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10-Q – Quarterly report [Sections 13 or 15(d)]

Eagle Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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10-Q – Quarterly report [Sections 13 or 15(d)]

Syros Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Syros Pharmaceuticals, 2017, AUG 9, 2017, View Source [SID1234521284]).

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Myriad Genetics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Myriad Genetics, AUG 9, 2017, View Source [SID1234520112]).

Mundipharma and CellAct announce new deal for the worldwide development and commercialization of smart chemotherapy CAP7.1

On August 9, 2017 the Mundipharma network of independent associated companies reported that it has acquired from CellAct the worldwide development, commercialization and manufacturing rights to CAP7.1 (Press release, Mundipharma, AUG 9, 2017, View Source [SID1234527604]). CAP7.1 is a novel pro-drug of anticancer agent etoposide which is metabolized into an active form by enzymes in the gastrointestinal tract that are particularly active in tumor cells. This innovative drug, invented at Charité – Universitätsmedizin Berlin, Germany, enables the focused release of this chemotherapeutic agent into tumor cells in higher doses while maintaining a good safety and tolerability profile1. The treatment will be progressed through Phase III trials by EDO, a company with a worldwide network of clinical connections and expertise in developing cancer therapies.

Biliary tract cancer, including gallbladder tumors, is the second most common primary hepatobiliary cancer, after hepatocellular cancer.2 Estimates suggest there are almost 140,000 deaths each year from biliary tract cancer; a 22% increase since 19903. Despite the availability of surgery and chemotherapy options for early and locally advanced disease, patients are not able to access any indicated second line treatments.

In Phase II studies CAP7.1 showed efficacy in this difficult to treat patient population, with 56% of patients meeting the primary objective of disease control, including tumour shrinkages.1 CAP7.1 treated patients displayed an estimated one-year survival rate of 40%, which is approximately 20% higher compared with current standard of care.4

Under the collaboration, CellAct will receive a double digit upfront payment and milestone payments. EDO will advance CAP7.1 into Phase III clinical trials and reformulate the drug to enable manufacturing scale-up. CellAct and Charité University Hospital will also both receive sales-related income through tiered royalties and milestone payments.

Dr Thomas Mehrling, Chief Executive Officer, EDO, said: "We are thrilled to be taking this promising treatment into the next phase of clinical trials. By working with a network of experienced clinical partners, EDO enables efficient drug development and we believe this will be of benefit to accelerate the development a potentially life-changing treatment in this area of great unmet patient need."

Paul Medeiros, Senior Vice President Corporate and Business Development, said: "At Mundipharma, discovering and developing novel medicines to treat underserved oncological diseases is a key strategic priority. Our alliance with CellAct adds an important new potential therapy to our oncology portfolio and builds on our expertise in smart chemotherapies."

Nalân Utku, Chief Executive Officer, CellAct, said: "The proven expertise of Mundipharma in medicines development and their commercial capabilities will enable the potential for CAP7.1 to help patients in this underserved disease area. This alliance will also provide a valuable exit for our investors Peppermint VC and NRW Bank who have been supporting this program for many years."

2X ONCOLOGY ANNOUNCES VALIDATION OF DRUG RESPONSE PREDICTOR (DRP) FOR ITS PARP INHIBITOR 2X-121

On August 9, 2017 2X Oncology, Inc. ("2X" or the "Company"), a precision medicine company developing targeted therapeutics to address significant unmet needs in women’s cancer, reported the successful validation of the Drug Response Predictor (DRP) for 2X-121, its Phase 2 PARP inhibitor recently licensed from Eisai (Press release, 2X Oncology, AUG 9, 2017, View Source [SID1234526102]).

"It is of great interest to see the Drug Response Predictor work for 2X-121, and the clear separation between responders and non-responders. This bodes well for the future role of 2X-121 in the treatment of cancer," stated Dr. Mansoor R. Mirza, chief oncologist, Department of Oncology, Copenhagen University Hospital-Rigshospitalet.

"In this DRP validation study, the diagnostic identified responders irrespective of BRCA mutation status, indicating that our compound may have broader application including tumors resistant to other PARP inhibitors," said George O. Elston, CEO of 2X Oncology.

2X-121 is a small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The drug candidate has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2. The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome PARP inhibitor resistance.

"PARP inhibitors are the most exciting new class of agent for the treatment of many gynecologic cancers," said Ursula Matulonis, M.D., Director, Gynecologic Oncology at the Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School. "Therapeutics such as 2X-121 that can overcome PARP inhibitor resistance, an important clinical problem today, will be a significant and welcome addition to the oncologists’ toolkit."

The drug candidate demonstrated clinical activity in a Phase 1 study in a number of cancers, including ovarian and breast. 2X-121 also has potential to treat brain metastases and primary brain tumors based on its ability to pass through the blood-brain barrier.

Separate, targeted Phase 2 studies of 2X-121 are planned using the validated DRP biomarker in metastatic breast cancer and recurrent ovarian cancer to identify patients likely to respond to and benefit from treatment with the drug.

"We look forward to the initiation of the Phase 2 clinical trials for 2X-121, leveraging the initial Phase 1 responder data and the validated DRP, later this year," Elston added.

Positive data from these studies will position the program for a pivotal Phase 2 study initiation as early as 2018.

In a blinded study of 13 patients, five of seven patients in the DRP-predicted responder group survived (Overall Survival-OS) at 400 days from commencement of treatment, compared with only one out of six patients surviving at 400 days for those predicted by the DRP score to be non-responders. This equates to a four-fold difference in overall survival between the patients predicted to respond and those not predicted to respond to treatment.

The DRP correctly predicted response to treatment and overall survival with a p-value of 0.07 and a hazard ratio on overall survival of 0.26 in this study.

About the Drug Response Predictor (DRP) Companion Diagnostic

Developed by and in-licensed from Medical Prognosis Institute A/S (MPI.ST), the DRP screening platform utilizes messenger RNA (mRNA) gene expression signatures from patient biopsies to identify patients with a high likelihood of responding to specific cancer-fighting therapies. This DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines, combined with clinical tumor biology and clinical correlates in a systems biology network. Specific DRPs are developed for each pipeline product, which will enable 2X Oncology to identify and predict which patients are most likely to respond and thereby benefit from a given pipeline product. This would enable likely responders to receive appropriate treatment while expediting the decision path for predicted non-responders, saving them critical time and money in their cancer fight.