On December 21, 2018 Oxford BioTherapeutics Ltd. ("OBT"), a clinical stage oncology company with a pipeline of immuno-oncology and antibody drug conjugate based therapies, reported that it has received US Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for OBT076, an experimental antibody drug conjugate (ADC) for the treatment of women with high risk HER2 negative breast cancer, as well as other solid tumors expressing this target antigen including gastric, lung, bladder and ovarian cancer (Press release, Oxford BioTherapeutics, DEC 21, 2018, View Source [SID1234532231]). The phase I study will be performed at a number of leading clinical centres across the United States.

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"With our highly experienced expert investigators, we hope to bring this new innovative treatment option to this high unmet medical need patient population with high risk Her2 negative breast cancer", said OBT’s Chief Medical Officer, Dr Rahim A Fandi. "We also aim to develop OBT076 for other solid tumors expressing the target antigen. OBT076/MEN1309 has already been shown to be well tolerated in an on-going phase 1 trial conducted in Europe under the sponsorship of Menarini Ricerche. OBT076/MEN1309 is an ADC drug, which is designed to target CD205 positive tumours and to reverse immune tolerance in patients with high risk breast cancer and other solid and liquid tumours. This is a great achievement by OBT’s team."

OBT Chief Executive Officer, Dr. Christian Rohlff said, "The FDA’s acceptance of the IND for OBT076 is an important milestone in OBT’s US product development strategy. We plan to conduct studies in the US that will extend the potential of this first-in-class molecule, beyond the cancer indications currently under evaluation in the Menarini Ricerche sponsored European trial, under the name MEN1309, to patients with other cancer types with a clear need for better treatment options. OBT076 is expected to play a key role in OBT delivering on its commitment to help patients with cancer, in particular those with high risk breast cancer. The start of this trial will herald an exciting start to 2019 for OBT."

About OBT076

OBT076, is an antibody drug conjugate (ADC) comprising a fully human antibody targeting CD205, coupled to the DM4 toxin from Immunogen. OBT076 is being developed for a number of CD205 driven tumors including Her2 negative breast cancer, gastric cancer, triple-negative metastatic breast cancer, bladder cancer and pancreatic cancers as well as Non-Hodgkin Lymphoma (NHL). Infiltration of primary localized breast tumors by pDC correlates with an adverse outcome, suggesting their contribution in the progression of breast cancer [1] and several other solid and liquid cancers. CD205 is overexpressed in subsets of Her2 negative breast cancer, triple negative breast cancer, gastric cancer, lung cancer, bladder cancer, pancreatic cancer, ovarian cancer and multiple liquid cancers including DLBCL.

OBT076 is currently also being tested in a multi-centre first-in-human clinical study under the name MEN1309 in major European oncology centres in Italy, Spain, Belgium and the UK in triple negative breast cancer (TNBC), pancreatic, and bladder cancers, as well as diffuse large B-cell lymphoma (DLBCL) under the sponsorship of Menarini Ricerche via a strategic alliance with OBT. The European first in human trial is successfully progressing the dose escalation phase that commenced by enrolling patients with solid tumors and has recently extended the enrolment to patients with NHL. The subsequent expansion cohorts’ phase of this European trial will aim to identify the recommended phase II dose in specific sold tumor indications as well as NHL.

On December 21, 2018 Novartis reported that the European Commission (EC) approved an expanded indication for Kisqali (ribociclib), the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent and sustained efficacy compared to endocrine therapy alone (Press release, Novartis, DEC 21, 2018, View Source [SID1234532215]). Kisqali is now approved in the European Union (EU) for the treatment of women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy and in women who have received prior endocrine therapy. Kisqali is also now approved in combination with endocrine therapy and a luteinising hormone-release hormone agonist (LHRH) for pre- and perimenopausal women with HR+/HER2- locally advanced or metastatic breast cancer.[1]

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EU approval follows a positive opinion granted in November by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based on MONALEESA-3 and MONALEESA-7 clinical trials, which demonstrated clinical benefit of Kisqali-based regimens, regardless of combination partner or menopausal status, as first or second-line treatment.[1] Read more about the positive CHMP opinion and the MONALEESA-3 and MONALEESA-7 clinical trial results here.

Important Safety Information from the Kisqali EU SmPC
Kisqali (ribociclib) is a prescription medicine approved in combination with an aromatase inhibitor or fulvestrant as initial endocrine – based therapy or following disease progression on endocrine therapy in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is not known if Kisqali is safe and effective in children or adolescents. Kisqali can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Kisqali is not indicated for concomitant use with tamoxifen due to an increased risk of QT prolongation. Patients should tell their health care provider right away if they have a change in their heartbeat (a fast or irregular heartbeat), or if they feel dizzy or faint. Kisqali can cause serious liver problems. Patients should tell their health care provider right away if they get any of the following signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark or brown (tea-colored) urine, feeling very tired, loss of appetite, pain on the upper right side of the stomach area (abdomen), and bleeding or bruising more easily than normal. Low white blood cell counts are very common when taking Kisqali and may result in infections that may be severe. Patients should tell their health care provider right away if they have signs and symptoms of low white blood cell counts or infections such as fever and chills. Before taking Kisqali, patients should tell their health care provider if they are pregnant, or plan to become pregnant as Kisqali can harm an unborn baby. Females who are able to become pregnant and who take Kisqali should use highly effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali. Do not breastfeed during treatment with Kisqali and for at least 3 weeks after the last dose of Kisqali. Patients should tell their health care provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements since they may interact with Kisqali. Patients should avoid grapefruit or grapefruit juice while taking Kisqali. The most common side effects (incidence >=20%) include infections, white blood cell count decreases, headache, cough, nausea, tiredness, diarrhea, vomiting, constipation, hair loss and rash. The most common Grade 3/4 side effects (incidence >5%) were infections, low neutrophils, low leukocytes, low red blood cells, abnormal liver function tests, low lymphocytes, low phosphate levels and vomiting. Abnormalities were observed in hematology and clinical chemistry laboratory tests.

