On November 11, 2021 Lunit reported that it will present three abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held in Washington D.C. and virtually November 10-14, 2021 (Press release, Lunit, NOV 11, 2021, View Source [SID1234595310]). The abstracts feature the predictive power of the company’s AI biomarker platform ‘Lunit SCOPE IO’, which is also on demonstration during the event in its booth #423, Exhibition Hall E.

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As a leading medical AI provider, Lunit focuses on developing the AI biomarker platform Lunit SCOPE IO, which analyzes cancer patients’ tissue slide images and predicts response to immunotherapy. According to the company, Lunit SCOPE IO analyzes a patient’s cancer tissue slide image by observing the distribution of tumor-infiltrating lymphocytes (TIL), one of the representative immune cells, and accurately classifying the result into three immune phenotypes (3-IP; inflamed, excluded, desert).

Lunit’s AI biomarker platform, Lunit SCOPE IO

In the main study presented at SITC (Free SITC Whitepaper) 2021, Lunit SCOPE IO was applied in a phase I/II clinical trial of a TGF-β inhibitor, MedPacto’s vactosertib, in combination with pembrolizumab to treat metastatic colorectal cancer patients. This clinical trial is significant because the novel treatment regimen targets a subpopulation of colorectal cancer patients known to have a very low overall response rate. The regular lack of response to immune checkpoint inhibitors such as pembrolizumab is expected to be overcome via combination with the TGF-β inhibitor vactosertib, changing the biology of the cancer to be responsive to the combination.

According to the study, among the group of patients categorized as high "immune-excluded" by Lunit SCOPE IO, 25% responded to treatment, compared to no response among the group of patients categorized as low "immune-excluded" by Lunit SCOPE IO.

"These results demonstrate that the AI-powered analysis of the immune cells surrounding the cancer is highly predictive of response to immunotherapy, and adds significant evidence to the usefulness of applying this technology in clinical practice to identify the right target patient population," explained Chan-Young Ock, Chief Medical Officer of Lunit.

"This study is also significant because the usefulness of Lunit SCOPE has been successfully demonstrated for combination immunotherapy, in addition to its usefulness for predicting response to monotherapy of immune checkpoint inhibitors, as previously demonstrated in ASCO (Free ASCO Whitepaper) 2019, 2020, 2021 and ESMO (Free ESMO Whitepaper) 2021," added Ock.

In the other two studies, the molecular mechanisms that are associated with Lunit SCOPE IO’s prediction of response to immunotherapy have been demonstrated. According to the studies, the "immune excluded" subpopulation categorized by Lunit SCOPE IO is linked to the APOBEC signature and subclonal tumor heterogeneity, as well as oncogenic PI3K/Akt/mTOR pathway, adding biological plausibility to why Lunit SCOPE IO is highly predictive of response to immunotherapy.

"Over the years we have been validating the predictive power of our AI biomarker through multiple studies and we are excited to present meaningful results at SITC (Free SITC Whitepaper) showing its further potential," said Brandon Suh, CEO of Lunit. "With the official launch of Lunit SCOPE IO for research use approaching within a few months, we hope our AI will contribute to offering optimized treatment to solid tumor cancer patients."

Lunit at SITC (Free SITC Whitepaper) 2021

Exhibition booth: #423, Exhibition Hall E (floor plan)

Poster Title: Spatial analysis of tumor-infiltrating lymphocytes correlates with the response of metastatic colorectal cancer patients treated with vactosertibin combination with pembrolizumab
Abstract number: 823
Session Date/Time: Nov. 12, 7:00 a.m. – 8:30 p.m. ET (on-site) and Nov. 12, 7:00 a.m. ET (ePoster)

Poster Title: Artificial intelligence powered spatial analysis of tumor infiltrating lymphocytes reveals Immune excluded phenotype related to APOBEC signature and clonal evolution of cancer
Abstract number: 830
Session Date/Time: Nov. 13, 7:00 a.m. – 8:30 p.m. ET (on-site) and Nov. 12, 7:00 a.m. ET (ePoster)

Poster Title: Comparison of PI3K/AKT/mTOR Pathway Profiles Amongst Three Immune Phenotypes Classified by Artificial Intelligence-Powered H&E Analyzer in Non-Small Cell Lung Cancer
Abstract number: 921
Session Date/Time: Nov. 12, 7:00 a.m. – 8:30 p.m. ET (on-site) and Nov. 12, 7:00 a.m. ET (ePoster)

On November 11, 2021 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported its third quarter ending September 30, 2021, financial highlights and provided a corporate update (Press release, AIkido Pharma, NOV 11, 2021, View Source [SID1234595309]).

