On August 20, 2024 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported a collaboration with Tempus, a technology company leading the adoption of AI to advance precision medicine and patient care, to advance the clinical development of BerGenBio’s selective AXL inhibitor bemcentinib in first line (1L) Non-Small Cell Lung Cancer (NSCLC) patients with STK11 mutations (STK11m) (Press release, BerGenBio, AUG 20, 2024, View Source [SID1234646019]). BerGenBio’s on-going BGBC016 Phase 1b/2a trial is designed to assess the benefit of adding bemcentinib to the current standard of care treatment (immunotherapy + doublet chemotherapy) in 1L STK11m patients, a population with poor outcomes and no specific therapies today.

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The collaboration will provide BerGenBio with access to a tailored cohort of Tempus’ real-world clinical and molecular data that is intended to establish a synthetic control to provide a contextual benchmark for BerGenBio’s innovative study, which aims to address the urgent medical need for effective treatments in STK11m NSCLC patients. Tempus’ comprehensive, AI-enabled platform will enable BerGenBio to receive customized analyses of Tempus data and gain deeper insights into the genomic landscape and therapeutic responses of NSCLC patients with STK11m.

Upon conclusion of the BGBC016 study, the parties intend to present insights derived from the resulting data to appropriate regulatory agencies as a next step in the further development of bemcentinib.

Martin Olin, CEO of BerGenBio, expressed enthusiasm about the collaboration, stating, "We are excited to partner with Tempus to harness the power of their advanced technology in our mission to improve outcomes for NSCLC patients with STK11 mutations. By integrating Tempus’ platform into our study, we aim to enhance our understanding of the disease biology and treatment outcomes, ultimately driving our ability to accelerate further development of bemcentinib".

"We are excited to collaborate with BerGenBio to accelerate the development of precision therapies for STK11m NSCLC patients," said Kate Sasser, Chief Scientific Officer at Tempus. "Together, we aim to unlock new insights that will ultimately improve patient outcomes and redefine the standard of care in this challenging disease setting."

On August 20, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM") reported the official print publication of the data analysis from a long-term Early Access Program ("EAP") studying the company’s drug Ampligen (rintatolimod) for the treatment of advanced pancreatic ductal adenocarcinoma ("PDAC") (Press release, AIM ImmunoTech, AUG 20, 2024, View Source [SID1234646003]). The manuscript titled "Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses," appears in the journal Clinical Cancer Research, one of oncology’s most prestigious journals.

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Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and tumors. Researchers at the Erasmus University Medical Center ("Erasmus MC") found that Ampligen treatment in pancreatic cancer patients enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1s) and T cells. Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronounced overexpression of genes related to DC and T cell activation. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients.

"We are grateful to the Erasmus team for their continued contributions to the advancement of Ampligen," said AIM Chief Executive Officer Thomas K. Equels "There remains a large and growing unmet need for safe and effective treatments for pancreatic cancer. This data continues to provide us with further insight into Ampligen’s ability to improve progression-free survival and overall survival and enables us to identify cancer patients who might benefit more from Ampligen treatment than they would from other known cancer treatments."

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and co-author of the published paper, added, "We continue to be encouraged by this data which suggests Ampligen infusions modulate PD-L1 and PD-L2 expression in the tumor microenvironment, while at the same time they upregulate Ki67+CD4+ and Ki67+CD8+ T-cells. We continue to make progress in the ongoing DURIPANC trial, which looks at the combination effect of Ampligen and AstraZeneca’s durvalumab and look forward to continuing evaluation of its potential for the treatment of pancreatic cancer."

In addition to the published manuscript, further commentary discussing the potential of Ampligen and two other drugs, referencing findings from the journal article, were published. Key highlights from the additional commentary include:

Ampligen has been found to be also safely used through a systemic route.
Interesting increases in cDC1 numbers and cytokines governing T-cell activation and migration are found to be upregulated.
Researchers detected an important enrichment of B-cell numbers in peripheral blood from patients treated with Ampligen.
B-cells correlated with long-term (>1 year) survival in a previous study.
AIM is currently evaluating Ampligen as a therapy for metastatic pancreatic ductal adenocarcinoma in the Phase 1b/2 DURIPANC clinical study (NCT05927142) and as a therapy for locally advanced pancreatic adenocarcinoma in the Phase 2 AMP-270 clinical study (NCT05494697).

