On May 22, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a pioneering global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs) while lowering costs, reported a research and development collaboration with Hospital Infantil Universitario Niño Jesús, Madrid, Spain, through its Biomedical Research Foundation, FIB, to establish a point-of-care center leveraging Orgenesis’ cell and gene therapy focused POCare Platform (Press release, Orgenesis, MAY 22, 2020, View Source [SID1234561710]).

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Under the collaboration agreement, FIB Hospital Infantil Universitario Niño Jesús will utilize Orgenesis’ CGT Biotech Platform to develop, optimize and manufacture cell and gene therapies. Orgenesis’ POCare Technologies enable hospitals to develop and supply cell and gene therapies, including Orgenesis’ proprietary POCare Therapies, by implementing Orgenesis’ proprietary know-how combined with automated, closed technology to process select cell therapies at each point-of-care site for the treatment of patients.

The first collaboration under the agreement between FIB Hospital Infantil Universitario Niño Jesús and Orgenesis involves the clinical development and validation of T-cell and dendritic cell-based therapies. Orgenesis’ CGT Biotech Platform, which combines processing and therapeutic technologies, is designed to allow for the efficient production of high quality, affordable cell and gene-based products. Upon successful completion of the first collaboration, Orgenesis and FIB Hospital Infantil Universitario Niño Jesús then plan to pursue the development of the Hospital’s oncolytic based cell therapy technology, Celyvir. This proprietary program represents a new strategy for the treatment of solid metastatic tumors based on oncolytic virotherapy administered by mesenchymal cells obtained from bone marrow.

Vered Caplan, CEO of Orgenesis, stated, "Hospital Infantil Universitario Niño Jesús will be an amazing addition to our POCare Network. We believe that our POCare Technologies will enable the hospital to advance this new therapy for the treatment of solid metastatic tumors based on oncolytic virotherapy. Our CGT Biotech Platform enables hospitals to accelerate the clinical development of life-saving therapies and potentially bring them to market in a more time and cost-effective manner. Furthermore, we expect that this collaboration will allow us to further develop and validate our POCare Therapies, including immune-oncology therapies."

Dr. Manuel Ramírez MD, PhD, Head of the Pediatric Advanced Therapies Unit at Hospital Infantil Universitario Niño Jesús in Madrid, commented, "We look forward to collaborating with Orgenesis in order to develop our oncolytic based cell therapy. By utilizing Orgenesis’ CGT Biotech Platform, we seek to reduce the cost of bringing our technology to market, enabling others to use it in their patients, assuring high quality standards by integrating Orgenesis’ proprietary POCare Technologies."

On May 22, 2020 Tetra Bio-Pharma Inc. ("Tetra" or the "Corporation") (TSXV: TBP) (OTCQB: TBPMF), a leader in cannabinoid-derived drug discovery and development, reported it has closed its previously announced public overnight marketed offering of units (the "Units") of the Corporation, including the partial exercise of the Agents’ (as defined below) over-allotment option (Press release, Tetra Bio Pharma, MAY 22, 2020, View Source [SID1234561075]). A total of 35,191,000 Units of the Corporation were sold at a price of $0.26 per Unit, for aggregate gross proceeds of $9,149,660 (the "Offering").

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Each Unit consisted of one common share (a "Common Share") in the capital of the Corporation and one Common Share purchase warrant (a "Warrant") of the Corporation. Each Warrant entitles the holder thereof to acquire one Common Share by paying an exercise price of $0.32 for a period of 36 months from the date of closing of the Offering.

The Offering was led by Raymond James Ltd. and Canaccord Genuity Corp. and included Echelon Wealth Partners Inc. (collectively the "Agents").

The Offering was completed pursuant to the Corporation’s Canadian base shelf prospectus dated April 1, 2020 (the "Base Shelf Prospectus"). A prospectus supplement (the "Prospectus Supplement") dated May 19, 2020 relating to the Offering was filed in each of the provinces of Canada. Copies of the Prospectus Supplement and accompanying Base Shelf Prospectus are available under the Corporation’s profile on SEDAR at www.sedar.com.

The Corporation intends to use the net proceeds of the Offering to continue the development of its clinical program, including Phase 2 and phase 3 clinical trials, toxicology, regulatory and manufacturing expenses related to QIXLEEF (PPP001).

The securities mentioned herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") or any U.S. state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws.

On May 22, 2020 Cardinal Health (NYSE: CAH) reported that it is sending an irrevocable notice of early redemption to the holders of the Company’s $500 million 4.625% notes due 2020 (Press release, Cardinal Health, MAY 22, 2020, View Source [SID1234560886]). The early redemption date is set to June 22, 2020, pursuant to the June 2, 2008 indenture and the notes.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

In accordance with the terms and conditions set forth in the indenture and the notes, the notes will be redeemed at a redemption price equal to the greater of (i) 100% of the principal amount of the notes to be redeemed or (ii) the sum of the present values of the remaining scheduled payments of principal and interest on the notes to be redeemed (exclusive of interest accrued to the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the then current adjusted treasury rate (as defined in the notes) plus 25 basis points, plus, in either case, accrued but unpaid interest on the principal amount being redeemed to the redemption date.

