On September 17, 2019 Navrogen, Inc. reported that it has raised $3.2M in convertible note financing to support its operations, Humoral Immuno-Oncology (HIO) discovery platform and preclinical therapeutic pipeline activities (Press release, Navrogen, SEP 17, 2019, View Source [SID1234539595]). The financing was led by Ben Franklin Technology Partners of South Eastern Pennsylvania and a number of private investors.

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Previous clinical studies have confirmed that tumors produce immune checkpoint factors that can suppress a patient’s immune response to dysregulated cancer cells. The most commonly studied factors have been those that suppress activation of CD8+ T-cells. The therapeutic and commercial success of antagonists against a subset of these checkpoint inhibitors has fueled the industry’s interest for developing additional drug candidates that can reverse immuno-suppressive mechanisms against T-cells. Alternatively, humoral immunity, which relies on antibody and complement mediated immune responses against dysregulated cancer cells, has recently been found to be suppressed by tumor-produced proteins, referred to as Humoral Immuno-Oncology (HIO) factors. These factors suppress patient’s endogenous humoral responses as well as the pharmacologic effects of antibody-based therapies such as Rituxan and Herceptin. Navrogen’s mission uniquely focuses on therapeutic solutions to reverse the immuno-suppressive mechanisms mediated by HIO-factors through proprietary screening platforms that identify tumor-derived proteins with HIO-factor activity as well as develop agents that can overcome a HIO-factor’s immuno-suppressive effects.

"Our HIO-factor discovery platforms have enabled us to identify a number of tumor-produced proteins that can suppress a patient’s endogenous humoral immune response against cancer cells as well as suppress the therapeutic efficacy of antibody-based drugs," stated Nicholas Nicolaides, Ph.D., Chief Executive Officer at Navrogen. "Importantly, we have been able to leverage these platforms to develop a pipeline of preclinical agents that can overcome their immuno-suppressive effects and are advancing these agents towards clinical trials."

Luigi Grasso, Ph.D., Chief Scientific Officer of Navrogen added, "It appears that the mechanism of tumor-mediated humoral immuno-suppression is broadly present in a number of cancer types. We are taking on the challenge to develop a new class of anti-cancer therapies for patients whose cancers are associated with elevated HIO-factors and are therefore in need of new medical options"

The use of proceeds, in addition to grant funding, will be used to expand Navrogen’s HIO-factor library and support preclinical development activities around its therapeutic pipeline.

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 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 The Children’s Cancer Therapy Development Institute (cc-TDI) reported the creation of Artisan Biopharma (artisanbio.com), a Public Benefit Corporation pediatric cancer biopharmaceutical company, wholly owned by the 501c3 nonprofit, cc-TDI (Press release, Children’s Cancer Therapy Development Institute, SEP 17, 2019, View Source [SID1234631990]).

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Artisan Biopharma (EIN 84-3079359) is a newly formed, angel-funded for-profit benefit corporation wholly-owned by the 501(c)3 nonprofit, cc-TDI. Our mission is to create a quiet cultural revolution in the way new drugs are brought to market for pediatric cancers. We incorporated September 17, 2019, and we are currently engaged with tax and security counsel to finalize our operational structure with respect to the nonprofit. Our stated mission as a public benefit corporation is to provide research and interventions related to the prevention and treatment of cancer in children.

Target market: Orphan drug indications in pediatric cancers
Few rare cancer patient populations with unmet clinical need are as vulnerable and in need of advocacy as children with cancer. Pharmaceutical companies have historically faced significant financial disincentives to pursue pediatric oncology therapeutics, including low incidence, high costs of conducting pediatric trials, and a lack of funding for early-stage research. We are leveraging the deep preclinical domain expertise of cc-TDI to more efficiently identify and in-license compounds. Our goal is to reverse the 40+ year drought represented by only 8 drug approvals for pediatric cancer. To achieve this goal, we aim to have 5 new compounds reach the clinic annually for children with high risk cancers.

Artisan advantage
The rapid advancement of new oncology drugs has created a massive, de-risked discovery tool for translational science, many of which remain novel molecular entities ready to match to rare disease indications. The founding equity investor of Artisan Biopharma, the Children’s Cancer Therapy Development Institute (cc-TDI.org), is an established partner to industry (NVS, PFE, LLY) for preclinical sciences. Artisan was formed as a natural opportunity to develop and market cancer drugs for childhood cancer, generating sustainable funding for cc-TDI’s drug discovery engine. Artisan launched with 15 pipeline candidates and a network of over 1200 families directly touched by pediatric cancer.