DermTech Presents Updates in Precision Medicine at 2020 Dermatology Drug Development Summit

DermTech, Inc. (NASDAQ:DMTK) (“DermTech”), a leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today the presentation of a precision medicine focused session at the fourth annual Dermatology Drug Development Summit. Held virtually this year, the Dermatology Drug Development Summit is the only industry-focused meeting dedicated to innovating, accelerating, and sharing pharmaceutical best practice on the development and bringing to market of new dermatological drugs, in the treatment of high unmet need. 

The session, titled, “Stickering it to Skin Disease: The Drive for Precision and Personalized Dermatology,” presented by Michael D. Howell, PhD, Chief Scientific Officer of DermTech, explored the current approaches to precision medicine in dermatology and the integration of precision medicine and biomarker approaches in clinical trials. Howell reviewed DermTech’s proprietary Smart Sticker platform and its use in early detection of skin cancers including cutaneous melanoma. Howell also discussed how non-invasive skin sampling can enhance precision medicine by detecting genomic and proteomic changes in the skin without the need for a skin biopsy. Finally, Howell discussed how the expanded use of DermTech’s breakthrough tool can guide personalized approaches to disease diagnosis and intervention.

The presentation is available for viewing here.

“The Dermatology Drug Development Summit brings together leaders in academia, government, and industry with a goal of driving innovative medicine in dermatology. The DermTech Smart Sticker is an innovative platform that non-invasively assesses genomic and proteomic changes in the skin before those changes can be visually detected. With more than 3,000 potentially identifiable dermatological diseases and an ever increasing armamentarium of therapies, the Smart Sticker technology enables innovative approaches to precision and personalized dermatology,” commented Howell.

About DermTech:

DermTech is the leading genomics company in dermatology and is creating a new category of medicine, precision dermatology, enabled by our non-invasive skin genomics platform. DermTech’s mission is to transform the practice of dermatology through more accurate diagnosis and treatment, and the elimination of unnecessary surgery, leading to improved patient care and lower costs. DermTech provides genomic analysis of skin samples collected non-invasively using an adhesive patch rather than a scalpel. DermTech markets and develops products that facilitate the early detection of skin cancers, and is developing products that assess inflammatory diseases and customize drug treatments. For additional information on DermTech, please visit DermTech’s investor relations site at: www.DermTech.com.

Forward-looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. The expectations, estimates, and projections of DermTech may differ from its actual results and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations with respect to: the performance, patient benefits, cost-effectiveness, commercialization and adoption of DermTech’s products, including the Smart Sticker platform, and the market opportunity therefor. These forward-looking statements involve

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Cleveland Orchestra presents ‘Music Medicine Initiative’

The concert videos were filmed at restaurants, shops and iconic locations throughout Greater Cleveland and will be released weekly on social media.

CLEVELAND — Cleveland Orchestra musicians have partnered together to film a new series of performance videos throughout Greater Cleveland for their new Music Medicine Initiative

Jessica Lee, the assistant concertmaster for the Orchestra, and her colleagues created the videos to share the healing power of music with healthcare workers, patients and those affected by the ongoing COVID-19 pandemic. 

The series of seven to ten videos will be released on a weekly basis on the Orchestra’s Facebook, Twitter Instagram and YouTube accounts beginning Monday, November 23.

“This series is a part of the Music Medicine Initiative: The Power of Music for Health and Well-Being, which is a community collaboration between The Cleveland Orchestra and Cleveland Clinic’s Art + Design Institute,” a new release surrounding the project states. 

The Orchestra and Cleveland Clinic partner on a number of projects to explore the intersection of music and medicine in both the local and global communities. A few of their recent collaborations include the Salute to Healthcare Heroes chamber concerts for Cleveland Clinic healthcare workers by Cleveland Orchestra musicians, performances by Cleveland Orchestra Youth Orchestra’s chamber music ensembles at Cleveland Clinic locations and co-hosting Music & the Brain symposia in the United States and Europe.

“As the pandemic hit us, I saw the deep stress and pain experienced by frontline workers and those affected by COVID-19,” said Lee. “There was also an enormous sense of isolation and a hunger for beauty around the world, so as I began this project I focused on the words ‘community’ and ‘connection,’ two things we are all especially longing for right now. This is what led me to film these videos in some of our beloved businesses in the Greater Cleveland community, to bring the joy of these places back into people’s lives while we are less able to visit and enjoy them. Music has the unique power to unite and heal where words cannot, and it is my hope that through these videos, we will lift the spirits of healthcare workers, patients, and our entire community.”


