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, Akeso, Inc. reported that, the Center for Drug Evaluation ("CDE") of the National Medical Products Administration (NMPA) of the People’s Republic of China (the "PRC") agreed to start the evaluation of the first-in-class novel drug Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104), which is an immuno-oncology therapy independently developed by the Company, plus platinum-based chemotherapy in combination with/without bevacizumab for a randomized, double-blind, placebo-controlled phase III clinical trial for first-line treatment of persistent, recurrent or metastatic cervical cancer (Press release, Akeso Biopharma, APR 28, 2021, View Source [SID1234633507]). This is the first phase III clinical trial of dual immunotherapy for first-line treatment of cervical cancer in the PRC.

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Recently, the Company successfully held a seminar of this global phase III clinical trial attended by experts and scholars of world-renowned gynecological oncology research institutions from China, the United States, Europe and Australia. The seminar reviewed the current status of cervical cancer treatment in the world, summarized the results of early stage clinical trials of Cadonilimab on several tumor indications, and discussed in detail the framework proposal of the global phase III clinical trial of Cadonilimab.

President & CEO of Akesobio, Michelle Xia, PhD, said, "Cadonilimab has demonstrated exceptional clinical efficacy in early stage clinical trials on cervical cancer. Based on this, the Company will further carry out the global phase III clinical trial for the first-line treatment of cervical cancer, which shows the excellent clinical operation efficiency of the company and will be beneficial to more patients suffering from cervical cancer around the world. The Company believes that Cadonilimab will become the first PD-1/CTLA-4 bi-specific antibody novel drug approved for market launch in the world."

Because of its satisfactory clinical data, Cadonilimab obtained fast track designation from the Food and Drug Administration of the United States (FDA) for treating patients with recurrent or metastatic cervical cancer after standard therapies in August 2020. Cadonilimab was also approved by the CDE for the inclusion in the "Breakthrough Therapy Designation" list for treating patients with recurrent or metastatic cervical cancer after standard therapies in October 2020. Patient enrollment of the registrational phase II clinical trial of Cadonilimab for the treatment of recurrent or metastatic cervical cancer was completed in January 2021 in the PRC.

INFORMATION ABOUT CADONILIMAB (PD-1/CTLA-4 BI-SPECIFIC ANTIBODY)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bi-specific PD-1/ CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated promising safety profile and efficacy.Our AK104 project has been incorporated in the Major New Drug Innovation Program under the 13th Five-year Plan for Major Technology Project (The 13th Five-Year Plan for Major Technology Project) issued by National Health Commission and Ministry of Science and Technology in 2017 and has been enlisted in the 2017 Pearl River Talent Program of Guangdong Province — Introduction of Innovation and Entrepreneurship Team Support Program (2017 Guangdong Province "Pearl River Talent Program" Introduction of Innovation and Entrepreneurship Team Support Project). It was also jointly rated by China Medical Biotechnology Association and Chinese Medicinal Biotechnology as one of the 2017 Top Ten Medicinal Biotechnology Advancements in China (2017 Top Ten Medicinal Biotechnology Advancements in China).It was also jointly rated by China Medical Biotechnology Association and Chinese Medicinal Biotechnology as one of the 2017 Top Ten Medicinal Biotechnology Advancements in China (2017 Top Ten Medicinal Biotechnology Advancements in China).It was also jointly rated by China Medical Biotechnology Association and Chinese Medicinal Biotechnology as one of the 2017 Top Ten Medicinal Biotechnology Advancements in China (2017 Top Ten Medicinal Biotechnology Advancements in China).

On April 28, 2021 Shanghai BDgene Technology Co., Ltd. ("BDgene"), a leading global gene therapy development company with original delivery technology, reported the company has successfully completed a round A financing of 60 million yuan (Press release, BDgene Therapeutics, APR 28, 2021, View Source [SID1234641044]). This financing was led by Tsinghua Holdings Capital , Ennovation Ventures, Longmen Capital, ETP Ventures, Innovation Angel Fund and other institutions followed in the investment. Probe Capital served as the exclusive financial advisor. The funds will be used for preclinical and clinical development of multiple products, laboratory and team building etc. BDgene had previously received a strategic investment from Serve Accurate Faithful Evaluation in June 2019 , and a pre-A round of investment from Keytone Ventures in March 2020.

