Last update 12 Sep 2024

Trabedersen

Last update 12 Sep 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

ASO

Synonyms

TGF-beta antisense, Trabedersen (INN/BAN), A-12009 FREE ACID

+ [6]

Target

TGF-β2

Mechanism

TGF-β2 inhibitors(Transforming growth factor beta 2 inhibitors)

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [4]

Active Indication

MelanomaPancreatic CancerPancreatic Ductal Adenocarcinoma+ [5]

Inactive Indication

Colorectal CancerCOVID-19Hemophilia B+ [3]

Originator Organization

Isarna Therapeutics GmbH

Active Organization

Oncotelic Therapeutics, Inc.

Isarna Therapeutics GmbH

Oncotelic, Inc.

Inactive Organization

Autotelic, Inc.

Development Center for Biotechnology

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (US), Rare Pediatric Disease (US)

Gene Sequence

Sequence Code 29532696

Source: *****

Clinical Trials associated with Trabedersen

NCT05425576 / Not yet recruitingPhase 2

Phase 2 Trial of TGF-β Inhibition (OT-101) With Anti-PD-1 (Pembrolizumab) in Patients With Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition

This is a study of OT-101, a TGF-b2 inhibitor in combination of pembrolizumab in patients with malignant pleural mesothelioma. Both efficacy assessment, and safety and tolerability of various dose of OT-101 in combination of pembrolizumab are evaluated.

Start Date01 Jun 2025

Sponsor / Collaborator

Oncotelic Therapeutics, Inc.

NCT06579196 / Not yet recruitingPhase 1/2IIT

Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1

The goal of this clinical trial is to: 1) evaluate the safety and recommended dose of the drug OT-101/Trabedersen when combined with Pembrolizumab and 2) determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer. The main question(s) it aims to answer are:
* What medical problems to participants have when taking OT101 together with Pembrolizumab?
* What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy?
* Does the combination therapy delay progression or relapse of the participant's Non-Small Cell Lung Cancer?
Participants will:
* Receive intravenous OT-101/Trabedersen for 4 days once every 2 weeks. Clinic visits are required to receive and disconnect the infusion.
* Receive intravenous Pembrolizumab once every 6 weeks.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Nebraska

NCT06079346 / RecruitingPhase 2/3

A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer

The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.

Start Date01 May 2024

Sponsor / Collaborator

Oncotelic Therapeutics, Inc.

100 Clinical Results associated with Trabedersen

100 Translational Medicine associated with Trabedersen

100 Patents (Medical) associated with Trabedersen

Literatures (Medical) associated with Trabedersen

01 Jan 2023·Methods in molecular biology (Clifton, N.J.)

Visualization of Differentiated Cells in 3D and 2D Intestinal Organoid Cultures.

Article

Author: Sato, Toshiro ; Sugimoto, Shinya ; Hanyu, Hikaru

The intestinal epithelium maintains self-renewal and differentiation capacities via coordination of key signaling pathways, including the Wnt, bone morphogenetic protein (BMP), epidermal growth factor (EGF), and Notch signaling pathways. Based on this understanding, a combination of stem cell niche factors, EGF, Noggin, and the Wnt agonist R-spondin was shown to enable the growth of mouse intestinal stem cells and the formation of organoids with indefinite self-renewal and full differentiation capacity. Two small-molecule inhibitors, including a p38 inhibitor and a TGF-beta inhibitor, were added to propagate cultured human intestinal epithelium but at the cost of differentiation capacity. There have been improvements in culture conditions to overcome these issues. Substitution of the EGF and a p38 inhibitor with insulin-like growth factor-1 (IGF-1) and fibroblast growth factor-2 (FGF-2) enabled multilineage differentiation. Monolayer culture with mechanical flow to the apical epithelium promoted the formation of villus-like structures with mature enterocyte gene expression. Here, we summarize our recent technological improvements in human intestinal organoid culture that will deepen the understanding of intestinal homeostasis and diseases.

