On November 6, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported a poster presentation of preclinical data by Jonathan Pachter, Ph.D., the Company’s Chief Scientific Officer, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting being held November 7-11, 2018, in Washington, D.C (Press release, Verastem, NOV 6, 2018, View Source;p=irol-newsArticle&ID=2375552 [SID1234530795]).

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"We have assessed the activity of duvelisib, our orally-administered dual inhibitor of PI3K-delta and PI3K-gamma, in combination with either immune checkpoint or co-stimulatory antibodies in syngeneic antitumor models," said Dr. Pachter. "Results to be presented at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting demonstrated that duvelisib shows strong anti-tumor synergy with PD-1 or OX40 antibodies. As a dual PI3K-delta/gamma inhibitor, duvelisib was found to reduce both immunosuppressive Tregs and myeloid cells in tumors more strongly than PI3K-delta, or PI3K-gamma only inhibitors, suggesting that it could be a highly-differentiated PI3K inhibitor for combination with immuno-oncology therapeutics. These preclinical results support clinical investigation of duvelisib in combination with immunotherapies for treatment of patients with hematological or solid tumor malignancies."

Details for the poster presentation are as follows:

Title: Synergistic efficacy of duvelisib with checkpoint or co-stimulatory antibodies in a B cell lymphoma model: Advantages of dual inhibition of PI3K-delta and PI3K-gamma

Abstract poster number: P373

Date and time: Friday, November 9, 2018 from 12:45-2:15 PM and 6:30 – 8:00 PM ET

Location: Hall E

A copy of the poster will be available here following its presentation at the meeting

On November 6, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that the company will host and webcast an investor event on Friday, November 9, 2018 at 6:30 p.m. Eastern Time in Washington, D.C (Press release, Aduro Biotech, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375696 [SID1234530875]). The event will feature special guest speaker Jason J. Luke, M.D., FACP, Assistant Professor of Medicine at the University of Chicago and a principal investigator for the Phase 1 dose-finding studies of ADU-S100 (MIW815), a novel STING (stimulator of interferon genes) pathway activator. ADU-S100 is currently being evaluated as a single agent and in combination with spartalizumab (PDR001), an investigational anti-PD-1 compound in patients with advanced/metastatic solid tumors or lymphomas.

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To access the live webcast and subsequent archived recording of this and other company presentations, please visit the investor section of Aduro’s website at www.aduro.com. The archived webcast will remain available for replay on Aduro’s website for 30 days.

Aduro’s posters will be on display on Friday, November 9, 2018 from 8 a.m. – 8 p.m. ET and Saturday, November 10, 2018 from 8 a.m. – 8:30 p.m. ET in Hall E. at the Walter E. Washington Convention Center. Details of Aduro’s posters and oral presentations are as follows:

P309 Phase I dose-finding study of MIW815 (ADU-S100), an intratumoral
STING agonist, in patients with advanced solid tumors or lymphomas
Session: Rapid Oral Abstract Presentation Session
Date: Saturday, November 10, 2018, 1:00 p.m. ET
Location: Room 204ABC, Walter E. Washington Convention Center

P351 ADU-S100 (MIW815) Synergizes with Checkpoint Inhibition to Elicit an
Anti-Tumor CD8+ T Cell Response to Control Distal Tumors

P516 SIRPα blockade increases the activity of multiple myeloid lineage cells,
enhances dendritic cell cross-presentation, and aids in remodeling the
tumor microenvironment
Session: Concurrent Session 104: Immune Checkpoints – Beyond PD-1
Date/Time: Friday, November 9, 2018, 4:30 p.m. ET
Location: Hall D, Walter E. Washington Convention Center

P517 Pan-allele anti-SIRPα antibodies that block the SIRPα–CD47 innate
immune checkpoint

On November 6, 2018 Fortis Therapeutics, Inc., an immuno-oncology biotech developing a novel antibody-drug conjugate (ADC) against CD46, reported the U.S. Food and Drug Administration (FDA) has cleared two investigational new drug (IND) applications for the company’s lead candidate, FOR46, for the treatment of metastatic castration-resistant prostate cancer and late-stage multiple myeloma (Press release, Fortis Therapeutics, NOV 6, 2018, View Source [SID1234530937]). The Phase 1 trial of FOR46 in metastatic castration-resistant prostate cancer is planned to launch by the end of the year. The second program, in late-stage multiple myeloma, is expected to move into clinical trials in early 2019.

