tissue factor

Genmab-Pfizer’s cervical cancer treatment is under EMA review. Credit: Jo Panuwat D / Shutterstock.com. The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for review of Genmab and Pfizer ’s tisotumab vedotin to treat recurrent or metastatic cervical cancer. The antibody-drug conjugate (ADC) would become the first treatment option in the European Union for adult cervical cancer patients whose disease has advanced on or following systemic therapy. The MAA submission is based on results from the randomised, international Phase III innovaTV 301 trial. The trial enrolled 502 patients who had received no more than two systemic regimens previously for recurrent or metastatic cervical cancer. Tisotumab vedotin demonstrated improved overall survival, progression-free survival and objective response rates. See Also: Regeneron’s linvoseltamab application accepted for review Biosyngen’s liver cancer therapy receives fast track designation The findings are compared to those obtained from chemotherapy treatments. The primary goal of the study was to assess overall survival, while secondary outcomes included progression-free survival and quality-of-life measures. Data from the innovaTV 204 Phase II single-arm trial of tisotumab vedotin monotherapy was also included in the application. The safety profile observed in the innovaTV 301 trial aligns with the known safety information provided in the US prescribing details. Genmab CEO Jan van de Winkel stated: “The validation of our application is an important milestone supporting our commitment to bringing a new therapeutic option for recurring or metastatic cervical cancer to more patients. “There continues to be a need for therapeutic options for these patients, and we’re dedicated to delivering potentially improved outcomes to women diagnosed with this devastating disease.” Tisotumab vedotin combines Genmab’s human monoclonal antibody targeting tissue factor with the ADC technology of Pfizer. Pfizer Oncology chief development officer Roger Dansey stated: “The milestone signifies our progress in exploring the availability of tisotumab vedotin for more patients with recurrent or metastatic cervical cancer. “We remain dedicated to collaborating closely with regulatory authorities, while we navigate the process to potentially deliver a new therapeutic option to people facing this debilitating disease.”

SOUTH SAN FRANCISCO, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced the appointment of Hans-Peter Gerber, Ph.D., as Chief Scientific Officer, effective September 18, 2023. Dr. Gerber brings over 25 years of drug discovery and development experience to Sutro, with extensive scientific background and expertise in ADCs, targeted oncology, and novel biotherapeutic platforms. “Dr. Gerber’s deep experience in the development of ADCs and other novel therapeutics make him an invaluable addition to our management team,” said Bill Newell, Sutro’s Chief Executive Officer. “With a demonstrated track record from target identification and selection of lead compounds to IND and subsequent regulatory filings, he is the ideal CSO for Sutro. As we continue to develop our pipeline, Dr. Gerber is well-positioned to execute on our goal of continuing to identify, design, and develop next-generation cancer drugs that will rapidly progress into the clinic.” “I was impressed by Sutro’s unique ability to design and manufacture precise targeted molecules, addressing current challenges in the development of biotherapeutics, as well as its already promising pipeline,” said Dr. Gerber. “It is an honor to join such a talented team and to have the chance to transform the lives of cancer patients by discovering and developing innovative treatments.” Dr. Gerber began his Biotech career at Genentech in the Department of Molecular Oncology, followed by various management roles at Seattle Genetics and Pfizer. He has a strong track record in leading cross-functional teams, innovative discovery and translational medicine, and contributions to IND filings and BLA submissions. Prior to joining Sutro, Dr. Gerber served as Chief Scientific Officer at Codeable Therapeutics, an ADC startup company focusing on the development of next generation ADCs that induce immunogenic cell death. Previously, he held executive roles at 3T Biosciences and Maverick Therapeutics. He has also served as an advisor for various Biotech startups, VCs, and Pharma companies and is currently a Board member at Athebio AG and Chairman of the Board at T-CURX. With over 100 peer-reviewed publications and 100 issued patents, he has an impressive record of high scientific achievement. He received an MS in Biochemistry and a PhD in Molecular Biology from the University of Zurich, Switzerland. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) In connection with Dr. Gerber’s appointment as Chief Scientific Officer, the Compensation Committee of Sutro’s Board of Directors granted to Dr. Gerber 175,000 shares of Sutro stock options and 150,000 restricted stock units (RSUs) of Sutro common stock. These grants were made as an inducement material to the Dr. Gerber’s acceptance of employment with Sutro and were approved by the Compensation Committee of Sutro’s Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs and stock options are subject to the terms and conditions of Sutro’s 2021 Equity Inducement Plan. One-fourth of the total number of shares subject to the RSUs will vest on the one-year anniversary of the Dr. Gerber’s hire date and annually thereafter until fully vested on the fourth anniversary, subject to Dr. Gerber’s continued service with Sutro on each such vesting date. One-fourth of the total number of shares underlying the stock options will vest on the one-year anniversary of Dr. Gerber’s hire date and 1/48th of the total number of shares underlying the stock options will vest each month thereafter until fully vested on the fourth anniversary of Dr. Gerber’s hire date, subject to Dr. Gerber’s continued service with Sutro on each such vesting date. The stock options have a term of ten years and an exercise price equal to the closing price of Sutro’s common stock on the grant date as reported by The Nasdaq Stock Market. About Sutro Biopharma Sutro Biopharma, Inc., is a clinical-stage company developing next-generation cancer therapeutics, principally antibody-drug conjugates (ADCs), designed for greater potency, tolerability and improved safety. Sutro’s cell-free technology, XpressCF®, enables the design and manufacture of homogeneous product candidates with precise and empirically-demonstrated positioning of linker-payloads and consistent drug antibody ratio (DAR). Sutro’s platform has produced six clinical stage candidates to date, including two wholly-owned ADCs—luveltamab tazevibulin, or luvelta, a folate receptor alpha (FolRα)-targeting ADC in clinical studies for ovarian and endometrial cancers, as well as STRO-001, a CD74-targeting ADC in clinical studies for B-cell malignancies. In addition, the Company has a robust pipeline of preclinical and discovery stage candidates including STRO-003, a ROR1-targeting ADC, and STRO-004, a tissue factor-targeting ADC. Sutro has also entered into high-value collaborations with industry partners, including Astellas and Merck (MSD outside of the United States and Canada); and Sutro’s platform technology enabled the formation of Vaxcyte. Sutro is headquartered in South San Francisco. For more information, follow Sutro on Twitter, @Sutrobio, or visit www.sutrobio.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, timing of announcements of clinical results, trial initiation, and regulatory filings, potential benefits of luvelta and the Company’s other product candidates and platform, potential future milestone and royalty payments, and potential market opportunities for luvelta and the Company’s other product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates and the Company’s ability to successfully leverage Fast Track designation, the market size for the Company’s product candidates to be smaller than anticipated, the impact of the COVID-19 pandemic on the Company’s business, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, the value of the Company’s holdings of Vaxcyte common stock, and the Company’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. ContactEmily WhiteSutro Biopharma (650) 823-7681ewhite@sutrobio.com

