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.

On December 9, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that it will host a key opinion leader ("KOL") webinar on MB-106, the Company’s CD20-targeted, autologous CAR T cell therapy for the treatment of B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL"), on Thursday, December 16, 2021, at 2:30 p.m. Eastern Time (Press release, Mustang Bio, DEC 9, 2021, View Source [SID1234596694]).

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The webinar will feature a presentation by Mazyar Shadman, M.D., M.P.H., Associate Professor at the Fred Hutchinson Cancer Research Center ("Fred Hutch") and a physician at Seattle Cancer Care Alliance, who will discuss updated interim results from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 for patients with relapsed or refractory B-NHLs and CLL. These data were selected for presentation at the the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting ("ASH2021"), which is being held December 11-14, 2021. Dr. Shadman, along with colleague Brian Till, M.D., also an Associate Professor at Fred Hutch and physician at Seattle Cancer Care Alliance, will be available to answer questions following the formal presentations.

Mustang Bio’s management team will provide additional details on the planned MB-106 Phase 1/2 clinical trial to be conducted under Mustang’s Investigational New Drug ("IND") application. The U.S. Food and Drug Administration accepted Mustang’s IND to initiate a multicenter Phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB-106 for relapsed or refractory B-NHLs and CLL.

To register for the event, please click here.

About Dr. Shadman
Mazyar Shadman, M.D., M.P.H., is an Associate Professor at the University of Washington ("UW") and Fred Hutch as well as a physician at Seattle Cancer Care Alliance. He is a hematologic malignancies expert who specializes in treating patients with lymphoma and CLL.

Dr. Shadman is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cells), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies.

Dr. Shadman received his M.D. from Tehran University in Iran. He finished an internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his fellowship training in hematology and medical oncology at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for the National Cancer Institute’s cancer research training program at Fred Hutch, where he studied cancer epidemiology.

About Dr. Till
Brian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW as well as a physician at Seattle Cancer Care Alliance. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.

Note: Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division, and exclusively licensed to Mustang in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. Additional information on the trial can be found at View Source using the identifier NCT03277729.

On December 9, 2021 Sesen Bio (Nasdaq:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported its anticipated regulatory path forward for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) following its Clinical Type A meeting with the US Food and Drug Administration (FDA), which occurred on December 8, 2021 (Clinical Type A Meeting) (Press release, Sesen Bio, DEC 9, 2021, View Source [SID1234596692]).

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Following the productive Clinical Type A Meeting, the Company believes it has greater clarity regarding the requirements for resubmission of the BLA and the trial design, which may include these elements:

A randomized clinical trial assessing the safety and efficacy of Vicineum compared to investigators’ choice of intravesical chemotherapy;
Trial may include both patients who have received adequate BCG1 and patients who have received less-than-adequate BCG;
Company encouraged to submit the final VISTA trial results with the resubmission; and
Anticipated randomized trial design is aligned with guidance the Company has received from the European Medicines Agency, which may help to coordinate the regulatory paths forward for Vicineum in the US and the European Union.
The Company expects to hold a Type C meeting with the FDA in early 2022 to discuss the protocol for the additional clinical trial.

"We are pleased to have greater clarity on the regulatory path forward to resubmit the BLA and ultimately bring Vicineum to market if approved," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Our team looks forward to working productively with regulators as we continue to focus on our mission of saving and improving the lives of patients."

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.