• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Dashboard
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlerts
    Company
    AboutQuantisnow PlusContactJobs
    Legal
    Terms of usePrivacy policyCookie policy

    Theriva™ Biologics Announces U.S. FDA Guidance on Design of Phase 3 Study of VCN-01 for the Treatment of Metastatic Pancreatic Cancer

    12/5/24 8:00:00 AM ET
    $TOVX
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $TOVX alert in real time by email

    ROCKVILLE, Md., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE:TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the outcomes of a recent Type D meeting with the U.S. Food and Drug Administration (FDA) to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC). The Company recently announced the completion of target enrollment into the multinational VIRAGE Phase 2b clinical study evaluating intravenous VCN-01 in combination with gemcitabine/nab-paclitaxel as a first line therapy for PDAC patients.

    Type D meetings are focused on a narrow set of issues that are used to discuss issues at key decision points to provide timely feedback critical to moving a drug development program forward. The FDA advised that the on-going VIRAGE Phase 2b study should not be expanded into a Phase 3 study; rather, the optimal path forward for the VCN-01 PDAC program is to conduct a stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel. The FDA provided general agreement with Theriva's proposed design for a Phase 3 clinical study and indicated that inclusion of additional standard-of-care chemotherapy for PDAC was not necessary as it would complicate the study design and analysis. The FDA meeting also highlighted the FDA's preferences regarding certain statistical elements of confirmatory clinical studies, including methods for sample size estimation and the study population(s) used for data analysis.

    "The FDA's advice on key elements of a potential confirmatory Phase 3 study evaluating VCN-01 plus gemcitabine/nab-paclitaxel as a first-line treatment for metastatic PDAC patients is critical as the VIRAGE study has entered final patient follow-up and we are actively planning the next steps in VCN-01 development," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "The feedback from the FDA and European regulatory agencies will facilitate the design of a Phase 3 study protocol that is expected to maximize our ability to provide a new therapeutic option to patients suffering this terrible disease."

    An additional meeting with the FDA will be requested after the completion of the VIRAGE study to discuss the details of the proposed confirmatory Phase 3 study protocol.

    About Pancreatic Ductal Adenocarcinoma

    Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma ("PDAC") accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

    About VCN-01

    VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient's immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in Company- and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.

    About Theriva™ Biologics, Inc.

    Theriva™ Biologics (NYSE:TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient's immune system. The Company's lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics' website at www.therivabio.com.

    Forward-Looking Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding the feedback from the FDA and European regulatory agencies facilitating the design of a Phase 3 study protocol; the protocol maximizing the Company's ability to provide a new therapeutic option to patients suffering pancreatic cancer. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to effectively design the Phase 3 study protocol; the Company's and VCN's ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned, generating positive clinical data that establishes VCN-01 may lead to improved clinical outcomes for patients with PDAC and other solid cancers; the Company's and VCN's product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company's and VCN's ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company's and VCN's products, developments by competitors that render such products obsolete or non-competitive, the Company's and VCN's ability to maintain license agreements, the continued maintenance and growth of the Company's and VCN's patent estate, the ability to continue to remain well financed, and other factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    For further information, please contact:

    Investor Relations:

    Chris Calabrese

    LifeSci Advisors, LLC

    [email protected]

    917-680-5608

    Source: Theriva Biologics, Inc.



    Primary Logo

    Get the next $TOVX alert in real time by email

    Chat with this insight

    Save time and jump to the most important pieces.

    Q&A

    New
    • What recent guidance did Theriva Biologics receive from the FDA regarding the Phase 3 study of VCN-01?

      Theriva Biologics announced that the FDA advised them to conduct a stand-alone Phase 3 study of VCN-01 combined with standard chemotherapy for PDAC, rather than expanding the VIRAGE study into Phase 3.

    • What is the mechanism of action of Theriva's clinical candidate VCN-01?

      Theriva's VCN-01 is an oncolytic adenovirus designed to selectively replicate within tumor cells and degrade the tumor stroma, enhancing the effects of chemotherapy and promoting immune responses against tumors.

    • What is the current status of the VIRAGE Phase 2b clinical study involving VCN-01?

      The ongoing VIRAGE Phase 2b clinical study has completed its target enrollment and evaluates VCN-01 in combination with gemcitabine/nab-paclitaxel for treating PDAC patients.

    • What did the FDA indicate about the inclusion of additional chemotherapies in the planned Phase 3 study for VCN-01?

      The FDA's meeting suggested that additional standard-of-care chemotherapy was unnecessary for the Phase 3 study as it would complicate the design and analysis.

    • What was the response from Theriva Biologics' CEO regarding the FDA's guidance on the Phase 3 study for VCN-01?

      The CEO of Theriva Biologics, Steven A. Shallcross, expressed that the FDA's feedback is critical for designing the Phase 3 study protocol to potentially offer a new treatment option for pancreatic cancer patients.

    Recent Analyst Ratings for
    $TOVX

    DatePrice TargetRatingAnalyst
    More analyst ratings

    $TOVX
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • SEC Form SC 13G filed by Theriva Biologics Inc.

      SC 13G - Theriva Biologics, Inc. (0000894158) (Subject)

      10/3/24 4:12:12 PM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13G filed by Theriva Biologics Inc.

