On July 27, 2020 Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee"), reported that it has submitted to the U.S. Food and Drug Administration a 505(b)(2) New Drug Application for Camcevi 42mg (FP-001 LMIS 50mg), a ready-to-use 6-month depot formulation of leuprolide mesylate (Press release, Foresee Pharmaceuticals, JUL 27, 2020, View Source [SID1234562417]). The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer.

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This NDA submission is supported by a previously communicated successful Phase 3 study in 137 Advanced Prostate Carcinoma patients, where treatment with LMIS 50 mg injection every 6 months was demonstrated to be effective, safe and well tolerated.

"In the NDA submission in 2019, FDA suggested that additional device design verification data on the combination product be provided. Since then, with tireless efforts and commitment from the Foresee team and collaborators, as well as continued support of our investors, we have undertaken diligent preparation for the requested information," said Dr. Ben Chien, Founder and Chairman of Foresee. "We are confident in the resubmission of the NDA."

"Next step for the FP-001 franchise will be to establish a strong commercial partnership in the US and to prepare for the NDA submission of the 3-month depot of Camcevi. We look forward to the successful launch of the FP-001 franchise, providing patients with its differentiated ready-to-use profile." said Dr. Ben Chien.

On July 27, 2020 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the second quarter ended June 30, 2020 (Press release, Medpace, JUL 27, 2020, View Source [SID1234562416]).

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Second Quarter 2020 Financial Results

Revenue for the three months ended June 30, 2020 decreased 4.3% to $205.0 million, compared to $214.1 million for the comparable prior-year period. On a constant currency organic basis, revenue for the second quarter of 2020 decreased 4.1% compared to the second quarter of 2019.

Backlog as of June 30, 2020 grew 14.6% to $1.3 billion from $1.2 billion as of June 30, 2019. Net new business awards were $254.1 million, representing a net book-to-bill ratio of 1.24x for the second quarter of 2020, as compared to $279.2 million for the comparable prior-year period. The Company calculates the net book-to-bill ratio by dividing net new business awards by revenue.

For the second quarter of 2020, total direct costs were $148.4 million, compared to total direct costs of $150.3 million in the second quarter of 2019. Selling, general and administrative (SG&A) expenses were $21.9 million in the second quarter of 2020, compared to SG&A expenses of $23.6 million in the second quarter of 2019.

GAAP net income for the second quarter of 2020 was $24.1 million, or $0.64 per diluted share, versus GAAP net income of $27.5 million, or $0.73 per diluted share, for the second quarter of 2019. This resulted in a net income margin of 11.8% and 12.8% for the second quarter of 2020 and 2019, respectively.

EBITDA for the second quarter of 2020 decreased 12.9% to $35.0 million, or 17.1% of revenue, compared to $40.2 million, or 18.8% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the second quarter of 2020 decreased 15.0% from the second quarter of 2019.

A reconciliation of the Company’s non-GAAP financial measures, including EBITDA and EBITDA margin to the corresponding GAAP measures is provided below.

Balance Sheet and Liquidity

The Company’s Cash and cash equivalents were $160.9 million at June 30, 2020, and the Company generated $44.3 million in cash flow from operating activities during the second quarter of 2020. During the second quarter of 2020, the Company repurchased approximately 0.11 million shares at an average price of $68.65 per share for a total of $7.6 million. The Company had $49.2 million remaining under its authorized share repurchase program at the end of the quarter.

Financial Guidance

The Company forecasts 2020 revenue in the range of $880.0 million to $920.0 million, representing growth of 2.2% to 6.9% over 2019 revenue of $861.0 million. GAAP net income for full year 2020 is forecasted in the range of $136.0 million to $144.0 million. Additionally, full year 2020 EBITDA is expected in the range of $180.0 million to $190.0 million. Based on forecasted 2020 revenue of $880.0 million to $920.0 million and GAAP net income of $136.0 million to $144.0 million, diluted earnings per share (GAAP) is forecasted in the range of $3.62 to $3.83. This guidance assumes a full year 2020 tax rate of 15.0% to 16.0% and does not reflect the potential impact of any share repurchases the Company may make pursuant to the share repurchase program.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, July 28, 2020, to discuss its second quarter 2020 results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 7182886.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available at 12:00 p.m. ET on Tuesday, July 28, 2020 until 12:00 p.m. ET on Tuesday, August 11, 2020. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 7182886.

