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Biotech Companies Making Strides in Pancreatic Cancer Treatment and Early Detection

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USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC, May 15, 2024 /PRNewswire/ — USA News Group – Hope is rising in the fight against one of the deadliest cancers in the world, as a new study recently claimed that a blood test can accurately detect early-stage pancreatic cancer with 97% accuracy. According to Johns Hopkins Medicine, up to 10% of patients who receive an early diagnosis become disease-free after treatment, meaning the earlier it’s detected, the better the patient’s chances to survive. The American Cancer Society estimates that about 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer in the USA this year, projecting about 51,750 people will succumb to the disease. Working diligently behind the scenes, several biotech drug developers are making progress in new treatments, including recent updates from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Candel Therapeutics, Inc. (NASDAQ: CADL), ABVC BioPharma, Inc. (NASDAQ: ABVC), CytomX Therapeutics, Inc. (NASDAQ: CTMX), and Amgen Inc. (NASDAQ: AMGN).

Pelareorep, an intravenously delivered immunotherapeutic agent being developed by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), is gaining momentum as a potential treatment for multiple cancers, especially breast cancer and pancreatic cancer. In late 2022, the FDA granted pelareorep Fast Track Designation for treating pancreatic cancer, following promising clinical results. Now Oncolytics has recently announced a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR), with the purpose of commencing planning activities for the evaluation of pelareorep in the treatment of first-line metastatic pancreatic ductal adenocarcinoma (PDAC), as part of GCAR’s anticipated master protocol for metastatic pancreatic cancer.

GCAR’s activities are already underway to finalize the seamless Phase 2/3 master protocol design that will evaluate multiple investigational therapies for pancreatic cancer treatment. Thus, the intent of the pelareorep study will be to produce registration-enabling data.

“We are thrilled to collaborate with GCAR and are honored that pelareorep has been selected as the first therapeutic for evaluation in GCAR’s planned adaptive trial in pancreatic cancer patients,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “We believe this opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients. GCAR’s anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner.”

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Oncolytics is also now advancing its lead asset further, having recently received regulatory clearance to evaluate pelareorep in combination with modified FOLFIRINOX +/- Tecentriq (from Roche) in pancreatic cancer in a new cohort from its ongoing GOBLET study, following German regulatory and ethics approvals. The new cohort is bolstered by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an inventive initiative aimed at rapidly advancing the development of new treatments for pancreatic cancer.

Achieving these positive results from the pelareorep/mFOLFIRINOX combination could greatly elevate Oncolytics’ prospects in tackling pancreatic cancer. Oncolytics has previously reported encouraging data from pelareorep paired with gemcitabine and nab-paclitaxel. The Oncolytics team believes that if the mFOLFIRINOX combination demonstrates improvements in response rate over historical control trials, this treatment approach could move forward to a registration-enabling study, offering two potential pelareorep-based therapies for pancreatic cancer patients. Additionally, planned translational research studies for this cohort will further explore the understanding of pelareorep’s mechanism of action, including its impact on the tumor microenvironment (TME).

As a part of this evaluation, Oncolytics will examine the relationship between tumor responses and the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect noted in previous pancreatic cancer studies. The company plans to start enrolling patients into the mFOLFIRINOX/pelareorep study cohort in Q2 2024.

For Candel Therapeutics, Inc. (NASDAQ: CADL), the FDA granted Orphan Drug Designation to their leading multimodal biological candidate, CAN-2409, for pancreatic cancer treatment. This recognition came shortly after Candel shared updated overall survival data from its ongoing randomized phase 2 clinical trial of CAN-2409 combined with valacyclovir (prodrug) and standard-of-care chemoradiation, followed by surgery for borderline resectable pancreatic ductal adenocarcinoma (PDAC).

“We recently reported data from the phase 2 randomized clinical trial of CAN-2409 in borderline resectable pancreatic cancer, showing that CAN-2409, when added to standard of care, more than doubled the median overall survival obtained with standard of care alone,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “We are pleased that the FDA has now granted Candel with both Orphan Drug and Fast Track Designation to this program, as we seek to reshape the treatment paradigm in pancreatic cancer.”

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Clinical-stage biopharmaceutical company ABVC BioPharma, Inc. (NASDAQ: ABVC) recently announced it has entered into a definitive agreement with private company OncoX BioPharma, Inc. in its fight against pancreatic cancer. Through its affiliate Rgene Corporation, ABVC and OncoX are set to collaborate on combination therapy the duo believes will help treat pancreatic cancer and improve patient outcomes significantly, with ABVC and Rgene set to receive an aggregate license fee of $12.5 million in cash or shares from OncoX within the next 30 days.

“We are excited to announce this collaboration with OncoX, which represents a significant step forward in our commitment to developing transformative treatments for pancreatic cancer,” said Dr. Uttam Patil, CEO of ABVC. “By combining our strengths, we can make meaningful progress in addressing this devastating disease. The collaboration will draw on ABVC’s portfolio of combination therapies pipeline, which has shown promise in preclinical and early clinical studies.”

Among ABVC’s portfolio is its ABV-1703 (IND 136309) for pancreatic cancer therapy. As part of an Investigational New Drug (IND) application for ABV-1703 is the proposal for the clinical investigation of BLEX 404 as a combination therapy drug with chemotherapy. BLEX 404 is made with the active ingredient glucan, which is extracted from Grifola frondose (maitake mushrooms), an edible fungus with high medical and commercial value in Asia.

“This partnership exemplifies our dedication to advancing the field of oncology and bringing hope to patients facing pancreatic cancer,” said Wen-Pin Yen, CEO of OncoX. “Together with ABVC, we are committed to pushing the boundaries of innovation to improve outcomes for patients in need. The two companies aim to deliver a novel treatment option for pancreatic cancer patients by combining their resources, expertise, and innovative approaches.”

Leading drug developer in the field of masked, conditionally activated biologic therapeutics, CytomX Therapeutics, Inc. (NASDAQ: CTMX), recently announced positive initial data from its ongoing CX-904 Phase 1a dose escalation clinical study with its global development partner, Amgen Inc. (NASDAQ: AMGN). CytomX and Amgen are collaborating on CX-904, a bispecific PROBODY candidate designed to engage T-cells by targeting the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells.

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Within the clinical study results, CX-904 not only demonstrated a favorable safety profile with no cytokine release syndrome, but also presented encouraging initial signs of efficacy observed for CX-904 in advanced pancreatic cancer, including 2 of 6 patients (33%) with a confirmed partial response, and all 6 patients (100%) with disease control.

“We are delighted to share these initial results today for CX-904, a highly innovative masked T-cell engager that embodies our vision at CytomX of transforming lives with safer, more effective therapies,” said Sean McCarthy, D.Phil., CEO and Chairman of CytomX. “These data build on more than a decade of innovation at CytomX, and, we believe, open broad new possibilities for T-cell engagers across many targets and cancer types. We look forward to continuing to explore the potential of this exciting agent in multiple EGFR positive cancers and to determining longer term strategy with our global development partner, Amgen.”

Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ 

USA NEWS GROUP
[email protected]
(604) 265-2873

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. (“MIQ”). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.

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While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

View original content:https://www.prnewswire.co.uk/news-releases/biotech-companies-making-strides-in-pancreatic-cancer-treatment-and-early-detection-302146516.html

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Nasdaq Profit Beats Estimates as Fintech Sales Soar

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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.

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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:

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  • 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.

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Source of the news: Reuters

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

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K1 Issues MariaDB Compulsory Acquisition Notices

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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

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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

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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.

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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

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Simona Covaliu Appointed New CRO of PayU GPO

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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.

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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:

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  • 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.

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