On August 9, 2018 i2 Pharmaceuticals, Inc., a biopharmaceutical company focused on next generation discovery and development of therapeutics with a focus on personalized cancer treatment, reported the appointment of David Stover, Ph.D., as Chief Executive Officer, effective July 1, 2018 (Press release, i2 Pharmaceuticals, AUG 9, 2018, View Source [SID1234528583]). Dr. Stover brings to i2 over 25 years of experience in both small-molecule and biologics drug discovery and development.

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"Dave is an accomplished pharmaceutical researcher and scientist with considerable experience in the development of novel antibody-based therapeutics," stated Bruce Eaton, Ph.D., i2’s Chairman of the Board. "We are extremely pleased to have Dave at the helm of the Company as we enter a strategic growth-phase driving our new business opportunities in antibody therapeutics."

Dr. Stover commented, "I am excited for this opportunity and look forward to working with the i2 team, Board members and advisors as we seek to optimize the value of the Company’s unique and proprietary suite of transformative technologies and assets. Our goal at i2 is to leverage the breadth of i2’s cutting edge discovery technologies to develop new novel-antibody based therapeutics."

Prior to joining i2 Pharma, Dr. Stover was most recently head of Agensys, Inc., an Astellas Pharma affiliate focused on antibody and antibody drug conjugate development, where he led a team of 240 employees in the research, clinical manufacturing and development of five investigational new drugs and four clinical proof of concepts during a 5-year period. Dr. Stover also founded the Oncology Biologics department at Novartis, where he served as its director, developing three clinical product candidates. Previously, he held the position of vice president of drug discovery at MDS Proteomics, where he managed research sites in Cambridge, MA, Charlottesville, VA and Toronto. Earlier in his career, Dr. Stover was the first employee and director of biochemistry at Kinetix Pharmaceuticals, a small-molecule kinase inhibitor company that was acquired by Amgen in 2000.

Dr. Stover earned his Ph.D. in Biochemistry at the University of Washington and holds a Bachelor of Science degree in Zoology from Duke University.

On August 9, 2018 JHL Biotech has reported it received a positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for its proposed bevacizumab biosimilar, JHL1149 to treat patients with non-small cell lung cancer (NSCLC) (Press release, JHL Biotech, AUG 9, 2018, View Source [SID1234528582]).

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The EMA, like other regulatory authorities such as the U.S. Food and Drug Administration and State Drug Administration of China (SDA), adopts the principle of a step-wise approach and the totality of the evidence from all studies in regulating the development and approval of biosimilars. In its correspondence to JHL, the EMA confirmed it agrees with JHL’s development approach, clinical development proposal, and study design of the global Phase III clinical study for JHL1149 in patients with non-small cell lung cancer (NSCLC). Based on the EMA’s review of these factors, the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully

On August 9, 2018 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended June 30, 2018 and provided a corporate update (Press release, Portola Pharmaceuticals, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363072 [SID1234528581]).

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"The second quarter of 2018 brought a significant addition to our product suite with the U.S. Food and Drug Administration’s Accelerated Approval of Andexxa and the initiation of our Early Supply Program. Together with Bevyxxa, we now have two FDA-approved, first-and-only medicines for their indications in the field of thrombosis with the potential to impact public health," said Mardi Dier, interim co-president and chief financial officer of Portola. "In the second half of the year, we remain focused on continuing to lay the foundation for the U.S. launch of Bevyxxa and preparing for a number of significant milestones, including our regulatory submission in the U.S. for the Generation 2 Andexxa product, review and potential approval for andexanet alfa in Europe, and determining the development and regulatory path forward for cerdulatinib, our Syk/JAK inhibitor and the third novel compound discovered in our labs."

Second Quarter 2018 Financial Results
Total revenue for the second quarter of 2018 was $4.0 million, compared with $3.8 million for the second quarter of 2017. This includes $1.7 million in collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company, Pfizer, Bayer Pharma, Janssen Pharmaceuticals and Daiichi Sankyo, as well as $2.2 million from initial sales of Andexxa in the U.S. under the Company’s Early Supply Program launched in May 2018, and $33,000 in product revenue from sales of Bevyxxa, which launched in the U.S. in January 2018.

