On March 27, 2017 ArQule, Inc. (Nasdaq: ARQL) reported that its partner, Kyowa Hakko Kirin, reported top-line results of the JET-HCC Phase 3 trial of tivantinib in Japan, and that the trial did not meet its primary endpoint of progression free survival (PFS) (Press release, ArQule, MAR 27, 2017, View Source [SID1234518273]).

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JET-HCC is a randomized, double-blind placebo-controlled study that enrolled approximately 190 Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma (HCC) with a history of prior sorafenib therapy, to evaluate the efficacy and safety of tivantinib.

The primary endpoint of the trial is PFS, and the top-line results did not show a significant difference in PFS between the tivantinib group and the placebo group. There were no new safety issues observed in the trial.

The details of the study results will be presented in an upcoming scientific forum.

"I would like to thank our partner, Kyowa Hakko Kirin, and all the participants in their study," said Paolo Pucci, Chief Executive Officer of ArQule. "The results are disappointing as there is a need for a second-line HCC therapy in Japan."

About Hepatocellular Carcinoma (HCC)

Liver cancer is the sixth most common cancer globally with 782,000 new cases in 2012 and is the second most common cause of cancer-related death with 745,000 deaths in 2012.1 HCC accounts for about 90 percent of primary liver cancers.2 Cirrhosis, chronic hepatitis B and C and smoking are recognized worldwide as factors increasing the risk of HCC.2

About Tivantinib (ARQ 197)

Tivantinib (ARQ 197) is an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase ("MET") and its biological pathway. Kyowa Hakko Kirin and ArQule entered into a license agreement for exclusive rights to the development and sale of tivantinib in Japan and certain parts of Asia (China, Korea, and Taiwan) on April 12, 2007.

On March 27, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported a substantial expansion of its niraparib clinical development program (Press release, TESARO, MAR 27, 2017, View Source [SID1234518284]). Following the landmark results of the Phase 3 NOVA trial of niraparib, a comprehensive portfolio review, and the FDA approval of ZEJULA (niraparib) for patients with recurrent ovarian cancer, TESARO is implementing its plans to initiate registration strategies in the settings of metastatic ovarian, breast and lung cancers.

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"Based on the unprecedented results of the NOVA trial in women with recurrent ovarian cancer, we previously announced the expansion and refinement of our PRIMA and QUADRA trials to include a broad patient population, and in the case of PRIMA, eliminated the enrollment requirement for a biomarker selected tumor. With the approval of ZEJULA in hand, we will now begin to execute on our plans to pursue potentially transformational applications of niraparib in a broad range of metastatic cancer indications," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We plan to expand our first-line ovarian cancer strategy to include a combination study that assesses the potential benefit of niraparib plus an anti-PD-1 antibody in the maintenance setting and initiate a clinical study of niraparib in combination with bevacizumab in patients with a first recurrence of ovarian cancer, with an intent to replace chemotherapy in this setting. We remain strongly committed to studying niraparib in the breast cancer setting and also expect to initiate a new trial of niraparib in combination with an anti-PD-1 antibody in women with metastatic triple-negative breast cancer. Finally, our goal to move niraparib into indications beyond ovarian and breast cancers encompasses plans to initiate a registration strategy for the first-line treatment of patients with metastatic non-small cell lung cancer that includes a phase 2 trial of niraparib in combination with an anti-PD-1 antibody in patients, regardless of PDL-1 tumor expression, and a phase 3 trial of niraparib in combination with an anti-PD-1 antibody in patients with high levels of PDL-1 tumor expression."

Niraparib is the only PARP inhibitor approved in the U.S. for the maintenance treatment of women with recurrent ovarian, fallopian or primary peritoneal cancers. This approval was based upon the results of a randomized, prospectively designed Phase 3 clinical trial where niraparib demonstrated a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer following a response to platinum-based chemotherapy.

