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Press Release

Nov 04, 2020
MATEON’S C001- A GLOBAL PHASE 2 STUDY FOR OT-101 AGAINST COVID-19- RECEIVED CLEARANCE FOR PATIENT ENROLLMENT

AGOURA HILLS, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (“Mateon” or the “Company”) (OTCQB:MATN) announced today the receipt of approval from Instituto Nacional de Salud (INS), the regulatory agency of Peru, to initiate the Company’s C001- Phase 2 clinical trial of OT-101, a TGF-β antisense, for the treatment of patients with mild to severe COVID-19 infection.

Mateon Therapeutics, Inc.
COVID-19 Vaccines


C001 trial is a multi-center, double blind, randomized, placebo-control study to evaluate safety and efficacy of OT-101 in combination with standard of care on two (2) patient cohorts – 1) mild or moderate disease, and 2) severe disease requiring mechanical ventilation or intubation. The study will enroll approximately 48 patients in Peru totaling 72 patients study wide. The primary efficacy endpoint is the proportion of subjects with clinical improvement score (measured by an 8‑point World Health Organization [WHO] COVID‑19 Clinical Improvement Ordinal Scale) as assessed by the Odds Ratio (OR) at Day 14.

“We are excited to be working with Centers of Excellence in Peru focusing on our promising and exciting therapeutic approach to treating patients diagnosed with COVID-19,” said Dr. Anthony Maida, Chief Clinical Officer – Translational Medicine, Mateon Therapeutics.

On October 19, 2020, Mateon announced the receipt of approval from Republica Argentina – Poder Ejecutivo Nacional of Argentina to initiate the Company’s Phase 2 clinical trial of OT-101 for the treatment of patients with mild to severe COVID-19 infection.

Dr. Maida observed that successive approval by major regulatory agencies in South America is indicative of high confidence of OT-101 as a potential treatment for COVID-19.

"We believe that the data will prove that COVID-19 is caused by the TGF-β surge. Mateon is diligently working with regulators across the globe to bring OT-101 to the patients," said Dr. Vuong Trieu, CEO of Mateon. "We are now entering the flu season and with the emergence of SARS-CoV-2/Influenza coinfection, the availability of OT-101 with therapeutic potential against both SARS-CoV-2 and influenza viruses would be essential to combat this pandemic."

About OT-101

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 that 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.

About Mateon Therapeutics

Mateon was created by the recent reverse merger with Oncotelic 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 Mateon/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 activity against SARS-CoV-2. Mateon/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. Mateon has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503). For more information, please visit www.oncotelic.com and www.mateon.com.

Mateon'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 Mateon Therapeutics, Inc.:

Amit Shah

ashah@oncotelic.com

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Source: Mateon Therapeutics, Inc.