Sorrento Receives FDA Clearance to Proceed With Clinical Trial for Anti-TROP-2 Antibody Drug Conjugate (TROP-2 ADC) for multiple solid tumors

On October 13, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that its partner Escugen Biotechnology Co, Ltd. ("Escugen") and Sorrento’s subsidiary Levena (Suzhou) Biopharma Co., Ltd. ("Levena") had received an approval letter from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Application for Clinical Trial (Acceptance No. CXSL2101069) of Recombinant Humanized Anti-Trop2 Mab-SN38 Conjugate (Press release, Sorrento Therapeutics, OCT 13, 2021, View Source [SID1234591169]). Today Sorrento announces that the US FDA has given clearance to proceed with clinical trials in cancer patients with relapsed or refractory solid tumors.

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Susan G. Komen® Announces $1.5 Million in Grants for Metastatic Breast Cancer Research

On October 13, 2021 Susan G. Komen, the world’s leading breast cancer organization, reported the awarding of $1.5 million for three new research projects that examine three unique areas focused on metastatic breast cancer (MBC) (Press release, Susan G Komen, OCT 13, 2021, View Source [SID1234591189]). The grants are part of the Susan G. Komen Metastatic Breast Cancer Collaborative Research Initiative, an innovative, first-of-its-kind collaboration between Komen, Duke Cancer Institute and the University of North Carolina Lineberger Comprehensive Cancer Center. The initiative is an effort to pair researchers from each of the organizations to work together to address significant gaps in our knowledge about MBC to advance patient care and improve patient outcomes.

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"We know that finding the cures for breast cancer will only be accomplished by working together through innovative research," said Paula Schneider, Komen’s president and CEO. "It’s this strong belief in the power of collaboration to advance discovery that led to this novel partnership between some of the leading researchers at two institutions that are known for their rivalry."

These three grants fall under Komen’s two primary research priorities, which are to find new ways to prevent, detect, and treat metastatic and aggressive breast cancers, as well as to understand and overcome the inequities that lead certain people and communities to have higher rates of mortality from breast cancer.

"This bold investment by Komen and its supporters is aimed at changing our fundamental understanding of metastatic breast cancer," said UNC Lineberger Director Shelley Earp, M.D. "Combining the creative minds of two of the country’s premier cancer centers is the way to probe the longstanding problem of breast cancer spread. Each of these approaches will yield groundbreaking knowledge to develop better, more effective treatments by harnessing a patient’s own immune system and will identify the biological and societal drivers that contribute to disparities in breast cancer outcomes among Black and white women."

"We are very grateful to Susan G. Komen for their long-term dedication to improving approaches to the prevention, diagnosis and treatment of breast cancer," said Michael B. Kastan, M.D., Ph.D., executive director of the Duke Cancer Institute. "Metastatic breast cancer remains a major challenge and this visionary funding mechanism brings together outstanding investigators and physicians from two neighboring institutions in collaborative projects that will make a difference for women in the state of North Carolina and around the country."

Thanks to a $500,000 lead gift by Blue Cross and Blue Shield of North Carolina (Blue Cross NC), we are able to award the Susan G. Komen and Blue Cross NC Metastatic Breast Cancer Disparities Collaborative Research Grant to:

A research team led by Drs. Jennifer Freedman and Steven Paterno of Duke Cancer Institute, and Dr. Katie Hoadley of the University of North Carolina Lineberger Comprehensive Cancer Center, who were awarded a grant to investigate how the ancestry of different populations impacts the immune response to metastatic breast cancer. The study leaders identified biological differences in certain genetic events (called RNA splicing) in tumors between those with African versus European ancestry. The team seeks to determine if these differences cause breast cancer cells to grow and spread more quickly in patients of African descent and contribute to higher metastasis and death rates among Black women. Improved understanding of these underlying molecular mechanisms may lead the way to better treatments and outcomes.
"We know that the health of our state depends on the health of all our communities – and to improve health equity, we must take a closer look at the factors that drive the disparities between Black women and metastatic breast cancer," said Dr. Kia Williams, associate medical director at Blue Cross NC. "We are excited to support Komen and researchers at UNC and Duke and eagerly await the invaluable scientific contributions to come from this collaborative effort."

