On January 10, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that enrollment is open at Erasmus Medical Center ("Erasmus MC") in a Phase 1b/2 clinical trial combining AIM’s Ampligen (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of pancreatic cancer (the "DURIPANC Study") (Press release, AIM ImmunoTech, JAN 10, 2024, View Source [SID1234639176]). Ampligen has shown therapeutic synergies with checkpoint inhibitors, potentially increasing survival rates and efficacy.

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AIM announced in January 2023 that it had entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca. The DURIPANC Study is an investigator-initiated, exploratory, open-label, single-center study with the full name "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect." The primary objective of the Phase 1b portion is to determine the safety of combination therapy with durvalumab and Ampligen. The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.

Prof. Casper H.J. van Eijck, MD, PhD, the DURIPANC Study’s Coordinating Investigator and a pancreato-biliary surgeon at Erasmus MC, stated, "While immune checkpoint inhibitors targeting PD1/PDL1 have shown promise in other solid tumors, they have shown limited efficacy thus far in ductal cancer of the pancreas. Findings from our previous study collectively provide compelling evidence that rintatolimod treatment enhances the immune response by activating immune cells in advanced PDAC, as well as highlighting its potential synergy with ICI therapy. Therefore, we are excited about the promise of combining Ampligen with durvalumab in a clinical study and we believe this approach could make a positive impact in the current treatment landscape for patients with metastatic pancreatic cancer and extend overall and progression free survival."

AIM recently received a U.S. patent for the use of Ampligen as part of a combination therapy with an anti-PD-L1 antibody.

AIM Chief Executive Officer Thomas K. Equels stated: "We believe that Ampligen has potential as both a monotherapy and a combination therapy, but a combination therapy could be much more enticing as a partnership or buyout target, as Ampligen would be enhancing an already approved drug in an established and successful Big Pharma market. Essentially, we are working to show that combining Ampligen treatment with an already established cancer treatment could help save even more lives."

Hear more from Tom Equels about the significance of this news in the latest "What this Means" video.

The DURIPANC Study is expected to enroll up to 18 subjects in its Phase 1b portion and up to 25 patients in its Phase 2 portion. Subjects will start with Ampligen 200 mg via IV infusion twice per week for a total of 6 weeks (12 doses). Ampligen dose will be escalated to 400 mg according to a 3+3 DLT design. The first dose of Ampligen will be administered preferably 4-6 weeks after the last chemotherapy FOLFIRINOX dose. After two doses of Ampligen, the first dose of durvalumab 1500 mg via IV infusion will be introduced in week 2. Patients will continue to receive 1500 mg durvalumab via IV infusion every 4 weeks for up to a maximum of 48 weeks (up to 12 doses/cycles) with the last administration on week 48 or until confirmed disease progression according to Response Evaluation Criteria in solid Tumors (RECIST 1.1), unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

On January 9, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME) (Paris:ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces that it successfully completed its pre-IND advice meeting with the US regulator, the Food and Drug Administration (FDA), discussing plans for the further clinical development of NOX-A12 as a treatment of aggressive adult brain cancer, glioblastoma (Press release, TME Pharma, JAN 9, 2024, View Source [SID1234639198]). Based on the feedback received, TME Pharma confirms that it is on track with preparations to file its Investigational New Drug (IND)1 application and the expedited regulatory pathway request on a timeline that will allow successful completion of both by the end of Q1 2024.

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"The informative discussion with the FDA allows our team to prepare an IND application that fits with the requirements of the US regulator in areas where there has been recent evolution in recommendations by the FDA’s Oncology Center of Excellence, such as the selection of the appropriate therapeutic dose of new oncology drugs2," said Aram Mangasarian, CEO of TME Pharma. "As a result, we are confident to be able to meet our target of having an FDA approved clinical trial protocol in glioblastoma with an expedited regulatory path in the US by the end of Q1 2024 in order to secure the funding for the necessary clinical trial via partnership, investment or other strategic transaction types. While the company plans to provide further updates on the status of applications during the ongoing discussions, the final trial design will be shared once the FDA has completed its assessment. We believe that the combination of a defined regulatory path and the mature data from the GLORIA brain cancer trial will, together, form an attractive package for potential partners."

On January 9, 2024 Menarini Silicon Biosystems, a pioneer of liquid biopsy technology, reported the publication, in the Journal of Clinical Chemistry, of the final results of the multicenter DETECT III clinical trial (Press release, Menarini Silicon Biosystems, JAN 9, 2024, View Source [SID1234639175]). This, interventional, investigator-initiated, phase III trial evaluated the efficacy of HER2-targeted therapy in metastatic breast cancer patients with HER2 negative tissue biopsy of the primary and/or metastatic site and HER2 positive CTCs detected with the CELLSEARCH system. Patients randomized to the treatment arm with reference HER2-targeted TKI (Tyrosine Kinase Inhibitor) lapatinib, in addition to standard therapy, showed greater overall survival (OS) over patients treated with standard therapy alone. This allowed physicians to consider early initiation of HER2-targeted therapy. Based on the primary tumor and/or metastatic site characteristics and the current standard of care, those patients would not have been eligible for HER2 targeted therapy.

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According to Prof. Dr. med. Wolfgang Janni, MD, PhD, Professor and Chair of the Department of Obstetrics and Gynecology at the University of Ulm, Germany, study director of the DETECT III trial: "the results of this trial suggest the potential of CTCs as noninvasive surrogates for invasive tissue-based biomarkers, as well as an early monitoring tool. CTC phenotyping could contribute to personalized treatment approaches that allow us to improve management of patients with advanced disease and discordant expression of the HER2 receptor".

