On September 17, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company") is reported the grant of patent no. 6576962 entitled "Antibody molecules to LAG-3 and uses thereof" by the Japanese Patent Office (Press release, Immutep, SEP 17, 2019, View Source [SID1234539611]).

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The claims of the patent are directed to LAG525, and to the use of LAG525 in the treatment of cancer and infectious disease. LAG525 is a humanised form of Immutep’s IMP701 antibody that was originally developed by Immutep S.A. (now Immutep S.A.S.), a wholly owned subsidiary of the Company. The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 13 March 2035.

About IMP701 and LAG525

IMP701 is a therapeutic antibody originally developed by Immutep S.A. to target LAG-3. This antagonist antibody plays a role in controlling the signalling pathways in both effector T cells and regulatory T cells (Treg). The antibody works to both activate effector T cells (by blocking inhibitory signals that would otherwise switch them off) and at the same time inhibit Treg function that normally prevent T cells from responding to antigen stimulation. The antibody therefore removes two brakes that prevent the immune system from responding to and killing cancer cells. In contrast, some other checkpoint antibodies in development target only the effector T cell pathway and don’t address the Treg pathway.

Rights to the development and commercialisation of IMP701 were licensed to CoStim Pharmaceuticals in 2012, which was subsequently acquired by Novartis in 2014.

LAG525, a humanised form of IMP701 is currently being evaluated in five Phase I and/or Phase II clinical trials, in combination with Novartis’ PD-1 inhibitor spartalizumab for the treatment of various cancers. Novartis has full responsibility for the continued development of the antibody program and Immutep is eligible to receive development-based milestone payments and royalties on sales following commercialisation of the antibody.

On September 17, 2019 Nordic Nanovector ASA (OSE: NANO) reported that it will today host an R&D day in Oslo (Press release, Nordic Nanovector, SEP 17, 2019, View Source [SID1234553445]). The programme will include presentations from three external experts and by Nordic Nanovector’s senior management team. The full programme of the event is available at www.nordicnanovector.com under press releases.

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The R&D day presentations will cover

the progress of the company’s research and pre-clinical projects
the clear medical need in the patient populations suffering from the diseases targeted by Nordic Nanovector products in development and
the latest data on some of the clinical trials currently being conducted.
In addition, the company will provide an update on its work and progress on the CMC (Chemistry, Manufacturing and Control) area, which will be a key part of the planned regulatory filing for Betalutin in the first half of 2021.

The pivotal Phase 2b PARADIGME trial of Betalutin in advanced recurrent follicular lymphoma (FL) is progressing with 83 sites in 24 countries open for enrolment as of September 16th, 2019.

"The clinical results obtained so far with Betalutin demonstrate that the rationale behind its design for the treatment of non-Hodgkin’s lymphoma was right", commented Dr Jostein Dahle, Chief Scientific Officer and Co-founder of Nordic Nanovector. "Over the last ten years we have continued to advance our knowledge of the biology of the disease and the peculiarities of our treatment modality in general and Betalutin in particular. We are very excited with the data we continue to generate and the opportunities that this information will provide to keep the company at the forefront of this race towards finding new and improved therapies or combinations that will benefit the thousands of patients still at need".

Dr J.P. Pouget, PhD, Radiobiology and targeted radiotherapy group Montpellier Cancer Research Institute (IRCM), French National Institute of Health and Medical Research (INSERM) will present interesting new pre-clinical results with Betalutin, including its increased therapeutic activity when combined with cell cycle inhibitors.

Dr Jostein Dahle will summarize the focus and most recent advances of Nordic Nanovector’s research. During his presentation, he will preview data that will be presented at the EANM (European Association of Nuclear Medicine) Congress in Barcelona in October that shows the synergistic effect of Humalutin with the PARP inhibitor Olaparib in DLBCL (Diffuse Large B Cell Lymphoma) cell lines.

Dr Jostein Dahle will also explain in detail some of the data that the company has generated with Alpha37 (an anti-CD37 mAb linked to alpha-particle generating lead 212). This will include demonstration of the superiority of Alpha37 to ibrutinib in an ibrutinib-resistant mouse model of CLL (chronic lymphocytic leukaemia). Ibrutinib is today the most widely used product in this indication, both first line and second line. These data have been selected for the highlights session of the already mentioned EANM Congress in Barcelona. Alpha37, which is partnered with OranoMed, has recently been awarded a grant of NOK 6 million by the Eurostar programme.

Prof Pier Luigi Zinzani, Professor of Hematology at Bologna University, will analyse the therapeutic landscape in recurrent FL and marginal zone lymphoma (MZL), reviewing the efficacy and safety profile of approved agents and products in development. Despite the availability of new therapies, the unmet medical need in recurrent FL and MZL is still high.

Dr Arne Kolstad from the Department of Oncology, Oslo University Hospital, and the Principal Investigator of the LYMRIT-37-01 trial, will hold a presentation which provides the latest update from this trial of Betalutin in patients with relapsed indolent NHL.

With a median follow-up time for responders of 30 months, this latest update confirms a median duration of response (mDoR) of 13.6 months for all 45 responders and an even more durable response of 32.0 months for the 22 patients showing a complete response (compared with 9.0 and 20.7 respectively last December at ASH (Free ASH Whitepaper)).

Dr Arne Kolstad will also present data from the first safety cohort of three patients of the Phase 1b Archer-1 study of Betalutin + rituximab (RTX) in relapsed/refractory follicular lymphoma. This open label, single-arm dose escalation study in 2L FL expects to recruit a total of 20-25 patients to evaluate the safety and tolerability of Betalutin in combination with RTX and to evaluate the preliminary anti-tumour activity of combination treatment.

