On November 5, 2019 OncoNano Medicine, Inc., a biotechnology company developing ultra pH-sensitive micelles for the detection, staging and treatment of cancer, reported two poster presentations – including a late-breaking abstract – for the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting to be held in National Harbor, Maryland, November 6-10 (Press release, OncoNano Medicine, NOV 5, 2019, View Source [SID1234550367]). OncoNano’s core technology is a library of tunable, ultra pH-sensitive micelles that exist intact under baseline physiological pH conditions but dissociate to release their payload under different, predesignated pH levels.

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"We are very pleased to share data for two of our lead products at the SITC (Free SITC Whitepaper) Annual Meeting this year," commented Ravi Srinivasan, CEO of OncoNano Medicine. "Our proprietary micelle technology is designed to enable us to deliver high-value and challenging payloads to target tissues with high specificity in ways that have not been possible before."

The first poster, which is a late-breaking abstract, will feature ONM-500 [Mi-Vax] – an injectable micelle composed of STING (Stimulator of Interferon Genes)-activating polymers and packaged with a human papilloma virus tumor specific antigen. These micelles are subcutaneously injected where they accumulate in the lymph nodes and are endocytosed by dendritic cells. The lower pH of intracellular endosomes causes micelle dissociation, releasing both the antigen and STING-activating polymer to coordinate a targeted attack on cancer cells. OncoNano was awarded a grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to continue the advancement of ONM-500 through pre-clinical and clinical development.

The second poster features ONM-400 [ON-BOARD], OncoNano’s injectable pH-sensitive therapeutic delivery platform that exploits a universal feature of cancer, the relatively acidic tumor microenvironment. ONM-400 can be loaded or conjugated with a variety of cancer therapeutics including cytokines, small molecules and engineered antibody fragments to focus therapeutic delivery specifically at the site of the tumor, minimizing off-target delivery to potentially improve the efficacy and safety profile. OncoNano plans to continue advancing the ONM-400 program through preclinical development and toward the clinical stage where there is substantial unmet need for more effective strategies to target cancer.

Late-breaking Poster Presentation
Abstract title: ONM-500 – A Novel STING-Activating Therapeutic Nanovaccine Platform for Cancer Immunotherapy
Presenting Author: Jason B. Miller, Ph.D., OncoNano Medicine, Inc.
Poster Number: P857
Date: November 8, 2019, 12:30-2:00 PM and 6:30-8:00 PM

Poster Presentation
Abstract title: Delivery of Interleukin-2 to the Acidic Tumor Microenvironment by Ultra-pH Sensitive Nanoparticles for Immunotherapy
Presenting Author: Xinliang Ding, Ph.D., OncoNano Medicine, Inc.
Poster Number: P617
Date: November 8, 2019, 12:30-2:00 PM and 6:30-8:00 PM

On November 5, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported preliminary results from its ongoing Phase 1 dose escalation study of COM701, a first-in-class anti-PVRIG antibody, in patients with advanced solid tumors (Press release, Compugen, NOV 5, 2019, View Source [SID1234550384]). COM701 was well-tolerated with no dose-limiting toxicities observed. Furthermore, COM701 demonstrated initial signals of anti-tumor activity in the heavily pretreated patient population enrolled on the study. The clinical data will be presented in a poster titled "Phase 1 Study of the Safety, Tolerability and Preliminary Anti-Tumor Activity of COM701 Monotherapy in Patients with Advanced Solid Tumors" at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019) on Friday, November 8, 2019.

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"We are encouraged by the emerging safety profile and initial signals of anti-tumor activity of COM701. While the primary objective of this portion of the trial was to test the safety and tolerability of COM701, we were excited to observe early signals of anti-tumor activity in the all-comer, extensively pretreated patient population enrolled, including patients with microsatellite stable colorectal cancer (MSS-CRC), which we may choose to further evaluate in future studies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe COM701 has the potential to broaden the checkpoint inhibitor landscape with a biology driven prioritization rationale that addresses indications most relevant to the PVRIG pathway. We look forward to initiating our biomarker driven COM701 monotherapy expansion cohorts in these four prioritized indications – ovarian, endometrial, breast and lung cancers."

