AIM ImmunoTech Inc. (NYSE: AIM) ("AIM" or the "Company") today announced that it has completed a clinical trial at Erasmus Medical Center ("Erasmus MC") Patient enrollment opens for the Phase 1b/2 clinical trial combining AIM's Ampligen ® (rintatolimod) with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi ® (durvalumab) in pancreatic cancer (the " DURIPANC Study "). Ampligen has shown synergy with checkpoint inhibitors, with the combination potentially improving survival and efficacy.

AIM announced in January 2023 that it had signed an externally sponsored clinical research collaboration agreement with Erasmus MC and AstraZeneca. The DURIPANC study is an exploratory, open-label, single-center study initiated by the researcher. The full name is " Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect (Efficacy of the anti-PD-L1 immune checkpoint inhibitor durvalumab combined with the TLR-3 agonist rintatolimod in the treatment of metastatic pancreatic ductal adenocarcinoma) . " The primary goal of the Phase 1b portion is to determine the safety of durvalumab and Ampligen combination therapy. The primary goal of the Phase 2 portion is to determine the clinical benefit of the combination therapy.

"While immune checkpoint inhibitors targeting PD1/PDL1 have shown therapeutic promise in other solid tumors," said Professor Casper HJ van Eijck, MD, lead coordinating investigator of the DURIPANC study and pancreaticobiliary surgeon at Erasmus MC. Efficacy in pancreatic ductal carcinoma has so far been limited. Our previous findings provide strong evidence that rintatolimod treatment enhances immune responses by activating immune cells in advanced PDAC and also highlights its potential synergy with ICI therapy. Therefore, we are excited about the prospect of combining Ampligen with durvalumab in clinical studies, an approach we believe could have a positive impact on the current treatment landscape for patients with metastatic pancreatic cancer and extend overall survival and progression-free survival. .”

AIM recently received a U.S. patent for Ampligen in combination with an anti-PD-L1 antibody .

Thomas K. Equels, chief executive officer of AIM, said: "We believe Ampligen has the potential to be used as a treatment either as a single agent or as part of a combination, but the combination may be more promising because Ampligen will enhance existing therapies. Therapeutic efficacy of an approved drug in a mature large pharma market. Essentially, we are trying to show that combining Ampligen therapy with an already approved cancer treatment will help save more lives."

To hear more from Tom Equels on the significance of this news, check out the latest "What this Means" video .

The DURIPANC study is expected to enroll up to 18 subjects in the Phase 1b portion and up to 25 patients in Phase II. Subjects will receive an intravenous infusion of 200 mg of Ampligen twice weekly for 6 weeks (12 doses). Ampligen dose will be increased to 400 mg based on a 3+3 dose-limiting toxicity (DLT) design. The first dose of Ampligen is preferably administered 4 to 6 weeks after the last dose of FOLFIRINOX chemotherapy. Following completion of two doses of Ampligen, the first dose of durvalumab 1500 mg will be administered intravenously at Week 2. Unless unacceptable toxicity occurs, consent is withdrawn, or any discontinuation criteria are met, patients will continue to receive durvalumab 1500 mg as an intravenous infusion every 4 weeks for up to 48 weeks (up to 12 doses/cycle) with the last dose Continue until disease progression is confirmed at Week 48 or according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immunopharmaceutical company focused on the research and development of treatments for various cancers, immune diseases and viral diseases, including coronavirus disease 2019 [COVID-19]. The company's lead product is a first-in-class investigational drug called Ampligen ®  (rintatolimod), a double-stranded RNA and highly selective TLR3 agonist immunomodulator that has shown efficacy in clinical trials against major cancers worldwide , viral diseases and immune system disorders with broad spectrum activity.

For more information, visit aimimmuno.com and follow the company on Twitter , LinkedIn and Facebook .

Cautionary Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). Words such as "may", "will", "anticipate", "plan", "anticipate", "continue", "believe", "potential", "is about to happen" and related variations and similar expressions (and others involving words or expressions indicating future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve various risks and uncertainties. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, as well as any of its subsequent Form 10-Q or Form 8-K filings with the U.S. Securities and Exchange Commission (SEC). Risk factors or cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. AIM requires, among other things, that the above statements be afforded the protection of the safe harbor for forward-looking statements contained in the PSLRA. AIM does not undertake to update such forward-looking statements to reflect events or circumstances after the date of this release.

 

Source: globenewswire.com

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