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Moderna Receives FDA Fast Track Designation for Zika Vaccine mRNA-1893
2019-08-21

Moderna, Inc., a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational Zika vaccine (mRNA-1893) currently being evaluated in a Phase 1 study for the prevention of Zika virus infection in healthy adults.

Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. Moderna previously received Fast Track designation for its methylmalonic acidemia (MMA) program (mRNA-3704), which is now recruiting patients for a Phase 1/2 clinical study.

“Protecting against Zika virus transmission, particularly in women during pregnancy, continues to be an area of high unmet need. Fast Track designation supports our belief in the clinical potential of mRNA-1893 and the importance of developing an effective vaccine that can be rapidly developed and deployed,” said Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. “Our Zika program is part of Moderna’s broader commitment to improving global public health through developing mRNA vaccines to prevent the spread of infectious diseases.”

mRNA-1893 contains an mRNA sequence encoding for the structural proteins of Zika virus and is designed to cause cells to secrete virus-like particles, mimicking the response of the cell after natural infection. Preclinical data published in The Journal of Infectious Diseases have shown that vaccination with mRNA-1893 protected against transmission of Zika virus during pregnancy in mice.1 mRNA-1893 is currently in a Phase 1 study evaluating safety, pharmacokinetics and pharmacodynamics in healthy volunteers.

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services (HHS); Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201600029C.

from--Pharma Focus Asia

In recent years, the size of the global pharmaceutical market has maintained a steady growth, with China, South Korea, India and other emerging markets presenting a rapid growth momentum. Due to the different intellectual property policies of different countries, the strategic layout of global intellectual property, the differences of pharmaceutical intellectual property policies of Asia-pacific countries, the patent review process, litigation procedures and Generic drug patent strategy have gradually become the hot spots of the pharmaceutical intellectual property industry.

 In this context, the 2019 Asia-pacific Pharmaceutical IP Leader Summit will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.


2019 Asia-pacific pharma IP Leader Summit 

Official registration and consultation channels:

ContactAnn

Phone: 021-65650305

EmailMarketing@zenseegroup.com

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Major Chinese biopharmaceutical company Hansoh Pharmaceutical Group Company Limited (Hanmori Pharmaceutical Group Co., Ltd., Hanso Pharmaceutical) and AI ) Atomwise, Inc., a leader in the field, announced the collaboration. The purpose of the collaboration is to design and discover potential drug candidates for a total of 11 private target proteins in multiple therapeutic areas.Atomwise and Hansoh Pharma scientific teams work closely together in each program. The combination of complementary expertise and technology has the potential to dramatically increase success rates and shorten schedules in drug discovery and clinical development.Dr. Aifeng Lyu, President of Jiangsu Hansoh Pharmaceutical Group Co., Ltd., a subsidiary of Hansoh Pharma, said: “Atomwise is the best partner for Hansoh Pharma to use AI technology to innovate and create diverse small molecule pipelines in oncology and other therapeutic areas. I am very impressed with the team and I believe that working together will provide a special opportunity to develop first-in-class and best-in-class therapeutics. "Dr. Abraham Heifets, CEO of Atomwise, said: “It is a great pleasure for us to partner with Chinese biopharmaceutical giant Hansoh Pharma. Hansoh Pharma shares our strong commitment to innovation and our mission to influence patient health globally.”Atomwise's world-class AI platform for structure-based drug design leads the way in finding hit compounds, selecting lead compounds from hit compounds, and optimizing lead compounds. Hansoh Pharma will contribute in its capacity in biological assays and medicinal chemistry, and will lead the subsequent preclinical and clinical development.Subject to the terms of the collaboration, Atomwise will receive revenue based on private technology fees, option exercise fees, royalties, and sublicenses and sales of assets created under the collaboration. Based on historical average sales of small molecule drugs, the overall potential value of this transaction for Atomwise may exceed the potential value of a hit drug if all projects succeed. Hansoh Pharma receives development and commercialization rights in all fields and regions.2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/404716/ will be held in Beijing  on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact:AnnPhone: 021-65650305Email:Marketing@zenseegroup.comhttp://www.zenseegroup.com/forms/view/22113/

