On April 28, 2021 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), reported that it has scheduled its first quarter 2021 financial results and corporate update for Wednesday, May 5, 2021 (Press release, Arbutus Biopharma, APR 28, 2021, View Source [SID1234578661]). The schedule for the press release and conference call/webcast are as follows:

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•1Q/2021 Press Release: Wednesday, May 5, 2021 at 7:30 a.m. ET
•1Q/2021 Conference Call/Webcast: Wednesday, May 5, 2021 at 8:45 a.m. ET
•Domestic Dial-In Number: (866) 393-1607
•International Dial-In Number: (914) 495-8556
•Conference ID Number: 4445858
A live webcast of the conference call can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Live Webcast.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID: 4445858.

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, 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 Pfizer Inc. (NYSE: PFE) reported that it has acquired Amplyx Pharmaceuticals, Inc., a privately-held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems (Press release, Pfizer, APR 28, 2021, View Source [SID1234597887]). Amplyx’s lead compound, Fosmanogepix (APX001), is a novel investigational asset under development for the treatment of invasive fungal infections.

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More than 1.5 million cases of invasive fungal infections occur worldwide each year, with mortality rates as high as 30-80% across infection typesi. Fosmanogepix has a novel mechanism of action with the potential to target fungal strains resistant to standard of care therapy. As there are only three classes of antifungal medications currently available, antifungal resistance can severely limit treatment options; a potential new therapeutic class may therefore be of importance for both physicians and patientsii. There has been no novel therapeutic class of antifungal therapies approved by the U.S. Food and Drug Administration (FDA) in nearly 20 years.

"The COVID-19 pandemic has been a stark reminder of the devastating impact of infectious diseases, highlighting the continuous need for new anti-infective therapies to treat both emerging and difficult to treat bacterial, viral and fungal infections," said Angela Lukin, Global President, Pfizer Hospital. "We are deeply committed to helping patients suffering from infectious diseases, continuously seeking opportunities to build our portfolio of anti-infective therapies. We’ve already invested in assets that, if approved, could help address drug-resistant bacterial infections and critical viral infections; with this acquisition, we look forward to progressing the development of a novel anti-fungal as well."

Fosmanogepix is currently in Phase 2 clinical trials evaluating the safety and efficacy of both intravenous (IV) and oral formulations for the treatment of patients with life-threatening invasive fungal infections caused by molds, yeasts and rare molds (e.g., Aspergillus spp, Candida spp including Candida auris, Fusarium spp. and Scedosporium spp). Fosmanogepix has demonstrated broad-spectrum activity in-vitro and has shown wide distribution to various tissues including the brain, lung, kidney and eye. With both IV and oral formulations in development, Fosmanogepix may allow for the transition from IV to oral, thus potentially enabling, for the benefit of patients, the continuation of treatment outside the hospital.

In addition to Fosmanogepix, with this acquisition, Pfizer has secured ownership of Amplyx’s early-stage pipeline that includes potential antiviral (MAU868) and antifungal (APX2039) therapies.

Globally, infectious diseases are responsible for more than 8.4 million deaths annually*iii, accounting for two of the World Health Organization’s top ten causes of death worldwideiv. Infections are caused by different types of pathogens, including bacteria, viruses, fungi and parasites, and can be acquired in the community or in a hospital or healthcare setting.

The acquisition of Amplyx follows an initial equity investment by Pfizer in December 2019 as part of Amplyx’s Series C financing. At that time, Pfizer joined a world class group of biotechnology investors that included 3×5 Partners, Adage Capital Management, Arix Bioscience, BioMed Ventures, Lundbeckfonden Ventures, New Enterprise Associates, Pappas Capital, RiverVest Venture Partners and Sofinnova Investments.

Financial terms of this acquisition were not disclosed.

DLA Piper LLP (US) served as Pfizer Inc.’s legal advisor for the transaction, while Cooley LLP served as Amplyx’s legal advisor and Evercore as its financial advisor.