1stOncology™: Cancer Intelligence Service – Page 16846 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, TNI BioTech, NOV 16, 2015, View Source [SID:1234508252])

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Xenetic Biosciences, Inc. Enters Into Asset Purchase Agreement With Financing Component for the Rights to Develop, Market and License Oncologic Drug Candidate Virexxa

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 [SID:1234514785]). 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.

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.

Array BioPharma And Pierre Fabre Announce Development And Commercialization Collaboration For Two Novel Oncology Products, Binimetinib And Encorafenib

On November 16, 2015 Array BioPharma Inc. (Nasdaq: ARRY) and Pierre Fabre reported a collaboration to globally develop and commercialize Array’s late-stage novel oncology products, binimetinib and encorafenib (Press release, Array BioPharma, NOV 16, 2015, View Source;p=RssLanding&cat=news&id=2112588 [SID:1234508595]). Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, are currently advancing in three, global Phase 3 trials for melanoma and ovarian cancer. Top-line results from NEMO, a Phase 3 study of binimetinib in patients with NRAS-mutant melanoma, are anticipated before the end of 2015. Array plans to host a conference call on November 16, 2015 at 9:00 am ET to discuss the collaboration.
Array BioPharma.

Under the terms of the agreement, Array will receive an upfront payment of $30 million and retains exclusive commercialization rights for binimetinib and encorafenib in the United States, Canada, Japan, Korea and Israel. Pierre Fabre will have exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. Array is entitled to receive up to $425 million if certain development and commercialization milestones are achieved, and is eligible for robust, tiered double-digit royalties. Array and Pierre Fabre have agreed to split future development costs on a 60:40 basis (Array:Pierre Fabre) with initial funding committed for new clinical trials in colorectal cancer and melanoma. All ongoing binimetinib and encorafenib clinical trials remain substantially funded through completion by Novartis.

Pierre Fabre Oncology, a business unit of the global 10,000-employee Pierre Fabre company, is supported by over 1,000 employees with a strong focus on European markets. In 2014, worldwide annual sales of Pierre Fabre Oncology products surpassed $200 million on the strength of the Oral Navelbine, Javlor and Busilvex brands. In addition, Pierre Fabre has a significant commitment and track record in pharmaceutical R&D, developing products for patients afflicted with lung, breast and other solid tumors and hematological cancers.

"In Pierre Fabre we selected a partner with a European and emerging market focus in oncology to develop and commercialize binimetinib and encorafenib in these geographies," said Ron Squarer, Chief Executive Officer, Array BioPharma. "With Phase 3 trials approaching data readouts, and over 30 additional Phase 1/2 trials underway, we are confident that binimetinib and encorafenib are well positioned for near-term regulatory submissions and significant commercial value."

"Pierre Fabre is strongly committed to develop and commercialize oncology products," said Frederic Duchesne, Chief Executive Officer, Pierre Fabre Pharmaceuticals. "This partnership with Array is aligned with our growth strategy in Pharmaceuticals, our geographic footprint, and our corporate mission to bring to the market novel oncology products which address unmet patient needs. Binimetinib and encorafenib will fit perfectly with our broad expertise in oncology and dermatology, and will strengthen our current portfolio and international presence."

The agreement remains subject to European Commission on Competition review and approval.

Calithera Presents Preclinical Study Findings for CB-839 at the 2015 Novel Cancer Therapeutics Summit

On November 16, 2015 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that it will announce new preclinical data today for its lead therapeutic candidate, CB-839, at the 2015 Global Technology Community (GTC) Novel Cancer Therapeutics Summit in San Francisco, California (Press release, Calithera Biosciences, NOV 16, 2015, View Source;p=RssLanding&cat=news&id=2112877 [SID:1234508306]). CB-839 is a potent, selective, orally bioavailable glutaminase inhibitor currently in phase I clinical trials. The first preclinical studies combining CB-839 with an immune checkpoint inhibitor were presented demonstrating that CB-839 significantly increases the rate of tumor regressions in syngeneic mice when CB-839 is added to anti-PD-L1.

"The new data presented at the GTC meeting provide us with the rationale to continue developing CB-839 in combination with multiple classes of therapeutics, and to expand our development program to include immunotherapy agents," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We continue to leverage our expertise in tumor and cellular metabolism to enhance our understanding of metabolic checkpoints in cancer."

Preclinical data will be presented in an oral presentation titled, "Identification of Biomarkers and Combination Agents for the Glutaminase Inhibitor CB-839 for the Treatment of Cancer," by Francesco Parlati, PhD, Senior Director of Biology at Calithera Biosciences. Included in the presentation are the results of studies investigating the preclinical anti-tumor activity of CB-839 in combination with an anti-PD-L1 antibody. The combination of CB-839 and anti-PD-L1 increased the number of tumor regressions seen with anti-PD-L1 treatment in the CT-26 syngeneic colon carcinoma model. Synergistic effects with CB-839 and anti-PD-L1 were also observed in a B16 melanoma model. PD-L1 ligation of PD-1 on the surface of T cells blocks metabolism of glucose and glutamine, depriving T cells of nutrients necessary for activation and differentiation. The mechanism of action of anti-PD-L1 combined with CB-839, two agents that effect metabolism in the tumor microenvironment, is being explored in further studies.

