Susan G. Komen and Amgen to Help People Understand and Monitor Breast and Bone Health

On May 19, 2021 Susan G. Komen, the world’s leading breast cancer organization, reported a new integrated campaign, in partnership with Amgen, to educate the breast cancer community about the link between breast and bone health, providing useful information for women of all ages and stages of breast cancer (Press release, Amgen, MAY 19, 2021, View Source [SID1234580299]).

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"Breast cancer treatment can affect bone health, and it is one of main areas where breast cancers spread when they metastasize. Yet no matter your age, health or breast cancer diagnosis, your bone health may also be at risk," said Paula Schneider, president and CEO of Susan G. Komen and a breast cancer survivor. "Women have long known that it is important to understand what is normal for their breast health and to talk to their doctor if they notice any changes. Women need to include their bones in this moment of vigilance."

Metastatic breast cancer, also known as stage IV breast cancer, is when the breast cancer spreads beyond the breast and nearby lymph nodes to other parts of the body, often the bones. When breast cancer cells spread to the bones, lesions can occur that cause the bones to break easily and may result in spinal cord compression. Research shows that 70 percent of women with bone metastasis will have a skeletal related event within two years of diagnoses. All of these skeletal complications can lead to chronic pain and the loss of mobility.

Through a mixture of facts and personal storytelling, the integrated campaign will drive people to komen.org/breast-and-bone-health, where women will be provided useful information about their breast and bone health, including:

Questions to ask your doctor about metastatic breast cancer and bone protection
How to protect bones from fractures and other problems, including through diet
What treatments may negatively impact bone health
What drugs are available to improve bone density
Amgen also provides additional information for people living with metastatic breast cancer on its website – Let’s Talk Bone Mets.

Together, the two organizations seek to inspire people to learn more about their breast and bone health and become empowered to monitor their health and have constructive conversations with their health care teams.

Genprex Announces Participation in Noble Capital Markets’ Virtual Roadshow Series

On May 19, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it will participate in Noble Capital Markets’ Virtual Roadshow Series, presented by Channelchek on May 20, 2021 (Press release, Genprex, MAY 19, 2021, View Source [SID1234580298]).

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The virtual roadshow will feature a corporate presentation from Genprex’s President and Chief Executive Officer, Rodney Varner, followed by a Q & A session proctored by Noble Senior Research Analyst, Robert LeBoyer. Registration is free and open to all investors, at any level.

Noble Capital Markets’ Virtual Roadshow Series
Presentation Date: May 20, 2021
Presentation Time: 1-2 p.m. EDT
Registration Link: https://bit.ly/3hyiXcs

Noble’s research, as well as news and advanced market data on Genprex is available on Channelchek.com.

MAIA Biotechnology, Inc. Raises $8.0 Million Financing to Advance Pipeline of Targeted Immuno-Oncology Studies

On May 19, 2021 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing first-in-class oncology drugs, reported that it has raised $8.0 million financing in a convertible note offering led by new investor Checkmate Capital Group with participation from other strategic and existing investors (Press release, MAIA Biotechnology, MAY 19, 2021, View Source [SID1234580297]). The proceeds of the financing will advance the company’s targeted immuno-oncology programs and will support the initiation of a Phase 1/2 clinical trial evaluating THIO followed by Libtayo (cemiplimab) in patients with advanced Non-Small Cell Lung Cancer (NSCLC). The Phase 1/2 clinical trial is expected to begin later this year.

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"We are excited to expand MAIA’s investor base and welcome several new investors who have extensive expertise in immuno-oncology and biotechnology investing. This funding round brings MAIA the necessary capital to accelerate development of the THIO program," stated Vlad Vitoc, MD, MAIA’s Chief Executive Officer and President. "We appreciate the investors’ recognition of THIO’s well-demonstrated clinical safety profile and promising efficacy potential in a variety of advanced tumors."

Lead investors in this financing included a diverse group of strategic investors, including Checkmate Capital Group, BRK Financial Group, and MDL Investments.

