Tillkännagivande • May 15
Sapu Nano And Oncotelic Therapeutics, Inc. Announce First Patient Dosed In Phase 1b Trial Of Sapu003, An Intravenous Deciparticle Formulation Of Everolimus Sapu Nano and Oncotelic Therapeutics, Inc. announced that the first patient has been dosed in the Phase 1b clinical trial of Sapu003, the Company’s investigational intravenous Deciparticle formulation of everolimus. The trial: SP-03-B101- Sapu003 in Patients with Advanced mTOR-sensitive Solid Tumors, (NCT07369505), is a Phase 1b, open-label, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. The investigational product is administered intravenously over 30 minutes once weekly in 4-week cycles. The study includes two cohort patients. Cohort A enrolls patients with HR-positive/HER2-negative breast cancer, receiving Sapu003 in combination with aromatase inhibitor and Cohort B enrolls patients with renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, or hepatocellular carcinoma, receiving Sapu003 as monotherapy. Dose escalation follows a Bayesian Optimal Interval design, with planned dose levels of 5 mg/m², 7.5 mg/m², and 10 mg/m², and an optional lower dose cohort of 3.5 mg/m² if required for safety. Sapu003 was designed to re-engineer everolimus, as a weekly IV Deciparticle formulation, with the goal of improving exposure control and expanding the therapeutic potential of mTOR inhibition. The Sapu003 program has also been featured at the 2025 San Antonio Breast Cancer Symposium, held December 9–12, 2025. The Sapu003 program is being developed in collaboration with Southern Oncology Clinical Research Unit, iNGENu CRO, and Shanghai Medicilon, supporting the clinical, translational, pharmacokinetic, and manufacturing development of Sapu003. Tillkännagivande • May 03
Oncotelic Therapeutics Advances Toward Commercial Launch of Ai-Enabled Robotics Platform Oncotelic Therapeutics, Inc. provided an update on the continued advancement of its proprietary AI platform and robotics integration as it approaches initial commercial deployment. Following the successful integration of approximately 28 million scientific abstracts - representing the totality of scientific knowledge - into its PDAOAI platform, the Company has achieved another milestone to enable real-time application within its jointly developed robotics platform with TechForce Robotics. This integration allows scientific knowledge to be directly embedded into automated workflows operating in regulated environments. The combined platform is designed to improve operational efficiency, reduce reliance on manual processes, and support compliance across pharmaceutical development and manufacturing. Initial deployments are expected in the coming weeks. The Company is also preparing to scale production capabilities to support anticipated demand as it advances toward broader commercialization. Tillkännagivande • Apr 01
Oncotelic Therapeutics, Inc. announced delayed annual 10-K filing On 03/31/2026, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Tillkännagivande • Mar 25
Oncotelic Therapeutics, Inc.'s Sapu Nano Launches Deciparticle Platform and Presents Clinical Pipeline Oncotelic Therapeutics, Inc. announced that its subsidiary Sapu Nano will formally introduce its Deciparticle nanomedicine platform and present its advancing clinical pipeline at BIO-Europe Spring 2026, where the company has been selected as a Presenting Company. The presentation will take place at Event: BIO-Europe Spring 2026, Session: Presenting Company, Location: Theater A, Date: March 25, 2026. During the session, Sapu Nano will unveil its proprietary Deciparticle platform, a next-generation drug delivery technology engineered to optimize tissue distribution, enhance therapeutic index, and enable intravenous delivery of highly hydrophobic oncology agents. The company will highlight two lead clinical candidates: Sapu003 (Everolimus for Injection), Intravenous formulation of everolimus, Designed to overcome limitations of oral exposure and tissue variability, Currently in Phase 1 clinical trials; Sapu006 (Docetaxel for Injection), Advanced formulation of docetaxel leveraging Deciparticle technology, Aimed at improving safety and efficacy versus conventional docetaxel formulations, Entering Phase 1 clinical trials. The presentation will emphasize Platform-level advantages of Deciparticle in sub-20 nm nanomedicine design, Improved pharmacokinetics and tissue targeting capabilities, Reduction of formulation-related toxicities associated with conventional excipients, Broad applicability across multiple hydrophobic drug classes. BIO-Europe Spring is one of the premier global partnering conferences for the life sciences industry, bringing together biotechnology, pharmaceutical, and investment leaders to foster strategic collaborations and advance innovative therapeutics. Sapu Nano is actively seeking strategic partnerships, co-development opportunities, and regional collaborations to accelerate the clinical development and commercialization of its Deciparticle pipeline. Tillkännagivande • Dec 16
Oncotelic Therapeutics and Brush and Key Foundation Announce Publication in International Journal of Molecular Sciences Highlighting Context-Dependent Biomarkers in Liver and Pancreatic Cancer Oncotelic Therapeutics, Inc. in collaboration with the Brush and Key Foundation,announced the publication of a peer-reviewed research article in the International Journal of Molecular Sciences titled “Comparative Tumor Microenvironment Analysis for HCC and PDAC Using KMplotter.” Chang, W.-H.; Shah, D.; Myers, S.; Potts, M.; Qazi, S.; Trieu, V. International Journal of Molecular Sciences2025, 26, 11920. The study presents a comprehensive, data-driven analysis of two emerging biomarkers—DNMT3A (DNA methyltransferase 3A) and GMPS (guanine monophosphate synthetase)—across hepatocellular carcinoma (HCC) and pancreatic ductal adenocarcinoma (PDAC). By integrating survival outcomes, transcriptomic profiling, and tumor microenvironment (TME) analyses from more than 7,000 patients, the authors demonstrate that the prognostic significance of these biomarkers is highly context-dependent, shaped by immune composition, metabolic reprogramming, and innate immune sensing pathways. The publication also reflects the educational mission of the Brush and Key Foundation, which supports young scholars through mentored research experiences that bridge scientific inquiry, critical thinking, and professional development. Tillkännagivande • Dec 03
Oncotelic and Sapu Nano Unveils Broad-Appointment of Broad-Appointment of Sapu Nano Nanomedicine Platform Capable of Formulating Multiple Hydrophobic Peptide, Macrolide, and Polyketide Drugs Oncotelic Therapeutics, Inc. announced new data demonstrating that its proprietary Deciparticle™? platform enables broad and consistent formulation of structurally diverse hydrophobic therapeutics--including macrolide mTOR inhibitors, cyclic peptides, linear peptides, ascomycin macrolactams, and polyketides-- while maintaining a precise sub-20 nm nanoparticle profile suitable for intravenous (IV) delivery. Tillkännagivande • Nov 15
Oncotelic Therapeutics, Inc. announced delayed 10-Q filing On 11/14/2025, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Oct 10
