On June 16, 2020 Ona Therapeutics, which is focused on the discovery and development of therapeutic biologics to treat metastatic cancer, reported the closing of a €30 million Series A financing, with participation from existing investor Asabys Partners and new investors Alta Life Sciences, Bpifrance – InnoBio 2, Fund+ and Ysios Capital. (Press release, Ona Therapeutics, JUN 16, 2020, View Source [SID1234561132])

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Ona Therapeutics was founded in 2019 by IRB Barcelona, ICREA and research scientists Salvador Aznar-Benitah and Valerie Vanhooren, with backing from Asabys Partners – Sabadell Asabys, which was instrumental in putting together the Series A. Its approach is based on pioneering work from Dr Aznar-Benitah published in Nature in 2017 that validates Metastasis-Initiating Cells as therapeutic targets in metastatic cancer. The research shows that blocking the pathways that allow fat metabolism in animal models of cancer inhibits the cells that give rise to metastases, with the potential to not only prevent the development of these malignant growths, but also to eliminate existing ones. Importantly, this stands out as a common feature shared among various metastatic tumors, such as oral, breast, ovarian, gastric, bladder, prostate and melanoma.

The financing will allow Ona Therapeutics to complete the pre-clinical development in a variety of tumor types and to move its lead candidate into first clinical studies in patients with metastatic cancer in 2023.

Valerie Vanhooren, CEO and co-founder of Ona Therapeutics, commented: "We are very pleased to attract such a strong syndicate of investors which validates our approach to developing novel therapies with the potential to treat multiple types of metastatic cancer. Our research demonstrates that the survival of metastatic cells is linked to the intake of certain saturated fats and if we block the capacity for intake of these fats, we significantly reduce the cell’s metastatic potential."

Alexandra Tolia, Partner at Fund+, said: "Fund+ looks to invest in potential world class opportunities by backing great teams and ground-breaking science in areas of major unmet medical need. Metastasis remains an enormous challenge and the cause of over 90% of all cancer deaths worldwide. Ona Therapeutics is in a unique position to offer a promising new treatment to patients that otherwise have extremely limited options for recovery."

Joël Jean-Mairet, Managing Partner at Ysios Capital, said: "Ona Therapeutics is founded on world class science out of leading Barcelona research institutes. In the last year it has made exceptional progress in validating its scientific approach and we are very pleased to support this capital raise. Over the past years, we have evaluated around 600 companies active in oncology and Ona Therapeutics stands out for its singularity and potential impact in patients."

The investor syndicate will join the Ona Therapeutics Board which will consist of: Jose Mesa (Alta Life Sciences), Jean-François Morin (Bpifrance – InnoBio 2), Alexandra Tolia (Fund+) and Joël Jean-Mairet (Ysios Capital), and Interim Chair, Clara Campàs (Asabys Partners).

Bpifrance has invested through its InnoBio 2 fund which is focused on the development of the most promising biotechnology start-ups in Europe, and in France. Alta Life Sciences´ fund invests in highly innovative research business opportunities, such as Ona Therapeutics which is addressing large unmet medical needs such as metastasis.

On June 16, 2020 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, and PETNET Solutions Inc., a Siemens Healthineers company specializing in the manufacturing and distribution of positron emission tomography (PET) radiopharmaceuticals, reported the signing of a commercial manufacturing and distribution agreement (Press release, Blue Earth Diagnostics, JUN 16, 2020, View Source [SID1234561131]). Under the new multi-year agreement, PETNET will expand production and continue distribution of Axumin as well as commercially manufacture and distribute Blue Earth Diagnostics’ investigational radiohybrid Prostate-Specific Membrane Antigen-targeted agent, rhPSMA-7.3 (18F), pending its successful development and potential FDA approval. PETNET is currently a supplier of rhPSMA-7.3 (18F) for Blue Earth Diagnostics’ Phase 3 rhPSMA-7.3 (18F) clinical trials in newly diagnosed and recurrent prostate cancer (LIGHTHOUSE NCT04186819 and SPOTLIGHT NCT04186845, respectively). Axumin is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment.

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"We are pleased to work in conjunction with PETNET Solutions, the leading supplier of PET radiopharmaceuticals in the United States, to continue to expand Axumin production and distribution in the United States," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Axumin launched as the first FDA-approved 18F imaging agent for recurrent prostate cancer in 2016, and is now available at more than 1,100 imaging centers across the United States. Based on Blue Earth Diagnostics’ success in using its extensive radiopharmacy network for U.S. Axumin production and distribution, we chose PETNET as a clinical trial manufacturer of rhPSMA-7.3 (18F) for our Phase 3 clinical trials. Under this new agreement, PETNET will also provide commercial production and distribution of rhPSMA-7.3 (18F) pending its successful development and potential FDA approval. We believe that the complementary mechanisms of action of Axumin and rhPSMA-7.3 (18F) may ultimately allow physicians and their patients flexibility in selecting the diagnostic agent most appropriate to each specific clinical situation. The new agreement expands Axumin production in 2021, so that physicians and patients may have more convenient access to the product."