Ecaterina Ileana Dumbrava, M.D., Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and presenting author, said "Expanding the reach of cancer immunotherapy drugs to broader patient populations is an urgent need given the number of patients with advanced cancer who are non-responsive or refractory to currently available therapies. The initial signals of anti-tumor activity of COM701 are encouraging, particularly given the heavily pretreated all-comer patient population, with the majority of patients refractory to previous therapy. We observed a trend in dose-response relationship in this hard-to-treat patient population and furthermore, encouraging signals of anti-tumor activity in five out of six treated patients with MSS colorectal, a challenging indication, typically not responsive to current immune checkpoint blockers."

The reported data are from the monotherapy arm of the ongoing, Phase 1, open-label, dose escalation study and include the first seven (7) cohorts (n=13) at dose levels of 0.01, 0.03, 0.1, 0.3, 1, 3, and 10 mg/kg IV every three (3) weeks.

Key findings presented at the poster in SITC (Free SITC Whitepaper) include data updated as of October 15, 2019:

COM701 was well-tolerated through 10 mg/kg with no dose-limiting toxicities observed.
The best timepoint response of stable disease (SD)/disease control rate reported in 9 of 13 patients (69%) with a median of seven prior anticancer therapies (range of 2-15).
All the patients with CRC (N=6) had microsatellite stable status, and 5 of 6 patients (83%) had best timepoint response of stable disease.
Pharmacokinetic profile supports IV Q3 weekly dosing.
Peripheral PVRIG receptor occupancy greater than or equal to 90% was demonstrated at COM701 ≥1 mg/kg.
There are two patients remaining on study treatment with COM701 monotherapy.
Enrollment to COM701 monotherapy dose at 20 mg/kg Q4 weekly is on-going.

The poster will be available on Compugen’s website following the poster presentation.

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial of COM701 (anti-PVRIG antibody) is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as of combination administration with Bristol-Myers Squibb’s Opdivo (nivolumab) in patients with advanced solid tumors. Additionally, secondary endpoints include preliminary anti-tumor activity, pharmacokinetics and pharmacodynamics of COM701 monotherapy as well as COM701 in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).

On November 5, 2019 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that Neurocrine Biosciences management will present at the following investor conferences (Press release, Neurocrine Biosciences, NOV 5, 2019, View Source [SID1234550498]):

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Matt Abernethy, Chief Financial Officer, will present at the Credit Suisse 28th Annual Healthcare Conference at 1:50 p.m. Mountain Time (3:50 p.m. Eastern Time) on Tuesday, Nov. 12, 2019, in Scottsdale, Arizona.
Kevin Gorman, Chief Executive Officer, will present at the Jefferies London Healthcare Conference at 10:00 a.m. Greenwich Mean Time (5:00 a.m. Eastern Time) on Wednesday, Nov. 20, 2019, in London.
The live presentations will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentations will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On November 5, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a conference call for Analysts and Institutional Investors at 5:00 p.m. ET on Tuesday, November 12, 2019 following release of its third quarter 2019 financial results (Press release, Oncolytics Biotech, NOV 5, 2019, https://ir.oncolyticsbiotech.com/news/detail/481/oncolytics-biotechr-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights [SID1234550292]).

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The live call may be accessed by dialing 844-407-9500 or callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at (877)-481-4010, using the replay code 56787 and will be available for one week.

A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months.

On November 5, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that Rick Pauls, President & Chief Executive Officer, will meet with institutional investors at the 10th Annual Craig-Hallum Alpha Select Conference on Tuesday, November 12, 2019, at the Sheraton New York Times Square Hotel in New York City (Press release, DiaMedica, NOV 5, 2019, https://ir.diamedica.com/news/detail/1582/diamedica-therapeutics-to-participate-in-10th-annual-craig-hallum-alpha-select-conference [SID1234550320]).

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Interested institutional investors should contact their Craig-Hallum sales representative to schedule a meeting.