On March 5, 2020 DermTech, Inc. (NASDAQ:DMTK) ("DermTech"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, reported that the Journal of Drugs and Dermatology has published the results of a large registry study confirming the clinical utility of the DermTech Pigmented Lesion Assay (the "DermTech PLA") (Press release, DermTech International, MAR 5, 2020, View Source [SID1234555238]). The study also confirmed the value of DermTech’s adhesive patch by demonstrating that community-based clinicians using the DermTech PLA were able to reduce unnecessary biopsies by up to 90%, lower healthcare costs and rule out melanoma via a genomics approach that elevates pigmented lesion management beyond what the eye can see.

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"The DermTech PLA helps clinicians employ precision dermatology and harness genomics technology to detect malignant changes that are otherwise unable to be identified visually or with histopathology, reducing the probability of missing melanoma to <1%," said Ronald Moy, M.D., member of the DermTech Scientific Advisory Board and former president of the American Academy of Dermatology. "DermTech’s PLA test has the potential to elevate patient care by bringing precision genomics detection to a field that has been relying on highly subjective measures to inform biopsy decisions."

This large, yearlong utility study, conducted in the United States, included 90 providers across 53 dermatology offices and assessed 3,418 pigmented lesions clinically suspicious for melanoma with the DermTech PLA. The results of the study demonstrate that:

Clinicians use the DermTech PLA test results to guide how they practice medicine (97.53% of PLA positive lesions are surgically biopsied and 99.94% of PLA negative lesions are followed clinically and not biopsied).
90.52% (n = 3, 094) of DermTech PLA registry study test results were negative for melanoma and 9.49% (n = 324) were positive.
There is no difference in how board certified dermatologists and other licensed clinicians follow DermTech PLA results to guide biopsy decisions—potentially expanding access to care for underserved populations who often delay treatment for a disease in which early detection is critical.
The DermTech PLA identifies the gene expression associated with early melanoma by catching malignant changes a pathologist cannot see and reduces the risk of missing melanoma from 17% to less than 1%.
"Having used the DermTech PLA more than 600 times, I have seen it bring relief to people who were facing hundreds of biopsies, people concerned with facial scars and people who have experienced painful wound healing," said Brook Brouha, M.D., Ph.D., lead author on the study. "Using the PLA as a pain-free option allows providers to detect cancer before it spreads."

Up to 90% of all biopsies for suspected skin cancer are performed unnecessarily because the current standard to assess pigmented lesions remains ambiguous. These avoidable surgeries often result in multiple scars and research has shown that about 27% of older people biopsied experience poor wound healing, bleeding, or infection.

The study, "Real-world Utility of a Non-invasive Gene Expression Test to Rule out Primary Cutaneous Melanoma – A Large US Registry," is the 15th peer-reviewed publication validating the benefits of the DermTech PLA.

"This is our largest utility study to-date and these data further support the high utility of DermTech’s PLA and the high negative predictive value of this precision dermatology technology," said John Dobak, MD, Chief Executive Officer of DermTech. "The DermTech PLA can detect malignant changes in gene expression at earlier stages which can help avoid unnecessary biopsies and reduce costs."

DermTech’s PLA, which is covered by Medicare, uses RT-PCR (reverse transcriptase–polymerase chain reaction) to measure the gene expression of two genes, LINC00518 (long-intergenic non-coding RNA 00518) and PRAME (preferentially expressed antigen in melanoma) to identify the malignant changes of melanoma on the genomic level. A DermTech PLA test is positive if LINC, PRAME, or both target genes are detected as these molecular pathology findings are known to correspond with histopathology findings of in situ or invasive primary melanoma in 7%, 50% and 93% of cases, respectively.

