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AIM ImmunoTech Announces Open Enrollment for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer

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.

Lantheus Expands Radiopharmaceutical Oncology Pipeline via Strategic Agreements with Perspective Therapeutics

On January 9, 2024 Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) reported it has entered into multiple strategic agreements with Perspective Therapeutics, Inc. (Perspective) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. Under the agreements, 1) Lantheus obtains an option to exclusively license Perspective’s Pb212-VMT-⍺-NET, a clinical stage alpha therapy developed for the treatment of neuroendocrine tumors, and an option to co-develop certain early stage therapeutic candidates targeting prostate cancer using Perspective’s innovative lead platform technology, for an aggregate upfront payment of $28 million in cash; 2) Lantheus has agreed to purchase up to 19.9% of Perspective’s outstanding shares of common stock for up to approximately $33 million, subject to completion of a qualified third party financing transaction and certain other closing conditions; and 3) Perspective intends to acquire the assets and associated lease of Lantheus’ radiopharmaceutical manufacturing facility in Somerset, New Jersey for an undisclosed price.

"These strategic transactions will expand our pipeline and create a pathway for impactful advancements in neuroendocrine tumors and prostate cancer," said Mary Anne Heino, Chief Executive Officer of Lantheus. "We are excited to partner with Perspective, which has developed a best-in-class alpha therapy platform for lead-based therapies, and we are particularly encouraged by the early data from VMT-⍺-NET. This potentially enables Lantheus to expand our pipeline into promising alpha therapies and further solidifies our position as the leading radiopharmaceutical-focused company."

Thijs Spoor, Chief Executive Officer of Perspective, stated, "Perspective stands at the forefront of innovation in precision oncology, particularly in the development of alpha therapies and complementary diagnostic imaging agents. In addition, Perspective’s acquisition of the Somerset radiopharmaceutical manufacturing facility will provide the company with an in-house manufacturing footprint to support its lead portfolio."

"This collaboration with Lantheus, a leader in the radiopharmaceutical space, marks a significant milestone in advancing treatment options for various cancers, bringing us closer to more effective and targeted interventions," continued Mr. Spoor.

The options took effect immediately following execution of the related definitive agreements. Under the terms of the option agreement, Lantheus also has a right of first offer and last look protections for any third party merger and acquisition transactions involving Perspective for a twelve-month period. The closing of Perspective’s acquisition of the assets and associated lease of the Somerset manufacturing facility is subject to customary closing conditions, including regulatory approval. The closing of Lantheus’ equity investment in Perspective is subject to the closing of Perspective’s next qualifying third party equity financing totaling at least $50 million (excluding Lantheus’ equity investment) and other customary closing conditions and will be consummated concurrently with the closing of Perspective’s next third party equity financing. The purchase price per share is also subject to adjustment based on such third party qualifying equity financing.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities of Perspective, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Lantheus, JAN 9, 2024, View Source [SID1234662964])

Alphamab Oncology Announced Innovative Bispecific Antibody Coupling Drug JSKN016 Clinical Study Accepted by CDE

On January 9, 2024 Alphamab Oncology (stock code: 9966.HK) reported an application for clinical trial of JSKN016, a new generation of bispecific antibody ADC drug, was officially accepted by CDE and will carry out clinical research on the treatment of advanced malignant solid tumors.

JSKN016 can simultaneously target HER3 (Human epidermal growth factor receptor 3) and TROP2 (Trophoblast cell surface antigen 2, Human trophoblastic surface antigen 2). After binding with TROP2 or HER3 on the surface of tumor cells, JSKN016 enters the lysosome through target-mediated endocytosis, releasing cytotoxic topoisomerase I inhibitor (TOPIi), and then inducing tumor cell apoptosis. In addition, the inhibitor can penetrate the cell membrane and enter the antigen-negative tumor cells to exert bystander effect.These effects can effectively inhibit the growth of tumor cells.

This is the first global clinical study of JSKN016 to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of JSKN016 in Chinese subjects with advanced malignant solid tumors.

About JSKN016

JSKN016 is a bispecific antibody conjugated drug (ADC) targeting HER3 and TROP2, which is developed inhouse with proprietary Glycan-specific conjugation platform. JSKN016 can induce apoptosis of TROP2 or HER3 positive tumor cells, and penetrate the cell membrane into antigen-negative tumor cells to exert bystander effect, thus effectively inhibiting the growth of tumor cells. The clinical study of JSKN016 for the treatment of advanced malignant solid tumors has been accepted by the CDE.

(Press release, Alphamab, JAN 9, 2024, View Source [SID1234657018])

TME Pharma Announces Successful Advice Meeting With US Food and Drug Administration on NOX-A12 Development in Brain Cancer

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.

"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."

Menarini Silicon Biosystems announces publication of the DETECT III trial results highlighting the potential clinical utility of HER2 testing in circulating tumor cells with CELLSEARCH

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.

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.