On December 9, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that data from a research collaboration with Vanderbilt University Medical Center demonstrating the capability of MammaPrint and BluePrint to identify differences in recurrence risk and tumor classification amongst different racial groups at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021) (Press release, Agendia, DEC 9, 2021, View Source;Breast-Cancers-in-Black-and-White-Women-Beyond-Clinical-Factors [SID1234596702]).

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The presentation, titled MammaPrint and BluePrint identify genomic differences in HR+ HER2- breast cancers from young Black and White women, highlights new data signaling that among young women (­<50 years of age) with localized hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, MammaPrint and BluePrint identified racial disparities in risk of recurrence and breast cancer subtype distribution not detected by existing clinical factors.

The analysis included 186 Black women and 186 White women under the age of 50 with stage I-III HR+ HER2- breast cancer, matched by age, tumor stage, nodal status and receptor status. Of these patients, Black women were significantly more likely to present as a MammaPrint High Risk 2, and in general had more High Risk tumors compared to White women – who were more likely to have Low Risk tumors, including more MammaPrint UltraLow Risk tumors – despite matching for clinical and pathologic features.

Additionally, the data demonstrated that estrogen-receptor-positive (ER+) tumors reclassified by BluePrint as Basal-type occur at a higher frequency in Black women compared to White women. Basal-type tumors often have worse outcomes compared to ER+, so it is essential to identify this reclassification in Black women to understand the tumor’s biology and ultimately provide better, personalized care. These data underscore the importance of MammaPrint Risk assessment and BluePrint subtyping for providing greater precision in the prediction of risk of recurrence and the selection of therapy.

"It is crucial to identify the genomic differences among young women with breast cancer that may be contributing to racial/ethnic survival disparities, especially given that Black women are more than 40% more likely to die from breast cancer compared to White women," said Sonya Reid, MD, MPH, Department of Medicine, Vanderbilt University Medical Center. "These data demonstrate the promise of personalized medicine to advance our understanding of racial differences on a genomic level to improve breast cancer outcomes across all racial and ethnic groups."

Agendia previously presented data at ASCO (Free ASCO Whitepaper) 2021 which also highlighted the importance of genomic insights that are representative of and effective for diverse patient groups, to better understand and begin to solve for disparities in outcomes.

"Black women continue to remain underrepresented in clinical trials, and this study signifies an important step in measuring the clinical and genomic differences of breast cancers in Black women, which will help to redefine the standard of care and guide treatment planning," said William Audeh, MD, Chief Medical Officer of Agendia and a study author. "These results provide novel insights about differences in tumor biology; MammaPrint and BluePrint have tremendous potential to add to our understanding of the causes of disparities in survival associated with race, and will help guide therapeutic strategies to improve outcomes. We greatly appreciate the opportunity to collaborate with Dr. Reid and her colleagues at Vanderbilt in this important research."

Agendia is dedicated to gathering data that has translational potential as well as immediate clinical impact for diverse patient populations. Providing novel insights about tumor biological differences and adding to the body of evidence of genomic profiling of breast cancer based on genetic ancestry is critical to improving patient outcomes. These data underscore the company’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

On December 9, 2021 Outcomes4Me Inc., a developer of a leading free mobile app and platform to navigate cancer treatment and care, reported, at the San Antonio Breast Cancer Symposium, findings from a study done in collaboration with the Mass General Cancer Center, Boston (Press release, Outcomes4Me, DEC 9, 2021, View Source [SID1234596700]). The pilot study analyzed the concordance of patient reported disease characteristics compared to electronic medical record (EMR) data. Outcomes4Me found that the data clearly points to the need for patients to have a better understanding of their breast cancer diagnosis. Patients’ understanding of their breast cancer diagnosis is important in order to improve treatment adherence, shared decision-making, and clinical trial matching. The study shows important discrepancies between EMR and patient self-reported information, shining a light on the need for better patient education and medical records access.

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The study, which collected data via a survey and an in-app questionnaire between June 2020 to December 2020, found that 97 percent of the study cohort reported that they "somewhat" or "strongly" understood their cancer diagnosis. Yet, 24 percent of patients answered "I don’t know" or "I’m not sure" to fundamental questions about their disease characteristics including hormone receptor (HR) status, and/or HER2 status.