On March 5, 2020 The Pancreatic Cancer Collective, the strategic partnership of Lustgarten Foundation and Stand Up To Cancer (SU2C), reported that it has awarded additional funding of up to $16 million to four teams of top researchers as part of its "New Therapies Challenge Grants," the American Association for Cancer Research (AACR) (Free AACR Whitepaper), Scientific Partner of SU2C, (Press release, The Pancreatic Cancer Collective, MAR 5, 2020, View Source [SID1234555260]).

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The additional support builds on a first round of funding announced in November 2018. These four teams originally received up to $1 million each to pursue preclinical work over 13 months, including several projects seeking to repurpose drugs approved for other uses for their potential to treat pancreatic cancer. These teams demonstrated the most promising preliminary results to allow them to take potential therapies into clinical trials. Pancreatic cancer is one of the deadliest forms of cancer, with a five-year survival rate of about 9 percent, according to the National Cancer Institute.

"These ‘Challenge Grants’ seeking new treatments for pancreatic cancer are working exactly as intended," said Phillip A. Sharp, PhD, the Nobel laureate and MIT scientist who serves as chair of the SU2C Scientific Advisory Committee. "These are important new investigations that have the potential to save lives with new approaches to therapy."

Each team will receive up to $4 million over a three-year term for the studies focused on clinical trials.

"We are impressed by the results of the first round," said David A. Tuveson, MD, PhD, chief scientist of the Lustgarten Foundation and director of the cancer center at Cold Spring Harbor Laboratory in New York. "Under this phased ‘Challenge Grant’ approach, teams are accelerating pre-clinical work and we are very eager to take the next step to bring new applications for pancreatic cancer treatment to clinical studies."

"It is gratifying to see the initial success of the New Therapies Challenge project, which we created to accelerate the research process and bring improved treatment options to patients," said Kerri Kaplan, president and CEO of the Lustgarten Foundation. "Through the Pancreatic Cancer Collective, these two leading cancer organizations have demonstrated the strength of collaboration. We are excited for the potential for breakthroughs in effective pancreatic cancer treatments and, eventually, a cure for this deadly disease."

The AACR (Free AACR Whitepaper) will support the administration of these projects receiving funding for the second round, including:

Targeting SHP2 in Pancreatic Cancer: Team leader: Rene Bernards, PhD, Netherlands Cancer Institute; co-leaders: Hana Algül, MD, PhD, Technical University of Munich, and Emile E. Voest, MD, PhD, Netherlands Cancer Institute. The team focuses on pancreatic tumors that have a mutation in the KRAS gene and has conducted preclinical testing of drug combinations that inhibit certain proteins in the malignant cells. In the second stage, the team will move into a phase I/Ib clinical trial to test the combination of SHP2 inhibitors (RMC4630) and ERK inhibitors (LY3214996). The results are expected to lay the basis for a phase II clinical trial.

Exploiting DNA Repair Gene Mutations in Pancreatic Cancer: Team leader: Alan D’Andrea, MD, Dana-Farber Cancer Institute; co-leader: James Cleary, MD, PhD, Dana-Farber Cancer Institute. The team has been seeking to evaluate DNA repair inhibitors and improve the use of PARP inhibitors, which interfere with the ability of cancerous cells to increase in number. The team’s preclinical data suggests that combining gemcitabine with inhibitors that target regulatory proteins involved in DNA repair could be an effective therapy in platinum-resistant pancreatic cancer. Based on these laboratory findings, the team is developing three pancreatic cancer clinical trials testing gemcitabine-based combinations: gemcitabine/ATR inhibitor BAY1895344; gemcitabine/CHK1 inhibitor LY2880070; and gemcitabine/WEE1 inhibitor AZD1775. The most promising combinations will be identified for potential validation in larger trials.

