On February 17, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported that it has scheduled its fourth quarter and year end 2021 financial results and corporate update for Thursday, March 3, 2022 (Press release, Arbutus Biopharma, FEB 17, 2022, View Source [SID1234608219]). The schedule for the press release and conference call/webcast are as follows:

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A live webcast of the conference call can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com.

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: 3977368.

On February 17, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, and its program development partner, EvviVax, S.R.L. ("Evvivax"), reported the publication of a manuscript detailing a preclinical study (the "study") showing that LinearDNA vaccines used for cancer immunotherapy produced a strong immune and specific antitumoral response in preclinical mouse models (Press release, Applied DNA Sciences, FEB 17, 2022, View Source [SID1234608218]). The study investigated the use of the LinearDNA platform to produce DNA vaccines targeting either tumor-associated antigens (TAA) and tumor-specific antigens (TSA or tumor neoantigens). The manuscript, "Linear DNA Amplicons as a Novel Cancer Vaccine Strategy," is published online on the bioRxiv.org preprint server and has been submitted for peer-reviewed publication. LinearDNA is Applied DNA’s proprietary, large-scale polymerase chain reaction ("PCR")-based manufacturing platform that allows for the large-scale production of specific DNA sequences.

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DNA vaccines that target TAAs hold promise as potential pan-cancer vaccines that, when used in conjunction with existing standards of care, can increase the efficacy of cancer immunotherapies. DNA vaccines targeting TSAs, otherwise known as personalized cancer vaccines, also hold great promise in immunotherapy as they can be customized to induce an immune response only against a patient’s tumor, thereby limiting on-target, off-tumor effects.

TAA: TERT Vaccine
One aspect of the study used a DNA vaccine targeting telomerase reverse transcriptase (TERT), a TAA that holds potential as a target for a pan-cancer vaccine. The TERT DNA vaccine was designed by EvviVax and exclusively licensed by the Company for the LinearDNA platform for veterinary applications. In prior clinical trials conducted by EvviVax, a plasmid form of the TERT DNA vaccine administered along with the standard of care chemotherapy was shown to increase the survival of canines with Stage III/IV B cell lymphoma from 37 weeks to 97 weeks. B-cell lymphoma is the most common type of non-Hodgkin lymphoma in canines, with lymphoma accounting for 15-20% of new cancer diagnoses in canines. For the study, the TERT DNA vaccine was administered to mice in either plasmid DNA or LinearDNA form and the immune response studied and compared. The study’s results demonstrated that both the plasmid DNA and LinearDNA forms of the TERT DNA vaccine induced comparable immune responses in mouse models.

TSA/Neoantigens Vaccine
The second aspect of the study utilized a personalized DNA vaccine specifically targeting several TSAs expressed in a colon cancer mouse model. Personalized cancer vaccines hold great promise in immunotherapy as they can be customized to induce an immune response only against a specific patient’s tumor, thereby limiting off-tumor effects and increasing efficacy and therapeutic index. In the study, LinearDNA and plasmid DNA forms of the personalized cancer vaccine were administered to mice in the colon cancer model. For both forms of the DNA vaccine, several cohorts also received immune checkpoint inhibitors (ICI) based on anti-CTLA-4 and/or anti-PD1. The study demonstrated that the LinearDNA personalized vaccine produces an equal or greater immune and antitumoral response than the plasmid form of the same DNA vaccine, particularly when coupled with ICI.

Dr. James A. Hayward, president and CEO of Applied DNA, stated, "The study demonstrates that LinearDNA and plasmid DNA can elicit a comparable immune response in animal cancer models. We believe this study validates the use of LinearDNA as a more cost- and time-efficient alternative to plasmid DNA for DNA-based cancer vaccines. Cancer immunotherapy is relevant to veterinary and human markets; the latter is expected to reach $169 billion by 2028. As the exclusive licensee of the TERT vaccine for veterinary applications, we believe these data support further investigation of the LinearDNA vaccine as a potential veterinary cancer immunotherapy and, beyond that, for human cancer immunotherapy."

Dr. Luigi Aurisicchio, CEO and chief scientific officer of Evvivax S.R.L., commented, "We believe that DNA vaccines for cancer hold immense promise for both human and veterinary applications. One obstacle to DNA vaccine manufacturing is their current production as plasmid DNA. We believe that the completely cell-free LinearDNA platform avoids the numerous pitfalls of plasmid DNA-based production, making it ideal for DNA vaccine manufacturing broadly, and in cancer immunotherapy, specifically."

On February 17, 2022 Alkermes plc (Nasdaq: ALKS) reported that new data from the ongoing phase 1/2 ARTISTRY-1 clinical trial for nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy (Press release, Alkermes, FEB 17, 2022, View Source [SID1234608217]). The data were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, taking place Feb. 17-19, 2022.

