On November 6, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the Credit Suisse 27th Annual Healthcare Conference on Tuesday, Nov. 13, 2018 at 10:20 a.m. MT (12:20 p.m. ET/5:20 p.m. GMT) from Scottsdale, Arizona (Press release, Alkermes, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375640 [SID1234530867]). In addition, Alkermes’ corporate presentation will be webcast live at the Jefferies London Healthcare Conference on Wednesday, Nov. 14, 2018 at 4:00 p.m. GMT (11:00 a.m. ET) from London, U.K. These presentations may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

On November 6, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it will report its financial results for the third quarter ended September 30, 2018, and provide a business update on Wednesday, November 14, 2018 after the close of the U.S. financial markets (Press release, RXi Pharmaceuticals, NOV 6, 2018, View Source [SID1234530887]).

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A live audio webcast will begin at 4:30 p.m. EDT. The webcast link is available under the "Investors – Events and Presentations" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States: +1 844-376-4678. International participants may access the event by dialing: +1 209-905-5958.

An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

On November 6, 2018 Forbius, a clinical stage company developing biotherapeutics targeting EGFR and TGF-β pathways, reported an invited oral presentation of AVID100 at the 9th Annual World ADC Meeting (Press release, Forbius, NOV 6, 2018, View Source [SID1234531668]). Robert Lutz, Chief Development Officer of Forbius, will give a presentation entitled "Preclinical & Clinical Development of AVID100: An EGFR-Targeting Antibody Drug Conjugate" on November 13, 2018 at 11 AM Pacific Time.

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The AVID100 Phase 1 study was completed mid 2018, having enrolled 24 patients, and established a recommended Phase 2 dose (RP2D) of AVID100 of 240 mg/m2 (~6 mg/kg). This is one of the highest RP2Ds reported for maytansinoid payload ADCs (Deslandes, MAbs. 2014 Jul 1;6(4):859–870) and is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events at RP2D were well-tolerated and grade 1 and 2 in severity. Of note, skin-related side-effects, that have been observed previously for therapeutic anti-EGFR antibodies, remained low grade and well tolerated.

AVID100 is currently undergoing Phase 2a clinical trials in EGFR overexpressing tumors to further evaluate safety and efficacy.

About AVID100
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) that was engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity, including in EGFR overexpressing tumor models that are resistant to marketed EGFR inhibitors. AVID100 is the only broadly active anti-EGFR ADC in clinical development.

With a pedigree stretching back almost a quarter of a century, BIO-Europe is not only Europe’s largest partnering conference but, according to a recent analysis by 1stOncology™ (also covering BIO International and BIO Asia), it is also one of the world’s richest displays of cancer drug development companies under one roof! With over 600 oncology companies from more than thirty different countries present at BIO-Europe 2018, this is truly a global event. Many of these have also just presented their latest scientific/clinical advancements at the freshly completed European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO 2018) congress. Now coming together at the BIO-Europe 2018 meeting they represent more than 5,500 cancer drugs, from discovery to marketed, and are responsible for more than 40% of the world’s current output in cancer R&D, see pipeline breakdown below.

These new cancer drug technologies are being developed from a wide array of organizations, from centuries old universities such as Jagiellonian University (Poland) founded in 1364, to startup companies like Cedilla Therapeutics (USA) and Epigene Therapeutics (Canada), both founded in 2018. Regardless of age they are all coming together at BIO-Europe 2018 to engage with global life science partners.

The global nature of this meeting is revealed when looking at the top nations with cancer drug developing companies present at this year BIO-Europe. It is no surprise to see the United States in first place with 190 companies, UK in second with 48 and Japan is in third place with 41 companies. Please see below table for the top ten nations at BIO-Europe 2018.

In today’s fast moving climate where a company can go from an idea to a public company in a blink of an eye, roughly one third of the 600 cancer companies are publicly traded at various stock exchange markets around the world. No less than seven of these have gone through their initial public offering in 2018 alone, namely ARMO BioSciences, ASLAN Pharmaceuticals, Autolus, BeiGene, Forty Seven, MorphoSys and Sutro Biopharma.

The number of cancer startups, founded in the last five years, present at the BIO-Europe meetings amount to almost fifty, see table below for breakdown per year.

The sizeable cancer pipeline of more than five and a half thousand drugs represented at BIO-Europe is a based on a very diverse selection of technologies and discoveries in cancer biology. Almost one third of these are Immune-Oncology (I-O) drugs including Immune Checkpoint drugs, Cancer vaccines, Bispecific immunomodulators, CAR/TCR therapies and Oncolytic virotherapies, see breakdown by type of I-O drugs below.

In the spotlight of this year’s Nobel Prize in Physiology or Medicine, companies at BIO-Europe feature nearly 300 different immune checkpoint drugs. Other hot progress areas in cancer therapeutics include DNA Damage Response (DDR) drugs, epigenetic therapies, Protein Kinase Inhibitors (PKIs) and Antibody-Dug Conjugates (ADCs).

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On November 5, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, reported that it has established a clinical trial collaboration agreement with Merck (known as MSD outside the U.S. and Canada) to conduct a Phase 1/2 study evaluating the safety and efficacy of the combination of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy , and FLX Bio’s investigational oral small molecule CCR4 inhibitor, FLX475, in patients with multiple types of cancer (Press release, FLX Bio, NOV 5, 2018, View Source [SID1234530726]).

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The open-label, dose-escalation and cohort expansion Phase 1/2 study is enrolling patients with multiple types of cancer at leading cancer centers across the United States, Australia and Asia. In addition to evaluating the safety and tolerability of FLX475 as a monotherapy and in combination with pembrolizumab, the study will evaluate changes in the tumor microenvironment and the antitumor activity of both monotherapy and combination therapy. For more information please visit clinicaltrials.gov identifier NCT03674567.

"We are extremely pleased to collaborate with Merck, an established leader in the field of cancer immunotherapy," said Brian Wong, M.D., Ph.D., CEO of FLX Bio. "KEYTRUDA is an anti-PD1 immunotherapy that has demonstrated efficacy in a range of cancers. FLX475 targets a novel mechanism to selectively inhibit the recruitment of regulatory T cells (Treg) into the tumor, where Treg potentially suppress the anti-tumor immune response; thus FLX475 has the potential to deepen and broaden the efficacy of KEYTRUDA when combined. We are excited to collaborate with the Merck team to evaluate the efficacy of a combination of FLX475 and KEYTRUDA which we believe could substantially improve patient outcomes."

Keytruda is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About FLX475
FLX475 is a best-in-class oral, small molecule antagonist of CCR4 which selectively blocks suppressive regulatory T cells in tumor tissue and promotes a durable anti-tumor immune response. FLX Bio has completed a study of FLX475 in healthy volunteers, demonstrating that the compound is safe with excellent pharmacokinetic and pharmacodynamic properties. In preclinical studies, FLX475 inhibited tumor growth and increased tumor regression as a single agent. In addition, FLX475 enhanced the anti-tumor effects of various checkpoint inhibitors as well as immune agonist antibodies. FLX475 also has the potential to enhance cell-based immunotherapies such as CAR-T and cancer vaccines. In contrast to depleting antibody approaches, FLX475 selectively blocks the recruitment of regulatory T cells to the tumor site and does not deplete cells beneficial to an anti-tumor response or regulatory T cells in healthy tissue.