On March 23, 2022 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 that it has launched Lucid Test Centers in three new metropolitan areas—Seattle, Washington, Portland, Oregon, and Boise, Idaho. Patients in these cities with chronic heartburn, also known as gastroesophageal reflux disease ("GERD"), and an order from their own physician or from a telemedicine physician provided to them after self-referral, can now undergo a brief, non-invasive, office-based test to detect esophageal precancer before it progresses to deadly esophageal cancer (Press release, Lucid Diagnostics, MAR 23, 2022, View Source [SID1234610759]). The test centers are staffed with Lucid-employed nurse practitioners 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 important milestone for Lucid and our EsoGuard commercialization efforts"

"This launch represents another important milestone for Lucid and our EsoGuard commercialization efforts," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "We now have completed the first stage of our Lucid Test Center program, an important pillar of our growth strategy—with test centers in seven metropolitan areas in the Southwest and Pacific Northwest".

"Our experience since the launch of our first test center in Phoenix, approximately six months ago, has validated our commercial strategy, which places a strong emphasis on driving primary care physician (PCP) orders for EsoGuard testing at Lucid Test Centers. During this period, we have honed our sales processes and training programs to drive this strategy. We are well positioned to proceed to the next stage of our Lucid Test Center program, with accelerated expansion into larger states across the nation. We have built a robust compliance program which allows us to proceed with this expansion, including in states with more complex laboratory regulations," Dr. Aklog added.

The new Lucid Test Centers operate in leased medical office suites located in Seattle, Washington, Portland, Oregon, and Boise, Idaho. 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. Each test center will initially be supported with two highly experienced sales representatives targeting PCPs. The test centers will also support Lucid’s EsoGuard Telemedicine Program, operated in partnership with independent third-party telemedicine provider, UpScript, to accommodate EsoGuard self-referrals.

About EsoGuard and EsoCheck

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 and EsoCheck are the missing element and 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.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which 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.

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 March 23, 2022 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported an overview of its innovative pipeline with a focus on five mid- to late-stage assets with first-in-class and/or best-in-class potential at its R&D Update Call (Press release, Merck KGaA, MAR 23, 2022, View Source [SID1234610758]).

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"At Merck KGaA, Darmstadt, Germany we are working to translate our extensive expertise and deep knowledge in key tumors and neurological and immunological diseases with a goal to change treatment paradigms and improve patient outcomes," said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck KGaA, Darmstadt, Germany. "With evobrutinib, xevinapant, and berzosertib, we have the opportunity to be not only first-in-class, but potential game-changers in how we treat MS, head & neck cancer and small cell lung cancer going forward."

Advancing Assets with Transformational Potential

Evobrutinib (BTK inhibitor) – A pioneering development program with a new mechanism of action (MoA) for the treatment of patients with relapsing multiple sclerosis (RMS) that has the potential to change the standard of care.

Oral, central nervous system (CNS)-penetrant, covalent Bruton’s tyrosine kinase inhibitor (BTKi) in development for RMS.
MoA combines potent B-cell inhibition to target acute inflammation (associated with relapses) with a central effect on microglia that aims to reduce chronic inflammation (associated with disease progression).
Comprehensive Phase II clinical data support best-in-class potential.
Evobrutinib is the first BTKi to have completed enrollment of the Phase III clinical trial program for relapsing multiple sclerosis, with data readout expected in Q4 2023.
Xevinapant (IAP antagonist) – As a potent oral antagonist of Inhibitor of Apoptosis Proteins (IAP) and the only IAP antagonist in late-stage development, xevinapant builds on our market-leading expertise in squamous cell carcinoma of the head and neck (SCCHN), aimed at maximizing the chances of a cure in locally advanced disease setting.

Ongoing Phase III TrilynX study for previously untreated unresectable locally advanced (LA) SCCHN in combination with platinum-based chemoradiotherapy.
Second global Phase III study to be initiated in the first half of 2022 to evaluate xevinapant in patients with cisplatin-ineligible LA SCCHN.
5-year update of OS data from Phase II study anticipated in 2022.
First launch expected in 2025.
Berzosertib (ATR inhibitor) – The lead candidate in our DNA Damage Response (DDR) inhibitor portfolio and the first ATR inhibitor with positive randomized clinical trial in any tumor type, seeks to exploit the synergistic effect of combining ATR inhibition with topoisomerase I inhibitors

Multiple mid-stage clinical trials in small cell lung cancer (SCLC) build on positive Phase II study results, with the goal of establishing a new standard of care in second-line SCLC.
Study planned for indication expansion in ovarian cancer and potentially in refractory GI cancers.
M1231 (MUC1/EGFR bi-specific ADC) – The first bi-specific ADC (antibody-drug conjugate) from our pipeline that aims to optimize targeting of cancer cells and overcome remaining safety limitations of conventional ADCs.

