Hepatocellular Carcinoma

“Fully Engaging The Human Immune System To Cure Disease,” Featuring CEO, Jeffrey MecklerRegistration now open at INDPMarch2024.TribePublic.com NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (NASDAQ: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announces that its CEO, Jeffrey Meckler, will present and participate in an open Q&A on Tribe Public’s Webinar titled, “Fully Engaging The Human Immune System To Cure Disease.” The event is scheduled to begin at 8:00am Pacific/11:00am Eastern on Wednesday, March 20, 2024. To register for the complimentary event, please visit Tribe Public’s website: INDPMarch2024.TribePublic.com. Once registered, participants may begin submitting their questions to research@tribepublic.com or share their questions via the ZOOM chat feature during the event. Tribe Public’s Managing Member, John F. Heerdink, Jr., will host the event and relay all questions to management.About Indaptus TherapeuticsIndaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy product candidates have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models. Please find more information at: www.indaptusrx.com.ABOUT TRIBE PUBLIC LLCTribe Public LLC is a San Francisco, CA based organization that hosts complimentary worldwide webinar & meeting events in the U.S. Tribe’s complimentary events focus on issues that the Tribe members care about with an emphasis on hosting management teams from publicly traded companies from all sectors & financial organizations that are seeking to increase awareness of their products, progress and plans. Tribe members primarily include Family Offices, Portfolio Managers, Registered Investment Advisors, Accredited Investors, Sell Side Analysts, and members of media. Tribe Members are encouraged to express their interest in speakers they care about and want to learn from at the Tribe Public website via the Tribe’s FREE “Wish List” process. Visit Tribe Public’s Website to learn more: http://www.tribepublic.com/Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things: our expectations and plans regarding our Phase 1 clinical trial of Decoy20, including the timing and design thereof; the anticipated effects of our product candidates, including Decoy20; the plans and objectives of management for future operations; our research and development activities and costs; the sufficiency of our cash and cash equivalents to fund our ongoing activities and our cash management strategy; and our assessment of financing options to support our corporate strategy. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to the following: our limited operating history; conditions and events that raise substantial doubt regarding our ability to continue as going concern; the need for, and our ability to raise, additional capital given our lack of current cash flow; our clinical and preclinical development, which involves a lengthy and expensive process with an uncertain outcome; our incurrence of significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability; our pursuit of a limited number of research programs, product candidates and specific indications and failure to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success; our ability to obtain and maintain regulatory approval of any product candidate; the market acceptance of our product candidates; our reliance on third parties to conduct our preclinical studies and clinical trials and perform other tasks; our reliance on third parties for the manufacture of our product candidates during clinical development; our ability to successfully commercialize Decoy20 or any future product candidates; our ability to obtain or maintain coverage and adequate reimbursement for our products; the impact of legislation and healthcare reform measures on our ability to obtain marketing approval for and commercialize Decoy20 and any future product candidates; product candidates of our competitors that may be approved faster, marketed more effectively, and better tolerated than our product candidates; our ability to adequately protect our proprietary or licensed technology in the marketplace; the impact of, and costs of complying with healthcare laws and regulations, and our failure to comply with such laws and regulations; information technology system failures, cyberattacks or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the caption “Risk Factors” included in our most recent Annual Report on Form 10-K filed with the SEC on March 13, 2024, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.Contact: investors@indaptusrx.comInvestor Relations Contact:CORE IRLouie Tomalouie@coreir.comMedia Contact:CORE IRJules Abrahamjulesa@coreir.com917-885-7378 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d4ab53c5-8aaa-474e-a0ea-f18365e9a1d5

