On July 16, 2020 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported the appointment of Jennifer K. Simpson, Ph.D., as President and Chief Executive Officer (Press release, Sun BioPharma, JUL 16, 2020, View Source [SID1234561935]). Dr. Simpson was also appointed to the Company’s Board of Directors. Dr. Simpson brings more than two decades of public company executive and fundraising experience in oncology drug development and commercialization to Sun BioPharma, most recently having served as CEO of Delcath Systems, Inc. Sun BioPharma co-founder Michael T. Cullen, M.D, MBA, will continue to serve as Executive Chairman of Sun BioPharma’s Board of Directors.

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"Recent interim clinical trial results demonstrated an overall tumor response rate of 62% for Sun BioPharma’s compound SBP-101, a significant improvement versus standard therapy for patients with pancreatic cancer," said Dr. Simpson. "I’m excited to join the team and help the Company realize the full potential of SBP-101 for patients in an area of unmet medical need having this orphan disease."

"Dr. Simpson’s career spans oncology drug development from early clinical stage through commercialization, and her executive experience and oncology product clinical and commercial expertise will expedite the access of cancer patients to this potential advance in treatment," said Dr. Cullen. "I am delighted to be working with her."

Dr. Simpson has more than 25 years of experience across a variety of executive, business operations, marketing and clinical development roles in the biopharmaceutical industry. Prior to her appointment as CEO of Delcath Systems, Dr. Simpson served as its Executive Vice President, and Global Head of Business Operations. Previous to joining Delcath, Dr. Simpson held a variety of positions of increasing responsibility at ImClone Systems, Inc. and Johnson & Johnson OrthoBiotech. Earlier in her career, she spent over a decade as a hematology/oncology nurse practitioner and educator. Dr. Simpson holds a Ph.D. in Epidemiology from the University of Pittsburgh, an M.S. in Nursing from the University of Rochester, and a B.S. in Nursing from the State University of New York at Buffalo.

Sun BioPharma is developing SBP-101 for first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA) when administered in combination with gemcitabine and nab-paclitaxel. SBP-101 is currently being evaluated at sites in the United States and Australia in the expansion phase of a clinical trial for patients with previously untreated metastatic PDA. For more information, please visit View Source

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial.

On July 16, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or the "Company") reported the grant of patent no. 10,711,060 entitled "Antibody molecules to LAG-3 and uses thereof" by the United States Patent and Trade Mark Office (Press release, Immutep, JUL 16, 2020, View Source [SID1234561933]).

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This new United States patent is directed to embodiments of LAG525, a humanised form of Immutep’s IMP701 antibody which is out-licensed to Novartis AG. In particular, the patent is directed to nucleic acid molecules that code for the LAG525 antibody, to expression vectors and host cells that comprise these nucleic acids, and to methods of producing the LAG525 antibody by culturing the host cells of the invention.

The application was originally filed as a second divisional application and this grant follows the grant of the first divisional application, as announced in March 2018. The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 26 March 2035 (including a 13 day patent term adjustment).

About IMP701 and LAG525

IMP701 is a therapeutic antibody originally developed by Immutep S.A. (now Immutep S.A.S.) 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 do not 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’ PD1 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 July 16, 2020 Genmab A/S (Nasdaq: GMAB) reported that worldwide net sales of DARZALEX (daratumumab), including sales of the subcutaneous formulation, as reported by Johnson & Johnson were USD 901 million in the second quarter of 2020 (Press release, Genmab, JUL 16, 2020, View Source [SID1234561932]). Net trade sales were USD 492 million in the U.S. and USD 409 million in the rest of the world. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On July 16, 2020 Seventy-five organizations from around the world have endorsed the new Brain Tumour Patients’ Charter of Rights, a document intended to help initiate positive change in the care of people diagnosed with brain and central nervous system tumours (Press release, EORTC, JUL 16, 2020, View Source [SID1234561931]). The Charter provides a framework for the reduction of inequalities in care and the achievement of policy objectives aimed at improving healthcare systems and communications. It can also be used by individual patients to underpin particular aspects of their care. Ultimately, the goal of The Brain Tumour Patients’ Charter of Rights is to achieve the best possible health and quality of life for adults, children and adolescents living with brain tumors by encouraging and supporting quality standards, policies, and practices.

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"Patients have always been at the core of EORTC scientific strategy focusing on major public health needs in oncology. With rare tumours standing high on the scientific agenda, the standards of care in neuro-oncology has been a flagship programme at EORTC," said Dr Denis Lacombe, EORTC Director General. "This charter greatly contributes to the efficient implementation of therapeutic progress by giving patients important rights for access to research and state of the art care."

The Charter sets out the rights to which all brain tumour patients and caregivers should be entitled no matter where they live in the world.

"The Brain Tumour Patients’ Charter of Rights has worldwide relevance," said Kathy Oliver, Chair of the International Brain Tumour Alliance (IBTA) and one of the members of the Charter drafting group. "We’re excited that so many patient organizations and professional societies are supporting the Charter and we hope it will prompt productive discussion and debate and bring about positive change where necessary. The Charter is the result of a truly global collaborative process to help people who are diagnosed with this devastating disease, and those who care for them and treat them."