"We are proud to continue working with Blue Earth Diagnostics as the U.S. commercial supplier in making Axumin available to imaging centers and their patients, and we are pleased that PETNET Solutions has been selected to manufacture and distribute rhPSMA-7.3 (18F)," said Barry Scott, Head of PETNET Solutions Inc. "PETNET’s broad national network of radiopharmacies enables us to increase access to 18F PET radiopharmaceuticals to help healthcare providers address society’s most challenging diseases."

About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including neuro-oncology.

About rhPSMA

rhPSMA-7.3 (18F) is an investigational imaging agent that consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with radioisotopes such as 177Lu and 225Ac for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, with an option to therapeutic rights. rhPSMA originated from the Technical University of Munich, Germany, and has been utilized clinically under German legislation at the Department of Nuclear Medicine there for the diagnostic imaging of men with both primary and recurrent prostate cancer. rhPSMA compounds have not received regulatory approval.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. Indication and Important Safety Information about Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On June 16, 2020 Perrigo Company plc ("Perrigo" or the "Company") (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that Perrigo Finance Unlimited Company, an indirect wholly-owned finance subsidiary of Perrigo (the "Issuer"), commenced a registered public offering of senior notes (the "Notes") (Press release, Perrigo Company, JUN 16, 2020, View Source [SID1234561130]). The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by the Company. The exact terms and timing of the offering will depend upon market conditions and other factors.

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Perrigo intends to use the net proceeds of the Notes offering to fund the redemption of the Issuer’s 3.500% Senior Notes Due March 15, 2021 and 3.500% Senior Notes Due December 15, 2021, with the balance, if any, for general corporate purposes, which may include the repayment or redemption of additional indebtedness.

BofA Securities, J.P. Morgan and Wells Fargo Securities are the joint book-running managers in the offering.

The offering is being made pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission. The offering will be made only by means of a prospectus supplement relating to the offering and the accompanying base prospectus, copies of which may be obtained by contacting: BofA Securities, Inc. at [email protected] or toll-free at (800) 294-1322; or by calling J.P. Morgan Securities LLC collect at (212) 834-4533; or by calling Wells Fargo Securities, LLC toll-free at (800) 645-3751 or emailing [email protected].

On June 16, 2020 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms and Ichor Medical Systems ("Ichor"), a privately held biotech company based in San Diego, CA, reported that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001 (Press release, Immunomic Therapeutics, JUN 16, 2020, View Source [SID1234561129]).

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ITI will leverage Ichor’s TriGrid Electroporation technology to increase cellular uptake of ITI-1001 when administered to patients with newly diagnosed Glioblastoma, or GBM. DNA vaccines delivered by conventional injection have experienced challenges to delivery efficiency, resulting in suboptimal immune responses in clinical trials. Ichor’s TriGrid technology utilizes the application of electrical fields in a target tissue to increase intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.

"We are excited to partner with Ichor on our ITI-1001 program. Their TriGrid technology is a great match for our nucleic acid approach. By combining our technologies, we aim to enhance immune responses to the viral antigens of Cytomegalovirus (CMV) expressed in GBM patients, and potentially achieve immune responses that target CMV-expressing GBM tumor tissue in the brain in our upcoming Phase I study with ITI-1001," said Dr. William Hearl, CEO of Immunomic Therapeutics. "We are pleased to collaborate with a recognized leader in the delivery of nucleic acid-based medicines and we look forward to initiating patient dosing in 2021."

ITI-1001, which leverages ITI’s proprietary and investigational UNITE platform to treat patients with newly diagnosed GBM, is designed to target the pp65, IE-1, and gB viral antigens of CMV, expressed in GBM, but not in normal brain cells. In March 2020, ITI announced that it had completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).

In the planned First-In-Human Phase I trial, ITI will evaluate the safety, tolerability, immunogenicity and preliminary efficacy of ITI-1001 in patients with newly-diagnosed GBM having unmethylated MGMT promoter mutations. The Phase I trial is anticipated to start in 2021.

"DNA vaccines are a promising platform for both therapeutic and prophylactic applications. Randomized, placebo-controlled trials have demonstrated that the TriGrid improves the potency of DNA vaccines compared to conventional injection," said Ichor CEO Bob Bernard. "We are eager to deploy our TriGrid technology with ITI’s UNITE-based GBM DNA vaccine to target an aggressive cancer for which novel therapies are desperately needed."

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On June 16, 2020 Mateon Therapeutics Inc. (OTCQB:MATN) reported the fruition of its licensing of OT-101/IL-2 combination to Autotelic BIO based on an agreement entered into between Oncotelic and Autotelic BIO, a South Korean Company, during 2018 (Press release, Mateon Therapeutics, JUN 16, 2020, View Source [SID1234561128]).

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OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.

OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 further demonstrate its utility as adjunct to other immunotherapies. Interleukin-2 (IL-2, Aldesleukin, PROLEUKIN) Immunotherapy is cancer treatment that stimulates the body’s immune system to fight cancer, such as melanoma.

"In addition to additional milestone payments under said agreement, Mateon also entitled to profit sharing and royalties arising from the commercialization and/or licensing of OT-101/IL-2 by Autotelic BIO", stated Amit Shah, CFO of Mateon Therapeutics. "We look forward to continue our collaboration with Autotelic BIO and to make this unique immunotherapy available to patients."