A Phase 2 Randomized Open-Label Controlled Study to Evaluate the Efficacy and Safety of Ampligen in Combination With Standard of Care Versus SOC Alone Following First-Line Therapy in Subjects With Locally Advanced Pancreatic Adenocarcinoma

The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma

Start Date01 Dec 2024

Sponsor / Collaborator

AIM ImmunoTech, Inc.

[+1]

NCT04093323 / RecruitingPhase 2IIT

A Phase II Study of Type-1 Polarized Dendritic Cell (aDC1) -Based Treatment in Combination With Tumor-Selective Chemokine Modulation (CKM: Interferon Alpha 2b, Rintatolimod and Celecoxib) in Melanoma Patients With Primary PD-1/PD-L1 Resistance

This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.

Start Date20 Nov 2024

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

NCT05756166 / RecruitingPhase 1/2IIT

Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer.

Start Date16 Feb 2024

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Rintatolimod

100 Translational Medicine associated with Rintatolimod

100 Patents (Medical) associated with Rintatolimod

Literatures (Medical) associated with Rintatolimod

01 Nov 2024·Journal for ImmunoTherapy of Cancer

Systemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer

Article

Author: Attwood, Kristopher ; Wang, Jianming ; Gnjatic, Sacha ; Ioannou, Giorgio ; De Souza, Igor ; Fitzpatrick, Victoria ; Kumar, Prasanna ; Miller, Janine ; Janes, Cayla ; Kokolus, Kathleen M ; Kalinski, Pawel ; Gandhi, Shipra ; Young, Jessica ; Opyrchal, Mateusz ; O’Connor, Tracey ; O'Connor, Tracey ; Roudko, Vladimir ; Levine, Ellis G ; Slomba, Ronald T ; Cortes Gomez, Eduardo ; Cappuccino, Helen ; Kalathil, Suresh ; Ozbey, Sinem ; Takabe, Kazuaki ; Edge, Stephen

Background:

Higher cytotoxic T lymphocyte (CTL) numbers in the tumor microenvironment (TME) predict pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) and positive long-term outcomes in triple-negative breast cancer (TNBC). pCR to NAC is achieved only in 30–40% of patients. The combination of NAC with pembrolizumab increases the pCR rate but at the cost of immune-related adverse events (irAEs). Based on these considerations, we tested if systemic infusion of the chemokine modulatory regimen (CKM; selective toll-like receptor 3 (TLR3) agonist rintatolimod, interferon (IFN)-α2b, and cyclooxygenase-2 (COX-2) inhibitor celecoxib) regimen can be safely combined with NAC to enhance intratumoral CTL numbers and NAC effectiveness.

Methods:

Phase I studyNCT04081389evaluated nine patients with early-stage TNBC who received 3 weeks of paclitaxel with CKM (dose-escalation of IFN-α2b), followed by 9 weeks of paclitaxel alone, dose-dense doxorubicin and cyclophosphamide, and surgery. Primary and secondary endpoints were safety and clinical efficacy, respectively.

Results:

The combination treatment was well-tolerated with no dose-limiting toxicities or irAEs. 5/9 patients achieved pCR and one patient had microinvasive disease (ypTmic). We observed elevated IFN signature and uniform decreases in CTL numbers (average 8.3-fold) in the blood of all treated patients. This was accompanied by reciprocal uniform increases in CD8β (overall 5.9-fold), CD8α/FoxP3 (2.11-fold), and CCL5 (4.73-fold) transcripts in TME, particularly pronounced in patients with pCR. Multiplex immunohistochemistry revealed selectively increased numbers of CTL (but not regulatory T cells) in both the epithelial and stromal tumor compartments and early decreases in the numbers of αSMA+vascular/stromal cells in the tumors of all pCR patients.

Conclusions:

Combined paclitaxel/CKM regimen was safe, with desirable TME changes and preliminary indications of promising pCR+ypTmic of 66%, comparable to the combination of NAC with pembrolizumab.

