On October 20, 2020 Oasmia Pharmaceutical’s CEO, Dr Francois Martelet reported that it will present at the Bio Europe’s Digital conference October 26-29, 2020 and take part in partnering meetings (Press release, Oasmia, OCT 20, 2020, View Source [SID1234568672]). The presentation will be made available on demand on the Bio Europe Digital website and accessible to attendees registered for the event. The presentation will also be uploaded onto Oasmia’s website following the event.

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On October 20, 2020 Carina Biotech and UniSA reported they have developed a new device to improve cancer immunotherapies (Press release, Carina Biotech, OCT 20, 2020, View Source [SID1234568669]).

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Our researchers at the University of South Australia have developed a novel approach based on microfluidic technology to "purify" the immune cells of patients in the fight against cancer.

UniSA’s Future Industries Institute PhD student Mona Elsemary (pictured) has developed a microfluidic approach to purify chimeric antigen receptor (CAR-T) cells, the bioengineered immune cells that are the basis of groundbreaking cellular immunotherapy – a transformative cancer therapy that harnesses the power of a patient’s immune system to fight their cancer.

Ms Elsemary’s work is part of Carina Biotech’s CAR-T development platform, which aims to produce effective treatments for solid cancers. Ms Elsemary will present her work tomorrow at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference on Tumor Immunology and Immunotherapy.

"CAR-T therapy has produced some remarkable results against blood cancers and there is a huge international research effort underway to transform this success into producing CAR-T treatments for solid cancers," Ms Elsemary says.

"However, the CAR-T manufacturing process continues to be hindered by significant barriers and high costs – preventing the full potential of this life-saving therapy being reached."

Such problems include the presence of non-viable cells and debris in the formulation and the presence of cryoprotectants (e.g., dimethyl sulfoxide or DMSO), typically used for the freezing and storage of CAR-T cell products.

The presence of dead cells can cause potentially severe side effects in recipients, and the US Federal and Drug Administration (FDA) has set strict viability specifications for CAR-T products, with approximately 10% of patients not receiving their treatment due to failure in meeting them.

The presence of cryoprotectants in final CAR-T products can also cause severe allergic reactions and toxic side effects in some patients.

"Current commercial CAR-T cell products still contain significant amounts of DMSO," Ms Elsemere says. "Therefore, there is a significant need for a method that effectively purifies CAR T cells prior to infusion to patients."

The approach was developed by the University of South Australia team led by Prof Benjamin Thierry in collaboration with Assoc Prof Majid Warkiani at the University Technology Sydney, and could achieve, within 30 minutes, depletion of over 70% of dead cells in the CAR T products, leading to an average of 20% increase in cell viability.

In addition, over 90% of the cryoprotectant DSMO is removed – all with no detrimental effect on the quality and functionality of the cells.

Ms Elsemary’s research could greatly benefit patients by reducing both manufacturing cost and side-effects commonly associated to CAR T cell therapy.

On October 20, 2020 Kureha Corporation reported its earnings forecast for the first six months of the fiscal year ending March 31, 2021 (FY2020), reflecting the Company’s recent performance (Press release, Kureha Corporation, OCT 20, 2020, View Source [SID1234568668]).

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The Company also resolved at its Board of Directors’ meeting held today to distribute retained earnings to shareholders of record September 30, 2020 (interim dividend) in accordance with Article 40 of the Companies Act.

1. Earnings forecast for the first six months of FY2020 (April 1, 2020-September 30, 2020)

Kureha’s earnings forecast for FY2020 has been withheld due to uncertainties regarding the impact of the COVID-19 pandemic on the Company’s business operations. However, based on assumptions and expectations in the light of recently available information, the Company projected its half-year earnings as provided in this document.

For the first six months of FY2020, revenue is expected to decrease due mainly to slower sales in the Advanced Materials segment compared with the same period in the previous year. Operating profit is forecast to fall substantially on the back of decreased revenue and due to the absence of other income recorded in the previous year, including a discount business purchase gain of 1,460 million yen associated with new consolidation, despite a decrease in SG&A expenses.