On July 27, 2020 ProMab Biotechnology, Inc., a leading developer of CAR-T/NK cell technology for global life sciences, reported it has successfully completed an investigator initiated trail (IIT) for CAR-T cell therapy (Press release, ProMab Biotechnologies, JUL 27, 2020, View Source [SID1234562415]). The study was conducted at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology by Prof. Hu Yu and Prof. Mei Heng in collaboration with Wuhan Sian Medical Technology using ProMab’s humanized CD19 CAR-T cells for 10 patients with relapsed and refractory CD19-positive B-cell malignant hematological tumors, including acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and patients with non-Hodgkin’s lymphoma (NHL). The study has received very promising results of the safety and efficacy of humanized CD19 CAR-T treatment. Among the 10 cases studied, 7 patients were in continuous remission. At present, the longest continuous remission was 9 months. The study also demonstrated that the Cytokine Release Syndrome (CRS) side effects were significantly reduced, specifically; there were 5 patients with level 1 side effects and 4 patients without CRS side effects at all. The results have demonstrated that the humanized CD19 CAR-T cell therapy is safe and effective. The data also indicated that the complete remission rate is greatly improved compared to the mouse version of CD19 CAR-T.

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ProMab’s humanized CD19 CAR-T platform is a CAR T-cell therapy approved for adults with treatment of relapsed and refractory hematological tumors. By empowering an individual’s immune system to recognize and destroy cancer cells, CAR-T cell therapy can give the individual a fighting chance when cancer returns or resists other treatments. "In our clinical study of 10 patients with hematological tumors who had experienced other treatment failures, ProMab helped 70% [7 out of 10] of patients achieve complete remission," said John Wu, President and CEO of ProMab. "We are aiming to provide patients with alternative means to treat their hematological tumors and save more lives. ProMab’s CAR-T/NK cell technology platforms can meet that goal. Our study with humanized CD19 CAR-T cells for the treatment of relapsed and refractory hematological tumors have demonstrated hope for patients and the future of CAR-T technology," added John Wu.

On July 27, 2020 Zebra Medical Vision, the deep-learning medical imaging analytics company, reported its sixth FDA 510(k) clearance for its mammography solution, HealthMammo, which has already received a CE mark. Zebra Medical’s algorithm empowers breast radiologists by prioritizing and identifying suspicious mammograms, providing a safety net for radiologists (Press release, Zebra Medical Vision, JUL 27, 2020, View Source [SID1234562414]). The suspicious mammograms are identified faster and read earlier than the current "first-in first-out" standard of care.

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This is Zebra Medical Vision’s first solution for Oncology to receive FDA clearance, as part of the company’s AI1 "All-In-One" bundle. Zebra Medical is also the first startup to receive FDA clearances for AI based technology across three imaging modalities – CT, x-ray and mammography, providing coverage for roughly 80% of the total imaging volumes.

Breast cancer is the most frequently diagnosed cancer among women, impacting 2.1 million women worldwide each year and causing the greatest number of cancer-related deaths among women. It is estimated that 627,000 women died from breast cancer in 2018, approximately 15 percent of all cancer-related female deaths. While breast cancer rates are higher among women in more developed regions, rates are increasing in nearly every region globally1.

Zebra Medical’s HealthMammo solution is an automatic AI tool that indicates "suspicious" or "not suspicious" for every 2D mammography performed. The mammograms are automatically sent to Zebra Medical’s imaging analytics platform, where they are processed and analyzed for suspected breast lesions. The HealthMammo product then returns its result to the radiologist, either by signaling within the worklist or by notifying the user in a dedicated application.

The algorithm can be used in single reader paradigms, supporting triage and workflow improvement (as cleared by the FDA) or in double reading paradigms, already available outside of the US, supporting the second radiologists and reducing their workload.