The first three videos in the new project include the following performances by musicians from the Cleveland Orchestra:

  • Movement 3 from Debussy’s String Quartet in G Minor, filmed at Luna Bakery in Cleveland Heights. Performed by Jessica Lee, assistant concertmaster (violin); Yun-Ting Lee (violin); Wesley Collins, principal viola (viola); and Dane Johansen (cello).
  • Telemann’s Concerto for Four Violins in D Major, filmed at Mitchell’s Ice Cream in Ohio City. Performed by Peter Otto, first associate concertmaster (violin); Jung-Min Amy Lee, associate concertmaster (violin); Jessica Lee, assistant concertmaster (violin); and Stephen Tavani, assistant concertmaster (violin).
  • Barber’s Dover Beach (poem by Matthew Arnold), filmed at Alley Cat Oyster Bar in downtown Cleveland. Performed by Jessica Lee, assistant concertmaster (violin); Yun-Ting Lee (violin); Wesley Collins, principal viola (viola); Dane Johansen (cello); and guest vocalist Thomas Meglioranza
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Basilea presents preclinical data on anti-angiogenic activity of derazantinib at ENA 2020

Basel, Switzerland, October 26, 2020

Basilea Pharmaceutica Ltd. (SIX: BSLN) today reported that data on the anti-angiogenic activity of the fibroblast growth factor receptor (FGFR) inhibitor derazantinib were presented at the 32nd EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics, that took place as a virtual event on 24-25 October, 2020. In addition to FGFR1-3 derazantinib also inhibits the vascular endothelial growth factor receptor 2 (VEGFR2). The presented data from several preclinical models demonstrate that derazantinib has an anti-angiogenic effect, which may contribute to its overall anti-tumor activity in FGFR-driven cancers.

The prevention of new blood vessel formation (anti-angiogenesis) is an established approach in cancer therapy as it deprives the growing tumor from oxygen and nutrients. VEGFR2 is a primary target for anti-angiogenic agents in the treatment of cancers.

Dr. Laurenz Kellenberger, Chief Scientific Officer, said: “Our development strategy for derazantinib is focused on strengthening the evidence for its differentiation versus other FGFR inhibitors. The preclinical data on derazantinib’s anti-angiogenic activity presented at the conference show that it may provide additional activity on top of its established primary anti-tumor effects in FGFR-positive solid tumors. Based on its unique kinase inhibition profile, we are exploring derazantinib’s potential for enhanced activity alone and in combination with other anti-cancer agents such as the anti-VEGFR2 antibody ramucirumab, or the PD-L1 immune checkpoint inhibitor atezolizumab within our ongoing clinical program FIDES.“

The following e-poster was presented at the EORTC-NCI-AACR Virtual Symposium 2020:

Presentation #

Authors/title

101

P. McSheehy, J. Boult, S. Robinson, F. Bachmann, M. El-Shemerly, L. Kellenberger, H. Lane

Derazantinib, an oral fibroblast growth factor receptor inhibitor, in phase-2 clinical development, shows anti-angiogenic activity in preclinical models

For further information, please visit https://event.eortc.org/ena2020

About derazantinib

Derazantinib is an investigational orally administered small-molecule FGFR inhibitor with strong activity against FGFR1, 2, and 3.1 FGFR kinases are key drivers of cell proliferation, differentiation and migration. FGFR genetic aberrations, e.g. gene fusions, mutations or amplifications, have been identified as potentially important therapeutic targets for various cancers, including intrahepatic cholangiocarcinoma (iCCA), urothelial, breast, gastric and lung cancers.2 In these cancers, FGFR genetic aberrations are found in a range of 5% to 30%.3
Derazantinib also inhibits the colony-stimulating-factor-1-receptor (CSF1R) kinase.1, 4 CSF1R-mediated signaling is important for the maintenance of tumor-promoting macrophages and therefore has been identified as a potential target for anti-cancer drugs.5 Preclinical data has shown that tumor macrophage depletion through CSF1R blockade renders tumors more responsive to T-cell checkpoint immunotherapy, including approaches targeting PD-1/PD-L1.67
Derazantinib has demonstrated antitumor activity and a manageable safety profile in a previous biomarker-driven phase 1/2 study in iCCA patients,8 and has received U.S. and EU orphan drug designation for iCCA. Basilea is currently conducting three clinical studies with derazantinib. The first study, FIDES-01, is a registrational phase 2 study in patients with inoperable or advanced iCCA. It comprises one cohort of patients with FGFR2 gene fusions and another cohort of patients with mutations or amplifications.

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Goldfinch Bio Presents Clinical Data from Phase 1 Trial Supporting Advancement of GFB-887 as a Precision Medicine for Patients with Kidney Diseases

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Goldfinch Bio, a clinical stage biotechnology company focused on discovering and developing precision medicines for the treatment of kidney diseases, today announced for the first time results from its Phase 1 clinical trial evaluating GFB-887, a first-in-class highly potent and selective inhibitor of Transient Receptor Potential Canonical Channel 5 (TRPC5), in healthy volunteers. The data are being presented today at the virtual American Society of Nephrology (ASN) Kidney Week 2020 Annual Meeting.

Goldfinch Bio is developing GFB-887 as a precision medicine for patients with kidney diseases characterized by overactivation of the TRPC5-Rac1 pathway, including focal segmental glomerulosclerosis (FSGS) and diabetic nephropathy (DN). Overactivation of the TRPC5-Rac1 pathway leads to injury of podocytes, which are cells lining the kidney that, in their healthy state, prevent essential protein loss (proteinuria). Injury to podocytes causes podocyte loss, proteinuria and, eventually, kidney failure. TRPC5-Rac1 pathway overactivation is the key cause of disease in a substantial portion of FSGS and DN patients, and there are currently no approved drugs that specifically target the TRPC5-Rac1 pathway in these diseases.

