On April 22, 2021 Candel Therapeutics, Inc., a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported it has completed enrollment for its Phase 1 clinical trial in patients with newly diagnosed high-grade glioma to evaluate the safety and efficacy of CAN-2409 in combination with immune checkpoint inhibitor Opdivo (nivolumab) and standard of care radiation therapy, as well as temozolomide for patients with methylated MGMT promoters (Press release, Candel Therapeutics, APR 22, 2021, View Source [SID1234578374]). The trial enrolled 35 evaluable patients and is being conducted in collaboration with Bristol Myers Squibb Company, manufacturer of Opdivo, and separately the Adult Brain Tumor Consortium at Johns Hopkins University.

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"The addition of CAN-2409 to immune checkpoint inhibitor treatment has the potential to train lymphocytes to specifically recognize tumor neoantigens and to change the ‘cold’, immunosuppressive tumor microenvironment, thereby synergizing with lymphocyte activation induced by nivolumab resulting in tumor cell destruction," said Paul Peter Tak, M.D., Ph.D., President and Chief Executive Officer of Candel Therapeutics. "With a significant number of patients affected each year and limited treatment options available, there remains a critical need for effective therapies in high-grade glioma. It is our hope that CAN-2409 can create new, more effective options for this patient population, and we look forward to the readout from this study next year."

The primary endpoints of the study are safety and tolerability of this combined treatment regimen. Secondary endpoints include overall survival, progression free survival and immunological biomarkers. For more information about this study, please visit: www.clinicaltrials.gov (NCT03576612).

Opdivo is a registered trademark of Bristol Myers Squibb.

About CAN-2409

CAN-2409, previously known as gene-mediated cytotoxic immunotherapy (GMCI), Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment, thereby training the immune system to recognize these antigens. The activated effector T cells have the potential to migrate to distant, uninjected metastases for broad anti-tumor activity. At the same time, the adenoviral capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This adjuvant effect helps create a better immune response against the tumor neoantigens released locally. This dual mechanism of antigen unmasking and immune activation may enable CAN-2409 to generate a powerful and lasting attack against a variety of the patient’s tumor-associated neoantigens, minimizing the possibility for antigen escape and tolerance development.

Because of its versatility, CAN-2409 may have the potential to treat a broad range of solid tumors. Combination activity with standard of care radiation therapy, surgery, immune checkpoint inhibitors

(ICI) and chemotherapy has already been shown in several preclinical and clinical settings. Candel has previously published preclinical data that supports combination of CAN-2409 with ICI. In a mouse model of glioblastoma unresponsive to ICI, addition of CAN-2409 was shown to modulate the immunosuppressive, unresponsive tumor microenvironment, resulting in a synergistic effect in vivo, with significantly improved survival in mice treated with CAN-2409 and ICI combination. Furthermore, CAN-2409 presents a favorable tolerability profile. More than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 for brain, prostate, lung, and pancreatic cancers in clinical trials.

On April 22, 2021 Clinical Outcomes Solutions (‘COS’), a global leader in the collection, analysis and reporting of patient-centered outcomes data with offices in Tucson and Chicago (USA) and Folkestone (UK), reported a collaborative partnership with Carevive Systems (‘Carevive’), the leading oncology-focused health technology company (Press release, Carevive Systems, APR 22, 2021, View Source [SID1234578408]).

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The two organizations, both deeply experienced with the collection and analysis of oncology data, are proud to announce that Carevive is joining the Oncology Outcomes initiative, launched in February 2019, to deliver world-class data and analysis to improve the patient experience and enhance survival outcomes of cancer patients.

The partnership will leverage Carevive’s innovative digital oncology platform to capture the patient experience while on treatment, and COS’ deep experience in analyzing these types of data, providing invaluable insights for life science companies and regulatory authorities.

The Carevive platform PROmpt enables cancer care teams to monitor and manage their patients remotely, which improves survival outcomes and patient quality of life. The platform also enables large-scale digital data collection via the Oncology Pragmatic Trial Investigator Network (Carevive OPT-IN), merging electronic medical records (EMR) with patient reported outcomes (PRO) to offer cancer centers a holistic, longitudinal view of their patient population for quality improvement and pathway enhancement purposes.

