On September 12, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its consolidated financial results for the first six months of 2019 (Press release, Innate Pharma, SEP 12, 2019, View Source [SID1234539489]). The financial statements are attached to this press release.

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"As Innate Pharma celebrates our 20th anniversary this month, we are proud to acknowledge our employees, patients, physicians, and other stakeholders who support our ambition to develop new oncology therapies for patients with high unmet medical need. We continue to deepen and mature our proprietary and partnered pipeline of assets to strengthen our broad and balanced portfolio," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We are committed to continuing to invest and execute on our corporate, clinical and commercial strategy, which has recently been strengthened by the recruitment of new executive leadership. This will support our international expansion and execute on our long-term strategy to become a rare hemato-oncology focused commercial franchise."

Webcast and conference call will be held today at 2:00pm (CEST)

Dial in numbers:

France and International: +33 (0)1 76 70 07 94 US only: +1 631 510 7495

PIN code: 5173329#

The Interim financial report, the presentation and access to the live webcast will be available on Innate Pharma’s website 30 minutes ahead of the conference.

A replay will be available on Innate Pharma’s website after the conference call.

Financial highlights of the first half of 2019:

The key elements of Innate Pharma’s financial position and financial results as of and for the six-month period ended June 30, 2019 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €200.3m** as of June 30, 2019 (€202.7m as of December 31, 2018), including non-current financial instruments amounting to €35.3m (€35.2m as of December 31, 2018). This follows receipt in January of €108.8m as the second and final payment associated with the signature of the agreement signed with AstraZeneca in October 2018, as well as the payment of $50m (or €43.8m) to AstraZeneca in relation to Lumoxiti agreement and additional considerations relating to monalizumab and anti-CD39, paid to Novo Nordisk A/S and Orega Biotech, for $15m (or €13.1m) and €7.0m, respectively.
As of June 30, 2019, financial liabilities amounted to €5.0m compared to €4.5m as of December 31, 2018.
Revenue and other income of €59.2m for the six-month period ended June 30, 2019, as compared to €23.0m for the first half of 2018, restated, of which €51.6m result from revenue from collaboration and licensing agreements and €7.6m from research tax credit.

Revenue from collaboration and licensing agreements mainly result from to the spreading of the upfront payment from the agreements signed with AstraZeneca in April 2015 and October 2018, based on the completion of the work the Company is engaged to perform (€24.3m for monalizumab and €22.5m for IPH5201).
Operating expenses of €45.9m compared to €37.9m for the first half of 2018, restated, of which 80% are related to research and development (R&D).
R&D expenses increased by €4.3m to €36.6m for the six month period ended June 30, 2019, as compared to €32.3m for the first half of 2018. This increase mainly results from an increase of €4.2m in amortization of intangible assets.
General and administrative (G&A) expenses increased by €3.7m to €9.3m for the six-month period ended June 30, 2019 as compared to €5.6m for the first half of 2018. This increase mainly results from the increase in non-scientific advisory expenses relating to fees incurred in connection with a potential capital raising activity.
A net loss of €3.8m resulted from distribution agreement in the context of the the launch of Lumoxiti in the US performed by AstraZeneca.
Net income for the first half of 2019 was €13.2m compared to a net loss of €15.1m for the first half of 2018 restated.

On September 12, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancer, reported its support for Childhood Cancer Awareness Month, designated as the month of September (Press release, Flex Pharma, SEP 12, 2019, View Source [SID1234539488]). Recognizing the work underway by the National Pediatric Cancer Foundation and the many other organizations, foundations and associations around the world to raise awareness of childhood cancers, Salarius joins with these groups in exploring targeted treatments for children and their families seeking new therapeutic options.

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According to data from the U.S. Centers for Disease Control and Prevention, approximately 15,000 U.S. children and adolescents younger than 20 years will receive a cancer diagnosis each year. In the past 40 years, less than 10 drugs have been developed for use in children with cancer, a number that pales in comparison to the hundreds developed for adult cancers. Despite improvements in overall survival rates, survival rates for some types of childhood cancer remain discouragingly low, and some childhood and adolescent cancer survivors often face long-term complications, including heart disease, infertility or secondary cancers related to their treatment.

