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 Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, reported that it will present new data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Congress 2022 taking place in Berlin, Germany on May 3-5, 2022 (Press release, Agendia, MAY 2, 2022, View Source [SID1234613327]).

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The first of the two poster presentations, entitled Equivalence of NGS-based MammaPrint 70-gene signature risk of recurrence and BluePrint 80-gene signature of molecular subtyping tests to the centralized microarray tests [234P], concludes that the next-generation sequencing (NGS) version of MammaPrint and BluePrint[1] is equivalent to the centralized microarray test, as demonstrated by results from various labs globally. This enables a more accurate decentralized solution to breast cancer care fostering worldwide accessibility to more reliable genomic testing.

"The accessibility of breast cancer care is crucial and by validating the interchangeability of the NGS version of MammaPrint and BluePrint compared to the standardized microarray tests, new doors are opened for global physicians who may need to rely on in-country platforms in order to secure the MammaPrint and BluePrint results their patients may require," said Annuska Glas, Senior Vice President Research and Development and Innovation at Agendia. "MammaPrint is a valuable tool to support treatment planning for breast cancer patients and with the decentralized NGS platform, this can be offered in even more countries. These findings further confirm that MammaPrint and BluePrint can provide the same accurate results through NGS."

Agendia is expanding novel ways to ensure accessibility of care worldwide by advancing solutions with a decentralized option for testing kits to run on an NGS platform, and innovative modalities such as digital AI pathology. This data presented at ESMO (Free ESMO Whitepaper) Breast follows an announcement from Agendia earlier this year that it is progressing its Digital MammaPrint artificial intelligence (AI)-powered platform in Brazil to potentially fundamentally change the way breast cancer is treated by providing essential information more quickly and elevating the capabilities of global physicians treating women with breast cancer in their local communities.

A second poster presentation, entitled Budget impact analysis for the Health Care Package by using MammaPrint in Belgium [238P], builds on earlier research from the landmark MINDACT trial and combines this with the results of the interim analysis of the pilot study performed in Belgium (unpublished data). The budget impact model shows that use of MammaPrint yields savings for breast cancer care in Belgium for the Belgian Health Care Package when compared to no gene expression profiling testing. According to the budget impact model, the use of MammaPrint in patients selected according to criteria of the pilot study leads to high savings. If gene expression profiling was performed for all clinical high risk patients, savings would even be higher.

By combining the cost of genomic testing with the savings made due to a net reduction in chemotherapy usage, the annual savings add up to more than €5,800,000, an average savings of €3,900 per patient, compared with standard clinical care of a patient with breast cancer in Belgium. MINDACT has produced previous multi-country health savings analyses, published in the European Journal of Cancer, showing that genomic testing is beneficial as it provides valuable insights that potentially allow patients to avoid the complexity of chemotherapy, passing down significant financial savings to them while also triggering significant cost savings for large health systems around the world.

"Drawing from the impact data used from the pilot study performed in Belgium, we are able to determine new insights that the use of MammaPrint could grant substantial cost savings to women who may not require chemotherapy and could ultimately alleviate some of the burden on Belgium’s health care system as a whole," said Pino Cusumano, MD, Breast Surgeon, Centre Hospitalier Chrétien, Liège in Belgium. "Data has previously demonstrated that by de-escalating women with Low Risk cases from chemotherapy treatment, outcomes are still as good and women are able to follow a more personalized treatment plan. We believe these data demonstrate that the previous analysis holds for the state of breast cancer care in Belgium in 2022, and that the overall patient benefit extends beyond physical care into financial wellness too."

Taken together, the two posters presented at ESMO (Free ESMO Whitepaper) Breast 2022 suggest that regardless of where the patient is located, she is able to receive the same high-quality results with the added benefit of cost-effective treatment planning.

"The studies presented at EMSO 2022 underpin our central efforts at Agendia to ensure our genomic tests are widely accessible and affordable, without compromising scientific integrity or decision-making, to bring the clarity women with breast cancer seek to guide their treatment planning," said Bastiaan van der Baan, Chief Clinical and Business Development Officer at Agendia. "Through our steadfast commitment to enable global adoption of MammaPrint and BluePrint, we look forward to continuing studies such as these to grow evidence supporting our mission to serve women with breast cancer throughout their treatment journey."

1MammaPrint and BluePrint next-generation sequencing kits are not yet cleared for sale in the United States by the US Food and Drug Administration; BluePrint has been CE-marked for use in Europe. BluePrint is also commercialized as a Laboratory Developed Test (LDT) and audited under CAP/CLIA in the United States.

On May 2, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the treatment of uveal melanoma (Press release, Ideaya Biosciences, MAY 2, 2022, View Source [SID1234613343]).

