On June 25, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), reported a new investigator-sponsored triple-negative breast cancer (TNBC) study to be managed by Rutgers Cancer Institute of New Jersey (Press release, Oncolytics Biotech, JUN 25, 2020, View Source [SID1234561481]). The phase 2 trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC.

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"We are very excited to evaluate pelareorep in TNBC, as prior clinical data show it has the potential to address a pressing unmet need in this challenging indication," said principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School. "Checkpoint inhibitors targeting interactions between PD-L1 and PD-1, while commercially successful, are ineffective in up to 80% of TNBC patients. This is often due to an immunosuppressive tumor microenvironment. Checkpoint inhibitors are beneficial in patients who have upregulation of PD-L1 expression in the tumor environment. Clinical data show that systemic pelareorep administration can upregulate PD-L1 expression in tumors across multiple breast cancer subtypes, highlighting its potential to substantially increase the percentage of patients who respond to checkpoint inhibitor therapy. Through the IRENE study, we aim to explore how pelareorep-induced adaptive immune responses synergistically interact with PD-1 inhibition to improve patient outcomes in TNBC."

The newly announced IRENE study represents an expansion of Oncolytics’ lead breast cancer program into a new disease subtype (TNBC). In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future pivotal studies by facilitating the patient selection process. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center, and is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte.

About IRENE

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

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 June 25, 2020 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the microbiome-immunoinflammation axis to develop next-generation therapeutics, reported a new financing totaling €46.3 million ($52.6million) to progress the clinical development of its therapeutic pipeline, including the first clinical trials of EO2401, a novel ‘OncoMimic’ cancer immunotherapy (Press release, Enterome, JUN 25, 2020, View Source [SID1234561479]).

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As part of this financing, Enterome has closed a Series E round with new investors including SymBiosis, LLC, a microbiome-focused investment vehicle, and Takeda Pharmaceutical Company Limited. Existing Enterome investors – Seventure, Health for Life Capital, Principia, Omnes Capital and Nestlé Health Science – also participated in the round. In addition, Enterome has made a first drawdown from a loan facility provided by the European Investment Bank (EIB) under a 2018 agreement.

Enterome will use the funds primarily to progress EO2401, an innovative, off-the-shelf immuno-oncology candidate, into the clinic in two cancer indications. The two Phase 1/2 clinical studies in glioblastoma and adrenal tumors, respectively, are planned to start during mid-2020. EO2401 is the first clinical candidate derived from Enterome’s first-in-class OncoMimics platform.

OncoMimics are microbiome-derived peptide antigens that closely mimic antigens expressed by tumor cells; they are selected based on their ability to trigger the rapid activation of memory T-cells that respond to gut bacteria and to direct a targeted cell-killing immune response against the tumor. EO2401 combines three OncoMimics present in aggressive cancers such as glioblastoma and adrenal malignancies.

Enterome expects its second OncoMimic candidate, EO2463, a new multi-peptide cancer immunotherapy, to enter the clinic in 2021 for the treatment of B-cell malignancies (lymphomas and leukaemias).

Enterome is also pursuing the development of its proprietary, next-generation EndoMimics platform, which is designed to produce a new generation of biologics with high potency and unique tolerability. These novel peptide/protein therapeutics are being developed for unmet medical needs in metabolic and inflammatory diseases.

Enterome’s lead EndoMimic candidate, EM101, is a human hormone mimetic produced by commensal bacteria. It is currently in pre-clinical development as a potential novel therapy for inflammatory bowel disease (IBD).

Enterome will continue to invest in developing its world-leading Metasecretome technology, of which both the OncoMimics and EndoMimics platforms are key components.

Pierre Belichard, Chief Executive Officer of Enterome, said: "We are extremely pleased to have completed this significant financing round, which represents an attractive balance of dilutive and non-dilutive funds. The financing will be used to progress EO2401, the first targeted immunotherapy generated from our unique OncoMimics platform. This platform capitalizes on the well-described, constant interaction between the microbiome and the immune system, resulting in a pool of memory T cells directed against specific commensal bacterial antigens that we have identified. We have discovered that some of these antigens bear striking similarity to those present on multiple cancer types and can induce a targeted, anti-tumor response – hence ’OncoMimics‘. We are exploiting this internal discovery to develop highly effective, off-the-shelf immunotherapies against cancers with significant unmet medical need. We look forward to starting the clinical development of this exciting new immunotherapy soon."

Enterome will also use the proceeds to support its global partner Takeda Pharma to deliver proof-of-concept clinical data with EB8018 (sibofimloc/TAK-018), an oral FimH blocker for the treatment of Crohn’s disease.

"Takeda’s participation in this fundraising round builds on our long-standing productive collaboration with Enterome which is focused on the clinical development of sibofimloc, an oral FimH blocker for the treatment of Crohn’s disease." said
Asit Parikh, M.D., Ph. D., Head, Gastroenterology Therapeutic Area Unit at Takeda.

On June 25, 2020 Aadi Bioscience, Inc. (Aadi), a privately held biopharmaceutical company focused on development and commercialization of nab-sirolimus (sirolimus albumin-bound nanoparticles for injectable suspension) in mTOR driven diseases, reported that the company has initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the treatment of advanced (metastatic or locally advanced) malignant PEComa (perivascular epithelioid-cell tumor) – a rare form of sarcoma driven by mTOR activation for which there is currently no approved therapy (Press release, Aadi, JUN 25, 2020, View Source [SID1234561478]). The company expects to complete the NDA submission in the 4th quarter of 2020.

