Reverse Merged with MATEON THERAPEUTICS Formally MATN
Oncotelic – Welcome to Oncotelic
$11 Billion Target Markets - 100+ Patent Applications - 2 Key Clinical Programs - 30+ Years Experience
Mateon has three major business segments: 1) PointR- developer of vision grid/cluster computing/AI to support drug development. 2) Mateon/Oxigene- developer of Vascular Disrupting Agent (CA4P and Oxi4503). FDA granted CA4P rare pediatric designation for pediatric melanoma in 2020 and OXi4503 rare pediatric designation for pediatric ALL. 3) Oncotelic- developer of OT-101 - an antisense against TGF-beta- for the treatment of cancers. OT-101 completed phase 2 with good safety and efficacy against pancreatic cancer, glioblastoma, and melanoma. OT-101 also been granted rare pediatric designation against pediatric DIPG in 2019. OT-101 is also being deployed against COVID-19. OT-101 is in phase 2 clinical trial against COVID. We are also developing Artemisinin in phase 4 clinical trial against COVID. It is approved by India for symptoms frequently observed in COVID. It is being launch by end of 2020. Global launch will be soon after.
Oncotelic (formerly known as Mateon Therapeutics, Inc.) was created by the 2019 reverse merger with Oncotelic, which became a wholly owned subsidiary of Oncotelic, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has shown activity against SARS-CoV-2 and COVID-19. 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 DIPG (OT-101), melanoma (CA4P), and AML (OXi4503). For more information, please visit www.oncotelic.com and www.Oncotelic.com.
ARTIShield ™/ARTIVedaTM- an Ethnobiology Drug
Mateon is pursuing several avenues with respect to the development and commercialization of ARTIShield™ in the treatment of COVID-19. ARTIShield™ is Ayurveda - Dvipaantara Damanaka - and is labeled as a capsule containing Artemisia Powder 500mg. It is a demonstration of how Ethnobiology can be used to drive drug development against emerging pandemics.
The classical pharmaceutical regulatory pathways have failed to provide fast-track to treatment and vaccines. Government resources have concentrated on a few candidates most of which have failed. The Ayurvedic medicine route is proving to be an accelerated pathway to deploy a well-known, abundantly available and cost effective Ayurvedic medicine that is safe and being proven in-vitro and large-scale clinical trial to be effective.
ARTIShield ™/ARTIVeda™ - Commercialization in India
Mateon announced that ARTIShield ™/ARTIVeda™ has been approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) in India for the treatment of various symptoms including fever and inflammation, which can be associated with COVID-19. ARTIShield™ is in co-development with Windlas Biotech Pvt. Ltd., Mateon’s commercial partner for India and is designed to be a readily available and cost-effective agent to combat COVID-19. ARTIVeda™ is the tradename for India and ArtiShieldTM is the tradename for outside of India. Mateon expects sales will commence in India before year end.
ARTI-19 Multi-national Phase IV Trial, Currently in India
Mateon announced the enrollment of its first patient in a Phase IV study ARTI-19, “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. This is a global study with India to contribute at least 300 patients to the total aggregate of 3000 patients. We expect preliminary top-line data for ARTI-19 sometime between Q420 and Q121.
OT-101 is an antisense against the host TGF-β 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-β 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-β 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). Cell Death & Differentiation 2020; https://doi.org/10.1038/s41418-020-0572-6.).
OT-101 is also being developed as an adjuvant for second generation COVID-19 vaccine. To avoid the two potential issues with 1st generation vaccine against COVID-19, we will be combining the 1st generation COVID-19 DNA vaccine with a TGF-β inhibitor (OT-101) to stimulate a strong immune response while suppressing the IgA class switching
ArtiVeda/ArtiShield – a natural derivative from the plant Artemisia – 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. Artemisinin derivatives are used to treat malaria. More Information.
OT-101 – an antisense against TGF-β2 – 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, also referred to Trabedersen, is a novel antisense oligodeoxynucleotide (ODN) developed by Oncotelic for the treatment of patients with pancreatic carcinoma, malignant melanoma, colorectal carcinoma, high-grade glioma (HGG), and other transforming growth factor beta 2 (TGF-β2) overexpressing malignancies (e.g., prostate carcinoma, renal cell carcinoma, etc.).
Trabedersen is a synthetic 18-mer phosphorothioate oligodeoxynucleotide (S-ODN) complementary to the messenger ribonucleic acid (mRNA) of the human TGF-β2 gene. Cancers overexpress TGF-β, which suppresses host innate immune response to the cancers. Treatment with OT-101 lifts the TGF-β 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.
OT-101 – an antisense against TGF-β2 –for the treatment of various viruses, including the SARS and the current COVID-19, on its own and in conjunction with other compounds.
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. US Food and Drug Administration (FDA) granted our request and designate OXi4503 (combretastatin A1-diphosphate; CA1P) for treatment of acute myeloid leukemia (AML) due to genetic mutations that disproportionately affect pediatric patients as a drug for a “rare pediatric disease”, as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360ff(a)(3)).
could aggravate the disease through Kawasaki reaction- IgA vasculitis. The company is aggressively pursuing the development of this 2nd generation COVID-19 vaccine expecting that the 1st generation vaccines would not be fully effective and may not be sufficiently protective to counter the current pandemic.
The development of OT-101 is important given the failure of other drugs leaving dexamethasone as the only clinically proven effective drug against COVID-19.