Akari Therapeutics, Plc, a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for nomacopan for the treatment of bullous pemphigoid (BP).“BP, a severe blistering skin condition with no approved treatments, is an exciting therapeutic target for our lead drug candidate, nomacopan. It is also a disease of increasing prevalence due to an aging population and improving diagnosis,” said Clive Richardson, Chief Executive Officer of Akari Therapeutics. “Orphan drug designation for nomacopan is a major step forward for the program, positioning nomacopan for eligibility for an additional seven years of marketing exclusivity in BP if nomacopan is approved by the FDA. This news is in addition to the recent orphan drug designation received for our HSCT-TMA program.”The Company plans to release new safety and efficacy data from an ongoing Phase II trial with nomacopan in patients with BP at an oral presentation by Dr. Christian Sadik at the 28th European Academy of Dermatology and Venereology (EADV) Congress on October 10, 2019. In August, the Company announced new data demonstrating the synergistic benefits of nomacopan’s dual C5 and LTB4 inhibitory activity in pemphigoid disease, generated by Dr. Christian Sadik’s group at University of Lubeck, Germany, and published in the August 2019 edition of JCI Insight [link].Orphan drug designation by the FDA is granted to promote the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and that are expected to provide significant therapeutic advantage over existing treatments. Orphan designation qualifies Akari for various benefits, including seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and a waiver of certain administrative fees.2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/404716/ will be held in Beijing  on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact:AnnPhone: 021-65650305Email:Marketing@zenseegroup.comhttp://www.zenseegroup.com/forms/view/22113/

China's leading biopharmaceutical company Hansoh Pharmaceutical Group Company Limited (" Hansen Pharmaceutical ") and drug discovery artificial intelligence (AI) Atomwise, Inc. (" Atomwise ") , a leader in the field, announced a collaborative design and discovery of potential drug candidates for up to 11 unexposed target proteins in a variety of therapeutic areas.Atomwise and Hansen Pharmaceutical's scientific team will work closely together in these projects. The combination of complementary expertise and technology is expected to significantly increase success and reduce timelines for drug discovery and clinical development.Dr. Lu Aifeng, President of Jiangsu Hansoh Pharmaceutical Group Co., Ltd., said: Hansen Pharmaceutical is committed to using AI technology to innovate and develop diverse small molecules in the field of cancer and other therapeutics. Atomwise is the right partner for Hansen Pharmaceuticals. We are very impressed with Atomwise's AI platform, capabilities and team. We believe that the two companies will have an excellent opportunity to develop similar and best-in-class therapeutic drugs. ."Dr. Abraham Heifets, CEO of Atomwise, said: "We are very excited to work with Hansen Pharmaceutical, China's leading biopharmaceutical company. Hansen Pharmaceuticals and we all have strong commitment to innovation and a common mission to influence the health of patients worldwide. ."The world-class AI platform for Atomwise structured drug design will guide efforts in hit discovery, accidental discovery to hit-to-lead selection, and optimization of lead compounds. Hansen Pharmaceuticals is committed to biological testing and pharmaceutical chemistry, as well as leading subsequent preclinical and clinical development activities.Under the terms of the partnership, Atomwise will receive undisclosed technology royalties, optional royalties, royalties, and subcontracting authorizations or revenue generated from the sale of the derivative assets. Based on the historical average turnover of small molecule drugs, the potential total value of all successful projects with Atomwise's transaction may exceed potential selling drugs. Hanson Pharmaceuticals will receive development and commercialization rights in all fields and geographies.2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/404716/ will be held in Beijing  on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact:AnnPhone: 021-65650305Email:Marketing@zenseegroup.comhttp://www.zenseegroup.com/forms/view/22113/

