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CAMBRIDGE, Mass., Feb. 26, 2024 /PRNewswire/ -- Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited committed to cutting-edge technology innovations and providing a total solution from "Idea to IND" ("I to ITM"), announced today that it has entered into a collaboration agreement with Boostimmune, a biotech company dedicated to developing next-generation anti-cancer therapies via modulating immune systems. The collaboration aims to leverage Nona's proprietary Harbour Mice® H2L2 (two light and two heavy chain) platform to accelerate the development of Antibody-Drug Conjugates (ADCs) against novel targets. Jingsong Wang, MD, PhD, Chairman of Nona Biosciences, expressed, "By leveraging our accumulated knowledge of ADC discovery and utilizing our advanced therapeutic antibody platforms validated by partners worldwide, this collaboration will expedite the development of first-in-class ADCs targeting cancer. Working alongside Boostimmune, we anticipate delivering transformative treatments, ultimately improving outcomes for all patients affected by cancer." Gwanghee Lee, Founder and CEO of Boostimmune, stated, "We are excited to collaborate with Nona Biosciences. Our strategic alignment of resources and knowledge will accelerate the development of ADC therapies against novel targets. Through this collaboration, we are confident in making significant strides in addressing the unmet needs of cancer patients." About Nona Biosciences Nona Biosciences (a wholly-owned subsidiary of HBM Holdings, HKEX: 02142) is a global biotechnology company committed to cutting-edge technology innovations and providing a total solution from "Idea to IND" ("I to ITM"), ranging from target validation and antibody discovery through preclinical research. The integrated antibody and antibody-related discovery services with multiple modalities range from antigen preparation, animal immunization, single B cell screening, to antibody lead generation and engineering, developability assessment and pharmacological evaluation, leveraging advantages of Harbour Mice® platforms and the experienced therapeutic antibody discovery team. Harbour Mice® generates fully human monoclonal antibodies in classical two light and two heavy chain (H2L2) format, and heavy chain only (HCAb) format. Integrating Harbour Mice® and a single B cell cloning platform, Nona Biosciences is focused on driving global inventions of transformative next-generation drugs. For more information, please visit: About Boostimmune Boostimmune is a biotech company developing innovative, first-in-class antibody-based therapies to address unmet needs in oncology. Its pipeline projects consist of naked monoclonal antibodies to modulate the tumor immune microenvironment, ADCs to novel targets with potential patient selection biomarkers and an ISAC (Immune Stimulator Antibody Conjugate) directly targeting immunosuppressive myeloid cells. Boostimmune was co-founded in 2021 by a world-class pioneering immunologist, Professor Tadatsugu Taniguchi at the University of Tokyo, who originally identified interferon beta, interleukin-2, and interferon regulatory factors (IRFs). SOURCE Nona Biosciences

Subsequent Phase Involves Completion of Chemistry, Manufacturing, and Controls (CMC) Information Ainos Intends to Submit Investigational New Drug Applications to the U.S. FDA for Multiple Candidates During the First Half of 2024 Candidates include HIV Oral Warts Orphan Drug, Sjogren's Syndrome, the Common Cold, and COVID-19 SAN DIEGO, CA / ACCESSWIRE / November 28, 2023 / Ainos, Inc. (NASDAQ: AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that its contract manufacturer, Swiss Pharmaceutical Co., Ltd. (Taiwan) ("Swiss Pharma"), has completed manufacturing of a Good Manufacturing Practice ("GMP") Clinical Batch of the Company's VELDONA® investigational new drugs. Mr. Chun-Hsien (Eddy) Tsai, Chairman, President and CEO of Ainos, commented, "This marks another important milestone for Ainos. We have been collaborating with Swiss Pharma since August 2022 with the ultimate goal of building a high-quality, cost-effective manufacturing solution for VELDONA®. This cooperation enables Ainos to advance our key programs so that we can facilitate delivery of high-quality, safe, and effective therapeutics to individuals seeking relief from immunity issues or viral infections." "Ainos has dedicated nearly four decades to the development of VELDONA®, accumulating a wealth of clinical data from 68 studies across 16 disease indications. Recognizing immunity as the root of many health issues, Ainos has developed VELDONA® to boost the immune response against disease and infection. Our team continues to explore these assets' latent values, including two drugs with U.S. FDA Orphan Drug Designation: oral warts in HIV-seropositive patients and Behçet's