On May 13, 2020 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that vorasidenib and ivosidenib clinical data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually May 29-31, 2020 (Press release, Agios Pharmaceuticals, MAY 13, 2020, View Source [SID1234557921]).

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The accepted abstracts are listed below and are available online on the ASCO (Free ASCO Whitepaper) meeting library website: View Source All oral and poster presentations will be available on demand for registered meeting attendees on the ASCO (Free ASCO Whitepaper) conference website beginning on May 29 at 8:00 a.m. ET.

Oral Presentation:

Title: Vorasidenib (VOR; AG-881), an inhibitor of mutant IDH1 and IDH2, in patients (pts) with recurrent/progressive glioma: Updated results from the phase I non-enhancing glioma population
Oral Abstract Session: Central Nervous System Tumors
Abstract: 2504
Presenter: Ingo K. Mellinghoff, M.D., Memorial Sloan Kettering Cancer Center

Poster Presentations:

Title: INDIGO: A global, randomized, double-blind, phase III study of vorasidenib (VOR; AG-881) vs placebo in patients (pts) with residual or recurrent grade II glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation
Poster Session: Central Nervous System Tumors
Abstract: TPS2574
Author: Ingo K. Mellinghoff, M.D., Memorial Sloan Kettering Cancer Center

Title: IDH1 mutation detection in plasma circulating tumor DNA (ctDNA) and association with clinical response in patients with advanced intrahepatic cholangiocarcinoma (IHC) from the phase III ClarIDHy study
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract: 4576
Author: Elia Aguado-Fraile, Ph.D., Agios Pharmaceuticals

Title: Ivosidenib (IVO) prior to hematopoietic cell transplant for patients with IDH1-mutant relapsed or refractory acute myeloid leukemia (R/R AML)
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7521
Author: Courtney D. DiNardo, M.D., University of Texas MD Anderson Cancer Center

On May 13, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will present new preclinical data on the anti-tumor activity of SY-5609, its highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor, in models of colorectal cancer (Press release, Syros Pharmaceuticals, MAY 13, 2020, View Source [SID1234557938]). These data will be presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (ASCO20) taking place May 29-31. Syros will also present on the design of its ongoing Phase 1 trial of SY-5609 at ASCO (Free ASCO Whitepaper)20.

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The abstracts for these presentation are now available online on the ASCO (Free ASCO Whitepaper)20 website, at View Source

Details of the poster presentations are as follows:

Presentation Title: Activity of SY-5609, an oral, noncovalent, potent, and selective CDK7 inhibitor, in preclinical models of colorectal cancer
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Presenter: Liv Johannessen, Ph.D., Syros
Abstract Number: 3585
Poster Number: 315

Presentation Title: First-in-human phase I study of SY-5609, an oral, potent, and selective noncovalent CDK7 inhibitor, in adult patients with select advanced solid tumors
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Presenter: Kyriakos P. Papadopoulos, M.D., South Texas Accelerated Research Therapeutics (START)
Abstract Number: TPS3662
Poster Number: 392

Presentations will be available for on-demand viewing on the ASCO (Free ASCO Whitepaper)20 website beginning May 29, 2020, at 8 a.m. EDT.

On May 13, 2020 Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) reported that Executive Chairman Robert J. Coury and President Rajiv Malik will present at the 2020 RBC Capital Markets’ Virtual Global Healthcare Conference on Tuesday, May 19, 2020 at 8 a.m. ET (Press release, Mylan, MAY 13, 2020, View Source [SID1234557954]).

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Interested parties can access a live webcast of the presentation via the investor relations section of Mylan’s website at investor.mylan.com. An archived version also will be available following the live presentation and can be accessed at the same location for a limited time.

On May 13, 2020 DCprime, the front-runner in the field of relapse vaccines, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for DCP-001, an allogeneic cancer relapse vaccine currently being evaluated in a European Phase II trial in Acute Myeloid Leukaemia (AML) patients who are ineligible for hematopoietic stem cell transplantation (Press release, DCPrime, MAY 13, 2020, View Source [SID1234561870]). The IND provides the possibility for DCprime to expand the ongoing ADVANCE-II trial into the Unites States, where DCP-001 had received orphan drug status in Q4 2019.

