What’s Driving ESMO 2018?

A recent analysis from 1stOncology/BioSeeker reveals the direction of commercial drug development emerging from the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 congress, featuring more than 2000 abstracts detailing the latest ground-breaking science/clinical development in oncology.

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While this analysis tells you all from which immunotherapies are dominating at E.S.M.O to development of novel targets, never previously pursued in oncology, the center stage for the “Commercial Interest at E.S.M.O Annual Meeting 2018” is to feature where E.S.M.O makes a footprint in the commercial cancer drug development landscape. What’s so compelling with the analysis is that is constructed from an exceedingly solid knowledge-base of more than 12,500 drugs, 4,000 companies/organizations and tens of thousands of interventional clinical trials in oncology.

The hotbed of this conference is energized from an underlying cluster of roughly 300 drugs ranging from preclinical to marketed in maturity (see pipeline breakdown by stage above). Two fifths (40%) of these are Immune-Oncology drugs including Immune Checkpoint drugs, Cancer vaccines, Bispecific immunomodulators, CAR/TCR therapies and Oncolytic virotherapies. In the spotlight of this year’s Nobel Prize in Physiology or Medicine E.S.M.O 2018 features nearly 40 different immune checkpoint drugs, by far the most reported on immunotherapy and even more so if we take into account all combination therapy reports with the same. Other hot progress areas in cancer therapeutics include DNA Damage Response (DDR) drugs, epigenetic therapies, protein kinase inhibitors and antibody-drug conjugates (ADCs).

The number of targets related to the aforementioned drugs is close to 200 were the top five drug targets are: KDR/VEGFR2 (17), EGFR (15), HER2 (14), KIT (13) and FLT4 (11) (see target breakdown above).

On the contrasting end of these we find fourteen unique targets belonging to first-in-class drugs like Astellas’ enfortumab vedotin, a fully humanized monoclonal antibody that delivers the microtubule-disrupting agent monomethyl auristatin E to tumors expressing Nectin-4, which is highly expressed in 97% of metastatic urothelial cancer patient samples.

There is a global presence of companies at E.S.M.O 2018 ranging from big pharma to startups like Arcus Biosciences (USA), CStone Pharmaceuticals (China), Neon Therapeutics (USA), NEOMED Therapeutics 1 (Canada) and Oblique Therapeutics (Sweden).

It is noteworthy to mention that both Arcus Biosciences and Neon Therapeutics are 2016 winners of the prestigious Fierce 15 Biotech award (see 2018 cancer winners here). This prestigious award has come to symbolize novelty and being at the forefront of biotechnology development among businesses. The winners of this award are aiming at breakthroughs and big things, not at being ‘me-too’. For an example Arcus Biosciences is reporting stellar safety data from its phase 1 study of AB928, a dual antagonist of the A2aR and A2bR adenosine receptors. This development is of course only the tip of the iceberg of clinical trial reports presented at this year’s conference. In a late breaking abstract (LBA) Friday (October 19) Merrimack Pharmaceuticals will be providing more information to their previous report in June about their failed CARRIE study, evaluating the addition of istiratumab (MM-141) to standard-of-care treatment in patients with previously untreated metastatic pancreatic cancer and high serum levels of free Insulin-like Growth Factor-1 (For more LBAs see Saturday, Sunday and Monday releases). The study did not meet its primary or secondary efficacy endpoints in patients who received istiratumab in combination with nab-paclitaxel and gemcitabine, compared to nab-paclitaxel and gemcitabine alone. These results were consistent in all subgroups analyzed.

In overall the late breaking abstracts presented at ESMO (Free ESMO Whitepaper) 2018 are testament to years of rapid growth of and interest in combination therapy trials and in particular with immune-checkpoint inhibitors. On Saturday (October 20th) Genentech/Hoffman-La Roche got the world’s attention with “game changing” results from their IMpassion130 study, a global, randomised, double-blind, phase 3 study of atezolizumab + nab-paclitaxel versus placebo + nab-paclitaxel in treatment-naive, locally advanced or metastatic triple-negative breast cancer (mTNBC). Among those who received the combination, the median survival was 21.3 months, compared with 17.6 months for those who received chemotherapy alone. The difference was not statistically significant. However, looking only at women with positive PD-L1 expressing tumors the median survival was 25 months in the combination group, versus 15.5 months with just chemotherapy. That finding has however not been analyzed statistically, and the patients are still being followed. These finds were simultaneously published in View Source">The New England Journal of Medicine and presented at ESMO 2018.