15 Aug 2024·Clinical cancer research : an official journal of the American Association for Cancer Research

Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell–Mediated T-Cell Responses

Article

Author: van Eijck, Casper H.J. ; van Eijck, Casper W.F. ; Mustafa, Dana A.M. ; Aerts, Joachim G.J.V. ; Kucukcelebi, Songul ; Willemsen, Marcella ; Fellah, Amine ; Vadgama, Disha ; Haddaoui, Hassana el

Abstract:

Purpose::

Amid the need for new approaches to improve survival in pancreatic ductal adenocarcinoma (PDAC), immune-based therapies have garnered interest. Rintatolimod, a Toll-like receptor 3 (TLR-3) agonist, is a potential candidate due to its dual impact on restraining PDAC cell functions and boosting the antitumor immune response. This study investigates the effect of TLR-3 activation through rintatolimod on the peripheral immune landscape of patients with advanced PDAC.

Experimental Design::

Paired blood samples of 30 patients with advanced PDAC, collected at baseline and after 12 rintatolimod intravenous infusions, underwent comprehensive transcriptomic NanoString and proteomic flow cytometry profiling. The impact of rintatolimod and immunologic factors on survival outcomes was assessed through univariate Cox proportional hazards models.

Results::

Rintatolimod treatment enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1) and T cells. Post-rintatolimod, the increased peripheral abundance of BTLA+ XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronouncedDCand T-cell activation gene overexpression. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-rintatolimod across all patients. However, those with progressive disease showed increased expression of genes encoding IDO1 and PD-1.

Conclusions::

This study presents compelling evidence of the immune-stimulatory properties linked to TLR-3 activation through rintatolimod. Rintatolimod may break immunologic tolerance by enhancing antitumor immunity through DC-mediated Th-cell responses. Furthermore, our findings lay the groundwork for investigating the potential synergy between TLR-3 activation and immune checkpoint inhibitor therapy to improve therapeutic outcomes.See related commentary by Martínez-Riaño et al., p. 3355

01 Apr 2023·Antiviral research

Ebola virus disease: In vivo protection provided by the PAMP restricted TLR3 agonist rintatolimod and its mechanism of action

Article

Author: Daino, Gian Luca ; Strayer, David ; Mitchell, William M ; Distinto, Simona ; Tramontano, Enzo ; Paulis, Annalaura ; Corona, Angela

Ebola virus (EBOV) is a highly infectious and lethal pathogen responsible for sporadic self-limiting clusters of Ebola virus disease (EVD) in Central Africa capable of reaching epidemic status. 100% protection from lethal EBOV-Zaire in Balb/c mice was achieved by rintatolimod (Ampligen) at the well tolerated human clinical dose of 6 mg/kg. The data indicate that the mechanism of action is rintatolimod's dual ability to act as both a competitive decoy for the IID domain of VP35 blocking viral dsRNA sequestration and as a pathogen-associated molecular pattern (PAMP) restricted agonist for direct TLR3 activation but lacking RIG-1-like cytosolic helicase agonist properties. These data show promise for rintatolimod as a prophylactic therapy against human Ebola outbreaks.

125

News (Medical) associated with Rintatolimod

10 Dec 2024

·www.globenewswire.com

Ampligen Co-Inventor and Former CEO Agrees to Join AIM Scientific Advisory Board if Kellner Group Nominees Are Elected