Salarius is developing Seclidemstat, a differentiated reversible inhibitor of the widely studied epigenetic enzyme lysine-specific demethylase 1 (LSD1), as a treatment for Ewing sarcoma, a rare, devastating and deadly pediatric bone and soft-tissue cancer for which there are no targeted therapies currently available. For these children, the standard of care is adult chemotherapy, radiation and often disfiguring surgeries.

Seclidemstat has received Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration. It is now in a Phase 1 clinical trial for Ewing sarcoma, and a second Phase 1 study for patients with advanced solid tumors resistant to standard-of-care therapies.

David Arthur, Chief Executive Officer of Salarius, stated, "There are 400 to 500 children diagnosed with Ewing sarcoma every year in the U.S., and the average age of diagnosis is about 15. These are children and young adults with their whole lives ahead of them. But figures show that roughly 40% to 45% either do not respond or relapse from the standard of care. With those patients, there is approximately an 80% five-year mortality rate. We are developing Seclidemstat to address this high-need pediatric cancer population and, in doing so, potentially offer hope for these children and their families."

Mr. Arthur added, "Our Phase 1 clinical trial of Seclidemstat in the Ewing sarcoma program is currently in the dose escalation phase, and we expect to establish the maximum tolerable dose in early-2020. We then expect to commence dose expansion with the potential for reporting early cohort data later in 2020."

About Seclidemstat

Seclidemstat (also known as SP-2577) is an investigational agent currently being evaluated in clinical trials. It is a small molecule in development by Salarius Pharmaceuticals, Inc. which inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme involved in regulating gene expression. LSD1 is often overexpressed in cancers and can promote disease progression. In certain cancers, higher levels of LSD1 are associated with poor patient prognosis. Seclidemstat has been shown to inhibit LSD1’s demethylation and scaffolding properties and has demonstrated potent therapeutic activity in preclinical models of Ewing sarcoma, a rare pediatric/adolescent bone and soft-tissue cancer.

On September 12, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported positive data from the Phase III IMpower110 study evaluating Tecentriq (atezolizumab) as a first-line (initial) monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (Wild-Type or WT) (Press release, Hoffmann-La Roche, SEP 12, 2019, View Source [SID1234539486]). The study met its primary endpoint in an interim analysis showing that Tecentriq monotherapy demonstrated a statistically significant overall survival (OS) benefit in people with high PD-L1 expression (TC3/IC3-WT), compared with chemotherapy alone. Safety for Tecentriq appeared to be consistent with its known safety profile and no new safety signals were identified. The study will continue to final analysis for patients with lower levels of PD-L1 expression.

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"We are encouraged that Tecentriq monotherapy has shown a significant survival benefit over chemotherapy as an initial treatment in people with squamous or non-squamous non-small cell lung cancer with high PD-L1 expression," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "These findings reinforce the potential of Tecentriq to play an important role in the treatment of multiple forms of lung cancer, and we look forward to discussing these data with health authorities."

Roche will now submit these data to global health authorities, including the FDA and EMA, and will discuss how best to bring this option to patients as quickly as possible. These data will be presented at an upcoming medical congress.

Currently, Roche has nine Phase III lung cancer studies underway evaluating Tecentriq as a monotherapy or in combination with other medicines across different types of lung cancer. Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower110 study
IMpower110 is a Phase III, randomised, open-label study to evaluate the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations (Wild-Type or WT).

A total of 572 people (555 WT) were enrolled and were randomised 1:1 to receive:

Tecentriq monotherapy, until loss of clinical benefit (as assessed by the investigator) or
Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint is OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).

About NSCLC
Lung cancer is the leading cause of cancer death globally.1 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.1 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.2 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.2

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy (CIT) that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On September 12, 2019 Celgene Corporation (NASDAQ: CELG) reported top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001 (Press release, Celgene, SEP 12, 2019, View Source [SID1234539485]). The study evaluated the efficacy and safety of investigational therapy CC-486 as maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) who achieved first complete response (CR) or complete response with incomplete blood count recovery (CRi) with induction chemotherapy (with or without consolidation). The study demonstrated that maintenance treatment with CC-486 resulted in a highly statistically significant and clinically meaningful improvement in overall survival compared to placebo. The key secondary endpoint of relapse-free survival (RFS) also showed a statistically significant improvement.

