On April 5, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company, taking a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, reported updated data following its presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Trovagene, APR 5, 2019, View Source;additional-patients-achieve-complete-response-at-two-highest-dose-levels-of-onvansertib-300825206.html [SID1234535017]). Additional data from its ongoing Phase 1b/2 study evaluating onvansertib in combination with standard-of-care chemotherapy in Acute Myeloid Leukemia (AML) demonstrates response to treatment in patients in the dose-escalation phase of the trial who received onvansertib at 27mg/m2 and 40mg/m2. The trial is now enrolling patients at the dose level of 60mg/m2 (approximately a 50% increase) in combination with either LDAC or decitabine.

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The greatest anti-leukemic activity, to-date, has been observed in the onvansertib + decitabine arm, now with 3 of 6 (50%) evaluable patients treated at the two highest dose levels tested to-date (27mg/m2 and 40mg/m2) achieving a complete response (2CR and 1CRi). The first patient in the onvansertib + LDAC arm has achieved a complete response at the highest dose level of 40mg/m2 of onvansertib.

"We are pleased with the response to treatment that we are seeing with onvansertib, as well as how safe and well tolerated it appears to be in this difficult-to-treat relapsed or refractory patient population," said Dr. Thomas Adams, Chief Executive Officer and Chairman of Trovagene. "As we continue advancing our AML trial to identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), we look forward to sharing additional readouts on the efficacy and safety of onvansertib and the potential opportunity to bring a much-needed new treatment option to relapsed or refractory AML patients."

About the Ongoing Onvansertib Phase 1b/2 Acute Myeloid Leukemia Trial

The Phase 1b/2 trial (NCT03303339) is a multi-center, open-label trial to evaluate the safety and efficacy of Onvansertib in combination with standard-of-care chemotherapy in AML patients who are ineligible for intensive induction therapy or whose disease is relapsed or refractory. In Phase 1b dose-escalation segment of the trial, the primary objective is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), using a traditional 3+3 design. In Phase 2 the MTD or RP2D will be administered to 32 patients to evaluate preliminary antitumor activity and to continue to evaluate the safety and tolerability of onvansertib in combination with standard-of-care chemotherapy. This trial is being led by Amer Zeidan, MBBS, MHS, assistant professor of Medicine at Yale School of Medicine, and Hematology expert at Yale Cancer Center, and Jorge Cortes, M.D., Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. The trial is being conducted at nine sites in the U.S.

About Onvansertib

Onvansertib is a first-in-class, 3rd generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple cancers, including leukemias, lymphomas and solid tumors. Separate studies with other PLK inhibitors have shown that inhibition of polo-like-kinases can lead to tumor cell death, including a Phase 2 study in Acute Myeloid Leukemia (AML) where response rates of up to 31% were observed when combined with a standard therapy for AML (low-dose cytarabine-LDAC) versus treatment with LDAC alone with a 13.3% response rate. A Phase 1 open-label, dose escalation safety study of onvansertib has been completed in patients with advanced metastatic solid tumor cancers and published in Investigational New Drugs. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) in this trial was 24 mg/m2. Trovagene has an ongoing Phase 1b/2 clinical trial with onvansertib in AML that was accepted by the National Library of Medicine (NLM) and is now publicly viewable on www.clinicaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03303339. Onvansertib has been granted Orphan Drug Designation by the FDA in the U.S. and by the EC in the European Union (EU) for the treatment of patients with AML.

Onvansertib targets the PLK1 isoform, only (not PLK2 or PLK3), is orally administered, has a 24-hour drug half-life with only mild to moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK1 inhibitor, onvansertib, with other compounds has the potential to improve clinical efficacy in Acute Myeloid Leukemia (AML), metastatic Castration-Resistant Prostate Cancer (mCRPC), Non-Hodgkin Lymphoma (NHL), Colorectal Cancer, Triple Negative Breast Cancer (TNBC), as well as other types of cancer.

