Form 8-K MATEON THERAPEUTICS INC For: Nov 18

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

Current Report

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

November 18, 2019

 

 

MATEON THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware		000-21990		13-3679168
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

29397 Agoura Road Suite 107

Agoura Hills, CA 91301

(Address of principal executive offices and Zip Code)

 

Registrant’s telephone number, including area code

(650) 635-7000

 

 

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

[  ]	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[  ]	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of class		Trading Symbols		Name of each exchange on which registered
N/A

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company [  ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

 

 

Item 8.01 Other Events

 

On November 18, 2019, Mateon Therapeutics, Inc. (the “Company”) issued a press release announcing it will present data updates regarding the anti-brain tumor activity of its 1^st in class RNA therapeutic OT101 during the upcoming 2019 Society for Neuro-Oncology (SNO) Annual Meeting on November 20-November 24 in Phoenix, Arizona (https://www.soc-neuro-onc.org/SNO/2019Annual/2019AnnualHome.aspx). A copy of that press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Information presented in Items 8.01 of this Current Report on Form 8-K and Exhibits 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Forward-Looking Statements

 

The press releases filed with this report contain “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by 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. In addition, when or if used in this communication, the words “will,” “may,” “would,” “approximate,” “expect,” “intend,” and similar expressions and their variants.. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including the risk factors included in the Company’s Annual Report on Form 10-K filed with the SEC on April 10, 2019. Forward looking statements are based on information available and assumptions as of the date of this report. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description		Incorporation by reference
99.1		Press Release		Filed herewith.

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	Mateon Therapeutics, Inc.
Date: November 20, 2019		/s/ Vuong Trieu
	By:	Vuong Trieu
		Chief Executive Officer

 

 

Mateon Therapeutics to Present New and Updated Data for OT101 (Trabedersen) Activity Against Brain Tumors at the 2019 Society for Neuro-Oncology (SNO) Annual Meeting

 

AGOURA HILLS, Calif., November 18, 2019 (GLOBE NEWSWIRE) — Oncotelic Inc. (“Oncotelic”), a wholly owned subsidiary of Mateon Therapeutics Inc. (OTCQB: MATN) dedicated to the development of innovative treatments for cancer, today announced that it will present data updates regarding the anti-brain tumor activity of its 1^st-in class RNA therapeutic OT101 during the upcoming 2019 Society for Neuro-Oncology (SNO) Annual Meeting on November 20-November 24 in Phoenix, Arizona (https://www.soc-neuro-onc.org/SNO/2019Annual/2019AnnualHome.aspx).

 

“We look forward to sharing the latest data on the clinical impact potential of OT101 that will add to the body of evidence supporting its potential as a future treatment option for high-grade glioma patients,” said Fatih Uckun, M.D., Ph.D., Chief Medical Officer, Mateon Therapeutics. “These presentations underscore our continued efforts to advance the standard of care and improve treatment expectations for brain tumor patients”, added Vuong Trieu, Ph.D, the Chief Executive Officer and President of Mateon Therapeutics.

 

On November 22, for the first time, the Mateon team will present a poster regarding the predictors of response and treatment outcome. Presentation details:

 

Abstract #: ATIM-10

Abstract Title: Clinical predictors of response for recurrent/refractory glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA, WHO grade III) patients treated with the anti-TGF ß 2 RNA therapeutic OT-101

Session: Poster Session

Date: Friday November 22, 2019

Presentation Time: 7:30 PM – 9:30 PM

 

On November 23, Dr. Uckun will give a talk as oral abstract speaker on the comparison between OT101 and the standard chemotherapy drug temozolomide in high-grade anaplastic astrocytoma patients. Presentation details:

 

Abstract #: ATIM-06

Presentation Title: Treatment of recurrent/refractory (R/R) anaplastic astrocytoma (AA, WHO grade 3) patients with anti-TGFß2 RNA therapeutic OT-101 versus temozolomide is associated with improved overall survival

Session: Concurrent Session 3B: Surgery/Radiation Therapy/CNS Metastasis (3B)

Date: Saturday November 23, 2019

Presentation Time: 1:40 PM – 1:50 PM

 

Later on November 23, the Mateon team will present a second poster with post-hoc analysis of the single agent efficacy of OT101 with prolonged follow-up results from the G004 Phase 2 clinical study. Presentation details:

 

Abstract #: ATIM-03

Abstract Title: Anti-TGFß2 RNA therapeutic OT-101 induces durable objective responses in patients with recurrent/refractory (R/R) glioblastoma multiforme (GBM, WHO grade 4) or anaplastic astrocytoma (AA, WHO grade 3)

Session: Poster Session

Date: Saturday November 23, 2019

Presentation Time: 5:00 PM – 7:00 PM

 

 

“The durable objective responses achieved in adult patients with recurrent/refractory high-grade gliomas after treatment with our lead anti-TGF beta2 compound OT-101 contribute to our optimism that new treatment strategies leveraging OT101 may favorably change the therapeutic landscape for difficult-to-treat brain tumors with a very poor prognosis”, Dr. Uckun explained.