This press release shall not constitute a notice of redemption of the notes, and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any state or other 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 other jurisdiction.

On May 22, 2020 Bayer reported that it has submitted an application for marketing authorization for its precision oncology treatment larotrectinib to the Ministry of Health, Labor and Welfare (MHLW) in Japan (Press release, Bayer, MAY 22, 2020, View Source [SID1234558519]). Larotrectinib is an oral TRK inhibitor that has been developed specifically to treat adults and children with locally advanced or metastatic solid tumors that have the rare genomic alteration called a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. The product is already approved in several countries under the brand name Vitrakvi, including the U.S., Brazil, Canada and countries of the European Union (EU). Filings in other regions are underway or planned.

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"With this submission, we are one step closer to providing patients and physicians in Japan with a highly selective treatment exclusively designed for adults and children with TRK fusion cancer, that has the potential to significantly improve treatment outcomes regardless of tumor type or patient age," said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division. "While cancers have previously been treated mainly in the body, larotrectinib was developed specifically to treat patients with TRK fusion cancer, regardless of where in the body the tumor originates. Larotrectinib represents an important advancement in the fight against this rare cancer, as it could replace costly treatment that is not targeted specifically to this cancer and does not have proven efficacy and safety in this patient population."

The submission to the MHLW is based on clinical trial data from the Phase I trial of adult patients, the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. In these trials, larotrectinib was investigated across more than 20 different histologies of solid tumors including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, cholangiocarcinoma, soft tissue sarcomas, salivary gland and infantile fibrosarcoma.

TRK fusion cancer is rare overall. It affects both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering the activation of an intercellular signaling cascade. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body.

About larotrectinib
Larotrectinib, a specific oral TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. The compound has demonstrated high response rates and durable responses with a favorable safety profile over three years in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors. It has the largest dataset and longest follow-up data of any TRK inhibitor. The trials are still ongoing, with the latest dataset published in The Lancet Oncology and additional updates planned to be presented at upcoming scientific meetings.

Larotrectinib was approved in September 2019 in the European Union under the brand name Vitrakvi for the treatment of adult and pediatric patients with solid tumors that display 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 no satisfactory treatment options. Vitrakvi has also received regulatory approval in additional markets, including the U.S, Brazil and Canada. Filings in other regions are underway or planned.

Following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019, Bayer has obtained the exclusive licensing rights for the global development and commercialization, including in the U.S., for larotrectinib and the investigational another TRK inhibitor selitrectinib (BAY 2731954) progressing through clinical development.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development.
Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On May 22, 2020 More than $10.2 million dollars in National Health and Medical Research Council (NHMRC) Investigator Grants has been awarded to five QIMR Berghofer scientists to further their cutting-edge research in their respective fields of cancer, infectious diseases and mental health (Press release, QIMR Berghofer Medical Research Institute, MAY 22, 2020, View Source [SID1234558427]).

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Investigator Grants are awarded to high-performing researchers at all career stages to allow them flexibility to pursue innovative research and to form collaborations without being restricted to a specific research project.

The grants were announced this week by the Federal Health Minister Greg Hunt.

QIMR Berghofer Senior Scientist and head of the Institute’s Cancer Genetics group, Professor Georgia Chenevix-Trench, was awarded more than $2.73 million to find more genetic risk factors for breast cancer.

Professor Chenevix-Trench has been involved in identifying more than 200 regions of the genome that contain variants that increase breast cancer risk. She will use the five-year grant to try to find the remaining genetic risk factors, explore how they work and what genes they influence, and if the information can be used to find new drug treatments for the disease.

Senior Scientist and head of QIMR Berghofer’s Molecular Parasitology group, Professor Don McManus, received $2.71 million to continue his work in developing new strategies to control and eliminate parasitic worm infections that affect the world’s poorest people.

Senior Scientist and the head of the Institute’s Oncogenomics group Professor Nick Hayward will use his $2.23 million grant to explore genetic approaches to increase survival and find potential cures for melanoma.

The head of the Institute’s Cancer program, Associate Professor Steven Lane, will utilise his $1.91 million grant to find clinical treatments that target genetic changes in patients with blood cancer.

Early career researcher, Dr Luke Hearne, was awarded an Emerging Leader Investigator Grant of $645,205 to investigate how deviations in brain networks give rise to symptoms of psychiatric disorders.

QIMR Berghofer’s Director and CEO, Professor Fabienne Mackay, welcomed the funding.

"These are all outstanding leaders in their research fields and these Investigator Grants will ensure they can continue to help lead health and medical advances for all Australians," Professor Mackay said.

"While a lot of the world’s attention is presently on the COVID-19 pandemic, it’s vital that other potentially life-saving research into other heath conditions and diseases continues as well."

The Investigator grant round is the NHMRC’s largest funding scheme with grants commencing in January 2021.