Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, today 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.

“It is gratifying to identify what we think is the fundamental evolutionary pathway for SARS-CoV-2,” said Dr. Vuong Trieu, CEO and Chairman of Oncotelic. “The analysis allows us to position our therapeutic and vaccine platform against ORF8 to address this pandemic as it further mutates.”

Mutational analysis of SARS-CoV-2. ORF8 and the evolution of the Delta and Omicron variants. Gopika Trieu, Vuong N Trieu. medRxiv 2021.12.19.21268069; doi: https://doi.org/10.1101/2021.12.19.21268069. https://www.medrxiv.org/content/10.1101/2021.12.19.21268069v1

In our analysis, we 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 we leverage our 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.

Supporting publications are as below:

[1]  F.M. Uckun et al., Repurposing Anti-Malaria Phytomedicine Artemisinin as a COVID-19 Drug, Front. Pharmacol. 12 (2021) 407. https://doi.org/10.3389/FPHAR.2021.649532/BIBTEX.

[2] F.M. Uckun, V. Trieu, Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children, 3 (2020) 19–21. https://doi.org/10.1542/hpeds.2020-0123.Harahsheh.

[3] F.M. Uckun, L. Hwang, V. Trieu, Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ards inCOVID-19, Clin. Investig. (Lond). 10 (2020) 35–44. https://doi.org/10.37532/2041-6792.2020.10(2).166.

[4] V. Trieu et al., Targeting TGF-β pathway with COVID-19 Drug Candidate ARTIVeda/PulmoHeal Accelerates Recovery from Mild-Moderate COVID-19, MedRxiv. (2021) 2021.01.24.21250418. https://doi.org/10.1101/2021.01.24.21250418.

About Oncotelic Therapeutics

Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) ("Oncotelic"), 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 an artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-β RNA therapeutic that exhibited single agent activity in relapsed/refractory cancer patients. OT-101 also has shown activity against SARS-CoV-2 and has completed a phase 2 trial against COVID-19 with data cleaning and datalock ongoing. 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 also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company also acquired PointR Data Inc. ("PointR") in November 2019.

For more information, please visit www.oncotelic.com

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, the progress, timing, 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. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements. 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. 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 filed with the SEC on April 15, 2021 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 as a result of new information future events, or otherwise.

Contact Information:
For Oncotelic Therapeutics, Inc.:
Amit Shah
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