On November 6, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that company management will participate in fireside chats at the following upcoming investor conferences (Press release, Loxo Oncology, NOV 6, 2018, View Source [SID1234530773]):

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Stifel Healthcare Conference in New York City on November 13, 2018 at 8:45 a.m. ET
Piper Jaffray Healthcare Conference in New York City on November 28, 2018 at 10:30 a.m. ET
Live webcasts of the fireside chats will be available at View Source

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.

On November 6, 2018 Oncoceutics, Inc. reported that it will host an investigator meeting and that initial efficacy data of its lead compound ONC201 in patients with H3 K27M-mutant gliomas will be presented at the 2018 Annual Meeting of the Society for Neuro-Oncology in New Orleans, on November 15th to November 18th (Press release, Oncoceutics, NOV 6, 2018, View Source [SID1234558365]).

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The company, along with scientific and medical collaborators, will give 10 presentations that describe several aspects of ONC201, including clinical efficacy and safety, mediated via highly specific interaction with dopamine receptor 2 (DRD2), unique molecular characteristics, and novel insights on dopamine receptor dysregulation in glioma. Moreover, presentations will include the preclinical effectiveness and mechanism of action of ONC206, another molecule from this newly established class of compounds, called imipridones. One of the highlights of the event will be an oral presentation entitled, "Integrated clinical experience with ONC201 in previously-treated H3 K27M-mutant glioma patients," which scored highly in the review process of the SNO conference and will be one of three selected abstracts to be presented by a discussant separate from the oral presentation. The data set that will be disclosed will focus on radiographic and clinical responses in H3 K27M-mutant glioma patients from several clinical programs with ONC201.

"The reported findings are very meaningful for the medical community, and we look forward to sharing our experience with ONC201 in this first group of patients," said Yazmin Odia, MD, Lead Physician of Medical Neuro-Oncology, Miami Cancer Institute. "Patients with H3 K27M-mutant gliomas have a dismal prognosis, and there is currently no known effective drug for these patients."

Additionally, Oncoceutics will hold an investigator meeting for physicians involved in ongoing and future clinical trials with ONC201.

"We are conducting a number of clinical trials to translate these compelling findings into robust clinical data sets," said Wolfgang Oster, MD, PhD, and CEO of Oncoceutics. "We are excited about the progress in our development programs and hope that our findings will make a difference for patients with unmet medical need. We are grateful to the Society for Neuro-Oncology and its members for their interest and collaboration."

More Information: Imipridone-related SNO 2018 Abstracts

ONC201 glioma clinical experience (3 abstracts)

ACTR-34 (Talk): Integrated clinical experience with ONC201 in previously-treated H3 K27M-mutant glioma patients, Chi et al, Sunday November 18th, 8:50-9:00am
ACTR-33 (Talk): Tumor Tissue Penetration and Pharmacodynamics of ONC201 in Adult Recurrent Glioblastoma Patients, Arrillaga-Romany et al, Friday November 16th, 2:40-2:45pm
PDCT-06 (Talk): Phase I clinical trial of ONC201 in pediatric H3 K27M-mutant glioma or newly diagnosed DIPG, Gardner et al, Friday November 16th, 8:22-8:26pm
DRD2 dysregulation in glioma and ONC201 preclinical efficacy (4 abstracts)

DRES-10 (Talk): DRD5 is a modulator of glioma susceptibility to DRD2 antagonism by ONC201, Prabhu et al, Sunday November 18th, 11:25-11:30am
EXTH-26 (Poster): Molecular determinant of clinical response to ONC201, an inhibitor of dopamine receptor 2 (DRD2) signaling, in glioblastoma patients, Li et al, Saturday November 17th
DDIS-12 (Poster): ONC201: The first selective, non-competitive DRD2/3 antagonist for clinical neuro-oncology, Prabhu et al, Saturday November 17th
DDIS-16 (Poster): ONC201 in combination with radiation exhibits synergistic efficacy in high grade gliomas and other advanced cancers, Tarapore et al, Saturday November 17th
Utility of imipridone scaffold in neuro-oncology (3 abstracts)

EXTH-64 (Talk): Imipridones Cause Metabolic Reprogramming and Elicit Unique Vulnerabilities in Glioblastoma, Ishida et al, Friday November 16th, 8:06-8:10pm
EXTH-17 (Talk): Selective, non-competitive DRD2/3 antagonism by imipridone ONC206 is effective in tumors with dopamine receptor dysregulation, Prabhu et al, Friday November 16th, 8:02-8:06pm
EXTH-58 (Poster): ONC206, an imipridone family member, suppresses glioblastoma cells via blocking cancer stemness pathways, Jung et al, Saturday November 17th