On September 2, 2019 Benelux’ largest biotech investor Aat van Herk commits a €20 million investment in diagnostics company SkylineDx after reaching major milestones in 2018, financing SkylineDx’ market potential of over $1 billion annually based on their current progress in the melanoma (skin cancer) field (Press release, SkylineDx, SEP 2, 2019, View Source [SID1234539178]). This melanoma test is discovered by a renowned US hospital and further optimized and developed by SkylineDx. Based on the unique combination of genetic information from the primary melanoma cells and other patient and tumor characteristics, the test is able to accurately predict the risk of having metastases present in the lymph nodes without having to undergo a surgery to remove (part of the) lymph nodes. Expert physicians estimate that up to 80% of these biopsies could be safely avoided as they turn out to have no sign of cancerous cells.

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"This capital commitment is a very significant call of confidence," says Dharminder Chahal, CEO SkylineDx. "With the financial requirements secured and Professor Alexander Eggermont on board as our medical advisor, we can initiate the necessary clinical studies in collaboration with expert physicians, patient associations and other stakeholders, in order to get this test from bench to bedside and reimbursed."

Professor Alexander Eggermont is the general director of cancer center Gustave Roussy in Paris and a highly respected expert physician in the melanoma space.

"It is a great feeling that our efforts are lining up, getting our dream – to improve a patient’s quality of life by enabling them to benefit from personal insights at the genetic level of their disease – within reach," concludes Dharminder Chahal.

On September 1, 2019 Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, and CHEPLAPHARM Arzneimittel GmbH (‘CHEPLAPHARM’), the family-owned pharmaceutical company based in Germany, have signed an exclusive distribution agreement for chemotherapy products Etopophos and Vepesid in Australia and New Zealand (Press release, Clinigen Healthcare, SEP 1, 2019, View Source [SID1234539174]).

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CHEPLAPHARM acquired the global rights to the products from Bristol-Myers Squibb (BMS) in August 2018. CHEPLAPHARM has global capabilities in manufacturing and distribution and will continue to supply and provide access to these medicines for patients. Clinigen has been appointed by CHEPLAPHARM to distribute Etopophos and Vepesid via the Group’s extensive infrastructure in Australia and New Zealand as part of CHEPLAPHARM’S network of exclusive cooperation partners.

Etopophos and Vepesid are etoposide products, a drug which is included on the World Health Organization Model List of Essential Medicines and is considered an essential medicine for priority diseases. Etopophos and Vepesid are currently approved for the treatment of:

Small Cell Lung Cancer – in combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer
Hodgkin’s Disease
Malignant (non-Hodgkin’s) lymphomas, especially of the histiocytic variety
Acute non-lymphocytic leukaemia
Testicular tumours in combination regimens for the treatment of refractory testicular tumours
Etopophos is also indicated as part of first-line combination regimens for the treatment of testicular tumours.

Benjamin Miny, Senior Vice President of Commercial Medicines, Clinigen Group, said:

"This agreement is in line with our in-licensing strategy in Commercial Medicines to focus on value-added oncology products and to partner with pharmaceutical companies to distribute and provide access to their products utilising our global infrastructure.

"CHEPLAPHARM is an important partner in Australia and New Zealand and these products are a fantastic fit for our portfolio. The agreement will provide healthcare professionals in the region with access to important treatments for their patients."

On August 30, 2019 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) reported that the company will present at the Baird 2019 Global Healthcare Conference on Wednesday, September 4, 2019 at 8:30 a.m. Eastern Time at the InterContinental New York Barclay Hotel (Press release, Idera Pharmaceuticals, AUG 30, 2019, View Source [SID1234539151]).

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A live audio webcast of Idera’s presentation will be accessible in the Investors and Media section of Idera’s website at View Source An archived version will also be available on the company’s website after the event for 90 days.

On August 30, 2019 CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company reported the United States Food and Drug Administration (FDA) has granted orphan drug designation to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of multiple myeloma (Press release, Carsgen Therapeutics, AUG 30, 2019, View Source [SID1234539153]).

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"FDA orphan designation is an important regulatory milestone in the continued development and commercialization of CT053 anti-BCMA CAR-T cells," said Dr. Zonghai Li, Founder, CEO and CSO of CARsgen. "CT053 has demonstrated outstanding potency in an exploratory phase 1 clinical study in China. A total of 19 of 24 patients with relapsed and refractory multiple myeloma showed complete response. And importantly, no event of grade 3 or higher cytokine release syndrome (CRS) was observed." The CT053 anti-BCMA CAR-T program has received Investigational New Drug (IND) clearance from the US FDA.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to pharmaceutical products which are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the CT053 anti-BCMA product would be eligible for certain benefits including seven years of market exclusivity in the United States following marketing approval by the FDA.

On August 30, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference and invited investors to participate by webcast (Press release, Exact Sciences, AUG 30, 2019, View Source [SID1234539154]).

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Baird Healthcare Conference, New York
Fireside Chat on September 4, 2019, at 12:50 p.m. EDT
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.