GILD?????,6;41a.m. 07-07-2020 .M. Mateon Therapeutics Appts.
Dr. Anthony Maida as Chief Clinical Officer - Translational Medicine
6:41 am ET July 7, 2020 (Globe Newswire) Print
Company expands its management team to accelerate the evaluation of OT-101 for Oncology and COVID-19
[below][ OT-101, a TGF-Beta antisense drug candidate]
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$MATN WORTH $$$$$'$
MATEON ANNOUNCES INITIATION OF PHASE 1B CLINICAL TRIAL ON OT-101/IL-2 COMBINATION THERAPY FOR SOLID TUMORS
2021-03-15 07:12 ET - News Release
AGOURA HILLS, California, March 15, 2021 (GLOBE NEWSWIRE)
-- Mateon Therapeutics Inc. (OTCQB:MATN) today announced the
regulatory approval from the Ministry of Food and Drug Safety of Korea for the phase 1b clinical trial of a patented OT-101/IL-2 combination.
This phase 1b clinical trial will confirm the safety and effectiveness of OT-101/IL-2
in solid cancer patients in cooperation with the UK global pharmaceutical company Clinigen Group.
The study will be conducted together with Autotelic BIO- a partner of Mateon on OT-101/IL-2 combination.
OT-101 has received orphan drug designation for
glioblastoma,
melanoma, and
pancreatic cancer.
Furthermore,
*****FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101*****
is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.
OT-101 has demonstrated robust efficacy
against pancreatic cancer, glioblastoma,
and melanoma during phase 2 clinical trials.
The demonstration that OT-101 will synergize with IL-2 further demonstrate its utility as adjunct to other immunotherapies.
Interleukin-2 (IL-2, Aldesleukin, PROLEUKIN®) Immunotherapy is cancer treatment that stimulates the body's immune system to fight cancer,
such as melanoma.
About Mateon Therapeutics
Mateon was created by the recent reverse merger with Oncotelic
which became a wholly owned subsidiary of Mateon Therapeutics Inc. creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer.
OT-101, the lead immune-oncology drug candidate of Mateon/Oncotelic,
is a first-in-class RNA therapeutic targeting TGF beta that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings.
The founding team members of Oncotelic were responsible for the development of Abraxane as chemotherapeutic agents for
breast,
lung,
melanoma, and
pancreatic cancer.
Abraxane was approved in 2005 and has more than $1B in sales annually.
The same founding team was responsible for the development of Cynviloq,
a next generation Abraxane, which was acquired by NantPharma for $1.3B.
Mateon/Oncotelic will leverage its deep expertise in oncology and
RNA therapeutic drug development to improve treatment outcomes and survival of cancer patients. For more information, please visit
http://www.oncotelic.com and www.mateon.com.
About OT-101
OT-101 is an antisense against the host TGF-ß 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-ß 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-ß 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.).
About Mateon Therapeutics
Mateon was created by the 2019 merger with Oncotelic,
which became
a wholly owned subsidiary of Mateon, 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 Mateon/Oncotelic,
is a first-in-class anti-TGF-ßRNA 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 paediatric cancers.
Mateon has rare paediatric designation for DIPG (OT-101),
melanoma (CA4P), and AML (OXi4503). For more information,
please visit
http://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, t
he 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 10, 2019 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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Mateon Therapeutics (OTC.QB: MATN), a late-stage biotechnology company developing Trabedersen (OT-101),
a TGF-B inhibitor with the potential for multiple therapeutic indications including glioblastoma,
pancreatic cancer,
melanoma and
COVID-19, appointed Anthony Maida, III, Ph.D., MA, MBA as Chief Clinical Officer - Translational Medicine for the Company.
Dr. Maida, a director of the Company since 2015, will retain his position as Board of Director. Dr. Maida is an expert in the clinical development of immuno-oncology and related products.
For close to 30 years, Dr. Maida has been involved in all aspects of commercial clinical, preclinical and scientific development of biotherapeutics including translational medicine,
protocol design,
FDA interactions,
manufacturing process validation, and
data assessment.
He has served in numerous executive and C-suite roles including Chairman,
Chief Executive Officer (CEO),
Chief Operating Officer (COO),
Chief Scientific Officer (CSO), and
Chief Financial Officer (CFO) for companies ranging from startups to public companies.
Dr. Maida has served on
multiple Boards of Directors and
Advisory Boards for public and
private companies,
hedge funds,
venture capital and pharma.
He is a member of the American Society of Clinical Oncology (ASCO),
the American Association for Cancer Research (AACR),
the Society of Neuro-Oncology (SNO),
the International Society for Biological Therapy of Cancer (iSBTC),
and the American Chemical Society (ACS).
Prior to graduate school,
Dr. Maida was Senior Controller for Lockheed Missile and Space Company,
reporting on $1.7 billion in revenue, and Vice President Finance - CFO of Lockheed DataPlan, Inc.
Dr. Maida holds a Ph.D. in Immunology (tumor immunology),
Master Degree in Toxicology,
an MBA and
two bachelor degrees (history and biology).
Dr. Maida, commented, "I look forward to driving the clinical development of OT-101 to its eventual approval as therapeutic
against COVID-19 and other indications.
The Mateon team has done a tremendous job bringing OT-101 to this stage of development and
I look forward to working closely with the entire clinical team,
our patients, our investigators, and our collaborators."
Dr. Vuong Trieu, Chief Executive Officer of Mateon said,
"We are honored that Dr. Maida has accepted the additional responsibilities within the Company.