Sapu Nano Unveils First-In-Human Clinical Trial of Sapu-003 at 8th Australian Translational Breast Cancer Research Symposium Sapu Nano announced the presentation of its poster, "Sapu-003: Novel Intravenous Deciparticle™? Everolimus Entering Phase 1 Study in Australia," at the 8th Australian Translational Breast Cancer Research Symposium (ATBCR 2025). Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics Inc. and Dragon Overseas Capital Limited. Sapu-003 is the first intravenous (IV) Deciparticle™? formulation of everolimus, an mTOR inhibitor widely used in oncology. While oral everolimus (Afinitor®?) has demonstrated efficacy in breast cancer, renal cell carcinoma, and neuroendocrine tumors, its broader use has been constrained by low bioavailability, variable systemic exposure, and gastrointestinal toxicities. The trial is being conducted in collaboration with SOCRU, a leading Phase 1 clinical unit in Australia; Inenu, a clinical research organization with deep early-phase expertise; and Medicilon, Sapu Nano's strategic partner for preclinical drug development. Together, these partnerships ensure robust clinical execution, regulatory alignment, and high-quality product supply for the study. The trial (ACTRN12625001083482) is now open for enrollment at leading oncology centers across Australia. Eligible participants include adults with advanced HR+/HER2- breast cancer or other mTOR-sensitive tumors who have exhausted standard therapies. Physicians are encouraged to refer patients who may benefit from participation. Tillkännagivande • Sep 24
Sapu Nano's Sapu003 Advances to Human Clinical Testing - Transforming Everolimus Delivery with Full Bio Availability for Breast Cancer Patients Sapu Nano announced that it has received approval from Australia's Human Research Ethics Committee (HREC) to begin enrolling patients in a Phase 1 human clinical trial of Sapu003--an injectable form of Everolimus--for the treatment of breast cancer. Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. and Dragon Overseas Capital Limited. Everolimus is already an FDA-approved drug (sold under the brand name Afinitor®?) for various cancers, including advanced breast cancer, kidney cancer, and certain rare tumors. However, in oral pill form, only about 10% of the drug is absorbed by the body, which limits how effective it can be. Using Sapu Nano's proprietary Deciparticle™? technology, Sapu003 is delivered intravenously (by injection), which allows 100% of the drug to reach the bloodstream. Preclinical studies suggest this approach could be more effective than the current oral version. Put simply, Sapu003 is a new way of giving an existing cancer drug so it works better. The pill form doesn't get fully absorbed, only about 10% makes it into the body. By delivering it as an injection, researchers can deliver the medicine at full strength, which could make it more effective at shrinking tumors. This first trial is the starting point to see if this improved version can give breast cancer patients longer-lasting benefits and new hope. Tillkännagivande • Sep 13
Oncotelic Therapeutics Highlights 2 Years of Clinical and Regulatory Advancements Across Late-Stage Pipeline Oncotelic Therapeutics, Inc. announced a summary of its major accomplishments over the past two years. These milestones underscore meaningful clinical progress and regulatory validation across the Company's lead drug candidates. Oncotelic's pipeline includes multiple late-stage programs targeting oncology and rare diseases, with several drug candidates achieving significant clinical milestones. Two-Year Clinical Progress Snapshot: OT-101 (TGF-b inhibitor): Phase 3 for pancreatic cancer, with additional applications in ARDS/COVID-19; OXi4503 (vascular disrupting agent): Phase 2 in AML/MDS; advancing toward pivotal phase 3 design; CA4P /Fosbretabulin: Late-stage oncology asset currently under repositioning; AL-101 (intranasal apomorphine): Phase 2 for Parkinson's disease and sexual dysfunctions; AL-102 (oligonucleotide antisense via intrathecal injection): Discovery stage for Alzheimer's disease; Pediatric Rare Disease Programs: Targeting orphan indications with the potential to generate Priority Review Vouchers (PRVs); Nanomedicine Pipeline: Advancing multiple 505(b)(2) drug candidates into clinical testing, leveraging the 505(b)(2) pathway--a faster and more cost-efficient route to market approval compared to a full New Drug Application (NDA). Tillkännagivande • Sep 05
Oncotelic Therapeutics, Inc. Provides Update on Its Clinical Pipeline Oncotelic Therapeutics, Inc. shares an update on its clinical pipeline and highlights the invaluable contributions of its Chairman and CEO Dr. Vuong Trieu, who is recognized worldwide for his extraordinary intellectual property portfolio and impact on the biopharma industry. Dr. Trieu is a prolific industry pioneer with over 500 filed patents and 75 issued patents covering biologics, small molecules, nanoparticles, diagnostics. Over his career he has invented, co-invented, and developed multiple novel therapeutics that have advanced to U.S. Food and Drug Administration approval or late-stage development. Most notably, Dr. Trieu co-invented and developed Abraxane®? (nab-paclitaxel), acquired by Celgene in 2010 as part of a $2.9 billion transaction. He later developed and sold Cynviloq™? (nanoparticle paclitaxel) to NantPharma in 2015 in a deal valued at $1.3 billion. His career contributions extend across oncology, cardiovascular, reproductive, infectious-disease, neuro-critical-care, aging, and rare diseases, with a consistent focus on delivering first-in-class therapeutics to address high unmet medical needs. OT-101 (TGF-b inhibitor): Phase 3 for pancreatic cancer, with additional applications in ARDS/COVID-19; OXi4503 (vascular disrupting agent): Phase 2 in AML/MDS; advancing toward pivotal phase 3 design; CA4P /Fosbretabulin: Late-stage oncology asset currently under repositioning; AL-101 (intranasal apomorphine): Phase 2 for Parkinson's disease and Sexual Dysfunctions; AL-102 (oligonucleotide antisense via intrathecal injection): Discovery stage for Alzheimer's disease; Pediatric Rare Disease Programs: Targeting orphan indications with the potential to generate Priority Review Vouchers (PRVs). Dr. Trieu's innovations form the cornerstone of OTLC's intellectual property portfolio, reinforcing the Company's strategy of building value through differentiated biotechnology assets with strong competitive barriers. Tillkännagivande • Jul 17
Oncotelic Therapeutics, Inc. Highlights Peer-Reviewed Publication Linking TGFB2 to Survival in Younger Pancreatic Cancer Patients Oncotelic Therapeutics, Inc. highlighted the publication of new translational research evaluating TGFB2 expression and promoter methylation as potential prognostic markers in pancreatic ductal adenocarcinoma (PDAC). The article, “TGFB2 Expression and Methylation Predict Overall Survival in Pancreatic Ductal Adenocarcinoma Patients,” appears in the International Journal of Molecular Sciences (IJMS). The work involved investigators affiliated with Sapu Biosciences, LLC (“Sapu”), a wholly owned subsidiary of GMP Biotechnology Limited (“GMP Bio”), of which Oncotelic holds a 45% ownership interest.†Access the publication: DOI 10.3390/ijms26136357 (open access via IJMS).Study Highlights Clinical data from the OT-101 P001 PDAC study suggest that targeting TGFB2 merits additional evaluation in younger patients; in a treated subset characterized by low IL-6, median OS was 12.7 months. Tillkännagivande • Jun 25
Oncotelic Therapeutics, Inc. Announces Publication of Landmark Study on TGFB2 Gene Methylation as A Positive Prognostic Marker in Pancreatic Cancer Oncotelic Therapeutics, Inc. announced the publication of a peer-reviewed research article highlighting TGFB2 gene methylation as a positive prognostic biomarker for pancreatic ductal adenocarcinoma (PDAC). The paper, published in collaboration with Sapu Biosciences, LLC ("Sapu"), a wholly owned subsidiary of GMP Biotechnology Limited ("GMP Bio"), in which Oncotelic owns a 45% stake, appears in the journal International Journal of Molecular Sciences and is entitled: TGFB2 Gene Methylation in Tumors with Low CD8+ T-Cell Infiltration Drives Positive Prognostic Overall Survival responses in Pancreatic Ductal Adenocarcinoma. The study was co-authored by Dr. Sanjive Qazi, Dr. Michael Potts, Scott Myers, Dr. Stephen Richardson, and Dr. Vuong Trieu. The data suggest that TGFB2 methylation is a favorable prognostic indicator and may inform patient stratification for therapies targeting TGFB2 mRNA--such as OT-101, Oncotelic's investigational antisense oligonucleotide. In addition, the study underscores the importance of profiling TGFB1, TGFB2, and TGFB3 methylation to better characterize tumor immune status and select candidates for immunotherapy in otherwise resistant " cold" tumors. Tillkännagivande • Apr 01
