On July 9, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that the Centers for Medicare & Medicaid Services (CMS) has established a unique, product-specific billing code for PEMFEXY (pemetrexed for injection) (Press release, Eagle Pharmaceuticals, JUL 9, 2020, View Source [SID1234561802]). This new Healthcare Common Procedure Coding System (HCPCS) code, or J-code, is J9304 (Injection, pemetrexed (PEMFEXY), 10 mg). The J-code will become effective on October 1, 2020.

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The new HCPCS code provides coding clarity to outpatient facilities and physicians who will administer PEMFEXY, facilitating access for patients and reimbursement from Medicare, Medicaid and commercial insurance.

In February 2020, Eagle received final approval of its New Drug Application (NDA) from FDA for PEMFEXY, a branded alternative to ALIMTA, following settlement of patent litigation with Eli Lilly and Company. The Company is entitled to initial market entry (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.

The Company also received a supplement approval from FDA for a 500mg multiple-dose vial of PEMFEXY on June 18, 2020.

About PEMFEXY

PEMFEXY is a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin.

On July 9, 2020 JS InnoPharm Ltd reported the enrollment of the first patient in a Phase 1, open-label, monotherapy dose-escalation and expansion study of JSI-1187, the company’s lead investigational drug candidate targeting the enzymes ERK1 and ERK2 (Press release, JS InnoPharm, JUL 9, 2020, View Source [SID1234561801]). The study is being conducted at 4 NCI-designated Comprehensive Cancer Centers in the U.S. JS InnoPharm holds the U.S. IND for JSI-1187, and this trial is being managed by Strategia Pharmaceuticals LLC, JS InnoPharm’s clinical development partner in the United States. Initiation of this clinical trial represents an important step in the company’s efforts to discover and develop precision medicine for cancer patients.

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of JSI-1187 in patients with relapsed, refractory solid tumors with MAPK mutations. The study will comprise three components: (1) a dose escalation phase of JSI-1187 monotherapy for patients with solid tumors, (2) a dose escalation phase of JSI-1187 in combination with BRAF inhibitor, dabrafenib, and (3) an expansion phase for patients with tumors harboring specific mutations.

"JSI-1187 is a selective ERK1/2 inhibitor. By utilizing an ERK inhibitor against tumors harboring mutations in the MAPK pathway, we hope to develop more effective single-agent and combination therapies by preventing the early development of resistance seen with current MAPK targeted agents," said Dr. Linda Paradiso, Chief Development Officer for Strategia Pharmaceuticals.

The Role of ERK in Cancer

MAPK signaling via the RAS-RAF-MEK-ERK cascade plays a critical role in cancer growth and proliferation. Alterations in the MAPK/ERK pathway are found in a variety of cancer types, with KRAS mutations in pancreatic (>90%), biliary tract (3-50%), colorectal (30-50%), lung (25-30%), ovarian (15-39%) and endometrial (18%) cancers; NRAS mutations in 20% of melanoma; and BRAF V600 mutations in 50% of melanoma and 7% of a variety of other tumor types. Although it has been demonstrated that BRAF/MEK inhibitor-targeted combination therapy provides a significant benefit beyond single agent therapy in melanoma and other cancers, the majority of patients eventually develop resistance and disease progression. Several mechanisms of acquired resistance have been identified and central to these mechanisms is the reactivation of ERK signaling. Therefore, ERK inhibition may provide the opportunity to avoid or overcome resistance from upstream mechanisms, as it is the most distal kinase of this signaling pathway.

About JSI-1187

JSI-1187 is a selective and orally administered small molecule inhibitor of ERK1 and ERK2. In preclinical studies, it demonstrated high potency against a variety of tumors with MAPK pathway mutations.

On July 9, 2020 Kronos Bio, Inc., dedicated to targeting oncogenic transcription factors and their associated transcriptional regulatory networks, reported results of a preclinical study of KB-0742, a highly potent, orally available and selective cyclin-dependent kinase 9 (CDK9) inhibitor. Results showed that KB-0742 inhibited tumor growth in a prostate xenograft model, as well as other cancers addicted to high levels of oncogenic transcription. The findings were presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II in June 2020 (Press release, Kronos Bio, JUL 9, 2020, View Source [SID1234561800]).

