On June 27, 2018 Kangpu Biopharmaceuticals, Ltd., a clinical-stage company based in Shanghai, China, reported that a phase I, multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary evidence of antitumor activity of KPG-121 in combination with Enzalutamide in adult subjects with metastatic castration-resistant prostate cancer (mCRPC) has been launched in the United States (Press release, Kangpu Biopharmaceuticals, JUN 27, 2018, View Source [SID1234527486]). The study takes place at 3 medical centers in the US; part of Accelovance’s network of HERO sites dedicated to early phase research in oncology. Specifics of the study can be found on www.clinicaltrials.gov/NCT03569280.

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About KPG-121
KPG-121 is a novel generation of Lenalidomide. Compared with Lenalidomide, KPG-121 has shown enhanced immunomodulatory activities and improved anti-angiogenic properties in the preclinical studies. Results from in vitro assays and in vivo studies of mCRPC animal xenograft models demonstrated that better efficacy was observed for KPG-121 compared to Lenalidomide, when combined with Enzalutamide, Abiraterone Acetate, Apalutamide or Darolutamide. In the combination studies with Enzalutamide, KPG-121 significantly improved anti-tumor efficacy when compared to Enzalutamide alone.

On June 28, 2018 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported the achievement of the second of two preclinical milestones towards an investigational new drug (IND) filing for ARGX-115, triggering a further $ 10 million payment from AbbVie (Press release, argenx, JUN 28, 2018, View Source;p=RssLanding&cat=news&id=2356311 [SID1234527488]).

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In April 2016, argenx entered into a development and exclusive license option agreement with AbbVie to develop and commercialize ARGX-115. Under the terms of that agreement, argenx has been responsible for conducting and funding all ARGX-115 research and development activities up to completion of IND-enabling studies.

Over the course of the past two years, argenx has been eligible to receive two preclinical milestones of $ 10 million each. The second milestone was achieved today.

About ARGX-115
ARGX-115 employs argenx’s SIMPLE Antibody(TM) technology and binds specifically to the protein glycoprotein A repetitions predominant (GARP), which plays a key role in the regulation of production and release of active transforming growth factor beta (TGF-beta). ARGX-115 is believed to selectively limit the immunosuppressive activity of activated regulatory T-cells (Tregs), thereby stimulating the immune system to attack cancer cells. While the normal function of Tregs is to suppress certain compartments of the immune system to prevent self-directed immune responses through the release of active TGF-beta, Tregs can also prevent the immune system from recognizing and suppressing pathogenic cells including cancer cells. We believe the selective inhibition of TGF-beta release by Tregs is potentially superior to systemic inhibition of TGF-beta activity or depletion of Tregs and may give rise to therapeutic products with an improved safety profile.

ARGX-115 was discovered under argenx’s Innovative Access Program with the de Duve Institute / Université Catholique de Louvain / WELBIO and exclusively licensed under a research and option agreement in 2013.

On June 26, 2018 Allergan plc (NYSE: AGN) reported that it intends to release second quarter 2018 financial results on Thursday, July 26, 2018, prior to the open of U.S. financial markets (Press release, Allergan, JUN 26, 2018, View Source [SID1234527470]).

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Allergan will host a conference call and webcast at 8:30 a.m. Eastern Time on Thursday, July 26, 2018 to discuss its financial results. The dial-in number to access the call is U.S./Canada (877) 251-7980, International (706) 643-1573, and the conference ID is 67781714.

A taped replay of the conference call will also be available beginning approximately two hours after the call’s conclusion, and will remain available through 11:30 p.m. Eastern Time on August 26, 2018. The replay may be accessed by dialing (855) 859-2056 or (404) 537-3406, and entering the conference ID 67781714.

To access the webcast, please visit Allergan’s Investor Relations website at View Source;. A replay of the webcast will also be available on Allergan’s Investor Relations website.

On June 26, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported the patient enrollment data for its Phase 2 open-label clinical trial of VAL-083 in bevacizumab (Avastin)-naïve recurrent glioblastoma multiforme (rGBM) patients with MGMT-unmethylated status (Press release, DelMar Pharmaceuticals, JUN 26, 2018, View Source [SID1234527471]).

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This trial is being conducted at MD Anderson Cancer Center and as of June 15, 2018, has enrolled 33 of the planned 48 patients. The trial is designed to determine the impact of VAL-083 treatment on overall survival compared to historical reference control.

