INTERFERON ALFA-2B(Merck Sharp & Dohme )

SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, today announced that the first patient has been dosed with CX-801 monotherapy in a Phase 1 study (NCT06462794) in patients with solid tumors. CX-801 is a dually-masked interferon alpha-2b PROBODY® cytokine with potential broad applicability in both traditionally immune-oncology sensitive as well as insensitive (cold) tumors. The CX-801 Phase 1 dose escalation study is designed to evaluate safety and signs of clinical activity for CX-801 as monotherapy and in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab). In dose escalation, the Phase 1 study will enroll patients with select solid tumors including advanced melanoma, renal cell carcinoma, and head and neck squamous cell carcinoma to inform a potential decision to move into Phase 1b indication-specific dose expansion cohorts. “Interferon-alpha-2b is a powerful immune-modulating cytokine that has demonstrated clinical activity in multiple cancer types such as metastatic melanoma, renal cancer and bladder cancer but its clinical benefit has been limited by significant toxicities when administered systemically. CX-801 utilizes CytomX’s industry leading conditional activation platform to maintain potency and expand interferon’s therapeutic index to potentially become a foundational component of immuno-oncology combination regimens,” said Wayne Chu, M.D., chief medical officer of CytomX Therapeutics. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA About CytomX Therapeutics. CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY® therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-904, CX-2051 and CX-801. CX-904 is a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells. CX-904 is partnered with Amgen in a global co-development alliance. CX-2051 is a conditionally activated ADC directed toward epithelial cell adhesion molecule, EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CX-2051 was discovered in collaboration with Immunogen, now part of AbbVie. CX-801 is an interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter). CytomX Therapeutics Forward-Looking StatementsThis press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-801, CX-904, and CX-2051, the potential benefits or applications of CytomX’s PROBODY® therapeutic platform, CytomX’s or its collaborative partners’ ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-801, and the timing of initial and ongoing data availability for CX-801, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel PROBODY® therapeutic technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials, including initial CX-904 results, may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-904 CX-2051 and CX-801; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; possible regulatory developments in the United States and foreign countries; and the risk that we may incur higher costs than expected for research and development or unexpected costs and expenses. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on August 8, 2024. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc. Company Contact:Chris OgdenChief Financial Officercogden@cytomx.com Investor Contact:Precision AQ (formerly Stern Investor Relations)Stephanie Ascherstephanie.ascher@precisionaq.com Media Contact:Redhouse CommunicationsTeri Dahlmanteri@redhousecomms.com

Company’s priority oncology clinical programs continue to advance toward key milestones Additional clinical trial site now open at University of Nebraska for Phase 2 study of Ampligen® for the treatment of pancreatic cancer (AMP-270) Ongoing progress toward Phase 1 data in clinical development program of Ampligen for the treatment of early-stage triple negative breast cancer Significant findings from a new analysis support the potential to identify patients with LAPC that could respond better to Ampligen Company bolsters patent portfolio for Ampligen as a potential therapy against Ebola virus disease OCALA, Fla., June 12, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, today provided an update on its ongoing clinical development programs evaluating Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immune-modulator with broad spectrum activity. AIM Chief Executive Officer Thomas K. Equels commented, “We have made promising progress across multiple clinical fronts, and I am proud of the dedication of our team and their evident operational execution. Ampligen continues to demonstrate significant potential across multiple types of cancers, immune disorders and viral diseases. We are committed to advancing Ampligen’s development and are poised to achieve multiple key milestones in 2023.” Ampligen Phase 2 Study as a Therapy for Locally Advanced Pancreatic Cancer ("LAPC”) (AMP-270) The AMP-270 clinical trial is the Company’s randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe. The Company is recruiting patients for its AMP-270 Phase 2 study of Ampligen as a therapy for LAPC. The lead site at the University of Nebraska Medical Center is now open and actively working to enroll patients. The Gabrail Cancer & Research Center in Canton, Ohio is also recruiting patients. Kelsey Klute, MD, Medical Director of the Pancreatic Diseases Specialty Clinic at Nebraska Medicine, commented, “We are pleased to join into what we believe is an important Phase 2 study that has the potential to address a much-needed treatment option for LAPC. Our team is actively working to enroll and treat patients on the study in a joint effort with all other clinical trial sites. We are encouraged by the potential of Ampligen and look forward to further exploring its potential in the treatment of LAPC.” AIM continues its efforts to open additional clinical sites at premier cancer centers across the United States and Europe. The Company remains optimistic for first patient enrollment in the second quarter of this year. For more information about the AMP-270 please visit ClinicalTrials.gov and reference identifier NCT05494697. Ampligen Phase 1 Study for the Treatment of Early-Stage Triple Negative Breast Cancer (“TNBC”) Ampligen is currently being evaluated in a Phase 1 study for TNBC by Roswell Park Comprehensive Cancer Center. The study is designed to evaluate the safety and tolerability of a combination of Ampligen and celecoxib with or without Intron A, when given along with chemotherapy. The primary endpoint was safety and tolerability. Secondary endpoints included pCR rate. Tumor and blood biomarkers were analyzed in exploratory studies. The goal of this approach is to increase survival. In November 2022, Roswell presented positive data at the SITC 37th Annual Meeting demonstrating the chemokine-modulating regimen including Ampligen was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic). Roswell has now completed the study and is currently analyzing data. Based on current timelines, the Company anticipates Roswell will release — via publications — full study results before the end of the year. For more information about the Phase 1 study of Ampligen for the treatment of TNBC, visit ClinicalTrials.gov and reference identified NCT04081389. Ampligen Analysis Demonstrating Potential as a Maintenance Therapy After Systemic Chemotherapy in Patients with Metastatic and LAPC A new analysis was recently presented in an abstract titled, “Immune Response in Stable Pancreatic Cancer after Rintatolimod Treatment,” by Professor C.H.J. van Eijck, MD, PhD of Erasmus Medical Center at the 2023 Annual Pancreas Club Meeting held in Chicago, Illinois. Findings from the analysis demonstrated that treatment of patients with LAPC after FOLFIRINOX with Ampligen (rintatolimod) may induce markers of dendritic cells and T cells in a subgroup of patients. The absence of these markers may predict tumor progression after FOLFIRINOX, providing the future possibility of identifying pancreatic cancer patients who could potentially respond to Ampligen. The results from the new analysis build on the previously reported peer-reviewed article “Rintatolimod (Ampligen®) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program,” published in March 2022 in the journal Cancers. Ampligen as a Potential Therapy Against Ebola Virus Disease (“EVD”) The South African Patent and Trademark Office (CIPC) has granted patent No. 2022/01079, titled “Compositions and Methods Useful for Ebola Virus Infection.” This pioneering patent recognizes the efficacy of AIM’s tdsRNA drug family, of which Ampligen is a member, as a potential solution to combat the devastating impact of Ebola outbreaks. Under the newly granted patent, a composition comprising tdsRNA may be used in a method that involves administering the composition to a subject to prevent, treat, inhibit, or attenuate an Ebola virus infection in that subject. Significantly, the composition may be used as a treatment for individuals already infected with the Ebola virus, or the composition may be used to prevent an Ebola infection. About Ampligen Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies. Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Ampligen is being used to treat pancreatic cancer patients in an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in SARS-CoV-2/COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions. 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 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 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” 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. Among other things, for those statements, the Company claims the protection of 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. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.