On July 26, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the management team will participate in BTIG 2022 Hybrid Biotechnology Conference in August 2022 (Press release, Gracell Biotechnologies, JUL 26, 2022, View Source [SID1234616969]).

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The Gracell team will conduct one-on-one meetings in person on August 8 and virtually on August 9.

On July 26, 2022 Q BioMed, Inc. (OTCQB: QBIO) a commercial-stage biotechnology development company reported a new publication supporting the potential superior safety and efficacy of its Uttroside-B chemotherapeutic to treat liver cancer vs the current first line FDA approved drug (Press release, Q BioMed, JUL 26, 2022, View Source [SID1234616968]).

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Liver cancer incidence rates have more than tripled since 1980, while the death rates have more than doubled during this time. More than 800,000 people are diagnosed with this cancer each year throughout the world and it accounts for more than 700,000 deaths annually. Hepatocellular Carcinoma (HCC) constitutes 90% of all liver cancer incidences, worldwide.

According to Research and Markets, the Global Sorafenib Market was valued at USD 1.08 Billion in 2020 and is projected to reach USD 1.18 Billion by 2027, growing at a CAGR of 1.21% from 2020 to 2027.

We previously reported the remarkable potency of Uttroside-B (Utt-B), against liver cancer cells. Recently, the U.S. FDA approved Utt-B as an ‘orphan drug’ against HCC. The current study validates the superior efficacy of Utt-B over sorafenib, the first-line FDA approved treatment option against HCC liver cancer.

The therapeutic efficacies of Utt-B vs. sorafenib against HCC were compared in vitro, using various liver cancer cell lines and in vivo, utilizing mice bearing human xenografts. The data indicate that Utt-B shows superior anti-HCC efficacy over sorafenib. Our previous report demonstrated the pharmacological safety of Utt-B in Chang Liver, the normal immortalized hepatocytes, and in the acute and chronic toxicity murine models even at high concentrations. Here, data shows that higher concentrations of sorafenib cause severe toxicity in acute and chronic in vivo models, indicating that, apart from the superior therapeutic benefit over sorafenib, Utt-B is pharmacologically safer and the drug-induced undesirable effects can be substantially alleviated in the context of HCC chemotherapy. This study highlights the therapeutic supremacy of Utt-B over sorafenib, the widely administered FDA-approved anti-HCC drug.

Denis Corin, Q BioMed CEO said, "This is another very compelling result and adds weight to the promise of an effective therapeutic for a patient population that desperately needs better and more treatment options. Having successfully completed a very challenging synthesis program, we are now finalizing manufacturing for tox studies, IND and a clinical partnership."

In more detail, researchers demonstrated the superior anti-clonogenic potential and anti-proliferating efficacy of Utt-B against liver cancer cells, compared to sorafenib in vitro. The pro-apoptotic potential of Utt-B is evident from the enhanced cleavage of caspases and significant increase in the percentage of apoptotic cells in Utt-B-treated HCC cells in comparison with sorafenib. Xenograft studies in immunocompromised murine models of human HCC exhibited a significant reduction in tumor development, with negligible side effects, in Utt-B-treated animals, whereas sorafenib treated mice exhibited symptoms of severe toxicity.

Undesirable effects associated with sorafenib chemotherapy is an impending problem in HCC patients. The present study attests to our previous report that Utt-B is pharmacologically safe up to five times the IC50 dose in acute and sub-chronic toxicity models, while even the IC50 dose of sorafenib is toxic to immunocompromised mice, and elevated doses of sorafenib induce adverse effects such as breathing problems, signs of hypertrophy, and mild regenerative changes in liver hepatocytes, in normal immune competent mice.

The researchers highlight Utt-B as a promising anti-HCC drug, owing to its enhanced therapeutic efficacy and pharmacological safety over sorafenib, the first-line treatment option for HCC.

This innovation has been granted a patent from the US, Canada, Japan and South Korea and has been conferred ‘Orphan Drug’ status against HCC by the U.S. FDA.

The research has been led by Dr. Ruby John Anto, a senior investigator at Rajiv Gandhi Centre for Biotechnology (RGCB). Q BioMed has the exclusive license to the technology through an agreement with RGCB and the Oklahoma Medical Research Foundation.

On July 26, 2022 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the second quarter 2022 on Thursday, August 4, 2022, after the close of U.S.-based financial markets (Press release, Nektar Therapeutics, JUL 26, 2022, View Source [SID1234616967]). Howard Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time.

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The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through September 4, 2022.

On July 26, 2022 Generate Biomedicines, whose machine learning-powered generative biology platform can rapidly invent new drugs across a wide range of protein modalities and previously undiscoverable protein therapeutics, reported that Alexandra Snyder, M.D. has been named Chief Medical Officer to oversee all clinical matters (Press release, Generate Biomedicines, JUL 26, 2022, View Source [SID1234616966]).

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"We’re delighted Alex is joining the Generate Biomedicines team as we move our lead programs through IND enabling studies and toward the clinic," said Mike Nally, Generate’s Chief Executive Officer. "Her impressive clinical experience, patient focus, and demonstrated leadership track record are crucial additions to our team as we pioneer the field of generative biology and pursue a broad portfolio of medicines."

Dr. Snyder remarked, "Generate is revolutionizing drug development through a powerful new approach to creating protein therapeutics. I am thrilled to be part of such a talented team that will dramatically improve our ability to solve complex biological challenges and help improve the lives of patients with a broad range of medical conditions."

