Innovation Pharmaceuticals Reports p53 Drug Candidate Therapeutic Potential Further Supported by Academic Research

Innovation Pharmaceuticals, Inc. | April 16, 2019

Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report recent academic and pre-clinical research further supports the therapeutic potential of Kevetrin, the Company’s p53 drug candidate, in leukemias and in combination with cancer immunotherapies. Kevetrin has been successfully evaluated in a Phase 1 clinical trial in advanced solid tumors and a Phase 2a clinical trial in late-stage ovarian cancer. Kevetrin and Acute Myeloid Leukemia Building on data presented at the 2017 European Hematological Association (EHA) Annual Meeting by independent cancer researchers and their conclusion —“Our results suggest Kevetrin is a promising new drug in AML patients treatment, both in wild type and, even more, in TP53 mutated tumors, through different molecular mechanisms, giving more therapeutic alternatives in the treatment of this disease.”—the Company has been notified that a related scientific article is under review for publication by a leading oncology journal. The paper details Kevetrin’s treatment potential in Acute Myeloid Leukemia (AML) by targeting p53 and several key leukemia-related genes. AML accounts for approximately one-third of all leukemias worldwide and has a 5-year survival rate of only 25 percent.

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Primary biliary cholangitis (PBC) is a chronic, rare disease characterized by cholestasis—the impaired flow of bile from the liver.1 The resulting increased bile acid concentrations cause cellular injury. Untreated PBC can lead to liver failure and death. The only currently approved treatment for PBC was ursodeoxycholic acid (UDCA). However, not all patients respond to UDCA. Intercept Pharmaceuticals—an emerging global biopharmaceutical company—sought to develop obeticholic acid (OCA) as an alternative treatment for PBC. OCA is a semi-synthetic analogue of the primary bile acid chenodeoxycholic acid with similar pharmacokinetic (PK) properties.2 Like other bile salts, OCA is metabolized via conjugation to glycine acid and taurine. OCA is a selective and potent farnesoid X receptor (FXR) agonist.2 FXR activation decreases the concentration of bile acids in the liver to reduce cellular injury. FGF-19 was used as a biomarker for OCA pharmacological activity.

Spotlight

Primary biliary cholangitis (PBC) is a chronic, rare disease characterized by cholestasis—the impaired flow of bile from the liver.1 The resulting increased bile acid concentrations cause cellular injury. Untreated PBC can lead to liver failure and death. The only currently approved treatment for PBC was ursodeoxycholic acid (UDCA). However, not all patients respond to UDCA. Intercept Pharmaceuticals—an emerging global biopharmaceutical company—sought to develop obeticholic acid (OCA) as an alternative treatment for PBC. OCA is a semi-synthetic analogue of the primary bile acid chenodeoxycholic acid with similar pharmacokinetic (PK) properties.2 Like other bile salts, OCA is metabolized via conjugation to glycine acid and taurine. OCA is a selective and potent farnesoid X receptor (FXR) agonist.2 FXR activation decreases the concentration of bile acids in the liver to reduce cellular injury. FGF-19 was used as a biomarker for OCA pharmacological activity.

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PHARMACY MARKET

Insilico Medicine Announced Strategic Collaboration with EQRx

Insilico Medicine | March 25, 2022

A clinical-stage end-to-end artificial intelligence driven drug discovery firm, Insilico Medicine announced the formation of a strategic partnership with EQRx, a company dedicated to creating and delivering novel medications to patients at much-reduced costs. The cooperation will use Insilico's Pharma.AI technology to accelerate the design and creation of de novo small molecules and EQRx's clinical development and commercialization experience. In addition, EQRx and Insilico will form a co-development partnership in which each party will get a profit share according to its investment level. The collaborative agreement identifies and selects up to three therapeutic targets using Insilico's AI-powered platform, Pharma. AI. From small molecule hit identification through lead optimization and preclinical candidate nomination, Insilico will guide the drug discovery process. EQRx will be in charge of clinical development, regulatory affairs, and commercialization. In addition, Insilico may invest in the product candidate(s) at different phases of clinical outcome in exchange for enhanced commercialization income. "Both EQRx and Insilico Medicine strive to accelerate the discovery and development of new medicines and make effective therapeutics more accessible and affordable. This partnership will combine our end-to-end AI-powered drug discovery capabilities with EQRx's innovative partnership model and expertise in clinical development and patient access to accelerate innovative therapies' discovery and development, " Alex Zhavoronkov, Ph.D., founder and founder CEO of Insilico Medicine "We are pleased to partner with Insilico Medicine, a leader in AI-based drug discovery," said Carlos Garcia-Echeverria, Ph.D., chief of Rx Creation at EQRx. "This collaboration will further expand our early-stage R&D efforts to fuel potential pipeline growth as we continue to apply the best of today's innovation in biomedical sciences and digital solutions to discover high-quality, innovative, and more affordable medicines."