"There is no doubt that the inaccuracies found in self-reporting suggest a need for improved patient education regarding key cancer characteristics and a need for caution when relying on self-reported characteristics for clinical trials matching and targeted patient education," said Maya R. Said, Sc. D., founder and CEO of Outcomes4Me. "These findings underscore a problem that all stakeholders here at the SABCS – practicing providers and researchers – involved in breast cancer need to have top of mind. The burden of improving patients’ understanding of breast cancer should not be on the patient alone."

The study also found that HR and HER2 status had limited concordance with the EMR, in contrast to a high degree of accuracy in self-reported metastatic status. Receptor status is critically important to understanding breast cancer and what treatment options are available, including clinical trials. Yet, only 55 to 61 percent of patients accurately self-reported their HR and/or HER2 status. In particular, HER2 status was only reported accurately among 64 to 70 percent of the cohort, compared to 79 to 89 percent of patients accurately reporting their metastatic status.

"Patient education is critical to shared decision making," said Steven Isakoff, MD, PhD, Breast Oncologist at Mass General Cancer Center and lead author on the study. "Patients need to have a better understanding of their breast cancer diagnosis in order to have more informed decision-making conversations. Without accurately knowing critical disease characteristics, our patients are not in the best position to make informed decisions with their oncologist."

These results further highlight the need for digital platforms to integrate self-reported characteristics with EMR access to help provide accurate patient information to address these critical needs. The Outcomes4Me platform was developed to enable this integration with a goal to impact patient empowerment and care. The Outcomes4Me app is available free to users on both the App Store and Google Play.

More about the Outcomes4Me Inc. study, done in collaboration with the Mass General Cancer Center, Boston:
Data was analyzed from a single institution pilot study (NCT04262518) and eligibility included breast cancer patients with any subtype or stage of invasive cancer presenting with a new diagnosis or for follow-up on active therapy. Outcomes4Me compared patient reported characteristics within a study specific survey and/or the Outcomes4Me app for stage (metastatic or not metastatic), recurrence history, hormone receptor status, HER2, and surgery history with the data recorded in the EMR. All statistics were descriptive. The company conducted the same comparison between patient reported clinical characteristics among real world users of the Outcomes4Me app and EMR records downloaded by that cohort of patients.

Access to the SABCS poster can be found on sabcs.org.

On December 9, 2021 CANbridge Pharmaceuticals, Inc., a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development and commercialization of transformative therapies, reported that it signed the collaboration on a rare disease research agreement with the Peking Union Medical College Hospital (PUMCH), on December 9, 2021 (Press release, CANbridge Life Sciences, DEC 9, 2021, View Source [SID1234596699]). Under terms of the agreement, the two parties will collaborate on research and development in rare disease drug innovation, translational medicine and clinical verification, leveraging their respective strengths to further improve the development of innovative rare disease drugs and drive medical research and the development of industrial systems for diagnosis and treatment.

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"We are delighted and honored to enter into the collaboration agreement with PUMCH, the only national lead organization of the National Collaborative Network for the Diagnosis and Treatment of Rare Diseases with extensive experience in the diagnosis, treatment and clinical research of rare diseases," said James Xue, Ph.D., CANbridge Founder, Chairman and CEO. "Working together, I believe we’ll be able to find a characteristically Chinese path for the development and innovation of rare disease treatments and to provide hope for patients with rare diseases and their families."

About the Peking Union Medical College Hospital (PUMCH)

Founded in 1921, the Peking Union Medical College Hospital (PUMCH) is a modern AAA hospital. In addition to providing medical services, it is also a teaching and research hospital. PUMCH is a national center designated by the National Health Commission (NHC) for guiding the diagnosis and treatment of intractable diseases and critical illness. It is also one of the first hospitals designated to provide healthcare services for government officials and foreigners, one of the national demonstration centers for higher medical education and the standard training of resident doctors, and one of the key national centers for clinical medical research and innovation. The hospital is known both in China and abroad for its full range of services strong human resources, prominent specialties, and overall strength. PUMCH was ranked No.1 twice during the nationwide performance evaluation of AAA public hospitals and topped the "Ranking of Chinese Hospitals," by Fudan University Institute of Hospital Management, for 12 consecutive years.

