Grid Therapeutics Initiates a Phase 2 Investigator-Sponsored Trial of GT103 in Combination with Merck’s Pembrolizumab in Patients with Advanced Stage Non-Small Cell Lung Cancer

On February 22, 2023 Grid Therapeutics, LLC, a clinical stage biotechnology company developing human-derived antibodies, reported the initiation of a combination Phase 2 investigator-sponsored study of its lead asset, GT103 (Press release, Grid Therapeutics, FEB 22, 2023, View Source [SID1234627739]). In this clinical trial, Grid’s GT103, a novel, first-in-class antibody targeting complement factor H, will be administered in combination with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. The trial will enroll patients with refractory non-small cell lung cancer ("NSCLC") who have progressed on no more than two lines of systemic therapy, including prior PD-1 treatment.

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"We are very excited to initiate this study to determine whether the therapy demonstrates clinical activity and tolerability observed in patients with advanced stage lung cancer in the Phase 1b study of GT103 alone"

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In this open-label, multi-center, single-arm Phase 2 clinical trial, Merck and Grid are each providing their respective drugs and funding support. This study is led by Jeff Clarke, M.D, member of the Duke Cancer Center Thoracic Clinic, Durham, NC. The study is managed by the Hoosier Cancer Research Network, a full-service contract research organization dedicated to providing efficiency and expertise in clinical trial services.

"We are very excited to initiate this study to determine whether the therapy demonstrates clinical activity and tolerability observed in patients with advanced stage lung cancer in the Phase 1b study of GT103 alone," said Dr. Clarke. "NSCLC is a difficult-to-treat cancer and patients, particularly in the relapsed/refractory setting, will benefit from novel therapeutic options to help improve disease outcomes."

About the Study

The Phase 2 open-label, clinical trial of GT103 is designed to assess the safety and tolerability of GT103 in combination with Merck’s pembrolizumab, as well as anti-tumor activity, response rates and overall survival. The study will enroll subjects with refractory NSCLC. Please refer to www.clinicaltrials.gov for additional clinical trial details.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

United Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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Capstan Therapeutics to Participate in Cowen 43rd Annual Health Care Conference

On February 22, 2023 Capstan Therapeutics, Inc., a biotechnology company dedicated to advancing in vivo reprogramming of cells through targeted lipid nanoparticles, reported that Capstan President and Chief Executive Officer, Laura Shawver, Ph.D., will participate in the upcoming Cowen 43rd Annual Health Care Conference, being held between March 6-8, 2023 at the Boston Marriott Copley Place in Boston, MA (Press release, Capstan Therapeutics, FEB 22, 2023, View Source [SID1234627555]).

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Capstan will be hosting one-on-one meetings with investors on Monday, March 6.

Aadi Bioscience to Present at the 43rd Annual Cowen Healthcare Conference

On February 22, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported participation at the 43rd Annual Healthcare Conference being held March 6-8, 2023, in Boston, MA (Press release, Aadi Bioscience, FEB 22, 2023, View Source [SID1234627554]).

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Brendan Delaney, Aadi Bioscience CEO, will join in a panel discussion entitled, "Tumor Agnostic Development," on Wednesday, March 8, 2023 at 9:10 AM ET. Company management will also participate in one-on-one meetings with investors during the conference.

The panel presentation will be webcast live on the IR pages of the Aadi Biosciences website and will be available for replay for approximately 30 days following the presentation.

Impact Biomedical and Global Research and Discovery Group Announce the Completion of Phase One of The Bne-1 Cancer Suppression Monoclonal Antibody Project

On February 22, 2023 Impact BioMedical and its research partner Global Research and Discovery Group reported that they have finished the first phase of a groundbreaking project that could give humans the edge over cancer (Press release, Impact BioMedical, FEB 22, 2023, View Source [SID1234627553]).

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The BNE-1 Antibody Project is the next evolutionary step of cancer research, seeking to develop cancer-suppressing antibodies that would give the human body the ability to not only fight against most cancers, but win.