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BUSINESS INSIGHTS

Xeris Pharmaceuticals Strengthens Its Patent Estate

XERIS PHARMACEUTICALS, INC. | August 20, 2021

Xeris Pharmaceuticals, Inc., a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that it has recently been granted three new patents relating to its formulation technology platforms. The U.S. Patent and Trademark Office granted U.S. Patent Nos. 10,987,399 and 11,020,403 to Xeris, and the China Intellectual Property Office granted Chinese Patent No. ZL201580042185.5 to Xeris. The US ‘399 patent covers storage-stable formulations of pramlintide, and the US ‘403 patent covers storage-stable formulations of benzodiazepines, both using Xeris’ proprietary XeriSol™ formulation technology. The Chinese ’185.5 patent covers pre-filled syringes containing a variety of active pharmaceutical ingredients, using Xeris’ proprietary XeriJect™ technology. These patents, and related patent applications that are pending in these and other patent offices around the world, also cover the uses of such products in treating a variety of diseases and disorders including diabetes. “Our strategy as a platform company is to patent early and often to continue to strengthen our position as a product development and formulation company. These new patent grants represent a significant expansion of Xeris’ intellectual property portfolio and help us to continue to invest in our innovation into life-saving therapies that can benefit patients worldwide,” said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “With the recent opening of our Research & Development center in Chicago, led by our Chief Scientific Officer and Xeris co-founder Dr. Steve Prestrelski, we anticipate that we will continue to develop and bring to the market novel solutions for treating and preventing a variety of human diseases and disorders, improving the quality of life for our patients and their families.” The granting of these patents expands the size of Xeris growing patent portfolio, bringing the total number of patents granted to Xeris worldwide to 121 (16 of which have been granted in the US). In addition to these new patent grants, Xeris has 120 patent applications pending worldwide, and expects to receive patent grants on several of those pending applications within the next several months. These patent grants, which provide Xeris the right to exclude others from making, selling, and using its proprietary technologies, will provide patent protection to Xeris on its proprietary pharmaceutical products for at least the next decade. All patents are owned by Xeris. About Xeris Pharmaceuticals, Inc. Xeris is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world. With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable drug products, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the U.S. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.

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PHARMACY MARKET

Eirion Therapeutics Announces Strategic Agreement for HTL Biotechnology to Become Eirion's Exclusive Botulinum API Manufacturer

Eirion Therapeutics, Inc. | September 09, 2021

Eirion Therapeutics, Inc., an aesthetic dermatology company headquartered in Woburn, Massachusetts, announced that HTL Biotechnology, the worldwide leader in biotechnology solutions using hyaluronic acid and other biopolymers, will become Eirion's exclusive botulinum active pharmaceutical ingredient (API) manufacturer. Botulinum is the active ingredient in Eirion's lead product candidate ET-01, a topical neuromodulator being developed for Crow's Feet wrinkles and primary axillary hyperhidrosis (excessive sweating) that is currently in Phase 2 clinical trials, as well as in their liquid injectable neuromodulator product candidate being developed for glabellar wrinkles, AI-09. As part of the agreement, HTL will build, validate and operate a botulinum manufacturing facility in the US. In the future, HTL expects to apply to the CDC to have the facility certified to manufacture botulinum and later apply to the FDA to have it certified as a GMP plant. Under the agreement, HTL will pay for the construction, the validation and the operation of the US manufacturing facility, which is expected to become operational in 2022. In exchange, Eirion will begin paying manufacturing fees to HTL in 2023, with HTL also later sharing in the potential commercial success of ET-01 and AI-09, if approved. "This agreement marks an important expansion of HTL's biotechnology platform beyond our already industry-leading work in hyaluronic acid and bio-polymer manufacturing, as well as a key milestone in HTL's expanding footprint in North America," commented HTL CEO Yvon Bastard. "HTL believes that Eirion's products could be game-changers in the aesthetic field thanks to their substantial benefits for patients. Providing leading, innovative companies with the solutions that will empower them to change the lives of patients is our core purpose, which explains why we are particularly excited by this partnership" added Charles Ruban, HTL deputy CEO. About Eirion Therapeutics, Inc. Eirion Therapeutics, Inc. is a privately held, clinical stage biopharmaceutical company that is developing next-generation prescription products for aesthetic dermatology. Eirion currently has a rich pipeline of products focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair greying. In the future, Eirion plans to also pursue additional indications that address other major unmet clinical needs for physicians and their patients. Earlier this year, Eirion closed a $40 million investment and licensing deal with Shanghai Haohai Biological Technology Ltd in China.

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