Sophiris Bio Reports Third Quarter Financial Results and Business Highlights

On November 16, 2015 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, reported financial results for the three and nine months ended September 30, 2015 (Press release, Sophiris Bio, NOV 16, 2015, View Source [SID:1234508265]).

Business Highlights:

On November 10, 2015, the Company announced final positive results from its Phase 3 "PLUS-1" study of PRX302 as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). PRX302 demonstrated a statistically significant improvement in International Prostate Symptom Score (IPSS) total score from baseline over 12 months compared to the vehicle-only control group (7.60 vs. 6.58 point overall improvement; p = 0.043), the primary endpoint of the study. The clinical relevance of the overall improvement in IPSS was assessed by an additional efficacy endpoint, the patient self-assessment of the impact of treatment on their quality of life, which was assessed using the 0 – 6 point Quality of Life from the IPSS questionnaire. The PRX302 average change from the 4.5 point baseline was a sustained 1.6 to 1.7 points improvement from Weeks 18 through 52, which was statistically significantly superior to patients treated with vehicle for every post-baseline visit beginning at week 18 (reaching p = 0.004). PRX302 treatment was generally well tolerated in the study and continues to demonstrate a favorable safety profile, with no evidence of any treatment related sexual or cardiovascular side effects.

A total of 17 patients with clinically significant, localized low to intermediate risk prostate cancer have been enrolled in the ongoing Phase 2a proof of concept study. The study utilizes previously obtained MRI images mapped to real time 3D ultrasound to target the delivery of PRX302 directly into and around a pre-identified clinically significant tumor. The study is being conducted at a single center well known for the focal treatment of prostate cancer in the UK. Although the primary objective of the study is to assess safety and tolerability, potential efficacy will be assessed by biopsy after six months. The Company expects to have initial data on histological and MRI changes after six months for approximately half the patients in early 2016 and final data on all patients in the second quarter of 2016.

"We have remained focused and diligent at Sophiris as we approach key data milestones, and that steadfast commitment and belief in our topsalysin programs is paying off," stated Randall Woods, president and CEO of Sophiris Bio. "The successful outcome of the Phase 3 PLUS-1 study indicates that patients treated with topsalysin experienced a significant improvement in their BPH symptoms and their quality of life. These data increase our confidence in the targeted mechanism by which topsalysin ablates prostate tissue, thus supporting our rationale for advancing the development of topsalysin as a treatment for localized prostate cancer. We are fast approaching another key data milestone in early 2016, in which we anticipate initial data from a Phase 2a proof of concept trial of topsalysin in patients with localized low to intermediate risk prostate cancer."

Financial Results

At September 30, 2015, we had cash, cash equivalents and securities available-for-sale of $9.9 million and net working capital of $7.6 million. We expect that our cash, cash equivalents and securities available-for-sale as of September 30, 2015 will be sufficient to fund our operations through the end of April 2016 assuming that we do not initiate any additional clinical development of PRX302. We will need to obtain additional capital to fund a second Phase 3 clinical trial of PRX302 for the treatment of the symptoms of BPH and for any future clinical development of PRX302 for the treatment of localized prostate cancer beyond our ongoing Phase 2a proof of concept clinical trial.

For the three months ended September 30, 2015

The Company reported a net loss of $3.7 million ($0.22 per share) for the three months ended September 30, 2015 compared to a net loss of $8.2 million ($0.49 per share) for the three months ended September 30, 2014.

Research and development expenses

Research and development expenses were $2.6 million for the three months ended September 30, 2015 compared to $6.7 million for the three months ended September 30, 2014. The decrease in research and development costs are attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial of PRX302 and costs associated with the manufacturing activities for PRX302. This decrease is partially offset by an increase in costs associated with the Company’s Phase 2a proof of concept trial for localized low to intermediate risk prostate cancer.

General and administrative expenses

General and administrative expenses were $0.9 million for the three months ended September 30, 2015 compared to $1.4 million for the three months ended September 30, 2014. The decrease is primarily due to a decrease in non-cash stock-based compensation expense and, to a lesser extent, a decrease in legal, accounting and personnel related costs.

For the nine months ended September 30, 2015

The Company reported a net loss of $11.7 million ($0.69 per share) for the nine months ended September 30, 2015 compared to a net loss of $25.4 million ($1.54 per share) for the nine months ended September 30, 2014.

Research and development expenses

Research and development expenses were $8.2 million for the nine months ended September 30, 2015 compared to $20.6 million for the nine months ended September 30, 2014. The decrease in research and development costs are attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial of PRX302 and costs associated with the manufacturing activities for PRX302. This decrease is partially offset by an increase in costs associated with the Company’s Phase 2a proof of concept trial for localized low to intermediate risk prostate cancer.

General and administrative expenses

General and administrative expenses were $3.0 million for the nine months ended September 30, 2015 compared to $4.3 million for the nine months ended September 30, 2014. The decrease is primarily due to a decrease in non-cash stock-based compensation expense and, to a lesser extent, a decrease in legal, consulting and personnel related costs.