On February 16, 2018 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported the presentation of two studies highlighting the clinical use of the DecisionDx-Melanoma gene expression profile test, which uses tumor biology to provide an individual risk of recurrence in cutaneous melanoma patients (Press release, Castle Biosciences, FEB 16, 2018, View Source [SID1234524026]). The data will be presented during the 74th Annual Meeting of the American Academy of Dermatology (AAD), held in San Diego, CA from February 16-18.

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The clinical impact study titled, "A Prospective Multicenter Study to Evaluate the Clinical Impact of a 31-Gene Expression Profile Test on Physician Recommendations for Management of Melanoma Patients," (Abstract 6798) will be presented during the Late-Breaking Research: Basic Science/Cutaneous Oncology/Pathology session at the meeting. Researchers found that physicians used test results to inform risk-appropriate changes in patient management while remaining within the context of established practice guidelines.

The second study titled, "Factors Impacting Dermatologists’ Decision to Utilize a 31-Gene Expression Profiling Test to Assess Metastatic Risk for Melanoma Patients," (Abstract 7061) examined clinicopathologic factors that impact dermatologists’ decisions to recommend the DecisionDx-Melanoma test for patients. The study found that a majority of clinicians would order the DecisionDx-Melanoma test for tumor thickness of 0.5 mm or greater with or without ulceration, and for thinner tumors if a factor such as ulceration were present.

Clinical Impact Study

This multicenter, prospective clinical impact study included 247 patients from 15 dermatology, medical oncology or surgical oncology centers. Patients were clinical Stage I or II at time of enrollment. The patient cohort has a median age of 63 years and median Breslow thickness of 1.1 mm.

Pre and post-test management recommendations were collected, including laboratory tests, imaging, frequency of clinical visits, adjuvant treatment discussion, and plans for referral to surgical or medical oncology. To assess clinical impact of the test, changes between pre- and post-test plans were categorized as an increase, decrease or no change in care.

Key Study Findings:

181 patients (73%) had a Class 1 (low-risk) result and 66 (27%) had a Class 2 (high-risk) result.
Overall 49% of patients tested experienced a change in clinical management recommendations following the receipt of the DecisionDx-Melanoma test.
Class 1 patients showed a 36% post-test change in management plans, while 85% of Class 2 patients had a change following the DecisionDx-Melanoma test.
79% of management changes were assessed to be in a risk-appropriate direction based on test result, with 91% of decreases in care documented for low-risk (Class 1) patients, and 72% of increases in care provided for high-risk (Class 2) patients.
The most significantly changed management modalities were follow-up frequency and imaging.
"Across the different practice settings in this study, the DecisionDx-Melanoma test informed risk-appropriate patient management decisions, consistent with previous publications demonstrating that the test impacts one in two clinical management decisions," said Federico Monzon, MD, Chief Medical Officer, Castle Biosciences. "These findings align with national guidelines, which recommend that a patient’s individual risk of recurrence should drive management decisions."

Utilization of Clinicopathologic Factors for Decision-Making

Results from a clinical utility study designed to determine which factors impact clinicians’ decisions to use the DecisionDx-Melanoma prognostic test were also presented during the AAD meeting. The impact on use of the test by Breslow thickness, ulceration, and sentinel lymph node biopsy (SLNB) status were evaluated using clinical vignettes and an interactive response methodology. The vignettes included tumors with Breslow thicknesses of 0.26, 0.50, 0.76 and 2.10 mm, with or without ulceration or knowledge of SLNB status. A total of 181 dermatologists completed the study.

Key Study Findings:

87% of dermatologists in this study would recommend the DecisionDx-Melanoma test for all tumors with a Breslow thickness of 0.5 mm or greater in the absence of ulceration and 78% in the presence of ulceration.
Presence of ulceration was associated with an increase in the number of dermatologists who would recommend the test for all but the thickest tumor assessed (2.10 mm).
For the thinnest tumor assessed (0.26 mm) the presence of ulceration significantly increased the number of dermatologists who would recommend the test from 22% to 67% (p<0.001).
SLNB negative status was associated with an increase in the number of physicians recommending the test for the thinnest tumors from 22% to 34% (p=0.033).
"Overall, tumor thickness and presence of ulceration were found to be the most impactful factors influencing clinicians’ decisions to order the DecisionDx-Melanoma test," said study co-author Darrell S. Rigel, M.D., M.S., Clinical Professor at New York University School of Medicine. "The study shows that dermatologists are making appropriate decisions to use the test as an important part of metastatic risk assessment in early stage patients."

About DecisionDx-Melanoma
The DecisionDx-Melanoma test uses tumor biology to provide a prediction of individual risk of melanoma recurrence beyond traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including 702 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multi-center studies which included over 1400 patients. Clinical impact has been demonstrated in multi-center and single-center studies showing that test results change approximately 50% of management decisions. More information about the test and disease can be found at www.SkinMelanoma.com.

