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This disclosure relates to methods of treatment using compound (1) or analogs thereof, and pharmaceutically acceptable salts thereof. Also disclosed are compounds of formula (10): as defined in the specification, and pharmaceutically acceptable salts thereof, as well as pharmaceutical compositions comprising the same. Methods of treatment, such as for cancer, are provided that comprise administering the compounds and their salts to a subject in need of such treatment.


This disclosure relates, at least in part, to a method of treatment. In one embodiment, the method of treatment comprises administering to a subject in need of such treatment a first therapeutic agent including compound (1): (structurally represented) or a pharmaceutically acceptable salt thereof in combination with a second therapeutic agent, wherein the first therapeutic agent and the second therapeutic agent are administered either simultaneously or sequentially.


This disclosure relates, at least in part, to a method of treatment. In one embodiment, the method of treatment comprises administering to a subject in need of such treatment a first therapeutic agent including compound (1): or a pharmaceutically acceptable salt thereof in combination with a second therapeutic agent, wherein the first therapeutic agent and the second therapeutic agent are administered either simultaneously or sequentially.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.61M | Year: 2015

DESCRIPTION provided by applicant ONC is a clinical stage first in class small molecule with demonstrated anticancer activity against aggressive refractory recurrent glioblastoma multiforme GBM tumors in vitro ex vivo and in vivo This novel compound imparts its antitumor effects through a unique mechanism of action that involves indirect dual inactivation of Akt and ERK in tumor but not normal cells Several academic investigators at premier institutions have demonstrated the optimal preclinical profile of ONC in a multitude of models These findings have prompted Oncoceutics to rapidly translate this product into the clinic to treat advanced cancer patients The first in man trial is a phase I II study that will include patients with GBM is scheduled to begin in early at MGH and has been reviewed by the FDA as part of the accepted IND Following completion of the dose escalation phase I portion of the trial supported by Oncoceutics the phase II trial can begin to evaluate the monoagent efficacy of ONC in patients with advanced GBM In this fast track application we propose to develop an automated manufacturing process to provide the clinical supply of drug product followed by evaluation of the clinical efficacy of the resulting product in patients with GBM Phase Aim Optimize ONC formulation and produce GMP product for GBM trial Phase Aim Evaluate clinical efficacy of oral ONC in GBM These studies will enable a development path for ONC to treat GBM which is otherwise unattainable based on investor feedback that indicates a clear need for pilot clinical data in the indication to enable private support This proposal seeks to make a novel anticancer agent available to patients in dire need of treatment options will push the product toward commercialization sufficiently derisk private investments to enable subsequent development and will advance the field forward by enabling clinical evaluation of a novel therapeutic mechanism PUBLIC HEALTH RELEVANCE This proposal seeks to develop a new cancer drug called ONC for patients that have a deadly aggressive brain tumor that does not respond to any available treatments ONC works very effectively in brain tumor cell models in laboratories does not have toxic side effects in animals at doses that shrink tumors and works by in a way that has never been discovered before The FDA recently gave their permission for ONC to be tested in humans for the first time The first part of this proposal will develop a manufacturin process that will produce drug for use in human studies The second part of this proposal will evaluate the ability of ONC to shrink brain tumors in a small number of patients If the drug works in this trial investors would be willing to support further develop of the drug so that it cn be approved to treat cancer in the US and eventually around the world