Thanks to a $500,000 gift by Gilead Sciences, Inc., we are able to award the Susan G. Komen and Gilead Sciences, Inc. for North Carolina’s Metastatic Breast Cancer Collaborative Research Grant to:

A research team led by Dr. Melissa Troester of the University of North Carolina Lineberger Comprehensive Cancer Center and Dr. Terry Hyslop of Duke Cancer Institute for their project that will seek to use information on tumor biology and social factors in UNC’s long-standing Carolina Breast Cancer Study (CBCS) to understand racial differences in breast cancer metastasis and death. Researchers will also evaluate how life stress contributes to higher metastasis rates and worse breast cancer outcomes in Black women when compared to white women. They aim to develop specific interventions to reduce metastasis that consider multiple factors from basic biology to societal factors in order to improve outcomes for Black women.
"As metastatic breast cancer disproportionately impacts Black women, this innovative research to better understand evidence-based solutions to improve outcomes for Black women is crucial," said Bill Grossman, M.D., Ph.D., Senior Vice President, Oncology Therapeutics, Gilead Sciences. "Gilead is proud to support Susan G. Komen in these much-needed efforts."

Thanks to funds raised by individuals and organizations in North Carolina and across the country, Komen is able to award:

A research team led by Dr. Benjamin Vincent of the University of North Carolina Comprehensive Cancer Center and Dr. Zachary Hartman of Duke Cancer Institute with a $500,000 grant for their project to develop a personalized anti-tumor vaccine strategy for patients with advanced Triple Negative Breast Cancer that would mobilize the body’s immune system (T cells) to shut down tumor growth and metastasis.
Spearheaded by Komen Development Director Pam Kohl, who is living with MBC, the Komen Collaborative Metastatic Research Initiative seeks to raise funds with the hope of accelerating discovery by connecting leading researchers from these two leading institutions. These three grants are the initial awards from this initiative. Those interested in supporting additional collaborations can donate at www.komen.org/mbccollaborative.

"Currently, there is no cure for MBC and the treatments are difficult at best," said Kohl. "Research is HOPE for the far too many of us who are living with MBC. This disease is smart, and it is relentless, but I know that these brilliant researchers at UNC and Duke will work every day to help give us the gift of time."

Twist Bioscience and the Broad Institute Create Custom Whole Exome Target Enrichment Panel for Clinical Research

On October 13, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported an agreement with the Broad Institute for the distribution of a customized next-generation sequencing (NGS) target enrichment exome panel designed for the identification and research of a wide range of cancer, rare and inherited disease genes from patient samples (Press release, Twist Bioscience, OCT 13, 2021, View Source [SID1234591190]). Twist will market this expert-developed exome panel as the Twist Alliance Clinical Research Exome.

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The Twist Alliance Clinical Research Exome helps support the Broad Institute Genomics Platform and was designed using validated data from clinical patient samples. The panel leverages Twist’s flexible NGS platform to easily and quickly customize content, resulting in a comprehensive survey of the exome with supplemental enrichment of clinically relevant areas of the genome related to cancer as well as rare and inherited diseases. By leveraging the best-in-class uniformity of Twist NGS probes, the assay enables a per sample cost and throughput efficiency that Broad has already leveraged to process more than 250,000 samples to date, keeping it on the leading edge of exome sequencing.

"Exome sequencing has long been a key part of our sequencing efforts for large cancer and germline research studies. Our development with Twist has leveraged many of our learnings on the technical side and pulls in knowledge from collaborating investigators to provide an enhanced exome that will increasingly span both research and clinical applications in which results are returned to patients" said Stacey Gabriel, senior director of the Broad Institute Genomics Platform.