On August 20, 2024 EMulate Therapeutics, Inc. ("Emulate") reported the Open Journal of Biophysics (OJBIPHY), publisher of over 200 peer-reviewed open access journals, has accepted its manuscript, titled "Magnetic Field Emulations of Small Inhibitor RNA: Effects on Implanted GL261 Tumors in C57BL/6 Immune Competent Mice" for publication (Press release, EMulate Therapeutics, AUG 20, 2024, View Source [SID1234646020]). This submission supports independent results in an animal model of Glioblastoma Multiforme (GBM), recently published by Mukthavaram et al. (Bioelectron Med 2024 Vol. 10 Issue 1 Pages 10), which demonstrates the ability of EMulate’s second signal treatment offering, A2. GBM is a rare brain glioma that currently has no established treatment on the market and is categorized by the U.S. Food and Drug Administration (FDA) as a highly underserved orphan disease (affects fewer than 200,000 in the U.S.). View Source

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The paper demonstrates EMulate’s A2 signal treatment targets the established immune checkpoint inhibitor targets of CTLA-4 and PD-1, reducing the expression of these immune system receptors and inhibiting the growth of tumors in a validated mouse model of GBM. These results support the observed outcomes from a Phase I clinical trial (NCT02507102) demonstrating safety and possible efficacy against GBM in humans.

"The results of this pre-clinical animal model study continue to demonstrate the potential of our ulRFE technology in the treatment of cancers and other challenging diseases with high unmet medical needs. We strongly believe in the potential benefits of this treatment in patients afflicted by cancer with these genetic targets, which we intend to confirm in future clinical trials," stated Xavier Figueroa, Ph.D., EMulate’s SVP of Pre-Clinical Development.

On August 20, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that it will present data from its FOCUS Phase 3 study at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, which convenes from September 13-17, 2024, in Barcelona, Spain (Press release, Delcath Systems, AUG 20, 2024, View Source [SID1234646005]).

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Poster Presentation Details

Title: Subgroup Analysis of FOCUS Phase 3 Trial Efficacy Results
Date: September 14, 2024
Time: 9:00 am
Location: Hall 6
Poster number: 1127P

The presentation will highlight the efficacy of the Melphalan/Hepatic Delivery System (Melphalan/HDS) in patients across six subgroups with unresectable metastatic uveal melanoma (mUM).

On August 20, 2024 Talus Bioscience, a drug discovery company founded by a world-class team of scientific leaders in proteomics, biochemistry, and machine learning, reported $11.2M in new venture funding (Press release, Talus Bioscience, AUG 20, 2024, View Source [SID1234646021]). The Seed+ round was led by Two Bear Capital, with participation from WRF Capital, NFX, YC Continuity Fund, Funders Club VC, and BoxOne Ventures.

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The funding will be invested to advance Talus Bio’s therapeutic programs, which include Brachyury-driven cancers and an undruggable transcription factor implicated in prostate cancer. It will also accelerate the expansion of the company’s proprietary Multiplexed Assays for the Rational Modulation Of Transcription Factors (MARMOT) platform.

MARMOT leverages new AI models trained on Talus Bio’s dataset for transcription factor activity, currently the largest in the world. MARMOT allows scientists to rapidly identify optimal candidates from billions of compounds, replacing time-consuming high-throughput screens, which have historically failed for transcription factors and are limited to millions of compounds. With MARMOT, machine learning models discover and optimize modulators for any given transcription factor target, enabling the massive acceleration of discovery screening in live, unmodified human cells where targets fold and function properly.

"This new funding from our exceptional partners validates and supports our work producing the first AI model to discover and optimize new modulators of any transcription factor," said Talus Bioscience CEO and Co-Founder Alex Federation, PhD. "With our growing team of leading data scientists, we can use tens of millions of data points generated from the MARMOT platform to predict the best places to look for new molecules to block disease-causing transcription factors. We’re just getting started as we source new partners to help advance the dozens of promising transcription factor candidates we have discovered to date."

Transcription factors are proteins that regulate the genome by binding to DNA and orchestrating which genes are turned on or off at any given time. When they go awry, they often drive cancer and other disease processes like diabetes, inflammatory diseases, fibrosis, and neurological conditions.

"Talus Bio’s platform incorporates advances in chemistry, proteomics and computational biology to generate a dataset that was previously impossible. The scale, comprehensiveness, and efficiency with which they can target transcription factors gives their AI approach a distinct advantage and has already generated a robust list of hits against attractive drug targets," said Avery Sonnenberg, PhD, Principal at lead investor Two Bear Capital. "We’re thrilled to be working with this exceptional team as they pursue both partnerships and internal development of these exciting programs which have the potential to redefine how we treat complex diseases and improve patient outcomes globally."