Connect with us
European Gaming Congress 2024

Latest News

Global Registrational Phase III Study of Olverembatinib for the Treatment of Patients with SDH-Deficient GIST Approved by the China CDE

Published

on

SUZHOU, China, and ROCKVILLE, Md., June 11, 2024 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Product Administration (NMPA) has approved a global registrational Phase III study of the company’s novel drug candidate olverembatinib (HQP1351), in patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had failed prior systemic treatment. This approval marks a major milestone in Ascentage Pharma’s clinical development in solid tumors.

This global, multicenter, single-arm, open-label, pivotal registrational Phase III study is designed to evaluate the efficacy and safety of olverembatinib in patients with SDH-deficient GIST. The CDE has agreed that results from the study can be used to support a future New Drug Application (NDA) for olverembatinib in SDH-GIST.

GIST is the most common type of soft tissue sarcoma that arises in the gastrointestinal track, with a global incidence of 1-1.5/100,000 per year.1 KIT and PDGFRA are key genetic drivers of GIST, and 85% – 90% of all patients with GIST harbor KIT or PDGFRA mutations. The introduction of tyrosine kinase inhibitors (TKIs) has improved the prognosis of patients with this subset of GIST. However, 85% of pediatric patients and 10%-15% of adult patients with GIST do not harbor KIT or PDGFRA mutations, thus belong to a subtype dubbed wild-type GIST. Depending on whether the SDH expression is lost in the patient, wide-type GIST can be further categorized into SDH-deficient and non-SDH-deficient GISTs.2-3

SDH-deficient GIST has unique clinical and pathological characteristics. According to existing literatures, SDH-deficient GIST has a median age of diagnosis of 21 years and is more common in women. SDH-deficient GIST, primarily arises in the gastric area with a high propensity to metastasize, is characterized in immunohistochemistry essays by the loss of SDHB protein expression. Patients with early-stage localized SDH-deficient GIST can be treated with surgeries, although most patients eventually relapse. At present, there is no standard treatment option for relapsed and advanced SDH-deficient GISTs. Imatinib is generally considered ineffective for the condition and other TKIs have also failed to demonstrate satisfactory efficacy2-5, offering a five-year event-free survival (EFS) rate of just 24%.4 Being commonly diagnosed at young ages, patients with SDH-deficient GIST endure significant impact on their quality of life and survival, therefore have urgent unmet medical needs for new treatment options.

Olverembatinib is an orally-available novel third-generation TKI developed by Ascentage Pharma. The drug has been granted a Breakthrough Therapy Designation by the China CDE for the treatment of patients with SDH-deficient GIST who had received first-line treatment. As a multi-targeted TKI, olverembatinib has shown excellent efficacy and manageable safety in patients with SDH-deficient GIST. Since 2022, the clinical study evaluating olverembatinib in SDH-deficient GIST has been selected for presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting for three consecutive years, including an oral report at the 60th ASCO Annual Meeting just took place this month. According to the latest results, olverembatinib has achieved a clinical benefit rate (CBR) of 92.3% in patients with SDH-deficient GIST.

Advertisement
Stake.com

Olverembatinib is the first China-approved third-generation BCR-ABL inhibitor. To date, the drug has been approved for two indications in China, including adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first-and second-generation TKIs. Olverembatinib is jointly commercialized in China by Ascentage Pharma and Innovent Biologics.

“In earlier studies, olverembatinib has already shown encouraging efficacy and favorable safety in patients with SDH-deficient GIST,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “We are excited by the approval for this global registrational Phase III study because it could potentially lead to a clinical breakthrough for another indication that currently lacks approved treatment options while marking a major milestone for Ascentage Pharma’s clinical development in solid tumors. Remaining steadfastly committed to the mission of addressing unmet clinical needs in China and around the world, we will expeditiously advance this clinical development program for the benefit of more patients.”

References

  1. Mantese G. Gastrointestinal stromal tumor: epidemiology, diagnosis, and treatment. Curr Opin Gastroenterol. 2019; 35(6): 555-559.
  2. Call JW, Wang Y, Rothschild S, et al. Treatment responses in SDH-deficient GIST. LRG Science, https://liferaftgroup.org/2019/08/treatmentresponses-in-sdh-deficient-gist-2/(2019, accessed 4 May 2022).
  3. Nannini M, Rizzo A, Indio V, et al. Targeted therapy in SDH-deficient GIST. Ther Adv Med Oncol. 2021; 13: 17588359211023278.
  4. Weldon CB, Madenci AL, Boikos SA, et al. Surgical Management of Wild-Type Gastrointestinal Stromal Tumors: A Report From the National Institutes of Health Pediatric and Wildtype GIST Clinic. J Clin Oncol. 2017; 35(5): 523-528.
  5. Mullassery D, Weldon CB. Pediatric/”Wildtype” gastrointestinal stromal tumors. Semin Pediatr Surg. 2016; 25(5): 305-310.

*Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.

About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials, including 6 global registrational phase III studies, in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.

Advertisement
Stake.com

Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company’s first approved product in China, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates.

Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

Forward-Looking Statements
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

Logo – https://mma.prnewswire.com/media/891219/Ascentage_Pharma_Logo.jpg

Cision View original content:https://www.prnewswire.co.uk/news-releases/global-registrational-phase-iii-study-of-olverembatinib-for-the-treatment-of-patients-with-sdh-deficient-gist-approved-by-the-china-cde-302168892.html

Advertisement
Stake.com
Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Latest News

Nasdaq Profit Beats Estimates as Fintech Sales Soar

Published

on

 

Nasdaq Inc. has reported earnings that exceeded analysts’ expectations, driven by a surge in fintech sales. This strong performance underscores the growing importance of fintech solutions in driving financial market innovation and growth.

Overview of Nasdaq’s Financial Performance

Nasdaq’s latest earnings report reveals impressive financial performance, with profits surpassing estimates due to robust growth in its fintech segment.

Advertisement
Stake.com

Key Financial Highlights:

  • Revenue Growth: Nasdaq reported a significant increase in revenue, primarily driven by its fintech sales.
  • Earnings Beat: The company’s earnings per share (EPS) exceeded analysts’ expectations, highlighting its strong financial performance.
  • Fintech Segment: The fintech segment emerged as a key growth driver, contributing significantly to the overall revenue increase.

The Role of Fintech in Nasdaq’s Growth

Nasdaq’s fintech solutions have played a pivotal role in its recent financial success, offering innovative technologies that enhance market operations and customer services.

Key Fintech Solutions:

  • Market Technology: Nasdaq’s market technology solutions provide advanced trading, clearing, and market surveillance capabilities to financial institutions and exchanges.
  • Data and Analytics: The company’s data and analytics solutions offer valuable insights and support informed decision-making for market participants.
  • Corporate Solutions: Nasdaq’s corporate solutions include governance, risk management, and compliance tools that help companies navigate complex regulatory environments.

Factors Driving Fintech Sales Growth

Several factors have contributed to the surge in Nasdaq’s fintech sales, reflecting broader trends in the financial technology sector.

Key Drivers:

Advertisement
Stake.com
  • Digital Transformation: The ongoing digital transformation in the financial industry has increased demand for advanced fintech solutions.
  • Regulatory Compliance: Growing regulatory requirements have driven demand for compliance and risk management solutions.
  • Market Volatility: Increased market volatility has highlighted the need for robust trading and market surveillance technologies.

Strategic Initiatives

Nasdaq has undertaken several strategic initiatives to capitalize on the growing demand for fintech solutions and drive long-term growth.

Strategic Focus Areas:

  • Innovation: Continuously investing in innovation to develop cutting-edge fintech solutions that address the evolving needs of the financial industry.
  • Partnerships: Forming strategic partnerships with other technology providers and financial institutions to enhance its product offerings and expand market reach.
  • Global Expansion: Expanding its presence in key markets around the world to capture new growth opportunities and serve a broader client base.

Future Prospects

Nasdaq’s strong financial performance and strategic initiatives position the company for continued growth in the fintech sector. The company plans to leverage its technological capabilities and market expertise to drive further innovation and expand its fintech offerings.

Growth Opportunities:

  • Product Development: Developing new fintech products and features to meet emerging market needs and regulatory requirements.
  • Mergers and Acquisitions: Exploring potential mergers and acquisitions to enhance its technology portfolio and market position.
  • Customer Engagement: Enhancing customer engagement through personalized solutions and services that address specific client needs.

Conclusion

Nasdaq’s impressive financial performance, driven by a surge in fintech sales, underscores the growing importance of fintech solutions in the financial market. The company’s strategic focus on innovation, partnerships, and global expansion positions it for continued growth and success. As Nasdaq continues to leverage its fintech capabilities, it is well-positioned to drive financial market innovation and deliver value to its clients and shareholders.

Advertisement
Stake.com

Source of the news: Reuters

The post Nasdaq Profit Beats Estimates as Fintech Sales Soar appeared first on HIPTHER Alerts.