A full-year earnings forecast (period April 2020 through March 2021) is not provided at this stage as the Company is still unable to make rational assessments regarding the full-year impact of the Covid-19 pandemic.

Cautionary note: Above forecasts are forward-looking in nature and based on assumptions and information available when this document was published. Actual results may differ due to unforeseeable risks and factors.

2. Distribution of retained earnings (interim dividend) Kureha’s Board of Directors has decided today to pay an interim dividend to shareholders of record September 30, 2020, as follows

[Dividend policy]
Kureha’s basic policy regarding dividend distribution is to pay a steady dividend to shareholders over a long period of time, while strengthening the Company’s financial structure to sustain long-term growth and future business development.

On October 20, 2020 AstraZeneca’s Tagrisso (osimertinib) reported that it has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent (Press release, AstraZeneca, OCT 20, 2020, View Source [SID1234568667]).

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While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.1-4

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2021.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Patients with early-stage EGFR-mutated lung cancer are still at considerable risk of recurrence after surgery and adjuvant chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients. This expedited review underscores the unprecedented disease-free survival benefit Tagrisso brings to patients in the adjuvant setting, and we will continue working with the FDA to provide this practice-changing treatment to patients as quickly as possible."

The sNDA was based on results from the ADAURA Phase III trial showing Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC, and also in the overall trial population of patients with Stage IB-IIIA disease, a key secondary endpoint.

In April 2020, an Independent Data Monitoring Committee recommended for the trial to be unblinded two years early, based on its determination of overwhelming efficacy. Investigators and patients continue to participate in the trial and remain blinded to treatment. The results from the ADAURA trial were presented during the plenary session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program in May 2020 and were recently published in The New England Journal of Medicine.

Tagrisso received Breakthrough Therapy Designation in this setting in July 2020. Tagrisso is approved for both the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the EU and many other countries around the world.

Lung cancer

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.5 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.6 The majority of all NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.1-3

For those with resectable tumours, the majority of patients eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.4 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.7-8

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.9-11 These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signalling pathways that drive the growth of tumour cells.12

ADAURA

ADAURA is a randomised, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumour resection and adjuvant chemotherapy as indicated. Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence.

The trial enrolled in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint is DFS in Stage II and IIIA patients and a key secondary endpoint is DFS in Stage IB, II and IIIA patients. The data readout was originally anticipated in 2022. The trial will continue to assess overall survival.

Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases. Tagrisso 40mg and 80mg once-daily oral tablets have received approval in the US, Japan, China, the EU and many countries around the world for 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC.

AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action.

AstraZeneca aims to address the unmet needs of patients with EGFRm tumours as a genetic driver of disease with the approved medicines Iressa (gefitinib) and Tagrisso and its ongoing LAURA, NeoADAURA and FLAURA2 Phase III trials.

AstraZeneca is committed to addressing tumour mechanisms of resistance through the ongoing SAVANNAH and ORCHARD Phase II trials, which test Tagrisso in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines.

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 seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics and Cell Therapies – 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.

On October 20, 2020 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported a business update and financial highlights for Q3 2020 for Nicox SA and its subsidiaries (the "Nicox Group"), as well as an update on key expected milestones (Press release, NicOx, OCT 20, 2020, View Source [SID1234568666]).