Oncotelic Therapeutics, Inc. announced delayed annual 10-K filing On 03/31/2025, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Tillkännagivande • Mar 25
Oncotelic Therapeutics, Inc. Announces Successful Completion of Phase 1 Trial of OT-101 and IL-2 Oncotelic Therapeutics, Inc. announced the successful completion of a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101,an antisense therapeutic targeting Transforming Growth Factor Beta 2 (TGFb2), with checkpoint inhibitors ("CKIs") and recombinant IL-2 (aldesleukin) ("IL-2"). The announcement coincides with a presentation delivered by Vuong Trieu, Ph.D., Chairman & CEO of Oncotelic, at the 5th Symposium on World Cancer Research (SWCR) 2025. TGFb2's Central role in Cancer and Beyond: Dr. Trieu presented evidence that TGFb2 is a critical driver of immunosuppression, fueling tumor progression by promoting an M2-like macrophage phenotype and blunting antitumor immunity. OT-101's Clinical Progress and Versatility: In pancreatic ductal adenocarcinoma (PDAC), OT-101 is currently in a Phase 3 clinical trial (the STOP-PC study) combined with mFOLFIRINOX. OT-101 has shown encouraging activity in gliomas, where high intratumoral TGFb2 expression correlates with poor prognosis. Next Studies Targeting TGFb2 and Beyond: With the newly completed OT-101 and IL-2 Phase 1 trial, Oncotelic is poised to begin further combination trials to determine the added efficacy of OT-101, IL-2, and CKIs in solid tumors such as lung cancer, melanoma, and colorectal cancer. Next wave of clinical trials aiming to knock down TGF b2 (e.g., with OT-101) paired with intervention with a complementary therapy, checkpoint blockade, IL-2, interferon-based regimens, or standard-of-care chemotherapy, depending on the tumor indication. Tillkännagivande • Jan 01
Oncotelic Therapeutics, Inc. Implements PDAOAI Platform Oncotelic Therapeutics, Inc. announced the implementation of its artificial intelligence (AI) platform PDAOAI. The platform is designed to streamline document search and analysis, to address the growing needs of knowledge-based industries including pharmaceutical and biotechnology. The company have been enhancing the capabilities of the platform over the past one year. The platform will be accessible via PDAO tokens, which the Company initially released to eligible shareholders in 2023. This search platform transforms how users navigate large document sets by enabling precise, parallel queries across structured datasets. It leverages advanced semantic filtering and large language model (LLM)-based contextual answering, built on patent-pending technology. Traditional AI chatbots often rely on broad, global search methods, which can lead to issues like dilution and bias. In contrast, this platform queries individual documents to deliver crisp, precise answers drawn from vast collections, including tens of thousands of scientific articles or enterprise-level knowledge bases. This method is intended to scale to support infinite documents, delivering precision-driven, fine-grained responses. PDAOAI is designed for enterprise users and scientists, currently with a particular emphasis on the biotechnology industry. Sapu Bioscience, LLC, a wholly owned subsidiary of GMP Biotechnology, Limited, in which the company is a 45% owner, leveraged PDAOAI to train staff and implement standard operating procedures (SOPs) enabling the facility to achieve GMP compliance within one year. This knowledge platform accelerated employee development from entry level to a very high level proficiency in record time. The platform will be governed through decentralized autonomous organization (DAO), Pet2DAO, using the PDAO token. This decentralized structure ensures transparent decision-making, community-driven governance, and eliminates reliance on centralized authorities for managing platform resources. Tillkännagivande • Nov 15
Oncotelic Therapeutics, Inc. announced delayed 10-Q filing On 11/14/2024, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Apr 02
Oncotelic Therapeutics, Inc. announced delayed annual 10-K filing On 04/01/2024, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Tillkännagivande • Mar 27
Oncotelic Therapeutics, Inc. Announces Linkage of Cancer and Lupus in Gliomas Patients Oncotelic Therapeutics, Inc. announced the peer reviewed publication of Transforming Growth Factor Beta 2 (TGFB2) mRNA Levels, in Conjunction with Interferon-Gamma Receptor Activation of Interferon Regulatory Factor 5 (IRF5) and Expression of CD276/B7-H3, Are Therapeutically Targetable Negative Prognostic Markers in Low-Grade Gliomas: Past, Present, and Future Strategies in the Treatment and Management of Gliomas. Understanding the role of IRF5 in both SLE and cancer opens an avenue for targeting IRF5 or its downstream pathways. This could offer new strategies for treating SLE and various cancers by modulating the immune response. Tillkännagivande • Aug 17
Oncotelic Therapeutics, Inc. announced delayed 10-Q filing On 08/15/2023, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • May 16
Oncotelic Therapeutics, Inc. announced delayed 10-Q filing On 05/15/2023, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Feb 07
Oncotelic Announces Initiation of Clinical Study in Non-Small Lung Cell Cancer Oncotelic Therapeutics, Inc. announced the initiation of its second investigator initiated studies (IIS) in a series of planned clinical studies. The company have submitted to US FDA a protocol for the study with approximately 30 patients with non-small cell lung cancer in collaboration with the Fred Hutchinson Cancer Center and a large pharmaceutical company in the field of immuno-oncology (IO). The study will be combining oligodeoxynucleotide OT-101 and a US FDA approved anti-PD-L1 checkpoint inhibitor. Near term, the Company is planning to initiate up to 7 clinical studies in various oncology indications along with ‘Centers of Excellence’ and major pharmaceutical companies. The first trial as noted in a prior press release is planned to be in patients with metastatic pleural mesothelioma. All studies will be assessing the tumor response to various combination studies assessing pre and post therapeutic biopsies measuring close to 800 genes, changes in phenotype and functionality, cytokines, suppressive immune cells; and their spatial distribution within the tumor. Tillkännagivande • Jan 26
