On May 7, 2018 Provectus reported the completion of enrollment of 24 patients with metastatic melanoma into the Phase 1b portion of the Company’s Phase 1b/2 study of intralesional ("IL") PV-10 in combination with KEYTRUDA (pembrolizumab), Merck & Co.’s systemic anti-PD-1 (programmed death receptor-1) antibody (ClinicalTrials.gov identifier: NCT02557321) (Press release, Provectus Pharmaceuticals, MAY 7, 2018, View Source [SID1234526176]). This study’s endpoints include those currently suitable for a registration trial.

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Provectus also plans to present comprehensive Phase 1b data in the first half of 2019.

Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com) ("Provectus" or the "Company") is a clinical-stage biotechnology company developing PV-10 as the first small molecule oncolytic immunotherapy for solid tumor cancers.

About PV-10

Provectus’ lead investigational oncology drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

About our Phase 1b/2 Study of PV-10 + KEYTRUDA for Metastatic Melanoma

Patients with metastatic melanoma having at least one injectable cutaneous or soft tissue lesion were eligible for participation in the Phase 1b portion of the study and received the combination of IL PV-10 and KEYTRUDA every three weeks for up to five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability. Objective response rate and progression-free survival are key secondary endpoints; both are assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter.

On May 7, 2018 Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, reported that Chief Commercial Officer William Meury will present at the Bank of America Merrill Lynch Healthcare Conference in Las Vegas, Nevada (Press release, Allergan, MAY 7, 2018, View Source(1) [SID1234526160]). The presentation will begin at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time) on Thursday, May 17, 2018.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at www.allergan.com/investors. The webcast can also be accessed through the following URL: https://www.veracast.com/webca…

An archived version will be available within approximately one hour of the live presentation, and can be accessed at the same location for 90 days.

On May 7, 2018 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the first quarter of 2018 (Press release, ArQule, MAY 7, 2018, View Source [SID1234526161]).

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For the quarter ended March 31, 2018, the Company reported a net loss of $6,532,000, or $0.07 per share, compared with net loss of $7,576,000, or $0.11 per share, for the quarter ended March 31, 2017.

At March 31, 2018, the Company had a total of approximately $42,884,000 in cash and marketable securities.

Key Highlights

ARQ 531, our potent and reversible BTK inhibitor, demonstrated good oral bioavailability and pharmacokinetics in data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) on April 15, 2018. The Phase 1a portion of the Phase 1a/b trial continues to recruit on schedule with no safety concerns, and we plan to present more advanced data at one or more major congresses later in 2018.
Miransertib, our lead proprietary AKT inhibitor, was featured in an oral presentation at AACR (Free AACR Whitepaper) in which it showed positive signs of activity in hormone- sensitive tumors with AKT1 or PI3K dysregulation. The Phase 1b trial of miransertib with anastrozole in patients with advanced endometrial cancer produced one complete response and three partial responses out of 8 patients and continues to recruit.
Miransertib has been granted Orphan Drug Designation by EMA for the rare disease, Proteus syndrome. We continue to make progress with our registrational strategy in Proteus syndrome; in addition, we are progressing our rare disease expansion strategy with the Phase 1/2 trial in PROS and Proteus syndrome which is recruiting on schedule.
The Company granted Basilea Pharmaceutica Ltd. ("Basilea") an exclusive license to develop and commercialize derazantinib, our pan-FGFR inhibitor, in all parts of the world except the People’s Republic of China, Hong Kong, Macau and Taiwan, where the Company has licensed rights to Sinovant Sciences, Ltd., a subsidiary of Roivant Sciences Ltd. Terms of the transaction include a $10 million upfront payment, an additional $326 million in regulatory and commercial milestones, and royalties on net sales ranging from single to double digits; Basilea will be responsible for all costs and expenses of development, manufacture and commercialization in its territory.
"We have continued to build on the momentum that we created during 2017 with presentations of important data at the recent AACR (Free AACR Whitepaper) meeting and the licensing of derazantinib to our partner, Basilea," said Paolo Pucci, Chief Executive Officer of ArQule. "This new partnership further supports our mid-term strategy by allowing us to develop derazantinib in ways that we could not have done on our own and by strengthening our balance sheet thus enabling us to focus more on our BTK and ATK programs in potential fast-to-market settings."

"After a very strong 2017 scientifically, our execution in 2018 continues to be at a high level, highlighted by continuing progress across all pipeline assets," said Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer of ArQule. "We are approaching therapeutic levels in the dosing of patients in the Phase 1a/b trial with our BTK inhibitor, ARQ 531, and look forward to presenting a comprehensive data set from that trial later this year. The AKT program is also progressing well in both rare diseases and oncology. We are launching an expansion of the Phase 1b trial with miransertib plus anastrozole in patients with advanced endometrial cancers and are executing our registrational strategy for Proteus and PROS."

Revenues and Expenses

Revenues for the quarter ended March 31, 2018, were $4,138,000 compared with revenues of zero for the quarter ended March 31, 2017. Research and development revenue in the quarter ended March 31, 2018 consisted of $3,000,000 from the February 2018 Roivant licensing agreement and $1,138,000 from our October 2017 non-exclusive license agreement for certain library compounds.

Research and development expenses in the first quarter of 2018 were $5,812,000, compared with $5,194,000 for the first quarter 2017.

Research and development expenses increased $0.6 million in the first quarter of 2018 compared to the first quarter of 2017 primarily due to higher outsourced pre-clinical, clinical and product development costs.