 

Last month, US Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for OT101/Trabedersen for the treatment of diffuse intrinsic pontine glioma (DIPG) as a drug for a “rare pediatric disease,” as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act. “Our recently published in silico validation of the TGF beta2 gene product, which is the molecular target for OT101/Trabedersen, as a target for immunotherapy in pediatric high-grade gliomas, especially DIPG, indicates that OT101 may also have future potential for the treatment of pediatric DIPG, an orphan disease with a low survival rate and no established or effective standard of care,” explained Dr. Uckun.

 

Dr. Trieu stated: “There is no standard treatment for progressive DIPG after the failure of radiation therapy and no salvage regimen has been shown to extend survival. Therefore, there is an urgent need for therapeutic innovations for treatment of DIPG. Further development of OT-101 may offer renewed hope for salvage therapy of pediatric DIPG patients who have this rare and fatal disease.”

 

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. The founding team members of Oncotelic were responsible for the development of Celgene’s Abraxane as a chemotherapeutic agent for breast, lung, melanoma, and pancreatic cancer. Abraxane was approved in 2005 and has more than $1B in sales annually. The same team was also responsible for the development of Cynviloq, a next generation Abraxane, which was acquired by NantPharma for $1.3B. 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. For more information, please visit www.oncotelic.com and www.mateon.com. The Chief Medical Officer of Mateon, Dr Fatih Uckun MD, PhD, is an internationally renowned KOL in pediatric cancer research and treatment. Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial Award of the Leukemia Society of America (now known as Leukemia and Lymphoma Society), the highest honor given to a Leukemia Society Clinical Scholar. Dr. Uckun completed his residency training in pediatrics, clinical fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation as well as postdoctoral research training in immunology at the University of Minnesota. Dr. Uckun has more than 30 years of professional experience in developmental therapeutics with a special emphasis on targeted therapeutics/precision medicines and biopharmaceuticals against childhood cancer. Dr. Uckun worked as a Professor of Pediatrics, Therapeutic Radiology-Radiation Oncology, Pharmacology, as well as Director of the Biotherapy Institute at the University of Minnesota (1986-1997), where he became the first recipient of the highly prestigious Endowed Hughes Chair in Biotherapy, and as a Professor of Pediatrics and Head of Translational Research in Leukemia and Lymphoma of the Children’s Center for Cancer and Blood Diseases at the University of Southern California (2009-2015). From 2012-2015, Dr. Uckun served as chair of the Biotargeting Working Group and a Member of the Coordination and Governance Committee of the NCI Alliance for Nanotechnology in Cancer. Prior to joining Mateon, Dr. Uckun served as Head of Immuno-Oncology at Ares Pharmaceuticals and Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health. Prior to this, he was Chief Scientific Officer of Jupiter Research Institute and, before that, held senior-level scientific and research positions at Parker Hughes Institute and its cancer center, Paradigm Pharmaceuticals, and the Children’s Cancer Study Group, an NCI-funded cooperative clinical trials consortium that coordinated pediatric leukemia trials at 120 institutions in the US, Canada, Australia and Europe. As a Vice Chair of the New Agents Committee as well as Member of the Leukemia Steering Committee of the Children’s Cancer Study Group, Dr. Uckun has helped design and direct several Phase I-III studies in pediatric cancer patients.

 

Mateon recently completed a merger with PointR, whereby PointR has become a wholly owned subsidiary of Mateon. The merger is intended to create a publicly-traded 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.

 

 

About Mateon’s Lead Product Candidate, OT101

 

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 (TGFB2) has been implicated as a key contributor to the immunosuppressive landscape of the TME in HGG. OT101, a first-in-class RNA therapeutic designed to abrogate the immunosuppressive actions of TGFB2, is Oncotelic’s lead anti-brain tumor drug candidate. OT101 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.

 

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 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

Email: [email protected]

 

 

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