On February 23, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors (Press release, Oncolytics Biotech, FEB 23, 2021, View Source [SID1234575453]).

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Newly published results show that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. Efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep ("pelareorep boost"), generating highly persistent CAR T cells, inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Survival data from the preclinical study are shown below:

"These very exciting data demonstrate pelareorep’s ability to overcome major shortcomings of CAR T cells," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Despite commercial success in hematological cancers, CAR T therapies have limited efficacy against solid tumors due to immunosuppressive tumor microenvironments (TMEs) that promote T cell exhaustion and exclusion. Pelareorep’s ability to reverse immunosuppressive TMEs has been well documented in the clinic, and combining CAR T cells with pelareorep may enable their success against solid cancers. This would be a major advancement, as it would substantially broaden the applicability of CAR T cells to a variety of highly prevalent and difficult-to-treat indications."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "While our primary focus is on advancing our lead breast cancer program to a registrational trial, we continue to evaluate additional opportunities to expand pelareorep’s business development and partnership potential. In clinical studies, pelareorep recruited high concentrations of T cells to solid tumors, positioning it to synergistically interact with checkpoint inhibitors. In this newly published study, we show the synergistic benefits of pelareorep can be extended to additional cutting-edge immunotherapeutic agents. Based on these findings, we are specifically exploring a partnership strategy to further the development of pelareorep as an enabling technology for CAR T cells and additional immunotherapies that require immune effector cell infiltration in solid tumors."

The electronic poster titled "Combination Therapy with Oncolytic Viruses and CAR T Cells," was developed in collaboration with researchers from the Mayo Clinic, Duke University, and Oncolytics. It is available on the Posters & Publications page of Oncolytics’ website (LINK).

About CAR T cells and CAR T therapy

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply, and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.1

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 February 23, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report business results for the fourth quarter and full year 2020 after the market closes on Thursday, February 25, 2021 (Press release, Supernus, FEB 23, 2021, View Source [SID1234575452]).

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Jack Khattar, President and CEO, and Jim Kelly, Executive Vice President and Chief Financial Officer, will host a conference call to present the fourth quarter and full year 2020 business and financial results on Thursday, February 25, 2021 at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

On February 23, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported that it will be February 26, 2021 and stop day will be Tuesday March 2, 2021 (Press release, Alligator Bioscience, FEB 23, 2021, View Source [SID1234575451]).

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Through the rights issue, which ended on January 25, 2021, Alligator raised approximately SEK 86m before deduction of issue related costs.

The rights issue has now been registered with the Swedish Companies Registration Office (Sw. Bolagsverket) and last day of trading in Alligator´s BTA will be February 26, 2021. Stop day will be March 2, 2021. Shares are estimated to be delivered on the shareholders´ account on March 4, 2021.

Advisers
Redeye AB acts as financial adviser, Setterwalls Advokatbyrå AB acts as legal adviser and Aktieinvest FK AB acts as issuing agent in connection with the rights issue.

On February 23, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported the promotion of Eric Feldman, M.D., to Senior Vice President and Chief Medical Officer (Press release, GlycoMimetics, FEB 23, 2021, View Source [SID1234575450]). Dr. Feldman joined the Company in 2019 and was previously Vice President, Global Clinical Development.

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"Eric is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders, and in the past two years, has established himself as a leader in our management group as well as in the trenches with our clinical operations team. Having spent his career dedicated to patients with hematologic malignancies, he is especially well positioned to lead our uproleselan program as it advances through Phase 3 clinical trials. In addition, his extensive clinical research background will serve us well as we drive forward other programs in our pipeline," said Rachel King, Chief Executive Officer.

Before joining GlycoMimetics, Dr. Feldman served as Chief Medical Officer at Amphivena Therapeutics, Inc., focusing on breakthrough blood cancer treatments and T-cell engagement technologies, and prior to that, he oversaw the myeloid leukemia antibody-drug conjugate (ADC) program at Seattle Genetics, Inc. He has led or participated in the conduct of numerous clinical trials, several leading to U.S. Food and Drug Administration (FDA) approval. Dr. Feldman’s extensive academic career includes a recent position as Professor of Medicine and Director of the Hematological Malignancies Service at Weill-Cornell/New York Presbyterian Hospital, as well as faculty positions at New York Medical College and the University of Texas, MD Anderson Cancer Center. Dr. Feldman has authored over 150 scientific articles and is a former Editor-in Chief of the journal Leukemia Research. He earned his medical degree at New York Medical College and holds a B.A. from Tulane University.