The Twist Alliance Clinical Research Exome will be available for customers in mid-October. The full design of this panel includes the Twist Core exome, the mitochondrial genome, and additional validated coding and non-exonic regions of interest such as the ACMG73 genes, supplemental coverage of regions from OMIM and COSMIC, and specific Broad-defined targets. To see Broad’s Director of Genomics Research and Development Brendan Blumenstiel presenting data on the panel, visit: View Source

"Typically, in cancer research studies, there is a great need to focus sequencing efforts on particular genes or mutations but often with a small number of samples available. Leveraging the Broad’s vast expertise, together we have developed a specialized custom panel that enables deeper sequencing, producing validated genetic variants that could be used for therapeutic intervention," said Emily M. Leproust, PhD, chief executive officer and co-founder of Twist Bioscience. "We are thrilled to bring this important tool to our customers to drive deep insights into research and potentially therapeutic development."

About Twist Alliance Panels

In partnership with leading research institutions from around the world, Twist has curated a collection of high-quality target enrichment panels for applications ranging from carrier screening to cancer diagnostics and whole exome sequencing. The Twist Alliance Panels combine the strengths of precise, highly uniform oligonucleotide synthesis with the specialty expertise of leading scientific research partners.

Well designed, custom target enrichment panels enable increased sequencing depth on target genes while reducing overall

FDA-Approved Drugs’ promises

On October 13, 2021 University of Zurich reported that discovered that antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), could slow pancreatic and colon cancer growth in mice (Press release, University of Zurich, OCT 13, 2021, View Source [SID1234591412]). Furthermore, in some cases, when antidepressants are combined with immunotherapy, the tumor could entirely disappear.

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Selective serotonin reuptake inhibitors 2016
Because the drugs the researchers used in their study are already FDA-approved, they could rapidly be available for cancer patients if human clinical trials confirmed the findings from the animal studies. The study was published in Science Translational Medicine.

Another animal study led by a team from the University of British Columbia showed that a drug used in cancer care could reinstate memory in mice with Alzheimer’s disease.

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The drug named Axitinib is FDA-approved to treat cancer. However, clinical trials are needed to see if the drug will show the same promising results in humans. The study was published in The Lancet.

Lixte Biotechnology Announces Collaboration with Netherlands Cancer Institute (Amsterdam) and Oncode Institute (Utrecht) to Identify the Most Promising Drug Combinations for its Lead Clinical Compound, LB-100, for Cancer Treatment

On October 13, 2021 Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT) reported entry into a collaboration with the Netherlands Cancer Institute, Amsterdam (NKI) , one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations (Press release, Lixte Biotechnology, OCT 13, 2021, View Source [SID1234591171]).

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The pre-clinical studies are directed by Professor René Bernards (NKI), a leader in using genome wide functional genetic techniques to identify effective drug combinations, new drug targets, and mechanisms of resistance to cancer drugs. Using this technology, prof. Bernards’ group identified the now FDA-approved combination of BRAF and EGFR inhibitors for a group of colon cancer patients (Nature 483, 100-103, 2012), and more recently reported the identification of a new two drug regimen for liver cancer, which in preliminary Phase 1 clinical trials appears to be more active than standard therapy (Nature 595, 730–734, 2021).

Dr. John S. Kovach, CEO and founder of Lixte, said "We are extremely pleased to have the opportunity to collaborate with Professor Bernards and his excellent group. There are many pre-clinical studies demonstrating the ability of our lead compound, LB-100, an inhibitor of protein phosphatase 2A, to potentiate the activity of different cytotoxic drugs. Its ubiquitous activity and low toxicity have made it challenging to select the most promising clinical targets for this novel compound. A targeted approach to cancer treatment has been a long-standing research goal. Prof. Bernards’ approach makes it possible to select among a multitude of compounds those most likely to be effective when combined with a second drug and/or in cancers with a particular molecular abnormality. The possibility of identifying which drug in combination with LB-100 and in which type of tumor is most likely to be beneficial is a very exciting prospect."

Professor Bernards commented, "We are excited to work with Lixte to identify the most powerful drug combinations of LB-100 for cancer therapy. Our unbiased genetic approach to identify synthetic lethal drug targets of LB-100 has proven its utility in our previous studies."