On June 20, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immunotherapy company developing first-in-class Superkines and Empowered Cytokines, presented new pre-clinical data on its IL-2 Superkine program, MDNA109 (Press release, Medicenna Therapeutics, JUN 20, 2019, View Source [SID1234537203]). The data was presented in a poster entitled "Engineering a long-acting CD122 biased IL-2 superkine displaying potent anti-tumoral responses" at the Inaugural Immuno-Oncology Pharma Congress, held from June 18-20, 2019 during World Pharma Week in Boston, MA.

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"We are excited with the pre-clinical results from our second oncology platform being built around MDNA109, on the back of promising clinical results from our Phase 2b MDNA55 recurrent glioblastoma trial presented this week at the same conference," said Dr. Fahar Merchant, President and CEO of Medicenna. "Unlike other engineered versions of IL-2 under development where both CD25 and, to a lower extent, CD122 activity is masked when compared to recombinant IL-2 (marketed as Proleukin), our long acting MDNA109 variant has disabled CD25 binding but stimulates potent CD122 activity relative to Proleukin. Disabled CD25 activity provides a much better safety profile while superior CD122 stimulation ensures potent recruitment of immune cells (Effector T cells and NK cells) responsible for attacking cancer," added Dr. Merchant.

Highlights from the presentation by Dr. Moutih Rafei, Associate Professor in the Department of Pharmacology and Physiology at the Université de Montreal and Head of Discovery at Medicenna, included the following

Durable Tumor Control With Strong Memory Response: When MDNA109-LA was co-administered with the immune-checkpoint blocker anti-cytotoxic T-Lymphocyte-Associated Protein (CTLA)4 in a colon cancer mouse model, 67% of animals with pre-established tumors remained tumor-free for over 100 days. When these animals received a second and third re-challenge of the tumor without further treatment, 100% and 75% remained tumor free, respectively, demonstrating a strong memory response.
Blunted Treg Activity But Potent Activation Of Naïve CD8 T Cells: A long-acting variant, MDNA109-LA1, engineered to mitigate Treg activation by abolishing binding to the CD25 had 50-fold decreased Treg activity and 6-fold higher activity towards naïve CD8 T cells for an overall 300-fold preferential activation of cancer killing T cells than recombinant IL-2.
Absence Of CD25 Binding: In addition, binding affinity studies using surface plasmon resonance confirmed absence of CD25 binding by MDNA109-LA1.
Potent Effects With Minimal Dosing: To further validate the potency of MDNA109-LA1 mice with pre-established aggressive B16F10 melanoma tumors showed potent tumor control with a weekly dosing schedule.
"These data show that MDNA109 long-acting variants can be expected to drive clinical efficacy beyond that seen with other treatments," states Dr. Rafei, "The use of Proleukin for the treatment of skin and renal cancer remains limited due to the poor half-life and severe toxicity. Data show that MDNA109-LA1 may not only minimize adverse effects, but could also eliminate immunosuppression caused by Tregs using a dosing schedule that is compatible with immune-checkpoint blockers. It’s clear from these recent data that MDNA109 is a highly versatile platform for multiple uses in immuno-oncology without complex manufacturing and lack of immunogenicity as demonstrated by in-silico analysis.

About MDNA109
Developed by scientists at Stanford University, MDNA109 is an engineered version of IL-2 that binds up to 200 times more effectively to IL-2Rβ (CD122), thus greatly increasing its ability to activate and proliferate the immune cells needed to fight cancer. MDNA109 is an IL-2 Superkine that preferentially drives the expansion and responses of effector T cells and Natural Killer (NK) cells over Treg cells. It is the only IL-2 in development with a distinct mechanism by virtue of its high affinity towards CD122 allowing it to effectively combat NK cell anergy (exhaustion) which occurs frequently after cancer immunotherapy.

On June 20, 2019 Syntrix Pharmaceuticals reported that it has dosed the first patient in its Phase 1/2 clinical trial that will combine SX-682 with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Syntrix, JUN 20, 2019, View Source [SID1234537202]). SX-682 is an oral dual inhibitor of CXCR1 and CXCR2 (CXCR1/2) being developed for the treatment of cancer.