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Key Expected Upcoming Milestones
NCX 470 Mont Blanc Phase 3 clinical trial: Top-line results from Mont Blanc, the first Phase 3 trial of NCX 470 for lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension are currently expected in Q4 2021. Mont Blanc is a 3-month safety and efficacy evaluation of NCX 470 ophthalmic solution, 0.1%, against latanoprost ophthalmic solution, 0.005%.
NCX 470 Denali Phase 3 clinical trial: The second Phase 3 trial in glaucoma, Denali, which is funded equally by Nicox and our Chinese partner Ocumension, is expected to start by the end of 2020 and will evaluate NCX 470 ophthalmic solution, 0.1%, versus latanoprost ophthalmic solution, 0.005%. The Denali trial will include clinical sites in both the U.S. and China, with the large majority of the patients to be recruited in the U.S. The Denali trial was designed to fulfill the regulatory requirements to support New Drug Application (NDA) filings in the U.S. and China.
NCX 4251 Mississippi Phase 2 clinical trial: A Phase 2 trial, Mississippi, for the treatment of acute exacerbations of blepharitis is targeted to be initiated in December 2020. This trial will include primary and secondary efficacy endpoints for blepharitis and dry eye disease respectively. Top-line results are currently expected in Q4 2021. If successful in meeting the primary endpoint for blepharitis previously agreed upon with the U.S. Food and Drug Administration (FDA), the trial could represent the first of two pivotal trials needed to support an NDA in the U.S.
ZERVIATETM China: A Phase 3 clinical trial intended to support an application for regulatory approval in China is expected to start by the end of 2020, conducted and financed by our partner Ocumension.
Nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors for IOP lowering: IND-track candidate expected to be announced shortly.
We continue to closely watch the spread and impact of the COVID-19 pandemic. We do not currently anticipate delays in our clinical timelines but we are monitoring the situation and will provide an update when needed.

Third Quarter 2020 and Recent Operational Highlights
The 0.1% dose of NCX 470 was selected in the adaptive design portion of the Mont Blanc Phase 3 clinical trial. This dose continues in the second part of Mont Blanc, a multi-regional, double-masked, 3-month, parallel group trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.1%, compared to latanoprost ophthalmic solution, 0.005%, in patients with open-angle glaucoma or ocular hypertension. The 0.1% dose will also be used in the Denali trial, the second Phase 3 glaucoma trial of NCX 470.
Nicox’s partner, Ocumension Therapeutics, received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out Phase 3 clinical trials with ZERVIATETM (ophthalmic solution of cetirizine), 0.24% for the treatment of ocular itching associated with allergic conjunctivitis, paving the way for a Chinese Phase 3 trial, expected to start in Q4 2020.
The total number of prescriptions1 for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, in the U.S. in the third quarter of 2020 increased by 45% compared to the third quarter of 2019 and by 17% compared to the second quarter of 2020. VYZULTA has also been approved in Ukraine, bringing the total number of countries or territories where VYZULTA is approved to market to seven.
ZERVIATETM (cetirizine ophthalmic solution), 0.24%, U.S. prescriptions2 in Q3 2020 increased by 176% over Q2 2020, which had been the first full quarter of sales following launch in the U.S. in March 2020.
We entered into an exclusive agreement with ITROM Pharmaceutical Group for the registration and commercialization of ZERVIATETM for the treatment of ocular itching associated with allergic conjunctivitis in Gulf and Arab markets.
Our partner Fera has informed us that the application with the U.S. FDA for an Orphan Drug Designation (ODD) for naproxcinod in sickle-cell disease has been refused but that Fera is reviewing how to respond to the points raised by the FDA and is also considering alternative indications for the development of naproxcinod.
Third Quarter 2020 Financial Highlights
As of September 30, 2020, the Nicox Group had cash and cash equivalents of €42.2 million as compared with €28.0 million at December 31, 2019 and €45.5 million at June 30, 2020 (including €5 million from the divestment of our VISUfarma shareholding in July). Net revenue3 for the third quarter of 2020 was €0.8 million (consisting of ZERVIATE and VYZULTA royalties and upfront payments from ITROM), compared to €0.5 million (consisting entirely of royalty payments) for the third quarter of 2019.

As of September 30, 2020, the Nicox Group had financial debt of €19.2 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2 million credit agreement, granted by Société Générale and LCL and guaranteed by the French State, granted in August 2020 in the context of the COVID-19 pandemic.

Only the figure related to the cash position of the Nicox Group as of December 31, 2019 is audited; all other figures of this press release are non-audited.