In spite of limited representation of a major therapeutic class like CAR/TCR therapies or the latest progress on targeting the CD47-SIRPA axis, all in all the ESMO (Free ESMO Whitepaper) congress is Europe’s largest clinical oncology meeting and a go-to place that acts as a sign-post on the road ahead in cancer drug development.

Agios to Webcast Conference Call of Third Quarter 2018 Financial Results on November 1, 2018

On October 18, 2018 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company will host a conference call and live webcast on Thursday, November 1, 2018 at 8:00 a.m. ET to report its third quarter financial results and other business highlights (Press release, Agios Pharmaceuticals, OCT 18, 2018, http://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-third-quarter-2018-financial [SID1234530260]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 5285068. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event

Bexion Pharmaceuticals, Inc. Represented at 15 th Annual BioNetwork Partnering Summit

On October 18, 2018 Bexion Pharmaceuticals, Inc., a clini cal stage biotechnology company focused on developing innovative cures for cancer, reported that Dr. Ray Takigiku, Founder and CEO of the Company presented recently at the 15 th Annual BioNetwork Partnering Summit, held in Laguna Nigel, CA from October 10 – 12, 2018 (Press release, Bexion, OCT 18, 2018, View Source [SID1234530294]). Chosen by the National Cancer Institute as part of its SBIR Investor Initiatives program, Bexion was among a select group of companies th at the N CI sponsored to present at this annual biotech industry financial partnering forum.

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Over 200 se nior decision makers in pharma and biotech deal making attend ed the conference to pursue relationships for partnerships and investment opportunities.

Dr. Takigiku presented the Bexion story to the audience and participated in numerous one to one meetings with pharma organizations.

About NCI SBIR Investor Initiatives Program

Through the Investor Initiatives Program, the National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Development Center connects NCI SBIR funded companies wi th potential investors and strategic partners to continue the research and commercialization efforts initially funded by NCI. Companies must apply and are selected by a panel of independent experts including over 50 Venture Capital organizations and potent ial strategic partners.

Delcath Announces Enrollment of First Patient in ALIGN Trial

On October 18, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that patient treatments have begun in the Company’s second global US registration trial investigating Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) in the treatment of patients with intrahepatic cholangiocarcinoma (ICC) (Press release, Delcath Systems, OCT 18, 2018, View Source;p=RssLanding&cat=news&id=2372259 [SID1234530000]).

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The University of Tennessee Health Science Center (UTHSC) in collaboration with Methodist University Hospital (MUH) and West Cancer Center (WCC) in Memphis, Tennessee have enrolled the trial’s first patient and treatments have begun by a team led by Dr. Evan S. Glazer. Dr. Glazer, a board certified surgical oncologist, is the principal investigator for the trial at the UTHSC/MUH/WCC location.

The trial, entitled A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma, (the ALIGN Trial) will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.

"ICC is a deadly form of liver cancer, and the current treatment options have only shown very limited benefit," said Dr. Evan Glazer, "Our team is encouraged by the initial data available for Melphalan/HDS and are pleased to participate in this trial to explore this therapy’s potential as a new treatment option for these patients. We are most excited by the multi-disciplinary approach that this trial takes to help our patients."

"We are delighted to be working with Dr. Glazer and the team in Memphis to initiate The ALIGN Trial," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "In this orphan population where there exists a large unmet need, this trial provides us with a potential second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for Delcath."

DXC Technology to Report Second Quarter 2019 Results on Tuesday, November 6, 2018

On October 18, 2018 DXC Technology (NYSE: DXC), the world’s leading independent, end-to-end IT services company, reported that it will release financial results for the second quarter of fiscal 2019 on Tuesday, November 6, 2018, at approximately 4:15 p.m. Eastern Standard Time (EST) (Press release, DynPort Vaccine Company, OCT 18, 2018, View Source [SID1234529972]).

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DXC Technology senior management will host a conference call and webcast on the same day at 5 p.m. EST. The dial-in number for domestic callers is (877) 260-1479. Callers who reside outside of the United States should dial +1 (334) 323-0522. The passcode for all participants is 4189723. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until November 13, 2018. Replay numbers can be found at the following link. The replay passcode is also 4189723.

DXC Technology Investor Day

DXC Technology will host its 2018 Investor Day on Thursday, November 8, 2018 in New York City, with presentations beginning at approximately 9:30 a.m. Eastern Standard Time (EST).

A webcast of the Investor Day and any presentation slides will be available on DXC’s Investor Relations website. The webcast will begin on Thursday, November 8, 2018 at 9:30 a.m. EST at View Source