Immunotherapy Targeting Mutant KRAS (mKRAS): Leader: Robert H. Vonderheide, MD, DPhil, Abramson Cancer Center at the University of Pennsylvania; co-leaders: Elizabeth M. Jaffee, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, and Beatriz Carreno, PhD, Abramson Cancer Center at the University of Pennsylvania. The team is developing an immunological approach to target mutations in the molecule KRAS, an underlying cause of most cases of pancreatic cancer. In the first round of funding, the team used innovative strategies in bioinformatics, biochemistry, and cell biology to identify specific mKRAS protein sequences that can be recognized by T cells. They then isolated a series of molecular receptors that enable T cells to home in on cancer cells expressing mKRAS. Based on these findings, the team is conducting two different clinical trials with novel vaccines aimed at triggering mKRAS immune responses in patients with resected pancreatic cancer. In round two of funding, the team plans to use the most promising T-cell receptor identified and conduct a clinical trial of engineered T-cell therapy for patients with metastatic pancreatic cancer.

Molecularly Targeted Radionuclide Therapy via the Integrin αvβ6: Team Leader: Julie Sutcliffe, PhD, University of California Davis; co-leader: Richard Bold, MD, University of California Davis. The team has been working to develop a peptide receptor radionuclide therapy (PRRT) that involves homing in on a protein called integrin αvβ6, a cell surface receptor that can be found in pancreatic cancers. The team has synthesized in the laboratory a pair of related peptide constructs that are tagged with two different radiolabels. One radiolabel facilitates the imaging of pancreatic cancer lesions in patients that can more likely benefit from the PRRT. The other radiolabel can facilitate the killing of the pancreatic cancer cells. The team has obtained promising results in the laboratory testing of the peptide constructs. In the second round of funding, the team will conduct a phase 1, first-in-human study to evaluate the feasibility, safety and efficacy of the two peptide constructs. The study will determine if one construct can detect lesions in patients with locally advanced or metastatic pancreatic cancer; establish the safety and tolerability of the pair; evaluate the maximum tolerated dose of the second construct; and, using pre-clinical models, establish an optimal dosing regimen.

The Lustgarten Foundation and Stand Up To Cancer have collaborated closely since 2012, jointly funding more than 400 investigators from nearly 70 leading research centers in the United States and the United Kingdom. These efforts include 18 multi-institutional teams, including Convergence Teams bringing together computational experts with clinical oncologists, and cancer interception — research supporting the earliest diagnosis of pancreatic cancer, even before the cancer may have fully formed. All told, these collaborative teams have planned, started, or completed nearly 30 clinical trials. The Pancreatic Cancer Collective is building on this momentum to push the boundaries of what can be accomplished even further.

On March 5, 2020, Celsion Corporation (the "Company") reported to Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital"), terminating the Common Stock Purchase Agreement dated October 28, 2019 (the "2019 Aspire Purchase Agreement") with Aspire Capital effective as of March 6, 2020. The 2019 Aspire Purchase Agreement provided that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was committed to purchase up to an aggregate of $10 million of shares of the Company’s common stock over the 24-month term of the 2019 Aspire Purchase Agreement at a price equal to (i) the lowest sale price of the Company’s common stock on the purchase date; or (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date (Filing, 8-K, Celsion, MAR 5, 2020, View Source [SID1234555303]). In consideration for entering into the 2019 Aspire Purchase Agreement, the Company issued to Aspire Capital 100,000 shares of the Company’s common stock.

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On November 8, 2019, the Company filed with the SEC a Registration Statement on Form S-1 registering all the shares of common stock that may be offered to Aspire Capital from time to time under the 2019 Aspire Purchase Agreement. From October 28, 2019 through the date of termination, the Company sold 1,500,000 shares of common stock under the 2019 Aspire Purchase Agreement generating proceeds of $2.3 million. Upon termination, the Company has no further obligations under the 2019 Aspire Purchase Agreement.

On March 5, 2020 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported that it plans to host a conference call on Thursday, March 12, 2020, at 8:30 a.m. ET to discuss its financial results for the quarter and full-year ended December 31, 2019, and recent operational highlights (Press release, Selecta Biosciences, MAR 5, 2020, https://selectabio.gcs-web.com/news-releases/news-release-details/selecta-biosciences-host-conference-call-and-webcast-discuss [SID1234555205]).

