On November 26, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported that it has been invited to participate in a panel presentation, entitled Gene &Cell Therapy: The Next Wave of Precision Medicine Panel, at 12:30 pm HKT on Tuesday, November 27th at the Goldman Sachs Asia Pacific Healthcare Forum in Hong Kong. John Prendergast, Ph.D., Heat’s Lead Director, will be presenting (Press release, Heat Biologics, NOV 26, 2018, View Source [SID1234531615]).

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The event will feature leading public and private healthcare companies with ongoing or planned activities in China. The forum is by invitation only.

On November 26, 2018 Palleon Pharmaceuticals, a leading biotech company focused on developing drugs that target Glyco-Immune Checkpoints to treat cancer, reported an oral presentation of preclinical data from its EAGLE platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy, taking place in Miami from November 27 – 30, 2018 (Press release, Palleon Pharmaceuticals, NOV 26, 2018, View Source [SID1234531616]).

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Li Peng, Ph.D., Vice President, Biotherapeutics Discovery at Palleon, will present the poster – "A novel immunomodulatory strategy of targeting Glyco-Immune Checkpoints using EAGLE technology to treat cancer" – on Friday, November 30, between 8:00 – 9:30 a.m., during a Special Session on Novel Targets, Pathways and Tools.

About EAGLE

Palleon’s EAGLE platform enables the development of drugs that inhibit Glyco-Immune Checkpoints by disabling the immunosuppressive function of tumor cell surface glycans. The critical challenge in this area arises from the complexity, heterogeneity and rapidly evolving nature of the tumor glycans. The EAGLE platform employs an enzyme/antibody bi-specific construct, which removes terminal sialic acids, the molecules that are responsible for suppressing the immune system, from cancer cell surface glycans in the tumor micro-environment. This enzymatic approach uniquely overcomes tumor glycan heterogeneity and makes tumors vulnerable to both innate and adaptive immune responses.

About Glyco-Immune Checkpoints

Cancer uses multiple pathways to evade the immune system, and Glyco-Immune Checkpoints are a significant and under-appreciated axis of immunosuppression in cancer. Tumors exploit Glyco-Immune Checkpoints through the alteration of glycans on the surface of their cells, impairing both innate and adaptive immune cells and resulting in a broad, comprehensive suppression of the anti-tumor immune response. Glyco-Immune Checkpoints had been overlooked relative to other anti-cancer strategies due to the complexity of glycoscience, and, until recently, the lack of scientific tools to demonstrate its relevance to immuno-oncology. Palleon has assembled the technologies needed to overcome these barriers and make drug development in this field possibl

On November 26, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the first patient was treated in a phase 2 study combining pelareorep with Merck’s Keytruda to treat advanced pancreatic adenocarcinoma (Press release, Oncolytics Biotech, NOV 26, 2018, View Source [SID1234531633]). The primary objective of the study is to determine the overall response rate (ORR) by iRECIST criteria. Secondary objectives include safety of the combination, immune response as determined by analysis of pre- and post-treatment biopsies and blood-based immune markers, determination of progression-free survival (PFS) by iRECIST criteria; and one-year, two-year and median overall survival (OS).

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"We are very excited to start enrollment in this combination study which expands upon our findings from an earlier Keytruda study in advanced pancreatic cancer," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "REO 024, our previous phase 1b study with Keytruda, showed objective response, long-term stabilization of disease and promotion of an inflamed phenotype in second line pancreatic cancer patients. This new phase two study should corroborate anti-tumor activity and potentially confirm predictive biomarkers laying the groundwork towards our goal of becoming a standardized backbone for checkpoint inhibitors."

This study is a phase 2, single arm, open-label study enrolling up to 30 patients with advanced pancreatic adenocarcinoma who experienced disease progression or did not tolerate first-line therapy. The principal investigator is Dr. Devalingham Mahalingam, of Northwestern University. The first 16 patients will be enrolled in stage one, and up to 14 additional patients will be enrolled in stage two if pre-specified criteria are met. The pre-defined criteria state that, for the primary objective, three or more responses out of 16 are needed in stage one to continue the trial to the full 30 patients.

For more information about the study, including a comprehensive list of inclusion and exclusion criteria, please visit: www.clinicaltrials.gov (identifier: NCT03723915).

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On November 26, 2018 Forbius, a clinical-stage company developing biologics for the treatment of cancer and fibrosis, reported that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application to conduct a Phase 1 clinical trial in solid tumors with immuno-oncology candidate AVID200, a rationally designed inhibitor of TGF-beta 1 & 3 (Press release, Forbius, NOV 26, 2018, View Source [SID1234531617]).

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The Phase 1 trial will evaluate safety, pharmacokinetics, pharmacodynamics, and antitumor effects of escalating doses of AVID200. This agent is the Company’s second innovative biologic to enter clinical development.

AVID200 is designed to selectively neutralize TGF-beta 1 & 3 with best-in-class pM potency, thus neutralizing the principal immunosuppressive TGF-beta isoforms. AVID200’s optimal selectivity is also designed to circumvent cardiac and other safety issues which have limited the applicability of older generation, non-selective TGF-beta inhibitors.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

AVID200’s immuno-oncology mode of action centers on reversal of both immunosuppression and fibrosis in the tumor stroma. In syngeneic mouse tumor models, AVID200 treatment led to T-cell activation, increased immune tumor infiltration, and increased efficacy of immune checkpoint agents.

"TGF-beta signaling has emerged as a key target to overcome tumor immunosuppression and resistance to immunotherapies, a major unmet medical need. AVID200 has the potential to significantly expand the number of cancer patients that benefit from checkpoint blockade and other immunotherapies. I am keen to evaluate the effects of AVID200 in this clinical trial," commented Dr. Lillian Siu, a senior medical oncologist and Director of the Phase I Program at Princess Margaret Cancer Centre in Toronto. Dr. Siu is one of the investigators leading the AVID200 Phase 1 study in solid tumors.

About AVID200

AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings being rationally designed to selectively neutralize TGF-beta 1 & 3 with pM potency, thus avoiding TGF-beta 2 related cardiac and hematopoietic toxicity. Overexpression of TGF-beta isoforms 1 & 3 is closely associated with the progression of fibrosis and cancer.

AVID200’s immuno-oncology mode of action centers on reversal of immunosuppression as well as a strong anti-fibrotic effect in the tumor stroma. Its development in this setting is supported by the previously announced peer-reviewed BioCanRx grant with a total project value of CAD$1,655,297.

AVID200 is undergoing Phase 1 clinical testing for the treatment of fibrotic diseases and immune oncology.

On November 20, 2018, Generex reported the Company’s wholly owned subsidiary, Antigen Express, Inc. ("Antigen") entered into a Clinical Trial Agreement with NSABP Foundation, Inc. ("NSABP") (Press release, Generex, NOV 26, 2018, View Source [SID1234531634]). Pursuant to the Clinical Trial Agreement, NSABP will conduct a Phase II Study to evaluate efficacy of administering Merck Sharpe & Dhome’s (‘Merck") Keytruda (pembrolizumab) in combination with Antigen’s AE37 cancer vaccine for the treatment of metastatic triple negative breast cancer. While Merck is not a party to the Clinical Trail Agreement, Merck is expected to provide Keytruda for the study pursuant to the Clinical Trial Collaboration and Supply Agreement between Antigen and Merck.

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