The BRAVO study is assessing niraparib in patients with breast cancer who are germline BRCA mutation carriers. This study is sponsored by TESARO and is being conducted by Breast International Group (BIG) and the European Organisation for Research and Treatment of Cancer (EORTC). Following a recent interim analysis of data by the independent data monitoring committee (IDMC), TESARO believes the BRAVO study is unlikely to produce data that is interpretable and therefore suitable for registration in this indication. A large number of patients in the chemotherapy control arm did not continue in the trial long enough to receive their first radiological scan, which is required to assess disease progression, resulting in an unusually high rate of censoring in the control arm. At this time, TESARO believes this is likely associated with the desire of patients who carry germline BRCA mutations to be treated with a PARP inhibitor rather than chemotherapy and the increased availability of PARP inhibitors. A final determination as to whether the planned enrollment in BRAVO should be completed will be made by the Steering Committee in the near term. No safety concerns have been noted by the IDMC with respect to niraparib. Approximately 5-10% of women with breast cancer are germline BRCA mutation carriers. TESARO expects the results and experience gained from the BRAVO trial to be supportive of the planned trial of niraparib in combination with an anti-PD-1 antibody in women with metastatic triple-negative breast cancer. Approximately 15-20% of women with breast cancer have triple negative breast cancer.

The expanded niraparib clinical development program now includes the following:

Ovarian Cancer

OvCa 3000-03-003: A Phase 3 clinical trial of niraparib in combination with an anti-PD-1 antibody in comparison to niraparib in first-line maintenance treatment of patients with advanced ovarian cancer who have responded to platinum induction therapy.

OvCa 3000-03-002: A Phase 3 clinical trial of niraparib in combination with bevacizumab in comparison to standard of care in patients with a first recurrence of ovarian cancer.

PRIMA: A Phase 3 clinical trial of niraparib in patients with advanced ovarian cancer who have responded to platinum induction therapy.

TOPACIO: A Phase 2 trial to evaluate the preliminary safety and efficacy of niraparib plus KEYTRUDA in patients with triple negative breast cancer and in patients with platinum resistant recurrent ovarian cancer being conducted by TESARO in collaboration with Merck.

QUADRA: A registration trial of niraparib for the treatment of patients with recurrent ovarian cancer who have received three or four regimens of therapy.

AVANOVA: An NSGO (Nordic Society of Gynaecological Oncology) Phase 1/2 trial (in collaboration with ENGOT) evaluating niraparib plus bevacizumab in patients with recurrent ovarian cancer.

Breast Cancer

TNBC 3000-03-004: A Phase 3 clinical trial of niraparib in combination with anti- PD-1 antibody in comparison to standard of care in patients with advanced triple negative breast cancer.

TOPACIO: A Phase 2 clinical trial to evaluate the safety and efficacy of niraparib plus KEYTRUDA in patients with triple negative breast cancer and patients with platinum resistant recurrent ovarian cancer being conducted by TESARO in collaboration with Merck.

Lung Cancer

Lung 3000-02-001: A Phase 2 clinical trial of niraparib in combination with an anti-PD-1 antibody in patients with advanced NSCLC and niraparib alone in patients with advanced squamous cell carcinoma of the lung.

Lung 3000-03-001: A Phase 3 clinical trial of niraparib in combination with an anti-PD-1 antibody in comparison to anti-PD-1 alone in patients with advanced NSCLC and high levels of PDL-1 tumor expression.

Prostate Cancer

Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

TESARO Investor Conference Call and Webcast
TESARO will webcast a conference call with investors and analysts today, March 27, 2017 at 4:30 PM ET. Investors and analysts may access this call by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international); no passcode is necessary. During this conference call, TESARO management will review the approval of ZEJULA and expanded niraparib development program, as well as answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.

About ZEJULA (Niraparib)
ZEJULA (niraparib) is an oral, once-daily poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor that is indicated in the U.S. for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in all clinical studies. Discontinue ZEJULA if MDS/AML is confirmed.

Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.

In clinical studies, the most common adverse reactions included: thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, abdominal pain/distension, mucositis/stomatitis, diarrhea, fatigue/asthenia, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash and hypertension.

Please see full Prescribing Information for additional Safety Information.

On March 27, 2017 EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, and Apeiron Biologics reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of dinutuximab beta for use in the treatment of high-risk neuroblastoma (Press release, EUSA Pharma, MAR 27, 2017, View Source [SID1234527665]).