Oncotelic Therapeutics, Inc. Initiates Clinical Trials Evaluating OT-101 against Metastatic Pancreatic Cancer ncotelic Therapeutics, Inc. announced that it has submitted a clinical study protocol to the US Food and Drug Administration (“FDA”) for the initiation of a Phase 2b/3 Trial (designated "P201") for OT-101, the Company's transforming growth factor beta 2 (“TGF-ß2”) inhibitor, as a treatment for metastatic pancreatic cancer. P201: A Randomized Phase 2b/Phase 3 Study of the TGF-ß2 Targeting Antisense Oligonucleotide OT-101 in Combination with FOLFOX Compared with FOLFOX Alone as Second-Line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine-Containing Regimen. OT-101 is a first-in-class anti-TGF-ß2 ribonucleic acid ("RNA") therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the COVID-19 virus in Phase 2 clinical trial- C001. About OT-101: OT-101, is a first-in-class anti-TGF-ß2 RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. HGGs are characterized by a T-cell exhaustion signature and pronounced T-cell hypo responsiveness of their tumor microenvironment (“TME”). TGF-ß2 has been implicated as a key contributor to the immunosuppressive landscape of the TME in HGG. OT-101 is designed to abrogate the immunosuppressive actions of TGF- ß2. In a completed Phase 2 clinical study, OT-101 exhibited clinically meaningful single-agent activity and induced durable complete and partial responses in recurrent and refractory adult HGG patients, including young adults with Glioblastoma Multiforme or Amyloidosis. OT-101 has been granted orphan designation by the FDA under the Orphan Drug Act (“ODA”). ODA provides for granting special status to a drug to treat a rare disease or condition upon request of a drug company. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. OT-101 also been granted Rare Pediatric Designation for DIPG. The FDA grants rare pediatric disease designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S. Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application or biologics license application for a product for the prevention or treatment of a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain priority review for any subsequent marketing application and may be sold or transferred. As previously reported, on March 31, 2022, Company entered into a joint venture, or JV, with Dragon Overseas Capital Ltd. (Dragon Overseas) and GMP Biotechnology Ltd. (GMP Bio). The JV and Oncotelic will develop and ultimately market OT-101, individually and/or in combination with other products. Oncotelic would receive up to $50 million on sale of the RPD voucher, following marketing approval of OT-101 for diffuse intrinsic pontine glioma, or DIPG, by the US Food and Drug Administration. Tillkännagivande • Dec 20
Oncotelic Therapeutics, Inc. Presents Clinical Data of Confirming TGF-BETA>2 as the Appropriate Target for Gliomas At JCA-AACR Meeting 2022 Oncotelic Therapeutics, Inc. announced it presented new clinical confirming TGF-ß2 as the appropriate target for gliomas at the 12th AACR-JCA Joint Conference: Breakthroughs in Cancer Research- Translating Knowledge into Practice December 10 - 14, 2022, Maui, Hawaii. TGF- ß consists of three highly similar isoforms: ß1, ß2, ß3; Retrospective analysis TCGA database demonstrated that high TGF-ß2, but not TGF-ß1 nor TGF-ß3, is prognostic indicator for worse OS. Reduced TGF-ß2 in Pediatric Brainstem Patients increased OS from 9 mos to 22 mos, N=95 pts, p<0.0001. Reduced TGF-ß2 in Gliomas patients treated with TMZ increased OS from 25 mos to 94 mos, N=230 pts, p<0.0001. Reduced TGF-ß2 in Gliomas patients treated with Radiation increased OS from 25 mos to 94 mos, N=293 pts, p<0.0001. Tillkännagivande • Nov 15
Oncotelic Therapeutics, Inc. announced delayed 10-Q filing On 11/14/2022, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Nov 09
Oncotelic Initiates Clinical Trials Evaluating OT-101 Against Pediatric Gliomas Oncotelic Therapeutics, Inc. announced that it has submitted a clinical study protocol to the US Food and Drug Administration (“FDA”) for the initiation of a Phase 1 Trial (designated "G101") for OT-101, the Company's transforming growth factor beta 2 (“TGF-ß2”) inhibitor, as a treatment for patients with recurrent/relapsed DMG. G101: An Open-label Dose Escalation Study to Evaluate the Safety and Tolerability of Repeated Cycles of OT-101 in Pediatric Diffuse Midline Glioma (“DMG”) Patients, Administered Intraventricularly. OT-101 is a first-in-class anti-TGF-ß2 ribonucleic acid ("RNA") therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the COVID-19 virus in Phase 2 clinical trial- C001. Tillkännagivande • Aug 16
Oncotelic Therapeutics, Inc. announced delayed 10-Q filing On 08/15/2022, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • May 26
Oncotelic Therapeutics Receives FDA Clearance for Phase 2 Clinical Trial of OT-101/Pembroluzimab Combination for Mesothelioma (M201) Oncotelic Therapeutics, Inc. announced the clearance of the Phase 2 clinical trial protocol for mesothelioma after filing the protocol to the Food and Drug Administration. Oncotelic is initiating a Phase 2 Investigator Initiated Study (IIS) clinical trial in patients with metastatic plural mesothelioma (MPM) in collaboration with Merck who is supplying pembrolizumab for the study. The trial is titled M201: Phase 2 Trial of TGF-ß Inhibition (OT-101) with Anti-PD-1 (pembrolizumab) in Patients with Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition. The trial is expected to enroll up to 63 patients across multiple centers in the U.S., including the center with the Principal Investigator - Melina Marmarelis, MD MSCE, Assistant Professor, Perelman School of Medicine, University of Pennsylvania, Medical Director of the University of Pennsylvania Pleural and Mesothelioma Center. This is a phase 2, open label, non-randomized, single arm Simon’s two stage study in subjects with malignant pleural mesothelioma failing to achieve or maintain response to checkpoint inhibition. Before the efficacy assessment portion, the study will first embark a run-in dose-escalation phase to evaluate safety and tolerability of various dose of OT-101 in combination of pembrolizumab, and to determine a recommended Phase 2 dose (RP2D) of 4 days continuous i.v. infusion for every two weeks regimen. Subjects received the RP2D in the run-in dose-escalation phase will be part of the first stage of the Simon’s two-stage design for effectiveness evaluation. A maximum of 63 subjects will be treated. Among them, a maximum of 30 subjects will be treated in the run-in dose-escalation phase to determine the MTD and RP2D. Thirty-nine subjects are required for the Simon’s two-stage assessment of efficacy: 19 subjects in the first stage, and 20 in the second stage. Subjects of the RP2D cohort in the run-in dose-escalation phase will be included in the first stage of the Simon’s two-stage assessment. To determine whether the administration of TGF-ß inhibitor (OT-101) in combination with pembrolizumab can provide improved tumor response (ORR) in MPM subjects that fail to achieve or maintain a response with anti-PD-1/PD-L1-based regimens. Secondary Objectives: to determine whether ORR induced by TGF-ß inhibition combined with PD-1 blockade will result in an improved duration of response (DOR) and 6-month and 12-month Overall Survival (OS) and progression-free survival (PFS) as compared to current data with single agent pembrolizumab.; To evaluate the safety and tolerability of the administration of OT-101, in combination with pembrolizumab in patients with mesothelioma. Exploratory Objective; To determine whether TGF-ß inhibition combined with PD-1 blockade will increase T cell infiltration, clonality in some tumors; and, the increased T cell infiltration, clonality (CD4, CD8 and Tregs) and IFN- ? signatures correlate with the reduced TBRS. To determine if pretreatment TBRS signature is predictive of improved efficacy per ORR, DOR, and 6-month and 12-month overall survival OS, and progression free survival PFS. Tillkännagivande • May 17
Oncotelic Therapeutics, Inc. announced delayed 10-Q filing On 05/16/2022, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • May 05
Oncotelic Appoints Seymour Fein M.D. as Chief Regulatory Officer Oncotelic Therapeutics, Inc. announced the appointment of Dr. Seymour Fein as its Chief Regulatory Officer. Dr. Fein will guide the company registration trials through their global submissions including FDA, EMA, and NMPA. Dr. Fein’s professional activities have been focused on drug development research for over 35 years. He has been extensively involved in the successful development of numerous drugs, biologics and medical devices during this time leading to FDA approvals for over 20 drugs (NDAs, sNDAs, BLAs) and devices (PMAs). Tillkännagivande • May 04
