On April 28, 2021 Illumina, Inc. (NASDAQ: ILMN) reported that it has committed US $60 million in sequencing capabilities to a global pathogen genomics initiative, in partnership with the Bill & Melinda Gates Foundation and other public and private entities (Press release, Illumina, APR 28, 2021, View Source [SID1234578684]). The initiative expands on the Africa Pathogen Genomics Initiative (Africa PGI) announced in October 2020, and will help create a comprehensive pathogen genomic network around the world, building critical public health capabilities in areas of need.

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Illumina will donate next-generation sequencing (NGS) platforms, reagents, and training support worth approximately US $60 million over five years. The expanded scope will begin with a focus on South Asia, equipping national public health institutions with better public health tools, bringing us closer to the vision of an early warning system for global pathogens.

"Rapidly identifying outbreaks and tracking their spread and evolution will save lives around the world and is essential to strengthening health care systems," said Francis deSouza, Chief Executive Officer of Illumina. "Genomics has the power to revolutionize the way public health entities manage biological threats, and this global initiative will help make NGS technology and expertise accessible in areas of need."

"Expanding access to pathogen sequencing will accelerate efforts to detect new epidemics before they spread widely and to monitor their transmission in real time for more targeted and precise response. Pathogen sequencing will also contribute to research and development efforts for new vaccines, diagnostics and treatments for current and emerging infectious diseases," said Trevor Mundel, President of Global Health, Bill & Melinda Gates Foundation. "It’s critical to empower scientists in South Asia, like we’re doing in Africa, with the tools they need to stay one step ahead of pathogens."

The model for the global initiative builds upon the framework of Africa PGI by bringing together key partners from public health institutions, government, private industry, and local labs to create a comprehensive ecosystem of support for successful genomics adoption, which extends beyond simply dropping in new technology. The initiative will consider issues such as logistics, training, and sustainability, and will expand by country depending on maturity and needs. Prioritized pathogens will be unique to each country or region, as the initiative empowers individual countries to drive the program according to their specific needs and priorities.

Genomics can enable early detection of novel viruses by rapidly characterizing new pathogens directly from specimens. Building pathogen genomics capabilities globally protects the health of everyone, since a threat in one place can quickly become a threat everywhere. In the future, genomics has the potential to concurrently provide comprehensive diagnosis of infections, antimicrobial resistance information, and pathogen surveillance for known and emerging threats.

On April 28, 2021 Silence Therapeutics plc, AIM: SLN and Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported that it has achieved another research milestone as part of its ongoing RNAi collaboration with Mallinckrodt plc ("Mallinckrodt") for complement-mediated diseases, triggering a further $2.0 million payment to Silence (Filing, 6-K, Silence Therapeutics, APR 28, 2021, View Source [SID1234578772]).

The milestone relates to pre-clinical development work on the SLN500 C3 targeting program, highlighting the successful ongoing collaboration between the two companies. Silence continues to work with Mallinckrodt to progress Investigational New Drug (IND) enabling studies for SLN501, the first nominated product candidate in the SLN500 program, this year.

The collaboration with Mallinckrodt is focused on the development and commercialization of RNAi therapeutics designed to inhibit or ‘silence’ the complement cascade, a group of proteins involved in the immune system and which play a role in the development of inflammation. Using Silence’s proprietary mRNAi GOLD platform, siRNAs engineered to inhibit each target in the collaboration will be optimized and investigated before progressing into clinical development.

In July 2019, Silence received an upfront payment of $20 million from Mallinckrodt for an exclusive worldwide license to siRNAs against one complement target, C3, and options to license siRNAs against up to two additional targets, each of which Mallinckrodt has exercised at $2 million per target. Under the terms of the agreement, Silence is responsible for preclinical activities and for executing development of each target through Phase 1, after which Mallinckrodt will assume responsibility for clinical development and global commercialization. Silence is also eligible to receive tiered double-digit royalties on net sales for each product candidate and up to $2 billion in total milestone payments across all three targets.

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On April 28, 2021 BerGenBio’s senior management team reported that will take place Wednesday 19th May 2021 at 10:00 am CET (Press release, BerGenBio, APR 28, 2021, View Source [SID1234578625]).

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The live webcast link will be available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

The first quarter report and presentation will be available on the Company’s website in the Investors/Financial Reports section from 7:00 am CET the same day.

On April 28, 2021 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the first quarter ended March 31, 2021 before the US financial markets open on April 30, 2021, rather than on May 3, 2021 as previously announced (Press release, Alexion, APR 28, 2021, View Source [SID1234578642]).

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Given the previously announced agreement to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials will be made available publicly on the Investor Relations page of our website at View Source Questions may be directed to the Investor Relations team via e-mail at [email protected] or the contact information below.

AstraZeneca and Alexion Combination

On December 12, 2020, AstraZeneca and Alexion announced that the companies entered into a definitive agreement for AstraZeneca to acquire Alexion, in which Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares (ADSs) for each Alexion share. Based on AstraZeneca’s reference average ADR price of $54.14 at the time of the announcement, this implied total consideration to Alexion shareholders of $39 billion or $175 per share. The acquisition has the potential to advance the shared science-led mission of both companies to leverage complementary approaches to developing life-changing medicines. The proposed combination will broaden Alexion’s footprint, enabling the company to help more patients, pursue innovative science in new areas and expand its therapies in additional geographies. In addition, the transaction delivers significant value for Alexion’s shareholders, who will have an important stake in the combined company’s future results. Subject to receipt of regulatory clearances and the approval by AstraZeneca and Alexion shareholders, the companies expect the acquisition to close in the third quarter of 2021.