Company Announcement Phase 3 innovaTV 301 confirmatory trial met its primary endpoint of improved overall survival (OS) at predetermined, independent interim analysis Trial results to be submitted for presentation at a future medical meeting Genmab and Seagen to engage in discussions with regulatory authorities Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) announced today that the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK® (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival (OS). An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance. The safety profile of TIVDAK in innovaTV 301 is consistent with the known safety profile of TIVDAK as presented in the U.S. prescribing information, and no new safety signals were observed. The results of innovaTV 301/ENGOT cx-12/GOG 3057, a global, randomized, open-label Phase 3 trial, add to the previous results of innovaTV 204, which served as the basis for the accelerated approval of TIVDAK in the United States. Subject to discussions with regulatory authorities, the results from innovaTV 301 are intended to serve as the pivotal confirmatory trial for the U.S. accelerated approval and support global regulatory applications. The innovaTV 301 China extension study has been initiated and continues to enroll patients, in collaboration with Zai Lab Limited. “TIVDAK is the only U.S. Food and Drug Administration-approved therapy in second-line recurrent or metastatic cervical cancer regardless of biomarker status, tumor histology and prior therapy,” said Roger Dansey, M.D., President of Research and Development and Chief Medical Officer at Seagen. “Demonstrating a survival benefit with the results of innovaTV 301 is a critical milestone in our efforts to ensure more adults living with advanced cervical cancer have an approved treatment option.” “With limited options for advanced cervical cancer patients who have progressed after front-line therapy, there is a need for therapeutic options with new mechanisms of action, particularly those with a demonstrated survival benefit,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. “These results provide hope for patients with recurrent or metastatic cervical cancer.” Results of the Phase 3 innovaTV 301 clinical trial will be submitted for presentation at an upcoming medical congress and discussed with regulatory authorities. About Cervical Cancer Cervical cancer remains a disease with high unmet need despite advances in effective vaccination and screening practices to prevent and diagnose pre-/early-stage cancers for curative treatment. Recurrent and/or metastatic cervical cancer is a particularly devastating and mostly incurable disease; up to 16% of adults are diagnosed with metastatic disease at diagnosisi,ii and, for adults diagnosed at earlier stages who receive treatment, up to 61% will experience disease recurrence and progress to metastatic cervical cancer.iii It is estimated that in 2023, more than 13,960 new cases of invasive cervical cancer will be diagnosed in the U.S. and 4,310 adults will die from the disease.iv About the innovaTV 301 Trial The innovaTV 301 trial (NCT04697628) is a global, randomized, open-label Phase 3 trial evaluating TIVDAK® (tisotumab vedotin-tftv) versus investigator’s choice of chemotherapy alone (topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who received no more than two prior systemic regimens in the recurrent or metastatic setting. Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology, and disease progression during or after treatment with a standard of care systemic chemotherapy doublet or platinum-based therapy (if eligible) are included. The main efficacy outcome measure is overall survival. The main secondary outcomes are progression-free survival, objective response rate, time to response and duration of response, as assessed by the investigator, as well as safety and quality of life outcomes. The study was conducted by Seagen in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057). For more information about the Phase 3 innovaTV 301 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov. About TIVDAK® (tisotumab vedotin) TIVDAK® (tisotumab vedotin) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Determination of TF expression is not required. Nonclinical data suggest that the anticancer activity of TIVDAK is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, TIVDAK also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. In September 2021, the U.S. Food and Drug Administration granted accelerated approval for TIVDAK in adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is the first and only approved ADC for the treatment of these patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The Phase 3 innovaTV 301 clinical trial, an open-label, randomized, global trial, is intended as the confirmatory trial for use in verifying and describing the clinical benefit and for global regulatory applications. About Genmab Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab. About Seagen Founded 25 years ago, Seagen Inc. is a global biotechnology company that discovers, develops, manufactures and commercializes targeted cancer therapeutics, with antibody-drug conjugates (ADCs) at our core. Our colleagues work together with urgency to improve and extend the lives of people living with cancer. An ADC technology trailblazer, approximately one-third of FDA-approved and marketed ADCs use Seagen technology. Seagen is headquartered in Bothell, Washington and has locations in California, Canada, Switzerland and across Europe. For additional information, visit www.seagen.com and follow us on Twitter and LinkedIn. About the Seagen and Genmab Collaboration Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share costs and profits for the product on a 50:50 basis. The content above comes from the network. if any infringement, please contact us to modify.