01 May 2022·Matrix biology : journal of the International Society for Matrix BiologyQ1 · BIOLOGY

Corneal fibroblast collagen type IV negative feedback modulation of TGF beta: A fibrosis modulating system likely active in other organs

Q1 · BIOLOGY

Review

Author: Sampaio, Lycia Pedral ; Hilgert, Guilherme S L ; Wilson, Steven E ; Shiju, Thomas M

Collagen type IV (COL IV) is a major component of basement membranes (BM) in all organs. It serves functions related to BM organization and modulates the passage of growth factors from one tissue compartment to another. COL IV binds transforming growth factor (TGF) beta-1 and TGF beta-2 and, therefore, is a major modulator of TGF beta pro-fibrotic functions. After fibrotic corneal injury, TGF beta enters into the stroma from the tears, epithelium, endothelium and/or aqueous humor and markedly upregulates COL IV production in corneal fibroblasts in the adjacent stroma far removed from BMs. It is hypothesized this non-BM stromal COL IV binds TGF beta-1 (and likely TGF beta-2) in competition with the binding of the growth factors to TGF beta cognate receptors and serves as a negative feedback regulatory pathway to mitigate the effects of TGF beta on stromal cells, including reducing the developmental transition of corneal fibroblasts and fibrocytes into myofibroblasts. Losartan, a known TGF beta signaling inhibitor, when applied topically to the cornea after fibrotic injury, alters this COL IV-TGF beta pathway by down-regulating COL IV production by corneal fibroblasts. Non-BM COL IV produced in response to injuries in other organs, including the lung, skin, liver, kidney, and gut, may participate in similar COL IV-TGF beta pathways and have an important role in controlling TGF beta pro-fibrotic effects in these organs.

17 Dec 2019·Current pharmaceutical designQ4 · MEDICINE

Therapeutic Potential of Targeting Transforming Growth Factor-beta in Colorectal Cancer: Rational and Progress

Q4 · MEDICINE

Review

Author: Hassanian, Seyed M ; Khorrami, Shadi ; Avan, Amir ; Gachpazan, Meysam ; Ferns, Gordon A ; Khazaei, Majid ; Kashani, Hoda

Background::

Colorectal cancer (CRC) is one of the most common types of cancer and is associated with an increasing rate of mortality. Transforming Growth Factor-Beta (TGF-β) is often upregulated in CRC, and appears to play an important role in regulating cell proliferation, migration, immune surveillance, apoptosis, cell differentiation, drug-resistance and many cellular processes that may be involved in CRC, and therefore underscores its potential value as a therapeutic target in the treatment of CRC. An increased expression of the TGF- β pathway has been associated with poor prognosis in several cancer types, including CRC.

Methods::

Here, we describe the critical role of the TGF-β pathway in CRC as well as the preclinical and clinical investigations on TGF-β inhibitors, with particular emphasis on recent findings with small-molecule inhibitors in CRC. Several TGF-β inhibitors (e.g., Trabedersen, Galunisertib, Gradalis, PF-03446962, NIS793) have been generated over the past decade for targeting this pathway.

Results::

There is accumulating evidence of the therapeutic potential of this and other TGF-β inhibitors for the treatment of other malignancies. These inhibitors might be used in combination with chemotherapy as well as with other biological agents, in order to overcome different resistance mechanisms. However, further studies are needed to identify determinants of the activity of TGF-β inhibitors, through the analysis of genetic and environmental alterations affecting TGF-β and parallel pro-cancer pathways.

Conclusion::

These studies will be critical to improving the efficacy and selectivity of current and future anticancer strategies targeting TGF-β.

News (Medical) associated with Trabedersen

12 Aug 2024

·www.prnewswire.com

Ocumension (01477.HK) Demonstrates Strong Operational Resilience, Commercialization Capabilities Reach New Heights

