On November 16, 2015 Xenetic Biosciences, Inc. (OTCQB:XBIO) (the "Company"), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, reported that it has entered into an Asset Purchase Agreement (the "APA") with AS Kevelt, an Estonian biotech company ("Kevelt") and OJSC Pharmsynthez ("Pharmsynthez", and together with Kevelt, "Sellers") (Press release, Xenetic Biosciences, NOV 16, 2015, View Source [SID1234537823]). Pursuant to the APA, the Sellers will transfer to the Company certain intellectual property rights with respect to Virexxa, and the Company will receive the worldwide rights to develop, market and license Virexxa for all uses, except for certain excluded uses within the Commonwealth of Independent States (the "CIS"), in exchange for 111.5 million shares of Company common stock and certain other consideration. Virexxa is a Phase II oncology drug candidate which is under investigation for the treatment of certain endometrial cancers. As part of this total consideration, the Company will also acquire Kevelt’s U.S. Orphan Drug designation for the use of Virexxa in the treatment of progesterone receptor negative endometrial cancer in conjunction with progesterone therapy.
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The APA also contains a financing component wherein the Company will receive from Pharmsynthez up to $3.5 million in bridge financing and a commitment of an additional $6.5 million in financing as part of a planned capital raise of at least $15 million and up-list to a national securities exchange.
"This transaction provides us with our first U.S. FDA IND-enabled clinical candidate for an orphan cancer indication," said M. Scott Maguire, Chief Executive Officer of Xenetic Biosciences. "Virexxa with orphan designation in the U.S. adds to our Phase II portfolio which also includes ErepoXen, our long-acting anemia drug candidate. As well as expanding our pipeline, the Company is pleased to receive financial commitments of up to $10M to fund our further development, as well as financial commitments to back our planned uplisting to a national securities exchange, an objective that remains a priority for the Company’s board."
This press release is not intended to describe this transaction in its entirety and the reader should refer to SEC form 8-K and related exhibits filed on November 16, 2015 for a complete description of this APA transaction.
About Virexxa
Virexxa (sodium cridanimod) is a small-molecule immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor (PrR) expression in endometrial tissue. Restoration of PrR expression may re-sensitize endometrial tumor tissue to progestin therapy in previously unresponsive tumors.
Virexxa is under investigation in a U.S. FDA IND-enabled Phase 2 open-label, multi-center, single arm study of sodium cridanimod in progesterone receptor negative recurrent or persistent endometrial carcinoma. This study will investigate the effect of sodium cridanimod on the levels of PrR in tumor tissue and how this effect correlates to a patient’s clinical response to progestin therapy.
Endometrial cancer is the most common gynecological malignancy and represents a major health concern, as overall five-year survival rates have not improved over the past three decades. Endometrial cancer patients whose tumors no longer express progesterone receptors are not candidates for progestin-based therapy. Virexxa may improve sensitivity to progestin therapy in subjects with advanced or recurrent PrR -negative tumors.
For more information:
clinicaltrials.gov/show/NCT02064725