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The presentation includes updated efficacy and safety data from the monotherapy arm of ARTISTRY-1, in which single-agent, anti-tumor activity of intravenous (IV) nemvaleukin was observed in patients with advanced renal cell carcinoma (RCC), including patients who were checkpoint inhibitor (CPI)-pretreated.

"Nemvaleukin’s single-agent activity is an important differentiating feature in the IL-2 space and suggests that nemvaleukin may contribute clinical benefit when used in combination regimens with other cancer treatments like checkpoint inhibitors," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "Together with the objective responses previously reported in the melanoma cohort of this study, these data in renal cell carcinoma show nemvaleukin’s monotherapy activity in two tumor types where high-dose IL-2 is approved, thus validating its novel molecular design."

Data highlights from the ASCO (Free ASCO Whitepaper) GU poster presentation include:

ARTISTRY-1, IV Nemvaleukin (6 μg/kg) Monotherapy Arm, RCC Patients
The ARTISTRY-1 monotherapy RCC cohort included 27 patients with advanced RCC, 56% of whom were CPI-pretreated. As of the Oct. 29, 2021 data cutoff:

Nemvaleukin monotherapy induced robust expansion of CD8+ T and natural killer (NK) cells, with minimal effect on regulatory T cells (Tregs).
Among 23 evaluable patients (with at least one post-baseline scan):
Four patients, all of whom were CPI-pretreated, achieved a partial response (one unconfirmed) and three of these patients continued on monotherapy.
Decreases in target lesions of up to 60% were observed.
Stable disease was observed in 10 patients.
Safety among these patients with advanced RCC was consistent with that which was previously reported for the IV nemvaleukin monotherapy-treated population in the ARTISTRY-1 study. Fever, chills, nausea and anemia were the most frequently reported adverse events (AEs), regardless of causality. Chills and anemia were the most commonly reported treatment-related AEs of grade ≥3. There were no deaths due to treatment-related AEs.

Details of the presentation are available on the ASCO (Free ASCO Whitepaper) GU website at View Source

Abstract: 330
Title: Nemvaleukin Alfa in Patients With Advanced Renal Cell Carcinoma: ARTISTRY-1
Presenter: Emiliano Calvo, M.D., Ph.D., Medical Oncologist and Director of Clinical Research at the START Madrid-Centro Integral Oncológico Clara Campal Hospital, Madrid, Spain
Presentation Date: The poster, along with a pre-recorded presentation, will be available on the ASCO (Free ASCO Whitepaper) GU virtual meeting platform beginning Feb. 17, 2022.

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 preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively 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 Nemvaleukin Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin 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 in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.

On February 17, 2022 The board of directors of AbbVie Inc. (NYSE: ABBV) reported a quarterly cash dividend of $1.41 per share (Press release, AbbVie, FEB 17, 2022, View Source [SID1234608216]).

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The cash dividend is payable May 16, 2022 to stockholders of record at the close of business on April 15, 2022.

Since the company’s inception in 2013, AbbVie has increased its dividend by more than 250 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On February 17, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics leveraging CRISPR-based technologies, reported that it will be hosting two virtual investor events in February (Press release, Intellia Therapeutics, FEB 17, 2022, View Source [SID1234608213]).

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Fourth Quarter and Full-Year 2021 Earnings – February 24, at 8:00 a.m. ET
Intellia will present its fourth quarter and full-year 2021 financial results.

To join the call, U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.
Please visit this link for a simultaneous live webcast of the call.
NTLA-2001 Interim Clinical Data Update – February 28, at 4:30 p.m. ET
Intellia will present additional interim clinical data from the ongoing Phase 1 study of NTLA-2001 in patients with transthyretin (ATTR) amyloidosis with polyneuropathy. The event will include a presentation by Ed Gane, MBChB, MD, FRACP, MNZM, Professor of Medicine at the University of Auckland, New Zealand and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital and an investigator in the ongoing NTLA-2001 Phase 1 study, along with members of Intellia’s management team.

To join the webcast, please visit this link, or the Events and Presentations page of the Investors & Media section on Intellia’s website at www.intelliatx.com.
A replay of the events will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at www.intelliatx.com for at least 30 days following the event.

About NTLA-2001
Based on Nobel Prize-winning CRISPR/Cas9 technology, NTLA-2001 could potentially be the first single-dose treatment for ATTR amyloidosis. NTLA-2001 is the first investigational CRISPR therapy candidate to be administered systemically, or through a vein, to edit genes inside the human body. Intellia’s proprietary non-viral platform deploys lipid nanoparticles to deliver to the liver a two-part genome editing system: guide RNA specific to the disease-causing gene and messenger RNA that encodes the Cas9 enzyme, which carries out the precision editing. Robust preclinical data, showing deep and long-lasting transthyretin (TTR) reduction following in vivo inactivation of the target gene, supports NTLA-2001’s potential as a single-administration therapeutic. Intellia leads development and commercialization of NTLA-2001 as part of a multi-target discovery, development and commercialization collaboration with Regeneron.