Oncotelic Therapeutics Inc (OTLC)

[Penny Stocks 2.0]

Overview

 

We are a clinical-stage biopharmaceutical developing drugs for the treatment of orphan oncology indications, developing antisense and small molecule injectable drugs for the treatment of cancer with a focus on rare pediatric cancers, and addressing the current global pandemic. As a result of the merger of Oncotelic and Oncotelic Inc. and the acquisition of PointR in April and November 2019, respectively, we believe we are well positioned as a biotech company with: 1) PointR AI/blockchain for superfast back office support, 2) Edgepoint for developing technologies for supporting our COVID-19 programs, 3) Oncotelic Inc.’s antisense platform with OT-101- the flagship drug candidate - targeting high value TGF-ß2 target for various cancers and COVID-19, 4) Artemisinin for COVID-19 and 5) the Company’s vascular disruptor proven safe in more than 500 patients capable of causing massive antigen release which would stimulate immune response against the tumor.

 

The Company is a developer of an antisense RNA therapeutic (“OT-101”) against TGF-ß as immunotherapy for a broad range of cancers. Cancers overexpress TGF-ß, which suppresses host innate immune response to the cancers. Treatment with OT-101 lifts the TGF-ß cloaking effect and allows innate or therapeutic immunity to attack and eliminate the cancers. We have completed phase 2 for pancreatic cancer and melanoma and phase 2 in glioblastoma with robust efficacy and safety. Last year, the Food and Drug Administration (“FDA”) granted us Rare Pediatric Designation (“RPD”) for pediatric Diffuse Intrinsic Pontine Glioma (“DIPG”). We are pushing forward into phase 3 either independently or through a proposed joint venture with a Chinese entity with clinical trials in China for pancreatic cancer. Other indications are to follow subsequently. In the United States of America (“United States”, “USA” or “US”) we will be focusing pediatric DIPG with the clinical trials for which we are in discussions with various parties on how to proceed with the program. This strategy of doing phase 3 trials in adults, including possibly in China, and doing rare pediatric pivotal trials in the US will allow us to capitalize on the voucher program in the US and subsequently leverage on the Chinese data for indication expansion into adult. By focusing on RPD we anticipate: 1) reducing the cost of clinical development by way of a smaller and faster clinical trial, 2) acceleration of approval, 3) obtaining regulatory/ marketing exclusivity for 12 years for small molecules and 17 years for biologics, and 4) obtaining a voucher worth upward of $100 million on approval. In the case of DIPG for OT-101 we are anticipating the trial would last no more than 2 years with 30 patients costing approximately $5-7 million with a substantial return on investment. This is the same strategy that we are adopting for our other pipeline drugs- CA4P and Oxi4503. These are vascular disruptor agents with extensive phase 1 and phase 2 testing, and which we feel are ready to enter into meaningful pivotal clinical trials. We are also developing OT-101, an antisense against TGF-ß2 – for the treatment of various viruses, including the Severe Acute Respiratory Syndrome (“SARS”) and the current coronavirus (“COVID-19”), on its own and in conjunction with other compounds. In addition, the Company is developing Artemisinin, through its product ArtiShieldTM. Artemisinin, purified from a plant Artemisia annua, is able to inhibit TGF-ß activity and is able to neutralize COVID-19. The Company’s test results during an in vitro study at Utah State University showed Artemisinin having an EC50 of 0.45 ug/ml, and a Safety Index of 140. Artemisinin can target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. Viral replication cannot occur without TGF-ß. Artemisinin also has been reported to have antiviral activities against hepatitis B and C viruses, human herpes viruses, HIV-1, influenza virus A, and bovine viral diarrhea virus in the low micromolar range. TGF-ß surge and cytokine storm cannot occur without TGF-ß. In a clinical study undertaken in India, clinical consequences related to the TGF-ß surge, including ARDS and cytokine storm, were suppressed by targeting TGF-ß with Artemisinin. The clinical study showing these results was a global study with India to contribute at least 120 patients to the total aggregate of 3000 patients. The ARTI-19 trials were conducted in India by Windlas Biotech Private Limited, the Company’s business partner in India, as part of the Company’s global effort at deploying ArtiShieldTM across India, Africa, and Latin America.

 

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The Company has also developed a cough app to help patients use to assess their respiratory condition at the onset of taking the drug and over the period of their treatment, which is key in COVID-19 patients. Patients would use the app to measure their coughs and get a real-time assessment of the cough to show how the patient is progressing in terms of their treatment. The Company has also developed a post marketing survey (“PMS”) tool for patients to use and provide data that would be useful to determine the efficacy of the drug. The cough app and PMS both use AI technologies. All in all, the drug plus the app and the PMS are a full 360 degree of treatment.

 

As we move into clinical and commercial development of our various products enumerated below, we are planning on implementing AI & vision powered Blockchain technology into our drug development process so that clinical development, clinical trials, and drug manufacturing can be done real time with full data integrity using AI/Vision powered blockchain technology.

 

We have seven primary drug and AI technology programs we are seeking to advance:

 

? OT-101 - an antisense against TGF-ß2 – for the treatment of solid tumors with focus on brain cancer in adult and DIPG in children. RPD for pediatric DIPG granted by US FDA.

 

? OT-101 - an antisense against TGF-ß2 –for the treatment of various viruses, including the SARS and the current COVID-19, on its own and in conjunction with other compounds.

 

? Artemisinin – a natural derivative from an Asian herb Artemisia Annua - Artemisinin has shown to be highly potent at inhibiting the ability of the COVID-19 causing virus to multiply while also having an excellent safety index.

 

? CA4P- a vascular disrupting agent (“VDA”)- in combination with Ipilimumab for the treatment of solid tumors with focus on melanoma in adult and pediatric melanoma. On May 4th, 2020, FDA granted Rare Pediatric Disease Designation for CA4P/ Fosbretabulin for the treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients as a drug for a “rare pediatric disease”.

 

? Oxi4503- a second generation VDA- for the treatment of liquid tumors with focus on childhood leukemia. RPD application for pediatric AML submitted to US FDA and favorable initial response obtained.

 

? Backoffice support using PointR fabric cluster computing grids for blockchain/AI for pharmaceutical manufacturing and clinical monitoring and PointR AI Navigator for drug development.

 

? Developing AI based technologies to enhance and support the development and commercialization of our Artemisinin based products.