On March 1, 2019, Spectrum Pharmaceuticals reported that it completed the sale of our seven then-commercialized drugs, including FUSILEV, KHAPZORY, FOLOTYN, ZEVALIN, MARQIBO, BELEODAQ, and EVOMELA (the "Commercial Product Portfolio") to Acrotech Biopharma LLC ("Acrotech") (the "Commercial Product Portfolio Transaction") (Press release, Spectrum Pharmaceuticals, MAR 1, 2019, View Source [SID1234538580]). Upon closing Spectrum Pharmaceuticals received $158.8 million in an upfront cash payment (of which $4 million is held in escrow). Spectrum Pharmaceuticals is also entitled to receive up to an aggregate of $140 million upon Acrotech’s achievement of certain regulatory (totaling $40 million) and sales-based milestones (totaling $100 million) relating to the Commercial Product Portfolio.
These Condensed Consolidated Financial Statements are recast for all periods presented to reflect the sale of the assets and liabilities associated with their Commercial Product Portfolio, as well as the corresponding revenue-deriving activities and allocable expenses of this commercial business within "discontinued operations" – see Note 11. Spectrum have presented their face financial statements in general conformity with our historical format, even where presented values are $-0- within continuing.

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On March 1, 2019 MaxCyte, the global cell-based medicines and life sciences company, reported that it has expanded its relationship with Kite, a Gilead Company, by entering into a multi-drug clinical and commercial agreement (Press release, MaxCyte, MAR 1, 2019, View Source [SID1234537626]). Under the terms of the agreement, Kite will use MaxCyte’s Flow Electroporation Technology to enable non-viral cell engineering for development of multiple CAR-T drug candidates for up to 10 targets.

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"We’re excited to take our relationship with Kite further into product development, providing the company the ability to leverage MaxCyte’s versatile cell engineering platform to enable the power of gene-editing for clinical and commercial development of critical new CAR-T therapeutics," said Doug Doerfler, President & CEO of MaxCyte, Inc.

The expansion of the Kite-MaxCyte relationship builds on an existing research agreement announced in November 2018. Under the terms of the new license agreement, Kite obtains non-exclusive clinical and commercial-use rights to MaxCyte’s cell engineering platform to develop CAR-T therapies, and MaxCyte will receive development and approval milestones and sales-based payments in addition to other licensing fees.

On March 1, 2019 Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA"), a leader in large-scale PCR-based DNA manufacturing, reported that LineaRx, Inc. ("LineaRx"), its wholly-owned subsidiary focused on next-generation biotherapeutics, will ship TK7 and ConTRT amplicons to Takis/Evvivax next week as part of the companies’ Joint Development Agreement ("JDA") entered into in September 2018 (Press release, Applied DNA Sciences, MAR 1, 2019, View Source [SID1234533907]).

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Per the JDA, LineaRx and Takis/Evvivax will jointly develop linear DNA expression amplicons for TK7 and ConTRT, two of Takis/Evvivax’s anti-cancer vaccine candidates, utilizing LineaRx’s validated linear DNA technology. Linear DNA amplicons carrying the DNA sequences for Takis/Evvivax vaccine candidates will be delivered to pre-clinical animal models via Takis/Evvivax’s proprietary electroporation technology.

In 2018, LinearRx and Takis/Evvivax’s collaboration showed immunogenicity in mice that were vaccinated with linear DNA against the human protein telomerase that is over-expressed in more than 85% of all cancers. "This year we are using ConTRT, an improved version of our telomerase vaccine and a unique personalized approach which includes an epitope-prediction pipeline and a delivery strategy to achieve an extremely effective cancer vaccine over what has been done previously," said Dr. Luigi Aurisicchio, CEO of Takis/Evvivax. "Each expression amplicon will undergo rigorous quality subject matter testing, immunogenicity testing, followed by a tumor challenge, with results planned for publication later this year."

"Our collaborations with Takis/Evvivax and other therapy developers are helping to validate LineaRx’s novel technology as a viable alternative to bacterially-produced plasmids, with the potential for increased patient safety and reduced costs, using new quality control protocols for large-scale PCR production at LineaRx. We believe that linear DNA and the establishment of new quality attributes for this new therapeutic field will change the way gene and immune therapies will be performed," stated Dr. James Hayward, president and CEO of Applied DNA. "Our implementation of testing for new quality attributes will support our preparation to approach FDA to seek approval for clinical study. Our know-how in the fields of therapeutic linear DNA production and the standardized PCR platforms in use at LineaRx enable us to create novel expression amplicons. We are extremely pleased with the progress we are making with Takis/Evvivax under our JDA."

On March 1, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a conference call and live webcast for Analysts and Institutional Investors at 8:30 a.m. ET on Friday, March 8, 2019 following release of its year end 2018 financial results (Press release, Oncolytics Biotech, MAR 1, 2019, https://ir.oncolyticsbiotech.com/news/detail/448/oncolytics-biotechr-to-host-conference-call-to-discuss-year-end-financial-results-and-operational-highlights [SID1234533905]).

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The live call may be accessed by dialing (877) 407-9205 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at (877) 481-4010, using the replay code 44902 and will be available for one week. A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months.

On March 1, 2019 CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, reported that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) (Press release, Carsgen Therapeutics, MAR 1, 2019, View Source [SID1234533883]).

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"At the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2018, our collaborator, Dr. Songfu Jiang presented encouraging safety and efficacy data in patients with rrMM who received CT053 BCMA-CAR-T cells. The IND clearance of BCMA-CAR-T cells by China’s NMPA is of great significance to CARsgen," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to JAMA Oncology, in 2016, there were about 130,000 cases of myeloma, which means from 1990 to 2016, incident cases of myeloma increased by 126% globally[1] and despite the development of novel therapies, multiple myeloma remains incurable and new treatment options are needed. As part of the CT053 development plan, we also intend to submit an IND application for BCMA-CAR-T cells to the U.S. FDA in 2019. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."