On April 5, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that Janssen Pharmaceutical K.K. has submitted a supplemental new drug application (sNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan, for the use of daratumumab (DARZALEX) in combination with lenalidomide and dexamethasone (Rd) as treatment for patients newly diagnosed with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplant (ASCT) (Press release, Genmab, APR 5, 2019, View Source [SID1234535016]). The MHLW will grant a priority review of the application, based on the Orphan Drug Designation given to DARZALEX for patients with newly diagnosed multiple myeloma. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"This marks the third major regulatory submission based on the MAIA data, following similar submissions earlier this year in the U.S. and Europe. The regulatory approvals will make daratumumab plus lenalidomide and dexamethasone a viable option for newly diagnosed multiple myeloma patients in these three major markets," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission is based on data from the Phase III MAIA study of daratumumab in combination with Rd as treatment for patients newly diagnosed with multiple myeloma, who are not candidates for high dose chemotherapy and ASCT. Data from the study was presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which took place in San Diego, California in December 2018.

About the MAIA (MMY3008) study
The Phase III study (NCT02252172) is a randomized, open-label, multicenter study that includes 737 newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and ASCT. Patients were randomized to receive either daratumumab in combination with lenalidomide (an immunomodulatory drug) and dexamethasone (a corticosteroid) or lenalidomide and dexamethasone alone. In the daratumumab treatment arm, patients received 16 milligrams per kilogram (mg/kg) weekly for first 8 weeks (Cycles 1 and 2), every other week for 16 weeks (Cycles 3 to 6) and then every 4 weeks (Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide is administered at 25 mg orally on days 1 through 21 of each 28-day cycle, and dexamethasone was administered at 40 mg once a week for both treatment arms. Participants in both treatment arms will continue Rd until disease progression or unacceptable toxicity. The primary endpoint of the study is PFS.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Approximately 6,313 new patients were expected to be diagnosed with multiple myeloma and approximately 4,338 people were expected to die from the disease in Japan in 2018.2 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.3 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.4

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,6,7,8,9

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, B and T-ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On April 5, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world, reported that Wei-Wu He, Ph.D., Executive Chairman of CASI, has been appointed Chief Executive Officer (Press release, CASI Pharmaceuticals, APR 5, 2019, View Source [SID1234535013]). Dr. He will continue to serve as Chairman of the Board of Directors. Dr. He succeeds Ken K. Ren, Ph.D. who for personal reasons is stepping down from his role as Chief Executive Officer but will remain on the Company’s Board of Directors.

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Prior to joining CASI as CEO, Dr. He had a very successful career building companies from early to revenue and profit stages. Most recent from his track record was serving as CEO of OriGene Technologies, Inc., which he co-founded and built into a profitable life science company that later merged with a publicly traded Chinese company, VICANBIO Cell & Gene Engineering Corp., Ltd. (SHA: 600645). Dr. He will continue in his role as Chairman of the Board of OriGene, and is also the founder and general partner of Emerging Technology Partners, LLC, a life sciences focused venture fund, and has been involved in funding over 60 biotech companies. In the earlier part of his career, Dr. He was one of the first few scientists at Human Genome Sciences, and prior to that, was a research fellow at Massachusetts General Hospital and Mayo Clinic. Dr. He is an author to 30 research publications and holder of over 32 issued patents.

"We are grateful for Ken’s dedication to CASI during the Company’s transition period and his role in the Company’s growth in China, the advancement of our pipeline and our fundraising initiatives," said Dr. He.

Dr. He continued, "This is an exciting inflection point in CASI’s history and I look forward to working with our management team to build a revenue-driven commercial company, with EVOMELA as the first product in our pipeline to launch this year. I am particularly excited to pursue additional products to complement our pipeline and therapeutic areas, while we concurrently advance our existing products to the market and serve our patients."

On April 5, 2019 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that its first quarter 2019 financial results will be released after market close on Thursday, May 9, 2019 (Press release, Coherus Biosciences, APR 5, 2019, View Source/news-releases/news-release-details/coherus-biosciences-report-first-quarter-financial-results-may" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-first-quarter-financial-results-may" rel="nofollow">View Source [SID1234535012]). Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call to discuss financial results and provide a general business update.