With Dr. Maida at the helm we have further strengthened our clinical operation to deliver shareholder values across our therapeutic platforms."
About Coronavirus Disease 2019
Mateon is currently developing OT-101 as a TGF-B inhibitor against the TGF-B surge associated with COVID-19 that potentially drive the diverse clinical symptoms observed with COVID-19.
Coronavirus entry into cells is followed by suppression of cellular replication and redirection of cellular machineries to the
replication of the virus.
Cell cycle arrest is also centrally mediated by up-regulation of TGF-B. SARS coronavirus upregulates TGF-B via its nucleocapsid protein and papain-like protease (PLpro).
SARS coronavirus PLpro activates TGF-B1 transcription both in
cell-based assay and in mouse model with direct pulmonary injection.
TGF-B overexpression in SARS patients lung samples also been demonstrated.
Suppression of TGF-B expression by OT-101 suppressed SARS-CoV1 and SARS-CoV2 replication in the viral replication assays.
This means as viral load increases there will be a proportional increase in TGF-B which in turn drives the progression of COVID-19 disease.
By targeting TGF-B, OT-101 shuts off the engine behind COVID-19 allowing patients to recover without going into respiratory crisis.
In fact, the administration of a soluble type II TGF-B receptor, which sequesters free TGF-B during lung injury and protected wild-type mice from pulmonary edema induced by bleomycin or Escherichia coli endotoxin.
Furthermore, mice specifically lacking bronchial epithelial TGF-b1 (epTGFbKO) displayed marked protection from influenza-induced weight loss, airway inflammation, and pathology.
Additionally, these mice exhibited a heighted antiviral state resulting in impaired viral replication in epTGFbKO mice.
Their publication succinctly described the impact of TGF-B suppression against viral infection and we would propose that TGF-beta inhibitor would result in very similar if not the same protective responses against COVID-19.
A TGF-beta inhibitor is expected to broadly impacted COVID-19 disease and we would encourage developers of TGF-beta to collaborate and build on these observations such that we can arrive at a cure for COVID-19- either as single agent or combination with Remdesivir.
About Mateon's Lead Product Candidate, OT-101
High-grade gliomas (HGG) are characterized by a
T-cell exhaustion signature and
pronounced T-cell hyporesponsiveness of their tumor microenvironment (TME).
Transforming growth factor beta 2 (TGF- B2) has been implicated as a
key contributor to the immunosuppressive landscape of the TME
in HGG. OT-101, a first-in-class RNA therapeutic designed to abrogate the immunosuppressive actions of TGF- B2, i
s Oncotelic's lead anti-brain tumor drug candidate.
OT-101 has been granted orphan designation by the FDA under the Orphan Drug Act (ODA).
ODA provides for granting special status to a drug to treat a rare disease or condition upon request of a drug company.
Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing.
In a completed Phase 2 clinical study, OT-101 exhibited clinically meaningful single-agent activity and induced durable complete and partial responses in recurrent and refractory adult HGG patients, including young adults with GBM or AA.
About Mateon Therapeutics
Mateon was created by the recent reverse merger with Oncotelic which became a wholly owned subsidiary of Mateon Therapeutics Inc. (OTCQB:MATN) creating an immuno-oncology company dedicated to the
development of first in class RNA therapeutics as well as small
molecule drugs against cancer.
OT-101, the lead immuno-oncology drug candidate of Mateon/Oncotelic, is a first-in-class anti-TGF beta RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings.
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 pediatric cancer patients.
Mateon has rare pediatric designation for DIPG (CA4P) and melanoma (CA4P). For more information, please visit
http://www.oncotelic.com and
http://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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Mateon Report Positive Results for Multiple COVID-19 Drug Candidates
OT-101 and two additional candidates demonstrated viral inhibition activity against coronavirus
March 25, 2020 08:00 ET | Source: Mateon Therapeutics
AGOURA HILLS, Calif., March 25, 2020 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (OTCQB:MATN) (“Mateon”) dedicated to the development of OT-101, a TGF-Beta antisense drug candidate,
today provided an update on its rapid antiviral response program targeting coronaviruses,
initially targeting COVID-19. OT-101 continued to show significant activity against coronaviruses and in the new testing results,
two additional therapeutic oligonucleotides designed to target COVID-19 also demonstrated potent anti-viral activity.
The candidates were all designed to work synergistically to avoid resistant mutations frequently seen with viral infections.
OT-101 and the other candidates work by inhibiting virus binding to its target, thereby stopping the virus from replicating itself and stopping viral induced pneumonia,
which often leads to patient complications.
The results of the new studies came through joint efforts between
Mateon and its partner, Golden Mountain Partners, LLC (GMP),
which have teamed up to build an international world class program
for rapid response against COVID-19 and future epidemics.
The Company has begun preparations to submit an
Investigational New Drug Application (IND) to the Food and Drug Administration (FDA)
for OT-101 against COVID-19 to expedite testing in COVID-19 patients.
The collaborative effort was able to manufacture and test multiple new therapeutic drug candidates within weeks from time of viral sequencing. The effort was built on the companies experience with the specific antisense backbone and its well described safety profile.
OT-101 is ready to move into clinical testing in COVID-19 patients and the new candidates can be ready shortly thereafter.
The anti-sense program that Mateon has developed has the potential to
go from concept to clinic in months, rather than years, which is highly suitable as a rapid response to pandemics.
Dr. Vuong Trieu, President and Chief Executive Officer of Mateon stated:
“We are excited about our platform for rapid response against viral epidemics and look forward to working with GMP to further expand on
that platform in the US and China.”
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