A total of 2,137 patients with HER2 negative MBC were screened for HER2 positive CTCs using Menarini Silicon Biosystems’ CELLSEARCH CTC System and the CELLSEARCH HER2 tumor phenotyping reagent*. 105 patients, with at least one detected HER2 positive CTC in the initial CTC screening phase, were randomized to either lapatinib in combination with standard therapy or to standard therapy alone. Patients in the lapatinib arm had a significantly improved OS with a median survival time of 20.5 months compared to a median survival time of 9.1 months for patients in the standard arm (HR 0.54; 95% CI 0.34–0.86; p = 0.008). While investigators acknowledge some limitations in the study design, the results indicate that CTC-guided treatment allocation may help optimize treatment strategies and should therefore be further investigated. The study also confirmed the prognostic role of CELLSEARCH CTC enumeration. Patients with no evidence of CTCs at the time of first follow-up showed a 3-fold increase in OS compared to patients with CTCs (42.4 months vs 14.1 months median OS; HR 0.33; 95% CI 0.16–0.68; p = 0.002)

"We are thrilled by the fact that the DETECT III study provides additional data further elucidating the potential value of our minimally invasive CELLSEARCH technology," said Fabio Piazzalunga, President of Menarini Silicon Biosystems. "This study is another example of why we are so committed to pursuing our investments in the CELLSEARCH platform in different cancer settings."

About the DETECT study program

DETECT is the largest study program utilizing Circulating Tumor Cell (CTC) count and HER2 phenotype assessment to personalize treatment strategies for HER2 negative MBC. The aim of this protocol was to evaluate the impact of adapting therapeutic interventions based on CTC phenotypes in patients with a discordant HER2 negative primary tumor biopsy and HER2+ over expression of CTCs in the metastatic setting. The study results consistently show the importance of adding HER2 targeted therapy in this patient population to improve long-term clinical outcomes.

About CELLSEARCH

CELLSEARCH is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs to aid physicians in managing patients with metastatic breast, prostate, and colorectal cancers when used in conjunction with other clinical methods of monitoring. The test is also approved by the China National Medical Products Administration (NMPA) for use in monitoring patients with Metastatic Breast Cancer. The CELLSEARCH System is the most extensively studied CTC technology, with research published in more than 650 peer-reviewed publications.

CELLSEARCH Circulating Tumor Cell Kit is not cleared or approved for use to guide specific treatment decisions. For more information on the full intended use and limitations of the CELLSEARCH system, please refer to the Instructions for Use at View Source

The CELLSEARCH HER2 tumor phenotyping reagent is available as a Research Use Only product in Europe and Asia Pacific.
In the USA only, the CELLSEARCH CTC test with HER2 biomarker is available to clinicians, through Menarini Silicon Biosystems’ CLIA registered clinical laboratory as a laboratory developed test.

On January 9, 2024 SkylineDx, an innovative diagnostics company focused on the research and development of molecular diagnostics, reported that the European Patent Office (EPO) has granted European Patent No. 3827101, marking a groundbreaking advancement in the field of cancer diagnostics and personalized treatment (Press release, SkylineDx, JAN 9, 2024, View Source [SID1234639173]).

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This patent introduces innovative approaches to classify and treat individuals afflicted with primary cutaneous melanoma based on the expression levels of gene expression signature , providing the foundation for highly precise diagnosis and personalized treatment plans.

Dharminder Chahal, CEO of SkylineDx, expressed his pride in this achievement, stating, "Obtaining the European Patent is a testament to SkylineDx’s commitment to advancing the field of melanoma diagnosis and treatment. It is a recognition of the important work that our team is doing in collaboration with Mayo Clinic. Our innovative methods for classifying and treating primary cutaneous melanoma represent a significant leap forward in providing personalized care for patients. We are proud to contribute to the improvement of patient outcomes and the advancement of medical research."

The significance of this patent lies not only in its scientific innovations but in its potential to improve the lives of individuals faces with primary cutaneous melanoma. SkylineDx’s dedication to pushing the boundaries of melanoma research and patient care shines through in this remarkable achievement.

On January 9, 2024 ConcertAI and Caris Life Sciences (Caris) reported a multi-year partnership to support AbbVie’s precision medicine-driven research and development efforts, and clinical trial optimization in oncology (Press release, Caris Life Sciences, JAN 9, 2024, View Source [SID1234639172]).

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The agreement will allow AbbVie to leverage Caris’ expansive real-world, multi-modal database in oncology and ConcertAI’s collection of research-grade clinical data across a wide range of cancers, to guide the development of novel therapies for patients most likely to benefit. The agreement will also allow AbbVie to utilize ConcertAI and Caris’ clinical network and laboratory capabilities combined with AI/ ML learning to optimize oncology clinical trials and patient enrollment.

"We are continuing to expand our drug discovery and development efforts in oncology, with the ultimate goal to deliver transformative treatments to cancer patients," said Tom Hudson, SVP, Chief Scientific Officer, Global Research at AbbVie. "This agreement marks a key step in that direction, as it represents a union of cutting-edge technology and pioneering science, leveraging the power of big data, artificial intelligence and machine learning to propel our efforts in the fight against cancer."

"This partnership furthers our goals of enabling causal biological inferences, where multi-modal data can be integrated with AI/ML-based approaches in drug discovery, translation and development, to accelerate oncology pipelines, and allow our biopharma partners to discover and deliver better medicines faster," said Jeff Elton, Ph.D., CEO of ConcertAI.

"We are thrilled to work with AbbVie, a leader in driving innovation in drug development, to support their work in oncology," said Dr. George W. Sledge, Jr., Chief Medical Officer of Caris. "This work may help identify novel targets and mechanisms, and key levers to drive clinical trial excellence to support AbbVie’s oncology portfolio."