1stOncology™: Cancer Intelligence Service – Page 8740 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Takeda Manufacturing Facilities in Japan and Ireland Recognized With Category Awards for 2021 Facilities of the Year

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"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

Akebia Therapeutics to Report First Quarter 2021 Financial Results and Discuss Recent Business Highlights

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]).

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

Alkermes Announces Two Abstracts Accepted for Presentation at 2021 American Society of Clinical Oncology Annual Meeting

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.

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.

Synthetic Biologics to Report 2021 First Quarter Operational Highlights and Financial Results on May 5, 2021

On April 28, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported that the Company intends to release its operational highlights and financial results for the quarter ended March 31, 2021 on Wednesday, May 5, 2021, and to host a conference call the same day at 4:30 p.m. ET (Press release, Synthetic Biologics, APR 28, 2021, View Source [SID1234578676]). The dial-in information for the call is as follows:

Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archived replay of the call will be available for approximately ninety (90) days at the same URL, View Source beginning approximately one hour after the call’s conclusion.

AC Immune Reports First Quarter 2021 Financial Results and Provides Corporate Update

On April 28, 2021 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases , reported its financial results for the quarter ended March 31, 2021 (Press release, AC Immune, APR 28, 2021, View Source;oq=AC+Immune+Reports+First+Quarter+2021+Financial+Results+and+Provides+Corporate+Update&aqs=chrome..69i57j69i61.671j0j7&sourceid=chrome&ie=UTF-8 [SID1234578674]). The Company also provided an overview of its recent clinical and corporate highlights and anticipated milestones for 2021.

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Our clinical and R&D accomplishments over the last quarter serve to strengthen our leadership in precision medicine for neurodegenerative diseases. Encouraging clinical results from both of our Alzheimer’s vaccine programs further reinforce our belief that early intervention, and ultimately prevention, using vaccines represents a key strategy in neurodegenerative diseases. To enable this strategy, we are advancing our suite of novel diagnostics, such as our alpha-synuclein imaging agent, which recently entered the clinic in Parkinson’s disease. Our vision is to address the heterogeneity of neurodegenerative diseases by pairing earlier, more accurate diagnosis with highly selective treatments that address the right proteinopathy, in the right patient, at the right time."

Prof. Pfeifer continued: "We are poised to achieve four additional clinical readouts in 2021, as we continue progressing our first-in-class preclinical programs addressing alpha-synuclein, TDP-43, and NLRP3-ASC towards the clinic, driving significant future value creation.

Q1 2021 Highlights

Clinical and R&D

Reported encouraging top line results from a first-of-its-kind Phase 1b study of anti-Abeta vaccine candidate ACI-24 in people with Down syndrome (DS). These results support further development in Down syndrome-related Alzheimer’s disease (AD). AC Immune also reported promising preclinical results for an optimized anti-Abeta vaccine formulation, for which it expects to file an investigational new drug application (IND) in Q4 2021.
Reported promising interim Phase 1b/2a results for ACI-35.030, a novel anti-phospho-Tau (pTau) vaccine candidate, showing strong safety and high titers of antigen-specific antibodies in 100% of older patients with early Alzheimer’s disease. The study is currently enrolling patients into the highest dose group, with further clinical readouts expected this year.
Advanced next-generation alpha-synuclein positron emission tomography (PET) tracer candidate, ACI-12589, into a first-in-human clinical study, with an expected data readout in Q3 2021
Identified and characterized the first biologically active small molecule Morphomer alpha-synuclein aggregation inhibitors, which significantly decreased alpha-synuclein aggregate formation in cellular assays by interfering with the fibrillation process
Reported key advancements for several therapeutic programs targeting the (NOD)-like receptor protein 3 (NLRP3) inflammasome, including small molecule inhibitors, which showed the first evidence of in vivo activity in a model of peripheral inflammation, as well as high-affinity monoclonal antibodies that bind extracellular components of the NLRP3 pathway and inhibit inflammasome-mediated immune response in vitro
Thought leadership

