Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA

On April 1, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the Company has completed the submission of its Biologics License Application ("BLA") under the FDA’s Rolling Review process for naxitamab after market close on March 31, 2020. Naxitamab is an investigational, monoclonal antibody that targets GD2 (Press release, Y-mAbs Therapeutics, APR 1, 2020, View Source [SID1234556063]). The naxitamab BLA is for the treatment of patients with relapsed/refractory high-risk neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 201 and 12-230, which the Company expects to present at a venue later this year.

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"As the father of a long-term high-risk neuroblastoma survivor, I am excited to see Y-mAbs first BLA submission in neuroblastoma completed. We believe this is a key milestone for families facing high-risk neuroblastoma and for Y-mAbs. We are very grateful to all our employees, consultants and clinical sites involved in developing naxitamab," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "With this submission, we look forward to working with the Agency to bring naxitamab to appropriate patients. We are excited to complete this submission and believe naxitamab can address a significant unmet medical need for children with relapsed/refractory high-risk neuroblastoma."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed naxitamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product and in Y-mAbs.

NEC charts global growth by appointing new CEO of Indian business

On April 1, 2020 NEC Corporation and NEC Technologies India reported the appointment of Mr. Aalok Kumar as the new President and Chief Executive Officer (CEO) of NEC Technologies India (Press release, NEC, APR 1, 2020, View Source [SID1234556061]).

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This change reflects NEC Corporation’s strong commitment to the country and India’s growing importance to the company’s global business.

With this appointment, Mr. Takayuki Inaba, former Chairman & Managing Director, has been appointed as Executive Chairman of NEC Technologies India.

Mr. Akihiko Kumagai, President of the Global Business Unit, NEC Corporation, said, "This management restructuring exercise is aimed at accelerating our evolution in India. Capacity building in India will not only bolster our business in this country but also support our global businesses."

Mr. Kumagai continued, "Aalok is an accomplished leader who brings a good mix of strategic thinking and operational excellence. His rich experience in business transformation and performance improvement, especially in Japan and other Asian markets, will help us accelerate our growth. With him onboard, we are confident that he will take NEC Technologies India to even greater heights and help India achieve its goals."

Mr. Aalok Kumar, President & CEO, NEC Technologies India, said, "India is a key market in NEC’s global growth strategy. With our huge pool of engineering and technology talent across various verticals, including public safety, communications infrastructure, aviation, logistics and transportation solutions, NEC is contributing significantly to the digital transformation of India."

"Our R&D efforts at NEC Laboratories India have enabled our ‘In India- For India’ strategy to develop innovative solutions that create social value and are globally scalable," he added.

Supported by a strong and talented workforce of over 6,000 local employees, NEC has successfully deployed a number of cross industry solutions for the infrastructure, aviation, logistics and transportation sectors.

Some key NEC projects in India include the Chennai-Andaman submarine cable project, which will bridge the digital gap between Andaman and Nicobar Islands by ensuring speedy internet access. In the aviation sector, NEC’s biometric-based paperless boarding solution will enable a seamless airport experience for passengers.

Container tracking and optimization solutions deployed by DMICDC Logistics Data Services – a joint venture between the Government of India and NEC – has allowed efficient management of 95% of the import-export container traffic at seaports throughout India, resulting in improved port operations across the country.

In collaboration with local government authorities, NEC is working on a number of smart city projects as well by setting up digital command and control centers for traffic management and public safety.

By collaborating with NEC Laboratories India in Bangalore, NEC Technologies India develops solutions across verticals such as Big Data, biometrics, mobile communications and retail that can be deployed both locally and internationally.

NEC Technologies India currently operates offices in New Delhi (head office), Ahmedabad, Bengaluru, Chennai, Mumbai, Noida and Surat.