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"Following encouraging clinical and preclinical data presented at medical conferences in 2019, 2020 should see the first results emerging from the ADVANCE-II study. The possibility to expand our trial activities into the United States is an important step and follows approvals by different European authorities in The Netherlands, Germany, Norway, Sweden, and recently also Finland," said Jeroen Rovers, MD, PhD, Chief Medical Officer of DCprime. "Although we are currently facing challenging times for clinical studies due to the Covid-19 crisis, DCprime remains committed to expanding its clinical network to support the development of relapse vaccines in AML and other cancer types. Securing the regulatory approval now, allows us to move quickly once the current clinical situation around Covid-19 improves."

The currently active international, multi-center, open-label proof-of-concept study ADVANCE-II is recruiting AML patients in complete remission, but with persistent measurable residual disease (MRD), which is associated with a high relapse rate. The effect of DCP-001 on MRD in combination with immunomonitoring will be used to evaluate the efficacy of DCprime’s relapse vaccination strategy.

Clinical data from a previously concluded Phase I clinical study that was presented at the 61st Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2019 demonstrated DCP-001’s potential to prolong relapse-free survival and overall survival in the post-remission setting.

On May 13, 2020 Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, and Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform therapy called Tumor Treating Fields, reported that the China National Medical Products Administration (NMPA) has approved the Marketing Authorization Application (MAA) for Optune in combination with temozolomide for the treatment of patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM (Press release, Zai Laboratory, MAY 13, 2020, View Source [SID1234557885]). GBM is the most common form of primary brain cancer, and Optune is the first treatment for glioblastoma approved in China in over 15 years.

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"The NMPA’s approval of Optune is a significant treatment advance for GBM patients in China and another important milestone for Zai," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "Optune was previously granted the Innovative Medical Device Designation, which highlights the differentiation and importance of this novel treatment for GBM patients. We appreciate the NMPA for their partnership through this rapid and thorough assessment of the Optune application, recognizing the high unmet medical need it serves. We look forward to working with Novocure to bring Tumor Treating Fields to GBM and other difficult to treat cancer indications."

"Novocure is working to extend survival in some of the most aggressive cancers through the development and commercialization of Tumor Treating Fields," said William Doyle, Novocure’s Executive Chairman. "Approval of Optune for GBM in Greater China extends the promise of Tumor Treating Fields therapy to patients in the world’s largest market. We thank Zai Lab for their commitment and hard work and congratulate them on their second product approval in six months."

Optune delivers Tumor Treating Fields therapy to the region of the tumor. Globally, more than 15,000 GBM patients have been treated with Optune, to date. Tumor Treating Fields is also approved by the U.S. FDA under the Humanitarian Device Exemption pathway for the treatment of malignant pleural mesothelioma (MPM), which is anticipated to be the next MAA filed with the NMPA. In addition to GBM and MPM, Tumor Treating Fields is under evaluation in global phase 3 pivotal trials for the treatment of brain metastases, non-small cell lung cancer, pancreatic cancer and ovarian cancer, and in phase 2 pilot trials for liver cancer and gastric cancer. Approximately 1.5 million patients a year in China are diagnosed with non-small cell lung cancer, pancreatic cancer, ovarian cancer and gastric cancer, collectively.

"In China, there are more than 45,000 patients diagnosed with GBM each year and this approval marks the first new treatment option for these patients in over 15 years," said Jiang Tao, M.D., Ph.D., Head of Beijing Neurosurgical Institute, Founder of Chinese Glioma Genome Atlas, and Professor of Beijing Tiantan Hospital. "Optune was recommended with Level 1 evidence as a treatment for newly diagnosed GBM patients in China’s Glioma Treatment Guideline in 2018, and we are excited to now have Optune available as part of the standard of care for GBM patients in China."

About Optune

Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Approved Indications (China)

Optune is intended as a treatment for adult patients (22 years of age or older) with recurrent supratentorial glioblastoma multiforme (GBM) diagnosed by histopathology or imaging, and newly diagnosed supratentorial GBM.

Newly diagnosed GBM

Optune with temozolomide (TMZ) is indicated for the treatment of adult patients with newly diagnosed GBM after surgery and radiotherapy.

Recurrent GBM

Optune is indicated for the treatment of recurrent GBM as a monotherapy.