Screening of subjects has begun at clinical study sitesThe Phase 2a study is being led by Principal Investigator, Dr. Stephen HarrisonAligos anticipates dosing the first subject in Q2 2024 with topline safety and efficacy data expected in Q4 2024 SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced the initiation of the Phase 2a HERALD study of ALG-055009 in subjects with metabolic dysfunction-associated steatohepatitis (MASH). Screening of subjects has begun at clinical study sites across the U.S. “ALG-055009 has enhanced potency, greater beta selectivity, and a favorable PK profile. We believe that these optimized pharmacologic properties may result in improved therapeutic outcomes for patients living with MASH. The initiation of the HERALD study is an important next step in achieving our goal to create a best-in-class thyroid hormone receptor beta agonist,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and CEO of Aligos Therapeutics. “This is an exciting time in the MASH space with the first drug recently approved, but we believe there is still a need for additional treatment options. We look forward to sharing topline HERALD data in Q4 this year.” The 12-week randomized, placebo-controlled trial will enroll 100 subjects with presumed MASH and liver fibrosis at stages 1-3 (F1-F3). Subjects will be randomized to receive one of four doses (0.3, 0.5, 0.7, 0.9 mg) of ALG-055009 or placebo (~20 subjects/arm) given orally once daily. In addition to collecting safety and pharmacokinetics (PK) data, this study will also assess multiple non-invasive biomarkers, which include Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) and other tests previously shown to be impacted by treatment with thyroid hormone receptor beta (THR-ß) agonists. Dosing is anticipated to begin in Q2 2024 and topline safety and efficacy data from this study is expected in Q4 2024. About ALG-055009ALG-055009 appears to be a best-in-class thyroid hormone receptor beta (THR-ß) agonist discovered by Aligos for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). ALG-055009 recently completed a Phase 1 first in human study, with preliminary data after single and multiple daily doses showing that ALG-055009 was well tolerated, had dose proportional pharmacokinetics (PK) and low variability, and demonstrated expected thyromimetic effects. Aligos has initiated the Phase 2a HERALD study of ALG-055009 to assess safety, PK, and multiple efficacy biomarkers such as Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF). Dosing is anticipated to begin in Q2 2024 and topline safety and efficacy data from this study is expected in Q4 2024. About MASHOne of the effects of improper diet and insufficient exercise is the accumulation of fatty deposits in the liver, referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), which was estimated to occur in approximately 30% of the worldwide population as of 2019. An estimated 1.5% to 6.5% of the global population is believed to have an ongoing inflammatory response to these excess fat deposits, which is referred to as metabolic dysfunction-associated steatohepatitis (MASH). In the United States alone, the prevalence of MASH is projected to increase from approximately 16.5 million in 2015 to 27.0 million in 2030. In the absence of changes in diet and exercise, the inflammation inherent in MASH persists and may result in progressive fibrosis of the liver, which may result in cirrhosis. These fibrotic changes are associated with numerous morbidities including recurrent hospitalization for complications of cirrhosis, hepatocellular carcinoma, need for liver transplant, and death. The first drug to treat this growing patient population, a THR-ß agonist, was recently approved for the treatment of MASH. About AligosAligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as chronic hepatitis B (CHB) and coronaviruses. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, the anticipation that the first subject will be dosed in the HERALD study in Q2 2024 with topline safety and efficacy data expected in Q4 2024 and the company looking forward to sharing such data in Q4 2024; the belief that the enhanced potency, greater beta selectivity, and favorable PK profile of ALG-055009 may result in improved therapeutic outcomes for patients living with MASH; the initiation of the HERALD study being an important step in achieving the goal of creating a best-in-class thyroid hormone receptor beta agonist; the belief that there is still a need for additional treatment options in the MASH space; and the estimation and projection of the prevalence of the MASH patient population. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, and the impact of global events and other macroeconomic conditions on the Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. CompanyJordyn TaraziVice President, Investor Relations & Corporate Communications(650) 910-0427jtarazi@Aligos.com MediaMichael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com

EMERYVILLE, Calif.--(BUSINESS WIRE)-- Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat cancer, today announced the advancement of its ARYA-3 clinical trial to Phase II (NCT04864054). This milestone represents one of the first engineered T-cell programs targeting solid tumors to reach Phase II. The ARYA-3 trial is evaluating Eureka’s investigational ARTEMIS® ECT204 T-cell therapy in adult patients with GPC3-positive advanced hepatocellular carcinoma (HCC), the predominant type of liver cancer. Glypican 3 (GPC3) is a promising target for HCC therapies and is found in more than 70% of HCC cells. The GPC3 protein is also expressed in other solid tumors, including ovarian and lung cancer. The ARYA-3 trial has successfully completed Phase I and is now enrolling patients in Phase II. During this phase, the treatment’s efficacy and safety are evaluated in a larger patient population, offering crucial insights into its potential therapeutic benefits. “We are excited by the favorable safety pro promising early efficacy signals in Phase I of our ARYA-3 study. Moving to Phase II marks a significant milestone in our mission to advance cutting-edge therapies for cancer treatment,” said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. “We remain committed to building a pipeline of next-generation T-cell therapy for solid tumors.” ARYA-3 is an Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy. In this study, a patient’s T cells are collected and genetically modified to express Eureka’s proprietary anti-GPC3 ARTEMIS T cell receptors (AbTCR). These modified T cells are then reintroduced into the patient to specifically seek out and destroy GPC3-expressing cancer cells. Eureka has previously demonstrated that its proprietary ARTEMIS T-cell receptor platform has several advantages over conventional chimeric antigen receptors (CARs), including better tumor infiltration, safety, and T cell persistence. The clinical trial is actively enrolling patients at both City of Hope and Kansas University Medical Center. Patients, caregivers and health care professionals interested in Eureka’s clinical trials and technology can find more information by visiting eurekaconnectme.com. ABOUT EUREKA THERAPEUTICS, INC. Eureka Therapeutics, Inc. is a privately held clinical-stage biotechnology company focused on developing novel T-cell therapies to treat cancers. Its core technology centers around its proprietary ARTEMIS® cell receptor platform and E-ALPHA® antibody discovery platform for the discovery and development of potentially safer and more effective T-cell therapies for the treatment of solid tumors and hematologic malignancies. The company currently has two clinical programs, ET140203 (ARYA-1 for adults and ARYA-2 for pediatrics) and ECT204 (ARYA-3), in Phase I/II US trials in patients with advanced liver cancer. Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information on Eureka, please visit . ARTEMIS and E-ALPHA are registered trademarks owned by Eureka.