Continue Reading

Latest News

K1 Issues MariaDB Compulsory Acquisition Notices

Published

on

MANHATTAN BEACH, Calif., July 26, 2024 /PRNewswire/ — Meridian BidCo LLC (“Bidco“), an affiliate of K1 Investment Management, LLC (“K1“), announced earlier this week that its tender offer to acquire the entire issued and to be issued share capital of MariaDB plc (“MariaDB“) for $0.55 per share (the “Offer“) had expired. The Offer was settled in accordance with its terms on July 25, 2024. Bidco now owns 61,263,283 MariaDB ordinary shares, representing 88.70% of the issued share capital of MariaDB as of July 22, 2024.

As previously announced, Bidco now intends to apply the provisions of Sections 456 to 460 of the Companies Act of 2014 of Ireland to acquire compulsorily, on the same terms as the Offer, any outstanding ordinary shares of MariaDB not acquired or agreed to be acquired pursuant to the Offer. 

On July 26, 2024, Bidco sent compulsory acquisition notices (the “Notices“) to those MariaDB shareholders who did not accept the Offer (the “Non-Assenting Shareholders“). Following the expiration of 30 calendar days from the date of the Notices, which is expected to be August 25, 2024 (the “Expiration Time“), unless a Non-Assenting Shareholder has applied to the Irish High Court and the Irish High Court orders otherwise, the shares of MariaDB held by Non-Assenting Shareholders will be acquired compulsorily by Bidco (without any action on the part of such shareholders) on the same terms as the Offer, on or about August 26, 2024. The cash consideration payable will be settled no later than three business days after the Expiration Time. There will be no redemption rights or liquidating distributions with respect to the Company’s warrants, which will expire worthless.

Following the compulsory acquisition process, Bidco intends to cause the ordinary shares of MariaDB to be delisted from the New York Stock Exchange and terminate the registration of the MariaDB ordinary shares under the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act“), and suspend MariaDB’s reporting obligations under the Exchange Act as promptly as possible.

Enquiries

Advertisement
Stake.com

Lazard (Financial Advisor to K1 and Bidco)
Adrian Duchini, Keiran Wilson, Charles White

                              Tel: +44 20 7187 2000

Haven Tower Group (Public Relations Advisor to K1)

Donald Cutler, Brandon Blackwell

                                                 Tel: +1 424 317 4850

Advertisement
Stake.com

Important Notices

The K1 Responsible Persons (being the investment committee of K1), the Bidco officers and the Meridian TopCo LLC Officers accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the K1 Responsible Persons, the Bidco Officers, the Topco Officers, (who have taken all reasonable care to ensure that such is the case) the information contained in this announcement for which they have accepted responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

Lazard Frères & Co. LLC, together with its affiliate Lazard & Co., Limited (which is authorised and regulated in the United Kingdom by the Financial Conduct Authority) (“Lazard“), is acting exclusively as financial adviser to K1 and Bidco and no one else in connection with the matters referred to in this announcement and will not be responsible to anyone other than K1 and Bidco for providing the protections afforded to clients of Lazard nor for providing advice in relation to the matters referred to in this announcement or any other matters referred to in this announcement. Neither Lazard nor any of its affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Lazard in connection with this announcement, any statement contained herein or otherwise.

Forward Looking Statements

This announcement (including any information incorporated by reference in this announcement), oral statements made regarding the Offer, and other information published by MariaDB, Bidco, K1 or any member of the K1 Group (as defined below) contain statements which are, or may be deemed to be, “forward looking statements.” Such forward looking statements are prospective in nature and are not based on historical facts, but rather on current expectations and on numerous assumptions regarding the business strategies and the environment in which any member of the K1 Group (including, after closing of the Offer, any of MariaDB and its subsidiaries and subsidiary undertakings (the “MariaDB Group“)) shall operate in the future and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by those statements. The forward looking statements contained in this announcement relate to K1, any member of the K1 Group’s (including any member of the MariaDB Group) future prospects, developments and business strategies, the progress of the compulsory acquisition process, the outcome of legal proceedings that may be instituted against the K1 Group and/or others relating to the Offer, potential adverse reactions or changes to business relationships resulting from the completion of the Offer, significant or unexpected costs, charges or expenses resulting from the Offer, negative effects of this announcement or the consummation of the Offer on the market price of MariaDB’s Shares, and potential failure to realize the expected benefits of the Offer and other statements other than historical facts. In some cases, these forward looking statements can be identified by the use of forward looking terminology, including the terms “believes,” “estimates,” “will look to,” “would look to,” “plans,” “prepares,” “anticipates,” “expects,” “is expected to,” “is subject to,” “intends,” “may,” “will,” “shall” or “should” or their negatives or other variations or comparable terminology. By their nature, forward looking statements involve risk and uncertainty because they relate to events and depend on circumstances that shall occur in the future. These events and circumstances include changes in global, political, economic, business, competitive, and market conditions and regulatory forces, future exchange and interest rates, changes in tax rates and future business combinations or disposals. If any one or more of these risks or uncertainties materializes or if any one or more of the assumptions prove incorrect, actual results may differ materially from those expected, estimated or projected. Such forward looking statements should therefore be construed in the light of such factors. Neither K1, Bidco nor any member of the K1 Group, nor any of their respective associates or directors, officers or advisers, provides any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward looking statements in this announcement shall actually occur. The forward looking statements speak only as of the date of this announcement. All subsequent oral or written forward looking statements attributable to any of K1 and all of its affiliates, including K5 Private Investors, L.P. (the “K1 Group“), or any of their respective associates, directors, officers, employees or advisers, are expressly qualified in their entirety by the cautionary statement above. K1 and the K1 Group expressly disclaim any obligation to update such statements other than as required by law or by the rules of any competent regulatory authority, whether as a result of new information, future events or otherwise.