M1231 delivers a cytotoxic payload to tumor cells expressing both MUC1 and EGFR and has a highly controlled drug-antibody ratio, which is anticipated to increase tumor specificity, selectivity, and efficacy.
Phase I clinical study to characterize the safety and preliminary activity is well underway, and efficacy expansions into late-stage non-small cell lung cancer and esophageal squamous cell carcinoma are expected to begin in 2022.
Enpatoran (TLR7/8 inhibitor) – Oral therapy that aims to overcome limitations of available lupus therapies by providing selective inhibition of lupus-relevant disease drivers, which may increase efficacy while preserving immunity against infections.

Highly specific potential first-in-class immune modulator blocking the activation of Toll-like receptor (TLR)7 and TLR8, known to be activated in lupus.
Initiation of Phase II studies in systemic lupus erythematosus (SLE) / cutaneous lupus erythematosus (CLE) in the first half of 2022.
Advancing the broader pipeline and portfolio

Merck KGaA, Darmstadt, Germany will initiate 11 new studies in 2022 across the early- and late-stage pipeline, including a Phase III confirmatory study with tepotinib in EGFRm MET amplification in NSCLC, five proof-of-concept studies including trials of M1774, an oral ATR inhibitor being evaluated as both a monotherapy and in combination with PARP inhibitors; the JAVELIN Bladder Medley umbrella study in the first-line urothelial carcinoma, combining avelumab with novel investigational agents including our anti-TIGIT M6223 and Nektar Therapeutics’ interleukin-15 (IL-15) receptor agonist, NKTR-255, in the maintenance setting; two first-in-human studies involving M9140, a next-generation ADC based on an internally developed linker-payload technology; and M1069, our dual adenosine receptor antagonist.

"Our rapidly progressing pipeline of in-house–discovered and partnered assets with first-in-class potential demonstrate the deep expertise and collaborative mindset of our R&D organization," said Joern-Peter Halle, Global Head of Research for the Healthcare business of Merck KGaA, Darmstadt, Germany. "We expect exciting new entries and substantial advances of our early- and late-stage pipeline in the next few years."

To access the presentation and a recording, please visit the Company’s website at View Source

Merck KGaA, Darmstadt, Germany’s Commitment to Cancer

Merck KGaA, Darmstadt, Germany is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer. Our oncology research efforts aim to leverage our synergistic portfolio in oncogenic pathways, immuno-oncology, and DNA Damage Response (DDR) to tackle challenging tumor types in gastrointestinal, genitourinary, and thoracic cancers. Our curiosity drives our pursuit of treatments for even the most complex cancers, as we work to illuminate a path to scientific breakthroughs that transform patient outcomes. Learn more at View Source

Merck KGaA, Darmstadt, Germany in Neurology and Immunology

Merck KGaA, Darmstadt, Germany has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS – Rebif (interferon beta-1a) and MAVENCLAD (cladribine tablets). Merck KGaA, Darmstadt, Germany aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to KGaA, Darmstadt, Germany`s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have the potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE).

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On March 23, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported it is presenting new data in scientific posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, which will be held in-person and online, April 8-13, 2022 (Press release, Personalis, MAR 23, 2022, View Source [SID1234610757]).

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"These abstracts demonstrate the full range of our capabilities in advancing the field of oncology, from a rich understanding of molecular-level interactions through clinical applications in multiple disease indications. The work also builds on the company’s strong foundation of genomic data generated with solid tumor tissue and expands into liquid biopsy with a unique, exome-wide approach," said Richard Chen, M.D., Chief Medical Officer and SVP of R&D of Personalis.

Personalis is presenting five posters, outlined below. Further details can be found at this link.

Title: Applying NeXT Liquid Biopsy, an exome-scale platform, to monitor and discover somatic variants in a broad set of cancer types
Overview: Circulating tumor cell-free DNA (ctDNA) has become a biomarker for prognosis and disease monitoring. However, studies typically utilize assays limited to a small set of genes that may miss biologically important and clinically actionable mutations. To address this limitation, we have developed a whole-exome scale cfDNA platform, NeXT Liquid Biopsy, that enables sensitive detection and tracking of somatic mutations in plasma samples across ~20,000 genes. The NeXT Liquid Biopsy platform monitors tumor variants and discovers novel mutations in the plasma, through analysis of tumor, normal and plasma samples from the same patient. The NeXT Liquid Biopsy platform enables the identification of somatic variants in liquid biopsy samples, following interventions such as surgery and treatment therapies. Here, we have applied NeXT Liquid Biopsy to profile the shedding of somatic mutations from more than 100 pan-cancer patients on an exome scale, detecting variants in well-characterized cancer driver genes and many events outside of traditional panel footprints.

Title: Accurate quantification of infiltrating B cell composition and clone diversity in tumor samples
Overview: The role of B cells as a prognostic biomarker remains elusive. For instance, infiltrating B cells in colorectal cancer have both positive and negative prognostic value. Thus, a scalable approach to quantify B cells and the B-cell receptor repertoire could yield novel insights into the role of B cells in tumor biology. To address this, we have developed immune cell quantification (InfiltrateIDTM) and immune receptor repertoire profiling (RepertoireIDTM) methods as part of the ImmunoID NeXT Platform, an augmented, immuno-oncology-optimized exome/transcriptome platform. We show that InfiltrateID and RepertoireID accurately capture the composition and clone diversity of infiltrating B cells in tumor samples. Furthermore, we apply the two methods to explore B cell infiltration and BCR repertoires across a set of more than 650 pan-cancer samples.