[ALXN-E]

Additional Information and Where to Find It

In connection with AstraZeneca’s proposed acquisition of Alexion (the "proposed transaction"), AstraZeneca filed with the U.S. Securities and Exchange Commission ("SEC") a registration statement on Form F-4 which includes a proxy statement of Alexion and a prospectus of AstraZeneca. The registration statement was declared effective by the SEC on April 12, 2021, and mailing of the definitive joint proxy statement/prospectus to the shareholders of Alexion occurred on or about April 12, 2021. Each of Alexion and AstraZeneca may also file other relevant documents with the SEC regarding the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE JOINT PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and the definitive proxy statement/prospectus and other documents containing important information about Alexion, AstraZeneca and the proposed transaction through the website maintained by the SEC at View Source Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion’s website at View Source or by contacting Alexion’s Investor Relations Department by email at [email protected]. Copies of the documents filed with the SEC by AstraZeneca will be available free of charge on AstraZeneca’s website at View Source or by contacting AstraZeneca’s Investor Relations department by email at [email protected].

Participants in the Solicitation

Alexion, AstraZeneca, their respective directors and certain of their executive officers and other employees may be deemed to be participants in the solicitation of proxies from Alexion’s shareholders in connection with the proposed transaction. Information about Alexion’s directors and executive officers is available in Alexion’s proxy statement for its 2020 annual meeting of shareholders, which was filed with the SEC on March 26, 2020, Alexion’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2020, which was filed with the SEC on February 16, 2021, and other documents subsequently filed by Alexion with the SEC. Information about AstraZeneca’s directors and executive officers is available in AstraZeneca’s Form 20-F filed with the SEC on February 16, 2021, and other documents subsequently filed by AstraZeneca with the SEC. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, are contained in the definitive joint proxy statement/prospectus filed with the SEC on April 12, 2021 and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. Free copies of these documents may be obtained as described in the paragraphs above.

No Offer or Solicitation

This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

On April 28, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study NKX019 in patients with relapsed or refractory B cell malignancies (Press release, Nkarta, APR 28, 2021, View Source [SID1234578663]).

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NKX019 is an off-the-shelf cancer immunotherapy candidate that uses NK cells engineered with a CD19-directed chimeric antigen receptor (CAR). The CAR is designed to target cancer cells expressing CD19, a clinically validated target, and to enhance the innate anti-tumor activity of NK cells. In addition, NKX019 is engineered with a membrane-bound form of IL-15, an important cytokine for NK cell survival, which has been shown in preclinical models to enhance NK cell proliferation, persistence and activity.

Initiation of a Phase 1 clinical trial of NKX019 in patients with relapsed/refractory B cell malignancies, including non-Hodgkin lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia, is planned for the second half of 2021.

"Academic studies have highlighted the ability of donor-derived NK cells, when collected from healthy donors, to effectively target and kill cancer cells without some of the safety risks commonly associated with T cell therapies," noted Kanya Rajangam, MD, PhD, Chief Medical Officer of Nkarta. "We look forward to evaluating NKX019 in our trial as a planned multi-dose, multi-cycle treatment regimen to determine its potential for enhanced anti-tumor activity with a beneficial safety profile."

"This IND clearance, our second in less than 10-months time, builds on the strong track record of the Nkarta team to deliver on challenging goals," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "Thanks to their outstanding efforts, Nkarta will soon have two differentiated co-lead programs, NKX101 and NKX019, in clinical trials as we look forward to the continued progress of our best-in-class, healthy donor-derived NK cell platform and pipeline of novel cell therapy candidates for cancer patients."

About NKX019
NKX019 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with a CD19-directed chimeric antigen receptor (CAR) and a proprietary, membrane-bound form of interleukin 15 (IL-15). CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. Via its CAR, NKX019 targets and binds to CD19 and eliminates CD19-expressing cells via a robust immune response in preclinical studies. Preclinical models also demonstrate enhanced proliferation, persistence and activity of NK cells with the membrane-bound IL-15, an important cytokine for NK cell survival. Initiation of a Phase 1 clinical trial of NKX019 in patients with relapsed/refractory B cell malignancies in multiple centers in the United States and Australia is planned for the second half of 2021.

About Nkarta’s Platform and Natural Starting Materials
Nkarta’s engineering platform utilizes healthy adult donors as the source for NK cells. By enlisting this natural source of NK cells, Nkarta starts with bona fide NK cells endowed with inherent tumor-recognizing ability and potent cytotoxic function. Healthy donor-derived NK cells are also available in abundance, providing a large quantity of cells with which to begin the efficient two-week manufacturing process. Finally, healthy donor-derived adult cells consist of a diverse repertoire of NK cells, providing Nkarta with the potential to capitalize on the inherent diversity of the innate immune system in selecting donors or NK cell populations with optimal characteristics.

About Nkarta’s NK Cell Technologies
Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to identify and kill tumor cells. To enhance the inherent anti-tumor activity of NK cells, Nkarta genetically engineers the cells with a targeting receptor designed to recognize and bind to cancer cells through recognition of specific surface proteins. This receptor is fused to co-stimulatory and signaling domains, which amplify cell signaling and NK cell cytotoxicity. Upon target binding, NK cells activate and release cytotoxic granules for target cell killing as well as cytokines that enhance the cumulative immune response. All of Nkarta’s current NK cell therapy candidates are also engineered with a membrane-bound IL-15, a proprietary version of an activating cytokine important for NK cell growth and enhancement of NK cell persistence.

Nkarta’s manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for extended periods and is designed to enable immediate, off-the-shelf administration to patients at the point of care.