Harvard University

IRVINE, Calif., Oct. 17, 2023 /PRNewswire/ -- VESICA HEALTH, INC., a multi-omics, liquid biopsy company transforming the management of hematuria patients and improving the early detection of bladder cancer, today announced the appointment of three accomplished industry veterans with proven executive leadership, strategic and commercial experience to its Board of Directors. Continue Reading "It is with great pleasure that we announce the appointment of Dr. Jan Groen, Mark McDonough, and Joe Sollee to our Board of Directors. Their extensive experience in genomics and molecular pathology spans across research and development, operations, finance, human resources, reimbursement, and corporate governance," commented Christopher Thibodeau, Chief Executive Officer of Vesica Health. "We are confident that the Board's collective strategic, operational, and commercial expertise will provide valuable insights and contributions to the organization, supporting management's efforts to maximize value for both patients and shareholders alike." Vesica is poised to immediately reap the benefits of its extensive clinical validation studies Tweet this "With a well-differentiated, scalable solution addressing a multi-billion-dollar market opportunity, I am thrilled to support Vesica's management team on its commercialization strategy," stated Mark McDonough. "Based on my experience, Vesica has a singular opportunity to not only take market share but drive widespread clinical adoption of its AssureDx test." "Vesica is uniquely positioned with an impressive portfolio of intellectual property issued both domestically and internationally," commented Joe Sollee. "The AssureDx test is equally well-suited to Vesica's laboratory services model, as well as IVD kits, thereby enabling the company to address its total available market directly and in combination with key strategic partners." "Vesica is poised to immediately reap the benefits of its extensive clinical validation studies and take market share with its AssureDx test, which promises to significantly enhance the quality of life for patients with hematuria and bladder cancer," stated Dr. Jan Groen. "Speaking on behalf of my fellow Board members, we are excited to be joining Vesica's Board at this important time for the company. We are eager to work alongside the management team to ensure that Vesica is well-positioned for successful commercialization." The Board of Directors will advise the company's management team on strategic, operational, and commercial objectives. Provided below are brief summaries of the Board's credentials: Dr. Jan Groen, Chair of the Board Dr. Groen is the Chairman & CEO of Intravacc (The Netherlands) a contract development & manufacturing organization for the development of innovative human vaccines. His career spans many years in biotechnology, formerly as CEO at MDxHealth (MDXH), where he established the company as a market-leading molecular diagnostic uro-oncology company in the U.S. and EU. Earlier, as the President and COO of Agendia, responsible for the diagnostic operations in the U.S. and EU, he led the introduction of the first FDA-cleared breast cancer recurrence assay in the U.S. He served as VP of Research & Development at Focus Diagnostics, a subsidiary of Quest Diagnostics in California, and co-founded ViroClinics B.V. and DxOrange B.V. He has held numerous scientific leadership positions at the Erasmus Medical Center, RIVM (National Institute of Public Health, NL) and Akzo-Nobel. Previously, Dr, Groen served on the Board of IBL-International (DE) and MyCartis (BE), presently serves as Chairman of the Board at Cergentis (NL), and currently as Independent Director at Novigenix (CH), and Chairman of the Board member Angle Plc. (UK). Mark McDonough, Independent Director Mr. McDonough is the CEO and Board member of ChromaCode, Inc, a genomics multiplexing company that leverages their High-Definition PCR (HDPCR™) platform to enable comprehensive, fast, less expensive testing solutions. Previously, he served as CEO of PierianDx where he raised ~$48M to fund the company's growth initiatives and successfully completed an exit to Summa Equity which resulted in the formation of Velsera. Mr. McDonough served as President, CEO, and Board member for Immunis.AI, a privately held pre-commercial liquid biopsy platform company, and at CombiMatrix, a publicly traded company and leader in high-complexity reproductive health testing. At CombiMatrix, he successfully led the company's turnaround growth and ultimately orchestrated its sale in November 2017. Earlier, he served in various leadership roles at high-growth diagnostic companies including US LABS (acquired by LabCorp) and Ventana Medical Systems (acquired by Roche). Mr. McDonough is a proud former Naval Officer having served as a Navigator and Communications Officer on the USS FLETCHER (DD 992). Joe Sollee, Independent Director Mr. Sollee is the Executive Vice President of Corporate Development and General Counsel at MDxHealth and has more than 20 years of experience in the healthcare industry, including senior management roles in both private and publicly listed pharmaceuticals, health information technology, and molecular diagnostics companies. He has served as chief legal counsel to MDxHealth since its inception in 2003. Prior to MDxHealth, he led the Life Sciences Practice