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Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10138603. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

On March 5, 2020 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported financial results for the fourth quarter and full year ending December 31, 2019 and provided corporate updates (Press release, Arcus Biosciences, MAR 5, 2020, View Source [SID1234555223]).

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"The robust expertise and integrated discovery and clinical organizations at Arcus, combined with the keen foresight of the Arcus team, continue to deliver." said Terry Rosen, Ph.D., Chief Executive Officer. "Early in the genesis of the company, adding both an anti-PD-1 antibody that exhibits clinical activity and safety profiles consistent with those of the currently approved agents and an anti-TIGIT antibody, a potential new immuno-oncology backbone therapy, has placed our development program in a particularly strong position. With emerging data reinforcing our leadership in the development of potential therapeutics that modulate the adenosine pathway and the initiation of a Phase 2 study for our anti-TIGIT antibody AB154, we see the upcoming catalysts in 2020 as important milestones in supporting Arcus’s long term vision to consistently create and bring genuinely breakthrough therapies to patients."

2019 Key Highlights

Announced Taiho’s exercise of its option for an exclusive license to zimberelimab, an anti-PD1 antibody, for its territories in Japan and other Asian countries (excluding China)

Initiated ARC-7, a randomized Phase 2 clinical trial of AB154, an anti-TIGIT antibody, for the treatment of non-small cell lung cancer (NSCLC)

The trial may support the global filing strategy for AB154 and zimberelimab and will include a zimberelimab monotherapy arm, a doublet combination of AB154 and zimberelimab, and a triplet combination including our dual A2a/A2b adenosine receptor antagonist (AB928) with AB154 and zimberelimab

Initiated activities for two Phase 2 randomized studies in clinical collaboration with Genentech to accelerate the development of AB928

Successfully passed futility analysis in the ARC-3 Phase 1b expansion, which will proceed to full enrollment to evaluate the efficacy of AB928 in combination with FOLFOX in colorectal cancer (CRC)

Presented data from all four of the dose-escalation portions of the AB928 combination trials establishing favorable safety, tolerability and early clinical efficacy, consistent with clinical hypotheses of the ability for AB928 to be combined with different backbone therapies

These data provided the foundation for the ongoing Phase 1b/2 efficacy trials in metastatic castrate resistant prostate cancer (mCRPC), CRC, NSCLC, pancreatic (PDAC), triple negative breast and renal cell cancers

Complemented Arcus’s existing Scientific Advisory Board with the formation of a distinguished Clinical Advisory Board (CAB) to further support Arcus’s progressing clinical programs. The CAB includes: Johanna C. Bendell, M.D., (Sarah Cannon Research Institute), Matthew D. Hellmann, M.D., (Memorial Sloan Kettering Cancer Center), Antoni (Toni) Ribas, M.D., Ph.D., (University of California-Los Angeles), Naiyer A. Rizvi, M.D., (Columbia University), and Mary-Ellen Taplin, M.D., (Dana-Farber Cancer Institute)

Appointed internationally renowned physician-scientist, Antoni Ribas, M.D., Ph.D. and biopharmaceutical industry leader Patrick Machado, J.D. to Arcus’s Board of Directors

Anticipated Corporate Milestones & Presentations

Anticipated Corporate Milestones

Initiate ARC-6, a Phase 1b/2 platform trial to evaluate the efficacy and safety of AB928 in multiple rationally selected combinations for the treatment of mCRPC in the first half of 2020; this will expand our strategy in prostate cancer and build on our current phase 1b expansion cohort

Preliminary Phase 2 randomization data from the two clinical collaborations with Genentech with AB928 in CRC and PDAC expected in the fourth quarter of 2020

Preliminary Phase 2 randomization data with AB154 from the ARC-7 trial in first-line NSCLC expected in the fourth quarter of 2020