Kellner Group Owns 5.04% of Outstanding Shares and is Fully Aligned with Stockholders Kellner Group Urges Stockholders of AIM Immunotech to Vote the Gold Card NEW YORK, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Ted Kellner, as the nominating stockholder and a nominee, together with his other nominees, Todd Deutsch, Robert L. Chioini and Paul W. Sweeney (collectively, the “Kellner Group,” “we” or “us” and, as nominees, the “Kellner Group Nominees”) today issue the following press release in connection with their efforts to bring accountability to the entrenched, incumbent Board of Directors of AIM Immunotech Inc. (NYSE American: AIM). The Kellner Group is pleased to announce that Dr. William A. Carter, MD, F.A.C.P., the founder and former CEO of AIM and inventor of Ampligen, has agreed to become Chairman of AIM’s Scientific Advisory Board in the event that the Kellner Group Nominees control the Board of Directors of AIM following the upcoming annual meeting. After meeting with Dr. Carter recently, Mr. Kellner remains convinced that Ampligen has great potential but only with a new AIM Board of Directors, and he asked Dr. Carter if he would be willing to serve on the intended Scientific Advisory Board, to which Dr. Carter agreed. Dr. Carter is the co-inventor of Ampligen®, joined AIM (f/k/a Hemispherx) in 1978, and served as: (a) Chief Scientific Officer from 1989-2016; (b) the Chairman of the Board of Directors from 1992-2016; (c) Chief Executive Officer from 1993-2016; (d) President from 1995 to 2006; and (e) a Director from 1987-2016. Dr. Carter was a leading innovator in the development of human interferon for a variety of treatment indications including various viral diseases and cancer. Dr. Carter received the first FDA approval to initiate clinical trials on a beta interferon product manufactured in the U.S. under his supervision. He received his M.D. degree from Duke University (with high honors) and underwent his post-doctoral training at the National Institutes of Health and Johns Hopkins University. Dr. Carter also served as Professor of Neoplastic Diseases at Hahnemann Medical University, a position he held from 1980 to 1998. Dr. Carter served as Professor and Director of Clinical Research for Hahnemann Medical University's Institute for Cancer and Blood Diseases, and as a member of the faculty at Johns Hopkins School of Medicine and the State University of New York at Buffalo. Dr. Carter is a Board-certified physician and author of more than 200 scientific articles, including the editing of various textbooks on anti-viral and immune therapy. Dr. Carter provided the following statement to Mr. Kellner: I am pleased to become Chairman of the Scientific Advisory Board under the board leadership of Ted Kellner and his nominees. Since my discovery of Ampligen™ (the major drug candidate of AIM) at Johns Hopkins Medical School/Hospital, numerous National Institutes of Health (NIH) multi-million dollar grants and contracts were awarded to various organizations under my leadership. The common theme of all of these major, highly competitive, financial awards is to achieve new potential treatments for devastating disorders, including cancer and serious allied disorders of immunity. While some promising results have been achieved, the goal of full commercialization has remained elusive under the current AIM leadership. The most important medical award this year (2024) - the Nobel Prize in Medicine – which was given to one of my previous post-doctoral students, provides real time evidence that this endeavor (RNA chemistry/clinical application) is an extremely important direction towards achieving rapid medical progress against devastating - presently untreatable - human illnesses. Thus, I know that the proposed new AIM board under your leadership, Ted, has the requisite talent to get AIM to the next level - commercialization. Several immediate steps which I believe I can help AIM in achieving include: 1: Restoring the previous excellent professional relationship with the Executive Office of the FDA Commissioner; 2: Restoring the previous excellent working relationships with the National Cancer Institute Director and Associate Directors; 3: Introducing the new AIM board and team to my historic clinical partnerships which have worked very effectively both in the U.S. as well as in Canada, Japan, and various European countries. I firmly believe that these restored, and new, relationships will lead to accelerated clinical trials directed towards Ampligen™ commercialization as well as to provide an important foundation of non-dilutive financing for the clinical tests. Overall, this new multifaceted clinical approach will lead to significantly accelerated clinical progress and commercialization under the leadership of the Kellner Group nominees. Ted Kellner issued the following statement in response to Dr. Carter’s agreement to serve as the Chair of the Scientific Advisory Board in the event that