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Highlights

Cash and investments exceeding $104 million reflecting very low cash burn over Q2
Monetization and liquidity event in DatChat representing over 600% ROI
Investment in Tevva Motors electric truck producer, a space with recent Rivian Automotive IPO, ticker symbol RIVN.
Investment in Kerna Health, fast growth tele-health business with recurring revenue and large contract backlog with possible liquidity event in 2022
New investment in Slinger Bag, displaying strong progress and potential near-term monetization
New investment in Kaya Holdings, first U.S. publicly traded company to hold and operate state-issued "touch-the-plant" licenses for the retail, cultivation, and production of cannabis
Anthony Hayes, CEO of AIkido, noted, "We are excited about our current pipeline portfolio, upcoming milestones and pending catalysts. This past quarter showcased our monetization strategy exemplified by a 600% ROI liquidity event in DatChat which went public over the summer. Additionally, we actively invested in several exciting high growth industries such as Electric Vehicles and Tele-health and we continue to actively pursue additional high growth interests with near term monetization events to help enhance shareholder value. We are pleased to also announce today our recent investments in the Cannabis and innovative sports industries that have strong growth potential. We are also working diligently to grow our drug platform through additional licensing efforts and are currently working on partnerships with academic institutions and private enterprise to find, fund and advance new drug compounds that can be brought to commercialization. We continue to maintain an extremely low cash burn and note that our valuation does not currently reflect the value of our assets. With our strong balance sheet, we have pulled our registration statement and we look forward to continued shareholder value creation."

Third Quarter Highlights

DatChat
On August 17, 2021, DatChat closed its initial public offering at an initial offering price to the public of $4.15 per share under the ticker DATS. On September 22, 2021, the Company sold 167,084 shares of DatChat common stock for net proceeds of approximately $0.9 million. As of September 30, 2021, the Company continued to hold 357,916 shares of DatChat valued at approximately $4.9 million.

Tevva Motors
On September 22, 2021, the Company agreed to purchase 29,004 Interests of Tevva Motors for approximately $1.0 million. Subsequently, on September 30, 2021, the Company entered into a second securities purchase agreement to purchase an additional 29,004 Interests of Tevva Motors for approximately $1.0 million. Tevva Motors Ltd is a UK-based, leading developer of modular electrification systems for medium duty commercial vehicles. This is an exciting space, with companies such as Rivian Automotive recently going public with very high valuations.

Kerna Health,
On September 15, 2021, the Company entered into a securities purchase agreement with Kerna Health Inc. Under Agreement, the Company agreed to purchase 1,333,334 shares of common stock of Kerna for $1.0 million. Kerna health is a fast-growing tele-health business with recurring revenue and large contract backlog and has the potential to lead to a liquidity event in 2022.

Slinger Bag
On August 6, 2021, the Company entered into a securities purchase agreement with Slinger Bag Inc. Under the Agreement, the Company agreed to pay $1.4 million to Slinger Bag for the issuance of a convertible promissory note in the principal amount of $1.4 million and a common stock purchase warrant. Slinger Bag which is currently listed on the OTC market under symbol SLBG, is a fast-growing leading connected sports company focused on delivering innovative, game improvement technologies and equipment across tennis and other ball sports.

Kaya Holding Corp
On September 29, 2021, the Company entered into a securities purchase agreement with Kaya Holding Corp. Under the Agreement, the Company agreed to purchase 8,325,000 shares of common stock of Kaya for approximately $0.7 million. Kaya Holding Corp is currently listed on the OTC market under the symbol KAYS and is the first U.S. publicly traded company to hold and operate state-issued "touch-the-plant" licenses for the retail, cultivation and production of cannabis.

Drug Development Pipeline Update
The Company’s pipeline consists of patented technology from leading universities and researchers and is currently in the process of developing its innovative therapeutic drug pipeline through strong partnerships with world renowned educational institutions, including the University of Texas at Austin, the University of Maryland, Baltimore and Wake Forest University.

The Company is also developing a broad-spectrum antiviral platform, in which the lead compounds have activity in cell-based assays against multiple viruses including Influenza virus, Ebolavirus and Marburg virus, SARS-CoV, MERS-CoV, and SARS-CoV-2, the cause of COVID-19.
Convergent Therapeutics
In January 2021, the Company invested in Convergent Therapeutics, which has exclusive rights to technology related to next-generation dual-action peptide receptor radionuclide therapy ("PRRT") for prostate cancer covered by multiple issued U.S. and foreign patents. Convergent is currently conducting advanced human trials relating to prostate cancer treatments utilizing PRRT that targets the prostate-specific membrane antigen ("PSMA") present on prostate cancer cells. The technology was developed under the direction of Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine.

Silo Pharma
In January 2021, the Company entered into an exclusive patent license agreement with Silo Pharma where Silo Pharma granted the Company a worldwide exclusive, sublicensable, royalty-bearing license to certain Silo Pharma owned provisional patent applications directed to the use of psilocybin in cancer treatment. The license is for "Field of Use" of "treatment of cancer and symptoms caused by cancer, including but not limited to pain, nausea, neuroinflammation, brain and neural dysfunction, depression, seizures, confusion, dizziness, numbness/tingling, dysfunction of the senses and all other symptoms that are caused by cancer of any type."

On November 11, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present at the 2021 Jefferies London Healthcare Conference (Press release, Fusion Pharmaceuticals, NOV 11, 2021, View Source [SID1234595308]). A recording of the presentation will be made available for on-demand viewing on Thursday, November 18, 2021 at 8:00am GMT. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

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A webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

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.