On December 21, 2018 Integra LifeSciences Holdings Corporation, a Delaware corporation (the "Company" or "us") reported that it has entered into a $150 million accounts receivable securitization facility (the "A/R Facility") to reduce outstanding revolving borrowings under the Company’s senior credit facility and to provide additional liquidity and funding for the ongoing business needs of the Company and its subsidiaries (Filing, 8-K, Integra LifeSciences, DEC 21, 2018, View Source [SID1234532306]).

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The documentation for the A/R Facility includes (i) a Receivables Financing Agreement (the "Receivables Financing Agreement") entered into by and among Integra Receivables LLC, a Delaware limited liability company and a newly formed bankruptcy-remote special purpose entity that is an indirect, wholly-owned subsidiary of the Company (the "Borrower"), Integra LifeSciences Sales LLC ("ILS Sales"), as Servicer (the "Servicer"), PNC Bank, National Association, as Administrative Agent, PNC Capital Markets LLC, as Structuring Agent, and certain lenders and group agents that are parties thereto from time to time (the "Lenders"), and (ii) a Purchase and Sale Agreement (the "Purchase and Sale Agreement") by and among ILS Sales, Integra Lifesciences Corporation, and certain other subsidiaries of the Company party thereto from time to time, as Originators (collectively, the "Originators"), the Servicer and the Borrower (collectively, the "Agreements").

Pursuant to the Purchase and Sale Agreement, the Originators have sold or contributed, and will continue to sell and/or contribute on an ongoing basis, certain eligible trade receivables, together with all related security and interests in the proceeds thereof, to the Borrower in exchange for a combination of cash, equity and/or subordinated notes issued by the Borrower to the Originators. Pursuant to the Receivables Financing Agreement, the Borrower may, from time to time, finance such trade receivables with a revolving loan from the Lenders secured by a pledge of such trade receivables, together with all related security and interests in the proceeds thereof.

The Originators and the Borrower provide customary representations and covenants under the Agreements. Receivables in the A/R Facility are subject to customary eligibility criteria, concentration limits and reserves. The Receivables Financing Agreement provides for certain Events of Default, as defined therein, upon the occurrence of which the Administrator may declare the facility Termination Date, as defined therein, to have occurred.

The amount of advances of the Lender outstanding at any one time under the Receivables Financing Agreement is limited to $150 million. As of December 21, 2018, there were $121.2 million of advances outstanding under the A/R Facility. The A/R Facility is for an initial three-year term as may be extended in accordance with the terms of the Receivables Financing Agreement.

ILS Sales serves as the servicer of the trade receivables under the A/R Facility. None of the Company, the Originators or the Borrower guarantees collectability of the trade receivables or the creditworthiness of obligors thereunder. However, the Company has provided a limited guaranty of performance in respect of the obligations of the Originators as originators under the Purchase and Sale Agreement and of the obligations of ILS Sales as servicer under the Receivables Financing Agreement.

On December 20, 2018 Vaccitech, a clinical stage developer of a universal flu vaccine and other vaccine-related products, reported that it has received a joint £6m investment from a Korean biotech company, GeneMatrix, and venture capital and private equity firm, Korea Investment Partners (Press release, Vaccitech, DEC 20, 2018, View Source [SID1234532187]).

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Vaccitech and GeneMatrix also intend to enter into a formal collaborative agreement that will create business synergies between the companies through expansion of advanced vaccine development programs in Korea. GeneMatrix has recently begun internal vaccine development through a Zika virus vaccine program, backed by a government grant from Korea Centres for Disease Control and Prevention. Vaccitech will use the present investment to advance ongoing clinical projects and expand its research and development efforts.

Tom Evans, Chief Executive Officer at Vaccitech, said:

"The GeneMatrix team is experienced in the infectious disease areas, especially in chronic Hepatitis B and Human Papilloma virus, which are a major unmet medical need, and our vaccine programs in such areas will be quite synergistic."

Soo-OK Kim, Chief Executive Officer at GeneMatrix, added:

"We hope the combination of Vaccitech’s T-cell induction platform and GeneMatrix’s molecular and therapeutic platform will lead to better clinical development of advanced vaccines and new therapeutics."

Vaccitech is a spin-out from the University of Oxford and is commercialising decades of viral vector vaccine research conducted at the University’s Jenner Institute. The company’s proprietary T-cell induction platform comprises non-replicating viral vectors that induce some of the most potent cell-mediated immune responses reported in humans against target pathogens and cancer. Vaccitech has multiple vaccine and therapeutic products targeting indications across infectious diseases and oncology.

On December 20, 2018 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conference and invited investors to participate via webcast (Press release, Illumina, DEC 20, 2018, View Source [SID1234532202]).

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J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 7, 2019
Presentation at 3:00 pm Pacific Time followed by a Q&A Session at 3:30 pm Pacific Time

The live webcast can be accessed in the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. A replay of the presentation will be posted on Illumina’s web site after the event and will be available for at least 30 days following.