Total operating expenses for the second quarter of 2018 were $107.7 million, compared with $69.6 million for the same period in 2017. Total operating expenses for the second quarter of 2018 included $13.2 million in stock-based compensation expense, compared with $13.3 million for the same period in 2017.

Research and development expenses were $66.4 million for the second quarter of 2018, compared with $49.3 million for the second quarter of 2017. The increase is due to the second Generation 2 Andexxa commercial manufacturing campaign. Selling, general and administrative expenses for the second quarter of 2018 were $40.2 million, compared with $20.3 million for the same period in 2017. The increase is due to the build-out of the field force and marketing spend for the Andexxa Early Supply Program and the Bevyxxa launch.

For the second quarter of 2018, Portola reported a net loss of $106.2 million, or $1.61 net loss per share, compared with a net loss of $69.7 million, or $1.22 net loss per share, for the same period in 2017. Shares used to compute net loss per share attributable to common stockholders were 65.9 million for the second quarter of 2018 compared with 57.1 million for the same period in 2017.

Cash, cash equivalents and investments at June 30, 2018 totaled $456.7 million, compared with $534.2 million as of December 31, 2017.

Based on the FDA approval of Andexxa in May 2018, the Company earned an additional $100 million milestone payment from its royalty-based financing arrangement with Health Care Royalty Partners.

Recent Achievements and Events

Received Accelerated Approval from the FDA for Andexxa and initiated commercial launch under the Early Supply Program.
Completed the second successful manufacturing campaign of Generation 2 Andexxa product.
Continued progress with the Bevyxxa U.S. commercial launch, including formulary wins, reimbursement coverage and physician education.
New interim results from the ongoing Phase 2a study of cerdulatinib presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper).
Four abstracts presented at the International Society on Thrombosis and Haemostasis (ISTH) meeting.
Received New Technology Add-on Payment for Andexxa from the Centers for Medicare and Medicaid Services.
Upcoming Milestones

Eight abstracts to be presented at the European Society of Cardiology (ESC) meeting.
Submit Prior Approval Supplement (PAS) for Generation 2 Andexxa product by the end of August, positioning the Company for a broader commercial launch in early 2019, upon FDA approval.
On track to deliver additional data to European regulatory authorities in the fourth quarter, with potential for European approval of andexanet alfa in the first half of 2019.
Ongoing discussion with the FDA on the potential regulatory pathway for cerdulatinib.
Conference Call Details
Portola will host a conference call today, Thursday, August 9, 2018, at 8:30 a.m. ET, during which time management will discuss the second quarter 2018 financial results, updates on the U.S. launches of Andexxa and Bevyxxa, and other matters. The live call can be accessed by phone by dialing (844) 452-6828 from the U.S. and Canada or 1 (765) 507-2588 internationally and using the passcode 6650817. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

On August 9, 2018 Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, reported the publication of an independent study from a dermatology practice, in a prospectively collected cohort, showing that the DecisionDx-Melanoma prognostic test can accurately identify patients at high and low risk of metastasis and death from melanoma (Press release, Castle Biosciences, AUG 9, 2018, View Source [SID1234528575]). Patients identified as high risk were found to be 22 times more likely to develop metastasis than those with a low-risk test result. Overall this 256-patient study is consistent with previous prospective and retrospective studies and confirms the prognostic value of the DecisionDx-Melanoma test. The study was authored by Dr. Bradley Greenhaw and colleagues and published in Dermatologic Surgery.

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Study Findings:

High negative predictive value of 98.6% provides a high degree of confidence in a low risk of metastasis for Class 1 patients.
Class 2 patients were 22 times more likely to develop metastasis than patients with a Class 1 result.
The 5-year melanoma-specific survival (MSS) rate was also significantly different between groups with 99% survival for Class 1 patients and 79% survival for Class 2 patients (p<0.0001).
The authors indicate that they now offer the DecisionDx-Melanoma test to all patients with invasive cutaneous melanoma and provide more intensive follow-up for Class 2 patients to support timely detection of metastasis and earlier intervention with therapy.
"These robust findings from an independent study demonstrating that the DecisionDx-Melanoma test can identify early-stage melanoma patients who are at high risk for metastasis and death are consistent with previous retrospective and prospective studies," said lead author Bradley Greenhaw, M.D., Dermatology Center of North Mississippi, Tupelo, Mississippi. "In this dermatology practice, as in many others across the country, the DecisionDx-Melanoma test has been incorporated into practice protocols to improve patient management decisions based on recurrence risk beyond clinicopathologic staging alone."

