On May 2, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported it expects to release its first quarter 2022 financial results before markets open on Monday, May 16, 2022 (Press release, Nuvo Pharmaceuticals, MAY 2, 2022, View Source [SID1234613311]). The Company will review the results of the first quarter 2022 in conjunction with the Annual Meeting of Shareholders (Meeting). The Meeting will be held in a virtual-only format.

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Details of the Meeting

The Meeting will take place online via live audio webcast on Monday, May 16, 2022 at 9:00 a.m. ET at www.virtualshareholdermeeting.com/mrv2022. Online access to the meeting will begin at 8:45 a.m. ET. Shareholders will not be able to attend the Meeting in person.

Miravo’s Notice of Meeting, Management Information Circular (Circular) and the accompanying form of proxy (collectively the Meeting Materials) were mailed on or about April 22, 2022. If you have not received your Meeting Materials, you should contact your broker, if you are a non-registered shareholder or contact Broadridge at [email protected], if you are a registered shareholder. The Meeting Materials outline in detail how to participate in the Company’s virtual Meeting. For people who would like to attend the meeting as a guest, details of the Meeting can be found under the Company’s profile on SEDAR – www.sedar.com.

Registered Shareholders

A registered shareholder is a shareholder who holds common shares of the Company (Common Shares) in their own name (that is, not in the name of, or through an Intermediary). A registered shareholder who owns Common Shares on the Record Date (March 28, 2022) may attend the Meeting online, vote shares electronically and submit questions during the Meeting by visiting: www.virtualshareholdermeeting.com/mrv2022. You will need to have your 16-digit Control Number (Control Number) that is found on the proxy accompanying the Circular to participate in the Meeting. If you do not have a Control Number, then you can attend the Meeting as a guest. You can also vote your shares in advance of the Meeting using the internet, by mail and by telephone by following the instructions on the form of proxy.

Voting by Proxy

A registered shareholder who is unable to attend the virtual Meeting, or does not wish to personally cast their vote(s), may authorize another person at the Meeting to vote on their behalf. This is known as voting by proxy. Registered shareholders should follow the instructions on the form of proxy enclosed with the Circular to authorize another person (Appointee) to vote on their behalf at the Meeting. You must provide your Appointee the exact name and eight character appointee identification number to access the Meeting. Valid Appointees may attend the Meeting online, vote shares electronically and submit questions during the Meeting by visiting www.virtualshareholdermeeting.com/mrv2022.

Attending the Meeting as a Non-Registered Holder

Only registered holders of Common Shares, or the persons they appoint as their proxies, are permitted to vote shares and submit questions at the Meeting. In many cases, Common Shares beneficially owned by a holder (Non-Registered Holder) are registered either in the name of an Intermediary or in the name of a Depository. In order for a Non-Registered Holder to vote their Common Shares at the Meeting, they must carefully follow the procedures and instructions received from the Intermediary.

Attending the Meeting as a Guest

Guests, including Non-Registered Holders, can attend the Meeting, but will not have the ability to ask questions or vote during the Meeting. Guests can join the meeting by visiting: www.virtualshareholdermeeting.com/mrv2022.

Technical Assistance during the Meeting

If you encounter any difficulties accessing the virtual meeting during the check-in or meeting time, please call the technical support number that will be posted on the Virtual Shareholder Meeting log in page.

On May 2, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, reported the presentation of new preclinical data from its differentiated allogeneic cell engineering platform at Keystone Symposia’s Precision Genome Engineering Conference, taking place April 27 – May 1, 2022, in Keystone, Colorado (Press release, Intellia Therapeutics, MAY 2, 2022, View Source [SID1234613310]). The data presented support the development of NTLA-6001, Intellia’s allogeneic CAR-T development candidate targeting CD30 for the treatment of CD30-expressing hematologic cancers, including relapsed or refractory classical Hodgkin lymphoma (cHL).

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"We are pleased to present promising preclinical data that led to the nomination of Intellia’s wholly owned allogeneic development candidate, NTLA-6001, for CD30-expressing hematologic lymphomas. NTLA-6001 is the first candidate using our differentiated allogeneic platform, which leverages a novel combination of sequential, LNP-delivered gene edits to yield T cells shielded from immune rejection," said Intellia Chief Scientific Officer Laura Sepp-Lorenzino, Ph.D. "Our approach to engineering T cells aims to solve key immunological challenges to allogeneicity, while retaining cell attributes necessary for potent and durable tumor killing. We look forward to advancing NTLA-6001 toward IND-enabling activities."

The data shared at Keystone demonstrated that Intellia’s proprietary allogeneic solution created T cells that not only avoided immune recognition by host CD4 and CD8 T cells, but also were protected from NK cell-mediated killing in in vitro and in vivo mouse models. Furthermore, allogeneic T cells engineered sequentially with LNPs retained high viability, cell expansion, memory phenotype, cytotoxic and cytokine secretion characteristics. Intellia’s allogeneic platform can be deployed for TCR-T and CAR-T cell therapy.

As part of these platform advancement efforts, Intellia evaluated multiple CD30 CAR constructs in a series of in vitro and in vivo experiments. The most potent CAR construct showed complete tumor regression and protection from tumor rechallenge in a T cell lymphoma model. This lead allogeneic CAR-T cell candidate, NTLA-6001, is now in preclinical development for cHL and certain CD30+ T cell lymphomas. CD30, the target for NTLA-6001, is a cell surface protein that is often overexpressed in a variety of hematologic cancers, making it an important candidate for CAR-T cell therapy.

The presentation is available on Intellia’s website at www.intelliatx.com.

On May 2, 2022 Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, reported that on April 29, 2022 it completed the previously announced acquisition of Héra SAS ("HRA") for €1.8 billion, or approximately $1.9 billion based on current exchange rates, in cash, accelerating its position as a leading global consumer self-care company (Press release, Perrigo Company, MAY 2, 2022, View Source [SID1234613309]).