Title: Exome-scale longitudinal tracking of emerging therapeutic resistance in GIST via analysis of circulating tumor DNA
Overview: Gastrointestinal stromal tumors (GIST) are lethal tumors characterized by constitutively activating mutations to KIT or PDGFRA. Transient disease control in the first-line setting is achieved via inhibition of tyrosine kinase signaling using the KIT inhibitor imatinib. As patients progress through subsequent lines of therapy, a molecularly heterogeneous disease evolves, characterized by distinct subtypes and shifting repertoires of exon-specific KIT variants that directly impact treatment outcomes. This study uses tumor-informed exome-scale liquid biopsy to identify and track the evolution of multiple resistance mechanisms in patients receiving tyrosine kinase inhibitors (TKIs) to address the unmet need of comprehensive understanding of GIST evolution in response to therapy.

Title: A high sensitivity, tumor-informed liquid biopsy platform, designed to detect minimal residual disease at part per million resolution
Overview: Tumor-informed liquid biopsy approaches have proven promising for detecting minimal residual disease (MRD) and recurrence of cancer following surgical resection or other therapy. However, current liquid biopsy MRD assays typically detect ctDNA in a range above 30 to 300 parts per million (PPM), leaving a significant fraction of MRD cases undetected, particularly soon after surgery and in early-stage cancers where ctDNA can be at very low levels. To address this, Personalis has developed NeXT Personal, a tumor-informed liquid biopsy assay that achieves sensitivity down to 1 PPM, therefore enabling earlier detection of MRD and recurrence.

Title: Mono-allelic immunopeptidomics data from 109 MHC-I alleles reveals variability in binding preferences and improves neoantigen prediction algorithm
Overview: This study extends the previously published MHC-I, pan-allelic neoantigen prediction algorithm, SHERPA, with immunopeptidomics from 84 additional mono-allelic transfected cell lines, totaling data from 109 unique alleles. SHERPA achieves model generalizability and 98% population allelic coverage by integrating nearly 500 additional public immunopeptidomics samples. As a result, SHERPA identifies 1.38-fold more immunogenic epitopes than either NetMHCPan-4.1 and MHCFlurry-2.0 and reveals strong correlations between evolutionary divergence and influential binding pocket positions in the MHC allele.

On March 23, 2022 Cyclica Inc. ("Cyclica"), a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, and Arctoris Ltd. ("Arctoris"), a tech-enabled biopharma company that combines its unique automation with computational approaches to progress drug discovery, reported that they have agreed to expand their partnership to progress drug discovery programs for novel neurodegenerative targets with a focus on Alzheimer’s disease (Press release, Cyclica, MAR 23, 2022, View Source [SID1234610756]). This planned expansion of the partnership follows the results from an initial engagement that yielded positive results for targets related to both oncology and neurodegenerative disease.

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"Cyclica’s platform and capabilities in combination with the biological assay development of Arctoris will enable us to yield meaningful results and advance research development for patients suffering from Alzheimers and other neurodegenerative diseases. The potential of combining our two specialties is very promising and we are extremely optimistic about the impact this partnership is expected to have on patients," shares Naheed Kurji, Co-Founder, President and CEO of Cyclica.

Dr. Martin-Immanuel Bittner, MD DPhil FRSA, CEO of Arctoris, comments by sharing, "Our joint drug discovery program focuses on dual specificity inhibitors – a very promising yet also challenging modality. Cyclica is one of the leaders in this space, leveraging their structure-based and AI-directed molecule design for polypharmacology, while at Arctoris we have built a particular expertise in complex mechanistic enzymology and advanced cell-based models in neurodegeneration. This is a highly synergistic partnership, and I am excited about what we can achieve together for patients around the world in an indication area in dire need of new and better treatment options."

Cyclica and Arctoris have long-term plans for their partnership as discussions are already underway about tackling additional therapeutic targets.

On March 23, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN), a leader in cell-free, enzymatic DNA production, reported that CEO Dr. James A. Hayward is invited to present at the 2022 Virtual Growth Conference presented by Maxim Group LLC and hosted by M-Vest, on March 28th – 30th from 9:00 a.m. – 5:00 p.m. EDT (Press release, Applied DNA Sciences, MAR 23, 2022, View Source [SID1234610755]). Dr. Hayward’s presentation will be available on-demand for the duration of the conference via the sign-up link: Sign up here to access the presentation

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During the virtual conference, investors will hear from executives from a wide range of sectors, including Biotech, Clean Energy, Electric Vehicles, Financial Services, Fintech & REITs, Gaming & Entertainment, Healthcare, Healthcare IT, Infrastructure, Shipping and Technology/Media/Telecom. The conference will feature company presentations, fireside chats, roundtable discussions, and live Q&A with CEOs moderated by Maxim Research Analysts.

This conference will be live on M-Vest. To attend, sign up to become an M-Vest member: Click Here to Reserve your seat