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This open-label clinical trial will evaluate the safety, tolerability, immune response markers, and overall response rates achieved with SX-682 in combination with KEYTRUDA in up to 77 patients with metastatic melanoma. The study is being conducted at the Massachusetts General Hospital and Dana-Farber Cancer Institute.

Patients will receive daily SX-682 monotherapy for three weeks followed by treatment with daily SX-682 in combination with KEYTRUDA. The study will evaluate biomarkers identified from paired biopsies taken before and after the three-weeks of monotherapy and combination treatments, as well as clinical outcomes observed over the course of the trial. Syntrix expects to report initial clinical data from the trial in the first half of 2020.

"CXCR1/2 is involved in virtually all human tumor types, where it suppresses anti-tumor immunity," said Stuart Kahn, MD, chief medical officer at Syntrix. "This clinical trial will allow us to explore the potential synergies between SX-682 and KEYTRUDA and offers the potential to treat metastatic melanoma that is otherwise poorly responsive to checkpoint inhibitors."

In preclinical studies, SX-682 enhances both PD-1 immune checkpoint blockade and T cell receptor engineered T cell immunotherapies (JCI Insight, Nature and Cancer Cell). Effects include a reduction of myelosuppressive cells in the tumor microenvironment and augmentation of NK and T cell infiltration into the tumor site. Clinical studies show an inverse correlation between CXCR1/2 ligands in the blood and survival of patients treated with anti-PD1 therapy.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

ABOUT SX-682: SX-682 is a clinical-stage oral allosteric small-molecule inhibitor of CXCR1 and CXCR2 (CXCR1/2). CXCR1/2 are a combined "master switch" of the immunosuppressive tumor microenvironment. Clinical studies have shown an inverse correlation between blood CXCR1/2 ligands and anti-PD1 response and survival. SX-682 has been validated in major solid tumor models, where it exhibits mono-agent activity, blocks metastasis, depletes MDSCs, activates infiltration and killing by immune effector cells, reverses chemo-resistance, and enhances anti-PD1.

On June 20, 2019 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) is collaborating with AstraZeneca, a global, science-led biopharmaceutical company, to further quality in cancer care for people with advanced ovarian cancer (Press release, AstraZeneca, JUN 20, 2019, View Source [SID1234537201]). This follows a recently announced and still active request for proposals, also in collaboration with AstraZeneca, on innovative approaches for improving care in unresectable stage III and IV non-small cell lung cancer. Letters of intent are due Monday, July 22, 2019, for this new opportunity, which is available to researchers at any of the 28 NCCN Member Institutions.

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"Advanced and recurrent ovarian cancer remains a treatment challenge," explained Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "It’s currently the deadliest gynecologic cancer, and requires a coordinated, multi-disciplinary approach. With this project, we’re looking for research that focuses on how to optimize multiple facets of management effectiveness by harnessing innovative technologies or addressing knowledge gaps."

Some areas of particular interest for proposals include:

Adhering to standard of care management
Delivering care through innovative methods (e.g. telemedicine and/or coordination of care between academic centers and community practices)
Improving adoption of appropriate genetic testing
Discovering new strategies for sharing and implementing novel findings expeditiously
Creating shared decision-making models
Improving the use of supportive services
Utilizing technology to enhance quality of life in patients
Proposals that are reproducible, scalable, rapidly implementable, and provide quantifiable outcome measures are preferred. NCCN ORP is also interested in discovering concepts to reduce financial toxicity, manage care across multiple facilities, increase clinical trial enrollment, and enhance shared decision-making and patient information.

The NCCN ORP fosters innovation and knowledge discovery that improve the lives of patients with cancer. Collaboration between NCCN Member Institutions is strongly encouraged in order to cultivate interactive sharing of knowledge and expertise, and to utilize the combined strengths of members. For more information and to read the entire Request for Proposals, visit NCCN.org/ORP.

On June 20, 2019 ImaginAb, Inc., a clinical stage immuno-oncology imaging company, reported that it will attend and present at the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held June 22-25, 2019, at the Anaheim Convention Center in Anaheim, California (Press release, ImaginAb, JUN 20, 2019, View Source [SID1234537200]).