Supporting early detection protocols, Zebra Medical Vision’s HealthMammo product helps health providers minimize the COVID-19-induced care gaps with an automated AI tool that can identify faster patients with suspicious lesions. According to the United States Food & Drug Administration (FDA) Mammography Quality Standards program (MQSA), approximately 40 million mammograms are performed in the U.S. every year. With the outbreak of coronavirus, annual mammography tests during lockdown were postponed or canceled. As a result, providers are dealing with substantial growing backlogs, as 100,000 screens are added every day in the US alone2, in addition to a 94% drop in mammography imaging volumes during lockdown3. Patients are experiencing increasing anxiety waiting to be tested and run the risk of missing the early detection component of annual screening which could result in an undetected cancer that keeps growing.

"As restrictions are lifted from the COVID-19 crisis, the backlog of mammograms has increased," says Dr. Michael Fishman, Breast Imaging Section Chief at Boston Medical Center (BMC), Massachusetts. "Zebra Medical Vision’s HealthMammo may help radiologists deal with the screening management strategy of the post COVID backlog and triaging."

"Our work is twofold: supporting the medical team’s overload and ensuring the well-being of patients, by supporting early detection and reducing the anxiety surrounding uncertainty," says Ohad Arazi, CEO of Zebra Medical Vision. "The fact that during initial testings we were able to identify 2 cases that were missed, and to have these women be recalled and diagnosed with cancer, shows the vast impact and potential contribution of AI in Oncology. With this fully commercial and regulated product, we aim to provide even more value and help patients and providers navigate the new COVID effected reality we are all facing. We’re proud of the achievements we’ve made in the past few months, providing U.S. healthcare with a growing portfolio of automatic solutions to enhance patient care, especially during these times."

Read more on Zebra Medical Vision’s blog:
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On July 27, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that data from the cervical cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the safety and efficacy of neratinib in HER2-mutated cancers, were published in the journal Gynecologic Oncology (Press release, Puma Biotechnology, JUL 27, 2020, View Source [SID1234562413]). The paper, "Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial," appears in the July 25, 2020 online issue at View Source(20)33660-X/pdf and will be published in a future print issue of the journal.

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The Phase II SUMMIT ‘basket’ trial is an open-label, international multi-histology study to evaluate the safety and efficacy of neratinib, administered daily to patients, across a broad spectrum of cancer types in patients whose tumors harbor activating HER2 somatic mutations. The primary endpoint was confirmed objective response rate. Secondary endpoints included response duration, clinical benefit rate, progression-free survival, overall survival, and safety.

Sixteen patients with HER2-mutant, persistent, metastatic or recurrent cervical cancer with disease progression after platinum-based treatment for advanced or recurrent disease were enrolled in the cohort and received oral neratinib daily with mandatory loperamide prophylaxis during the first cycle.

Three of 12 RECIST-measurable patients had confirmed partial responses (overall response rate of 25%; 95% CI 5.5–57.2%); three had stable disease more than 16 weeks (clinical benefit rate of 50%; 95% CI 21.1–78.9%). Response duration for responders were 5.6, 5.9, and 12.3 months. Median progression-free survival was 7.0 months (95% CI 1.0–18.3 months) and the median overall survival was 16.8 months (95% CI 4.1–months not evaluable).

The safety profile observed in neratinib-treated cervical cancer patients in SUMMIT was consistent with that reported for HER2-positive metastatic breast cancer. Diarrhea (75%), nausea (44%), and decreased appetite (38%) were the most common of all grade adverse events. One patient (6%) reported grade 3 diarrhea. The rate of grade 3 diarrhea was considerably lower than reported for metastatic breast cancer patients. While this is a limited dataset, more remains to be revealed as more patients are enrolled. There were no grade 4 events, and no diarrhea-related treatment discontinuations.

Dr. Bradley J. Monk, Professor in the Division of Gynecologic Oncology, University of Arizona College of Medicine and Medical Director of the US Oncology Research Network Gynecological Program, said, "Neratinib demonstrates encouraging clinical activity in metastatic cervical cancer patients with tumors harboring an activating HER2 mutation. Given the limited options for the treatment of cervical cancer after platinum-based therapy failure, neratinib warrants further investigation in this molecular-defined patient population."

The data was initially presented by Anishka D’Souza, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine of University of Southern California (USC), during the scientific plenary session at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting in March 2019.

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer. We look forward to the further development of neratinib in this patient population."