the Kellner Group Nominees control the Board of Directors of AIM following the upcoming annual meeting: The Kellner Group wishes to thank Dr. Carter for agreeing to help us with his deep and unquestioned expertise in Ampligen™ and its history. We believe together we can finally restart a focused clinical program. I have great confidence in Dr. Carter’s scientific record. With his help and the Kellner Group Nominees in control, I am committed to using my resources and network to make real progress towards value creation and commercialization. THE KELLNER GROUP URGES ALL STOCKHOLDERS TO VOTE ON THE GOLD PROXY CARDTODAY TO ELECTTED D. KELLNER, TODD DEUTSCH, ROBERT L. CHIOINI AND PAUL SWEENEY If you have any questions, require assistance in voting your GOLD proxy card, or need copies of the Kellner Group’s proxy materials, please contact Okapi Partners at the phone numbers or email address listed below. Please also visit https://okapivote.com/AIM/ for additional information. Contact: Okapi Partners LLC1212 Avenue of the Americas, 17th Floor,New York, New York 10036Stockholders may call toll-free: (844) 343-2621Banks and brokers call: (212) 297-0720Email: info@okapipartners.com Important Information and Participants in the Solicitation The Kellner Group has filed a definitive proxy statement and associated GOLD proxy card with the Securities and Exchange Commission (“SEC”) to be used to solicit votes for the election of its slate of highly-qualified director nominees at the upcoming annual meeting of stockholders of AIM. Details regarding the Kellner Group nominees are included in its proxy statement. THE KELLNER GROUP STRONGLY ADVISES ALL STOCKHOLDERS OF AIM TO READ THE PROXY STATEMENT AND OTHER PROXY MATERIALS AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Information regarding the identity of participants in the Kellner Group’s solicitation, and their direct or indirect interests, by security holdings or otherwise, is set forth in the Kellner Group’s proxy statement. Stockholders can obtain a copy of the proxy statement, and any amendments or supplements thereto and other documents filed by the Kellner Group with the SEC for no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the following website: https://www.okapivote.com/AIM. Investors can also contact Okapi Partners LLC at the telephone number or email address set for the above. As a result of Dr. Carter’s agreement to serve as Chair of AIM’s Scientific Advisory Board if the Kellner Group Nominees are elected and his agreement to be named and to include the text of his statement in this press release, he may be deemed a participant in the Kellner Group’s solicitation. Dr. Carter is retired and his principal address is 89501 Old Highway, Tavernier, Florida 33070-2144. Dr. Carter does not own any shares of AIM’s common stock. Additionally, (i) during the past ten (10) years, Dr. Carter has not been convicted in a criminal proceeding (excluding traffic violations or similar misdemeanors); (ii) he does not directly or indirectly beneficially own any securities of the Company; (iii) he does not own any securities of the Company of record but not beneficially; (iv) he has not purchased or sold any securities of the Company during the past two years; (v) as he does not own any of the Company’s securities beneficially or of record, no part of the purchase price or market value of the securities of the Company owned by her would be represented by funds borrowed or otherwise obtained for the purpose of acquiring or holding such securities; (vi) he is not, and has not been within the past year, a party to any contract, arrangement or understanding with any person with respect to any securities of the Company, including, but not limited to, joint ventures, loan or option arrangements, puts or calls, guarantees against loss or guarantees of profit, division of losses or profits, or the giving or withholding of proxies; (vii) no associate of his owns beneficially, directly or indirectly, any securities of the Company; (viii) he does not own beneficially, directly or indirectly, any securities of any parent or subsidiary of the Company; (ix) neither he nor any of his associates was a party to any transaction, or series of similar transactions, since the beginning of the Company’s last fiscal year, or is a party to any currently proposed transaction, or series of similar transactions, to which the Company or any of its subsidiaries was or is to be a party, in which the amount involved exceeds $120,000; (x) neither he nor any of his associates has any arrangement or understanding with any person with respect to any future employment by the Company or its affiliates, or with respect to any future transactions to which the Company or any of its affiliates will or may be a party; and (xi) he does not have a substantial interest, direct or indirect, by securities holdings or otherwise, in any matter to be acted on at the annual meeting of stockholders.