COS is a global leader in delivering innovative science to capture and communicate the patient voice, in order to provide actionable evidence through qualitative and quantitative research, with a specific focus on Clinical Outcomes Assessments in the oncology space. Through the partnership, COS will apply this expertise to providing data analytic support to generate insights from these novel patient experience datasets.

Stacie Hudgens, Chief Executive Officer at COS, said: "We are very excited to announce this partnership with Carevive, an organization that shares our deep-rooted passion for world-class oncology research to improve the patient experience.

"The depth and breadth of the Carevive datasets provide access to a host of data on solid tumors and liquid cancers, and will enhance our ability to improve the patient journey."

Bruno Lempernesse, Chief Executive Officer at Carevive, said: "Carevive is committed to reshaping the way cancer care is delivered so that therapies can become more personalized through the use of real-world patient data. We are delighted to announce this partnership with COS, an organization that has supported the development of our patient experience data collection efforts from its inception. By combining COS’ FDA and industry expertise with Carevive data, this partnership provides a model of how to approach real-world evidence and patient-reported outcomes with cancer care teams, regulatory authorities and life science companies."

Tara Symonds, Chief Science Officer at COS, added: "We have seen the benefit from monitoring patient symptoms over time while on treatment across numerous cancer types. Oncology treatments are highly toxic and can cause significant side effects. Thus, effective, real-time monitoring enables far quicker intervention and the opportunity to improve the patient experience and enhance symptom management.

"Research conducted by renowned medical oncologist and PRO expert Ethan Basch M.D., has shown that such intervention can add six months to survival, a significant finding for the benefit of patients with cancer. Digital Health Solutions, such as the Carevive platform, are the key to demonstrating the extent to which patients’ symptoms and quality of life are improved by particular treatments, and are rapidly becoming a critical tool for our clients when conducting real-world assessments of the impact of their drugs.

"The platform also offers additional benefits, such as the opportunity to design real-world studies for our clients, which would not be possible without access to Carevive’s database."

On April 22, 2021 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it will host its virtual R&D Day for analysts and investors at 10:00 a.m. – 1:00 p.m. ET on Wednesday, April 28, 2021 (Press release, Trillium Therapeutics, APR 22, 2021, View Source [SID1234578359]).

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The R&D Day agenda will include:

·a clinical update for TTI-622 and TTI-621,
·new strategic priorities in terms of target indications and drug combinations across hematologic malignancies and solid tumors, and
·updated milestones and guidance for 2021.

More information on Trillium’s R&D Day will be available at: ir.trilliumtherapeutics.com/events-and-presentations/RD-Day

You can join the webcast at: View Source

On April 22, 2021 Synthekine Inc., an engineered cytokine therapeutics company, reported a new agreement with Stanford University to license cytokine partial agonist programs for IL-10, IL-12 and IL-22 (Press release, Synthekine, APR 22, 2021, View Source [SID1234578375]). These programs augment a growing pipeline of selective cytokine partial agonists at Synthekine that is maturing toward clinical development.

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Most cytokines are pleiotropic and drive a range of signaling responses across multiple cell types, which limits their potential as therapeutics. Research conducted in the laboratory of Chris Garcia, PhD, a Howard Hughes Medical Institute Investigator and professor of structural biology at Stanford, has shown that IL-10, IL-12, and IL-22 can be tuned to achieve specific signaling. Modifying these cytokines enables selective activity to be directed to specific cell types for therapeutic benefit, often by decoupling efficacy from toxic effects driven by non-specific immune system activation. Synthekine plans to leverage discoveries in IL-12, recently published in the journal Cell, to develop potential treatments for cancer, and the discoveries in IL-10, recently published in the journal Science, and IL-22, recently published in the journal Immunity, to develop potential treatments for autoimmune disease.

"Synthekine was founded two years ago with several cytokine partial agonist programs based on the work from the Garcia Laboratory, and we have already moved two of those programs into IND enabling development," said Debanjan Ray, CEO of Synthekine. "Extending our license with Stanford allows us to bring in three new promising cytokine partial agonist programs that we believe have considerable potential in treating cancer and autoimmune disease."

On April 22, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its first quarter 2021 financial results on Thursday, May 6, 2021 (Press release, BioCryst Pharmaceuticals, APR 22, 2021, View Source [SID1234578360]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 2660434. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 2660434.