PUMCH is a leader in rare diseases. In 2016, PUMCH led the national key research program, the Clinical Cohort Study of Intractable and Rare Diseases, and built China’s National Registration System for Intractable and Rare Diseases, which became one of the largest platforms for information about rare diseases in the world. Within the framework of the NHC’s Expert Committee on the Clinical Care and Accessibility for Rare Diseases, PUMCH led top Chinese experts to draft China’s First List of Rare Diseases and compiled and published Interpretation of China’s First List of Rare Diseases, Guidelines for the Diagnosis and Treatment of Rare Diseases (the 2019 edition) (released by the NHC), and Rare Diseases, a textbook for graduate students during the 13th Five-Year Plan period. The hospital has also been driving technical training on the diagnosis and treatment of rare diseases across the country. Currently, PUMCH is undertaking research projects of the State Key Laboratory of Rare Diseases, the National Center for Translational Medicine, the National Center of the National Collaborative Network for the Diagnosis and Treatment of Rare Diseases, and the National Center for the Quality Control of Rare Diseases. The hospital is building a national center for research and innovation with respect to the diagnosis and treatment of rare diseases with all the necessary clinical resources and expertise.

On December 9, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that its Board of Directors has approved a new share repurchase program effective immediately, which authorizes the Company to purchase up to $750 million of the Company’s outstanding common stock over the next three years (Press release, Halozyme, DEC 9, 2021, View Source [SID1234596698]). The Company plans to enter into an accelerated share repurchase (ASR) program transaction with a financial institution in the coming week, subject to market conditions. The Company plans to purchase up to $250 million worth of shares by the end of 2022, including the $150 million ASR, pending market conditions and other factors.

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"Our second share repurchase authorization demonstrates Halozyme’s commitment to a balanced capital allocation strategy that includes investing in our operations, capital return and potential M&A," said Dr. Helen Torley, president and chief executive officer. "We are pleased that our strong cash generation and balance sheet enables us to return capital to investors while maintaining our ability to invest in our future to sustainably grow our business."

This share repurchase program follows the recent completion of the Company’s prior $550 million three-year share repurchase program, which was completed in less than two years.

The amount and timing of shares repurchased under the share repurchase program will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements. Repurchases may be commenced or suspended at any time or from time-to-time at the Company’s discretion without prior notice. Repurchases may be made through both public market and private transactions. The Company plans to fund repurchases from its existing cash balance. The Company’s Board of Directors will regularly review this capital return policy in connection with a balanced capital allocation strategy focused on funding growth.

On December 9, 2021 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported the launch of its Artificial Intelligence (AI) Academy, an innovative initiative that will bring to life an immersive learning experience for Moderna employees, in partnership with Carnegie Mellon University (CMU) (Press release, Moderna Therapeutics, DEC 9, 2021, View Source [SID1234596697]).

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The AI Academy is intended to educate and empower employees at all levels to identify and integrate AI and machine learning solutions into every Moderna system and process to bring mRNA medicines to patients.

"Moderna is advancing mRNA medicines at a breadth, speed, and scale that is uncommon in the biopharmaceutical industry, and we attribute this speed in part to the incorporation of digital technologies in our company," said Stéphane Bancel, Chief Executive Officer of Moderna. "As we look at the next 10-20 years, we believe that we have to learn as fast as we can to maximize the impact of mRNA technologies on patients and scale our company in very different ways than large companies have scaled in the last decades. We believe AI is a key enabler of our ability to build the best version of Moderna now and into the future. This AI Academy will enable us to make AI part of our ways of working, part of our DNA. We look forward to driving this with Carnegie Mellon’s team."

CMU’s Department of Statistics & Data Science, a part of the Dietrich College of Humanities and Social Sciences, and the Tepper School of Business are collaborating with professors across the University to design and deliver Moderna’s AI Academy. This unique program will deliver a tailored curriculum structured for working professionals focused on topics including data quality and data visualization, statistical thinking and models, machine learning algorithms and AI ethics. The breadth and depth of content will help all employees think strategically about how to leverage AI in their specific job functions. The AI Academy will connect Moderna staff directly with CMU’s faculty both in person and online using the Integrated Statistics Learning Environment (ISLE), an interactive educational platform developed at the University. U.S. News & World Report ranks CMU as the top university for graduate education in AI, as well as computer science.

"We are excited to deliver a world-class AI curriculum to Moderna and support the company’s deep-rooted commitment to discovery and innovation that protects public health," said CMU President Farnam Jahanian. "With decades-long leadership in the field, Carnegie Mellon is uniquely positioned to help businesses learn how to use AI to drive the kinds of breakthroughs needed to address urgent societal challenges. It’s rewarding to partner with a pioneering biotech company that is dedicated to adapting its business and its workforce to this critical technology."

Moderna will launch the program next week with its first cohort of students and is targeting early 2022 for the full rollout.