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CC-486 was well-tolerated and there were no unexpected safety events in QUAZAR AML-001. This phase 3 study enrolled 472 patients, randomized 1:1 to receive either oral CC-486 300mg or placebo once daily for 14 days of a 28-day cycle plus best supportive care until disease relapse.

"AML remains a deadly blood cancer where most patients are not curable and less than 30% of patients survive five years1," said Jay Backstrom, M.D., M.P.H., Chief Medical Officer for Celgene. "The CC-486 QUAZAR AML-001 study is the first phase 3 trial to demonstrate that the addition of maintenance therapy has the potential to extend overall survival in a broad population of patients with newly diagnosed AML who have achieved remission with induction chemotherapy."

Data from QUAZAR AML-001 will be submitted to a future medical meeting. Celgene also plans regulatory submissions for CC-486 beginning in the first half of 2020.

CC-486 is an investigational compound and not approved for any use in any geography.

About QUAZAR AML-001

Phase 3, randomized, double-blind, placebo-controlled study of CC-486 as AML maintenance therapy in patients who achieved first CR or complete response with incomplete blood count recovery (CRi) with induction chemotherapy (with or without consolidation) The primary endpoint of the study was overall survival. Key secondary endpoints included relapse-free survival (RFS), safety and tolerability, healthcare resource utilization and patient-reported outcomes per the FACIT-Fatigue Scale and EQ-5D questionnaire. The study enrolled 472 patients, randomized 1:1 to receive either oral CC-486 300mg or placebo once daily for 14 days of a 28-day cycle plus best supportive care until disease progression.

About CC-486

CC-486 is a cytidine nucleoside analogue and incorporates into DNA and RNA. The main mechanism of action is thought to cause DNA hypomethylation and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The antineoplastic effect of CC-486 is hypothesized to cause death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanism.

About AML

Acute myeloid leukemia (AML) is a type of cancer in which the bone marrow makes abnormal blast cells that are supposed to grow into different types of blood cells. It may present in multiple subtypes based on the maturity of the cancer cells at diagnosis.2 There will be an estimated 21,450 new cases of AML in the United States this year, accounting for 1.2% of all cancer cases, with an estimated 10,920 deaths resulting from the disease. There are an estimated 61,048 people living with AML in the United States.3

On September 12, 2019 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the start of recruitment of newly diagnosed brain cancer patients in a Phase 1/2 clinical trial combining the CXCL12 inhibitor NOX-A12 with radiotherapy (Press release, NOXXON, SEP 12, 2019, View Source [SID1234539484]). NOX-A12 is thought to inhibit the influx of "repair cells" from the bone marrow to the tumor, an unwanted consequence of radiotherapy that leads to a replacement of the destroyed blood vessels within the tumor which ultimately results in a recurrence of the disease.

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The safety and first efficacy data obtained in this study will support the definition of a Recommended Phase 2 Dose (RP2D) for this new treatment approach to guide further clinical developments. The non-invasive assessment of the changes in tumor vascularization by MRI is expected to confirm the predicted mechanism mode of action for the inhibition of CXCL12 in combination with radiotherapy.

"NOX-A12 combined with radiotherapy is a novel and promising approach with the potential to effectively treat brain cancer patients for which there are currently no optimal therapies. The demand from the clinical community to test this combination has been very strong and we are pleased to initiate this trial. We expect data from the first cohort of patients to be available in mid-2020," said Jarl-Ulf Jungnelius, Chief Medical Officer of NOXXON.

The trial will be conducted at three hospitals in Germany. Up to three escalating doses of NOX-A12 will be administered in combination with standard radiotherapy to newly diagnosed patients with brain tumors who would not benefit from the current standard of care of chemoradiotherapy and whose tumors cannot be fully resected by surgery. The main objective of the study is to assess the safety and tolerability of this combination. Secondary endpoints include activity of the therapy, assessed through the monitoring of tumor vascularization by MRI scans, progression-free survival, overall survival and rates of response.

CEO of NOXXON, Aram Mangasarian, will host a webinar on September 23, 2019 at 03.00 p.m. CEST, and will be joined by Dr. Frank Giordano, Vice Chairman of Radiation Oncology Department at University Medical Centre Mannheim for the presentation and Q&A session. To join the webinar, please send an email to [email protected].