provide a strong foundation for further exploration of PROphet’s application in other cancer indications and treatment contexts.

"This research marks another important milestone for OncoHost, as it demonstrates the versatility and potential of our PROphet platform across different cancer types. By validating the use of our proteomic model in renal cell carcinoma, we are moving closer to our goal of providing personalized treatment plans that significantly improve patient outcomes," said Ofer Sharon, MD, CEO of OncoHost. "We are honored to partner with Dana-Farber in presenting these findings at ESMO (Free ESMO Whitepaper) 2024 and look forward to further expanding the clinical applications of our technology."

Poster Presentation Details
Title: A plasma proteomic based algorithm is associated with prognosis in renal cell carcinoma
Presentation #: 1707P
Title: A plasma-based proteomic platform for predicting clinical benefit from immune checkpoint inhibitors in multiple cancers.
Presenter: Eddy Saad, MD, MSc, Postdoctoral Research Fellow at Dana-Farber Cancer Institute
Date: Sunday, 15 September 2024