      SC 13G - Theriva Biologics, Inc. (0000894158) (Subject)

      10/2/24 10:53:47 AM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $TOVX
    Leadership Updates

    Live Leadership Updates

    See more
    • Theriva Biologics Announces Appointment of Ramon Alemany, Ph.D., to Senior Vice President of Discovery

      -Appointment expected to aid advancement of Theriva's discovery program and strengthen collaboration with the Institut Catala d'Oncologia (ICO) and the Biomedical Research Institute of Bellvitge (IDIBELL)- ROCKVILLE, Md., May 23, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE:TOVX), ("Theriva" or the "Company"), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the appointment of Dr. Ramon Alemany as Senior Vice President of Discovery, effective immediately. Dr. Alemany will oversee Theriva's discovery and development pipeline and will continue to serve as Chair of the Scientific Advisory Board. D

      5/23/23 8:00:00 AM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $TOVX
    SEC Filings

    See more

    $TOVX
    Press Releases

    Fastest customizable press release news feed in the world

    See more

    $TOVX
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more

    $TOVX
    Financials

    Live finance-specific insights

    See more
    • Theriva Biologics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits

      8-K - Theriva Biologics, Inc. (0000894158) (Filer)

      5/8/25 4:30:50 PM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 424B5 filed by Theriva Biologics Inc.

      424B5 - Theriva Biologics, Inc. (0000894158) (Filer)

      5/8/25 9:05:23 AM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form EFFECT filed by Theriva Biologics Inc.

      EFFECT - Theriva Biologics, Inc. (0000894158) (Filer)

      5/8/25 12:15:07 AM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Theriva Biologics Announces Closing of $7.5 Million Public Offering

      ROCKVILLE, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE:TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the closing of its previously announced "reasonable best efforts" public offering of 6,818,180 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 6,818,180 shares of common stock at a combined offering price of $1.10 per share and accompanying warrant (the "Offering"). The Company received aggregate gross proceeds of approximately $7.5 million, before deducting placement agent fees and oth

      5/8/25 4:30:00 PM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Theriva Biologics Announces Pricing of $7.5 Million Public Offering

      ROCKVILLE, Md., May 07, 2025 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE:TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the pricing of its "reasonable best efforts" public offering for the purchase and sale of up to 6,818,180 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 6,818,180 shares of common stock at a combined offering price of $1.10 per share and accompanying warrant (the "Offering"). The Company expects to receive aggregate gross proceeds of approximately $7.5 million, before deducting placeme

      5/7/25 9:17:49 AM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Theriva™ Biologics Announces Primary Endpoints for Efficacy and Safety Achieved in VIRAGE Phase 2b Clinical Trial of VCN-01 with Gemcitabine/nab-Paclitaxel in Newly-Diagnosed Metastatic Pancreatic Cancer Patients

      - Patients treated with VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy had increased overall survival, progression free survival, and duration of response compared to patients treated with gemcitabine/nab-paclitaxel SoC - - VCN-01 was well-tolerated, with transient and reversible adverse events (AEs), meeting primary safety endpoint - - Greater differences between the treatment arms were observed in patients receiving 2 doses of VCN-01 - - Data to be reviewed during a Key Opinion Leader webinar Featuring Dr. Manuel Hidalgo Medina and Dr. Mike Pishvaian on Wednesday May 7th, 2025 at 0800 US EDT - ROCKVILLE, Md., May 07, 2025 (GLOBE

      5/7/25 7:00:00 AM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 4 filed by Director Wolf Jeffrey Alan

      4 - Theriva Biologics, Inc. (0000894158) (Issuer)

      5/1/25 4:02:16 PM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 4 filed by CEO and CFO Shallcross Steven A

      4 - Theriva Biologics, Inc. (0000894158) (Issuer)

      5/1/25 4:01:54 PM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 4 filed by Director Kraws Jeffrey J

      4 - Theriva Biologics, Inc. (0000894158) (Issuer)

      5/1/25 4:01:06 PM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Theriva™ Biologics Reports Full-Year 2023 Operational Highlights and Financial Results

      – The independent data monitoring committee (IDMC) recommended the continuation of VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma (PDAC), with no safety concerns raised - - VIRAGE remains on track to complete enrollment in the first half of 2024- - As of December 31, 2023, Theriva Biologics reports $23.2 million in cash, which is expected to provide runway into the first quarter of 2025 - - Conference call and webcast to be held on Monday, March 25 at 8:30 a.m. ET - ROCKVILLE, Md., March 25, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE:TOVX), a diversified clinical-stage company developing ther

      3/25/24 7:30:00 AM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Theriva™ Biologics to Host Conference Call and Webcast to Discuss Full Year 2023 Operational Highlights and Financial Results

      ROCKVILLE, Md., March 19, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE:TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that it plans to host a conference call on Monday, March 25, 2024, at 8:30 a.m. ET to discuss its financial results for the full year ended December 31, 2023 and provide a corporate update. Individuals may participate in the live call via telephone by dialing 1-877-451-6152 (domestic) or 1-201-389-0879 (international) and using the conference ID: 13744453. Participants are asked to dial-in 15 minutes before the start of the call to register. Investors and th

      3/19/24 8:00:00 AM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Theriva™ Biologics Reports Third Quarter 2023 Operational Highlights and Financial Results

      - VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma remains on track to complete enrollment in the first half of 2024; multiple patients have received second doses of VCN-01, which continues to be well tolerated with a safety profile consistent with prior clinical trials - - Presented survival outcomes data from the Phase 1 investigator-sponsored study evaluating VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck at the European Society for Medical Oncology (ESMO) Congress 2023 - - Data from the Phase 1 investigator-sponsored stu

      11/13/23 8:00:00 AM ET
      $TOVX
      Biotechnology: Pharmaceutical Preparations
      Health Care