On February 16, 2018 Immunomic Therapeutics (ITI), pioneering the study of investigational LAMP-based nucleic acid immunotherapy programs, reported that the company will participate at the 2018 BIO CEO & Investor Conference in two events (Press release, Immunomics, FEB 16, 2018, View Source [SID1234524030]):

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Monday, February 12, 2018, 7-9 p.m. EST, New York Marriott Marquis, Manhattan Ballroom

Scientific American Panel: "Hot Topics in Biotech: Cancer at a Crossroads"As new financing models become increasingly complex, immuno-oncology technologies present a promising, but complex landscape. Scientific American is hosting a salon conversation with leading industry experts like ITI focused on immuno-oncology.
Panel participants:
William Hearl, Ph.D., Founder & CEO, ITI
Jeremy Abbate, VP & Publisher, Scientific American
Andrew Marshall, Chief Editor, Nature Biotech
Barbara Ryan, Life Sciences Capital Markets & Strategy Advisor, Financial Communications, CNBC
Cliff Ransom, Executive Editor, Scientific American

Tuesday, February 13, 2018, 2:45 p.m. EST, Gilbert Room, New York Marriott Marquis

Corporate presentation: ITI’s Founder & CEO, William Hearl, Ph.D., will present an overview of the company and its LAMP-Vax technology.
About LAMP-Vax

ITI’s investigational LAMP-Vax platform is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put LAMP-Vax technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. LAMP is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of LAMP in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for LAMP-Vax therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On February 16, 2018 The US Food and Drug Administration (FDA) reported the approval of apalutamide (Erleada, Janssen) for the treatment of patients with nonmetastatic prostate cancer who are at high risk for disease spread because treatment with hormone therapy is not effective and thus their disease is castration resistant (Press release, ChemDiv, FEB 16, 2018, View Source [SID1234524028]).

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Apalutamide.svg

This is the first FDA-approved treatment for nonmetastatic, castration-resistant prostate cancer. It is also the first time the FDA used metastasis-free survival (MFS) as the primary endpoint in its decision making.

"In the trial supporting approval, apalutamide had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public," said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press statement.

Apalutamide is an orally administered androgen-receptor inhibitor.

The FDA based its new approval on safety and efficacy data from the phase 3 SPARTAN (Selective Prostate Androgen Receptor Targeting With ARN-509) trial. Investigators randomly assigned 806 men to receive treatment with apalutamide (240 mg per day) and 401 to receive placebo; all participants also received hormone therapy, either gonadotropin-releasing hormone analogue therapy or surgical castration.
All of the men had also undergone previous definitive treatment, either surgery or radiotherapy, for prostate cancer, but their PSA scores doubled within 10 months or less following treatment, despite hormone therapy.

Median MFS, which was the primary endpoint, was 40.5 months in the apalutamide group as compared with 16.2 months in the placebo group (P < .001). That translated into a 72% reduction in the relative risk for metastasis or death with the new drug (hazard ratio, 0.28; 95% confidence interval [CI], 0.23 – 0.35).

In addition, the results with apalutamide were superior for all secondary endpoints compared to placebo, including time to metastasis, progression-free survival, and time to symptomatic progression; all were significantly longer with apalutamide (P < .001 for all comparisons).

On February 16, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that the company is scheduled to present at the 2018 RBC Capital Markets Healthcare Conference at 9:30 AM ET on Wednesday, February 21, 2018 in New York City (Press release, Pacira Pharmaceuticals, FEB 16, 2018, View Source;p=RssLanding&cat=news&id=2332988 [SID1234524038]).

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A live audio webcast of the Pacira presentation can be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the presentation date.

On February 15, 2018 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2017 and recent corporate developments (Press release, Genocea Biosciences, FEB 15, 2018, View Source [SID1234524004]).

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"We’ve had a productive start to 2018 and are encouraged by both the progress with our lead neoantigen cancer vaccine, GEN-009, and the broader application of our ATLAS technology to cancer," said Chip Clark, president and chief executive officer of Genocea. "Notably, we believe that our $55 million financing suggests a strong endorsement of our technology, our corporate strategy, and our team. We continue to advance GEN-009, bringing us very close to filing our first cancer vaccine IND. We are also continuing to explore partnership opportunities for our ATLAS platform, a technology that we believe uniquely differentiates us from our peers as the only platform to identify true T cell antigens, which we anticipate will result in more effective cancer vaccines."