Group at the law firm of Kennedy Covington (now K&L Gates) and held senior legal and management positions at TherapyEdge and Triangle Pharmaceuticals. In addition, he has practiced as a corporate attorney in the Washington D.C. legal firm Swidler & Berlin and as an investment banker at Smith Barney in New York. Mr. Sollee received a Juris Doctorate in Law and a master's degree in international law from Duke University, a BA degree from Harvard University, and has been awarded New York, Washington D.C. and North Carolina legal bar certifications. About AssureDx™ Vesica Health's patented, noninvasive, urine-based AssureDx test helps physicians accurately triage hematuria patients, distinguishing those at increased risk for bladder cancer, who may benefit from immediate referral to urology and clinical evaluation, from those at very low risk for bladder cancer, who may safely avoid invasive procedures and secondary cancer risk from harmful CT scans. AssureDx biomarkers and technology have been extensively reported in 20 peer-reviewed and published studies on over 5,878 patients, including three sequential, prospective clinical validation studies, delivering robust clinical performance with a 0.96 AUC (area under the receiver operating characteristic curve), 99% Negative Predictive Value (NPV), 96% Sensitivity and 83% Specificity for the detection of bladder cancer in hematuria patients. AssureDx also provides urologists with a noninvasive method to monitor bladder cancer patients at increased risk of recurrence after initial treatment, thereby improving patient management and outcomes. About Vesica Health, Inc. Vesica Health's mission is to transform the management of hematuria patients and improve the early detection of bladder cancer. Each year it is estimated that upwards of 17M (1-in-5) adults will present with hematuria, the primary symptom of bladder cancer, yet despite guideline recommendations only ~12% of patients are referred to urology for clinical evaluation. As a consequence, ~20% of bladder cancers are missed each year, leading to later-stage disease at diagnosis and higher mortality. Vesica has translated 20 years of advanced multi-omics research in bladder cancer into a well-validated, commercial-ready precision diagnostic test to improve the evaluation of hematuria, early detection of disease, and recurrence monitoring. For more information, please visit . For more information: Vesica Health Corporate Communications [email protected] This company announcement contains forward-looking statements and estimates with respect to the anticipated future performance of Vesica Health and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. Vesica Health expressly disclaims any obligation to update any such forward-looking statements in this announcement to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This company announcement does not constitute an offer or invitation for the sale or purchase of securities or assets of Vesica Health in any jurisdiction. No securities of Vesica Health may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws. NOTE: The Vesica Health wordmarks and logos, including Vesica Health, and AssureDx are trademarks or registered trademarks of Vesica Health, Inc. All other trademarks and service marks are the property of their respective owners. SOURCE Vesica Health

VANCOUVER, British Columbia, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing novel multifunctional biotherapeutics, today announced that its board of directors will nominate Dr. Nancy Davidson for election to its board of directors at the Company’s upcoming annual general meeting of stockholders to be held on December 7, 2023. “As the Company continues to execute on our strategy to support the approval and commercialization of zanidatamab while targeting five IND filings for new product candidates before the end of 2027, we are pleased to announce a significant proposed addition to our board of directors. With two prior additions to our board of directors already during 2023, these changes help secure the diversity of leadership experience required to successfully achieve our growth ambition over the next several years and beyond,” stated Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “With this in mind, we are delighted to invite Dr. Davidson to join our board of directors. Dr. Davidson’s substantial expertise in the field of oncology and foundational work in advancing insights in cancer biology from the bench through clinical studies and into the patient community arrives at a crucial time as we prepare for pivotal milestones in our product pipeline.” “I am excited to be nominated to join the Zymeworks board of directors, and deeply share in its patient-centered mission and commitment to improving the standard of care for difficult-to-treat cancers,” stated Dr. Nancy Davidson, MD. “I look forward to using my clinical experience to contribute to the development of data-driven and differentiated next-generation therapies for patients with inadequate treatment options.” Dr. Davidson is an oncologist and researcher who is a top opinion leader in the field of breast cancer biology and treatment, with a particular interest in developing evidence-based clinical pathways in breast cancer treatment. She has contributed foundational research to the understanding of how hormones affect gene expression