Impact BioMedical and GRDG researchers said that they had successfully completed cloning three new antibody libraries and will now move ahead to advanced "tumor-killing assays" to determine the scope of efficacy against most of the cancers that are available for analysis.

"I am very pleased that we now have the antibodies successfully cloned, stable in stasis and look forward to beginning the second phase of this work," said Daryl Thompson, Director of Scientific Initiatives at Global Research and Discovery Group. "As we progress, this research will give us new insights on not only the ways of fighting cancer, but also how the human body can respond and thrive in the face of threats."

The BNE-1 Antibody Project got its genesis in a previous cancer-fighting effort, the CRST-1 Project. The earlier research focused on developing a natural, cancer-fighting drug, which inspired by a friendship between Thompson and Marco Island native Christy Bastian.

Thompson met Christy Bastian in August 2020 through a mutual friend and the two sparked a friendship. When they met, Bastian was in her second cancer battle. She had fought breast cancer into remission in 2012, but was stricken with a rare and aggressive cancer in 2020 when she met Thompson. Despite her decade-long cancer battles, she had maintained a positive attitude, but the fight had taken its toll, she told Thompson.

Her resolve to fight struck a chord with Thompson, who reasoned that instead of focusing on a person’s will to fight, why not focus on cutting cancer’s ability to attack.

"I was literally sitting there listening to someone tell their story about how they’re dealing with cancer, and I realized that it’s not how hard you punch, but maybe it’s more just a will to fight?" said Thompson. "If her will to fight is working for her survival, what if we could take that away cancer’s ‘will to fight’, its tenacity. That’s Pim."

Pim (proviral integration site for moloney murine leukemia virus) according to the National Institutes of Health, plays a key role in the expression or activation of several cancers. According to Thompson, PIM is what stimulates a cancer cell’s ability to fight against drugs that are designed to kill it. Shutting down PIM will shut down cancer’s ability to live.

That work led to the identification of the molecule that assists in inhibiting Pim, CRST-1 — named after Christy Bastian.

"When Daryl told me about the concept of the CRST-1, and how he came to that name, I was honored," said Bastian. "To be affiliated with the initial research and to now to see how this next evolutionary phase develops gives me hope that one day cancer will be a thing of the past."

CRST-1 is a non-toxic treatment that has no side effects. It is designed to accompany traditional cancer treatments to increase the effectiveness of the drugs used. It was shown to inhibit PIM 1 and PIM 3 respectively in cell phosphorylation assays.

"The CRST-1 project yielded an important drug discovery," said Thompson. "The current BNE-1 project is the next step from CRST-1, to develop cancer-suppressing antibodies."

And as with the CRST-1 Project, which is named after Christy, the BNE-1 Project is named in honor of a friend’s wife who passed from cancer, Bonnie.

"This research is personal for me, and the development of these new strategies should be personal for anyone who knows or has known someone who has fought this disease," said Thompson.

The impact of this research could also have a global impact, according to Roscoe Moore, GRDG Chief Scientific Advisor Dr. Roscoe M. Moore, Jr., the retired United States Assistant Surgeon General and former Epidemic Intelligence Services (EIS) Officer at the U.S. Centers for Disease Control.

"This line of research represented in BNE-1 Project is important because it is based in naturally-occurring phenomena and, as such, is easier to replicate around the world, especially in places where advanced medical cancers therapies are not readily available," said Moore.

The announcement of a successful end of the first phase of research is relevant as it comes on the edge of the Marco Island "Imagination Ball" held later this month at the JW Marriot as a fundraiser for the American Cancer Society. The CRST-1 project — and Christy Bastian’s story — was first revealed at the Imagination Ball several years ago at the Project’s inception.

"I am especially fond of the Imagination Ball, as I have always considered Marco Island and the Everglades home," said GRDG’s Thompson. "I view this current BNE-1 project and as one of our most challenging but important projects in part because it was inspired and conceptualized at Marco Island, which I find endearing."