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Following receipt of Breakthrough Therapy, Fast Track, and Orphan Designations, the initiation of the NDA submission for nab-sirolimus is an important milestone for Aadi and a step towards the goal of treating high unmet need diseases with established mTOR pathway activation," said Neil Desai, Ph.D., Chief Executive Officer of Aadi. "We are proud to have completed the AMPECT Study, the first prospective clinical trial for advanced PEComa, and will continue to work expeditiously to complete the submission and bring this potential new therapy to patients.

About Aadi Bioscience and nab-sirolimus (ABI-009)

Aadi is a clinical stage biopharmaceutical company led by Dr. Neil Desai, an inventor of ABRAXANE and the albumin-based technology platform. Aadi’s lead product nab-sirolimus (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) is an mTOR inhibitor complexed with human albumin that has significantly higher tumor accumulation, mTOR target suppression and improved efficacy over other mTOR inhibitors in preclinical models. mTOR as a therapeutic target is well recognized in oncology, however Aadi aims to develop the full potential of albumin-bound sirolimus in therapeutic areas and diseases that are driven by mTOR activation and where the mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety or effective targeting to the disease site. These indications include oncology, cardiovascular, CNS, mitochondrial disease and diseases of ageing. Aadi’s ongoing and planned clinical trials include Oncology (first-line treatment of advanced colorectal cancer with respect to PTEN status, pediatric tumors, advanced sarcoma, newly diagnosed and recurrent glioblastoma, advanced neuroendocrine tumors), Cardiovascular indications (pulmonary arterial hypertension), CNS indications (surgically refractory epilepsy) and Mitochondrial disease (Leigh Syndrome).

About PEComa

Perivascular epithelioid-cell tumors, defined by the World Health Organization as "mesenchymal tumors composed of distinctive cells that show a focal association with blood-vessel walls and usually express both melanocytic and smooth muscle markers," are a rare subset of soft-tissue sarcomas, with an undefined cell of origin. Malignant PEComas may arise in almost any body site (typically the uterus, retroperitoneum, lung, kidney, liver, genitourinary, and gastrointestinal tract) and can have an aggressive clinical course including distant metastases and ultimate death. Cytotoxic chemotherapies typically used for sarcoma show minimal benefit and there are currently no drugs approved for this disease. Malignant PEComas have been shown to frequently harbor mutations in the TSC1 and/or TSC2 genes that result in the activation of mTORC1 pathway. Therefore, mTORC1 signaling is a promising therapeutic target for malignant PEComa.

On June 25, 2020 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the publication of a new research paper released today in Frontiers in Bioengineering and Biotechnology (Press release, Cellectis, JUN 25, 2020, View Source [SID1234561477]). This article describes an innovative and easy-to-implement procedure which will streamline the manufacturing of allogeneic ‘off-the-shelf’ CAR T-cell therapies.

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The methodology described in this article defines a novel non-mechanical purification strategy to generate TCRαβ negative (allogeneic) cells for CAR T-cell therapies. With an early and transient expression of an anti-CD3 CAR in the engineered donor T-cells, Cellectis programed these cells to self-eliminate the remaining TCR+ cell population and obtained an ultrapure TCRαβ(-) population (up to 99.9%) at the end of the CAR-T production.

"We propose a novel, modular and broadly implementable methodology that can efficiently eliminate residual TCRαβ+ cells during the early steps of the allogeneic CAR T-cell generation process without altering key characteristics (T-cell differentiation, exhaustion markers, proliferative capacity and target cell killing capacity)", said Alexandre Juillerat, Ph.D., Team Leader, Innovation Department and NY Laboratory Head, Cellectis. "This study provides a proof of concept to produce the next generation of allogeneic ‘off-the-shelf’ CAR T-cell therapies," he added.

Using Cellectis’ proprietary technologies, TALEN gene editing together with our PulseAgile cell electroporation device, the innovation team developed a new strategy to achieve purification levels compatible with manufacturing and clinical requirements, including the prevention of GvHD. This new method offers optimal outcome for potential future applications in both liquid and solid tumor development programs.

Alexandre Juillerat, Ph.D., Team Leader, Innovation Department and NY Laboratory Head, Cellectis

Alexandre Juillerat, Ph.D., graduated in Chemistry from the University of Lausanne, Switzerland. After receiving his Ph.D. in 2006 in protein engineering from the École Polytechnique Fédérale de Lausanne (EPFL, Switzerland), he moved to the laboratory of Structural Immunology at the Institut Pasteur in Paris, France. In 2010, he joined the R&D department of Cellectis in Paris, France, working on the development and implementation of sequence specific designer nucleases including the transcription activator-like effector nucleases (TALEN). He then joined the Cellectis facility based in New York, NY, leading projects associated with the development of the T-cell chimeric antigen receptor (CAR) technology. Cellectis’ New-York-based innovation team is constantly at the forefront of pioneered research, inventing and generating robust, first-in-class allogeneic CAR T-cell product candidates that address multiple unmet cancer needs.

On June 25, 2020 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the closing of an additional 3,375,000 shares of common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares from Leap’s previously announced public offering (Press release, Leap Therapeutics, JUN 25, 2020, View Source [SID1234561476]). After giving effect to the full exercise of the option, the aggregate gross proceeds to Leap from this offering were approximately $51.75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Leap.

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Piper Sandler & Co. and Raymond James & Associates, Inc. acted as book-running managers for the offering. Robert W. Baird & Co. Incorporated acted as the lead manager. H.C. Wainwright & Co. and Ladenburg Thalmann & Co. Inc. acted as co-managers.

The securities were offered and sold pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223419) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on March 2, 2018 and was declared effective by the SEC on March 16, 2018. A preliminary prospectus supplement and the related prospectus has been filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected] or Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.