On December 19, 2017 Saniona, a leading biotech company in the field of ion channels, reported that its spin-out company, Scandion Oncology, has raised DKK 2 million in a private placement. Scandion intends to use the proceeds to develop its lead compound, SCO-101, for the treatment of chemotherapy resistant cancer and to mature the company for a potential public listing (Press release, Scandion Oncology, DEC 19, 2017, View Source;lang=en-GB&companycode=s-sanion&v= [SID1234522693]).

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Scandion Oncology raised DKK 2 million from a group of investors including member of the management and board of directors. The company expects to raise additional financing during spring 2018 either through an additional private placement or a public listing. Saniona owns 47.3% of Scandion Oncology following this initial financing round. The founders, management and the other shareholders of Scandion Oncology are independent of Saniona’s board, management and major shareholders of Saniona.

"Our clinical candidate SCO-101 represents a first-in-class treatment for chemotherapy resistant cancer, which is one of the most important challenges in modern oncology. With the successful closing of this private placement, we can now initiate the development of SCO-101 and prepare for the Phase 2a study in chemotherapy resistant cancer. In parallel, we are preparing for our next financing round and are diligently working to mature the company for a potential public listing," said Kim Arvid Nielsen, CEO of Scandion Oncology.

Jørgen Drejer, CEO of Saniona, added, "I am very pleased with the progress in our spin-out, Scandion Oncology. We believe that Scandion Oncology’s development of innovative therapies for chemotherapy resistant cancers will benefit not only cancer patients but also Saniona’s shareholders. Scandion Oncology has established the company within its own facilities and appointed an independent board of directors. Furthermore, the company has acquired a complementary asset from a third party and entered into a collaboration with Cambrex for the manufacture of GMP material for SCO-101."

Scandion Oncology was founded in May 2017 and subsequently acquired Saniona’s clinical candidate, SCO-101, which has been evaluated in Phase 1 studies for another indication. In 2015 Saniona granted scientists at the University of Copenhagen, Denmark rights to test SCO-101 and related compounds in their screening systems. This led to the discovery that certain compounds displayed the potential to overcome chemotherapy resistance by restoring the sensitivity of cancer cells toward standard chemotherapy. The parties filed a patent and formed Scandion Oncology for further development and commercialisation of this discovery. In addition to SCO-101, Scandion acquired a platform comprised of a large series of chemical analogues and associated knowledge.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: [email protected]

Kim Arvid Nielsen, CEO, Scandion Oncology, Mobile: +45 2143 1017, E-mail: [email protected]

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 09:45 CET on December 19, 2017.

ON December 19, 2017 Tanvex rported that its recently completed pharmacokinetics (PK) study of the company’s biosimilar product candidate, TX16, showed favorable results supporting PK similarity of TX16 and the reference product, US-licensed Avastin (Press release, Tanvex BioPharma, DEC 19, 2017, View Source [SID1234524595]). In a prospective, single dose, double blinded, parallel group study conducted in 69 healthy adult male subjects, the test to reference ratio of geometric least squares (LS) mean and corresponding 90% confidence interval (CI) for the primary endpoint, AUC 0-∝, were within the acceptance range of 80.00 to 125.00%. In addition the test to reference ratios of geometric LS means and corresponding 90% CIs of the other PK endpoints, AUC 0-t and C max, were also within the acceptance range of 80.00% to 125.00% demonstrating similar peak concentrations and extent of exposure between TX16 and Avastin.

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Overall, both TX16 and Avastin were generally safe and well tolerated by the study subjects, with mild to moderate treatment-emergent adverse events and no severe or serious adverse events reported.

Avastin (bevacizumab) is a vascular endothelial growth factor-specific angiogenesis inhibitor approved in the US for the treatment of multiple indications in combination with other agents, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

According to IMS data, US sales of Avastin were US$3.1 billion in 2016.

On December 19, 2017 Aviragen Therapeutics Inc. and Vaxart, Inc. presented Investor Presentation (Presentation, Nabi Biopharmaceuticals, DEC 19, 2017, View Source [SID1234522710]).

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On December 19, 2017 Array BioPharma (Nasdaq: ARRY) reported that it has entered into a clinical trial collaboration agreement with Pfizer to investigate the safety and efficacy of several novel anti-cancer combinations, including Array’s MEK inhibitor, binimetinib, with Pfizer’s investigational PARP inhibitor talazoparib, and avelumab*, a human anti-PD-L1 IgG1 monoclonal antibody (Press release, Array BioPharma, DEC 19, 2017, View Source;p=RssLanding&cat=news&id=2323331 [SID1234522694]).

