AGOURA HILLS, Calif., Oct. 20, 2021 (GLOBE NEWSWIRE) — Oncotelic Therapeutics, Inc. (“Oncotelic” or the “Company”) (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology today announced an update on the Phase 2 C001 Covid Study and the OT-101-ONC program for the potential first-in-class investigational TGF-β immunotherapy, OT-101, in difficult-to-treat cancers.

On October 18, Data lock and SDTMs & ADaMS Databases were generated for Phase 2 C001 Covid Study: “A Double-Blind, Randomized, Placebo Controlled, Multi-Center Study of OT 101 in Hospitalized COVID-19 Subjects”. The top line data will be reported when data analysis is completed.

The OT-101-ONC program is designed to assess the impact of OT-101 across multiple cancer indications where local tumoral secretion of TGF-β suppressed the clinical activity of checkpoint inhibitors, CAR-T, and vaccine. The OT-101-ONC program has been moving forward steadily through strategic alliance with top pharmaceutical companies. OT-101-ONC program was expanded to include mesothelioma, melanoma, glioblastoma, and pancreatic cancer.

Ongoing OT-101-ONC trials

IL-2: Phase 1b trial combination of OT-101 with IL-2 (Proleukin®, Aldesleukin) in collaboration with Clinigen Group and ABIO. Trial scheduled to completed in 2020.

PD-1: Multiple phase 2 trials combination of OT-101 with a PD-1 inhibitor in collaboration with a top-five pharmaceutical company. The participating members of this consortium will be disclosed in future dates when allowed. Trials scheduled to initiate throughout 2021-2022. Of note is the biomarker program spanning mesothelioma, glioblastoma, lung, and colorectal cancers where AI driven transcriptome analyses will be used to derived the predictive biomarker for TGF-β therapeutics including OT-101.

“The ground work laid down for IL-2 and PD-1 will serve as the foundation of future strategic alliances to include CAR-T and Vaccine.” said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.

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 May 20, 2020 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

[email protected]


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