On November 11, 2021 In partnership with the VA Palo Alto Health Care System, precision oncology company Lucence reported that it is launching its first early detection study in the United States evaluating the use of its liquid biopsy technology in a screening context (Press release, Lucence, NOV 11, 2021, View Source [SID1234595307]). The study, led by Rajesh Shah, MD, of the VA Palo Alto Healthcare System and Stanford University, will test the feasibility of using non-invasive liquid biopsy in patients at high-risk for lung cancer as a screening tool in combination with positron emission tomography–computed tomography (PET/CT).

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The prospective, observational study, Liquid Biopsy in Combination with PET/CT Versus PET/CT alone in Diagnosis of Small Lung Nodules will compare the sensitivity and specificity of PET/CT in combination with liquid biopsy in detecting lung cancer in nodules six to 20 millimeters in size compared to PET/CT alone. The study will enroll high-risk patients who have at least one lung nodule deemed suspicious for cancer. Secondary endpoints include sensitivity and specificity of ctDNA genotyping and sensitivity and specificity of DNA methylation in detecting lung cancer. DNA methylation has emerged as a promising biomarker for early detection of lung cancer.

"Lung cancer is more prevalent among Veterans, but outcomes are better if cancer is detected earlier. There is a significant unmet need for a cost-effective, noninvasive assay to better identify patients with lung cancer, especially among Veterans," said Dr. Rajesh Shah, MD, Director of Interventional Radiology and Associate Chief of Radiology at the VA Palo Alto Health Care System and the study’s Principal Investigator.

Lung cancer is the second most diagnosed cancer and the most common cause of cancer-related deaths in the United States. Early detection of lung cancer has been shown to reduce mortality by 20%. The current standard of care for screening individuals at high risk of lung cancer is low dose computed tomography followed by additional invasive testing, such as percutaneous biopsy, bronchoscopy, or surgical procedure, if nodules are present. The expansion in early screening has led to an increase in patients with false positives who must then undergo uncomfortable and potentially complicating invasive tissue biopsies. A sensitive and specific non-invasive blood test for lung cancer screening could reduce costs and morbidity associated with unnecessary biopsy. This study is a significant step towards determining the feasibility of that approach on a large scale.

"A non-invasive liquid biopsy screening test that enables physicians to eliminate unnecessary invasive tests could both improve outcomes and the patient experience while reducing costs," said Min-Han Tan, MBBS, PhD, Founding CEO of Lucence. "We are excited to initiate this study —the first study examining the use of Lucence’s AmpliMark technology for early detection of cancer in the United States—with the VA Palo Alto Health Care System to continue to develop evidence for liquid biopsy’s utility across the patient journey. We are proud to be partnering with Dr. Shah and the VA Palo Alto to serve such an important population."

Earlier this year, Lucence launched LIQUIK, Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients With Advanced Non-Small Cell Lung Cancer, examining the use of the company’s amplicon-based LiquidHALLMARK liquid biopsy assay versus tissue biopsy in detecting guideline-recommended biomarkers in lung cancer. LiquidHALLMARK is currently available to US oncologists as a laboratory developed test.

On November 11, 2021 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported it has launched Lucid Test Centers in three new metropolitan areas—Denver, Salt Lake City, and Las Vegas. Patients in these cities with chronic heartburn, also known as gastroesophageal reflux disease ("GERD"), who are referred by their primary care physician (PCP) or who self-refer can now undergo a rapid, non-invasive, office-based test to detect esophageal precancer before it progresses to deadly esophageal cancer (Press release, Lucid Diagnostics, NOV 11, 2021, View Source [SID1234595306]). The test centers are staffed with Lucid-employed clinical personnel who use Lucid’s EsoCheck Cell Collection Device ("EsoCheck") to collect surface esophageal cells which are sent for Lucid’s EsoGuard DNA Esophageal Test ("EsoGuard"). Lucid believes EsoGuard and EsoCheck constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths, through the early detection of esophageal precancer in at-risk GERD patients.

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"This launch represents another significant milestone for Lucid and our EsoGuard commercialization efforts"

"This launch represents another significant milestone for Lucid and our EsoGuard commercialization efforts," said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. "The Lucid Test Center program, an important pillar of our growth strategy, has now advanced from a pilot program in Phoenix to a regional program covering the major cities of the Southwest. We look forward to the next phase which will focus on the Pacific Northwest and steady expansion nationwide thereafter."

"We believe these Lucid Test Centers will play a vital role in driving EsoGuard referrals, as the vast majority of GERD patients are cared for by PCPs, not gastroenterologists. Our Phoenix experience over the past three months has demonstrated that each test center can be operated with very modest fixed costs and attractive margins. We also learned that the key to driving PCP EsoGuard referrals is matching each test center with experienced, highly-driven sales representatives, most commonly from the diagnostics or pharmaceutical sectors, who exclusively call on PCPs," Dr. Aklog added.

The new Lucid Test Centers operate in leased medical office suites located in Lone Tree, Colorado, Murray, Utah, and Henderson, Nevada. Each test center is staffed by an EsoCheck-trained nurse practitioner and medical assistant employed by Lucid. Lucid estimates that a single nurse practitioner can perform up to twenty EsoCheck procedures per day and expects each center to cover its personnel and medical office leases costs with only a few tests per week.

Lucid has hired six very experienced sales representatives targeting PCP’s—two for each metropolitan area. The test centers will also support the upcoming EsoGuard Telemedicine Program, operated in partnership with independent third-party telemedicine provider UpScript, to accommodate EsoGuard self-referrals from direct-to-consumer marketing. The telemedicine program will soon launch as a pilot in Phoenix and similarly expand to other test center cities.

