Agenus to Provide Corporate Update and First Quarter 2021 Financial Report

On April 22, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that it will release its first quarter 2021 financial results before the market opens on Thursday, May 6, 2021 (Press release, Agenus, APR 22, 2021, View Source [SID1234578411]). Agenus executives will host a conference call and webcast at 8:30 a.m. ET the same day to discuss the results and to provide a corporate update.

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Conference Call
Dial-in numbers: (800) 446-1671 (US) or (847) 413-3362 (International); Confirmation Number: 50150591.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

ImmunityBio Announces 100th Patient Dosed with Proprietary Natural Killer Cells; NK Trials Cover Multiple Indications

On April 22, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported it has administered its proprietary Natural Killer cells to more than 100 patients (Press release, NantKwest, APR 22, 2021, View Source [SID1234578346]). The cells were administered as part of combination therapies in trials across multiple indications, including pancreatic, triple-negative breast, and Merkel Cell Carcinoma cancers. The 100th patient to receive ImmunityBio’s NK cells is participating in the company’s QUILT 88 trial for pancreatic cancer (NCT04390399).

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To support that scale of testing, the company has manufactured more than 5 trillion clinical-grade, off-the-shelf NK cells (haNK, PD-L1.t-haNK) since 2017 and has more than 2.7 trillion cryopreserved cells in storage, representing a pipeline of 1,400 doses for our clinical trials. Over the last six months, ImmunityBio has invested in substantial upgrades to its cell therapy production equipment, as well as in process improvements, resulting in a 400% increase in process performance.

"We believe ImmunityBio is the first natural killer cell therapy-based company to accomplish manufacturing, storage and administration of cryopreserved NK cells at this scale," said ImmunityBio CEO Richard Adcock. "As a result of developing increased efficiencies and driving best manufacturing practices, we will be able to accelerate the development of our cell therapy platforms and immunotherapies to deliver better outcomes for patients in their fight against cancer and infectious diseases."

ImmunityBio’s off-the-shelf Natural Killer cell platform is comprised of several allogeneic NK therapies derived from the company’s proprietary, universal NK-92 cell line, a fast growing, stable NK cell line that is uniquely amenable to complex genetic enhancements and large-scale production. The NK platform has demonstrated the ability to induce cell death in cancers and virally infected cells through a variety of concurrent mechanisms including innate killing, antibody-mediated killing, CAR-directed killing and a combination of both antibody-mediated and CAR-directed killing.

The platform is designed to be manufactured as an "off-the-shelf" therapy that can be molecularly engineered in a variety of ways to boost its killing capabilities against cancers and virally infected cells. Unlike normal natural killer cells, NK-92 cells lack inhibitors that are often exploited by diseased cells to ward off an NK cell attack. They also are designed to deliver a more lethal blow to their target with a larger payload of lytic enzymes and cytokines. ImmunityBio has extensive cell therapy and adenovirus vector manufacturing expertise, with a combined footprint of more than 400,000 square feet of manufacturing facilities in Los Angeles, San Diego, and Louisville, Colorado, with capacity to expand as demand warrants.

"By improving our proprietary manufacturing and distribution processes now, we are in a strong position to meet future commercial demand in the challenging field of cellular therapeutics," Adcock said.

Pfizer Declares Second-Quarter 2021 Dividend

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."

Paige and Leica Biosystems Partner to Expand Access to Computational Pathology Products for Pathology and Oncology Research

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."

Monopteros Therapeutics Initiates Clinical Trial to Reprogram Regulatory T Cells in Solid Tumors

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.