On April 22, 2021 Pfizer Inc. (NYSE: PFE) reported that its board of directors declared a 39-cent second-quarter 2021 dividend on the company’s common stock, payable June 4, 2021, to holders of the Common Stock of record at the close of business on May 7, 2021 (Press release, Pfizer, APR 22, 2021, View Source [SID1234578362]). The second-quarter 2021 cash dividend will be the 330th consecutive quarterly dividend paid by Pfizer.

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The board has decided to maintain Pfizer’s quarterly dividend at its current rate despite the planned declaration of a dividend payment by Viatris Inc. that would be payable to those Pfizer shareholders that have elected to continue holding Viatris shares received from the combination of Upjohn and Mylan. This decision results in an increased dividend income to those shareholders continuing to own shares of both Pfizer and Viatris.

"We are pleased to be in a position to return capital to our shareholders as a result of our expected strong financial performance," stated Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. "Our ability to fulfill our purpose and create meaningful value for patients is behind our expected strong financial performance and will remain a core focus."

On April 22, 2021 Paige, a global leader in AI-based digital diagnostics, and Leica Biosystems, a globally recognized cancer diagnostics and workflow solution leader, reported a strategic partnership to expand access to computational pathology products for clinical and translational research (Press release, Paige AI, APR 22, 2021, View Source [SID1234578378]). The partnership brings Paige’s AI-enabled research software for tumor detection, grading and quantification to Leica Biosystems digital pathology platform in select countries throughout North America and Europe.

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The companies will collaborate to streamline and accelerate research workflows in pathology and oncology for higher quality, improved consistency and faster throughput. Leica Biosystems will distribute Paige’s research-use-only (RUO) computational pathology products, starting with Paige Prostate RUO, that identify areas of interest in tumor tissue and help researchers quantify and subtype tissue more efficiently and objectively. This software will be paired with Leica Biosystems digital pathology platform including slide image scanners and image management software. Additional detection efforts will focus on other indications.

"We are excited to partner with Leica Biosystems in our mutual goal to define the future of cancer research through the expanded access of computational pathology products for research," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "By combining our proprietary software with the reliability of Leica hardware, we can better serve the research needs of the pathology community as it undergoes a rapid digital transformation."

"We are very excited about this collaboration with Paige. Our goal is to provide our customers with the tools that they need to continue to advance research and ultimately patient care," said Christopher Riley, President of Leica Biosystems. "Paige’s AI-powered solutions are central to this effort."

On April 22, 2021 Monopteros Therapeutics Inc. ("Monopteros"), a clinical-stage biotechnology company developing MPT-0118, a first-in-class MALT1 inhibitor for the treatment of solid tumors, reported that it has dosed the first patient in its Phase 1/1b dose escalation and cohort expansion clinical trial (Press release, Monopteros Therapeutics, APR 22, 2021, View Source [SID1234578347]). The trial aims to evaluate the safety, efficacy, and pharmacology of MPT-0118 and to demonstrate the reprogramming of regulatory T cells.

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Monopteros’ clinical program is based on research by Thorsten Mempel, MD, of Massachusetts General Hospital and Harvard Medical School and published in Nature in 2019.1 He discovered that regulatory T cells ("Tregs") located in the tumor microenvironment have an increased dependence on the MALT1 enzyme. Inhibition of MALT1 results in the selective reprogramming of the tumor-associated Tregs, characterized by the loss of their immunosuppressive function and pro-inflammatory interferon-gamma production. The resulting tumor inflammation is recognized as essential for the success of checkpoint inhibitor therapy. Treg reprogramming through MPT-0118 therefore has the potential to enable a powerful anti-tumor immune attack in cancer patients that are otherwise not responsive to checkpoint inhibitor therapy.2,3

"Immunosuppressive regulatory T cells are preventing many patients with solid tumors from realizing the durable benefit from cancer immunotherapy currently achieved by a minority of patients," commented Keith Flaherty, MD, director of developmental therapeutics at the Massachusetts General Hospital Cancer Center and chairman of the Monopteros clinical advisory board. "MPT-0118 demonstrates the potential to reprogram Tregs, which can be an essential mechanism for increasing the response rates of checkpoint inhibitors for patients with these common cancer types."

Monopteros started its operations in the first quarter of 2019 following a $20 Million Series-A commitment by Medicxi and recruited a team of experienced drug developers and advisors to advance MPT-0118 to the clinic.