Oncotelic Therapeutics, Inc. Appoints Fatih Uckun as Chief Medical Officer OncotelicTherapeutics, Inc. announced the appointment of Dr. Fatih Uckun as its Chief Medical Officer. Dr. Uckun will be responsible for execution of internal company led registrational trials. Prior to joining Oncotelic, Dr. Uckun served as Chief Medical Officer and Chief Scientific Officer of Reven Pharmaceuticals (from 2020 to 2022), Chief Medical Officer of Ares Pharmaceuticals (from 2017 to 2022). Tillkännagivande • Apr 01
Oncotelic Therapeutics, Inc. announced delayed annual 10-K filing On 03/31/2022, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Tillkännagivande • Jan 20
Oncotelic Presenting OT-101 Oncology Program at Biotechgate Digital Partnering Oncotelic Therapeutics, Inc. announced the OT-101 oncology program (“OT-101-ONC”) is designed to assess the impact of OT-101 across multiple oncology indications, where local tumoral secretion of TGF-ß suppressed the clinical activity of checkpoint inhibitors, CAR-T, and vaccine. The OT-101-ONC program has been moving forward steadily through strategic alliances planned with top pharmaceutical companies. Of note is the biomarker program spanning mesothelioma, glioblastoma, lung and colorectal cancers, where AI driven transcriptome analyses will be used to derive the predictive biomarker for TGF-ß therapeutics such as OT-101. In June 2020, the Food and Drug Administration (the “FDA”) granted accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [=10 mutations/megabase (mut/Mb)] solid tumors, as determined by a FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Tillkännagivande • Jan 07
Oncotelic Therapeutics, Inc. Initiates Phase 1 Trial Evaluating CA4P in Combination with Pembrolizumab for Melanoma OncotelicTherapeutics, Inc. announced that it has submitted a clinical study protocol to the United States Food and Drug Administration for the initiation of a Phase 1 Clinical Trial for CA4P, the Company’s Vascular Disrupting Agent, in combination with Anti-PD-1 (pembrolizumab) as a treatment for patients with Melanoma. The Phase 1 Clinical Trial is designated as S101: Phase 1, Prospective, Multicenter, Open-Label, Single Arm Study of Safety and Initial Efficacy of CA4P in Combination with anti-PD1 (pembrolizumab) in Patients with Recurrent Metastatic Cutaneous or Uveal Melanoma. CA4P has been evaluated in over 500 patients and treated in 17 clinical studies to date. These included multiple Phase 1 dose escalation studies, with dose cohorts up to 114 mg/m2, when used as monotherapy, 63 mg/m2 when used in combination with paclitaxel, and 63 mg/m2 when used in combination with bevacizumab. Based on the early Phase 1 studies, CA4P was further studied in larger Phase 2 studies including: Ovarian cancer - 60 mg/m2 CA4P in combination with 15 mg/kg bevacizumab (n=54) in combination with physician’s choice chemotherapy; Anaplastic thyroid cancer - 60 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=51); Platinum resistant ovarian cancer - 63 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=44); Non-small cell lung cancer - 60 mg/m2 CA4P in combination with bevacizumab and with paclitaxel and carboplatin q3wk (n=31). CA4P was generally well tolerated in these studies, and toxicity did not appear to be significantly related to dose frequency. The Company believes that the combination of CA4P together with checkpoint inhibitors, such as pembrolizumab, could be synergistic. Mechanistically, the trial is also designed to assess the impact of CA4P on tumoral TGF-ß signature which would allow us to integrate CA4P into the TGF-ß platform as combination with checkpoint inhibitors, CAR-T, and vaccine/oncolytic viruses. Tillkännagivande • Dec 23
Oncotelic Announces ORF8 Mutations are Driving the Evolution of the Delta and the Omicron Variants OncotelicTherapeutics, Inc. announced that it has performed mutational analysis of SARS-CoV-2 and demonstrated that the open reading frames 8 (“ORF8”) is potentially driving the evolution of the Delta and the Omicron variants. ORF8 protein is abundantly secreted in COVID patients. Fatality in hospital patients is associated with higher serum levels of ORF8. ORF8 is one of the least well conserved and most variable parts of the SARS-CoV-2 genome. In analysis, the company identified 30 high entropy amino acid residues which underwent a progressive evolution to arrive at the current dominant variant - Delta variant. The virus underwent mutational waves, with the first wave made up of structural proteins important in its infectivity, and the second wave made up of the ORFs important for its contagion. The most important driver of the second wave is ORF8 mutations at residue 119 and 120. Further mutations of these two residues are creating new lineage trees that are offshoots from the Delta backbone. More importantly the further mutational expansion of the S-protein in the emerging Omicron variant is now followed with the acquisition of ORF8 mutations 119 and 120. The Delta variant evolved to surpass the endogenous resistant to the virus in India and it is likely that the next evolutionary offshoot from the Omicron will evolve to surpass the endogenous resistant to the virus in Africa. Further mutational changes to ORF8 could create a stronger variant of the Delta lineage or grafting of the F120 mutation onto other backbones, such as the Omicron backbone, and which could also potentially create a stronger variant. It is imperative that leverage current breathing room to engineer therapeutics such as Artemisinin and OT-101 on top of vaccine targeting ORF8 for a long-drawn-out war against this virus. Tillkännagivande • Nov 24
Oncotelic Announces Positive Topline Data for OT-101 C001 COVID Study OncotelicTherapeutics, Inc. announced that its COVID-19 trial (“C001”) for OT-101 has successfully met its safety and efficacy endpoints. OT-101 is a first-in-class anti-TGF-ß ribonucleic acid (“RNA”) therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the SARS-CoV-2 virus, the virus that causes COVID-19, and is currently being evaluated in the Company’s C001 clinical trial against hospitalized severe COVID-19 patients. Both tumor cells and SARS-Cov-2 induce TGF-ß as part of their immune evasion mechanism. Consequently, inhibiting TGF-ß by OT-101 is expected to impact both cancer and COVID. By targeting the host protein, OT-101 is expected to work against multiple respiratory viruses, including related emerging variants, unlike traditional antiviral drugs and vaccines. On October 18, Data lock and Study Data and Analysis Data Models (SDTMs & ADaMS Databases) were generated for a Phase 2 C001 Covid Study: “A Double-Blind, Randomized, Placebo Controlled, Multi-Center Study of OT-101 in Hospitalized COVID-19 Subjects”. The trial compares OT-101 + Standard of Care (“SOC”) versus Placebo + SOC (N= 32 pts at 2:1 randomization ratio). SOC includes dexamethasone, the only drug known to improve outcomes in severe cases of COVID-19. The top line data is: Safety endpoints met. OT-101 as a TGF-ß inhibitor was safe to administer to COVID-19 patients including severe/critical COVID-19 patients. Efficacy signals were obtained. End of treatment (Day 7) mortality for the entire study population was 4.5% OT-101 versus 20% for placebo. Incidence of >96% viral load knockdown on End of Treatment (Day 7) was 89% for OT-101 versus 67% for placebo. Overall survival improved 3X for critical COVID-19 pts (4 days for placebo versus 14 days for OT-101, p < 0.0166). Tillkännagivande • Aug 25
