On November 19, 2019 Aptus Clinical reported that it has been appointed full service clinical CRO partner by Artelo Biosciences Inc. (through their fully owned UK subsidiary, Trinity R&D Ltd.) to deliver the upcoming Phase 1B/2A trial of their synthetic cannabinoid, ART27.13 (Press release, Aptus Clinical, NOV 19, 2019, View Source [SID1234551458]). This latest agreement builds on an earlier research and development partnership agreement, where Aptus successfully designed and supported the critical path pre-clinical experiments and completed key clinical strategy and planning activities for Artelo.

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Andrew Yates, ART27.13 Project Director at Trinity R&D said "We are delighted with the progress that this project has made in transitioning through the discovery phase and into preparation for clinical testing in just 16 months. The depth and breadth of experience that our Aptus colleagues have brought to this project and their flexible collaborative approach has been key in helping us achieve this significant project milestone for ART27.13. We look forward to continuing to work with Aptus and our investigators in testing the clinical utility of ART27.13 in patients with cancer associated weight loss."

Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences, commented, "Aptus Clinical have proved themselves to be a true partner with us on the ART27.13 project. They have approached the inevitable challenges associated with any drug project in a fully supportive and flexible way with a total focus on doing the right things to move the project forward. We look forward to continuing our collaboration Aptus on this next phase of the ART27.13 journey.

Steve McConchie, Chief Executive Officer of Aptus Clinical, added, "Cancer related anorexia affects about 60% of advanced cancer patients and is an area where new treatment options are desperately needed. As a full-service Clinical CRO focused on transforming promising projects into valued medicines we are honoured to have been selected to deliver a trial that is so important for both Artelo and patients with cancer."

Photo (Left to right): William O’Brien, FD Trinity R&D; Andy Yates ART273 Project Leader, Trinity R&D; Kath Lowry, Snr Project Manager, Aptus Clinical; Greg Gorgas, President and CEO Artelo Biosciences; Steve McConchie, CEO Aptus
Clinical

On November 19, 2019 Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH, OTC: MCUJF), a cardiovascular pharmaceutical company, reported that it will release financial results for the quarter ended September 30, 2019 on Tuesday, November 26, 2019 (Press release, Medicure, NOV 19, 2019, View Source [SID1234551492]). The third quarter financial statements will be made available on the Company’s website at www.medicure.com. Medicure will hold a conference call and webcast regarding the results on Wednesday, November 27, 2019 at 7:30 AM Central Time (8:30 AM Eastern Time).

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Conference Call Info:

Topic: Medicure’s Q3 2019 Results

Call date: Wednesday, November 27, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 7343307#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On November 19, 2019 Genprex, Inc.("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that its collaborators from The University of Texas MD Anderson Cancer Center ("MD Anderson") presented positive preclinical data for the combination of TUSC2 immunogene therapy with an anti-PD1 antibody, pembrolizumab, and for the combination of TUSC2 immunogene therapy, pembrolizumab, and chemotherapy for the treatment of some of the most resistant metastatic lung cancers, including the KRAS and LKB1 mutations, at the American Association of Cancer Research Tumor Immunology and Immunotherapy Meeting 2019 (Press release, Genprex, NOV 19, 2019, View Source [SID1234551459]). The TUSC2 gene is a tumor suppressor gene and is the active agent in Genprex’s Oncoprex immunogene therapy.

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The poster, entitled "Efficacy of Novel Immunogene-Combinations for KRAS and LKB1 mutant NSCLC in a Humanized Mouse Model" shows that TUSC2 confers sensitivity to checkpoint blockade for some of the most resistant metastatic human cancers, including the KRAS and LKB1 mutations, in mice with human immune cells (humanized mice) with lung metastases. When TUSC2 was combined with anti-PD1 therapy, pembrolizumab, in humanized mice with KRAS and LKB1 lung metastases, there was significantly increased antitumor activity than when compared to either agent alone. This combination and model also demonstrated TUSC2-related NK (Natural Killer) cell activation. A significantly higher percentage of CD56+NK and CD56+CD59+active NK cells, which are immune cells that have been activated to kill cancer cells, were found in the mice that received TUSC2 alone and in those that received the combination of TUSC2 and pembrolizumab than in those that received pembrolizumab alone.

