On November 19, 2020 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, reported that the company has extended the term of the research program under its existing 2017 research collaboration and license agreement with Merck toward developing a clinical candidate for the treatment of type 1 diabetes and an additional undisclosed autoimmune disease (Press release, Cue Biopharma, NOV 19, 2020, View Source [SID1234608288]).

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"We are very pleased with the progress to date in our ongoing strategic collaboration with Merck," said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. "Extending the research term of our agreement based on promising preclinical data with a goal of identifying a clinical candidate underscores the significant potential of our therapeutic Immuno-STAT (Selective Targeting and Alteration of T cells) platform and CUE-300 series in the treatment of debilitating autoimmune diseases."

Under the terms of the extension, Cue Biopharma will receive additional financial research support to further study and develop promising preclinical biologics with the objective of identifying clinical candidates.

Cue Biopharma entered into an exclusive patent license and research collaboration agreement with Merck in November 2017 to develop biologics for the treatment of selected autoimmune diseases. For further information regarding the amendment, please refer to the Current Report on Form 8-K to be filed by Cue Biopharma with the SEC on November 19, 2020.

About Immuno-STAT
Immuno-STAT biologics are being designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drug candidates is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On November 19, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical stage biopharmaceutical company focused on developing novel treatments for chronic kidney diseases and neurological disorders, reported that Rick Pauls, President and CEO of DiaMedica, will participate in a fireside chat and host one-on-one meetings with investors at the Piper Sandler 32nd Annual Virtual Growth Conference (Press release, DiaMedica, NOV 19, 2020, View Source [SID1234571419]). The fireside chat will be available on the Piper Sandler Conference website to registered attendees on November 23rd at 10:00 AM ET to December 3, 2020.

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The Company will host the one-on-one meetings with investors on Tuesday, December 1, 2020, meetings can be requested exclusively via Piper Sandler.

A replay of the fireside chat can be accessed under Events and Presentations in the Investors section of our website at View Source

On November 19, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported positive results from ReoGlio, an investigator-sponsored, phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM) (Press release, Oncolytics Biotech, NOV 19, 2020, View Source [SID1234571435]). The results, which were featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting, show a compelling signal of efficacy and demonstrate the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients.

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"The ReoGlio trial results add to a robust set of clinical data supporting the safety, tolerability, and efficacy of pelareorep in a broad range of indications," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "The median progression-free survival (PFS) of approximately eight months is encouraging in this challenging indication, particularly considering the improved median PFS correlated with the dose of pelareorep administered. Together, these results drive momentum to develop pelareorep across a spectrum of cancer indications."

The podium presentation, Pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) with standard chemoradiotherapy/adjuvant temozolomide for glioblastoma multiforme (GBM) patients: ReoGlio phase I trial results, was given by Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. Key data and conclusions from the presentation include:

Evaluable patients treated at pelareorep dose level-2 (3×1010 TCID50) had an estimated median PFS of 9.4 months (n=6; 95% CI: 4.2-10.6)
Evaluable patients treated at pelareorep dose level-1 (1×1010 TCID50) had an estimated median PFS of 6.1 months (n=6; 95% CI: 4.9-9.2)
The estimated median PFS of all evaluable patients, regardless of pelareorep dose level, was 7.8 months (n=12; 95% CI: 4.9-9.7)
Pelareorep, in addition to GM-CSF, standard chemoradiotherapy, and adjuvant temozolomide, was safe and well-tolerated
Oncolytics remains focused on the clinical advancement of pelareorep and will continue evaluating new commercial opportunities for pelareorep, while prioritizing the current programs and achieving the expected milestones for those in breast, gastrointestinal, and hematological malignancies. Oncolytics thanks the University of Leeds, Cancer Research UK, and The Brain Tumor Charity for designing, managing, and funding the ReoGlio trial.

About ReoGlio

The ReoGlio trial was an investigator-sponsored phase 1b, open-label trial evaluating the combination of pelareorep and GM-CSF, alongside standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial, twelve of which were evaluable for efficacy analyses. The primary objective of the study was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to gain a preliminary assessment of the activity of the pelareorep-GM-CSF combination and to assess treatment compliance. The trial was designed and managed by the University of Leeds and funded through grants provided by Cancer Research UK and The Brain Tumor Charity.

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 19, 2020 Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology therapeutics, reported that data from a Phase I Dose Escalation Study of its lead candidate PT-112, an immunogenic cell death (ICD) inducer, in patients with relapsed or refractory multiple myeloma will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually from December 5-8, 2020 (Press release, Phosplatin, NOV 19, 2020, View Source [SID1234571451]).

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Title:

A Phase I Dose Escalation Study of PT-112 in Patients with Relapsed or Refractory Multiple Myeloma

Abstract availability:

Saturday, December 5 through Monday, December 7, 2020, from 7:00 a.m. to 3:30 p.m. (Pacific Time), on the ASH (Free ASH Whitepaper) Annual Meeting and Exposition site and the Phosplatin Therapeutics web site

Session:

653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I

Lead Author:

Taxiarchis Kourelis, M.D., Division of Hematology, Assistant Professor of Medicine, Mayo Clinic College of Medicine Rochester, Minnesota

Under this year’s virtual meeting format, Dr. Kourelis will present a pre-recorded, narrated slide presentation on the multi-center dose escalation study of PT-112 in multiple myeloma patients who are relapsed or refractory to available therapy (NCT03288480). The study was designed and launched following non-clinical work conducted in the Cancer Genetics Laboratory of P. Leif Bergsagel, M.D. at the Mayo Clinic in Scottsdale, Arizona.

About PT-112

PT-112 is a novel small molecule conjugate of pyrophosphate that possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents the best-in-class small molecule inducer of this immunological form of cancer cell death and is currently under Phase II development. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase Ib study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase I study in patients with relapsed or refractory multiple myeloma to be presented at ASH (Free ASH Whitepaper) is the third completed Phase I study of PT-112.

On November 19, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) (FSE: TQB2), a leader in full-service, therapeutic antibody discovery and development, reported that it has entered into a research agreement with Genmab A/S (Nasdaq: GMAB), an international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer (Press release, ImmunoPrecise Antibodies, NOV 19, 2020, View Source [SID1234571420]). IPA will generate novel bispecific antibody combinations using Genmab’s proprietary DuoBody platform and IPA’s proprietary antibodies in the field of infectious disease. The development of IPA’s proprietary antibodies into DuoBody constructs enables additional, novel formulations as the Company investigates a series of combinations in parallel.

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"Partnering with Genmab aligns with IPA’s mission to develop safe and effective therapies for patients, in this case, specifically pertaining to the growing demand in infectious disease," said Dr. Jennifer Bath, Chief Executive Officer of ImmunoPrecise Antibodies. "This agreement further complements our strategy to ensure that the full potential of our infectious disease programs is realized, which includes establishing productive partnerships to increase opportunities for ideal formulations with the highest safety and efficacy profiles."

The DuoBody technology is a proprietary platform of Genmab applied in the discovery and development of bispecific antibodies across several therapeutic areas including cancer, hemophilia, autoimmune, infectious, and central nervous system diseases. DuoBody technology has been successfully used in many Genmab internal or partnered investigational clinical therapies.

As a part of the partnership, Genmab and IPA will negotiate in good faith an agreement for the commercial use of resulting DuoBody products.