Most recently, Dr. Snyder was a principal at the private equity firm Two River where she was responsible for setting the translational and clinical strategy and execution for Two River’s portfolio of novel biotech companies. Previously she was the Head of Translational Oncology at Merck. In this role, Dr. Snyder was responsible for conducting Merck-sponsored clinical trials across pipeline combination therapies at worldwide sites and the companion diagnostic strategy, biomarker programs and quantitative pharmacology for oncology clinical trials. Prior to joining industry, she practiced oncology at Memorial Sloan Kettering Cancer Center; she is currently a voluntary faculty member at Bellevue Hospital and New York University.

Dr. Snyder graduated summa cum laude from Princeton University with a degree in history and a minor in music. She received her medical education at Mount Sinai Medical School, graduated with the highest overall standing, and was an internal medicine resident at Mount Sinai Hospital and a medical oncology fellow at Memorial Sloan Kettering Cancer Center.

About Generative Biology

Generative biology represents a fundamental shift in therapeutic development that is driven by machine intelligence. This new approach leaves traditional trial and error methods of drug discovery behind and is ushering in a new era of programmable drug engineering. Rather than "discovering" what’s observable in the lab, Generate Biomedicines is creating therapeutic opportunities by identifying specific biological processes involved in disease that can be modulated with a wide range of protein modalities. The promise of generative biology goes beyond existing proteins found in nature and can generate entirely novel, de novo proteins that are purpose-built to address an existing or emerging therapeutic need. Generative biology will enable therapeutic achievements never before possible, creating entirely new ways to treat all types of diseases, drastically increasing the success rate, and reducing the time required for drug discovery.

On July 26, 2022 Spectrum Solutions, LLC reported the publishing of findings from their research collaboration with the University of California at Los Angeles (UCLA) and Dr. David Wong, UCLA School of Dentistry (Press release, Spectrum Solutions, JUL 26, 2022, View Source [SID1234616965]). The project has successfully demonstrated a superior ability to detect circulating tumor DNA (ctDNA) from saliva. Specifically, amplified EGFR mutations associated with non-small cell lung cancer (NSCLC) using Spectrum’s saliva collection and preservation system with the Electric Field–Induced Release and Measurement (EFRIM) electrostatic platform.

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The BIO Journal is the first journal to provide comprehensive peer-reviewed coverage of biospecimen procurement, processing, preservation, and banking, including ethical, legal, and societal considerations. The published research, "Proficiency Testing of Epidermal Growth Factor Receptor Mutations Detection in Saliva Using Spectrum Saliva Collector (SDNA-1000) and Preservative Solution Detected by Electric Field-Induced Release and Measurement," Feng Li et al, can be found in the Ahead of Print section online and Manuscript ID: BIO-2022-0093 – VOLUME 20, ISSUE 4 / AUGUST 2022.

Most lung cancers (85 percent) fall into the category called non-small cell lung cancer (NSCLC). Though this form of lung cancer progresses more slowly than small cell lung cancer (SCLC), 40 percent of those living with NSCLC will have it spread beyond the lungs by the time it is diagnosed. Many advances in targeted treatments for lung cancer are based on the evaluation of three EGFR gene mutations. Current methods for diagnosis and monitoring include invasive tissue biopsies, which create clinical obstacles for ongoing mutation analysis and cancer treatment. The less invasive liquid biopsy options using free floating cell-free DNA (cfDNA) or circulating tumor DNA (ctDNA) in solid tumor cancers, have quickly become an important part of the screening, diagnosis and monitoring process for cancer patients.

"The ability to detect EGFR mutations using ctDNA enables a broad range of clinical applications for laboratory medicine such as the early detection of disease, practical applications of personalized treatments, predicting treatment response and monitoring resistance," said Rohit Gupta, Chief Medical Officer for Spectrum Solutions. "Proving it can be done using saliva is groundbreaking."

The ctDNA associated with NSCLC, termed ‘ultra-short’ ctDNA (usctDNA), is a third smaller in size than the average fragment. This has made it extremely hard to detect using current liquid biopsy technology, especially without additional amplification. Prior to this study, Wong’s team published on the successful detection of the same usctDNA EGFR mutations from both early and late-stage patients living with NSCLC in both blood and saliva. When paired with new technology developed at UCLA by Dr. Wong, known as EFIRM, study findings have demonstrated an impressive 14-fold amplification of detectable usctDNA from saliva collected and stabilized using Spectrum’s SDNA-1000 compared to raw or neat saliva. Additionally, after diluting the signal down to 10 percent of the original concentration, the team continued to see enhanced amplification benefits from the Spectrum device, leading scientists to believe detection of a single ctDNA fragment may now be possible.

"Achieving detectable concentrations of ctDNA in body fluids is not an easy task. The significance of successfully demonstrating this capability with saliva is the holy grail of liquid biopsy research," said Dr. David Wong, UCLA School of Dentistry. "The discovery delivers, for the first time, a noninvasive opportunity for detection and the ongoing ‘real-time’ understanding of somatic mutation activity to direct and redirect successful treatment strategies."

"Understanding how many face the likelihood of treatment resistance, it is actually life changing to know the results from this research collaboration with Dr. Wong and UCLA has real power to positively impact patient outcomes," said Steve Fanning, CEO of Spectrum Solutions. "For patients, the ability to use the self-collection of saliva empowers a new, safer, easier and pain-free era of detection and treatment innovation with real at-home remote care possibilities."