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According to the data, BDgene was established in 2018 and is an innovative company focusing on the development of in vivo gene editing and in vitro transgene therapy therapies. Since its establishment, the company has attracted much attention from investment institutions and has received investment from many institutions. Why is it sought after by capital? What is the core technology? What are the competitive advantages of leading products?

Gene therapy has become the third revolutionary therapy, but delivery technology is still the most difficult point

For difficult to treat genetic, infectious, and degenerative diseases, gene therapy has the characteristic of "can be cured once". In recent years, it has become the third revolutionary therapy after chemical drugs and antibody drugs.

From the first appearance of the third-generation gene editing technology CRISPR in 2012, to the first in-vivo clinical trials of CRISPR in March 2020, to October 2020 after CRISPR won the Nobel Prize in Chemistry and other major events, the gene editing technology gradually matured , But delivery technology has always been the biggest obstacle in the field of gene editing therapy.

In January 2020, Nobel Prize winner Jennifer Doudna wrote an article in "Nature" magazine that "Delivery remains perhaps the biggest bottleneck to somatic-cell genome editing".

In the past, gene therapy delivery technologies that have been clinically verified by humans in the world mainly include three platforms: Adeno-associated virus, lentivirus vector, and lipid nanoparticles. These platforms have certain drawbacks for gene editing delivery. The ideal gene editing delivery tool needs to have both instantaneous and high-efficiency characteristics to ensure the safety and effectiveness of the treatment.

Create China’s original delivery technology to help gene therapy achieve a leap from "1 to 100"

Dr. Cai Yujia, the founder of BDgene, studied under the professors of Karolinska Institutet in Sweden, the Secretary-General of the Nobel Committee, Professor Thomas Perlmann, and Professor Jacob G. Mikkelsen, Aarhus University, Denmark, and he received a doctorate degree in gene therapy. He has mastered the core technology of gene therapy vectors and has rich experience in the production design and transformation of gene therapy virus vectors. After returning to China, he served as a researcher at the Institute of Systems Biomedicine, Shanghai Jiaotong University. In recent years, BDgene has successfully developed VLP-mRNA, a gene therapy delivery platform that has been clinically validated by humans, to deliver CRISPR/Cas9 mRNA to achieve safe and controllable gene editing therapy in vivo.

BDgene successfully completed the world’s second clinical study of in vivo CRISPR gene editing therapy in early November 2020 (in March 2020, Editas’ Zhang Feng team completed the world’s first case), which is also the world’s first CRISPR antiviral therapy Clinical research. This delivery technology delivers Cas9 mRNA through the lentiviral shell, which combines the high efficiency of viral vectors in infecting cells (in vitro infection rate of 99.8%, in vivo infection rate> 50%) and transient mRNA expression (degraded within 72 hours). Therapeutic effects have been achieved on animal models of different diseases, with technical advantages such as transient expression in vivo, no long-term safety risks associated with AAV expression of CRISPR, no obvious off-target, and low immunogenicity. Currently, with the permission of the Ethics Committee of the Eye, Ear, Nose and Throat Hospital Affiliated to Fudan University, the team of Professor Hong Jiaxu is presiding over the initial safe and controllable clinical application research based on this technology. In the future, this technology will be extended to the treatment of other viral infections, eye diseases and neurological diseases.

Mr. Zhang Yang, Chairman of Tsinghua Holdings Capital said, "The gene therapy industry has the characteristics of huge market space and extremely high technical threshold. In the past, gene editing technology has gradually broken through, but delivery technology is still the biggest bottleneck. In the past 10 years, Dr. Cai Yujia has been devoted to the development of gene therapy Delivery technology, It has successively successfully developed multiple original delivery technology platforms such as virion delivery CRISPR/Cas9 mRNA technology and next-generation lentivirus delivery technology. BDgene’s original viral keratitis treatment product has perfect preclinical animal experiment data. It is currently conducting non-registered human clinical trials in top domestic eye hospitals. BDgene also deployed gene editing technology to treat hereditary, infectious and degenerative diseases, viral vectors to treat blood diseases, and mRNA vaccines. "

Speaking of this Series A financing being exclusively led by Tsinghua Holdings Capital, Mr. Zhang Yang said, "Thank you very much for the trust of BDgene founder Professor Cai Yujia and old shareholders. In the future, he will support the development of the company in the long-term and jointly promote BDgene’s original delivery technology and The product helps gene therapy to achieve a leap from "1 to 100", so that more patients who are refractory to and incurable can really benefit in the future."

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.