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 210.00K | Year: 2015

DESCRIPTION provided by applicant ONC is a clinical stage first in class small molecule with demonstrated anticancer activity against aggressive refractory recurrent glioblastoma multiforme GBM tumors in vitro ex vivo and in vivo This novel compound imparts its antitumor effects through a unique mechanism of action that involves indirect dual inactivation of Akt and ERK in tumor but not normal cells Several academic investigators at premier institutions have demonstrated the optimal preclinical profile of ONC in a multitude of models These findings have prompted Oncoceutics to rapidly translate this product into the clinic to treat advanced cancer patients The first in man trial is a phase I II study that will include patients with GBM is scheduled to begin in early at MGH and has been reviewed by the FDA as part of the accepted IND Following completion of the dose escalation phase I portion of the trial supported by Oncoceutics the phase II trial can begin to evaluate the monoagent efficacy of ONC in patients with advanced GBM In this fast track application we propose to develop an automated manufacturing process to provide the clinical supply of drug product followed by evaluation of the clinical efficacy of the resulting product in patients with GBM Phase Aim Optimize ONC formulation and produce GMP product for GBM trial Phase Aim Evaluate clinical efficacy of oral ONC in GBM These studies will enable a development path for ONC to treat GBM which is otherwise unattainable based on investor feedback that indicates a clear need for pilot clinical data in the indication to enable private support This proposal seeks to make a novel anticancer agent available to patients in dire need of treatment options will push the product toward commercialization sufficiently derisk private investments to enable subsequent development and will advance the field forward by enabling clinical evaluation of a novel therapeutic mechanism PUBLIC HEALTH RELEVANCE This proposal seeks to develop a new cancer drug called ONC for patients that have a deadly aggressive brain tumor that does not respond to any available treatments ONC works very effectively in brain tumor cell models in laboratories does not have toxic side effects in animals at doses that shrink tumors and works by in a way that has never been discovered before The FDA recently gave their permission for ONC to be tested in humans for the first time The first part of this proposal will develop a manufacturin process that will produce drug for use in human studies The second part of this proposal will evaluate the ability of ONC to shrink brain tumors in a small number of patients If the drug works in this trial investors would be willing to support further develop of the drug so that it cn be approved to treat cancer in the US and eventually around the world


This disclosure relates, at least in part, to a method of treatment. In one embodiment, the method of treatment comprises administering to a subject in need of such treatment a first therapeutic agent including compound (1): or a pharmaceutically acceptable salt thereof in combination with a second therapeutic agent, wherein the first therapeutic agent and the second therapeutic agent are administered either simultaneously or sequentially.


