On May 2, 2022 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the Company will release its first quarter 2022 financial results on Monday, May 16, 2022, before the U.S. financial markets open (Press release, Compugen, MAY 2, 2022, View Source [SID1234613342]). Management will not host a conference call to accompany this release.

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Management plans to provide a corporate update at two global investor healthcare conferences in June 2022. Details of the planned presentations will be provided closer to the events.

On May 2, 2022 NKGen Biotech Inc., a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that three abstracts with clinical information on its NK cell therapy (SNK01) were accepted for presentation at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022 in Chicago, Illinois (Press release, NKMax America, MAY 2, 2022, View Source [SID1234613279]).

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Details of the presentations are as follows:

Poster Discussion

Title: Interim Analysis of a Phase I Study of SNK01 (Autologous Non-genetically Modified Natural Killer Cells with Enhanced Cytotoxicity) and Avelumab in Advanced Refractory Sarcoma

Authors: Sant P. Chawla, Victoria S. Chua, Erlinda Maria Gordon, Ted T. Kim, William Feske, Brenda L. Gibson, Paul Y. Chang, Debra Robinson, Paul Y. Song

Session Type: Poster Discussion

Session Title: Sarcoma

Session Date and Time: Sunday, June 5, 2022, 8:00 am – 11:00 am; Discussion 11:30 am – 1:00 pm CDT

Poster Presentation

Title: Preliminary Analysis of a Phase I Study of SNK01 (Autologous Non-genetically Modified Natural Killer Cells with Enhanced Cytotoxicity) Monotherapy in Patients with Advanced Solid Tumors

Authors: Victoria S. Chua, Sant P. Chawla, Erlinda Maria Gordon, Ted T. Kim, Simranjit Sekhon, William Feske, Lucia Hui, Brenda L. Gibson, Paul Y. Chang, Debra Robinson, Paul Y. Song

Session Type: Poster Presentation

Session Title: Developmental Therapeutics – Immunotherapy

Session Date and Time: Sunday, June 5, 2022, 8:00 am – 11:00 am CDT

Poster Presentation

Title: The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors

Authors: Anthony B. El-Khoueiry, Paul Y. Song, Jennifer Rubel, Dorna Y. Pourang, Christa Raab, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada

Session Type: Poster Presentation

Session Title: Developmental Therapeutics – Immunotherapy

Session Date and Time: Sunday, June 5, 2022, 8:00 am – 11:00 am CDT

Abstracts will be released to the public on Friday, May 26, 2022 at 5:00 pm EDT.

More information on the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting and related posters sessions can be found at www.asco.org

On May 2, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that five abstracts covering preclinical data from its hypoimmune and fusogen platforms were accepted for either oral or poster presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting taking place May 16-19, 2022 in Washington, D.C (Press release, Sana Biotechnology, MAY 2, 2022, View Source [SID1234613295]).

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"We will have a strong presence at ASGCT (Free ASGCT Whitepaper), with presentations of data from multiple technology platforms, including two oral presentations on our hypoimmune platform and two posters on our fusogen platform," said Steve Harr, MD, Sana’s President and CEO. "We remain excited with the progress we are making with these platforms that are targeted to address some of the major challenges faced in the field of gene and cell therapy. Our goal is to file two INDs this year from two of these platforms, with the aim of translating our exciting scientific progress into beneficial therapeutics for patients."

The ASGCT (Free ASGCT Whitepaper) abstracts are available to the public at View Source

Oral Presentations:
Title: Hypoimmune mouse primary pancreatic islet cells survive and functionally rescue allogeneic diabetic mice
Summary: Hypoimmune islet cells transplanted intramuscularly may be capable of persisting and functioning in diabetic patients without immune suppression
Abstract Number: 1244
Session: Cell Therapies for Hematological Disorders
Date/Time: Thursday, May 19, 2022 from 10:30 a.m. – 10:45 a.m. ET

Title: Generation of off-the-shelf allogeneic hypoimmune Tregs
Summary: A method to genetically engineer immune evasive "hypoimmune" regulatory T cells (Tregs) ex vivo that, in the assays tested, are immune evasive, functional, and protected from innate immune reactivity
Abstract Number: 1254
Session: Cell Therapy Product Engineering, Development or Manufacturing
Date/Time: Thursday, May 19, 2022 from 11:15 a.m. – 11:30 a.m. ET

Poster Presentations:
Title: Retargeted "fusosomes" for in vivo delivery to T cells
Summary: In vivo delivery of a CD19 CAR transgene payload with either CD8- or CD4-targeting vectors in Nalm-6 tumor bearing mouse models demonstrated robust production and persistence of CAR T cells, leading to tumor eradication
Abstract Number: 1081
Session: Cancer – Immunotherapy, Cancer Vaccines III
Date/Time: Wednesday, May 18, 2022 from 5:30 p.m. – 6:30 p.m.

Title: Fusosome-targeted gene transfer to human hepatocytes
Summary: Proof of principle data showing efficient delivery of a reporter transgene to human hepatocytes in vivo using a humanized liver mouse model
Abstract Number: 875
Session: RNA Virus Vectors
Date/Time: Wednesday, May 18, 2022 from 5:30 p.m. – 6:30 p.m. ET

Title: A novel VCN assay that detects lentiviral vector integrations while overcoming limitations caused by plasmid residuals
Summary: Data from a novel assay that relies on a unique amplicon and droplet digital PCR process that is specific to only reverse-transcribed self-inactivating viral vector nucleic acids
Abstract Number: M-305
Session: Pharmacology / Toxicology Studies or Assay Development
Date/Time: Monday, May 16, 2022 from 5:30 p.m. – 6:30 p.m. ET
About Hypoimmune Platform
Sana’s hypoimmune platform is designed to create cells ex vivo that can "hide" from the patient’s immune system to enable the transplant of allogeneic cells without the need for immunosuppression. We are applying the hypoimmune technology to both pluripotent stem cells, which can then be differentiated into multiple cell types, and to donor-derived allogeneic T cells, with the goal of making potent and persistent CAR T cells at scale. Preclinical data demonstrates across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. Our most advanced programs utilizing this platform include an allogeneic CAR T program targeting CD19+ cancers and stem-cell derived pancreatic cells for patients with type 1 diabetes.

About Fusogen Platform
Sana is developing re-targetable fusogens as a platform technology to enable the in vivo delivery of genetic payloads to specific cell types. Fusogens can bind to cell-surface proteins on the target cell type and, when combined with delivery vehicles to form fusosomes, deliver a genetic payload directly to the cell’s cytoplasm. We have shown in preclinical studies that we can engineer fusogens to specifically target diverse cell surface receptors that allow cell-specific delivery across multiple different cell types. Our most advanced programs utilizing this platform include in vivo CAR T cell fusosome product candidates targeting CD19+ cancer cells, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and acute lymphocytic leukemia.

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.