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Perrigo President and CEO, Murray S. Kessler commented, "We are excited to close this acquisition and welcome the talented HRA team to the Perrigo family. Completing this transaction marks the culmination of our three-year transformation plan that has returned Perrigo to its self-care roots. The addition of HRA advances Perrigo’s vision of making lives better with quality affordable self-care products that consumers trust everywhere they are sold. It also accelerates our sales and earnings growth and is expected to enhance our margins. Our global businesses are now more intertwined and unified than ever before as we focus on expanding our geographic reach, driving category penetration and delivering new product innovation that leverages our consumer-centric mindset."

On May 2, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research reported the acceptance of an abstract for a poster presentation at the upcoming European Society for Medical Oncology Breast Cancer Meeting, which is taking place both online and in-person at hub27 – Messe Berlin in Berlin, Germany from May 3-5, 2022 (Press release, Oncolytics Biotech, MAY 2, 2022, View Source [SID1234613308]).

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The accepted abstract (#364) is available on the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting website. Included in the abstract are new results from cohort 1 and cohort 2 of the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, each of which enrolled ten HR+/HER2- early-stage breast cancer patients. These patients were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1) or with (cohort 2) the PD-L1 checkpoint inhibitor atezolizumab. Evaluation of these cohorts was the primary focus of AWARE-1 as HR+/HER2- is the breast cancer subtype Oncolytics intends to investigate in a future registrational study.

Results of this exploratory study described in the abstract show pelareorep’s potential to induce an inflamed tumor phenotype and its synergy with atezolizumab. They also support pelareorep’s immune-based mechanism of action and suggest that the combination of pelareorep and atezolizumab may improve outcomes in breast cancer. Additional details on analyses and results described in the abstract will be provided following the publication of its corresponding poster, in accordance with the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting’s embargo policies.

Details on the abstract and upcoming poster presentation are shown below.

Title: The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients – results from AWARE-1 study

Category: Biomarkers and translational research and precision medicine

Abstract Number: 364

Presentation Date: May 4, 2022

Presentation Time: 12:15 p.m. CET

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.

On May 2, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported topline results from the six-week, Phase 2a, open-label, single-arm AESOP trial of avasopasem evaluating its ability to reduce the incidence of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy (Press release, Galera Therapeutics, MAY 2, 2022, View Source [SID1234613307]).

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The multicenter Phase 2a trial enrolled 39 patients (62 screened) with unresectable Stage 3A/3B or post-operative Stage 2B non-small cell (NSCLC) or limited-stage small cell (SCLC) lung cancers. Thirty-five patients completed treatment with 60 gray of intensity-modulated radiation therapy (IMRT) plus chemotherapy over six weeks. Of these 35 patients, 29 received at least five weeks of 90 mg of avasopasem on the days they underwent IMRT. These 29 patients were evaluated as the pre-specified per protocol population. Patients enrolled in this trial were considered at high risk for developing esophagitis due to the amount of radiation planned to be delivered to the esophagus.1 Patients were assessed and classified according to NCI-CTCAE criteria.2

Incidence of esophagitis by grade and timepoint in the AESOP trial (per protocol, n=29):

Grading Scale for Esophagitis per NCI Criteria
Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated
Grade 3 Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated
Grade 4 Life-threatening consequences; urgent operative intervention indicated
Grade 5 Death
Only two of the 29 patients (7%) experienced Grade 3 esophagitis at any time, with neither patient experiencing Grade 3 for more than one week. No patients experienced Grade 4 or 5 esophagitis at any point during the trial. These data compare favorably to the literature in which approximately 20-30 percent of these patients experienced Grade 3 or 4 esophagitis.3 Avasopasem was generally well tolerated. The adverse events experienced are comparable to those expected with chemoradiotherapy.

"These encouraging results demonstrate avasopasem’s potential to meaningfully reduce radiotherapy-induced Grade 3 or worse esophagitis," said Mel Sorensen, M.D., Galera’s President and CEO. "Patients with lung cancer undergoing chemoradiotherapy are at high risk of severe and potentially life-threatening esophagitis, including an inability to eat or swallow, severe pain, ulceration, infection, bleeding and weight loss, and there are no established drug therapies. Following the positive Phase 3 results of avasopasem in radiotherapy-induced severe oral mucositis (SOM), we believe these results in esophagitis support the safety and efficacy of avasopasem as a potential therapy to prevent the most severe forms of radiotherapy-induced toxicities."

Approximately 50,000 lung cancer patients undergo standard-of-care chemoradiotherapy every year in the U.S. and are at risk of developing esophagitis.

About Radiotherapy-Induced Esophagitis
Radiotherapy-induced esophagitis is a common and debilitating adverse effect that develops in patients receiving radiotherapy, most commonly for lung, esophageal, breast or head and neck cancers or for lymphoma. Radiotherapy-induced esophagitis is inflammation, edema, erythema, and erosion of the mucosal surface of the esophagus caused by radiotherapy. Esophagitis can be life-threatening, and symptoms include an inability to swallow, severe pain, ulceration, infection, bleeding and weight loss and may require hospitalization. There are currently no FDA-approved drugs and no established guidelines for the treatment of radiotherapy-induced esophagitis.

About Avasopasem
Avasopasem manganese (avasopasem, or GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiation-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.

About the Phase 2a AESOP Trial
The AESOP trial is an open-label, multicenter trial designed to evaluate the ability of avasopasem to reduce the incidence of radiotherapy-induced esophagitis in patients receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B non-small cell lung cancer, or small cell lung cancer treatable with chemoradiotherapy. For more information, please visit View Source