The poster also shows that TUSC2 increases the effectiveness of anti-PD1 checkpoint blockade combined with platinum chemotherapy in humanized mice with lung metastases with KRAS and LKB1 mutations, thus demonstrating that TUSC2 may improve on first-line standard of care for lung cancer. The combination of TUSC2 with pembrolizumab and carboplatin, a platinum chemotherapy, in humanized mice with KRAS and LKB1 lung metastases resulted in metastasis regression significantly greater than either TUSC2 alone or pembrolizumab combined with carboplatin treatments. This model showed significantly fewer or no visible tumor nodules after treatment with the TUSC2 combination as compared with other groups, and it showed strong antitumor efficacy. The combination of TUSC2 with pembrolizumab and carboplatin resulted in complete eradication of anti-PD1 resistant lung metastases in the humanized mouse model.

"These data not only further support existing preclinical data showing that Oncoprex immunogene therapy is synergistic with anti-PD1 therapy, but they also offer new data demonstrating that Oncoprex improves on the combination of anti-PD1 therapy and chemotherapy, today’s first line standard of care for lung cancer," said Julien L. Pham, MD, MPH, President and Chief Operating Officer of Genprex. "In a sophisticated humanized mouse model, the combination of TUSC2 with pembrolizumab and carboplatin resulted in complete eradication of anti-PD1 resistant lung metastases in some of the most resistant cancer mutations. This is highly encouraging and provides us with a strong indication that the combination could lead to similar results in the clinic."

The poster authors are Ismail M. Meraz, Mourad Majidi, Meng Feng, RuPing Shao, Min Jin Ha, Jeffrey Morris, Elizabeth J. Shpall, Jack A. Roth, all of MD Anderson Cancer Center, Houston, TX. Jack A. Roth has ownership interest in and is a consultant/advisory board member for Genprex, Inc.

On November 19, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported an update on its operational developments for the third quarter ended September 30, 2019 (Press release, Celyad, NOV 19, 2019, View Source [SID1234551477]).

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Filippo Petti, CEO of Celyad stated, "We have reported a steady stream of encouraging news from our pipeline throughout the third quarter and subsequent weeks, including preliminary Phase 1 data for our first-in-class, non-gene edited allogeneic CYAD-101 CAR-T product candidate, the introduction of our proprietary OptimAb manufacturing process to our autologous relapsed/refractory acute myeloid leukemia program led by CYAD-01, and CYAD-02, the acceptance of the IND application for our next-generation candidate CYAD-02, and the advancement of our shRNA technology platform related to our CYAD-200 series of allogeneic product candidates. We continue to establish our position as innovative leaders in the industry as we focus on our core mission of developing innovative CAR-T therapies for cancer patients."

"In addition, with the closing of our global equity offering in September, we believe the company has sufficient capital resources to enable it to complete its next major clinical milestones, including the upcoming data releases from the CYAD-01 program in relapsed/refractory acute myeloid leukemia," continued Filippo Petti.

Third Quarter 2019 and Recent Business Highlights

Successfully dosed the first relapsed/refractory (r/r) acute myeloid leukemia (AML) patient in the DEPLETHINK Phase 1 trial with CYAD-01 produced with OptimAb manufacturing process.
Presented preliminary data from the ongoing dose-escalation Phase 1 alloSHRINK trial evaluating CYAD-101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual meeting.
Results from the trial demonstrated a favorable tolerability profile for CYAD-101, with encouraging anti-tumor activity in the refectory metastatic colorectal cancer (mCRC). Two patients experienced a confirmed partial response, and five patients experienced stable disease for a period of three months or more. In addition, there was no clinical or laboratory evidence of graft-versus-host disease (GvHD).
Completed enrollment in the dose-escalation segment of the alloSHRINK trial with additional results from the trial anticipated during first half 2020.
Continued advancement of proprietary non-gene edited allogeneic short hairpin RNA (shRNA) platform related to the CYAD-200 series of shRNA-based allogeneic CAR-T candidates.
Closed global equity offering with gross proceeds of $20.0 million (approximately €18.2 million) in September 2019.
Third Quarter 2019 Financial Review

As of September 30, 2019, the Company ended the quarter with a treasury position of €44.6 million ($48.8 million), which includes net proceeds of €17.0 million from the global equity offering in September 2019. Net cash burn over the third quarter of 2019 amounted to €6.1 million, in line with expectations. The Company confirms its previous guidance that its treasury position should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into first half 2021.