In the first safety cohort an overall response rate of 100% was observed with three complete responders and importantly no dose limiting toxicities. Full data read out from this study is expected in the second half of 2020.

With Nordic Nanovector’s strategic priorities focused on efforts to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments, we decided together with our partner Heidelberg Pharma to discontinue development of NNV014 (anti-CD37 ADC), an early stage discovery project in leukaemia.

"The data presented during this R&D day highlights our potential to become a leader in radiopharmaceuticals and our commitment to deliver innovative products for the patients suffering from these devastating diseases", commented Eduardo Bravo, CEO of Nordic Nanovector. "We are very pleased with the latest results from the LYMRIT-37-01 study and with the early indications from the first safety cohort in Archer-1. These encouraging data support our decision to broaden the clinical development of Betalutin in NHL and to develop the regulatory and commercial strategy for a commercial launch in the US. We are entering an exciting phase in the company’s development with key data due to be reported next year and the prospect of our first regulatory filing for Betalutin in third line FL in the first half of 2021."

On September 17, 2019 Linnaeus Therapeutics, Inc. ("Linnaeus"), a privately held biopharmaceutical company focused on the development and commercialization of novel, small molecule oncology therapeutics, reported that it has closed a $12 million series B financing (Press release, Linnaeus Therapeutics, SEP 17, 2019, View Source [SID1234539579]). Kairos Ventures, of Beverly Hills, California, led the financing with participation by the Penn Medicine Co-Investment Fund at the University of Pennsylvania.

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The company intends to use the proceeds from the financing to conduct its phase 1/2 clinical trial of its lead compound, LNS8801, in patients with advanced cancer.

"We are thrilled with the progress Linnaeus has made in the twelve months since the closing of our Series A round," said Patrick Mooney, M.D., chief executive officer of Linnaeus. "With the Series B investment closed we now look forward to advancing LNS8801 into our phase 1/2 clinical studies that should commence in the coming weeks."

On September 17, 2019 Mylan N.V. (NASDAQ: MYL) reported the U.S. launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, a generic version of AstraZeneca’s Faslodex Injection (Press release, Mylan, SEP 17, 2019, View Source [SID1234539596]). Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used to treat certain types of advanced breast cancer in women who have experienced menopause as monotherapy and in advanced or metastatic breast cancer in combination with other products.

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"Mylan’s launch of Fulvestrant Injection represents an important addition to our growing oncology portfolio and, more importantly, expands the available treatment options for women who are facing advanced or metastatic stages of breast cancer," said Mylan President Rajiv Malik. "The launch also reinforces our scientific expertise in bringing to market complex products, like injectables, which further enhances our institutional business and exemplifies our continued commitment to expanding access to medicine."

Mylan is dedicated to supporting patients at every stage of cancer care with more than 50 oncology supportive care, therapeutic and diagnostic products in the U.S.

Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, had U.S. sales of approximately $550 million for the 12 months ending June 30, 2019, according to IQVIA.

Currently, Mylan has 151 ANDAs pending FDA approval representing approximately $88.4 billion in annual brand sales, according to IQVIA. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $59.2 billion in annual brand sales, for the 12 months ending June 30, 2019, according to IQVIA.

Fulvestrant Injection is a prescription medicine used to treat women with:

Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), who have gone through menopause, in combination with ribociclib as their first endocrine therapy or after their cancer has progressed while on prior endocrine therapy
HR-positive, HER2-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib whose disease has progressed after endocrine therapy

On September 17, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported a significant milestone in its Nu.QTM Capture development program: the ability to enrich nucleosomes, and therefore, DNA of tumor versus non-tumor origin (Press release, VolitionRX, SEP 17, 2019, View Source [SID1234539597]). This breakthrough could be used in two ways, firstly to increase specificity in Volition’s current assays by removing the background signal and secondly, as an enabling technology in sequencing-based liquid biopsies by enriching nucleosomes of cancer origin from the blood.

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Dr. Mark Eccleston, one of the founding Scientists and the Business Development Director at Volition commented, "I am extremely excited that this enabling technology could bridge the gap between Volition’s epigenetic profiling approach to early detection and those sequencing approaches that have so far been limited to personalized treatment selection. The recent results could impact the entire sector and highlight Volition as a leader in the field of Clinical epigenetics. The next step in our Nu.QTM Capture development work, which is underway and will be reported in the coming months, is to determine the level of discrimination of tumor-derived nucleosomes using mass spectrometry, immunoassay and sequencing to provide a complete analysis of cell-free nucleosomes."

Dr. Jake Micallef, Chief Scientific Officer at Volition added, "Volition is focused on advancing the science of epigenetics and has developed an extensive understanding of chromosome and nucleosome structures, particularly in blood. I believe all the work we have done over the past 9 years, including what I believe should be a breakthrough patent we filed last week with the aim of securing Nu.QTM Capture intellectual property, puts us at the cutting edge of epigenetics."

Volition is currently developing Nu.QTM products that can detect cancer by measuring circulating nucleosomes in the blood by low-cost immunoassay. In addition to these diagnostic products, Volition, through its Nu.QTM Capture platform, has developed the ability to enrich nucleosomes of cancer origin from the blood which will be valuable for wider profiling approaches such as mass spectrometry (for target discovery) and simplification of sequencing approaches, opening up the potential for its Nu.Q-Seq approach as well as partnering/licensing opportunities.