Executive ChangeDrug Approval

06 Dec 2024

·www.globenewswire.com

AIM ImmunoTech Participates in Virtual Investor KOL Connect Segment

Segment featuring Dr. Charles Lapp, ME/CFS Key Opinion Leader and founder of the Hunter-Hopkins Center is now available here OCALA, Fla., Dec. 06, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), today announced the release of a Virtual Investor KOL Connect segment featuring Dr. Charles Lapp, AIM’s Consulting Medical Officer. Dr. Lapp is also the founder of the Hunter-Hopkins Center in Charlotte, N.C., and a Key Opinion Leader who has been treating Chronic Fatigue Syndrome and Fibromyalgia for over 25 years. As part of the segment, Dr. Lapp discussed results from AIM’s Phase 2 study evaluating the efficacy and safety of Ampligen® as a potential therapeutic for people with the Post-COVID condition of fatigue (“AMP-518”; NCT05592418). The Virtual Investor KOL Connect Segment can be accessed here. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.

Phase 2

05 Dec 2024

·www.businesswire.com

ISS Recommends AIM ImmunoTech Shareholders Vote “FOR” Company Nominees Nancy K. Bryan and Dr. William M. Mitchell

OCALA, Fla.--( BUSINESS WIRE )--AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that independent proxy advisory firm Institutional Shareholder Services Inc. (“ISS”) has recommended that shareholders vote “FOR” Company nominees Nancy K. Bryan and Dr. William M. Mitchell at the upcoming 2024 Annual Meeting of Stockholders (the “Annual Meeting”), presently scheduled for December 17, 2024. In reaching its recommendation against giving the activist investors’ (the “Activist Group”) nominees control of the AIM Board of Directors (the “Board”), ISS noted the following: 1 “ …the [Activist Group] plan is limited, only one of its nominees has relevant life sciences expertise, and half of its slate has apparent ties to individuals with concerning backgrounds.” ISS flags specific concerns with Activist Group nominee Robert L. Chioini and recommends shareholders vote AGAINST Mr. Chioini and fellow nominee Todd A. Deutsch: “ Given Chioini's track record at [Rockwell Medical] and his connections to [securities law felons] Tudor and Xirinachs, he does not appear to be an appropriate choice for the AIM [B]oard.” Finally, ISS concludes that a solution along the lines of AIM’s settlement proposal to the Activist Group represents a reasonable compromise: “ Perhaps the [C]ompany's suggestion that the [B]oard be expanded with two or more additional independent directors mutually agreed by both sides would be the most logical solution.” Unfortunately, the Activist Group has consistently demanded upwards of $8 million in expense reimbursement for prior failed litigation in order to consummate a settlement agreement. AIM notes that ISS did not appear to take into account the extensive financial interconnections between Ted D. Kellner and Paul W. Sweeney that the Company had recently highlighted . It is essential that investors are aware of the following: In a glowing testimonial, Mr. Kellner proclaims himself as the “largest investor in almost every deal” 2 put together by PS Capital Partners , the private equity firm co-founded by Mr. Sweeney. The fact that Mr. Kellner is apparently the largest investor in almost all of Mr. Sweeney’s deals is not disclosed in the Activist Group’s definitive proxy statement , 3 preventing the Board and investors from making an informed decision about the Activist Group’s nominees. We believe this reflects the same pattern seen from the Activist Group in prior years – repeated attempts to obfuscate the group’s interconnections and mislead AIM shareholders . Dr. William M. Mitchell, Chairman of the Board, stated: “ We are grateful ISS recommended in favor of electing two of our nominees, Nancy Bryan and myself, while highlighting our leadership experience and expertise in the life sciences industry. In not recommending turning over control of the Board to the Activist Group, ISS notes that the Activist Group’s proposed plan for AIM is not sufficiently detailed and also takes into account the Activist Group’s connections to securities law felons. “ However, we disagree with several of ISS’s conclusions. First, AIM’s ability to garner government funding and industry grants for clinical trials is beneficial because it allows the Company to avoid paying out of pocket for these trials. That third parties such as Merck and AstraZeneca are willing to fund these clinical trials demonstrates that major industry organizations recognize Ampligen’s potential. “ Second, both Tom Equels and Stewart Appelrouth bring expertise to the Board that is critical to the success of AIM, and we strongly urge shareholders to