Pipeline Updates

CYAD-01 – Autologous NKG2D-based CAR-T

CYAD-01 continues to advance the Phase 1 THINK and DEPLETHINK clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). In September, the Company successfully administered CYAD-01 produced with the OptimAb manufacturing process to a patient enrolled in cohort 3 (300 million cells) of the Phase 1 DEPLETHINK trial. The proprietary OptimAb manufacturing process utilizes a shortened cell culture and incorporates a selective PI3K inhibitor. This results in a product that is enriched for T cells with a memory-like phenotype. Preclinical data demonstrate that CYAD-01 produced using the OptimAb manufacturing process drives improved anti-tumor activity in an aggressive AML model compared to CYAD-01 produced with the mAb manufacturing process.

The Company is scheduled to present the latest clinical results from the Phase 1 THINK and DEPLETHINK trials, which utilized CYAD-01 produced with the previous mAb manufacturing process, as well as provide updates on the development program for r/r AML and MDS and proprietary OptimAb manufacturing process at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held on December 7-10 in Orlando, Florida.

CYAD-02 – Autologous NKG2D-based CAR-T

In June, the U.S. Food & Drug Administration accepted the Investigational New Drug (IND) application for CYAD-02, a next-generation, autologous NKG2D-based CAR-T candidate. CYAD‑02 incorporates short hairpin RNA (shRNA) technology to target the NKG2D ligands MICA and MICB. The single shRNA modulates the expression of both ligands, which translates to encouraging increases in vivo engraftment and anti-tumor activity in preclinical studies.

The Company is scheduled to present preclinical data for CYAD-02 at the upcoming ASH (Free ASH Whitepaper) conference. In addition, the company plans to initiate the Phase 1 CYCLE-01 study evaluating the CYAD-02 following preconditioning chemotherapy in r/r AML in early 2020.

CYAD-101 – TIM-based Allogeneic NKG2D-based CAR-T

Celyad’s first-in-class, non-gene edited allogeneic clinical candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial. At the SITC (Free SITC Whitepaper) 34th Annual Meeting, the Company presented preliminary data from the ongoing alloSHRINK trial assessing safety and clinical activity of CYAD-101 in patients with relapsed or refractory metastatic colorectal cancer (mCRC) who had progressed beyond second line metastatic chemotherapy. Preliminary data showed no clinical evidence of GvHD has been observed following 35 injections of CYAD-101, supporting the ability of the company’s novel inhibitory peptide T cell receptor (TCR) inhibiting molecule (TIM) to reduce signaling of the TCR complex through a non-gene edited approach. Treatment with CYAD-101 with prior FOLFOX preconditioning chemotherapy to control the host-versus-graft (HvG) reaction was well-tolerated, with no report of dose-limiting toxicity. No patients discontinued treatment due to adverse events. In addition, the regimen demonstrated encouraging anti-tumor activity, with two patients experiencing a confirmed partial response according to RECIST 1.1 criteria, and five patients experiencing stable disease of more than or equal to three months of duration. Tumor burden decrease was observed in six out of 12 patients in total.

Preliminary results from the completed dose-escalation segment of the alloSHRINK trial are expected in the first half of 2020. This will include three additional patients at dose level three (one billion cells per infusion) of the trial, for a total of nine patients in the cohort, as planned per the protocol.

Based on the data presented to date, the Company plans to expand the trial to further evaluate CYAD-101 with prior FOLFOX chemotherapy in refractory mCRC patients. Enrollment in the expansion segment of the trial is expected to begin in mid-2020 following the production of additional CYAD-101 cells.

CYAD-200 Series – shRNA-based Allogeneic CAR-Ts

The Company continues to pursue the development of the proprietary non-gene edited allogeneic shRNA SMARTvector platform and progress towards filing IND applications for the CYAD-200 series of shRNA-based allogeneic CAR-T candidates, including CYAD-211, the Company’s CAR-T therapy targeting B-cell maturation antigen (BCMA) for the treatment of multiple myeloma.

Key Upcoming Milestones

Poster presentations of THINK Phase 1 trial and DEPLETHINK Phase 1 trial evaluating CYAD-01 produced with the mAb manufacturing process for the treatment of r/r AML and MDS at the 61st ASH (Free ASH Whitepaper) Annual Meeting, which will be accompanied by an investor and analyst event (live and webcast) hosted by company on Monday, December 9th.
Initiation of the Phase 1 dose-escalation CYCLE-01 trial evaluating CYAD-02, following preconditioning chemotherapy, for the treatment of r/r AML and MDS is expected in early 2020.
Anticipated completion of enrollment of the DEPLETHINK Phase 1 trial evaluating CYAD-01 produced with the OptimAb manufacturing process during first half 2020.
Updated results from the completed dose-escalation segment of the alloSHRINK trial are expected in first half 2020, including an additional three patients at dose level three (one billion cells per infusion) of the trial.
Submission of IND application for CYAD-211 (shRNA-based allogeneic BCMA CAR-T candidate) for the treatment of patients with multiple myeloma is anticipated during first half 2020.
Initiation of the dose-expansion segment of the alloSHRINK trial is anticipated to begin in mid-2020.