SHANGHAI, Aug. 12, 2024 /PRNewswire/ -- On August 12, Ocumension Therapeutics (Shanghai) Co., Ltd. (01477.HK, hereinafter referred to as "Ocumension" or the "Company") released its 2024 Interim Results Report. During the reporting period, the company achieved operating revenue of RMB 168 million, representing a year-on-year increase of 61.6%. The gross margin was 59.2%, and the adjusted loss amounted to RMB 101 million, narrowing by 20.0% year-on-year. This significant growth in performance is attributed to the accelerated advancement of the company's commercialization process and the steady increase in market penetration. Additionally, the company's operational efficiency improved markedly, and its cost control capabilities were further optimized. Rapid Expansion of Core Products Leads to New Growth in the Ophthalmic Drug Market During the reporting period, the company's core products expanded rapidly, with ongoing efforts to build commercialization capabilities and continuously enhance core competitiveness. In the first half of the year, the company's commercialized products generated revenue of RMB 168 million, reflecting a year-on-year growth of 61.6%. Several products, including OT-204, OT-1004, and OT-306, all saw steady increases in market share, contributing to the strong market position of Ocumension in the ophthalmic drug market. Notably, one of the company's commercialized products, Yusheying® (for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye), was included in the National Medical Insurance Directory at the beginning of the year. The demand for this medication has rapidly increased over the past six months. Since the implementation of the new insurance directory, Yusheying® has completed nearly 2,000 injections in the first half of the year, showcasing its market potential and the high level of patient recognition. Furthermore, during the reporting period, Ocumension remained committed to broadening product accessibility to benefit a wider patient population. The company pursued a dual strategy: on one hand, it actively expanded hospital coverage and accelerated product hospitalizations to fully tap into the commercial potential of its mature products; on the other hand, it promoted new products through academic outreach, driving a leap in sales revenue. Nationally, the company has covered 10,970 hospitals, including 1,652 tertiary hospitals, supported by a professional commercial team of over 250 people. This extensive commercial network lays a solid foundation for the future market entry of Ocumension's ophthalmic product portfolio. In response to the increasing commercialization demand, Ocumension's Suzhou factory successfully initiated the first batch of commercial production of 0.3% Sodium Hyaluronate Eye Drops (0.4ml: 1.2mg) in July this year. Leveraging advanced manufacturing processes, efficient supply chain management, and a commitment to excellence, the first batch of "Ocumension-made" Sodium Hyaluronate Eye Drops will be produced at the fastest speed, bringing relief to patients suffering from dry eye syndrome. Strong R&D Capabilities, Comprehensive Development of Ophthalmic Drug Pipeline On July 5, a national plan supporting the development of innovative drugs throughout the entire chain was introduced. The central government has provided multi-dimensional support for the development of innovative drugs, which has greatly boosted market confidence. According to industry experts, the current surge in domestic R&D enthusiasm means that the strength of a company's R&D capabilities will be a key factor in determining its ability to stand out and succeed in this "marathon" race. According to the announcement, R&D expenses in the first half of 2024 reached RMB 59 million. Since its listing, Ocumension has prioritized investment in R&D, which, supported by its outstanding R&D capabilities and forward-looking strategic planning, has established its leading position in the field of ophthalmic drugs. This also provides the necessary ammunition for the company to rapidly capture the market in the future. Sustained and stable R&D investment ensures that Ocumension can steadily advance various R&D projects around its core product lines. During the reporting period, the allergic conjunctivitis drug OT-1001 (Cetirizine Hydrochloride Eye Drops) is expected to receive marketing approval soon; OT-101 (0.01% Atropine Sulfate Eye Drops) is progressing rapidly, with the first global patient in the Phase III MRCT having completed three years of treatment; OT-502 (Dexamethasone Implant) completed Phase III clinical trials and will soon submit an NDA; and the self-developed Class 1 new drug OT-202 (Spleen Tyrosine Kinase Inhibitor) for the treatment of dry eye syndrome completed Phase II clinical trials, achieving primary endpoints. In addition, OT-702 (Aflibercept Biosimilar) has completed Phase III clinical trials with positive results, and the NDA has been submitted to and accepted by the CDE. As an important component of Ocumension's commercialization strategy, OT-702 will effectively fill the gap in the company's portfolio for anti-VEGF drugs targeting retinal diseases. Leveraging the company's strong ophthalmic platform and extensive commercialization channels, this high-quality drug will be made available to more patients with retinal diseases. It is understood that the outstanding performance of anti-VEGF drugs in the treatment of retinal diseases has opened up a billion-dollar ophthalmic market. As more new ophthalmic drugs are developed in the future, the potential for market growth remains enormous. Currently, the company owns 25 drug assets targeting the anterior and posterior segments of the eye, including three products in Phase III clinical trials and three products in the registration phase for marketing approval. Ocumension remains one of the innovative pharmaceutical companies with the most products in Phase III clinical trials and the registration phase for marketing approval in the Chinese ophthalmic drug market. According to industry professionals, the company's continuous increase in R&D investment is a strong indicator of its profitability and demonstrates the company's strategic determination to drive development through innovation. By actively laying out product pipelines in niche areas and developing innovative drugs, the company is establishing a solid foundation for product line expansion and core product cultivation, contributing to its long-term sustainable development. Booming Ophthalmic Market Continues to Unleash Potential In recent years, the ophthalmic sector, as a representative of non-oncological fields, has attracted increasing interest from various companies. Pharmaceutical giants have been entering the ophthalmic sector one after another. In December 2023, Johnson & Johnson acquired a gene therapy for X-linked retinitis pigmentosa (XLRP) from MeiraGTx in a transaction valued at $415 million; in November 2023, AbbVie reached an agreement with Aldeyra, acquiring exclusive rights to the new dry eye disease drug Reproxalap for $401 million; in April 2023, Astellas invested $5.9 billion to acquire Iveric Bio, gaining access to a new drug for geographic atrophy, avacincaptad pegol; and at the end of 2022, Amgen acquired Horizon, securing Tepezza, a new drug for thyroid eye disease... Pharmaceutical giants have recognized the current transformation in the ophthalmic market's scale and structure, driven by the emergence of innovative technologies. As the aging population and widespread use of electronic devices increase the incidence of various eye diseases, Frost & Sullivan predicts that the global ophthalmic drug market will reach $46.4 billion by 2025 and $73.9 billion by 2030. In the future, as more clinical needs for ophthalmic diseases are explored and met, the market is poised for further explosive growth in various sub-segments. SOURCE OcuMension