“We are excited to share these first-in-human data, which demonstrate that GFB-887 is well-tolerated and suggest a dose-dependent reduction in urinary Rac1, confirming GFB-887 target engagement in the podocyte,” said Anthony Johnson, M.D., President and Chief Executive Officer of Goldfinch Bio. “Suppressing the TRPC5-Rac1 pathway has the potential to deliver clinically meaningful benefit to patients by reducing proteinuria and, as a result, preserving native kidney function. Supported by the Phase 1 data, we are now underway with our Phase 2 TRACTION-2 study of GFB-887 in FSGS and DN, as we continue to advance our mission of protecting patients from the inevitability of dialysis and kidney transplant by delivering precision medicines for subsets of kidney disease.”

Data from the Phase 1 Clinical Trial

The primary objective of the randomized, double-blinded, placebo-controlled trial was to assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamics (PD) of GFB-887 in healthy volunteers. A key exploratory objective was to characterize changes in urinary Rac1. Urinary Rac1 concentration may predict therapeutic response to TRPC5 inhibition.

The study enrolled 70 subjects, who were randomized four to one to receive GFB-887 at seven dose levels (ranging from 5 mg to 900 mg) or placebo.

Primary Objective: Safety, Tolerability and PK Data

GFB-887 was observed to be well-tolerated at all doses. There were no dose-limiting toxicities, severe adverse events (AEs) or abnormalities in laboratory or clinical assessments. In total, 38 percent of subjects who received GFB-887 reported AEs, compared to 21 percent of subjects treated with placebo. GFB-887-treated subjects reported headache more frequently than placebo-treated subjects (28.6% versus 7.2% respectively). The only other AE that was reported in two or more GFB-887-treated subjects was nausea (3.6%). Slight, asymptomatic reductions in blood pressure were observed in subjects treated at the highest doses.

The PK profile of GFB-887 is consistent with once-daily dosing, with a half-life ranging from 55 to 68 hours. A single 40 mg dose was also shown to exceed the preclinical

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Gilead Presents New Data from Antiviral Development Programs at IDWeek 2020

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of 18 abstracts spanning the company’s HIV treatment and prevention and COVID-19 clinical development programs during the virtual IDWeek 2020 conference from October 21-25. The breadth of data reflects Gilead’s commitment to advancing antiviral innovation aiming to help end the HIV epidemic and to addressing the treatment needs of patients with COVID-19.

“The global HIV epidemic and the COVID-19 pandemic are two of the most complex public health challenges of our time,” explained Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “The data presented at IDWeek reflect the latest progress in Gilead’s antiviral drug discovery and development and underscore our commitment to supporting the global health community to quickly and effectively respond to devastating viral outbreaks worldwide.”

At IDWeek 2020, Gilead will present results from the ongoing DISCOVER multi-center randomized clinical trial, evaluating the safety and efficacy of Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for PrEP® and a new analysis leveraging a novel statistical method to estimate the background HIV incidence rate in DISCOVER. Separate data from DISCOVER will provide insight into the impact of age and comorbidities on renal outcomes for study participants. In addition to new data from the DISCOVER trial, the key findings from an analysis examining real-world patterns of persistence with Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for PrEP® in at-risk populations will be presented in an oral presentation.

Gilead also will present new data on the efficacy and safety of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in certain populations of people living with HIV that have historically been underrepresented in HIV clinical research. The latest data from Gilead’s HIV treatment research program to be presented include an oral presentation on 48-week outcomes from the landmark community-based and designed BRAAVE study evaluating the safety and efficacy of switching to Biktarvy among Black American adults living with HIV who are virally suppressed. Findings on the efficacy of Biktarvy in people living with HIV who are virologically suppressed with end-stage renal disease and requiring chronic hemodialysis will also be presented.

Data on Gilead’s investigational antiviral Veklury® (remdesivir) for injection (100 mg) administered by intravenous infusion for the treatment of COVID-19 include two oral presentations examining the safety and efficacy of Veklury in hospitalized patients with moderate COVID-19 and global geographical disparities in clinical outcomes of hospitalized patients with severe COVID-19 treated with Veklury in Gilead’s open-label, Phase 3 SIMPLE studies.

Select accepted abstracts are as follows:

HIV prevention research

  • Oral 103: Persistence on Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for HIV Pre-Exposure Prophylaxis: Insights From Real-World Evidence

  • Poster 999: Using the Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Adherence-Efficacy Relationship to Calculate Background HIV Incidence: Results From the DISCOVER trial

  • Poster 985: Impact of Age and Medical Comorbidities on Renal Outcomes in the DISCOVER Trial

  • Poster 995: Safety and Efficacy of Emtricitabine/Tenofovir Alafenamide (F/TAF) and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for PrEP in DISCOVER Participants Taking

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