"We are pleased with the accelerated patient enrollment of our ongoing VAL-083 Phase 2 trial at MD Anderson Cancer Center. Presently, the trial is approximately six months ahead of schedule and based on the trial’s protocol design, we anticipate the primary endpoint of median overall survival to be reached approximately three months after the final patient is enrolled," said Saiid Zarrabian, President and Chief Executive Officer of DelMar.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class," DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute ("NCI"). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance in vitro. Further details regarding these studies can be found at:

View Source

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. VAL-083 has been granted fast-track status for the treatment of recurrent GBM by the US FDA.

On June 26, 2019 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, and CStone Pharmaceuticals, a privately-held biopharmaceutical company devoted to developing a new generation of innovative drugs, reported an exclusive collaboration and license agreement for the development and commercialization of ivosidenib (TIBSOVO; AG-120) in Mainland China, Hong Kong, Macau and Taiwan ("Territory"), either as a monotherapy or in combination with other therapies (Press release, Agios Pharmaceuticals, JUN 26, 2018, View Source [SID1234537653]). Discovered and developed by Agios, ivosidenib is an investigational, first-in-class, oral, targeted inhibitor of the mutant isocitrate dehydrogenase-1 (IDH1) enzyme. CStone Pharmaceuticals will be responsible for conducting the development and commercialization activities for ivosidenib in hematologic and solid tumor indications in the Territory, with an initial focus in acute myeloid leukemia (AML) and cholangiocarcinoma. Agios will retain all rights to ivosidenib in the rest of the world.

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"CStone Pharmaceuticals brings together a highly experienced leadership team and drug development capabilities that will enable us to reach patients with IDH1 mutant cancers in Greater China who could benefit from ivosidenib," said David Schenkein, M.D., chief executive officer at Agios. "In addition to the clinical development activities that CStone will be leading, we also have the opportunity to leverage CStone’s network to expand our ongoing and future global clinical trials of ivosidenib into Greater China."

Subject to the terms of the agreement, Agios will receive an upfront payment of $12 million and will be eligible to receive up to $412 million in milestone payments, of which $147 million are related to development and regulatory events and $265 million to the achievement of certain sales levels. Approximately half of the milestone payments are related to the development and commercialization of ivosidenib in AML, cholangiocarcinoma and other potential indications. The other half are payable only if development and commercialization of ivosidenib in brain cancer indications, including glioma, are pursued as part of the collaboration at a later date. In addition, CStone Pharmaceuticals will pay Agios tiered royalties ranging from the mid to high-teens as a percentage of annual net sales of ivosidenib in the Territory. CStone Pharmaceuticals will be responsible for all costs associated with development and commercialization activities for ivosidenib conducted in the Territory under the agreement.

"We’re very pleased to partner with Agios to advance the global development of ivosidenib, which has clearly demonstrated significant benefit to patients with AML as well as potential utility in other IDH1m cancers," said Frank Jiang, M.D., Ph.D., chief executive officer at CStone Pharmaceuticals. "Given ivosidenib is currently under U.S. FDA priority review for IDH1m relapsed or refractory AML patients, it is the most advanced program in our pipeline. The partnership will also allow us to explore ivosidenib in combination with other products in our portfolio."

About Ivosidenib (TIBSOVO / AG-120)
Ivosidenib is an investigational first-in-class, orally available, selective, potent inhibitor of the mutated IDH1 protein and is a highly targeted investigational medicine for the treatment of patients with cancers that harbor an IDH1 mutation. IDH1 is a metabolic enzyme that is mutated in a wide range of cancers, including acute myeloid leukemia, cholangiocarcinoma and glioma. Ivosidenib is currently under U.S. FDA priority review for IDH1m R/R AML patients with a PDUFA action date of August 21, 2018. The following clinical trials of ivosidenib are ongoing:

Phase 1 trial of ivosidenib or enasidenib in combination with 7+3 in patients with newly diagnosed IDHm AML who are eligible for standard-of-care chemotherapy
Phase 3 AGILE trial of ivosidenib in combination with azacitidine in patients with newly diagnosed IDH1m AML who are not eligible for standard-of-care chemotherapy
Phase 3 ClarIDHy trial of ivosidenib in advanced IDH1m cholangiocarcinoma
Perioperative study comparing ivosidenib and AG-881 in IDH1m low-grade glioma