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After releasing first quarter 2019 financial results, the company will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information

When: Thursday, May 9, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 2969536
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On April 4, 2019 Sinovant Sciences and Roivant Sciences reported the launch of Cytovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative cellular therapeutics in Asia. Cytovant will focus on development programs that have the potential to transform the treatment of diseases that are prevalent in Asian patients (Press release, Sinovant Sciences, APR 4, 2019, http://www.cytovant.com/d65 [SID1234557522]). Concurrent with the company’s launch, Cytovant has entered into a multi-program license and collaboration agreement with Medigene AG, a clinical stage biotechnology company focusing on the development of T cell immunotherapies.

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Medigene has granted Cytovant exclusive licenses to develop, manufacture, and commercialize Medigene’s research-stage T cell immunotherapy targeting NY-ESO-1 as well as a DC vaccine targeting WT-1 and PRAME, in Greater China, South Korea, and Japan. In addition, Cytovant and Medigene have entered into a strategic collaboration and discovery agreement for T-cell receptor (TCR) immunotherapies for two additional targets. Medigene will be responsible for the generation and delivery of the TCR constructs using its proprietary TCR discovery and isolation platform. Following this research collaboration period, Cytovant will assume sole responsibility for the development and commercialization of these TCR therapies in the relevant countries. The TCRs to be generated by Medigene will be tailored specifically to Asian patients.

Under the terms of the transaction agreements, Medigene will receive an overall upfront payment of USD 10 million as well as potential development, regulatory, and commercial milestone payments which in aggregate could total over USD 1 billion for the four products across multiple indications. Furthermore, Medigene will be eligible to receive royalty payments on net sales of the products in a low double-digit percentage in the relevant countries. Additionally, Cytovant will reimburse all R&D costs incurred by Medigene within the collaboration.

"T cell receptors are the scouts of the immune system," said Prof. Dolores Schendel, CEO/CSO of Medigene. "They help T cells recognize and destroy cancer cells. We use our sophisticated screening systems to generate tailored TCR therapies for patient populations with specific genetic characteristics. This partnership implements Medigene’s strategy to discover TCRs with various HLA specificities in order to address different populations and markets. Cytovant, with its highly experienced management and scientific team was launched by Sinovant and Roivant to achieve excellence in cell therapies and we are proud to be part of this story of delivering various TCR projects as well as our DC vaccine for development in East Asia."

"The complexities of end-to-end cell therapy manufacturing, development, and commercialization in Asia require regional focus, specialization, and knowledge," said Benjamin Zimmer, President of Roivant Health. "Roivant and Sinovant have built Cytovant precisely to address these scientific and logistical complexities. We are excited to announce this strategic alliance with Medigene, one of the leading companies in the field of T cell-based therapies, to deliver important new cellular immunotherapies to Asian patients as quickly as possible."

Dr. John Xu, a molecular immunologist by training and translational scientist, has joined Cytovant and will serve as the company’s President. Prior to joining Cytovant, Dr. Xu was President and Chief Scientific Officer of Mab-Legend Biotech, a Shanghai-based antibody discovery company. Previously, Dr. Xu also served as Chief Scientific Officer of Shanghai Benemae Pharmaceutical Corporation and as Head of the Biologics Group at GSK China. He received his B.S. in cell biology and genetics from Peking University and his Ph.D. in biochemistry and molecular biology from Harvard University.

"We are thrilled to welcome John to Cytovant," said Dr. Xinan Chen, Executive Chairman of Sinovant. "John’s deep scientific expertise and knowledge of Asia’s health priorities make him an ideal leader for the company as we prepare to rapidly scale its research and development activities. The launch of Cytovant represents an important milestone in Sinovant’s evolution as a platform for entrepreneurs like John and we look forward to building Cytovant with him."