vote for their reelection. As CEO, Mr. Equels has extensive familiarity with Ampligen. He was responsible for the focus on pancreatic ductal cancer and the initiation of the first clinical trial development in the Netherlands with no clinical trial cost to AIM. Definitive clinical trials are well underway and indicate the likelihood of proven efficacy in this high value, devastating cancer with limited treatment options. Moreover, Mr. Equels is an inventor of record for several patents assigned to AIM. These include (1) the combination of Ampligen with immune checkpoint inhibitors for the treatment of challenging cancers; (2) a novel method for the treatment of Chronic Fatigue Syndrome; and (3) methods and compositions for treating debilitating endometriosis, which affects a significant number of premenopausal women. Mr. Appelrouth is a nationally recognized forensic CPA who brings valuable financial and regulatory expertise to the boardroom. He serves as the essential function of financial expert for AIM’s audit committee. Both have helped drive the Company’s shift in focus towards high-value indications. “ We firmly believe the Board has the right experience and backgrounds to continue overseeing its strategy to create long-term value for patients and shareholders. Our Board members remain committed to supporting clinical development programs in areas with critical unmet needs, especially in the high-value pancreatic cancer space, to unlock the potential of Ampligen and deliver significant long-term value for all shareholders. “ We look forward to continuing to engage with AIM shareholders in advance of the Annual Meeting.” AIM encourages shareholders to vote “ FOR ” ALL four of the Board’s incumbent candidates – Stewart L. Appelrouth , Nancy K. Bryan , Thomas K. Equels and Dr. William M. Mitchell – in connection with the Annual Meeting, on the WHITE universal proxy card. For more information on how to vote, visit: www.SafeguardAIM.com . *** About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen ® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. For more information, please visit aimimmuno.com and connect with the Company on X , LinkedIn , and Facebook . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date does not guarantee that Ampligen will be approved as a treatment or therapy for any diseases or conditions. The Company urges investors to consider specifically the various risk factors identified in its most recent Annual Report on Form 10-K, and any risk factors or cautionary statements included in any subsequent Quarterly Report on Form 10-Q or Current Report on Form 8-K, filed with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Important Additional Information The Company, its directors and executive officers, Peter W. Rodino, III and Robert Dickey, IV, are deemed to be “participants” (as defined in Section 14(a) of the Securities Exchange Act of 1934, as amended) in the solicitation of proxies from the Company’s stockholders in connection with the Annual Meeting. The Company filed its definitive proxy statement (the “Definitive Proxy Statement”) and a WHITE universal proxy card with the SEC on November 4, 2024 in connection with such solicitation of proxies from the Company’s stockholders. STOCKHOLDERS OF THE COMPANY ARE STRONGLY ENCOURAGED TO READ SUCH DEFINITIVE PROXY STATEMENT, ACCOMPANYING WHITE UNIVERSAL PROXY CARD AND ALL OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY AS THEY CONTAIN IMPORTANT INFORMATION ABOUT THE ANNUAL MEETING. The Definitive Proxy Statement contains information regarding the identity of the participants, and their direct and indirect interests, by security holdings or otherwise, in the Company’s securities and can be found in the section titled “Principal Stockholders” of the Definitive Proxy Statement and available here . Information regarding subsequent changes to their holdings of the Company’s securities can be found in the SEC filings on Forms 3, 4, and 5, which are available on the Company’s website available here or through the SEC’s website at www.sec.gov . Stockholders will be able to obtain the Definitive Proxy Statement, any amendments or supplements thereto and other documents filed by the Company with the SEC at no charge at the SEC’s website at www.sec.gov . Copies will also be available at no charge at the Company’s website at https://aimimmuno.com/sec-filings/ . 1 Permission to quote ISS neither sought nor obtained. Emphasis added. 2 See PS Capital Partners’ Testimonials Page available at: https://pscapitalpartners.com/testimonials/ . 3 See Definitive Proxy Statement filed by the Activist Group with the U.S. Securities and Exchange Commission (the “SEC”) on November 6, 2024.