News Article | October 6, 2015
Site: www.businesswire.com

HUMMELSTOWN, Pa.--(BUSINESS WIRE)--Oncoceutics announced the closing of a Series A financing round, led by Spring Mountain Capital, LP, with participation by additional private investors. The company will use the proceeds of the financing in conjunction with non-dilutive grant awards, public-private partnerships and academic alliances to continue the development of its lead drug compound, ONC201, a first-in-class, orally-active small molecule that penetrates the blood-brain barrier and exhibits strong anticancer activity in aggressive preclinical models of a number of different types of cancer, including lymphoma and glioblastoma multiforme (GBM). The company recently completed the first-in-man study of ONC201 at the Rutgers Cancer Institute of New Jersey and defined the recommended phase II dose (RP2D) that will be used in subsequent clinical studies. "Oncoceutics’ progress in the past year since our initial investment is impressive,” said Raymond Wong, Managing Director and Head of Private Equity at SMC, and member of the Oncoceutics Board of Directors. “The company successfully completed a phase I study and is transitioning into several phase II trials, extended its IP position through the issuance of additional patents, and determined that ONC201 engages a clinically-validated signaling pathway by a novel trigger that is clearly distinct from available therapies. We are excited about deepening our partnership with Oncoceutics by leading this Series A financing round and look forward to bringing this potentially breakthrough first-in-class cancer drug to patients.” "We are very grateful for support from Spring Mountain Capital and our other private investors,” said Lee Schalop, MD, Chief Business Officer and co-founder of Oncoceutics. “They have elected to significantly increase their investment in Oncoceutics based on our substantial progress since the closing of our Series Seed financing round a year ago. We’ll be able to complete our Phase II program in both solid tumors and hematologic malignancies using the funds from this financing round along with additional resources available to our company from alliances and grant awards, including a recent award from National Cancer Institute." Wolfgang Oster, MD PhD, CEO, Chairman and co-founder of Oncoceutics, added, “This funding round marks important progress for Oncoceutics that sets the stage to definitively prove the clinical value of its lead drug ONC201 and its analogs in cancer therapy. It demonstrates the mutual confidence our leadership team, supporters and collaborators have in the merit of our products.” "The promise that ONC201 holds and that may be extended through the portfolio of analogs under development could provide a significant benefit to several major cancer populations,” commented Keith Flaherty, MD, Director of Developmental Therapeutics, Cancer Center, Massachusetts General Hospital, and a member of Oncoceutics’ Scientific Advisory Board. “It is remarkable that this compound demonstrates potent anti-cancer effects in preclinical models, yet exhibits a benign safety profile as identified in the first human phase I study with ONC201.” Oncoceutics, Inc. is a clinical-stage drug discovery and development company targeting the most potent suppressor pathways in human cancer. The first lead compound to result from this program is ONC201, a small molecule drug with a unique mechanism of action that causes significant anti-tumor activity in a variety of types of human cancer. The company is currently enrolling patients in clinical trials of ONC201 that began in January 2015, following acceptance by the U.S. Food and Drug Administration of Oncoceutics’ Investigational New Drug (IND) application for ONC201 in 2014. Oncoceutics and collaborative organizations have received grants over the last two years from the National Institutes of Health, the Pennsylvania Department of Health and The Musella Foundation. The company has also leveraged additional funding for multiple Phase I/II clinical trials from academic medical research partners. Founded in 2001 and located in New York City, Spring Mountain Capital, LP (“SMC”) is a private investment management firm that focuses on alternative asset investing. SMC’s Private Equity Group provides expansion stage capital to lower middle market companies that are capitalizing on breakthrough innovations, paradigm shifts or fundamental market or behavioral changes. The Private Equity Group at SMC focuses on the two sectors of the U.S. economy with the most change and highest growth potential: technology-enabled and healthcare businesses. Within these high-growth areas, it seeks to make value investments by capitalizing on market dislocations, information asymmetry, illiquidity and complexity. For further information, please visit http://www.springmountaincapital.com/. To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.


News Article | March 31, 2015
Site: oncoceutics.com

Hummelstown, PA (March 31, 2015) – Oncoceutics, Inc. announced that the company was awarded a Small Business Innovation Research (SBIR) grant by the National Cancer Institute (NCI). The combined Phase I/II Fast Track grant will support a clinical trial in ONC201 in advanced brain cancer, furthering the clinical development of the company’s lead compound. ONC201 is a first-in-class small molecule with consistent antitumor activity in difficult-to-treat cancers. Preclinical research has demonstrated that ONC201 penetrates the blood-brain barrier and is robustly effective in models of glioblastoma multiforme (GBM), the most common and aggressive form of human brain cancer with very limited treatment options. The Fast-Track SBIR grant is awarded in two parts to support multiple aspects of ONC201 clinical development over a two and a half year period. The first phase of the grant will support the development of formulation and GMP-manufacturing of ONC201. The second phase of the grant will support the evaluation of ONC201 in patients with advanced GBM in a Phase II clinical trial that will be conducted by Dr. Andrew Chi at Massachusetts General Hospital and the Dana-Farber / Harvard Cancer Center. “ONC201 exhibits a compelling monoagent efficacy profile against several cancers with a particularly strong efficacy profile against GBM,” said Joshua Allen, PhD, VP Development, of Oncoceutics. “Multiple facets of the chemical and biological profile of ONC201 point to GBM as an ideal lead indication for this exciting first-in-class drug.” “We greatly appreciate the NCI’s support and endorsement as we work with preeminent leaders in GBM research to evaluate the therapeutic potential of ONC201 for this indication, which is in dire need of meaningful treatment options,” commented Martin Stogniew, PhD, Chief Development Officer of Oncoceutics. “The chemical attributes of ONC201 are ideally suited to traverse the blood brain barrier. That dovetails with the powerful effect of the compound that we observed in preclinical testing of ONC201 in GBM.” About Oncoceutics Oncoceutics, Inc. is a drug discovery and development company targeting the most potent suppressor pathways in human cancer. The first lead compound to result from this program is ONC201, a small molecule drug with a unique mechanism of action that causes significant anti-tumor activity in a variety of types of human cancer. The Company is currently enrolling patients in clinical trials of ONC201, which began in January 2015, following acceptance by the U.S. Food and Drug Administration of the Company’s Investigational New Drug (IND) application for ONC201 in 2014. Oncoceutics and collaborative groups have received approximately $5 million in grants over the last two years from the National Institutes of Health, the Pennsylvania Department of Health, and The Musella Foundation, and the company has leveraged additional funding from academic medical research partners that support multiple Phase I/II clinical trials. Visit Oncoceutics or contact Rohinton Tarapore for more information. Safe Harbor Forward-Looking Statements To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.