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The marketing authorisation application included data developed from multiple clinical trials across Europe that included over 1,000 patients receiving dinutuximab beta. The clinical development was led by the SIOPEN academic neuroblastoma group and supported by Apron Biologics2. EUSA Pharma holds the exclusive global rights to dinutuximab beta.

Lee Morley, EUSA Pharma’s Chief Executive Officer, said, "This positive CHMP opinion is an important milestone for EUSA as we work to bring dinutuximab beta to children suffering from the high risk form of the devastating disease, neuroblastoma. This cancer is responsible for up to 10% of childhood tumors, and with treatment options limited we are working hard to make this life saving therapy available to children around the world. Following this positive opinion in Europe, we plan to submit dinutuximab beta for approval in the United States in the coming year."

Dr. Hans Loibner, Apeiron Biologic’s Chief Executive Officer, said, "We are delighted with the CHMP positive opinion for dinutuximab beta, which follows our extensive development work with a number of partners, in particular the SIOPEN group. Dinutuximab beta represents an important potential treatment in an area of significant unmet need, and we look forward to working with EUSA to make this product available around the world."

Dinutuximab beta is currently used in Europe under a managed access program as part of treatment regimens for high-risk neuroblastoma. Following the CHMP positive opinion, the European Commission will now issue a formal decision on approval, and if approved dinutuximab beta will be indicated for use in the 28 countries of the European Union in children aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2). Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.

– Ends –

About dinutuximab beta and neuroblastoma
Neuroblastoma is an orphan oncology condition with significant unmet medical need. It accounts for up to 10% of childhood tumors and affects approximately 1,200 children in Europe each year. Dinutuximab beta is currently used extensively across Europe under a managed access scheme and is included in a number of treatment protocols for high-risk neuroblastoma.

Dinutuximab beta is an anti-GD2 monoclonal antibody that significantly improves event-free and overall survival in children with high-risk neuroblastoma, with a favorable safety profile compared to other immunotherapies. Dinutuximab beta forms an important part of treatment regimens for high-risk neuroblastoma and dinutuximab beta’s novel features offer the potential for further development to expand its current role. Dinutuximab beta has orphan drug designation in the US and EU, and EUSA plans to file the product for approval in the United States in 2017.

On March 27, 2017 Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), a clinical-stage biopharmaceutical company developing novel therapies for cancer, reported financial results for the fourth quarter and full year ended December 31, 2016 and provided an update on the Company’s corporate and clinical development activities, including the proposed merger with Molecular Templates, Inc (Press release, Threshold Pharmaceuticals, MAR 27, 2017, View Source [SID1234518410]).

Threshold announced on March 17, 2017 that it had entered into a definitive agreement under which Molecular Templates will merge with a wholly owned subsidiary of Threshold in an all-stock transaction. The transaction will result in a combined company focused on the development of novel treatments for cancer. Longitude Capital, a U.S. based venture capital firm, will invest $20 million at the close of the transaction, subject to certain conditions, including the receipt of additional equity financing commitments of an additional $20 million.

Barry Selick, Ph.D., Chief Executive Officer of Threshold, said, "On behalf of the Company and the entire board of directors, I’d like to thank Threshold shareholders for their support while we conducted our extensive and thorough review of strategic alternatives, after very challenging clinical outcomes for evofosfamide and tarloxotinib." Dr. Selick further stated, "We believe Molecular Templates’ lead product candidate, MT-3724, and our lead product candidate, evofosfamide, in addition to Molecular Templates’ innovative technology platform will result in a combined company that has significant value for its stakeholders."

Recent Highlights
About the Proposed Merger
The transaction has been approved by the board of directors of both companies. The merger is expected to close in the second quarter of 2017, subject to the approval of the stockholders of each company as well as other customary conditions. Upon closing of the transaction, Threshold will change its name to Molecular Templates, Inc. and plans to change its ticker symbol on the Nasdaq Capital Market to MTEM. On a pro forma basis and based upon the number of shares of common stock to be issued in the merger, current Threshold shareholders would own approximately 34.4 percent of the combined company and current Molecular Templates shareholders would own approximately 65.6 percent of the combined company although the actual allocation will be subject to adjustment based on Threshold’s net cash balance.