disease. We look forward to continuing our collaboration with Swiss Pharma as we advance our portfolio of VELDONA® product candidates." Swiss Pharma has conducted testing, manufacturing, and packaging of VELDONA®'s GMP Clinical Batch for Ainos under both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice ("PIC/S GMP") and the United States Food and Drug Administration's (the "U.S. FDA") Current Good Manufacturing Practice regulations. Following release of the GMP Clinical Batch by Swiss Pharma, Ainos intends to initiate the preparation of Chemistry, Manufacturing, and Controls ("CMC") information for submission of Investigational New Drug ("IND") applications for several programs. The Company will initially submit an IND application for conducting Phase II studies for treatment of mild COVID-19 symptoms during the first quarter of 2024. After this, Ainos intends to submit a number of additional IND applications during the first half of 2024, including Phase III studies for treatment of oral warts in HIV-seropositive patients (designated an orphan drug by the U.S. FDA), Phase III studies for Sjögren's syndrome, and Phase III studies for the common cold. "Type I interferon (IFN) has demonstrated immunomodulating effects and an ability to interfere with viral replication, making it potentially an effective antiviral agent. Our prior studies have demonstrated that VELDONA® could inhibit respiratory virus infections, including influenza and the common cold. Patients with severe and critical COVID-19 conditions seem to be affected by an impairment in type I IFN response (no IFN-beta and low IFN-alpha production and activity). We are investigating whether impaired type I IFN could be related to persistent high blood viral loads and inflammatory responses in COVID-19 cases." stated Mr. Albert Yu, Ph.D., Ainos' VP of Drug Development. Following promising results from preclinical studies of VELDONA® against COVID-19, Ainos is ready to initiate "A Multicenter, Randomized, Parallel, Phase II Study to Evaluate the Efficacy of VELDONA® in Patients with Mild COVID-19" in Taiwan. This study aims to evaluate the efficacy of VELDONA® in subjects presenting mild symptoms of COVID-19. Subjects will receive either a daily oral dose of VELDONA® or a standard of care (SoC) for a duration of five days, and will be evaluated throughout a 28-day study period. About Ainos, Inc. Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on the development of novel point-of-care testing ("POCT"), low-dose VELDONA® interferon therapeutics, and synthetic RNA-driven preventative medicine. The company's products include VELDONA® clinical-stage human therapeutics, VELDONA® Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women's health and certain common sexually transmitted infections ("STIs"). To learn more, visit . Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date. About Swiss Pharmaceutical Co., Ltd (Taiwan) Swiss Pharmaceutical was established in the 1950s with a mission to develop and manufacture quality pharmaceutical products. It operates with a commitment to continuous improvement and advancement. Headquartered in Tainan City, Taiwan, its facilities have been PIC/S GMP certified by the Taiwan Food and Drug Administration and inspected by the U.S. Food and Drug Administration. To learn more, visit . Forward Looking Statements This press release contains "forward-looking statements" about Ainos within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate", "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements. Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the planned drug treatments announced in this press release; the Company's dependence on projected revenues from the sale of COVID-19 test kits and its VELDONA® Pet line of supplements; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2022 and other reports filed with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's reports filed with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release. The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law. Investor Relations Contact ICR, LLC Robin Yang Tel: +1 646-224-6971 Email: Ainos.IR@icrinc.com SOURCE: Ainos, Inc. View source version on accesswire.com:

PT-112's mechanism of action inhibits ribosomal biogenesis, promoting immunogenic cancer cell death through cancer cell organelle stresses Data presented at the Society for Immunotherapy of Cancer's 38th Annual Meeting NEW YORK, Nov. 4, 2023 /PRNewswire/ -- Promontory Therapeutics Inc., a Phase 2 stage biotech company advancing immunogenic small molecule approaches in oncology, today presented data demonstrating the molecular mechanism of its lead therapeutic candidate, PT-112, and its ability to induce immunogenic cell death (ICD) in cancer cells. Data suggest that PT-112-induced ICD is mediated by endoplasmic reticulum (ER) and mitochondrial stresses, which are specific intra-cellular events that comprise part of the larger ICD mechanism. The presentation was made at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting, taking place November 1-5, 2023 in San Diego. The work was designed in collaboration with the Galluzzi Lab at Weill Cornell Medical College in New York, in order to elucidate the sequence of events – beginning with inhibition of ribosomal biogenesis and culminating in selective ICD – underlying PT-112's immune effects. Analyzing a panel of mouse cell lines engineered to lack specific genes involved in mitochondrial apoptosis (Bcl2, Bax and Bak1), flow cytometry, immunoblotting, RT-PCR, and immunofluorescence microscopy were used to determine the impact of PT-112 on ER and mitochondrial stress, as well as immunogenic signaling. "Our continued studies of PT-112 provide mechanistic insights for this promising immunogenic small molecule, which has shown clinical activity in patients with a variety of cancers," said Promontory Therapeutics Senior Vice President of Research and Development Tyler Ames, PhD. "This particular work sheds light on how PT-112 encourages the immunogenic cell death of cancerous cells through ER stress and mitochondrial dysfunction, both of which are known to contribute to immune signaling." Study findings include: PT-112 drives ER stress and mitochondrial dysfunction, which promote ICD. PT-112 effects on mitochondria included increases in mitochondrial mass and reactive oxygen species, changes in membrane polarization, and the release of mitochondrial DNA into the cytosol, a potent immunogenic signal. Some of these effects were impacted by the absence of Bax and Bak1. PT-112 elicits the phosphorylation of eukaryotic translation initiation factor 2 subunit alpha (EIF2S1, best known as eIF2α), indicating ER stress and the activation of the integrated stress response (ISR). There is an increase in the levels of Ifnb1 mRNA after PT-112 exposure, indicating PT-112 induces type 1 interferon responses. PT-112 is the subject of ongoing Phase 2 clinical trials for metastatic castrate-resistant prostate cancer and thymic epithelial tumors, and a completed Phase 2a trial in non-small cell lung cancer. In previous mechanism of action research, data showed that PT-112 causes ribosomal biogenesis inhibition and nucleolar stress, which is the likely driver of PT-112-induced cancer organelle stresses and ICD. For more information about Promontory Therapeutics and PT-112, visit . About PT-112 PT-112 is a novel inhibitor of ribosomal biogenesis, which leads to selective immunogenic cancer cell death (ICD). PT-112's mechanism of action governs intracellular events that cause the release of damage associated molecular patterns, known to bind to dendritic cell and natural killer cell receptors, prompting an anti-cancer immune response. PT-112's potential best-in-class ICD effects may create the conditions for effective and durable responses to treatment. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and data were published in eClinicalMedicine, part of The Lancet. The company's Phase 2 study of PT-112 in late-stage metastatic castration-resistant prostate cancer patients is underway in the United States and France. An active Phase 2 trial is also on-going with the National Cancer Institute utilizing PT-112 in thymic epithelial tumors, a rare disease with no FDA approved drug, for which PT-112 has received FDA Orphan Drug designation. An additional Phase 2a study has been successfully completed for non-small cell lung cancer in combination with PD-L1 inhibition. About Promontory Therapeutics Promontory Therapeutics Inc. is a privately held, clinical stage drug development company focused on small molecule immunotherapy in cancer. The company's lead therapeutic candidate PT-112 has demonstrated single-agent and combination anti-cancer activity and an attractive tolerability profile across three Phase 1 studies. PT-112 is the subject of ongoing Phase 2 clinical trials for metastatic castration-resistant prostate cancer in the United States and France, thymic epithelial tumors with the National Cancer Institute, and a completed Phase 2a trial in non-small cell lung cancer. As part of its recent research and development expansion into France, Promontory was selected as the first international company member of the Paris-Saclay Cancer Cluster, Europe's emerging biotech hub for oncology. To learn more about Promontory Therapeutics, visit the company's website here. CONTACTS: Promontory Therapeutics: Brooke Raphael, MS VP, Strategy & Operations Tel: +1 (646) 974-6453 Email: [email protected] Investors: Stan Musial Chief Financial Officer Tel: +1 (646) 222-6932 Email: [email protected] Media: Alexis Feinberg ICR Westwicke Tel: +1 (203) 939-2225 Email: [email protected] SOURCE Promontory Therapeutics Inc.