General and administrative expenses in the first quarter of 2018 were $2,351,000, compared with $2,074,000 for the first quarter of 2017. General and administrative expenses increased $0.3 million in the first quarter of 2018 compared to the first quarter of 2017 primarily due to higher labor related costs of $0.2 million and professional fees of $0.1 million.

2018 Updated Financial Guidance

As a result of the April 2018 exclusive license agreement with Basilea, our guidance for 2018 is being updated. For 2018, ArQule now expects revenue to range between $14 and $17 million. Net use of cash is expected to range between $27 and $29 million for the year. Net loss is expected to range between $16 and $21 million, and net loss per share to range between $(0.18) and $(0.24) for the year. ArQule expects to end 2018 with between $40 and $42 million in cash and marketable securities.

Conference Call and Webcast

ArQule will hold its first quarter 2018 financial results call today, May 7, 2018 at 9:00 a.m. ET. The live webcast can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investor and Media" section of our website, www.arqule.com, under "Events & Presentations."

Cellular Biomedicine Group has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 7, 2018 Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer treatment decisions, reported the presentation of data supporting clinical use of the DecisionDx-Melanoma test to inform sentinel lymph node biopsy (SLNB) recommendations (Press release, Castle Biosciences, MAY 7, 2018, View Source [SID1234526162]). The study was presented as a poster at the American College of Mohs Surgery (ACMS) 50th Annual Meeting in Chicago.

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The study found that the DecisionDx-Melanoma test result can be used with clinicopathologic factors to inform patient discussions and recommendations for SLNB in line with national melanoma clinical practice guidelines.

Study Background:

SLNB is recommended to assess prognosis of melanoma patients. Current guidelines recommend that clinicians discuss the SLNB procedure with patients who have a greater than 5% likelihood of SLN positivity; the guidelines do not generally recommend the procedure if a patient has a less than 5% likelihood of SLN positivity.
Previously, a patient’s risk for SLN positivity has been determined using traditional clinicopathologic features such as Breslow’s thickness and ulceration status. Importantly, it is recognized that older patients have a lower likelihood of SLN positivity but are at higher risk of recurrence and death from melanoma.
The DecisionDx-Melanoma test is a 31-gene expression profile (GEP) test that uses tumor biology to provide an individual risk of recurrence in cutaneous melanoma patients. The validity and performance of the test has been confirmed in three multicenter archival tissue studies involving 690 patients and three prospective studies involving 702 patients. The test has been shown to be an independent predictor of recurrence compared to clinicopathologic factors of Breslow’s thickness, ulceration status, mitotic rate and SLN status.
This study was designed to determine whether the test could be used along with clinicopathologic factors to improve identification of patients with a low likelihood of SLN positivity (<5%) as well as those with a higher likelihood.
Key Study Findings:

Using the DecisionDx-Melanoma GEP test in combination with clinicopathologic factors of age and T category, an algorithm predicting the likelihood of SLN positivity was validated in two independent, prospective, multicenter cohorts totaling 1,421 patients.
For patients with T1-T2 tumors older than 65 years of age who had a Class 1A test result (lowest risk of recurrence), SLN positivity was less than the 5% threshold below which guidelines do not generally recommend the procedure.
For patients with T1-T2 tumors who had a Class 2B test result (highest risk of recurrence), SLN positivity exceeded the 10% threshold for all age groups. Guidelines suggest that patients whose SLN positivity risk exceeds 10% be offered the SLNB procedure.
The impact of not performing SLN biopsy in Class 1A patients was evaluated based on a retrospective dataset of 690 patients with long-term follow-up. At 5 years, Class 1A patients with T1-T2 tumors had a melanoma-specific survival of 99.6%, overall survival of 98.2%, and distant metastasis-free survival of 95.3%.
"The incorporation of the DecisionDx-Melanoma test result, along with tumor thickness and age, helps to identify a group of patients who have a likelihood of a positive sentinel lymph node of less than 5%, suggesting they may be able to safely avoid the SLNB procedure," said Federico Monzon, M.D., FCAP, Chief Medical Officer at Castle Biosciences. "Based on these study results, the DecisionDx-Melanoma test can inform the discussion of SLNB options with melanoma patients and provides an important advance in the management of early stage melanoma patients."

Oral Presentation Features Initial Data from Cutaneous Squamous Cell Carcinoma GEP Test Development Program

Also at the meeting, Dr. Sarah Arron, M.D., Ph.D., Associate Professor in the Department of Dermatology at the University of California San Francisco, presented initial data from Castle Biosciences’ prognostic GEP test in development for cutaneous squamous cell carcinoma (cSCC).

The goal of the development program is to validate a prognostic test that can predict which cSCC patients are at higher risk of metastasis or recurrence and thus inform clinical management decisions. Data from a development cohort of samples show that preliminary predictive models can improve upon current staging methods. These results support the feasibility of the program to develop a clinically valuable test to predict which cSCC patients are at higher risk for recurrence.

"For patients with cutaneous squamous cell carcinoma, accurate prediction of their individual risk of recurrence or metastasis remains a challenge," commented Dr. Arron, who is an investigator for the study. "The development of a prognostic test that improves risk prediction could better inform important management decisions such as optimal surgical procedure, use of adjuvant radiation and selection of patients for SLNB or adjuvant immunotherapy, and has the potential to drive improvements in patient management."

Continued collaborative site recruitment and development activities are ongoing.

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of 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 1,300 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 multicenter studies that included over 1,400 patients. Clinical impact has been demonstrated in multi-center and single-center studies showing that test results impact clinical management decisions for one of every two patients tested. More information about the test and disease can be found at www.SkinMelanoma.com.