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The companies are entering into this collaboration to explore the potential benefits of combining molecularly targeted therapeutics with the body’s innate cancer-fighting abilities using immunotherapy.

"Array is excited to announce this partnership with Pfizer, an established global leader in Oncology therapeutics," said Ron Squarer, Chief Executive Officer, Array BioPharma. "These novel approaches combining targeted therapy and immunotherapy hold great potential to help patients fighting cancer in different indications, with an initial main focus on lung and pancreatic cancer."

"Preclinical data indicate that combining binimetinib with an immune checkpoint inhibitor and talazoparib could be a rational combination to test in the clinic," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "We are looking forward to initiating the clinical studies with Array BioPharma to explore anti-tumor activity across various novel combination strategies, including both doublet and triplet approaches."

Under the terms of the agreement, Array and Pfizer will collaborate on a Phase 1b clinical trial to explore a series of novel combinations, investigating the safety and efficacy of the combination of binimetinib, avelumab and talazoparib across various tumor types. A multi-arm clinical trial is expected to establish recommended doses of different regimens combining the drugs. Initially the focus will be in non-small cell lung cancer (NSCLC) and pancreatic cancer, and additional indications will be explored at a later stage. The study is expected to begin by the third quarter of 2018, and results will be used to determine optimal approaches to further clinical development of these combinations.

Under the collaboration agreement, the trial will be sponsored and funded by Pfizer, with Array providing binimetinib supply.

*Avelumab is jointly developed by Merck KGaA, Darmstadt, Germany and Pfizer. Avelumab is under clinical investigation for treatment of NSCLC and pancreatic cancer and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for these indications by any health authority worldwide.

About Binimetinib
MEK is a key protein kinase in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage, small molecule MEK inhibitor which targets key enzymes in this pathway. Binimetinib is an investigational medicine and is not currently approved in any country.

Binimetinib is being studied in clinical trials in advanced cancer patients, including the Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma and the Phase 3 BEACON CRC trial in patients with BRAF V600E-mutant colorectal cancer.

About Avelumab
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including nine Phase III trials, and more than 7,000 patients across more than 15 different tumor types, including gastric/gastroesophageal junction, non-small cell lung cancer, renal cell carcinoma and ovarian cancer. For a comprehensive list of all avelumab trials, please visit clinicaltrials.gov.

Indications in the US
The FDA granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information from the US FDA Approved Label
The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com.

About Talazoparib
Talazoparib is an investigational anti-cancer compound called a PARP (poly ADP ribose polymerase) inhibitor. Preclinical studies suggest that talazoparib is highly potent and has a dual mechanism of action, with the potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on the sites of DNA damage. Talazoparib is currently being evaluated in advanced germline (inherited) BRCA+ breast cancer as well as other cancer types with deficiencies in DNA damage repair (DDR). Talazoparib has not been approved by any regulatory authorities for the treatment of any disease.

On December 18, 2017 AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations) (Press release, AstraZeneca, DEC 18, 2017, View Source [SID1234522687]). The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.

The submission acceptance is based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.

On 28 September 2017, the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of Tagrisso in the 1st-line treatment of patients with metastatic EGFRm NSCLC. The use of Tagrisso in this indication is not yet approved by the FDA.

About NSCLC

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-quarter of all cancer deaths, more than breast, prostate and colorectal cancers combined. Approximately 10-15% of patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. These patients are particularly sensitive to treatment with currently-available EGFR-TKIs, which block the cell-signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to EGFR-TKI treatment leading to disease progression. Approximately half of patients develop resistance to approved EGFR-TKIs such as gefitinib and erlotinib due to the resistance mutation, EGFR T790M.Tagrisso also targets this secondary mutation that leads to disease progression. There is also a need for medicines with improved CNS efficacy, since approximately 25% of patients with EGFR-mutated NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.

About Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have been approved in more than 60 countries, including the US, EU, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being investigated in the adjuvant setting and in combination with other treatments.

About the FLAURA trial

The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg once daily vs standard-of-care EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC. The trial was a double-blinded, randomised trial, with 556 patients across 29 countries.

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing medicines to help every patient with lung cancer. We have two approved medicines and a growing pipeline that targets genetic changes in tumour cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

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