News Article | March 31, 2015
Site: oncoceutics.com

Hummelstown, PA (March 31, 2015) – Oncoceutics, Inc., a drug discovery and development company targeting the most potent suppressor pathways in human cancer, along with its collaborators, has been selected to present at the 106th Annual Meeting of the American Association for Cancer Research (AACR), to be held in Philadelphia. The seven abstracts selected for presentation include results of preclinical studies that continue to demonstrate the robust efficacy of ONC201, Oncoceutics’ new oncology drug, in aggressive and refractory cancers. The presentations will also further elucidate the mechanism of action that underpins ONC201’s compelling efficacy and safety profile. Clinical trials for ONC201 are currently underway. Abstract Details: Early integrated stress response induction of ATF4 is required for the anticancer effects of the dual Akt/ERK inhibitor and TRAIL pathway inducer ONC201/TIC10. Kline et al. Abstract Number: 674 Presentation Time: Sunday Apr 19, 2015 1:00 PM – 5:00 PM Session Category: Experimental and Molecular Therapeutics Session Title: Signal Transduction Inhibitors Location: Poster Section 28 TRAIL pathway inducer ONC201/TIC10 primes multiple myeloma cells (MM) for apoptosis by downregulating X-linked inhibitor of apoptosis. Kline et al. Abstract Number: 2942 Presentation Time: Tuesday Apr 21, 2015 8:00 AM – noon Session Category: Molecular and Cellular Biology Session Title: Cell Death Therapies 1 Location: Poster Section 2 ONC201/TIC10 targets colorectal cancer stem cells and bulk tumor cells via an Akt-Foxo3a-TRAIL-dependent mechanism. Prabhu et al. Abstract Number: 4241 Presentation Time: Tuesday Apr 21, 2015 1:00 PM – 5:00 PM Session Category: Tumor Biology Session Title: Therapeutics Targeting Cancer Stem Cells Location: Poster Section 21 In vitro efficacy profiling of ONC201 in cancer cells reveals sensitivity pattern that is consistent with ER stress response. Allen et al. Abstract Number: 4475 Presentation Time: Tuesday Apr 21, 2015 1:00 PM – 5:00 PM Session Category: Experimental and Molecular Therapeutics Session Title: Novel Targets 2 Location: Poster Section 31 ONC201 is non-toxic at efficacious doses in vitro and in vivo. Allen et al. Abstract Number: 4479 Presentation Time: Tuesday Apr 21, 2015 1:00 PM – 5:00 PM Session Category: Experimental and Molecular Therapeutics Session Title: Novel Targets 2 Location: Poster Section 31 Cytotoxicity, Biochemical Activity, and Structural Analysis of ONC201 Clinical Material and Comparisons to a Biologically Inactive Isomer. Wagner et al. Abstract Number: 4499 Presentation Time: Tuesday Apr 21, 2015 1:00 PM – 5:00 PM Session Category: Experimental and Molecular Therapeutics Session Title: Novel Targets 2 Location: Poster Section 31 ONC201/TIC10 is effective as a monoagent and synergizes with chemotherapy to induce cell death in non-Hodgkin’s lymphoma. Talekar et al. Abstract Number: 5387 Presentation Time: Wednesday Apr 22, 2015 8:00 AM – noon Session Category: Experimental and Molecular Therapeutics Session Title: Histone Deacetylase Inhibitors, Methyltransferase Inhibitors, and Other Targets Location: Poster Section 29 About Oncoceutics Oncoceutics, Inc. is a drug discovery and development company targeting the most potent suppressor pathways in human cancer. The first lead compound to result from this program is ONC201, a small molecule drug with a unique mechanism of action that causes significant anti-tumor activity in a variety of types of human cancer. The Company is currently enrolling patients in clinical trials of ONC201, which began in January 2015, following acceptance by the U.S. Food and Drug Administration of the Company’s Investigational New Drug (IND) application for ONC201 in 2014. Oncoceutics and collaborative groups have received approximately $5 million in grants over the last two years from the National Institutes of Health, the Pennsylvania Department of Health, and The Musella Foundation, and the company has leveraged additional funding from academic medical research partners that support multiple Phase I/II clinical trials. Visit Oncoceutics or contact Rohinton Tarapore for more information. Safe Harbor Forward-Looking Statements To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.


