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Oasmia launches the ovarian cancer treatment drug Apealea® in Sweden, Denmark and Finland

On January 20, 2020 Oasmia Pharmaceutical AB reported is launching its product, Apealea 60 mg, in Sweden, Denmark and Finland (Press release, Oasmia, JAN 20, 2020, View Source [SID1234556565]). The first batch of the drug has been shipped to distributors in these countries.

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Apealea is a patented, water-soluble, intravenously injectable formulation of paclitaxel, developed using Oasmia’s proprietary technology platform – XR17 – which facilitates the solubility of paclitaxel. Paclitaxel is a chemotherapy medication used to treat a number of types of cancers. Apealea has been authorized for marketing by the European Commission. Apealea in combination with Carboplatin is approved for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

"The launch of Apealea in the Nordic countries enables therapeutic potential for patients in need of innovative cancer treatment. This is an important milestone for Oasmia in its transition towards becoming a fully integrated pharmaceutical company. As a second step, we intend to continue our efforts of engaging strategic partners for Apealea in other territories", comments Sven Rohmann, acting CEO of Oasmia.

"Oasmia has fulfilled all the regulatory requirements required for launch of the drug in the EU. The next intended step for us is to prepare for the submission for a regulatory approval from the United States Food and Drug Administration to obtain access to the U.S. market", says Nina Heldring, Chief Medical Officer at Oasmia.

Oasmia will participate as official sponsor of the 41st EORTC-PAMM Winter Meeting in Stockholm between February 13th – 15th 2020. The Winter Meeting is organized under the umbrella of the European Organization for Treatment of Cancer (EORTC) intended to provide opportunities for interdisciplinary and international exchange of knowledge on optimizing cancer treatment.

Applied Cells Announces Evaluation of Its New MARS Platform at The University of Pennsylvania

On January 20, 2020 University of Pennsylvania (Penn) and Applied Cells Inc., a Santa Clara, California based biotechnology company, reported that they have entered into a Collaborative Research Agreement to evaluate Applied Cells new generation cell isolation and sample preparation system, "MARS", in cancer and immunology research at Penn (Press release, University of Pennsylvania, JAN 20, 2020, View Source [SID1234553351]).

Applied Cells proprietary innovative MARS platform, short named after "Multi-physics Automated Reconfigurable Separation", is ideal for high-throughput, high-efficiency, high-recovery, automated cell separation and sample preparation. Modular design of MARS allows flexible configurations to meet versatile workflows for rare cell analysis, immune cell profiling, and cell therapy, with capabilities including target cell enrichment, cell purification, and cell concentration.

"We are excited by the opportunity to evaluate the MARS instrument from Applied Cells, as if we are successful, it will allow us to identify rare populations for diagnostic markers and potentially isolate new cellular therapeutics," said Jonni Moore, PhD, Professor of Pathology and Laboratory Medicine at the Hospital of the University of Pennsylvania. "Applied Cells MARS system could be a powerful companion to our cell isolation and identification technologies, and we are very excited by this prospect."

"Applied Cells is bringing benefit to our customers by enabling successful isolation of target cells from complex blood and tissue samples for broad downstream analysis platforms," said Yuchen Zhou, Founder and CEO of Applied Cells. "Teaming up with Penn, a world leader in medical research and modern medicine, enables us to bring our leading-edge products into the hands of researchers at the forefront of advanced medicine discoveries, and help them achieve their goals more quickly and bring greater value to our society as whole."

Transcenta Announces Acceptance by NMPA of IND Application of a Novel Humanized Claudin 18.2 Monoclonal Antibody

On January 20, 2020 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, R&D and manufacturing of antibody-based therapeutics, reported that an investigational new drug (IND) application of its humanized Claudin 18.2 (CLDN18.2) monoclonal antibody (also known as TST001 internally) for the treatment of solid tumors submitted by its Suzhou subsidiary Mabspace Biosciences has been accepted by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China (Press release, Transcenta, JAN 20, 2020, View Source [SID1234553350]). The IND enabling CMC work was done in its Hangzhou subsidiary HJB. TST001 is the first program developed by Transcenta since merger and it took less than 12 months from the identification of preclinical candidate to IND filing.

TST001 is a humanized mAb targeting CLDN18.2, which is strictly expressed by the differentiated epithelial cells of the gastric mucosa in normal tissues and typically overexpressed in gastroesophageal cancer, pancreatic cancer, and other solid tumors. TST001 mainly kills tumor cells by antibody-dependent cellular cytotoxicity (ADCC). TST001 displayed significantly higher binding affinity to CLDN18.2 relative to a competitor molecule, lower fucose content, binds to a different binding epitope, which resulted in over 100-fold improved ADCC activity in tumor cells with varying CLDN18.2 expression, especially in CLDN18.2 low expressing tumors.

"We are very glad to be able to file the first IND at the anniversary of our merger. The advantage with an integrated platform is fully reflected in this program. TST001 provides us an important opportunity to target not only first line gastric cancer with Claudin18.2 expression, which are highly prevalent in Asia, but also several other globally prevalent tumor types with CLDN18.2 expression. These tumors, usually neither PDL1 positive nor responsive to checkpoint inhibitors, are an area of significant unmet medical needs. The development of TST001 will be guided by a novel companion diagnostic antibody developed by Transcenta which only binds CLDN18.2 but not CLDN18.1, a closely related isoform expressed in normal lung tissue. The US IND filing will be followed shortly. We look forward to expediting the development of TST001 to bring more effective treatment to a large number of cancer patients," said Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.

Neurocrine Biosciences Announces Conference Call and Webcast of Fourth Quarter and Year-End 2019 Financial Results

On January 20, 2020 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report fourth quarter and year-end 2019 financial results after the Nasdaq market closes on Tuesday, Feb. 4, 2020 (Press release, Neurocrine Biosciences, JAN 20, 2020, View Source [SID1234553349]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

Participants can access the live conference call by dialing 877-876-9173 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

NOXXON Announces Another Capital Increase of €0.5 Million Through a Private Placement of Shares

On January 20, 2020 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 that following discussions with investors it has received commitments for an investment of another €0.5 million through a private placement to complement the private placement of €0.5 million announced on January 14, 2020 (Press release, NOXXON, JAN 20, 2020, View Source [SID1234553345]).

"With this capital increase we welcome a new group of European investors to NOXXON. Consistent with our recent capital increases, for which we have attracted long-term equity investors, there are no warrants or other option-like instruments attached to this financing," said Aram Mangasarian, CEO of NOXXON.

The price agreed with investors was aligned with the private placement of the previous week at €0.51 per share. As such, it is anticipated that 980,391 new shares will be issued in the context of this financing. Closing and settlement of this transaction is expected within the next seven days.

See the annex of this press release for further details on the dilution related to this transaction.