Co-sponsored a virtual Global Down Syndrome Forum that brought together thought leaders on Down syndrome and Down syndrome-related Alzheimer’s disease to discuss the unmet need and underlying causes of this important health challenge, as well as the broader implications for clinical development in other Alzheimer’s disease populations.
Hosted a comprehensive webinar focusing on the Company’s proprietary Morphomer platform underlying the generation of therapeutic and diagnostic small molecules, which featured presentations and a Q&A session with members of AC Immune’s Management and R&D Teams.
Strengthening of Board

Welcomed Dr. Alan Colowick, an experienced biotech and investment executive, to the Company’s Board of Directors

Achieved and Anticipated 2021 milestones

Clinical Milestones

ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a in AD interim results in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)
JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose)
Alpha-synuclein PET imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; readout expected in Q3
ACI-24 anti-Abeta vaccine in DS: reported Phase 1b top line results in Q1; to present further study results at the Alzheimer’s Association International Conference 2021 in Q3
ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2
Semorinemab anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in moderate AD in Q2
ACI-3024 small molecule MorphomerTM Tau aggregation inhibitor: select NeuroOrphan indication for further development in Q2
ACI-24 in DS: submit investigational new drug (IND) application for optimized vaccine formulation in Q4
Preclinical Milestones

Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q3
TDP-43 imaging agent: initiate investigational new drug (IND)-enabling studies in Q3
Morphomer NLRP3-ASC: report in vivo proof-of-concept results in a non-central nervous system (CNS) disease model and begin in vivo proof-of-concept studies with validated candidate in CNS in Q4
Anti-NLRP3-ASC antibody: begin in vivo proof-of-concept studies in Q4
Anti-TDP-43 antibody: initiate IND-enabling toxicology studies in Q4
TDP-43 biofluid diagnostic: establish validation-ready assay in Q4
Therapeutic and Diagnostic Pipeline Overview

On March 23, 2021, the Company provided a comprehensive overview highlighting strong progress across its clinical and preclinical development pipeline. This supplemental material can be viewed and downloaded in the investor section of the Company’s website.

Analysis of Financial Statements for the quarter ended March 31, 2021

Cash Position: The Company had a total cash balance of CHF 216.1 million, composed of CHF 151.1 million in cash and cash equivalents and CHF 65 million in short-term financial assets. This compares to a total cash balance of CHF 225.9 million as of December 31, 2020. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without potential incoming milestone payments.
Contract Revenues: The Company did not record contract revenues for the three months ended March 31, 2021, a decrease of CHF 12.3 million from the comparable period. The decrease is predominantly related to a CHF 10 million milestone payment as well as CHF 2.1 million in R&D activities recognized in 2020, which did not repeat.
R&D Expenditures: R&D expenses decreased by CHF 1.9 million for the three months ended March 31, 2021 to CHF 13.3 million.
Discovery and preclinical expenses (+1.2 million): The Company increased expenditures across a variety of its discovery and preclinical programs. These include investments to advance the optimized formulation of our ACI-24 vaccine, the expansion of our Morphomer Tau program into NeuroOrphan indications and various other investments across our programs.
Clinical expenses (-4.1 million): The Company decreased expenditures across multiple clinical programs, as certain clinical activities completed or incurred significant scaling up in the prior period. For example, the Company completed its clinical activities to complete the Phase 1 trial of our Morphomer Tau asset in partnership with Lilly. Additionally, the Company incurred less expense for ACI-24 for DS-related AD as a result of prior period scaling up activities for a Phase 2 clinical trial which were not repeated in the current period.
Salary- and benefit-related costs (+1.1 million): The Company’s salary- and benefit-related costs increased primarily due to the internal reallocation of certain employees’ salaries and annualization of 2020 hires and increases in share-based compensation
G&A Expenditures: For the three months ended March 31, 2021, G&A decreased by CHF 0.2 million to 4.3 million. This decrease is predominantly related to the internal reallocation of certain employees’ salaries.
Other Operating Income: The Company recognized CHF 0.4 million in grant income for R&D activities performed under our MJFF and Target ALS grants, an increase of CHF 0.3 million compared to the prior period
IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 16.7 million for the three months ended March 31, 2021, compared with net loss of CHF 7.7 million for the comparable period in 2020
2021 Financial Guidance

For the full year 2021, the Company expects its total cash burn to range between CHF 65 million ‒75 million.