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FOR46 targets a novel immune modulatory receptor, CD46, which is highly expressed in multiple tumor types and is part of the tumor’s immune defense shield. While CD46 is expressed throughout the body, preclinical studies show that FOR46 activity is primarily restricted to prostate and other tumor tissue types, as opposed to normal tissue.

"CD46 is an attractive target for a number of cancers but has yet to be exploited due to its role in healthy tissues," said Jay Lichter, Ph.D., President and CEO of Fortis Therapeutics. "FOR46 cracks the code, in a sense, by binding a specific conformational epitope of CD46, that appears to be specific to tumor cells. This results in targeted tumor killing, while not impacting the natural role of CD46 in the complement system."

Discovery of FOR46

The FOR46 program originated at the University of California, San Francisco, in the laboratory of Bin Liu, Ph.D. It was identified through an antibody selection process that uses living tumor cells residing in their tissue microenvironment, thereby preserving the natural range of surface antigens present on the cells.

"It’s really a testament to the work of our scientists and the scientists at UCSF. By generating antibodies against tumor cells in situ, we developed a drug that readily translates to animal studies and, soon, human trials," said Marc Nasoff, Ph.D., Chief Scientific Officer of Fortis Therapeutics. "We’re confident in the science and in our therapeutic, which builds upon decades of innovation and refinement of antibody-drug conjugates."

To create FOR46, the fully human antibody was conjugated to a potent payload using a proven chemistry platform with well-characterized in vivo properties. Early in vitro studies of FOR46 have demonstrated its potential to kill tumor cells with no effect on normal cells. In rodents with human prostate cancer, it eliminated the tumor and led to long-term survival.

Fortis Therapeutics exclusively licensed rights to the antibody in 2016, and the company maintains a strong intellectual property position.

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 South Korean pharmaceutical company Yuhan reported that it has signed a licensing and cooperation agreement valued at up to $1.25bn with Janssen Biotech to out-license a lung cancer drug candidate called Lazertinib (Press release, Genosco, NOV 5, 2018, View Source [SID1234530717]).

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The new clinical-stage therapeutic is an oral, mutant-selective, irreversible, third generation EGFR tyrosine-kinase inhibitor. It is intended for the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor mutations.

Under the terms of the agreement, Janssen will pay $50m upfront to Yuhan, which is also eligible for up to $1.205bn in potential development and commercial milestones.

Yuhan may also receive additional tiered double-digit royalties on net sales in the future.

As part of the collaboration, Janssen will develop, manufacture and commercialise Lazertinib. The deal provides the company with exclusive global rights to the drug candidate, excluding Korea, where Yuhan will retain licensing rights.

The companies will partner on global clinical trials, which are expected to commence next year, to assess Lazertinib as monotherapy and combination therapy.

Yuhan president and CEO Lee Jung-hee was quoted by koreaherald.com as saying: "Yuhan is committed to developing Lazertinib as an effective treatment option for patients suffering from NSCLC.

"Janssen, with strong scientific expertise in lung cancer and oncology, is the best strategic partner to achieve this mission."
"And Janssen, with strong scientific expertise in lung cancer and oncology, is the best strategic partner to achieve this mission. We are excited to start this collaboration and dive into advancing this treatment regimen with a focus on improving the lives of people who suffer from lung cancer."

Currently, Lazertinib is being investigated in Phase I and II trials in Korea. It is said to have demonstrated favourable disease activity in NSCLC patients with acquired resistance to EGFR-TKIs, with or without brain metastasis.

The drug candidate was also found to be well-tolerated with low Grade 3 or higher adverse events rates.