On April 28, 2021 Ultimovacs ASA ("Ultimovacs", ticker ULTI) reported that an abstract on the Company’s Phase I trial evaluating its universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab in patients with metastatic malignant melanoma has been accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting to be held virtually Friday, June 4, 2021 through Tuesday, June 8, 2021 (Press release, Ultimovacs, APR 28, 2021, View Source [SID1234578685]).

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The abstract, titled "A Phase I Clinical Trial Investigating the Telomerase Vaccine UV1 in Combination with Pembrolizumab in Patients with Advanced Melanoma", will provide an overview of the open-label, single-arm study investigating the safety and tolerability for the UV1/pembrolizumab combination.

Details of the virtual poster presentation are as follows:

Title: A Phase I Clinical Trial Investigating the Telomerase Vaccine UV1 in Combination with Pembrolizumab in Patients with Advanced Melanoma

Abstract Number: 2620

Session: Developmental Therapeutics—Immunotherapy

The corresponding abstract will be published by ASCO (Free ASCO Whitepaper) on Wednesday, May 19th at 5:00 pm EDT / 11:00 pm CEST. The poster presentation will be available on demand for all conference attendees starting on Friday, June 4th at 9:00 am ET / 3:00 pm CEST. The poster will also be made available on the Company’s website at the same time on June 4th.

About UV1

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as an "off-the-shelf" therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

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 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it was awarded by the International Society for Pharmaceutical Engineering (ISPE) for the 2021 Facility Of the Year Awards (FOYA) in two categories (Press release, Takeda, APR 28, 2021, View Source [SID1234578683]). Takeda’s new solid pharmaceutical packaging building in Hikari, Japan, was recognized with the 2021 "Process Intelligence and Innovation" category award. Additionally, the end-to-end high potent drug facility in Grange Castle, Ireland, was selected as "Facility Integration" category winner.

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"I am honored that Takeda receives two awards for the production and packaging of small molecule solid dosage form products," said Thomas Wozniewski, global manufacturing & supply officer of Takeda. "In 2018, the Los Angeles plasma facility received two FOYA awards, now, two of our sites in Japan and in Europe got awarded in the categories ‘Process intelligence and innovation’ as well as ‘Facility integration’. This illustrates that Takeda is constantly investing into state of the art facilities applying best in class process as well as digital standards. Both projects in Hikari and in Grange Castle also demonstrate that significant technology improvements for small molecule modalities are still achievable, both in a cost as well as in a time efficient manner."

Takeda’s Hikari plant is located in the south of Japan in the Yamaguchi prefecture. One of Takeda`s largest plants, it features advanced production systems for active pharmaceutical ingredients (API), drug formulation, biological products, and others offering a stable supply of high-quality pharmaceutical products throughout the world. The project at the Hikari site is a four-story building designed to elevate pharmaceutical packaging operations to a new industrial standard. The facility features highly automated end-to-end packaging equipment, including "end of line" case packers, automated guided vehicles (AGVs) and robots to feed the automated storage and retrieval system (ASRS). Additionally, the site developed and introduced an automatic line clearance system (ALC) with 360° cameras and laser sensors utilizing artificial intelligence (AI) to help significantly increase efficiency in the pharmaceutical packaging process. Takeda’s Hikari plant exemplifies how novel application of commercially available and custom developed process manufacturing tools leads to superior results and advanced process understanding.

The Grange Castle site in Ireland is located in the Dublin area, and it includes three manufacturing facilities. The production facility which now got awarded by the ISPE is a standalone, high containment, cutting-edge production facility dedicated to manufacturing Takeda’s treatment for multiple myeloma. The application of good design practices and superior conceptual planning led to the excellent integration of facility and process. The innovative design as an ‘all-in-one’ facility incorporates the entire end-to-end production process from active pharmaceutical ingredients to drug product and packaging under one roof. This significantly simplifies the supply chain for one of Takeda´s global oncology products to ensure unconstrained availability to patients worldwide.

"The design teams have implemented best-in-class digital technologies to guarantee the facilities use the latest developments in paperless automation, robotics and augmented reality. This strategic use of digital and automated systems has led to a state-of-the-art facility design that positions Takeda as a frontrunner in our industry," added Gunter Baumgartner, head of Global Engineering at Takeda.

An official ceremony of all winning projects and awards is planned at this year’s ISPE Annual Meeting & Expo in Boston, MA, in November.

About the ISPE Facility of the Year Awards Program
Established in 2004, the Facility of the Year Awards (FOYA) recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operations, while sharing the development of new applications of technology and cutting-edge approaches. For more information, visit View Source

On April 28, 2021 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported plans to release its financial results for the first quarter ended March 31, 2021, on Monday, May 10, 2021 before the opening of the financial markets (Press release, Akebia, APR 28, 2021, View Source [SID1234578678]).

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Akebia will host a conference call at 9:00 a.m. Eastern Time on Monday, May 10, to discuss its first quarter financial results and recent business highlights. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 6250159. The call will also be webcast LIVE and can be accessed via the Investors section of the Company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through May 16, 2021. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 6250159. An online archive of the conference call can be accessed via the Investors section of the Company’s website at View Source

On April 28, 2021 Alkermes plc (Nasdaq: ALKS) reported the acceptance of two abstracts related to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place virtually June 4-8, 2021 (Press release, Alkermes, APR 28, 2021, View Source [SID1234578677]). New data from the phase 1/2 ARTISTRY-1 clinical trial evaluating the tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with pembrolizumab (KEYTRUDA) will be shared in a poster discussion session. In addition, data supporting the recommended phase 2 dose (RP2D) for nemvaleukin administered subcutaneously from the phase 1/2 ARTISTRY-2 clinical trial will be shared in a separate poster.

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Details of the presentations are as follows:
Abstract: 2513
Title: ARTISTRY-1: Nemvaleukin alfa monotherapy and in combination with pembrolizumab in patients (pts) with advanced solid tumors
Presenter: Valentina Boni, M.D., Ph.D., Medical Oncologist and Principal Investigator, START Madrid at Centro Integral Oncológico Clara Campal
Presentation Date/Time: The on-demand poster discussion session will take place on June 4, 2021 from 9:00 – 10:00 a.m. ET.

Abstract: 2552
Title: Selection of the recommended phase 2 dose (RP2D) for subcutaneous nemvaleukin alfa: ARTISTRY-2
Presenter: Omid Hamid, M.D., Chief of Research and Immunotherapy, The Angeles Clinic and Research Institute
Presentation Date: The poster presentation will be available on-demand to attendees beginning June 4, 2021.

About Nemvaleukin alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin alfa as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.