On November 19, 2020 JOINN Laboratories, China’s leading preclinical contract research organization (CRO), reported that it has partnered with Integral Molecular to provide researchers in China with rapid antibody specificity testing against the entire human membrane proteome using Integral Molecular’s Membrane Proteome Array (MPA) technology (Press release, Integral Molecular, NOV 19, 2020, View Source [SID1234571450]). The ability to select lead candidates with high specificity will reduce safety liabilities prior to clinical development of therapeutic antibodies and CAR-T cancer treatments.

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Off-target binding of antibodies can result in severe or life-threatening adverse events, especially when antibody binding is used to direct cell killing, as with CAR-T cell therapeutics. Specificity testing using Integral Molecular’s MPA is now routinely included in investigational new drug (IND) applications submitted to regulatory agencies.

"At JOINN, we provide preclinical research services for most of the CAR-T cell therapeutics being developed in China," said Mr. Leon (Jingliang) Gu, EMT & VP of JOINN Laboratories. "We understand the possible consequences of misdirected cell killing and why MPA data represents a valuable component of preclinical packages submitted to the U.S. FDA and the National Medical Products Administration (NMPA) in China."

The MPA antibody specificity profiling service was developed by Integral Molecular as a comprehensive approach to detect binding of antibodies, cells, and other biologics to membrane protein targets for early de-risking of drug development. The MPA is the largest library of human membrane proteins, covering 94% of the membrane proteome and includes nearly all G protein-coupled receptors (GPCRs), ion channels, and transporters expressed in live cells.

On November 19, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, reported positive new interim data from its ongoing ReSPECT Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL), in patients with recurrent glioblastoma (GBM) (Press release, PLUS THERAPEUTICS, NOV 19, 2020, View Source [SID1234572301]). These results were presented in an electronic poster entitled, "Safety and Feasibility of Rhenium-186 Nanoliposomes (RNL) in Recurrent GBM: the ReSPECT Phase 1 Trial," at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting, which is taking place virtually November 19-21, 2020.

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The interim data set shows that intratumoral RNL can successfully deliver up to fifteen times the absorbed dose of radiation administered by standard external beam radiation therapy (EBRT) without significant toxicity. These data support progression to the ReSPECT trial’s sixth dose escalation cohort.

"The results we have seen thus far from ReSPECT are encouraging and support the continued development of RNL as a potential new option for recurrent GBM patients," said Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principle investigator of the study. "With limited therapeutic options for these patients, we remain committed to advancing this clinical program to further investigate the therapeutic potential of RNL."

"Treatment for glioblastoma remains a significant challenge as current therapies have exhibited limited efficacy," stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "RNL’s novel design allows the drug to be targeted directly into the tumor using a small catheter and enabling greater control of radiation dosing. These encouraging data reinforce RNL’s potential to deliver targeted high-dose radiation in a safe, effective, and convenient manner."

Key R esults from the I nterim A nalysis

All 15 patients in the first five of six planned cohorts have completed treatment.
RNL treatment volume and radiation dose increased successfully from 0.66 milliliter (mL) to 8.8 mL and 1.0 millicurie (mCi) to 22.3 mCi, respectively.
Cohort 5 patients received an RNL average absorbed radiation dose of 423 Gray (Gy).
RNL has been well-tolerated, and no dose-limiting toxicity has been observed despite markedly higher absorbed doses of radiation compared to EBRT.
Most adverse events (AEs) were considered causally unrelated to RNL except scalp discomfort, which was considered related to the surgical procedure. Neither the incidence nor severity of AEs appeared to increase with increasing doses of RNL.
Four serious adverse events (SAEs) were reported, none of the SAEs were considered causally related to RNL.
Median survival duration in patients that previously received bevacizumab (n=7) was 4.8 months, while median and mean survival durations in patients that were bevacizumab-naïve (n=8) are currently 11.0 months (range 3.5 – 33) and 15.4 months (95% CI 7.4 – 23.4), respectively, with four patients still alive.
Two patients survived greater than 30 months after therapy with RNL.
The sixth dose escalation cohort of the ReSPECT trial is underway and one patient has thus far been treated. The sixth cohort is expected to fully enroll by the end of 2020. In September 2020, the U.S. Food and Drug Administration (FDA) granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with glioblastoma. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).

Webinar details

The Company will host a webinar today, Thursday, November 19, 2020, 4:30 to 5:30 p.m. ET discussing these data. Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio, will provide an update on the ReSPECT trial and provide insight on the trial data. In addition, a patient with recurrent GBM from the ReSPECT trial will provide their treatment experience with RNL.

Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, and Gregory D. Stein, M.D., M.B.A., Senior Vice President, Clinical Development of Plus Therapeutics, will discuss the technology behind RNL as well as the current treatment landscape and unmet medical need in treating patients with recurrent GBM.

The live webinar with accompanying slides will be available in the Events page of the ‘Investors’ section of the Plus Therapeutics website or by clicking here. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events section of the Company’s website for 90 days.

A live audio conference will be available by dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering Conference ID 6095968.

Andrew J. Brenner, M.D., Ph.D.

Dr. Brenner is a nationally known expert in the treatment of brain and breast cancers, with a particular research interest in developing new treatments. He has served on multiple committees and panels including for the National Institutes of Health, National Cancer Institute, Department of Defense Breast Cancer Research Program, and others. He has also served on advisory committees for a number of companies to help direct development of new drugs. His laboratory work developing new treatments has been funded by the Food and Drug Administration, National Cancer Institute, and Cancer Prevention and Research Institute of Texas. He has published nearly 50 original research articles in peer reviewed journals. Dr. Brenner is a member of the Plus Therapeutics Scientific Advisory Board.

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.