Phase 3AcquisitionClinical Result

29 Jul 2024

·www.globenewswire.com

Product Manager Scott Myers to Present at 2nd Global Summit on Artificial Intelligence

AGOURA HILLS, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or “Our”), announced today that Product Manager Scott Myers, working through GMP Biotechnology Limited, our 45% Joint Venture with Dragon Capital Limited, will be presenting at the 2nd Global Summit on Artificial Intelligence. The summit, which is being hosted digitally, is centered on the theme “Pioneering the New Era: Advancing Global Development through Artificial Intelligence.” A copy of the presentation will be made public after the summit. “I am honored to be presenting. The PubMed Corpus Builder is just one of the tools we have developed that our scientists use regularly. We are proud to be pioneering cutting-edge technology throughout our company,” said Scott Myers, Product Manager. Title: Using AI to Autonomously Find and Retrieve Large Amounts of Specific Medical Papers for Use in Cancer Research and Development Abstract: The PubMed Corpus Builder, part of the Orion AI Suite developed by Scott Myers and others at Sapu Bioscience LLC, is designed to create a comprehensive document corpus from the PubMed Central Database based on one broad user given query and specified parameters. It utilizes LLMs to generate multiple search queries aimed at retrieving a wide range of unique documents. After downloading, vector search refines the document selection, allowing for advanced filtering, such as identifying documents with specific types of graphs, which standard search engines cannot achieve. The documents can then queried using multimodal technology, enabling the LLM to view and interpret graphs and charts as images, thus adding another level of detail to answers. Additionally, the system can conveniently email both the PubMed URLs and actual PDF files to users. The PubMed Corpus Builder dramatically speeds up the research process, allowing scientists to efficiently find and filter through hundreds of documents in minutes. More information about the summit can be found: https://artificial-intelligence.hspioa.org/ About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (“AML” through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the Company’s product candidates and the potential use of the Company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform, the success of any contemplated transactions similar to the one under this press release. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether because of new information, future events, or otherwise. Contact Information:For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com