Eric Poma, Ph.D., Chief Executive Officer of Molecular Templates, will become Chief Executive Officer of the combined company. Following the merger, the board of directors of the combined company will consist of seven seats and will be comprised of two representatives from Molecular Templates, two representatives from Threshold, and three representatives to be mutually agreed upon by Molecular Templates and Threshold. The Company’s current chairman of the board of directors, Barry Selick, Ph.D., will become chairman of the board of the combined company following the merger.

Evofosfamide
The Company’s lead product candidate is an investigational hypoxia-activated prodrug that is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Recent updates include:

· Held first meeting with the Japanese PMDA (Pharmaceutical and Medical Devices Agency) to present the improvement in overall survival that was observed in the Japanese sub-population of the MAESTRO Phase 3 trial. While the PMDA indicated that the current analysis of the MAESTRO data is not sufficient to support the submission of a New Drug Application ("NDA") in Japan, the Company is in ongoing discussions with the PMDA to clarify the scope of an additional study, the results of which may then support the submission of an NDA for evofosfamide in Japan.

· Investigator-sponsored and cooperative group clinical trials investigating evofosfamide in patients with pancreatic neuroendocrine tumors (pNET), recurrent glioblastoma (GBM) and hepatocellular carcinoma (HCC) and advanced biliary tract cancer (BCT) remain ongoing

· In the second quarter, the Company plans to commence a Phase 1 clinical trial evaluating evofosfamide in combination with the immune checkpoint antibody, ipilumumab, at the M.D. Anderson Cancer Center in Houston Texas to potentially improve the efficacy of immune checkpoint antibody as an anti-cancer therapy.

TH-3424
TH-3424 is the Company’s small-molecule drug candidate being evaluated for the treatment of hepatocellular (liver) cancer (HCC), castrate resistant prostate cancer (CRPC), T-cell acute lymphoblastic leukemias (T-ALL), and other cancers expressing high levels of aldo-keto reductase family 1 member C3 (AKR1C3). Tumors overexpressing AKR1C3 can be resistant to radiation therapy, chemotherapy and anti-androgen therapy. TH-3424 is a prodrug that selectively releases a potent DNA cross-linking agent in the presence of AKR1C3. Recent updates include:

· Entered into a collaboration with the National Cancer Institute (NCI) to explore the effects of TH-3424 against T-ALL xenograft cell lines with high AKR1C3 expression. The studies will be conducted through the NCI-funded Pediatric Preclinical Testing Program (PPTp). Threshold will supply TH-3424, and the NCI will fund the studies that will be conducted at the PPTP leukemia research sites.

· Investigational New Drug (IND)-enabling studies of TH-3424 have been initiated in collaboration with Ascenta Pharmaceuticals, Ltd.

Fourth Quarter and Year End 2016 Financial Results
· As of December 31, 2016 and 2015, Threshold had $23.6 million and $48.7 million in cash, cash equivalents and marketable, respectively. The net decrease of $25.1 million was a result of operating cash requirements for the year ended December 31, 2016.

· No revenue was recognized in the fourth quarter and year ended December 31, 2016 compared to $65.9 million and $76.9 million for the same periods in 2015. Revenue for the quarter and year ended December 31, 2015 related to the amortization of the aggregate of $110 million in upfront and milestone payments received from the Company’s former collaboration with Merck KGaA, Darmstadt, Germany. The revenue from the upfront payment and milestone payments received under the agreement were previously being amortized over the relevant performance period, rather than being immediately recognized when the upfront payment and milestones were earned or received. As a result of Merck KGaA, Darmstadt, Germany’s and the Company’s decision to cease further joint development of evofosfamide in December 2015, the Company immediately recognized all of the remaining deferred revenue into revenue during the quarter ending December 31, 2015. Also as a result of the termination of the agreement, the Company is no longer eligible to receive any further milestone payments from Merck KGaA, Darmstadt, Germany.