and cell growth in breast cancer, and how hormonal deprivation and other therapies trigger breast cancer cells to kill themselves through apoptosis, or programmed cell death. Her lab studies have paved the way for new clinical trials of drugs that exploit these pathways to kill breast cancer. She has also led several critical clinical trials that have advanced the care of breast cancer patients through combining chemotherapy and hormone therapy for premenopausal women with the disease and has guided several important national clinical trials of potential new therapies, including chemo-endocrine therapy for premenopausal breast cancer and anti-angiogenesis therapy for advanced disease. Dr. Davidson is currently the Executive Vice President for Clinical Affairs, Raisbeck Chair for Collaborative Research and Professor of Fred Hutchinson Cancer Center (“FHCC”). She also serves as a Professor at the University of Washington Department of Medicine based in Seattle. Prior to joining FHCC, she spent time at the National Cancer Institute, Johns Hopkins in Baltimore and the University of Pittsburgh. Dr. Davidson is a past-President of both the American Society of Oncology (ASCO) and the American Association for Cancer Research (AACR) and has served on a variety of board of directors and advisory committees in the oncology field. She has authored more than 400 publications during her career. After receiving a B.A. in Molecular Biology from Wellesley College, she went on to obtain an M.D. from Harvard Medical School. Dr. Davidson completed her residency in Internal Medicine at John Hopkins Hospital and a fellowship at the National Cancer Institute. About Zymeworks Inc. Zymeworks Inc. (Nasdaq: ZYME) is a global biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks' mission is to make a meaningful difference for people impacted by difficult-to-treat cancers and other serious diseases. Zymeworks' complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using Zymeworks' proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each of BeiGene and Jazz with exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab is currently being evaluated in global Phase 1, Phase 2, and Phase 3 clinical trials, including certain ongoing pivotal clinical trials as a treatment for patients with HER2-expressing cancers. Zymeworks' next clinical candidate, zanidatamab zovodotin (ZW49), is a HER2-targeted bispecific antibody-drug conjugate (ADC) developed using Zymeworks' proprietary Azymetric™ and ZymeLink™ Auristatin technologies. Zanidatamab zovodotin is currently being evaluated in a Phase 1 clinical trial for patients with a variety of HER2-expressing, HER2-amplified or HER2-mutant cancers. Zymeworks is also advancing a deep pipeline of product candidates based on its experience and capabilities in both ADC and multispecific antibodies (MSAT). In addition to Zymeworks' wholly owned pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to potential therapeutic effects and commercial potential of zanidatamab and Zymeworks' other product candidates; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; the ability to advance product candidates into later stages of development; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “progress”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for its quarter ended June 30, 2023 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Zymeworks Media Contact:Diana Papove Director, Corporate Communications media@zymeworks.com (604) 678-1388 Zymeworks Investor Contact: Shrinal Inamdar Director, Investor Relations ir@zymeworks.com(604) 404-0995

-- Awards presented at the 5th Annual LEAD conference for women in oncology and hematology -- SCOTTSDALE, Ariz., Oct. 16, 2023 /PRNewswire/ -- This past weekend, Women Leaders in Oncology® (WLO) presented its "Woman Oncologist of the Year" award to Julie Gralow, MD, FACP, FASCO, Chief Medical Officer and Executive Vice President of the American Society of Clinical Oncology® (ASCO). WLO also presented its "2023 Rising Star" award to Jaydira Del Rivero, MD, Physician Scientist in the Developmental Therapeutics Branch of the National Cancer Institute (NCI). The presentation occurred in Scottsdale, Arizona during the fifth annual LEAD conference, which strives to empower women leaders in the fields of hematology and oncology by providing essential clinical updates, career development, and professional networking. "While women are becoming more prevalent within the field of oncology, a gender imbalance persists at the leadership level," said Deanna B. van Gestel, Founder and CEO of Vaniam Group and WLO. "Women are less likely to be lead authors on peer-reviewed publications, principal investigators in clinical trials, or keynote speakers at industry conferences. Dr. Gralow is a true leader in this field, distinguished not only by her work to advance breast cancer research, but also to promote greater equity across cancer care. Similarly, Dr. Del Rivero is an outstanding physician-scientist who has demonstrated exceptional resilience and dedication throughout her career, overcoming multiple obstacles to become the first in her family to complete medical school. She will surely continue to make important contributions to the field, while serving as an inspiration to other women considering careers in oncology. We congratulate them both." LEAD is a conference