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ImaginAb will be presenting at the following sessions during the conference.

Imaging the Immune System: CD8+ and Beyond
Ian Wilson, CEO will present during the CMIIT Emerging Technologies session: Emerging Technologies – A Look into the Future of Molecular Imaging and Therapy
Date & Time: Sun, June 23, 5:30 PM – 5:45 PM PDT
Location: Room 201D

PET scanner harmonization for multi-center clinical trials using 89Zr tracers in partnership with Clinical Trials Network (CTN)
Abhinay Joshi, Director of Imaging and Imaging Technologies, ImaginAb, Inc., will be presenting during the session MTA II: Data Analysis & Management Posters
Date & Time: Tuesday, June 25, 3:00 PM – 4:30 PM PDT
Location: Exhibit Hall A

ImaginAb’s lead product, CD8 tracer 89Zr-Df-IAB22M2C (89Zr), is a first in class imaging agent that visualizes the immune system using non-invasive, whole-body in vivo PET imaging of CD8 T cells. Currently, in Phase II multi-center clinical trials at world-renowned imaging and cancer centers in North America, the 89Zr ImmunoPET agent detects and visualizes CD8 T cells using ImaginAb’s ‘minibody’ technology. This provides highly-specific, quantitative assessment of the immunological status of individual cancer lesions within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient.

ImaginAb, in partnership with CTN, has for the first time, implemented the harmonization of image acquisition and reconstruction parameters which are essential in undertaking multi-center 89Zr Immuno-PET imaging clinical trials.

The SNMMI 2019 Annual Meeting – the premier educational, scientific, research and networking event in nuclear medicine and molecular imaging – provides physicians, technologists, pharmacists, laboratory professionals and scientists with an in-depth view of the latest research and development in the field as well as providing insights into practical applications for the clinic.

ImaginAb will be based at Booth 783 in the Exhibition Hall, and in addition to presenting at the conference, will be hosting meetings with clinical investigators, pharmaceutical companies, and partner organizations.

For further information or to schedule a meeting, please contact:

ImaginAb
Ian Wilson
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications
Mary Clark, Supriya Mathur
Email: [email protected]
Phone: +44 20 3950 9144

On June 20, 2019 Adaptive Biotechnologies reported that it has secured contractual agreements or positive medical policies for the clonoSEQ Assay with several of the largest national private health insurers in the United States, as well as significant regional coverage, bringing the total number of covered lives to more than 140 million (Press release, Adaptive Biotechnologies, JUN 20, 2019, View Source [SID1234537199]). The agreements and medical policies expand access to clonoSEQ for minimal residual disease (MRD) testing in patients with lymphoid cancers. clonoSEQ is the first and only FDA-cleared test for assessing and monitoring MRD in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL), helping to track a patient’s cancer and inform treatment decisions. clonoSEQ announced Medicare coverage in January 2019, and private insurer access has steadily increased in the first half of 2019. Coverage of clonoSEQ testing is generally consistent with the assay’s FDA label and includes assessment of MRD at multiple time points throughout therapy to monitor treatment responses and help predict outcomes in patients with MM and ALL.

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"There are over 600,000 patients living with lymphoid blood cancers in the United States alone. As patients are living longer than ever before due to new therapies, clinicians need a better tool to monitor disease burden and treatment response on a regular basis," said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. "This positive momentum provides patients with a standardized, accurate and sensitive tool to inform personalized treatment decisions. We look forward to continuing to work with payors around the country to ensure patients in need have access to clonoSEQ."

About the clonoSEQ Assay

The clonoSEQ assay was granted de novo designation and marketing authorization by FDA for the detection and monitoring of minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. clonoSEQ is the first and only FDA-authorized in vitro diagnostic assay for MRD testing. It is also the first clinical diagnostic powered by immunosequencing to receive FDA clearance. clonoSEQ leverages Adaptive’s proprietary immunosequencing platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes are strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with ALL and MM. clonoSEQ testing is covered by Medicare and an expanding list of private payors in alignment with the FDA label.

clonoSEQ is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.