The BIO Asia 2017 meeting is an exclusive partnering forum offering an unique possibility to find and evaluate oncology opportunities in an Asian setting (1stOncology Insights, BioSeeker Group, MAR 1, 2017, http://www.bioseeker.com/market-research-report/finding-and-evaluating-oncology-opportunities-at-bio-asia-2017-a-1stoncology-insights-report.html [SID1234518080]).
In a recent analysis, based on the communicated participants at the time*, the oncology position and activities of 61 companies has been featured by the analyst team at 1stOncology for the benefit its audience. In overall, an extensive partnering review has been done of close to 900, partnered or as yet un-partnered, drugs in 17 "hot" areas in oncology, including:

· Most recent Positive/Negative Developments (226/43)
· Start-Ups (4)
· Fierce 15 Drugs (53)
· Orphan Drugs (252)
· Breakthrough Therapies (31)
· Cancer Vaccines (59)
· CAR/TCR Therapies (14)
· Immune Checkpoints (67)
· Epigenetic Therapies (35)
· Protein Kinase Inhibitors (194)
· Antibodies in Oncology (345)
· Cancer Peptides (47)
· RNA Therapies (13)
· Conjugated Drugs (109)
· Biomarker/Companion Diagnostic Drugs (166)
· Combination Therapy Drugs (492)
· Biosimilars/Biobetters (27)

Area (Number of Drugs in Each Area)

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This independent, third-party breakdown analysis gives a landscape of oncology opportunities which guides corporate interest in how to allocate time and spend resources around BIO Asia where it reaps the most value. Undoubtedly, immuno-oncology will continue being the center piece of attention in general and immunecheck point inhibitors in particular.

Furthermore almost one thousand corporate developments have been analyzed detailing the latest positive and negative pipeline development for circa 250 top cancer drugs throughout 2016 to present, giving a comprehensive insight to current developments such as successful clinical trials, trials with missed primary endpoints, new or terminated partnerships, M&A and much more.

The 1stOncology team recognizes that contacts are key to actively drive forward partnering activities so special for BIO Asia 2017 they have set out to boost the event with giving access to circa 300 contacts in business development and licensing people within the featured companies, allowing the thrifty to reach out quickly and directly to the right person of interest for initial introductions, partnership discussions, pre-booking meetings etc.

*As of February 24, 2017

On March 1, 2017 Celgene Corporation (CELG) and Agios Pharmaceuticals (AGIO) reported that the U.S. Food and Drug Administration (FDA) has accepted Celgene’s New Drug Application (NDA) for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation (Press release, Agios Pharmaceuticals, MAR 1, 2017, View Source;p=RssLanding&cat=news&id=2250587 [SID1234517906]). The NDA was granted Priority Review and has been given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30, 2017. Celgene completed the NDA submission in late December 2016.

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"We accelerated this application – submitting the NDA just three years after the first patient was treated in the enasidenib pivotal investigational trial – because we believe that there is a significant unmet need for people with relapsed or refractory AML," said Michael Pehl, president, Hematology/Oncology for Celgene. "The acceptance of the enasidenib NDA is a significant milestone in what we hope will be a new era of molecularly targeted therapies for patients with this devastating disease."

Enasidenib is a first-in-class, oral, targeted inhibitor of mutant IDH2. The NDA submission is based on results from AG221-C-001, a single-arm phase I/II study of enasidenib in patients with advanced hematologic malignancies with an IDH2 mutation. Early data from the relapsed or refractory AML patients in this study were presented at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

"Having received NDA acceptance and priority review for enasidenib, we look forward to working with our partner Celgene and the FDA to advance a first-in-class therapy for relapsed or refractory AML with an IDH2 mutation," said David Schenkein, M.D., chief executive officer at Agios. "We hope that the continued adoption of molecular profiling and availability of new targeted therapies such as enasidenib will have a significant impact on patients living with AML."

Additionally, Abbott has submitted a Premarket Approval (PMA) application for the FDA approval of an IDH2 assay on the Abbott m2000 RealTime System, a polymerase chain reaction (PCR) molecular diagnostics instrument. IDH2 mutations occur in about 8 to 19 percent of AML patients. Recent publications have highlighted the advances in the understanding of the genetics underlying AML and the need for routine mutational analysis at diagnosis and relapse.

Celgene is also evaluating enasidenib compared with conventional therapy in older patients with an IDH2 mutation and relapsed or refractory AML in the ongoing phase III IDHENTIFY trial (NCT02577406).

Enasidenib is an investigational drug that has not been approved for any use in any country.

About Acute Myelogenous Leukemia (AML)

AML, a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia affecting adults. Undifferentiated blast cells proliferate in the bone marrow rather than mature into normal blood cells. AML incidence significantly increases with age, and according to the American Cancer Society, the median age of onset is 66. Less than 10 percent of U.S. AML patients are eligible for bone marrow transplant and the vast majority of patients do not respond to chemotherapy and progress to relapsed/refractory AML. The five-year survival rate for AML is approximately 20 to 25 percent. IDH2 mutations are present in about 8 to 19 percent of AML cases.

Merrimack 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, Merrimack, MAR 1, 2017, View Source [SID1234517916]).

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Aduro Biotech 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, Aduro Biotech, MAR 1, 2017, View Source [SID1234517920]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Intrexon 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, Intrexon, MAR 1, 2017, View Source [SID1234517944]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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