Acquisition

11 Jun 2024

·www.globenewswire.com

ONCOTELIC TO PRESENT AT THE 20TH ANNUAL CONGRESS OF INTERNATIONAL DRUG DISCOVERY SCIENCE & TECHNOLOGY

AGOURA HILLS, Calif., June 11, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) announced today its CEO- Dr. Vuong Trieu will speak at the 20th Annual Congress of International Drug Discovery Science & Technology (IDDST) (Europe), June 17-19, 2024 at Budapest, Hungary. Title: TGFB2 therapeutic for the treatment of CRC, GBM, and PDAC Anirudh Kolanu, K. Khuranu, A. Mehta, T. Sanil1, G. Trieu, and Dr. Vuong Trieu* Abstract: OT-101, an antisense against TGFB2, is being tested in phase 3 clinical trials for pancreatic cancer and glioblastoma. It was previously reported to have robust clinical activity in those indications as well as in melanoma. Here, we explore the potential application of OT-101 in colorectal cancer (CRC) through the analysis of CRC patients treated with OT-101 during its clinical development, as well as through bioinformatic. Intravenous therapy with OT-101 in melanoma, colorectal cancer, and pancreatic cancer was evaluated in P001- a phase I/II study. A total of 62 patients were enrolled; 38 patients with pancreatic cancer, 19 patients with melanoma, and 5 patients with colorectal cancer. Full pharmacokinetic evaluation of these patients demonstrated a drug effect with improved progression-free survival (PFS) with increased drug exposure defined by AUClast. The CRC patients were heavily pretreated with multiple lines of previous therapies (4,5,5,6,8), reflected in short overall survival times (2.1, 2.5, 3.0, 5.7, 7.3 months). High AUC exhibited a doubling of PFS to 84 days versus 40 days. A sample of 4259 colorectal adenocarcinoma cancer patients from cbioportal was analyzed. The low expression of two genes: TGFB2 and TGFM6 improved OS. The combination of TGFB2 and TGFM6 was superior to TGFB2 or TGFM6 alone, with TGFB2 being the dominant factor. There was strong but not overlapping sexual dimorphism among the two genes separately but not when used together. The TGFB/TGM6 impact was most significant on Mesenchymal CMS- increasing median survival from 42 months with high TGFB2/TGM6 to 132 months with low TGFB2/TGM6- a threefold improvement with a highly significant p-value of 1.4e-5. Statistical significance was not observed when the genes were used separately. Suppression of TGFB2, i.e., through OT-101, is a potential approach for the treatment of CRC.especially OT-101 treatment of TGM6 low patients. "It is gratifying to identify what we think is the fundamental role of TGFM6 and TGFB2 in cancer," said Dr. Vuong Trieu, CEO and Chairman of Oncotelic. "Considering the work done here by our interns drawn from local high schools through Brush&Key Foundation for Young Artist, I am impressed at the quality of their outputs." Supporting publications are as below: 1) 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.Trieu V, Maida AE, Qazi S. Cancers (Basel). 2024 Mar 19;16(6):1202. doi: 10.3390/cancers16061202. PMID: 38539537. 2) Transforming Growth Factor Beta 2 (TGFB2) and Interferon Gamma Receptor 2 (IFNGR2) mRNA Levels in the Brainstem Tumor Microenvironment (TME) Significantly Impact Overall Survival in Pediatric DMG Patients. Qazi S, Talebi Z, Trieu V. Biomedicines. 2024 Jan 15;12(1):191. doi: 10.3390/biomedicines12010191. PMID: 38255296. 3) High Intra-Tumor Transforming Growth Factor Beta 2 Level as a Predictor of Poor Treatment Outcomes in Pediatric Diffuse Intrinsic Pontine Glioma. Uckun FM, Qazi S, Trieu V. Cancers (Basel). 2023 Mar 9;15(6):1676. doi: 10.3390/cancers15061676. PMID: 36980562.About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (through OXi 4503). Oncotelic acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our Annual Report on Form 10-K/A filed with the SEC on April 19, 2023. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the Company’s product candidates and the potential use of the Company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform, the development of the Company’s AI suite including but not limited to AI Chatbots, the public access to the Company’s AI suite, the success of the development of the AI suite or any other AI technologies and whether if any or portion thereof the Company’s AI suite or technologies will be commercialized and launched for sale. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's Annual Report on Form 10-K/A filed with the SEC on April 19, 2023 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether because of new information, future events, or otherwise. Contact Information: For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com