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IDEAYA is currently evaluating the synthetic lethal combination of darovasertib, a PKC inhibitor, and crizotinib, a cMET inhibitor, in patients with metastatic uveal melanoma (MUM) and in patients with GNAQ or GNA11 mutant solid tumors, in an ongoing Phase 1/2 clinical trial (NCT03947385) pursuant to a clinical trial collaboration and supply agreement with Pfizer.

"We are excited to advance darovasertib towards a potential registration-enabling trial in metastatic uveal melanoma, and the orphan-drug designation is an important step towards our goal to bring this novel therapy to patients," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs, at IDEAYA Biosciences.

Orphan-drug designation (ODD) is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the U.S. Under the ODD, IDEAYA may be entitled to certain tax credits, exemption from user fees, and seven years of statutory marketing exclusivity, subject to FDA approval of a marketing application for darovasertib as a designated orphan-drug product.

As of May 1, 2022, Darovasertib has been evaluated in over 200 patients, including 74 patients in combination with crizotinib. The company is targeting a clinical data update for darovasertib and crizotinib combination in mid-2022, including tolerability and clinical efficacy. IDEAYA is also planning to seek FDA regulatory guidance for a potential registration-enabling trial design to evaluate the darovasertib and crizotinib combination in MUM in mid-2022. IDEAYA is preclinically evaluating potential expansion opportunities for darovasertib in other oncology indications, including in additional cMET-driven tumors, such as hepatocellular carcinoma and non-small cell lung cancer, and in KRAS G12C non-small cell lung cancer.

On May 2, 2022 OSE Immunotherapeutics reported the grant of a new patent from the European Patent Office (EPO) strengthening the protection covering its novel myeloid cell immune checkpoint target, CLEC-1 (a C-type lectin receptor), and its use in cancer treatment (Press release, OSE Immunotherapeutics, MAY 2, 2022, View Source [SID1234646965]). This patent provides a protection until 2037.

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CLEC-1 is a C-type lectin receptor with demonstrated potential to inhibit the functions of myeloid cells and to block anti-tumor responsiveness of T-lymphocytes. Myeloid cells have the ability to accumulate in the tumor microenvironment and deregulate the immune activation of T-lymphocytes. CLEC-1 is a new therapeutic target of interest in immuno-oncology.

Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics, comments: "This European patent is a major step that provides products targeting CLEC-1 a strong intellectual property and a broad scope as it notably covers the use of antagonist antibodies targeting CLEC-1 in cancer treatment. The patent has been extended to other major territories with the notice of allowance already granted in the United States and the patent granted in Japan."

Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics adds: "Based on our fruitful collaboration with the CR2TI research team*, we now have preclinical results identifying CLEC-1 and its antagonists as an innovative immunotherapy that releases the brakes on macrophage phagocytosis and dendritic cells antigen presentation and demonstrates synergistic anti-cancer effects, in particular when combined with chemotherapy. The latest preclinical efficacy data open the pathway for the development of monoclonal antagonist antibodies targeting new myeloid checkpoint inhibitor target CLEC-1, and for future translational clinical development of an innovative cancer immunotherapy."

*Collaborative program between OSE Immunotherapeutics and Dr Elise Chiffoleau’s (View Source) research teams (Center for Research in Transplantation and Translational Immunology (CR2TI), UMR1064, INSERM, Nantes University at Nantes University Hospital).

On May 2, 2022 Scribe Therapeutics Inc., a molecular engineering company creating the most advanced technologies for CRISPR-based genetic medicine, reported Biogen Inc. (Nasdaq:BIIB) has exercised an option for an additional disease target in gene therapy as part of the companies’ ongoing research collaboration to develop and commercialize CRISPR-based medicines (Press release, Scribe Therapeutics, MAY 2, 2022, View Source [SID1234613280]). The expanded collaboration further validates Scribe’s position as a leading organization driving the development of novel CRISPR-based therapeutics that treat the underlying cause of disease.

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"At Scribe, we continue to push the boundaries of molecular engineering to fulfill the profound promise of CRISPR-based therapeutics and are pleased to have our collaborators at Biogen continue to support and expand our collaboration towards this goal," said Benjamin Oakes, CEO and co-founder of Scribe Therapeutics. "Scribe’s custom-designed CRISPR platforms, molecules, and delivery technologies are overcoming the technical hurdles that challenge many genetic targeting technologies and we are thrilled to continue to drive forward a new era of truly transformative genetic medicines."

In 2020, Scribe announced their research collaboration with Biogen to develop and commercialize CRISPR-based therapies that address an underlying genetic cause of Amyotrophic Lateral Sclerosis (ALS).