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 Hoffmann-La Roche reported that Rozlytrek (entrectinib) is the second histology independent drug to be recommended by NICE for use on the Cancer Drugs Fund (CDF), following a green light for Bayer’s Vitrakvi (larotrectinib) earlier this year (Press release, Hoffmann-La Roche, JUN 25, 2020, View Source [SID1234561463]).

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As a histology independent treatment, the drug targets all solid tumours that have a certain genetic mutation (a neurotrophic tyrosine receptor kinase (NTRK) gene fusion), regardless of where the cancer originated in the body.

As NICE notes, this is particularly beneficial to patients with some rare types of cancer where treatment options are currently limited.

Between 600-700 people have solid tumours with NTRK gene fusions. For those aged 12 years and older who have no satisfactory treatment options, treatment with Rozlytrek will be funded via the CDF, once a European marketing authorisation is granted.

The EMA’s human medicines committee recently backed the approval of the drug as monotherapy for adults and paediatric patients 12 years of age and older, with solid tumours expressing an NTRK gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor.

"People across England will be among the first in Europe to benefit from a new generation of medicine that targets tumours based on their genetic make-up, rather than where they are in the body," noted Karen Lightning-Jones, head of Personalised Healthcare and Strategic Partnerships, Roche Products Limited.

"We are proud to have worked in partnership with NHSE, NICE and the Accelerated Access Collaborative, to fast-track access. We look forward to the English Genomic Medicine Service being able to operate at full capacity and help identify those patients who may benefit from entrectinib."

Meindert Boysen, deputy chief executive and director of the centre for health technology evaluation at NICE, said the decision to approve CDF funding for the drug "is another positive step forward for cancer care driven by genomics. Treatments like entrectinib, have the potential to revolutionise how we treat cancers by targeting a genetic mutation that activates tumour growth irrespective of the solid tumour’s location."

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 Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to utilizing proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, reported the closing of a Series D financing round, raising $110 million (Press release, Poseida Therapeutics, JUN 25, 2020, View Source [SID1234561464]). The financing was led by funds advised by Fidelity Management Research Company, LLC, with participation by Adage Capital Management and Schonfeld Strategic Advisors. A number of current investors also participated in the financing.

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BofA Securities is acting as sole placement agent for the financing.

"This financing supports the approach we are taking to leverage our broad proprietary gene engineering platform technologies, including the piggyBac DNA Modification System and Cas-CLOVER site-specific gene editing system, for the creation of numerous differentiated cell and gene therapy product candidates," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida.

Poseida’s portfolio includes allogeneic and autologous CAR-T product candidates in both hematological and solid tumor oncology indications, as well as liver-directed gene therapy programs in orphan genetic diseases.

On June 24, 2020 Generon BioMed Inc, an innovative biotech company developing novel biological therapeutics, announced on 24 June 2020 that it has rebranded to Evive Biotech – effective immediately Generon BioMed Inc, an innovative biotech company developing novel biological therapeutics, announced on 24 June 2020 that it has rebranded to Evive Biotech – effective immediately. The name change reinforces the company’s commitment to addressing unmet medical needs for patients worldwide.

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"We are very excited and proud to announce our new corporate identity," said Dr. Jacky Liu, CEO of Evive Biotech. "Evive Biotech is a contemporary, international brand that we feel better reflects and articulates who we are as a business and the ambitions that we hold as an Asian-rooted firm with a global outlook. As we transition to the next phase of our development, we believe that the new brand will unite us all still further as we strive to bring breakthrough therapies to patients."

Since its inception in 2004, the company has been focused on addressing unmet medical needs in oncology and inflammatory disorders that are difficult to treat and present a challenging prognosis. In that time, the company has established state-of-the-art cGMP facilities and global operations in the United States, Singapore, and China and today employ over 200 people worldwide. The company combines strong research and clinical development capabilities with exceptional regulatory expertise to bring innovative therapies to market faster.

The rebrand also marks an exciting time for Evive Biotech as it seeks to advance a portfolio of novel drug candidates through its proprietary technology platforms, and ensure broad access to treatment options for patients. These candidates include F-627 for the treatment of chemotherapy-induced neutropenia (CIN), and F-652 that is under development to treat alcoholic hepatitis (AH) and acute graft-versus-host disease (GVHD). F-652 was granted orphan drug status by the U.S. FDA in 2019.

. The name change reinforces the company’s commitment to addressing unmet medical needs for patients worldwide.

"We are very excited and proud to announce our new corporate identity," said Dr. Jacky Liu, CEO of Evive Biotech. "Evive Biotech is a contemporary, international brand that we feel better reflects and articulates who we are as a business and the ambitions that we hold as an Asian-rooted firm with a global outlook. As we transition to the next phase of our development, we believe that the new brand will unite us all still further as we strive to bring breakthrough therapies to patients."

Since its inception in 2004, the company has been focused on addressing unmet medical needs in oncology and inflammatory disorders that are difficult to treat and present a challenging prognosis. In that time, the company has established state-of-the-art cGMP facilities and global operations in the United States, Singapore, and China and today employ over 200 people worldwide. The company combines strong research and clinical development capabilities with exceptional regulatory expertise to bring innovative therapies to market faster.

The rebrand also marks an exciting time for Evive Biotech as it seeks to advance a portfolio of novel drug candidates through its proprietary technology platforms, and ensure broad access to treatment options for patients. These candidates include F-627 for the treatment of chemotherapy-induced neutropenia (CIN), and F-652 that is under development to treat alcoholic hepatitis (AH) and acute graft-versus-host disease (GVHD). F-652 was granted orphan drug status by the U.S. FDA in 2019.