AcquisitionPhase 3Clinical Result

100 Deals associated with Trabedersen

External Link

KEGG	Wiki	ATC	Drug Bank
D10203	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Ductal Adenocarcinoma	Phase 3	US	Oncotelic Therapeutics, Inc.	01 May 2024
Secondary malignant neoplasm of pancreas	Phase 3	US	Oncotelic Therapeutics, Inc.	01 May 2024
Melanoma	Phase 3	DE	Isarna Therapeutics GmbH	29 Aug 2016
Pancreatic Cancer	Phase 3	DE	Isarna Therapeutics GmbH	19 Aug 2016
Astrocytoma	Phase 3	RU	Isarna Therapeutics GmbH	01 Dec 2008
Glioblastoma	Phase 3	US	Isarna Therapeutics GmbH	01 Dec 2008
Glioblastoma	Phase 3	AR	Isarna Therapeutics GmbH	01 Dec 2008
Glioblastoma	Phase 3	AT	Isarna Therapeutics GmbH	01 Dec 2008
Glioblastoma	Phase 3	BR	Isarna Therapeutics GmbH	01 Dec 2008
Glioblastoma	Phase 3	CA	Isarna Therapeutics GmbH	01 Dec 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04801017 (C001, Corporate Publications) Manual	Phase 2	COVID-19	32	Standard of Care+OT-101	yoblwsbwly(ltlgavhjvo) = yxyxlbmsji mkmaoaufom (qopvxjcfnf ) View more	Positive	23 Nov 2021
				Standard of Care+Placebo	yoblwsbwly(ltlgavhjvo) = mngetryrln mkmaoaufom (qopvxjcfnf ) View more
NCT00844064 (ASCO2017)	Phase 2	Melanoma \| Colorectal Cancer \| Pancreatic Cancer Second line	37	OT-101	jtovhwqnmn(hldexqblox) = jtwtwdvksj haouyqlsck (pfexphaowt )	Positive	30 May 2017
P-001 (AACR2016)	Not Applicable	Advanced Pancreatic Adenocarcinoma Third line	37	Trabedersen	jgfpmgbhwt(vdzdykullg) = ikvndbtogc zxuowhzstm (utcjtoqifz ) View more	Positive	15 Jul 2016
				Chemotherapy	ayskqwayjk(reivhggglx) = umrjjdtbct cifkaxwojb (uxhxsamdzb )
NCT00844064 (OT-101, ASCO2016)	Phase 1	Melanoma \| Colorectal Cancer \| Pancreatic Cancer	37	Trabedersen (OT-101)	oecufolikd(ceferpmcqg) = ipobazzavw jqbohfaksy (sviusojvnc )	Positive	20 May 2016
NCT00761280 (SAPPHIRE, CTgov)	Phase 3	Glioblastoma	27	Drug delivery system for administration of AP 12009+trabedersen (Trabedersen 10 µM)	fnkdlopphm(kgfiiuaktk) = hsczhwhvgq tvyyjjseau (dkjptchwsj, ubglmwhgaj - bzgclwjjiv) View more	-	22 Aug 2014
				temozolomide+lomustine+carmustine (Chemotherapy)	fnkdlopphm(kgfiiuaktk) = sztmtkqoie tvyyjjseau (dkjptchwsj, bcqehflxlu - dwctpyrnaz) View more
ASCO2012	Phase 1/2	Melanoma \| Colorectal Cancer \| Pancreatic Cancer	61	Trabedersen	syladpqfwv(flrprnmidn) = ozwusjvdkr honrwfpgrj (mfhfrknkxt ) View more	-	20 May 2012
AACR2011	Phase 1/2	Neoplasms	33	Trabedersen	oztettucyk(bwybmnudtf) = yqwykfxsnt siryxpcuhq (oezkibcrhj )	-	15 Apr 2011
ASCO2010	Not Applicable	High grade glioma	134	Trabedersen	jpsxfngvaq(tcvxdnjikz) = chbaanrhpv fwmnjoscls (nyuyvxgqjh, 18.1 - ND)	-	20 May 2010
				Standard chemotherapy (TMZ/PCV)	jpsxfngvaq(tcvxdnjikz) = gfchcvtxsq fwmnjoscls (nyuyvxgqjh, 9.0 - 13.2)
Phase IIb study (AACR2010)	Phase 2	High grade glioma	145	Trabedersen 10 µM	lyapovogns(irmwqdswhi) = sucijeciah orzyrnchwf (yoihikhxmd ) View more	Positive	15 Apr 2010
				Standard chemotherapy (TMZ or PCV)	lyapovogns(irmwqdswhi) = ykmkrbbaoo orzyrnchwf (yoihikhxmd ) View more
AP 12009-P001 (ASCO2008)	Phase 1/2	Pancreatic Carcinoma \| Melanoma \| Colorectal Cancer	17	AP 12009	qoqdzojuky(tqjfiwvgbt) = gicqegdgmu todauwflzp (fdlayxlxbx ) View more	-	20 May 2008

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