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer (EAC). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment. The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard is that missing element.

EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer. EsoGuard is commercially available in the U.S. as a Laboratory Developed Test (LDT) performed at a CLIA/CAP-certified laboratory.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.

On November 11, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that completed a Type B Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant (Press release, Gamida Cell, NOV 11, 2021, View Source [SID1234595304]). The FDA requested that Gamida Cell provide revised analysis of the manufacturing data generated at Gamida Cell’s wholly-owned commercial manufacturing facility to demonstrate the comparability to the omidubicel that was produced at the clinical manufacturing sites for the Phase 3 study. The FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated. The company will continue to work collaboratively with the FDA and anticipates submitting the BLA in the first half of 2022 in lieu of the company’s previous plan to submit the BLA by the end of 2021.

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"Despite the delay in timing to bring omidubicel to patients after a potential FDA approval, we are encouraged by the FDA’s reaction to our Phase 3 data as the pivotal trial of omidubicel. We have gained further clarity with the FDA on the requirements for demonstrating comparability for our commercial manufacturing facility," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "With the FDA’s feedback in hand, we believe that we are one step closer for omidubicel to be made available to patients in need."

Omidubicel, an investigational advanced cell therapy for allogeneic bone marrow transplant

Omidubicel is the foundational product based on Gamida Cell’s proprietary NAM-enabled cell expansion technology. It is the first cell therapy for bone marrow transplant to receive Breakthrough Therapy Designation from the FDA. The BLA submission will be based on the results of an international, randomized Phase 3 study of omidubicel that was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to patients who received a standard umbilical cord blood transplant. The study achieved its primary endpoint, a statistically significant reduction in time to neutrophil engraftment, as well as all key secondary endpoints. A key milestone in a patient’s recovery, neutrophil engraftment is a measure of how quickly the stem cells a patient receives in a bone marrow transplant are established and begin to make healthy new cells. In the Phase 3 study, the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001). Additionally, the study met key secondary endpoints related to the speed of platelet engraftment, decrease in infections and reduction in hospitalizations, all significant clinical measures in bone marrow transplant.

On November 11, 2021 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that 4D pharma management will participate in the Jefferies London Virtual Healthcare Conference, being held November 18-19, 2021 (Press release, 4d Pharma, NOV 11, 2021, View Source [SID1234595303]).

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On November 11, 2021 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) Platform, reported a Series B funding round of $50 million driven by a syndicate of private investors, including Juan Jaen, Ph.D., President of Arcus Biosciences and Bill Rieflin, Executive Chairman of the Board at NGM Biopharmaceuticals (Press release, Shasqi, NOV 11, 2021, View Source [SID1234595302]). The funds will be used to advance the Phase 1/2 clinical study of SQ3370 for the treatment of injectable, advanced solid tumors, and will enable Shasqi to expand its click chemistry platform to create therapeutics that do not require intratumoral injections.

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"Data from our lead program shows us that click chemistry works in humans and the early validation gives us even greater confidence in our approach. This round of financing will enable us to advance SQ3370 through clinical development, while simultaneously advancing multiple next-generation click chemistry programs, beginning with an antibody-directed program that will unlock the potential of click chemistry to target tumors that cannot be reached with injections, significantly expanding our platform," said José M. Mejía Oneto, M.D., Ph.D., founder and CEO of Shasqi. "We expect this expansion to open up the path for the platform to antibody-based approaches, immune cell engagers, radiopharmaceuticals and more. We thank all of our investors for their continued support and enthusiasm."

"Shasqi’s approach enables us to look across the spectrum of the industry’s most powerful tumor killing therapies with a new lens," said Dr. Jaen. "The next iterations of the technology will enable Shasqi to use even more powerful payloads and localize drugs at tumors that cannot be injected. There is an enormous opportunity to dramatically improve the efficacy of powerful therapies by localizing them, which could help increase the number of patients who benefit. I look forward to supporting the company’s progress, given the platform’s potential to transform the treatment landscape and patients’ lives."

Mr. Rieflin commented, "The Shasqi team has parlayed $18 million into an ongoing Phase 1/2 clinical study of SQ3370 and a click chemistry platform that is poised for expansion into antibody-based and other targeted modalities. I’ve been impressed with the dedication and capital efficiency of the team and can’t wait to see what’s possible with the proceeds of this Series B financing."

Shasqi plans to initiate two development programs over the next two years and explore a variety of other approaches in partnership with industry leading oncology companies.

With SQ3370, Shasqi advanced the first click chemistry-based therapy into human clinical studies. Interim clinical data from the Phase 1 clinical study of SQ3370, Shasqi’s lead program, in advanced sarcomas and other solid tumors, was presented earlier this year at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and will be presented at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)s (SITC) (Free SITC Whitepaper) 36th Annual meeting. The data provides initial validation for Shasqi’s platform, demonstrating an encouraging safety profile and early signs of clinical activity. Based on this data, Shasqi plans to begin a Phase 1 expansion cohort of its clinical study of SQ3370 for the treatment of soft tissue sarcoma in patients who are unable to tolerate chemotherapy in Q1 2022 and expects to share pharmacokinetic and biomarker data by Q2 2022. In 2022, Shasqi is planning to initiate a Phase 2 registration study of SQ3370.

About CAPAC and SQ3370:
SQ3370 is the first click chemistry-based treatment to be tested in humans, and utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the site of the tumor. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing drugs and various modalities that have a limited therapeutic window.