"As experienced investors in successful immuno-oncology companies, we have been deeply impressed with the THIO pre-clinical results in multiple difficult-to-treat tumor types. The data from sequential administration of THIO followed by Libtayo raise the prospect of a groundbreaking advancement in cancer treatment," commented Alex Monsef, Managing Director from Checkmate Capital Group. "We see the THIO program as having the potential to transform the immuno-oncology landscape. We are thrilled to invest in this exciting technology platform led by a world class oncology team at MAIA."

About the Phase 1/2 Clinical Trial in Advanced Non-Small Cell Lung Cancer (NSCLC)

This trial (THIO-101) will be the first to test THIO’s immune system activation followed by administration of the checkpoint inhibitor Libtayo (co-developed by Regeneron and Sanofi), allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor.

The trial will assess the safety, mechanistic activity and immune system activation of four THIO dose levels, each in separate arms. Each dosing arm will then be evaluated further for efficacy based on Overall Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS) and Overall Survival (OS). Additional patients may be recruited for further clinical evaluation in any of the THIO arms based on safety and clinical benefit. Each arm of the trial will enroll up to 40 evaluable patients.

About THIO

THIO (aka 6-thio-dG, 6-thio-2’-deoxyguanosine) is a first-in-class small molecule that is the only cancer telomere targeting agent currently in development. THIO selectively kills telomerase-positive cancer cells, which account for more than 85% of human cancers. THIO’s activity was shown to be specific to tumor types with active telomerase, an enzyme that is silent in most healthy cells. Telomerase recognizes THIO and selectively incorporates it into the telomeres in tumor cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends, which results in rapid tumor cell death. Low doses of THIO, followed by anti-PD-L1 or anti-PD1 therapy, completely eliminated advanced tumors in pre-clinical models and produced cancer cell-specific immune memory, where the immune system continued to be active against the cancer cells after extended periods of time, with no additional treatment. These results demonstrate how the THIO-produced telomere stress increases innate sensing and adaptive anti-tumor immunity, which provides a strong rationale for sequentially combining telomere-targeted therapy with immunotherapy. THIO is investigational and has not been approved yet for any use by regulatory authorities.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide. It is estimated that, in 2020, more than 2.2 million new cases were diagnosed globally, including 228,000 new cases in the U.S. Approximately 85% of all lung cancers are NSCLC and an estimated 80% of these cases are telomerase positive. While immunotherapies have transformed advanced NSCLC treatment in recent years, there remains a significant unmet need to optimize treatment of patients and offer additional clinical options.

Humanigen to Present at Jefferies Healthcare Conference

On May 19, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported that the Company’s management team will participate in a fireside chat at the Jefferies Healthcare Conference being held from June 1-4, 2021 (Press release, Humanigen, MAY 19, 2021, View Source [SID1234580296]).

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Management will discuss its lead product, lenzilumab, which recently completed a Phase 3 clinical trial of in patients hospitalized with COVID-19, including the publication of the results of the trial and the status of the Company’s submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration, in addition to providing an update on the Company’s commercial preparation efforts for lenzilumab, and an overview of the Company’s other development programs.

Details for the upcoming webcast is below:

Jefferies Healthcare Conference

Live Fireside Chat
Date: Wednesday, June 2, 2021
Time: 4:00 PM ET
Link: View Source

Castle Biosciences to Participate in the Oppenheimer MedTech, Tools, & Diagnostics Summit

On May 19, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported that management will participate in the Oppenheimer MedTech, Tools, & Diagnostics Summit, May 26, 2021 (Press release, Castle Biosciences, MAY 19, 2021, View Source [SID1234580295]). Derek Maetzold, president and chief executive officer, and Frank Stokes, chief financial officer, will provide a pre-recorded investor presentation and will be available for virtual one-on-one investor meetings during the conference.

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Meetings may be requested exclusively through Oppenheimer. The pre-recorded company presentation will be available via the conference site on May 26, 2021, and on the Castle Biosciences website at View Source from May 26 – June 16, 2021.