Upcoming Conferences

Celyad’s management team is scheduled to participate in the following conferences during the remainder of 2019:

Jefferies London Healthcare Conference, November 20 – 21
Evercore ISI HealthCONx Conference, December 3 – 5
61st ASH (Free ASH Whitepaper) Annual Meeting, December 7-10

On November 19, 2019 Torque, a clinical-stage immuno-oncology company developing Deep Primed T cell immunotherapy to direct immune power deep within the tumor microenvironment, reported additional preclinical data for its lead Deep IL-15 Primed T cell, Deep IL-12 Primed T cell, and Deep TLR Primed T cell therapeutics programs (Press release, Torque Therapeutics, NOV 19, 2019, View Source [SID1234551493]). The data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy taking place November 17–20, 2019 in Boston.

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"IL-15 and IL-12 are potent cytokines with complementary tumor-attacking capabilities that have been explored as cancer immunotherapies, but severe side effects have limited their clinical success. The preclinical data we presented at this year’s AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy demonstrate that co-administering Deep IL-12 Primed and Deep IL-15 Primed T cells directs the stimulatory activity of these cytokines to the tumor microenvironment and leverages their complementary biology to prime and boost the immune response of T cell therapies to achieve superior efficacy, with limited systemic exposure and toxicity," said Thomas Andresen, PhD, Chief Scientific Officer of Torque. "In addition, we presented data demonstrating that Deep TLR Primed T cells leverage the immune-stimulating potential of TLR agonists to achieve superior anti-tumor efficacy while avoiding systemic exposure and toxicities, the key current bottlenecks to successful TLR therapy."

Highlights of the two preclinical presentations follow, and copies of the posters are available on the Torque website: https://bit.ly/34yZnTU

Poster A68: "Combining Deep IL-12 Primed and Deep IL-15 Primed T cells induces potent antigen-dependent in vitro cytotoxicity and in vivo antitumor activity"
Presenter: Elena Geretti, PhD, Torque
Date & Time: Monday, November 18, 12:30 p.m.–3:00 p.m.
Key findings from the study:

In preclinical models, co-administration of Deep IL-12 and Deep IL-15 T cells leveraged their complementary immunodulatory functions and elicited superior anti-tumor activity and was well tolerated, without notable toxicity.
Poster B66: "Deep TLR Primed T cells induce potent antitumor activity without systemic toxicity"
Presenter: Nathan Westcott, Torque
Date & Time: Tuesday, November 19, 4:30 p.m.–7:00 p.m.
Key findings from the study:

In preclinical models, Deep TLR Primed T cells released a potent small-molecule TLR agonist over an extended period of time and increased anti-tumor activity while avoiding systemic exposure and toxicities.
About Deep-Primed T Cell Therapeutics
Torque is developing a new class of Deep-Primed cellular immunotherapy designed to overcome the key challenges limiting broad use of cellular therapy in oncology, including the ability to target tumors that express multiple heterogeneous antigens, the ability to overcome the immunosuppressive tumor microenvironment that shuts down T cell function, and the need for cost-effective outpatient treatment with a high margin of safety. Deep-Priming is a unique technology platform that harnesses natural T cell biology and the power of cytokine activation to prime and boost a full immune response in the tumor microenvironment. Deep-Primed T cells are designed to:

1. Activate a Deep Immune Response Against Solid Tumors & Hematologic Cancers: Natural T cell receptors are primed to target multiple tumor antigens and retain their natural ability to integrate with the full immune system to direct a deep and comprehensive immune response against cancer.
2. Prime and Boost Broad Immune Cell Engagement to Overcome Immunosuppression in the Tumor Microenvironment: Deep-Primed T cells carry surface-anchored cytokines and immunomodulators to jump-start the engagement and coordination of the full network of immune cells to direct immune power in the tumor microenvironment, without significant systemic exposure.

Torque’s first clinical program, TRQ-1501 (Deep IL-15 Primed T cells), has received FDA Fast Track designation for the treatment of relapsed or refractory solid tumors and lymphomas and is currently in a Phase 1/2 clinical trial for this indication.