"We have achieved our goal of expeditiously bringing Dr. Mempel’s breakthrough research to the clinic while both confirming and expanding on his results," said Peter Keller, CEO. "We now shift our focus to the clinical development of MPT-0118 and to bringing the benefits of immunotherapy to more patients with solid tumors."

In the Phase 1/1b clinical trial, MPT-0118 is provided to patients as a tablet formulation for oral dosing.

On April 22, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) and Obsidian Therapeutics reported that the two companies have entered into a strategic research collaboration and licensing agreement focused on the discovery of novel therapies that regulate gene editing for the treatment of serious diseases (Press release, Obsidian Therapeutics, APR 22, 2021, View Source [SID1234578363]). The collaboration leverages Obsidian’s cytoDRiVE platform technology to discover gene-editing medicines whose therapeutic activity can be precisely controlled using small molecules and Vertex’s established scientific and clinical capabilities in small molecule, cell and genetic therapies to more rapidly bring these approaches to patients.

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"This collaboration with Obsidian builds upon and will expand Vertex’s leadership in small molecule and genetic therapies, and we’re excited to partner with the team at Obsidian to explore the capabilities of their technology," said Vertex’s David Altshuler, Executive Vice President, Global Research and Chief Scientific Officer. "The ability to tune gene-editing activity to a specific level is an important innovation that has the potential to address several serious diseases."

"At Obsidian, we’re using our cytoDRiVE technology to pioneer a new generation of engineered cell and gene therapies for patients with serious diseases," said Paul Wotton, Chief Executive Officer of Obsidian Therapeutics. "Partnering with Vertex, an established leader at the forefront of genetic therapies, will further advance our technology into the gene therapy field and accelerate development of controllable gene editing therapies for patients."

About the Collaboration

Under the terms of the agreement, Obsidian will use its cytoDRiVE technology to develop novel regulated gene editing therapy candidates for multiple serious diseases. Obsidian grants Vertex the exclusive option to license worldwide rights to candidates discovered and developed under the collaboration. Following Vertex’s exercise of its options, Vertex will be responsible for further preclinical and clinical development and commercialization.

Vertex will pay Obsidian up to $75 million in upfront payments and research milestones that may be paid during the research term, including an equity investment in Obsidian. Obsidian is eligible to receive up to $1.3 billion in potential payments based upon the successful achievement of specified research, development, regulatory, and commercial milestones across up to five potential programs. In addition, Vertex will pay tiered royalties on future net sales on any products that may result from this collaboration. Specific diseases that are the subject of this collaboration are not disclosed.

On April 22, 2021 Illumina, Inc. (NASDAQ: ILMN) and Kartos Therapeutics, Inc. reported a new partnership to co-develop a TP53 companion diagnostic (CDx) based on the content of Illumina’s comprehensive genomic profiling assay, TruSight Oncology 500 (TSO 500) (Press release, Illumina, APR 22, 2021, View Source [SID1234578379]). This companion diagnostic for multiple hematologic indications will be the first to use TSO 500 with peripheral whole blood as a diagnostic sample type.

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"With this partnership, Illumina will expand the TruSight Oncology offerings into hematologic malignancies," said Phil Febbo, MD, Chief Medical Officer of Illumina. "By leveraging our technology and harnessing the expertise at Kartos, we continue to advance Illumina’s commitment to develop standardized, globally distributable tools for precision oncology."

The initial focus of the collaboration will be the co-development of multiple CDx claims in blood cancers for Kartos’ KRT-232, a potent and selective oral MDM2 inhibitor that activates p53 to drive tumor cell death in TP53 wild-type cancers.

"Kartos is dedicated to developing novel, targeted therapeutics that meaningfully improve the lives of patients with cancer," said Jesse McGreivy, MD, Chief Executive Officer and Chief Medical Officer at Kartos. "This partnership will allow us to capitalize on TSO 500 as we explore the expanded use of KRT-232, which offers a unique mechanism to restore the function of p53, one of the most critical tumor suppressor proteins, resulting in apoptosis of malignant cells across a variety of hematologic and solid tumor types."

The collaboration with Kartos builds on a solid history and varied portfolio of Illumina’s oncology partnerships with industry leaders, with the united goal of advancing cancer diagnostics and precision medicine.

About TruSight Oncology 500

TSO 500 is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic (IVD) test to the TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500.