Recent Milestones & Events

November 2017: At the 32nd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2017), Genocea presented data demonstrating the power and versatility of its ATLAS platform and its potential superiority to in silico methods of neoantigen identification, as well as data highlighting the discovery of unexpected and novel T cell antigens for vaccines against colorectal cancer and non-small cell lung cancer.
January 2018: Genocea announced completion of a $55 million financing, including significant investments by New Enterprise Associates (NEA) and Vivo Capital (Vivo).
January 2018: The U.S. Patent and Trademark Office issued an allowance on United States Patent 9,873,870, further strengthening the company’s intellectual property position on its ATLAS platform for the identification and characterization of neoantigens and tumor-associated antigens.
January 2018: Genocea and Oncovir, Inc. entered into a license and supply agreement for Oncovir’s Hiltonol (poly-ICLC) adjuvant, a key component of Genocea’s personalized cancer vaccine candidate, GEN-009.
Anticipated Upcoming Milestones & Events

Q1 2018: The company expects to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for its GEN-009 personalized cancer vaccine.
March 2018: Genocea management is scheduled to present at the Cowen and Company Annual Health Care Conference in Boston (March 12-14), and at the Needham & Co. Annual Healthcare Conference in New York City (March 27-28).
Mid-2018: Genocea plans to initiate a Phase 1/2a clinical trial for GEN-009 in patients with a variety of tumor types. The first part of this trial is expected to enroll 6 patients with no evidence of disease but a high likelihood of relapse. Safety and immunogenicity data will be monitored, with preliminary results expected in the first half of 2019.
Corporate Update and Financial Guidance
In January 2018, Genocea completed a $55 million equity financing, including significant investments from NEA and Vivo. Net proceeds from the equity financing were approximately $51.7 million.

Genocea continues to explore strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy to treat the large patient population infected with genital herpes, many of whom are dissatisfied with their current treatment options.

In January 2018, Genocea entered into an amendment to its loan agreement with Hercules that provides, at no incremental cost to Genocea, for a deferred principal payment period of 3 months commencing on February 1, 2018. During this time Genocea will continue to make monthly payments of interest. Genocea has initiated a process to restructure or refinance the debt facility to better align repayment of the debt with its new corporate strategy and anticipated clinical milestones. If this process is successful, the company expects to be able to defer certain debt principal payments, thereby reducing expected significant cash payments in 2018 and 2019 relating to the current debt facility.

Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the second half of 2019 without assuming the expected benefit of the restructuring or refinancing of its debt facility.

Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers and referencing the conference ID number 7396178. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 30 days.

Fourth Quarter 2017 Financial Results

Cash Position: As of December 31, 2017, cash and cash equivalents were $12.3 million compared to $22.0 million as of September 30, 2017.
Research and Development (R&D) Expenses: R&D expenses decreased approximately $3.9 million to $7.9 million for the quarter ended December 31, 2017 from $11.8 million for the same period ended December 31, 2016. The decrease was primarily driven by $6.5 million in reduced GEN-003 costs, as a result of the strategic shift and restructuring announced in September 2017. Decreases in GEN-003 costs were offset by a $3.9 million increase in costs incurred on the Company’s GEN-009 program as it continued to develop its supply chain and manufacturing capabilities to prepare for the planned IND filing and initiation of clinical trials for GEN-009.
General and Administrative (G&A) Expenses: G&A expenses decreased approximately $1.4 million to $2.5 million for the quarter ended December 31, 2017 from $3.9 million for the quarter ended December 31, 2016. The decrease was driven by reduced compensation, consulting and professional service costs, depreciation and facility related costs.
Net Loss: Net loss was $10.7 million for the quarter ended December 31, 2017, compared to a net loss of $16.0 million for the same period in 2016.

Full Year 2017 Financial Results

Cash Position: As of December 31, 2017, cash and cash equivalents were $12.3 million compared to cash, cash equivalents, and investments totaling $63.4 million as of December 31, 2016.

R&D Expenses: R&D expenses increased approximately $4.6 million to $39.2 million for the year ended December 31, 2017 from $34.6 million for the year ended December 31, 2016. On a program basis, GEN-009 and other immuno-oncology costs increased by $9.5 million, driven primarily by increased headcount, consulting and professional service costs, manufacturing and clinical and lab related costs in anticipation of the expected IND filing for GEN-009 in early 2018. GEN-003 costs increased $1.9 million, driven by increased external manufacturing related expenses, headcount and consulting and professional service costs in advance of the previously planned Phase 3 trials, offset by decreased clinical and lab related costs. Increased spending on these programs was offset by lower costs on other infectious disease programs previously deprioritized in 2016.

G&A Expenses: General and administrative expense decreased $2.0 million to $13.4 million for the year ended December 31, 2017 from $15.4 million for the year ended December 31, 2016. Decreases were driven by lower consulting and professional services costs, facility-related costs and depreciation.

Restructuring: As a result of the Company’s strategic shift to immuno-oncology, which was announced in September 2017, restructuring charges of $2.6 million were incurred for employee severance, employee benefits, contract terminations and asset impairment. Of these charges, $1.1 million were paid through December 31, 2017, $0.5 million were recorded as accrued expenses at December 31, 2017 and $1.0 million were non-cash charges recorded during the year ended December 31, 2017.

Net Loss: Net loss was $56.7 million for the year ended December 31, 2017, compared to a net loss of $49.6 million for the year ended December 31, 2016.