Study Details:

The study was conducted at a single dermatology center and included 256 patients who were identified using the center’s prospectively collected melanoma registry. Patients were diagnosed with cutaneous melanoma during the previous 5 years and were prospectively tested with DecisionDx-Melanoma as part of their initial diagnostic work-up or tested as part of their follow-up care. Retrospective chart review was used in cases of missing data in the registry.
86% of patients had American Joint Committee on Cancer (AJCC) Stage I melanoma, and 14% had Stage II disease.
214 patients had a Class 1 DecisionDx-Melanoma test result; 42 patients were Class 2. Mean follow-up time was 23 months.
The paper can be accessed at the Dermatologic Surgery website.

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. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

On August 9, 2018 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the second quarter ended June 30, 2018 and provided a corporate update (Press release, Aviragen Therapeutics, AUG 9, 2018, View Source [SID1234528574]).

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"We are encouraged by the recent publications in Vaccine and the Journal of Clinical Investigation Insight recognizing the unique ability of our oral recombinant vaccines to elicit both systemic and mucosal immune responses, further validating the value of our proprietary platform," said Wouter Latour, M.D., chief executive officer of Vaxart. "Our team is fully focused on advancing our vaccine programs, and we are on track to initiate our Phase 1 norovirus bivalent study and Phase 2 norovirus challenge study later this year."

Second Quarter 2018 and Recent Highlights:

Corporate:

· On May 31, 2018, the Company presented additional data on the previously disclosed Phase 1 norovirus vaccine trial in a poster presentation at the American Society of Microbiology 2018. As described in the poster, the Vaxart GI.1 norovirus tablet vaccine generated IgG and IgA antibodies in serum that were highly cross-reactive against other GI genotypes, specifically GI.3 and GI.4.

· On June 4, 2018, Vaxart reported the topline results from a Phase 2 clinical trial evaluating teslexivir, a small-molecule antiviral for the treatment of condyloma that Vaxart obtained in the acquisition of Aviragen earlier in 2018, in which the primary efficacy endpoint was not achieved.

· On June 27, 2018, the Company announced the publication of preclinical results from its oral F-protein based Respiratory Syncytial Virus (RSV-F) vaccine in Vaccine. As described in the article, the oral RSV-F vaccine candidate provided complete sterilizing protection against RSV infection in the cotton rat challenge model at the target dose.

· On July 12, 2018, Vaxart announced the publication of the comprehensive results of the previously disclosed Phase 1 clinical trial with its norovirus oral tablet vaccine in the Journal of Clinical Investigation Insight. As reported in the article, the vaccine generated robust systemic and mucosal immune responses, including mucosal IgA, memory B cells, and serum blocking antibody titers (BT50), all potential correlates of protection.

Second Quarter 2018 Financial Results

· Vaxart ended the quarter with cash and cash equivalents of $23.9 million compared to $17.5 million at March 31, 2018. The increase was primarily due to $12.0 million received from royalty payments offset by cash used in operations.

· Revenue for the quarter was $0.6 million compared to $1.9 million in the second quarter of 2017. The decrease was due to lower revenues from the contract with HHS BARDA, where activities are winding down.

· Research and development expenses were $5.0 million for the quarter compared to $4.3 million for the second quarter of 2017. The increase was due to additional personnel, amortization of intangibles and clinical trial costs resulting from the merger with Aviragen, offset by lower expenditures on the HHS BARDA activities and Vaxart’s norovirus Phase 1 clinical trial.

· General and administrative expenses were $1.8 million for the quarter compared to $0.7 million for the second quarter of 2017. The increase was due to the additional costs of being a public company, including the costs of additional personnel and higher legal and other services.

· During the quarter, Vaxart recognized an impairment charge of $1.6 million resulting from the write-off of the teslexivir intangible asset acquired in the merger with Aviragen.