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"Current therapies that block androgen signaling are effective in prostate cancer, but most ultimately develop resistance. These preclinical study results provide strong evidence that KB-0742 inhibits tumor growth in vivo," said Norbert Bischofberger, Ph.D., President and Chief Executive Officer of Kronos. "Based in part on these data, we plan to advance KB-0742 into clinical development for the treatment of transcriptionally-addicted cancers. We anticipate submitting an IND in the fourth quarter of this year and initiating a Phase 1 dose-escalation study in early 2021."

In this study, which was conducted in collaboration with the Koehler Lab at the MIT Center for Precision Cancer Medicine and Koch Institute For Integrative Cancer Research at MIT, researchers used the small molecule microarray (SMM) discovery platform to identify novel modulators of the androgen receptor capable of overcoming therapy resistance in prostate cancer cells. The SMM screen identified KI-ARv-03, a small molecule that blocks androgen receptor dependent gene expression and is a highly selective inhibitor of the androgen receptor cofactor CDK9. KB-0742 is a more potent and drug-like small molecule CDK9 inhibitor designed and optimized at Kronos Bio.

KB-0742 showed selectivity for CDK9 over other CDK family members, downregulated AR-dependent oncogenic transcription, and reduced tumor cell growth and promoted apoptosis in vitro. Additionally, oral administration of KB-0742 (administered as a 3-day on/4-day off regimen) to mice that had been engrafted with castration resistant prostate cancer cells significantly inhibited tumor growth with modest effects on body weight. In a subsequent mouse xenograft study using a MYC-dependent acute myeloid leukemia model, KB-0742 administration again resulted in significant tumor growth inhibition with dose-dependent effects on pharmacodynamic markers of CDK9 inhibition in tumor.

On July 9, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of an independent, systematic review and meta-analysis demonstrating that its DecisionDx-Melanoma test is a significant predictor of recurrence and metastatic risk in patients with invasive cutaneous melanoma (Press release, Castle Biosciences, JUL 9, 2020, View Source [SID1234561799]).

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The article titled, "A Systematic Review and Meta-Analysis of Gene Expression Profiling for Primary Cutaneous Melanoma Prognosis," appeared in SKIN: The Journal of Cutaneous Medicine.

The study found that of all gene expression profile tests reported for cutaneous melanoma, DecisionDx-Melanoma was the only test described in the literature or commercially available with sufficient evidence to qualify for inclusion in the study. This is the second recently published systematic review and meta-analysis that demonstrates the independence and significance of DecisionDx-Melanoma prognosis for recurrence and metastatic risk in patients with invasive cutaneous melanoma.

Lichtman et al. Study Background and Results:

The purpose of this systematic review and meta-analysis was to consolidate the rapidly evolving body of data on gene expression profiling (GEP) in melanoma prognosis.
This study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)1.
The systematic review identified several GEP assays that have been described in the literature. However, aside from DecisionDx-Melanoma, none of the reported studies were supported by consistent reporting of results or enough evidence for inclusion in the meta-analysis performed by study co-authors.
The DecisionDx-Melanoma test was found to be a consistent, independent and significant predictor of survival, with a significant association between Class 2 test results and recurrence-free (Hazard Ratio [HR] = 7.22; p <0.00001), distant metastasis-free (HR = 6.62; p <0.00001) and overall (HR = 7.06; p <0.00001) survival rates.
DecisionDx-Melanoma test results were also associated with sentinel lymph node biopsy status (odds ratio calculation; p<0.00001).
Results of the study indicate that the DecisionDx-Melanoma test achieved the highest Strength of Recommendation Taxonomy (SORT) level of evidence for a prognostic biomarker (Level 1 evidence). The SORT system is used by the American Academy of Dermatology (AAD) and other organizations to evaluate the quality, quantity and consistency of evidence supporting tests such as DecisionDx-Melanoma. The SORT scale evaluates both the quality of the evidence (Level 1, 2 or 3) and strength of the recommendation (A, B or C).

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through March 31, 2020, DecisionDx-Melanoma has been ordered more than 56,800 times for use in patients with cutaneous melanoma.

On July 9, 2020 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its second quarter 2020 financial results on Thursday, July 30, 2020 after the close of financial markets (Press release, Seattle Genetics, JUL 9, 2020, View Source [SID1234561797]). Following the announcement, Company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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Thursday, July 30, 2020
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 866-248-8441 (domestic) or +1 720-452-9102 (international); conference ID 1128188
Webcast with slides available at www.seattlegenetics.com in the Investors section. A webcast replay will be archived on the Company’s website.