· Research and development expenses were $3.0 million for the fourth quarter ended December 31, 2016, compared to $11.4 million for the same period in 2015. The $8.4 decrease in research and development expenses, net of reimbursement for Merck KGaA, Darmstadt, Germany’s 70 percent share of total eligible collaboration expenses for evofosfamide, was due primarily to a $4.6 million decrease in employee related expenses, including a $1.0 million decrease in non-cash stock-based compensation expense and a $3.8 million decrease in clinical development expenses and consulting expenses. Research and development expenses were $16.6 million for the year ended December 31, 2016, compared to $40.3 million for the same period in 2015. The $23.7 million decrease in research and development expenses, net of reimbursement for Merck KGaA, Darmstadt, Germany’s 70 percent share of total eligible collaboration expenses for evofosfamide, was due primarily to a $14.1 million decrease in employee related expenses, including a $2.8 million decrease in non-cash stock-based compensation expense, a $8.3 million decrease in clinical development expenses and a $1.3 million decrease in consulting expenses.

· General and administrative expenses were $2.0 million for the fourth quarter ended December 31, 2016 compared to $2.2 million for the same period in 2015. The decrease in general and administrative expenses was due primarily to a $0.2 million decrease in employee related expenses. General and administrative expenses were $7.8 million for the year ended December 31, 2016 compared to $9.7 million for the same period in 2015. The $1.9 million decrease in general and administrative expenses was due primarily to a $1.5 million decrease in employee related expenses and $0.4 million in consulting expenses.

· Non-cash stock-based compensation expense included in total operating expenses was $0.7 million and $3.1 million for the fourth quarter and year ended December 31, 2016, respectively, compared to $2.0 million and $6.8 million for the same periods in 2015, respectively. The decrease in stock-based compensation expense was due to the amortization of a smaller number of options with lower fair values.

· Net loss for the fourth quarter ended December 31, 2016 was $3.7 million compared to net income of $69.7 million for the same period in 2015. Included in the net loss for the fourth quarter of 2016 was an operating loss of $5.0 million and non-cash income of $1.2 million compared to an operating income of $52.3 million and non-cash income of $17.4 million for the fourth quarter of 2015. Net loss for the year ended December 31, 2016 was $24.1 million compared to net income of $43.8 million for the same period in 2015. Included in the net loss for 2016 was an operating loss of $24.3 million and non-cash income of $0.1 million compared to an operating income of $26.9 million and non-cash income of $16.8 million for the year ended December 31, 2015. The non-cash income is related to changes in the fair value of the Company’s outstanding warrants that was classified as other income (expense).

About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe hypoxic tumor conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

About TH-3424
TH-3424 is small-molecule drug candidate being evaluated for the potential treatment of hepatocellular (liver) cancer (HCC), castrate resistant prostate cancer (CRPC), T-cell acute lymphoblastic leukemias (T-ALL), and other cancers expressing high levels of aldo-keto reductase family 1 member C3 (AKR1C3). Tumors overexpressing AKR1C3 can be resistant to radiation therapy and chemotherapy. TH-3424 is a prodrug that selectively releases a potent DNA cross-linking agent in the presence of AKR1C3. Preliminary nonclinical toxicology studies suggested an adequate therapeutic index that the Company believes warrants conducting Investigational New Drug (IND)-enabling toxicology studies, which are being done in collaboration with Ascenta Pharmaceuticals, Ltd.

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On March 23, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a clinical late-stage biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, reported that data from its successful Phase 2a study of topsalysin, which evaluated the drug as a focal treatment for localized prostate cancer, will be presented as a poster on March 26, 2017 at the 32nd Annual European Association of Urology in London, UK (Press release, Sophiris Bio, MAR 23, 2017, View Source [SID1234518267]). The poster has been selected by conference organizers as one of the best posters at the congress.

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Abstract No. 758: "Intra-prostatic injection of PRX302 to focally ablate clinically significant prostate cancer: An open label, phase 2a study"
Presenting Author: Dr. Yaalini Shanmugabavan, Division of Surgery and Interventional Sciences, University College London, London, UK
Poster Session: Poster Session 57 – Prostate cancer: Is the future focal?
Time: March 26, 2017 from 3:45 pm – 5:15 pm GMT

The abstract related to the poster can be accessed through the European Association of Urology Congress website at View Source