Separately, Dr. Helen Thackray, M.D. F.A.A.P., has decided to leave the company to pursue another opportunity. She joined the company 15 years ago, and most recently served as Senior Vice President, Clinical Development and Chief Medical Officer.

"Helen’s contributions to the Company have been invaluable, leading two programs to late-stage development, and creating important relationships with clinicians all over the world. We are grateful for her years of service to GlycoMimetics and wish her well in her next endeavor," said Ms. King.

About Uproleselan (GMI-1271)

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. FDA and from the Chinese regulatory authority for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

On February 23, 2021 Elicio Therapeutics, a private biotechnology company developing a pipeline of potent immunotherapies based on its proprietary lymph-node targeting Amphiphile technology, reported it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration for ELI-002 (Press release, Elicio Therapeutics, FEB 23, 2021, View Source [SID1234575449]). ELI-002 is an Amphiphile (AMP) KRAS therapeutic vaccine containing AMP mKRAS peptides and a proprietary AMP CpG adjuvant, administered subcutaneously. The company’s novel therapeutic vaccine targets KRAS mutations that drive 99% of all KRAS-driven cancers. Phase I/II clinical trials of ELI-002 will enroll patients with mKRAS+ pancreatic ductal adenocarcinoma (PDAC) and other solid tumors. KRAS mutations are present in 90% of pancreatic cancers, 40% of colorectal cancers, 30% of non-small cell lung, 30% of bile duct, 14% of endometrial, and 14% of ovarian cancers. Elicio is developing ELI-002 to treat and prevent disease recurrence with potential to help one quarter of solid tumor patients.

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"Previous vaccine approaches utilizing synthetic peptides have not effectively targeted the critical immune cells residing in the lymph nodes and have elicited only weak or undetectable immune responses in patients," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "The Amphiphile technology allows us to simultaneously generate immune response to all the mutations commonly present in KRAS driven cancers by targeting antigenic peptides with a powerful adjuvant directly to the lymph nodes, significantly amplifying the resulting immune responses, and producing highly functional mKRAS-specific T cells capable of destroying mKRAS positive cells like tumor cells."

Elicio’s Phase I/II trial will identify patients with PDAC and other solid tumors who have undergone standard of care surgery and neoadjuvant/adjuvant chemotherapy, that have persistent positive circulating tumor DNA indicating likely recurrence and rapid progression. Patients are studied in a window of opportunity after standard therapy is complete but before their tumors have had a chance to grow to a size where they are normally seen in radiographic scans.

"To date, "drugging" mKRAS directly has only been achieved in recent clinical trials for the G12C allele, using covalent inhibitors. Most human tumors have different mutations, where G12C is not a driver mutation. The ELI-002 therapeutic vaccine covers 99% of all mKRAS tumors creating the opportunity for improved durability of response and eradication of cancer," said Julian Adams Ph.D., chief executive officer of Gamida Cell and Chairman of Elicio Therapeutics’ Board of Directors.

About ELI-002

ELI-002 is an "AMP KRAS-vaccine" containing Amphiphile mKRAS peptides and a proprietary Amphiphile adjuvant, AMP CpG, administered subcutaneously. Elicio’s ELI-002 targets KRAS mutations, present in approximately 25% of all human solid tumors. The Amphiphile mKRAS peptides and Amphiphile CpG are targeted directly to the lymph node as a result binding to tissue albumin after injection, leading to accumulation of the complex into lymph nodes where the peptides and CpG payloads are delivered directly to key immune cells resulting in unprecedented efficiency. ELI-002 has the potential to become a multi-targeted mKRAS therapeutic vaccine with the ability to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal, lung, bile duct, endometrial, and ovarian. Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell-therapy amplifiers to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy amplifiers directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.