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VolitionRx Limited Commences Lung Cancer Clinical Study with Fosun Long March in China

On July 18, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported that has executed a contract under the previously announced Memorandum of Understanding, with Shanghai Fosun Long March Medical Science Co., Ltd. ("Fosun Long March") to help introduce the Nu.Q(TM) platform to China (Press release, VolitionRX, JUL 18, 2019, View Source [SID1234537610]). Based on recent promising proof-of-concept data using Volition’s product-grade Nu.Q assays, the parties have commenced a clinical study in China in lung cancer.

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Dr. Jasmine Kway, Chief Executive Officer of Singapore Volition, commented: "We are happy to have executed this agreement with Fosun Long March and are delighted that the clinical study is already underway and expected to be completed by the end of this year."

Dr. Yuejian Zhang, Chairman of Fosun Long March, remarked: "We were impressed with Volition’s preliminary data, particularly in lung cancer, and are happy to have started work on these initial clinical studies. Whilst China represents a little under 20% of the world’s population, it accounted for almost 24% of cancer diagnoses and 30% of cancer-related deaths worldwide in 2018, almost a third of which were due to lung cancer and colorectal cancer. We look forward to completing this important study and working together with Volition to launch Nu.Q in China."

"The need for a simple, easy to use, cost effective test for cancer is truly universal and we hope very much that our Nu.Q tests can help revolutionize the way cancer is diagnosed worldwide," commented Cameron Reynolds, Chief Executive Officer of Volition. "We see Asia, and particularly lung cancer in China, as a key market for Volition. We are excited about the commencement of our work in China and look forward to a successful collaboration with Fosun Long March."

About Fosun Long March

Established in 1989, Fosun Long March is the investment platform of in-vitro diagnostics division of Fosun Pharma Group and has since accelerated merger and acquisition of new products introduction into China. With its wide range of in-vitro diagnostics products, strength in manufacturing and strong nation-wide sales network, Fosun Long March is one of the most influential brands in in-vitro diagnostics in China.

Fosun Long March’s network and expertise will assist Volition with the facilitation and coordination of the collection, provision and testing of blood samples using Volition’s proprietary Nu.Q(TM) assays for the clinical studies, with Fosun’s hospitals, research institutions and clinics, as well as other third-party hospitals, universities, research institutions and clinics in China.

Alkermes to Host Conference Call to Discuss Second Quarter 2019 Financial Results

Blueprint Medicines Announces European Medicines Agency Validation of Marketing Authorization Application for Avapritinib for the Treatment of PDGFRα D842V Mutant GIST and Fourth-Line GIST

On July 18, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that the European Medicines Agency (EMA) has validated the company’s Marketing Authorization Application (MAA) for avapritinib for the treatment of adult patients with PDGFRα D842V mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST (Press release, Blueprint Medicines, JUL 18, 2019, View Source [SID1234537608]). Validation of the MAA confirms that the application is sufficiently complete to begin the formal review process. Avapritinib is an investigational, potent and highly selective KIT and PDGFRA inhibitor for patients with advanced GIST. The European Commission has granted orphan medicinal product designation to avapritinib for the treatment of GIST.

"Prognoses are traditionally poor for patients with PDGFRα D842V mutant GIST and fourth-line GIST, and currently no effective therapy exists for either population," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "Avapritinib is specifically designed to inhibit the disease drivers of GIST, including mutant kinases associated with treatment resistance, representing a promising therapeutic approach. We look forward to working expeditiously with the EMA to bring this potential new treatment option to patients."

In June 2019, Blueprint Medicines announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant GIST, regardless of prior therapy, and fourth-line GIST.

About GIST

GIST is a sarcoma, or tumor of bone or connective tissue, of the gastrointestinal (GI) tract. Tumors arise from cells in the wall of the GI tract and occur most often in the stomach or small intestine. Most patients are diagnosed between the ages of 50 to 80, and diagnosis is typically triggered by GI bleeding, incidental findings during surgery or imaging and, in rare cases, tumor rupture or GI obstruction.

Most GIST cases are caused by a spectrum of clinically relevant mutations that force the KIT or PDGFRA protein kinases into an increasingly active state. Because currently available therapies primarily bind to the inactive protein conformations, certain primary and secondary mutations typically lead to treatment resistance and disease progression.

In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type. Mutational testing is critical to tailor therapy to the underlying disease driver and is recommended in expert guidelines. Currently, there are no approved therapies for patients with KIT-driven GIST whose disease progresses beyond imatinib, sunitinib and regorafenib. In patients with metastatic PDGFRα D842V-driven GIST, progression occurs in a median of approximately three to four months with available therapy.

About Avapritinib

Avapritinib is an investigational, oral precision therapy that selectively and potently inhibits KIT and PDGFRA mutant kinases. It is a type 1 inhibitor designed to target the active kinase conformation; all oncogenic kinases signal via this conformation. Avapritinib has demonstrated broad inhibition of KIT and PDGFRA mutations associated with GIST, including potent activity against activation loop mutations that are associated with resistance to currently approved therapies.

Blueprint Medicines is initially developing avapritinib for the treatment of advanced GIST, advanced systemic mastocytosis (SM), and indolent and smoldering SM. The FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRα D842V mutation and one for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia. The European Commission has granted orphan medicinal product designation to avapritinib for the treatment of GIST and mastocytosis.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of avapritinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for avapritinib in the rest of the world.

Select Medical Holdings Corporation Announces Estimate of Certain Results for Second Quarter Ended June 30, 2019 in connection with Refinancing Discussions

On July 18, 2019 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM) is reported currently in discussions with its lenders regarding a proposed refinancing of certain of its outstanding indebtedness (Press release, Select Medical, JUL 18, 2019, View Source [SID1234537607]). In connection with such discussions, Select Medical reported an estimate of certain results for its second quarter ended June 30, 2019 in advance of the announcement of actual results, which is expected to occur after market close on August 1, 2019.

Select Medical expects its net operating revenue for the second quarter of 2019 to be in the range of $1.360 billion to $1.362 billion. Select Medical expects earnings excluding interest, income taxes, depreciation and amortization, stock compensation expense, non-operating gain (loss), and equity in earnings (losses) of unconsolidated subsidiaries, or Adjusted EBITDA, for the second quarter of 2019 to be in the range of $185.5 million to $187.0 million. The above expectations regarding Select Medical’s results for the second quarter of 2019 are management estimates and projections based on currently available information, and are subject to change upon completion of Select Medical’s financial statement closing process.

The Company is not providing a reconciliation of estimated Adjusted EBITDA to Net Income for the second quarter of 2019. At this point in its financial statement closing process, the Company is unable to estimate, without unreasonable efforts, certain individual items required to reconcile estimated Adjusted EBITDA with the most directly comparable GAAP financial measure (Net Income). These items include income tax expense and equity in earnings of unconsolidated subsidiaries.

Conference Call

As previously announced, Select Medical will host a conference call regarding its second quarter results, as well as its business outlook, on Friday, August 2, 2019, at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 5489707. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 12:00pm ET, August 9, 2019. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 5489707. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

Diplomat to Release Second-Quarter 2019 Operating Results August 9

On July 18, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that it will release its second-quarter 2019 operating results before market open Friday, August 9. A conference call and live webcast will be held at 8:30 a.m. ET (Press release, Diplomat Speciality Pharmacy, JUL 18, 2019, View Source [SID1234537606]).

Shareholders and interested participants can listen to a live broadcast by calling 833.286.5805 (647.689.4450 for international callers) and entering participation code 7394702, starting about 15 minutes before the call. A live webcast of the conference call will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. The site will host an audio recording and supplemental investor information for 90 days.