Oncotelic Therapeutics, Inc. Reports PulmoHealTM/ ArtiVedaTM Proven Active against Mild and Moderate COVID-19 Following the Preplanned Prospective Analysis of ARTI-19 Clinical Trial OncotelicTherapeutics, Inc. reported that PulmoHealTM/ArtiVedaTM has proven active against mild and moderate COVID-19 following the preplanned prospective analysis of ARTI-19 clinical trial (NCT05004753- A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19). The study report will serve as the basis for Oncotelic’s regulatory submission for marketing approval of PulmoHealTM/ArtiVedaTM. In summary, based on the study results, it was shown that Artemisinin 500 mg capsule administered once daily for 5 days: was effective in treating subjects with mild and moderate COVID-19, artemisinin+SOC group showed significant improvement over SOC in WHO severity scale on Day 4 and Day 5 with p=0.0045 and p=0.0370, respectively. decline in body temperature was faster and higher in Artemisnin+SOC group by day 2 in comparison to SOC arm, no clinically significant changes in biochemistry or hematology parameters, was safe and well-tolerated by the study subjects. Tillkännagivande • Aug 17
Oncotelic Therapeutics, Inc. announced delayed 10-Q filing On 08/16/2021, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Aug 06
Oncotelic Therapeutics, Inc. announced that it has received $0.6985 million in funding from Autotelic Inc. Oncotelic Therapeutics, Inc. (OTCPK:OTLC) announced that it has entered into securities purchase agreement for private placement of 4 convertible promissory note at a price of $174,625 for gross proceeds of $698,500 on August 4, 2021. The company issued two notes for $250,000 each to Autotelic Inc, $123,500 to Larn Hwang and one note in the amount of $75,000 to Amit Shah. The note bears interest rate of 5% per annum. The securities are issued pursuant to exemption provided under Regulation D. Tillkännagivande • Jun 16
Oncotelic Therapeutics, Inc. Closes Covid-19 Clinical Trial Early Oncotelic Therapeutics, Inc. announced that, as of June 11, 2021, Oncotelic has discontinued enrollment in its OT-101 clinical trial in patients with COVID-19. The trial completed randomization of 32 out of 36 patients planned, on an intent to treat basis. The total of 32 patients consisted of 20 Part 1 patients, being patients with less severe disease and requiring none to low flow oxygen, and 12 Part 2 patients, being patients with more severe disease and requiring high flow oxygen with or without mechanical ventilation. OT-101 is an antisense against the host TGF-ß protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome (Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3) and acute respiratory distress syndrome (ARDS) (Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-ß with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. (Lond.) 2020; 10(2), 167-176. DOI: 10.4172/Clinical-Investigation.1000166.). TGF-ß is elevated in COVID-19 (Xiong Y. et al. Transcriptomic characteristics of bronchoalveolar lavage fluid and peripheral blood mononuclear cells in COVID-19 patients. Emerging Microbes & infections 2020; 9:1, 761-770, DOI: 10.1080/22221751.2020.1747363. Agrati C. et al. Expansion of myeloid-derived suppressor cells in patients with severe coronavirus disease (COVID-19). Tillkännagivande • May 18
Oncotelic Therapeutics, Inc. announced delayed 10-Q filing On 05/17/2021, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Apr 03
Oncotelic Therapeutics, Inc. announced delayed annual 10-K filing On 04/01/2021, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Tillkännagivande • Mar 16
Mateon Announces Initiation of Phase 1B Clinical Trial on OT-101/IL-2 Combination Therapy for Solid Tumors Mateon Therapeutics Inc. announced the regulatory approval from the Ministry of Food and Drug Safety of Korea for the phase 1b clinical trial of a patented OT-101/IL-2 combination. This phase 1b clinical trial will confirm the safety and effectiveness of OT-101/IL-2 in solid cancer patients in cooperation with the UK global pharmaceutical company Clinigen Group. The study will be conducted together with Autotelic BIO- a partner of Mateon on OT-101/IL-2 combination. OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic. OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 further demonstrate its utility as adjunct to other immunotherapies. Interleukin-2 (IL-2, Aldesleukin, PROLEUKIN®) Immunotherapy is cancer treatment that stimulates the body's immune system to fight cancer, such as melanoma. Tillkännagivande • Mar 10
Mateon Therapeutics, Inc. Announces Enrollment Enrollment of its Sentinel Part 1 and Part 2 COVID-19 Mateon Therapeutics, Inc. announced that it has completed the enrollment of its sentinel Part 1 and Part 2 COVID-19 patients which allows for the continuing expansion to the targeted 18 patients in part 1 and 18 patients in part 2. Additionally, the targeted enrollment of the 18 patients of Part 1 has also been reached. The study was conducted through Oncotelic, Inc. As explained in a prior press release, the trial is a multi-center, double blind, randomized, placebo-control study to evaluate safety and efficacy of OT-101 in combination with standard of care on two (2) patient cohorts Part 1 which constitutes mild or moderate disease patients, and 2) Part 2 which constitutes severe disease patients requiring mechanical ventilation or intubation. The primary efficacy endpoint is the proportion of subjects with clinical improvement score (measured by an 8-point World Health Organization COVID-19 Clinical Improvement Ordinal Scale) as assessed by the Odds Ratio (OR) at Day 14. These 6 sentinel patients (three per cohort) were treated every 24 hours sequentially, as a precaution to detect any acute adverse events associated with the delivery of OT-101. No acute adverse events related to OT-101 were observed. Tillkännagivande • Feb 23
Mateon Therapeutics, Inc. and Windlas Biotech Limited Launches Pulmoheal™, A Combined Lung Therapy and Ai Telemedicine 360° Solution Mateon Therapeutics, Inc. and Windlas Biotech Pvt. Ltd. announced the launch in India of PulmoHeal™ a first-of-its-kind integrated, consumer-centric solution for respiratory wellness. The combined drug + AI telemedicine 360o care solution is designed to support the estimated 100 million people in India who suffer from respiratory problems and address the underlying challenges of a lack of cost-effective and lab-free methods for early diagnosis of diseases. PulmoHeal™ consists of three components: the drug PulmoHeal™, a broad-spectrum, lung therapy food supplement that is supported by a multi-centre rigorous clinical study that has demonstrated efficacy against a viral respiratory infection- COVId-19;a mobile app called ArtiHealth™ powered by Mateon’s AI supercomputing platform that allows patients to submit a questionnaire and a daily cough recording to receive real-time information on their respiratory function and progress over time; and a post-marketing survey platform to crowd-source user experience for new indications. Artemisinin - the active component in PulmoHeal™- is derived from the extract of the indigenous plant Artemisia, which has exhibited multiple pharmacological activity against inflammation, viral infections, and lung repair. Tillkännagivande • Feb 18
Mateon Therapeutics, Inc. Partners with The Chopra Foundation for Development of PulmoHea and ARTIVeda Mateon Therapeutics, Inc. announced a global partnership with Chopra Foundation to collaborate on research and development of PulmoHeal™ and ARTIVeda™ for COVID-19 and other infectious diseases through joint research between Mateon and Foundation Principal Investigators (PI) from premium US universities. The Chopra Foundation will introduce PulmoHeal™ and ARTIVeda™ to its networks of Ayurveda physician and clinics throughout India and worldwide and promote the clinical data supporting the efficacy of this therapy. Mateon and the Chopra Foundation have also agreed to collaborate on future research with ARTIVeda™ and PulmoHeal™, with the Chopra Foundation providing its deep real-world experience in Ayurvedic medicine. Together, Mateon and Chopra Foundation intend to develop of Ayurvedic medicine as an important partner in an integrative patient care platform. Tillkännagivande • Feb 04