News Article | February 15, 2017
Site: cen.acs.org

In 2014, Kim Janda of Scripps Research Institute California discovered that ONC201, a drug candidate under development at Oncoceutics, had been patented with an incorrect chemical structure. Scripps applied for a new patent on the compound with the correct structure and licensed it to another company, Sorrento Therapeutics. But this doesn’t mean the dispute is over. Janda argues that Scripps’s application for a composition-of-matter patent, which would grant rights to the molecule itself, would take precedence over Oncoceutics’s method-of-treatment patent, which grants rights to the molecule’s applications. In such cases, a company can’t legally profit from the use of a patent-protected substance without licensing it from its owner. Scripps’s patent is still under review. “This is an interesting saga, and it would seem freighted with money and emotion,” says intellectual property attorney Kendrew H. Colton of Fitch, Even, Tabin & Flannery LLP in Washington, D.C. The story of ONC201’s incorrect structure started in 1973, when pharmaceutical company Boehringer Ingelheim obtained a now-expired German patent on the compound, then called TIC10. The patent showed a structure with three central rings fused linearly. But the patent’s chemical recipe for making TIC10 produced a compound with one of the rings at an angle to the other two. The National Cancer Institute later included TIC10 and its incorrect linear structure in a compound database. A Pennsylvania State University group found TIC10 in the database and discovered that the agent, synthesized using the patent’s recipe to produce the nonlinear structure, had potent anticancer activity. Penn State patented TIC10 with the misassigned structure and licensed it to Oncoceutics, which renamed it ONC201. Janda then found the structural error, and Scripps applied for a new patent, sparking the current dispute. Oncoceutics has licenses to six ONC201-related patents. Five were issued in time to include the correct structure. The patent just reissued, the first in the series, was the only one with the wrong structure. Oncoceutics chief development officer Martin Stogniew replies that company officials “do not see any route for a valid composition-of-matter patent for the ONC201 structure” for Scripps because the molecule “was synthesized and disclosed in 1973” and the first ONC201 patent preceded Janda’s finding. In 2014, patent attorneys told C&EN that Scripps’s composition-of-matter patent could run into trouble because the institution had applied for it after others had made the critical discovery that ONC201 has anticancer activity, and because Penn State Research Foundation, the method-of-treatment patent holder, could have determined the structure correctly if it had realized it was wrong. As the legal battle continues, Oncoceutics has been moving ahead with testing ONC201 in six Phase I and Phase II trials against solid tumors, multiple myeloma, non-Hodgkin lymphoma, acute leukemia, and glioblastoma. The company is also developing two ONC201 analogs. Colton points out that in 2015 the U.S. Court of Appeals for the Federal Circuit upheld a patent with a corrected chemical structure. But if the Scripps patent is approved, he notes, Oncoceutics might be subject to Scripps’s composition-of-matter rights.

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