designed for women in oncology and hematology. The goal of this conference is to empower women leaders in the hematology and oncology space by providing essential clinical updates, career development, and professional networking. Sessions include discussions on the importance of women's leadership, career development workshops, and clinical sessions on biomarkers and oncology therapies. At each year's LEAD conference, WLO presents the LEAD awards. Past recipients of the Woman Oncologist of the Year award include Christine Chung, MD (2022), Pamela Kunz, MD (2021), Reshma Jagsi, MD, DPhil (2020), and Claire Verschraegen, MD (2019). Past recipients of the Rising Star award include Carolyn Presley, MD, MH (2022), Ana Velázquez Mañana, MD (2021), Narjust Duma, MD (2020), and Shikha Jain, MD, FACP (2019). Julie Gralow, MD, FACP, FASCO Dr. Gralow is the Chief Medical Officer and Executive Vice President of the American Society of Clinical Oncology (ASCO). She serves as a public spokesperson and expert commenter for ASCO, and an ambassador to ASCO members and cancer organizations across the United States and worldwide. Dr. Gralow is a breast medical oncologist and Professor (emeritus) at the University of Washington (UW) School of Medicine, where she served >25 years on faculty as Director of Breast Medical Oncology, founding member of the UW Breast Cancer Equity Initiative, and Medical Director for Women's Cancer-related Population Health. She also served as an adjunct professor in the University of Washington's Department of Global Health, as a faculty member of the UW's Ellison Center for Russian, East Europe and Central Asian studies, and as an advisory council member for the Uganda Cancer Institute's adult Hematology/Oncology Fellowship Training Program. She is a recognized leader in breast cancer clinical research, and is the former Executive Officer for Breast and Lung Cancer and Vice Chair of the Breast Cancer Committee for the SWOG Cancer Clinical Trials Network. Dr. Gralow is committed to improving the quality of life for patients with cancer, and is co-Founder of Team Survivor Northwest, a non-profit aimed at helping female cancer survivors improve their health through fitness and exercise. She is also strongly committed to advancing equity in cancer care. As founder of the Women's Empowerment Cancer Advocacy Network (WE CAN), she supports patient advocates in low- and middle-resource countries. Dr. Gralow received the ASCO Humanitarian Award in 2018 for her work in empowering women cancer patients and survivors globally. Dr. Gralow received her bachelor's degree from Stanford University and her medical degree from the University of Southern California School of Medicine. She trained in internal medicine at Brigham and Women's Hospital at Harvard Medical School and completed a medical oncology fellowship at University of Washington/Fred Hutchinson Cancer Research Center in Seattle. Jaydira Del Rivero, MD Dr. Del Rivero is a Physician Scientist in the Developmental Therapeutics Branch of the National Cancer Institute (NCI). She is the Principal Investigator of the Natural History Study for Neuroendocrine Neoplasm and Adrenocortical Cancer to provide the basis of further development of therapeutic interventions, prevention/screening guidelines, endpoints for future clinical trials and the PI of various treatment studies for neuroendocrine neoplasms. Dr. Del Rivero earned her medical degree from the Faculty of Medicine at the University of Veracruz in Veracruz, Mexico. She then completed her internal medicine residency at Woodhull Medical and Mental Health Center/New York University (NYU)-Langone Medical Center in Brooklyn. Following residency, she completed a fellowship in endocrinology at the Inter-Institute Endocrinology Training Program (IETP) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Child Health and Human Development (NICHD), and the National Institute of Dental and Craniofacial Research (NIDCR) where she was part of a research team developing clinical trials for pheochromocytoma and paraganglioma. Dr. Del Rivero then joined as Assistant Professor at the Montefiore Einstein Center for Cancer Care (MECCC) focusing on the management of all endocrine tumors, such as advanced gastroenteropancreatic neuroendocrine tumors, adrenocortical cancer, pheochromocytoma/paraganglioma and other endocrine malignancies. She subsequently completed a second fellowship in oncology at the National Cancer Institute. Dr. Del Rivero is board certified in Internal Medicine, Endocrinology, Diabetes and Metabolism and Oncology and her current efforts is the development of novel treatment approaches and targeted therapies for endocrine malignancies such as advanced gastroenteropancreatic neuroendocrine tumors, adrenocortical cancer and pheochromocytoma/paraganglioma. About Women Leaders in Oncology (WLO) Created in 2014 by Ms. van Gestel, WLO is focused on growing a community and fostering meaningful connections for women in oncology drug development, clinical research, and medical practice. WLO facilitates networking, mentorship, and research funding for women across oncology at all levels, along with sponsorship opportunities that enable corporations to exceed their Diversity, Equity, and Inclusion (DE&I) goals in a measurable and impactful way. Media Contact: David Whitrap [email protected] SOURCE Vaniam Group LLC