Mateon Therapeutics, Inc. Announces Completion of Arti-19 and Publication of Positive Interim Data Mateon Therapeutics, Inc. announced that its ARTI-19 trial, evaluating ARTIVeda™ /PulmoHeal™ against COVID-19 in India, has completed randomization of all 120 patients and final analysis is expected in March 2021. When ARTIVeda™ /PulmoHeal™ was added to the standard of care (SOC), more patients recovered faster than SOC alone. 31 of 39 (79.5%) of patients taking became asymptomatic after 5-day of therapy. In comparison, only 12 of 21 control patients (57.1%) treated with SOC alone became asymptomatic on day 5 (P=0.028, Fisher’s exact test) For the sicklier pts (WHO scale 4), the median time to becoming asymptomatic was only 5 days for the ARTIVeda™ /PulmoHeal™ + SOC group (N=18), as compared to 14 days for the SOC alone group (N=10) (P=0.004, Log-rank test). These data sets provide clinical support that targeting the TGF-ß pathway with ARTIVeda™ /PulmoHeal™ may contribute to a faster recovery of patients with mild to moderate COVID-19. Windlas is a 20-year-old company with a strong track record of research, development, manufacturing and distribution of pharmaceutical products in India, USA and several other emerging markets. It has four large scale manufacturing facilities employing more than 1500 employees and is the 5th largest Contract Development and Manufacturing Organization (CDMO) serving top innovator as well as generic pharma companies across the world. It has developed more than 500 different formulations (> 2 billion doses annually) of anti-viral, cardiovascular, anti-diabetic, anti-infective, CNS and dermatology products. The product, ARTIVeda™, is a formulated plant extract of the indigenous plant Artemisia, known in Sanskrit texts as Damanaka. ARTIVeda™ is the first Ayurvedic drug against COVID-19 through TGF-ß inhibition. ARTIVeda™ is expected to be effective through the entire infection cycle. The active component of ARTIVeda™ has been identified as artemisinin. Through proprietary GMP quality extraction and manufacturing processes, the Artemisia extract was rendered active against SARS-CoV-2 with robust Safety Index (SI) greater than 100 (ratio of nonspecific cell kill versus viral kill). Other extracts have SI <10. Testing was performed at the US NIAID core viral laboratory. The product is protected by a patent portfolio of over 15 international patents by Mateon’s R&D. The mechanism of action against COVID-19 has been confirmed in 5 key peer reviewed international scientific/medical publications. ARTIVeda™ is designed to target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. A phase IV trial looking at ARTIVeda™ in COVID-19 is ongoing in India and globally. Tillkännagivande • Feb 02
Mateon Therapeutics, Inc. Launches its Artificial Intelligence Telemedicine Platform for Post Marketing Survey to Support the Launch of its Drug Product, PulmoHealTM Mateon Therapeutics, Inc. announced that it has launched its artificial intelligence (AI) telemedicine platform for post marketing survey (PMS) to support the launch of its drug product, PulmoHealTM. The PMS module, with its previously announced AI mobile app, ArtiHealthTM, rounds out the company’s AI telemedicine solution. The combination of the drug and telemedicine targets patients for respiratory health, including COVID-19, in India. Initially the drug and device combination will only be available in India through Indian partner, Windlas, with the drug marketed under brand name PulmoHealTM. Artemisinin- the active component of PulmoHealTM- displays multiple pharmacological actions against inflammation, viral infections, cell and tumour proliferation, inflammation, invasion, and metastasis. The use of artemisinins against different respiratory diseases has been widely investigated but not in a systematic way. PMS platform is meant to collect large amount of real-world evidence for safety and efficacy that would be instrumental in disease expansion of PulmoHealTM. The interim report of 60 patients of the ARTI-19 study found PulmoHealTM to be significantly effective by more than doubling the recovery rate of COVID-19 patients. Tillkännagivande • Jan 14
Mateon Announces Positive Interim Results from ARTI-19 Clinical Trial Evaluating Covid-19 Therapeutic Mateon Therapeutics, Inc. reported positive interim results from its ARTI-19 clinical trial evaluating ARTIVedaTM against COVID-19. ARTIVeda is Mateon’s lead Ayurvedic drug against COVID-19 in India and is being developed by Mateon in partnership with Windlas Biotech Private Limited (India). ARTI-19 India is being conducted by Windlas as part of Mateon’s global effort to deploy ARTIVeda across India, Africa, and Latin America. These interim results are based on 60 randomized patients (out of 114 randomized to date) across 3 sites in India: No adverse events were reported that required discontinuation of treatment; A majority of the 60 patients who received ARTIVeda plus Standard of Care (SOC) recovered faster than those who received SOC alone, with SOC defined as treatment with Remdesivir, Ivermectin, Dexamethasone, Heparin, as well as Paracetamol, B complex, Vitamin-C, and Zinc. The median time to asymptomatic WHO scale of 1 was 5 days for ARTIVeda plus SOC as compared to 14 days for SOC alone. The differences were statistically significant meaning unlikely to happen by chance. The trend was more pronounced with higher initial disease status. Log rank statistics: WHO-scale 2,3,4: p= 0.0369 /RR = 1.476 (0.8957-2.433), WHO-scale 3,4: p= 0.026/RR = 1.581 (0.9094-2.747), WHO-scale 4: p= 0.0043/RR = 2.038 (0.9961-4.168). RR = rate ratio for recovery. The ARTI-19 India trial is slated to complete enrollment of 120 randomized patients by end of January, 2021, with final data available 6-8 weeks thereafter. Upon completion of the trial, it is Mateon’s objective to file for Emergency Use Authorization (EUA) with regulatory authorities around the world, including India, the United States, and the United Kingdom; discussions regarding EUA with several of these authorities have commenced. ARTIVeda combines Mateon’s TGF beta platform and ethnobiology drug knowledge for rapid development and deployment of the drug product against the COVID-19 pandemic. Windlas is a prominent global CDMO (contract development and manufacturing organization) that also manufactures, markets and distributes its own branded products (allopathic, nutraceutical and AYUSH formulations) through its “affordable generics platform” spanning over 950 wholesalers across India. Windlas products are sold in markets across the globe in India, USA, Sri Lanka, Vietnam, Thailand, Myanmar, and Africa. Tillkännagivande • Nov 12
