On March 17, 2021 FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cells (iPSC) technologies, and Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that Sana has been granted a non-exclusive right to use FUJIFILM Cellular Dynamics’ iPSC platform for the development of commercial cell therapies (Press release, Sana Biotechnology, MAR 17, 2021, View Source [SID1234584002]). As a treatment modality, cell therapies have the potential to augment, repair, or replace human biology, including organs, tissues and cells.

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Under the agreement, FUJIFILM Cellular Dynamics grants Sana a non-exclusive license under intellectual property rights owned or controlled by FUJIFILM Cellular Dynamics, and will provide iPSC cell lines (including research-grade and/or Good Manufacturing Practices (GMP)-grade iPSC lines) to Sana. Sana may use the iPSC cell lines, and exercise the licensed intellectual property rights, for the research and development, and with respect to GMP-grade cell lines, clinical and commercial manufacture, and commercialization, of cell therapies derived from such lines. Terms of the agreement were not disclosed.

"FUJIFILM Cellular Dynamics is a leading global player in the field of iPSCs. Our history in manufacturing iPSCs for research-purposes has provided us with the foundational expertise to manufacture quality GMP-grade iPSC lines," said Takeshi Yamamoto, chief executive officer, FUJIFILM Cellular Dynamics. "Sana is developing a broad and compelling pipeline of iPSC-derived cellular therapies, and we are pleased to grant them the rights to our iPSC platform with a vision of providing more treatment options for patients."

"Sana is committed to the development of engineered cells as medicines that can be manufactured at scale and supplied to patients globally," said Stacey Ma, executive vice president, technical operations, Sana. "FUJIFILM Cellular Dynamics is a long-standing innovative leader in this field, and we are thrilled to have the opportunity to combine their expertise in GMP-grade iPSC cell lines with our investment in differentiating and manufacturing cells at scale for patients across a number of diseases."

On March 17, 2021 Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, reported the closing of a $53 million (£38 million) Series B financing round (Press release, Amphista Therapeutics, MAR 17, 2021, View Source [SID1234576767]). The round was co-led by Forbion and Gilde Healthcare. Additional investors in this round include Novartis Venture Fund, and Eli Lilly and Company, joining existing investor BioMotiv and founding investor Advent Life Sciences. The proceeds will be used to accelerate the company’s growing pipeline of potent and selective bifunctional molecules, known as ‘Amphistas’ to the clinic and to extend its proprietary TPD platform.

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Amphista’s CEO Nicola Thompson said, "This financing round, led by an outstanding investor syndicate, is a strong endorsement of our world class team and our novel approach. Amphista will now accelerate its oncology pipeline towards the clinic and extend our portfolio into indications largely inaccessible by traditional TPD approaches, such as diseases of the central nervous system (CNS). This oversubscribed Series Bsupports our ambition as a world-leading next generation protein degradation company delivering ground-breaking new medicines to patients in areas of high unmet need."

Rogier Rooswinkel, Partner at co-lead investor, Forbion said, "We are delighted to have selected Amphista as the first company to invest in from our fifth fund that closed late last year. Amphista combines several attributes we typically look for: a world-class team, innovative science, and a disruptive technology that has the potential to improve treatment options and thus impact many patients’ lives."

Stefan Luzi, Partner at co-lead investor Gilde, said, "Amphista emerged as the best-in-class protein degradation company in our comprehensive landscaping effort. We believe this team, who are pioneers in this field, combined with a truly unique platform, will unlock the full therapeutic potential of a broad range of disease targets. Amphista represents a strong fit with Gilde’s longstanding strategy of identifying Europe’s leading science and of engaging with experienced drug developers to build and support high growth (bio)pharma companies."

Amphista’s TPD approach offers a greatly improved way of treating disease and modulating drug targets, using synthetic small molecule degraders. Amphista’s next generation bifunctional degraders use a novel set of mechanisms that make use of a wider range of the body’s own innate protein degrading proteins, instead of the very narrow set of ubiquitin E3 ligase-based mechanisms used by most other TPD companies. This proprietary approach offers the potential to overcome many of the limitations seen with current TPD approaches, providing the opportunity to treat a wider range of diseases. Amphista is focused on biological targets with a high level of clinical or genetic validation, allowing the team to focus on the translation of their novel TPD approach for clinical benefit in areas of high unmet need.

In association with this financing, Amphista has added the following leading life science executives to the Board: Stefan Luzi, Partner at Gilde Healthcare; Rogier Rooswinkel, Partner at Forbion; and Florian Muellershausen, Managing Director at Novartis Venture Fund.

On March 17, 2021 CNS Pharmaceuticals, Inc. Presented the Corporate Presentation (Presentation, CNS Pharmaceuticals, MAR 17, 2021, View Source [SID1234576790]).

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On March 17, 2021 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported its financial results for the fourth quarter and full year 2020, and provided a corporate update (Press release, Xenetic Biosciences, MAR 17, 2021, View Source [SID1234576810]).

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"Notwithstanding the challenges presented by the COVID-19 pandemic, 2020 was a year of significant progress for the Company, including the establishment of partnerships and academic collaborations and advancement in our development efforts, in particular with respect to CAR design and model cell line development, as well as the strengthening of our financial position. Our focus remains on advancing the XCART platform, and we look forward to further evaluation of our XCART process in a clinical setting during our upcoming exploratory study in Eastern Europe," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Our goal remains to complete our preclinical development phase and advance into a Phase 1 study as quickly as possible."

XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T therapy targeting tumor specific antigens that are independent of CD19 or other antigens common to all B-Cells. Lead program for Non-Hodgkin lymphomas, an area of significant unmet need, with the potential to address an initial global market opportunity of over $5 billion annually.[1]

Program Highlights:

Collaboration with Pharmsynthez and multiple academic institutions in Eastern Europe to optimize the overall XCART workflow, including clinical manufacturing processes, and ultimately to conduct a first in-human study in B-cell Non-Hodgkin lymphoma (NHL) patients.
Research and development collaboration with Scripps Research covering design and implementation of the preclinical development program, as well as method development activities supporting process development for clinical manufacturing.
Upcoming Potential Milestones

Initiation of exploratory patient biopsy study in Eastern Europe.
Seeking U.S. FDA INTERACT meeting.
Initiating process development for clinical CAR T manufacturing.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlights:

Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of blood coagulation disorders.
Takeda currently has one active development program underway.
Royalty payments of approximately $0.4 million received in 2020 as Takeda’s sublicensee has now launched the relevant product in multiple global markets.
Company’s partner, PJSC Pharmsynthez, announced positive Phase 3 trial results and filed a registration dossier in Russia to obtain approval of Epolong, a polysialylated form of human erythropoietin as a treatment for anemia in patients with chronic kidney disease.
Summary of Financial Results for Fiscal Year 2020

Net loss for the year ended December 31, 2020, was approximately $10.9 million. R&D expenses for the year ended December 31, 2020, were $1.7 million compared to $4.9 million for the year ended December 31, 2019. The decrease was primarily due to IPR&D expense of $3.0 million incurred during the year ended December 31, 2019. General and administrative expenses decreased by approximately $1.3 million, or 28.1% for the year ended December 31, 2020, to $3.4 million from $4.7 million in the comparable period in 2019, primarily due to approximately $1.1 million of transaction costs associated with the XCART acquisition incurred during the year ended December 31, 2019. At December 31, 2020, the Company reported working capital was approximately $11.4 million compared to $9.7 million at December 31, 2019. During the year ended December 31, 2020, working capital increased by $1.8 million due to the Company’s December 2020 registered direct common stock offering resulting in approximately $5.4 million in net proceeds. This increase in working capital was substantially offset by the Company’s net loss for the year ended December 31, 2020. The Company ended the year with approximately $11.5 million of cash.

On March 17, 2021 111, Inc. ("111" or the "Company") (Nasdaq: YI), a leading tech-enabled healthcare platform company committed to digitally connecting patients with medicine and healthcare services in China, reported it has entered into a strategic cooperation agreement with BeiGene, Ltd. (NASDAQ:BGNE; HKEX:06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide (Press release, BeiGene, MAR 17, 2021, View Source [SID1234576828]).

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BeiGene currently markets two internally discovered oncology medicines in China: BTK inhibitor, BRUKINSA (zanubrutinib), and anti-PD-1 antibody, tislelizumab. It also markets or plans to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma.

Cancer is the leading cause of death in China, and the number of cancer patients is on the rise. According to data from the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO), in 2020, 4.6 million new cases of cancers were diagnosed in China, accounting for 23.7% of the world’s total cases, and there were 3 million cancer deaths in the country, accounting for 30% of the world’s total. Meanwhile, cancer treatment resources are mostly concentrated in China’s first- and second-tier cities. Therefore, the current challenge in the treatment of cancer in China lies not only in the availability of safe and efficacious drugs, but also in the fact that a large number of cancer patients in the country face the unfortunate situation of needing to seek both immediate medical treatment and long-term follow-up care outside of their local communities.

Answering the urgent call to make cancer care more efficient and patient-friendly in China, the two companies will cooperate around a "Internet + Medicine & Healthcare" model, leveraging 111’s Internet hospital, smart supply chain network, data-driven AI solutions, such as digital advertising, and online and offline direct-to-patient (DTP) delivery of medicines to create an unique oncology management platform. The platform will further empower doctors to improve the efficiency of patient management, especially for patients outside of the hospital, and will not only extend their service cycles, but also expand their service radius. At the same time, through this efficient and convenient doctor-patient communication platform, it will be possible to provide patients with a digital, one-stop service for medical care and medicine, improving the accessibility of BeiGene’s innovative oncology drugs.

According to Dr. Wu Xiaobin, president of BeiGene, the Internet+ model will be a catalyst for driving innovation in oncology, and he hopes that this partnership with 111 will enable BeiGene to further its innovative goals through the wings of digitization. By leveraging the power of the Internet, BeiGene will be able to bring its innovative drugs and services to more patients nationwide.

Ms. Wu Qingyi, Chief Commercial Officer of BeiGene Greater China, said, "In order to further promote the commercialization of oncology innovative drugs, we hope to use 111’s industry leading technology and digital service to establish the "last mile" delivery of oncology disease medical services in China. This will allow us to provide more high-quality innovative medicines and improve the accessibility of our medical resources to patients in China."

Dr. Yu Gang, Co-founder and Executive Chairman of 111, Inc., commented, "We are excited to partner with a leading company specializing in the development of innovative therapies in oncology. Both inside and outside of China, traditional pharmaceutical product marketing mainly targets clinicians, with relatively little attention devoted to end patients. However, in the era of digital healthcare services, and through the empowerment of the Internet, pharmaceutical companies can now deliver "patient-centered" care by prioritizing the needs of the patients. With the Internet’s ability to transcend the boundaries of time and geography, it can help doctors establish truly integrated online and offline disease management services throughout the patient care continuum – from diagnosis to treatment to post treatment follow-up care. We are confident that, by relying on our comprehensive digital "medical care + medicine" platform, 111 can help expand the commercial reach of BeiGene’s innovative oncology drugs as well as advance the adaption of innovative medical service models in China."

111’s strategically located, technology-driven fulfillment centers currently serve more than 300,000 pharmacies in China that comprise its online and offline integrated virtual pharmacy network, empowering the Company’s ability to offer 24-hour delivery in most major cities and 72-hour delivery nationwide.