WEDNESDAY, SEPTEMBER 11, 2019I-Mab Biopharma (I-Mab), a China and U.S.-based clinical stage biopharmaceutical company exclusively focused on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases announces the signing of a collaboration agreement with Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences), an innovation-driven biopharmaceutical company to evaluate the combination therapy of I-Mab's TJD5, a proprietary innovative CD73 antibody with Junshi Biosciences' Toripalimab (Trade name: Tuoyi), a recombinant humanized anti-PD-1 monoclonal antibody in patients with cancers in China.Dr. Jingwu Zang, Founder and Chairman of I-Mab, commented, "TJD5 is an innovative CD73 antibody with best-in-class potential that has entered into Phase I trial in the US. We are very pleased to collaborate with Junshi to explore the clinical synergies with Toripalimab which is an innovative drug with distinctive treatment advantages. We are looking forward to bringing more clinical benefits to patients across various cancer types."Dr. Ning Li, CEO of Junshi Biosciences, commented, "As an anti multi-tumor drug, toripalimab has shown good safety and efficacy in clinical trials with mono and combination therapy. We believe, through the cooperation with I-Mab, we could continue to explore the combination potential of toripalimab and innovative drugs to improve the outcomes of immune-oncology therapy, lightening hope for more patients.2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/404716/ will be held in Beijing  on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact:AnnPhone: 021-65650305Email:Marketing@zenseegroup.comhttp://www.zenseegroup.com/forms/view/22113/

TUESDAY, SEPTEMBER 10, 2019ProBioGen AG, a premier service and technology provider for complex therapeutic antibodies and glycoproteins, today announced the closing of a license agreement with Bayer AG for the  GlymaxX® Technology. Under the terms of the agreement, Bayer will leverage the technology to further increase the potency of an undisclosed antibody candidate for oncological indications.ProBioGen’s proven antibody-dependent cellular cytotoxicity (ADCC) enhancing technology GlymaxX® will be applied during cell line development.“We are glad to add Bayer to our list of licensees”, says ProBioGen’s Chief Executive Officer Dr. Wieland Wolf. “The GlymaxX® technology is clinically proven and is a very flexible technology which is liked by all cell lines.”About ProBioGen AGProBioGen is a premier, Berlin-based specialist for developing and manufacturing complex therapeutic antibodies and glycoproteins. Combining both state-of-the-art development services, based on ProBioGen’s CHO.RiGHT™ expression and manufacturing platform, together with intelligent product-specific technologies yields biologics with optimized properties.Rapid and integrated cell line and process development, comprehensive analytical development and following reliable GMP manufacturing is performed by a highly skilled and experienced team.All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).ProBioGen was founded 1994, is privately owned, and located in Berlin, Germany.About GlymaxX®The GlymaxX® technology, developed by ProBioGen, prevents the cellular synthesis of the sugar “fucose” and hence, in antibody-producing cells, its addition to the N-linked carbohydrate part of the antibody. The absence of fucose is known to greatly enhance ADCC. The GlymaxX® technology is based on the stable introduction of a gene for an enzyme which blocks the producer cells’ fucose biosynthesis pathway. As a unique feature, differentiating it from other approaches, GlymaxX® can be applied to both novel or already existing antibody producer cell lines, and entire antibody expression and discovery platforms, without negatively affecting their productivity or other product characteristics.Furthermore, a single GlymaxX® cell line can be flexibly used to produce differently fucosylated products, depending on the upstream process: In fucose-free medium the antibody is quantitatively afucosylated. The same GlymaxX® cell line grown in fucose-containing medium however, uses the provided fucose and produces fully fucosylated antibody. Thus, a GlymaxX® cell line can by employed to produce different products: For instance ADCC-enhanced GlymaxX® antibodies or wildtype-like, fully fucosylated mAbs, for a parallel Antibody-Drug-Conjugate (ADC) project.Finally, GlymaxX® has been used by biosimilar-developing companies to adjust a specific content of fucose in order to match the originators glycoprofile. Overall, GlymaxX® is simple, rapid, potent, and universally applicable to different CHO hosts and all other eukaryotic cell species.ProBioGen offers its GlymaxX® technology royalty-free and non-exclusively as a service or as an individual license.2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/404716/ will be held in Beijing  on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact:AnnPhone: 021-65650305Email:Marketing@zenseegroup.comhttp://www.zenseegroup.com/forms/view/22113/

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