The Charter enumerates ten fundamental categories of "rights" for brain tumour patients that every country should strive to deliver:

Acknowledgment and Respect
Appropriate Investigation of Signs and Symptoms
A Clear, Comprehensive, Integrated Diagnosis
Appropriate Support
Excellent Treatment and High-Quality Follow-Up Care
The Care Relationship
Supportive/Palliative Care
Rehabilitation and Wellbeing
Medical Information and Privacy
Appropriate End-of-Life Options and Care
Within each category, specific policies, practices, and standards – a number of which will be aspirational in some countries – are defined.

The Brain Tumour Patients’ Charter of Rights was developed through a multi-stakeholder and iterative process and is a "living document", subject to annual review.

ABOUT BRAIN TUMOURS

There are over 100 histologically distinct types of primary brain and central nervous system (CNS) tumours, each with its own spectrum of clinical presentations, treatments, and outcomes. [1]
Brain and CNS tumours can affect anyone of any age – from very young babies, children and adolescents to young adults, older adults and the elderly.
Brain and CNS tumours are responsible for substantial symptoms, side effects and mortality worldwide.
The worldwide incidence rate of primary malignantbrain and other CNS tumours in 2018, age-adjusted using the world standard population, was 3.5 per 100,000. Incidence rates by sex were 3.9 per 100,000 in males and 3.1 per 100,000 in females. This represented an estimated 162,534 males and 134,317 females who were diagnosed worldwide with a primary malignant brain tumour in 2018, an overall total of 296,851 individuals. [2]
In the United States, brain tumours kill more children under 15 years than any other cancer. [1]
In 2016, malignant brain and CNS tumours were responsible for 227,000 deaths globally with an age-standardised death rate of 3.24 per 100,000 person-years. [3]
Central Brain Tumour Registry of the United States (CBTRUS) Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2012–2016, View Source
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A (2018). Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 68(6):394–424. View Source View Source.
The Lancet Neurology, https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(18)30468-X/fulltext

On July 15, 2020 Cancer Research UK reported that it has developed plans to become a leaner, more focused organisation following the devastating impact of COVID-19 on its fundraising income (Press release, Cancer Research UK, JUL 15, 2020, View Source [SID1234562078]). The charity is making difficult decisions to significantly reduce how much it spends on beating cancer, its operations and the number of staff following an anticipated £300 million decline in fundraising income over the next three years, but is more focussed than ever on staying at the forefront of the global fight against cancer.

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The charity plans to rebuild, adapting to the changed world and finding new opportunities, in order to continue to make an impact for people with cancer. There will be a continued focus on world-class research and shaping the UK’s science ecosystem, and a commitment to influencing and providing excellent information across cancer prevention, diagnosis and treatment.

Read more from Cancer Research UK’s chief executive Michelle Mitchell on plans to rebuild and adapt.
But due to the projected drop in income, of £160 million this year (30%) and £300 million over three years, the charity needs to make tough choices about where and how it spends its money. There will be a greater focus on investing strategically for the future, whilst contracting in other areas amidst continued financial uncertainty.

Regrettably, Cancer Research UK will have to stop some programmes of work, reduce the amount or scope of other activities, and will be reducing the size of its workforce by 500 roles (circa. 24%), not including trading. The recruitment freeze that was put in place as an early response to COVID-19 will reduce the impact on existing staff, but sadly the charity expects to make 295-345 redundancies (14-17%) not including trading, within six months.

The charity also recently announced unavoidable cuts to its life-saving research. It plans to introduce a new research model designed to maximise impact from a lower level of spend, and will reduce its research spend to £250 million within four to five years – a cut of £150m from what the charity had planned to spend. But Cancer Research UK is doing everything it can to find more financial support, and is calling on the Government to help find a solution to this funding gap. The transition to a new funding model will be phased carefully to minimise the impact on the research community and existing portfolio. The commitment to maximising research impact remains, and the charity will continue to back the best researchers around the world.

The plan also outlines how Cancer Research UK will be more focused than it has ever been – doing less, but maintaining the highest quality in its work. It will deepen relationships with its supporters, so that thanks to their generosity it can return to growth as quickly as possible. The charity will continue to invest in digital transformation, basing its approach on how supporters want to engage, and will reach out to philanthropic individuals and organisations around the world to support its work.

Michelle Mitchell, chief executive at Cancer Research UK said: "We’re living through a global crisis unlike any other and, as it’s unfolded, it’s become clear that there’ll be a huge economic impact for years to come. As the world’s leading cancer charity dedicated to saving lives through research, we must always focus on delivering our pioneering work into the prevention, diagnosis and treatment of cancer.

"We made some very difficult decisions early on to mitigate the impact on our work; we moved all of our staff to 80% pay, furloughed 60% of staff, and cut £44 million from our research. But it is with a heavy heart that I can confirm we will have to reduce the size of our workforce, and make significant cuts to our research spend, as a result of the situation we find ourselves in. With such a significant shortfall in income, we cannot afford to keep spending at the same levels. But that doesn’t make those decisions any easier. We’re keeping our dedicated, hard-working staff up to date on developments as we have them, and their professionalism throughout this period has been hugely appreciated.

"I am confident that through our world-leading research, information and influencing, we will continue to make transformative steps in the prevention, diagnosis and treatment of cancer. This plan sets the direction for a new phase in the life of Cancer Research UK and will help us respond to the changed world, quicker than we’ve ever done before. We will emerge a streamlined charity, but still with a resolute drive for impact. Together, we will still beat cancer and realise our ambition to improve cancer survival to 3 in 4 by 2034."

Cancer Research UK remains committed to ensuring at least 80p in every £1 raised is available to spend on beating cancer.