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U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

On June 7, 2018 Pfizer Inc. (NYSE:PFE) reported that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib (Press release, Pfizer, JUN 7, 2018, View Source [SID1234527237]). The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population.

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"Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease," said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. "Today’s filing acceptances are just the latest example of the success of Pfizer’s precision medicine approach to drug development, in this case targeting the faulty DNA damage repair process associated with BRCA mutations. We are now one step closer to offering a potential alternative to chemotherapy for these patients."

The FDA grants Priority Review designation to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in December 2018.

The pivotal, randomized EMBRACA trial evaluated once-daily talazoparib compared to physician’s choice chemotherapy (capecitibine, eribulin, gemcitabine or vinorelbine) in 431 patients with an inherited BRCA1/2 mutation and locally advanced or metastatic triple negative (TNBC) or hormone receptor-positive (HR+)/HER2- breast cancer. The study met its primary endpoint, demonstrating superior progression-free survival (PFS) with talazoparib versus chemotherapy. The PFS benefit was consistent across prespecified subgroups, including those who had a history of brain metastases, patients previously treated with chemotherapy, TNBC patients and those with HR+ disease. Grade ≥3 adverse reactions with talazoparib that occurred with a frequency of at least 10% were anemia (35%), neutropenia (17%) and thrombocytopenia (17%). The primary results were presented at the 2017 San Antonio Breast Cancer Symposium. For more information on the EMBRACA trial, go to www.clinicaltrials.gov.

About Talazoparib

Talazoparib is an investigational anti-cancer medicine called a PARP (poly ADP ribose polymerase) inhibitor. Preclinical studies suggest that talazoparib is highly potent and has a dual mechanism of action, with the potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on the sites of DNA damage. Talazoparib is currently being evaluated in advanced gBRCAm breast cancer and early triple negative breast cancer as well as DNA damage repair (DDR)-deficient prostate cancer and in combination with immunotherapy in various solid tumor types. Talazoparib has not been approved by any regulatory authorities for the treatment of any disease.

About Germline (Inherited) BRCA-Mutated Breast Cancer

BRCA1 and BRCA2 are human genes that produce proteins involved in DNA repair. When either of these genes is altered or mutated, DNA repair may not progress correctly. This can lead to the development of certain types of cancer such as breast cancer.1,2,3 BRCA mutations can be hereditary (germline) or occur spontaneously (somatic).1 Together, BRCA1 and BRCA2 mutations account for about 25 to 30 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers.4,5 It is estimated that about 72 percent of people who inherit a BRCA1 mutation and about 69 percent who inherit a BRCA2 mutation will develop breast cancer by age 80.1 Epidemiologic studies indicate that individuals with gBRCAm breast cancer are diagnosed at a median age of 40-45, which is approximately 20 years younger than the overall breast cancer population.6

BRCA-mutated breast cancer is considered metastatic if it has spread beyond the breast to other parts of the body, including the bones, liver, lung or brain. There is currently no cure for metastatic breast cancer, the most advanced stage (stage IV) of the disease. The goal of treatment is to delay or slow disease progression while maintaining quality of life.

Myovant Provides Corporate Update and Reports Financial Results for Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2018

On June 7, 2018 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases, or Myovant, reported corporate updates and reported financial results for the fourth fiscal quarter and full fiscal year ended March 31, 2018 (Press release, Myovant Sciences, JUN 7, 2018, http://investors.myovant.com/news-releases/2018/06-07-2018-210515945 [SID1234527236]).

"I am proud of the Myovant team and our fiscal 2017 clinical and corporate accomplishments. Our energy continues to be focused on completing patient enrollment for our ongoing global Phase 3 clinical development programs of relugolix for the treatment of heavy menstrual bleeding associated with uterine fibroids, endometriosis-associated pain and advanced prostate cancer," stated Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "With our recent capital raise and corporate progress, we believe we are well positioned to execute and advance our corporate mission."

Fourth Fiscal Quarter 2017 and Recent Business Highlights

On March 26, 2018, an additional $15.0 million of Myovant’s financing commitments from Hercules Capital, Inc., or Hercules, was funded prior to the March 31, 2018, term commitment termination date, resulting in $40.0 million total principal amount outstanding under the loan and security agreement.
On April 2, 2018, Myovant entered into a share purchase agreement with Roivant Sciences Ltd., or RSL, Myovant’s majority shareholder, pursuant to which Myovant issued and sold to RSL 1,110,015 common shares at a purchase price of $20.27 per common share in a private placement, or the Private Placement. Myovant received gross proceeds of $22.5 million at the closing of the Private Placement.
On April 2, 2018, Myovant also entered into a Sales Agreement with Cowen and Company, LLC, to sell common shares having an aggregate offering price of up to $100.0 million through an "at-the-market," or ATM, equity offering program. In the first quarter of fiscal 2018, Myovant issued and sold 2,767,129 common shares under this program at a weighted-average-price of $21.47 per common share for aggregate net proceeds of approximately $57.6 million, after deducting commissions.
On April 20, 2018, Myovant announced a partnership with PERIOD, Inc., a youth-led non-profit organization focused on menstrual equity, to elevate the conversation around period health, including an Ask Me About Periods campaign on college campuses around the country.
On May 30, 2018, Myovant entered into a Commercial Manufacturing and Supply Agreement with Takeda Pharmaceutical Company Ltd., or Takeda, pursuant to which Takeda will manufacture and supply Myovant with relugolix drug substance to support the commercial launch of relugolix, if marketing authorization is granted. Takeda has agreed to assist with the transfer of technology and manufacturing know-how to a second contract manufacturing organization of Myovant.
In May 2018, following the completion of a Phase 1 study, Myovant initiated a Phase 2a clinical trial in healthy female volunteers to characterize the dose response curve in the controlled ovarian stimulation setting prior to studying MVT-602 in infertile woman seeking pregnancy.
Fourth Fiscal Quarter and Full Fiscal Year 2017 Financial Summary