Mateon Therapeutics and Windlas Biotech Enter into Definitive Agreement to Commercialze Artiveda™ Against Covid-19 Mateon Therapeutics announced an agreement with Windlas Biotech Pvt. Ltd. of India (Windlas) to commercialize ARTIVeda™. ARTIVeda™ is Mateon’s lead ethnobiology drug against COVID-19. With clinical data supporting anti-viral activity in-vitro and in-vivo, and with its high safety index, the commercial path has been accelerated both as an Ayurvedic therapy and Nutraceutical in India that can be prescribed by physicians. The company with and through company commercialization partners Windlas, are in active discussion with large distributors, marketers, and manufacturers to establish a consortium for distribution of this drug product in an equitable manner across all territories. Early data from ARTI-19 suggests efficacy trend and safety, which is further supported by an independent recently completed study published in Int J Antimicrob Agents. 2020 Nov. 2. In this study, time to undetectable SARS-CoV-2 RNA in the treatment group was significantly less than the control group (Treatment: 10.6±1.1 days), Control: 19.3±2.1 days) and Length of hospital stay for Treatment group was 13.3±4.8 days, and Control was 21.3±9.1 days. Windlas is a leading CDMO since last 20 years. It promotes more than 120 chronic and acute care branded products (allopathic, nutraceutical and Ayush formulations) through its “affordable generics platform” spanning over 950 wholesalers across India. Windlas branded medicines and wellness products are sold in several markets across the globe like Sri Lanka, Vietnam, Thailand, Myanmar etc. In order to maximize the accessibility and the reach of “ARTIVeda™”, Mateon and Windlas intend to launch it through its distribution network as well as through strong co-marketing partners who are existing clients of Windlas. Tillkännagivande • Nov 06
Mateon Therapeutics, Inc. Announces the Receipt of Approval from Instituto Nacional De Salud (Ins), the Regulatory Agency of Peru, to Initiate the Company’s C001- Phase 2 Clinical Trial of OT-101 Mateon Therapeutics, Inc. announced the receipt of approval from Instituto Nacional de Salud (INS), the regulatory agency of Peru, to initiate the Company’s C001- Phase 2 clinical trial of OT-101, a TGF-ß antisense, for the treatment of patients with mild to severe COVID-19 infection. C001 trial is a multi-center, double blind, randomized, placebo-control study to evaluate safety and efficacy of OT-101 in combination with standard of care on two (2) patient cohorts – 1) mild or moderate disease, and 2) severe disease requiring mechanical ventilation or intubation. The study will enroll approximately 48 patients in Peru totaling 72 patients study wide. The primary efficacy endpoint is the proportion of subjects with clinical improvement score (measured by an 8-point World Health Organization [WHO] COVID-19 Clinical Improvement Ordinal Scale) as assessed by the Odds Ratio (OR) at Day 14. On October 19, 2020, Mateon announced the receipt of approval from Republica Argentina – Poder Ejecutivo Nacional of Argentina to initiate the Company’s Phase 2 clinical trial of OT-101 for the treatment of patients with mild to severe COVID-19 infection. Tillkännagivande • Oct 20
Mateon Therapeutics, Inc. Receives Approval from Republica Argentina for Phase 2 Global Study for OT-101 Mateon Therapeutics, Inc. announced the receipt of approval from Republica Argentina – Poder Ejecutivo Nacional, to initiate the Company’s Phase 2 clinical trial of OT-101, a TGF-ß antisense, for the treatment of patients with mild to severe COVID-19 infection. This multi-center, double blind, randomized, placebo-control study will evaluate the safety and efficacy of OT-101 in combination with standard of care on two patient cohorts – 1) mild or moderate disease, and 2) severe disease requiring mechanical ventilation or intubation. The study will enroll approximately 24 patients in Argentina with an aggregate total of 72 pts study wide. The primary efficacy endpoint is the proportion of subjects with clinical improvement score as assessed by the Odds Ratio at Day 14. Tillkännagivande • Oct 08
Mateon Therapeutics, Inc. Announces First Patient Enrolled in ARTI-19: A Multicenter Interventional Study of ArtiShield Against COVID-19 Mateon Therapeutics, Inc. announced the first patient enrolled this week in its Phase IV study ARTI-19. This is a global study with India to contribute at least 120 pts to the total aggregate of 3000 pts. The study evaluates the safety and efficacy of Artemisia absinthium Powder 500mg capsule (ArtiShieldTM) in the treatment of adults with COVID-19. Top-line data from ARTI-19 is expected by end of fourth quarter of 2020. The ARTI-19 trial was recently cleared by Indian regulatory authorities, and is registered under the Clinical Trials Registry India (CTRI) with three active sites and additional sites to be added as the trial progresses and expands. ARTI-19 trial registration information can be found at: CTRI/2020/09/028044. Phase IV study to evaluate the safety and efficacy of ArtiShieldTM on COVID-19 subjects as Interventional. ARTI-19 in India is being conducted by Windlas Biotech Private Limited, as part of Mateon’s global effort at deploying ArtiShieldTM across India, Africa, and Latin America. Tillkännagivande • Oct 06
Mateon Therapeutics, Inc. and Windlas Biotech Limited Announce ArtiShield Is Now Approved for Manufacture and Marketing by the Ministry of AYUSH Mateon Therapeutics, Inc. announced that ArtiShield is now approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy), license number UK.AY-401/2018, for the treatment of various symptoms like fever and inflammation. ArtiShield is in co-development with Windlas Biotech Pvt. Ltd. ArtiShield is being evaluated against COVID-19 in ARTI-19- a phase IV study in India. ArtiShield is designed to be a readily available and cost-effective agent to combat COVID-19, with Windlas providing the capability to manufacture the doses necessary to support this endeavor. ARTI-19 in India is a A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19. This trial will compare the efficacy of oral doses with standard-of-care (SOC) versus SOC alone. Oral administration of Artemisia absinthium Powder 500mg capsule/day for 5 days with SOC per cycle with the option to repeat as needed until disease is resolved or subject is discharged, up to a total of consecutive 3 cycles (5 days treatment, 5 days off). SOC is standard-of-care as per Clinical Management Protocol: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division). Safety is defined as: 1) Adverse events (AEs) during the study and 2) Serious adverse events (SAEs) during the study. Efficacy is defined as: 1) Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale and 2) Relief in the sign and symptoms of COVID-19 per the Duration of Symptoms. ArtiShield is the Ayurveda - Dvipaantara Damanaka- and is labeled as capsule containing Artemisia absinthium Powder 500mg. Its use in this trial is per Ayurvedic text: fever and inflammation. The application of Ayurvedic agent to treat the symptoms of COVID-19 such as fever, headache, and inflammation is appropriate. Artemisinin is an active component of ArtiShield. Artemisinin is able to inhibit TGF-ß activity and is able to neutralize SARS-CoV-2 (COVID-19) in vitro at an EC50 of 0.45 ug/ml (based on Mateon’s test result at Utah State University), and a Safety Index of 140, which is better than remdesivir and chloroquine. The unpurified herb extract has no anti-viral activity. ArtiShield is designed to target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. ArtiShield is being evaluated against COVID-19 in ARTI-19- a phase IV study in India. Tillkännagivande • Jun 30
Mateon Therapeutics, Inc. announced that it has received $2 million in funding Mateon Therapeutics, Inc. (OTCPK:MATN) announced that a private placement of a convertible note for gross proceeds of $2,000,000 on June 29, 2020. The transaction will include participation from returning investor Golden Mountain Partners. The note bears an interest of 2% per annum, has a term of 1 year and is personally guaranteed by Vuong Trieu, chief executive officer of the company. The note is convertible at the 1 year anniversary of the note, at the common stock price of the company on conversion with no discount. The investor does not have the option to convert prior to the 1-year anniversary.