Executive Change

100 Deals associated with Rintatolimod

External Link

KEGG	Wiki	ATC	Drug Bank
D09661	Rintatolimod	L03A	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Fatigue Syndrome, Chronic	AR	AIM ImmunoTech, Inc.	01 Jan 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Pancreatic Adenocarcinoma	Phase 2	US	AIM ImmunoTech, Inc.	01 Dec 2024
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	NL	AIM ImmunoTech, Inc.	09 Jan 2024
Secondary malignant neoplasm of pancreas	Phase 2	NL	AIM ImmunoTech, Inc.	09 Jan 2024
Post Acute COVID 19 Syndrome	Phase 2	US	AIM ImmunoTech, Inc.	30 Jun 2023
Colorectal Cancer	Phase 2	-	AIM ImmunoTech, Inc.	11 Apr 2022
COVID-19	Phase 2	US	Roswell Park Comprehensive Cancer Center	17 Nov 2020
Hematologic Neoplasms	Phase 2	US	Roswell Park Comprehensive Cancer Center	17 Nov 2020
Malignant Solid Neoplasm	Phase 2	US	Roswell Park Comprehensive Cancer Center	17 Nov 2020
Adenocarcinoma of prostate	Phase 2	US	AIM ImmunoTech, Inc.	29 Nov 2019
Prostate Cancer, Hereditary, 7	Phase 2	US	AIM ImmunoTech, Inc.	29 Nov 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05592418 (AMP-518, Corporate Publications) Manual	Phase 2	Post Acute COVID 19 Syndrome	66	Ampligen	raylftlgcs(pptqobzddc) = between the Ampligen and placebo groups reached or approached statistical significance at several timepoints during the treatment phase. ykiqsxtbju (jxuqdhaesh ) View more	Positive	08 Feb 2024
NCT05592418 (AMP-518, Corporate Publications) Manual	Phase 2	Post Acute COVID 19 Syndrome	66	Placebo		Positive	08 Feb 2024
NCT03734692 (GlobeNewswire) Manual	Phase 2	Recurrent ovarian cancer	-	Ampligen+pembrolizumab	bhocrojadd(ejecyoddjm) = Longitudinal comparison of biomarkers in tumor microenvironment showed a gradual, durable response over time in T lymphotactic CXCR3 ligands and cytolytic factors nblofwpipb (ojuhwjrbuz )	Positive	08 Nov 2023
NCT04081389 (CTgov)	Phase 1	Triple Negative Breast Cancer \| Early Stage Breast Carcinoma	9	Interferon Alpha-2b (Arm 1: Interferon Alpha-2b at DL 1)	qhotwknfno(hzyjtspndm) = tcxccdzoyr dgmglswyaz (yeywlqmuud, kzqhwtpdzk - mbzlxjangn) View more	-	11 Sep 2023
NCT04081389 (CTgov)	Phase 1		9	Interferon Alpha-2b (Arm 2: Interferon Alpha-2b at DL 2)	qhotwknfno(hzyjtspndm) = ygqnlxljrh dgmglswyaz (yeywlqmuud, iikdsyttwm - ieghxeyudw) View more	-	11 Sep 2023
Corporate Publications Manual	Phase 1	-	40	Rintatolimod	hqhjayihdb(ksknacwbdp) = gyhraziglc wgjwqfnwmz (gjfukowgjf )	Positive	08 Dec 2022
Corporate Publications Manual	Phase 1	-	40	Placebo	hqhjayihdb(ksknacwbdp) = wwidqsmrec wgjwqfnwmz (gjfukowgjf )	Positive	08 Dec 2022
NCT04081389 (SITC2022) Manual	Phase 1	Triple Negative Breast Cancer ER Negative \| HER2 Negative \| PR Negative	9	celecoxib+interferon (IFN)-α2b+rintatolimod	aoqoofoxqe(nsadcgdwlp) = vfdayurbln judoqtpzcs (vsercixoia ) View more	Positive	01 Nov 2022
NCT03403634 (AACR2022) Manual	Phase 2	Colorectal Liver Metastases Microsatellite Stable (MSS)	12	celecoxib+IFNα2b IV+rintatolimod	xrjqrydkkk(buucbbftgq) = increased inuqlmfzmt (vkdkwggbgz ) Met View more	Positive	15 Jun 2022
NCT03599453 (AACR2022)	Early Phase 1	Metastatic Triple-Negative Breast Carcinoma	6	Systemic rintatolimod and interferon-α2b	lwejbqpokx(tsefrkzeom) = miiylnzbyk zlwwkrlzqj (kgleenfznn ) View more	-	15 Jun 2022
NCT03599453 (GlobeNewswire) Manual	Phase 1	Metastatic Triple-Negative Breast Carcinoma Triple Negative	6	IFN-2+Celecoxib+Ampligen+Pembrolizumab	mcrqafynhs(zfsqoixaci) = hdsmysguxy gdlahxenvz (tfoteynfbc ) View more	Positive	11 Apr 2022
NCT03734692 (Biospace) Manual	Phase 2	Ovarian Cancer	17	Cisplatin+Rintatolimod+Pembrolizumab	xkywmhlqpe(lsaujbyymn) = eaxvemwsjg clueaviycf (lrfbdvylvv ) View more	Positive	09 Mar 2022
Pubmed \| Cancers (Basel) Manual	Not Applicable	Pancreatic Cancer	81	FOLFIRINOX+Rintatolimod	tmqydsvwud(mljwydhnng) = omofwyjlja hccfnoaotm (qwnvrfabks ) View more	Positive	08 Mar 2022
Pubmed \| Cancers (Basel) Manual	Not Applicable	Pancreatic Cancer	81	FOLFIRINOX+Placebo	tmqydsvwud(mljwydhnng) = bnhybhuyda hccfnoaotm (qwnvrfabks ) View more	Positive	08 Mar 2022

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