Advertisement
Stake.com

Further Information

This announcement is for information purposes only and is not intended to, and does not, constitute an offer to sell or invitation to purchase any securities, or the solicitation of any vote or approval in any jurisdiction pursuant to the Offer or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. In particular, this announcement is not an offer of securities for sale into the United States. No offer of securities shall be made in the United States absent registration under the Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. The release, publication or distribution of this announcement in certain jurisdictions may be restricted by law and therefore persons in such jurisdictions into which this announcement is released, published or distributed should inform themselves about and observe such restrictions.

View original content:https://www.prnewswire.co.uk/news-releases/k1-issues-mariadb-compulsory-acquisition-notices-302207896.html

Continue Reading

Latest News

Simona Covaliu Appointed New CRO of PayU GPO

Published

on

 

Simona Covaliu has been appointed as the new Chief Risk Officer (CRO) of PayU Global Payment Organization (GPO). This significant appointment marks a strategic move by PayU to bolster its risk management framework amid the evolving landscape of financial technology and payment solutions.

Background and Expertise

Simona Covaliu brings a wealth of experience and expertise to her new role. With a strong background in risk management, she has previously held senior positions in several leading financial institutions. Her extensive knowledge of regulatory compliance, operational risk, and strategic risk management makes her an ideal fit for PayU’s ambitious growth plans.

Advertisement
Stake.com

Career Highlights:

  • Senior Risk Management Roles: Covaliu has held various senior positions where she successfully implemented robust risk management frameworks.
  • Regulatory Expertise: Her deep understanding of global regulatory requirements has been instrumental in navigating complex compliance landscapes.
  • Strategic Leadership: Covaliu has a proven track record of leading risk management teams and driving strategic initiatives to mitigate risk.

Role and Responsibilities

As the new CRO of PayU GPO, Covaliu will be responsible for overseeing the company’s global risk management strategy. Her primary focus will be on enhancing risk mitigation practices, ensuring regulatory compliance, and protecting the organization against emerging threats.

Key Responsibilities:

  • Risk Assessment: Conducting comprehensive risk assessments to identify potential threats and vulnerabilities.
  • Regulatory Compliance: Ensuring that PayU complies with all relevant regulations and industry standards.
  • Strategic Risk Management: Developing and implementing strategic risk management initiatives to safeguard the company’s operations.
  • Operational Risk Management: Enhancing operational risk management practices to improve efficiency and resilience.

Strategic Vision

Covaliu’s appointment reflects PayU’s commitment to strengthening its risk management framework and maintaining the highest standards of regulatory compliance. Her strategic vision will play a crucial role in driving the company’s growth and ensuring its long-term success.

Strategic Goals:

Advertisement
Stake.com
  • Enhanced Risk Framework: Building a robust risk management framework that aligns with PayU’s growth objectives.
  • Global Compliance: Ensuring compliance with regulatory requirements across all markets where PayU operates.
  • Innovation and Resilience: Leveraging innovative risk management practices to enhance operational resilience and support business continuity.

Conclusion

Simona Covaliu’s appointment as the new CRO of PayU GPO underscores the company’s dedication to robust risk management and regulatory compliance. With her extensive experience and strategic vision, Covaliu is well-positioned to lead PayU’s risk management efforts and support its continued growth in the dynamic fintech landscape.

Source of the news: Fintech Futures

The post Simona Covaliu Appointed New CRO of PayU GPO appeared first on HIPTHER Alerts.

Continue Reading

Trending