Research and development (R&D) expenses for the quarter ended March 31, 2018, were $40.1 million compared to $19.0 million for the comparable period in 2017. R&D expenses for the fiscal year ended March 31, 2018, were $116.8 million, compared to $43.5 million for the prior fiscal year. The increase for both the quarter and the year primarily reflects the progress of Myovant’s ongoing five Phase 3 clinical trials of relugolix, which were initiated in 2017, and additional personnel-related expenses as a result of an increased number of R&D employees.

General and administrative (G&A) expenses for the quarter ended March 31, 2018, were $7.3 million, compared to $3.9 million for the comparable period in 2017. G&A expenses for the fiscal year ended March 31, 2018, were $24.2 million, compared to $12.4 million for the prior fiscal year. The increase for both the quarter and the year primarily reflects increases in personnel-related expenses, professional service fees, and other administrative expenses to support Myovant’s headcount growth and expanding operations.

Interest expense for the quarter and year ended March 31, 2018, was $1.1 million and $2.0 million, respectively, while there was no interest expense in the comparable prior year periods. Interest expense for both the quarter and the year consisted of interest expense related to financing agreements with NovaQuest Pharma Opportunities Fund IV L.P., or NovaQuest, and Hercules as well as the associated non-cash amortization of debt discount and issuance costs.

Net loss for the quarter ended March 31, 2018, was $48.3 million, compared to $21.7 million for the comparable period in 2017. Net loss for the fiscal year ended March 31, 2018, was $143.3 million, compared to $83.4 million for the prior fiscal year. On a per common share basis, net loss was $0.81 and $0.37 for the quarters ended March 31, 2018 and 2017, respectively, and $2.41 and $1.70 for the fiscal years ended March 31, 2018 and 2017, respectively. The increase in the net loss and net loss per common share for both the quarter and the year were driven primarily by the increase in costs associated with Myovant’s ongoing Phase 3 clinical trials, which were initiated in 2017, as well as increased personnel-related expenses. The net loss for the prior fiscal year of $83.4 million included $27.5 million of non-cash expense resulting from changes in the fair value of the Takeda warrant liability, which expired on April 30, 2017.

Capital resources: Cash and committed funding totaled $200.6 million at March 31, 2018, consisting of $108.6 million of cash and $92.0 million of remaining financing commitments available from NovaQuest under the NovaQuest Securities Purchase Agreement and the NovaQuest Equity Purchase Agreement. In the first quarter of fiscal year 2018, Myovant further strengthened its balance sheet, raising $22.5 million with the completion of the Private Placement of 1,110,015 common shares to RSL and raising net proceeds of approximately $57.6 million, after deducting commissions, from the issuance and sale of 2,767,129 common shares pursuant to its ATM program. Approximately $40.6 million of capacity remains available under the ATM program.

About Relugolix

Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone, or GnRH, receptor antagonist that has been evaluated in over 1,600 study participants in Phase 1, Phase 2 and Phase 3 clinical trials. In these trials, relugolix has been shown to be generally well tolerated and to suppress estrogen and progesterone levels in women and testosterone levels in men. Common side effects observed were consistent with suppression of these hormones. In the ongoing Phase 3 SPIRIT clinical trials in women with endometriosis-associated pain and the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids, relugolix is undergoing evaluation with and without low-dose hormonal add-back therapy, the addition of which is expected to decrease potential relugolix side effects such as bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix alone in men with advanced prostate cancer.

Corporate Presentation, dated June 7, 2018

On June 7, 2018, TG Therapeutics, Inc. (the "Company") presented the corporate presentation at the Jefferies 2018 Global Healthcare Conference, held at the Grand Hyatt Hotel, in New York City (Presentation, TG Therapeutics, JUN 7, 2018, View Source [SID1234527235]).

Corporate Presentation current as of June 7, 2018

On June 7, 2018 Karyopharm Therapeutics Inc presented the Corporate Presentation is current as of June 7, 2018 (Presentation, Karyopharm, JUN 7, 2018, View Source [SID1234527234]).

Iovance Biotherapeutics, Inc., Corporate Presentation – June 2018.

On June 7, 2018 Iovance Biotherapeutics, Inc. (the "Company") presented the presentations at healthcare conferences (Press release, Iovance Biotherapeutics, JUN 7, 2018, View Source [SID1234527233]).