Preliminary Phase 1b expansion data with AB928 in multiple tumor types expected starting in mid-2020

Phase 1a dose-escalation data in the ARC-8 trial evaluating AB680, the first small-molecule CD73 inhibitor to enter the clinic, in combination with zimberelimab and gemcitabine/nab-paclitaxel in patients with PDAC, anticipated starting in mid-2020; Phase 1b expansion cohort anticipated to start in mid-2020

Clinical studies with at least two new therapeutic candidates from existing development programs (PI3Kg; HIF-2a; Axl; PAK4) planned to begin in late 2020/early 2021

Upcoming Presentations

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2020; San Diego Convention Center, San Diego, CA; April 24-29, 2020

Abstract Number LB-387: Efficacy and Safety of AB928 plus modified FOLFOX-6 (mFOLFOX-6) in Participants with Metastatic Colorectal Cancer (mCRC): Initial Results at the Recommended Dose for Expansion (ARC-3)

Abstract Number 393: Dual A2aR/A2bR antagonism with AB928 suppresses the effects of adenosine on both immune and cancer cells in the tumor microenvironment

Abstract Number 6649: Inhibiting adenosine signaling and KRAS enhances the effect of α-PD-1 therapy in a KRASG12C/TP53R172H/+ pancreatic cancer model

Abstract Number 686: Selective inhibition of hypoxia-inducible factor (HIF)-2α for cancer

Abstract Number 4214: Discovery and characterization of potent and selective AXL receptor tyrosine kinase inhibitors for cancer therapy

Please refer to Arcus’s pipeline at www.arcusbio.com for the company’s most current pipeline and development plans.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2019

Cash, cash equivalents and investments in marketable securities were $188.3 million as of December 31, 2019, compared to $259.7 million at December 31, 2018. The decrease was due to the utilization of cash to fund our research, development and administrative operations. Based on our current operating plans, we anticipate that our cash, cash equivalents and investments will be sufficient to fund operations into 2021.

Revenues: Collaboration and license revenue was $9.8 million for the fourth quarter of 2019 and $15.0 million for the year ended December 31, 2019, compared to $1.6 million and $8.4 million, respectively, for the same periods in 2018. The increase in revenue during the fourth quarter as compared to the same period of the prior year was primarily due to Taiho Pharmaceutical’s exercise of its option for our anti-PD-1 antibody program, including zimberelimab. The increase in revenue for the full year 2019 as compared to 2018 is primarily due to Taiho’s exercise of its option for our anti-PD-1 antibody program, including zimberelimab, and an upward remeasurement of the initial transaction price for our existing agreement with Taiho following our adoption in 2019 of the new GAAP revenue accounting standard, ASC 606. The overall increase for the full year 2019 is partially offset by a $3.0 million fee that we recognized in 2018 following Taiho’s exercise of its option for our adenosine receptor antagonist program (AB928).

R&D Expenses: Research and development expenses were $20.7 million for the fourth quarter of 2019 and $78.5 million for the year ended December 31, 2019, compared to $11.4 million and $49.6 million, respectively, for the same periods in 2018. The increase in research and development expenses was primarily due to an increase in clinical activities to support our four programs in clinical development and an increase in R&D headcount and related costs.

G&A Expenses: General and administrative expenses were $6.6 million for the fourth quarter of 2019 and $25.2 million for the year ended December 31, 2019, compared to $3.6 million and $13.6 million, respectively, for the same periods in 2018. The increase in general and administrative expenses was primarily due to an increase in G&A headcount and related costs, as well as additional compliance costs related to operations as a public company.

Net Loss: Net loss was $16.6 million for the fourth quarter of 2019 and $84.7 million for the year ended December 31, 2019, compared to $12.3 million and $49.6 million for the same periods in 2018, respectively. The increase in net loss as compared to the prior periods was primarily attributable to an increase in operating expenses as noted above.