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.

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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.

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]).

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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.

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

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On November 13, 2015 the U.S. Food and Drug Administration reported that it has granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC) (Press release, , NOV 13, 2015, View Source [SID:1234508240]). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.
Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the lung. The EGFR gene is a protein involved in the growth and spread of cancer cells.

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"Our understanding of the molecular basis of lung cancer and reasons these cancers become resistant to prior treatments is rapidly evolving," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "This approval provides a new treatment for patients who test positive for the EGFR resistance mutation, T790M, and is based on substantial evidence from clinical trials that shows Tagrisso had a significant effect on reducing tumor size in over half of patients who were treated."

Today, the FDA also approved the first companion diagnostic test (cobas EGFR Mutation Test v2) to detect the type of EGFR resistance mutation that Tagrisso is known to target. The newly approved version (v2) of the test adds the T790M mutation to the clinically relevant mutations detected by the original cobas EGFR Mutation Test (v1).

"The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "The availability of the cobas EGFR Mutation Test v2 meets a need for the detection of this important EGFR gene mutation, which can alter treatment effectiveness."

The safety and efficacy of Tagrisso were demonstrated in two multicenter, single-arm studies involving a total of 411 patients with advanced EGFR T790M mutation-positive NSCLC whose disease worsened after treatment with an EGFR-blocking medication. In these two studies, 57 percent of patients in the first study and 61 percent of patients in the second study experienced a complete or partial reduction in their tumor size (known as objective response rate).

Continued approval for this indication may be contingent upon further confirmatory studies.

The most common side effects of Tagrisso are diarrhea, skin and nail conditions such as dry skin, rash and infection or redness around the fingernails. Tagrisso may cause serious side effects, including inflammation of the lungs and injury to the heart. It also may cause harm to a developing fetus.

The FDA granted Astra Zeneca breakthrough therapy designation, priority review and orphan drug designation for Tagrisso. Breakthrough therapy designation is granted for a drug that is intended to treat a serious condition when, at the time an application is submitted, preliminary clinical evidence indicates that a drug may demonstrate substantial improvement over available therapies. Priority review designation is granted to drug applications that show a significant improvement in safety or effectiveness in the treatment of a serious condition. Orphan drug designation provides incentives such as tax credits, user fee waivers, and eligibility for market exclusivity to assist and encourage the development of drugs for rare diseases.

Tagrisso was approved under the agency’s accelerated approval program, which allows the approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.

Tagrisso is marketed by Astra Zeneca Pharmaceuticals based in Wilmington, Delaware. The cobas EGFR Mutation Test v2 is marketed by Roche Molecular Systems of Pleasanton, California.

On November 13, 2015 KaloBios Pharmaceuticals, Inc. (Nasdaq:KBIO) reported that it will wind down its operations and that it has engaged the Brenner Group to lead those efforts (Press release, KaloBios, NOV 13, 2015, View Source [SID:1234509374]).

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"Recent discussions around a number of possible strategic transactions have ended, and as a result, the company believes it is highly unlikely that continuing to explore strategic alternatives could generate a viable transaction within the time frame allowed by our limited cash resources," said Herb Cross, Chief Financial Officer and Interim Chief Executive Officer.

The company will discontinue its two current development programs, KB004, being studied in Phase 2 for certain hematologic malignancies, and lenzilumab, or KB003, scheduled to initiate Phase I development later this year in chronic myelomonocytic leukemia (CMML). KaloBios has engaged the restructuring firm of The Brenner Group to assist in the wind down of operations and liquidation of the company’s assets. The company recently announced a reduction in operations and headcount affecting approximately 60% of the company’s 28 employees. As a part of its wind down and handing over management of the wind down to The Brenner Group, the company expects to phase out the remaining employees over the next thirty to sixty days. As a result of these developments, the company will not be able to file its Form 10-Q for the third quarter, primarily due to resource constraints.

As a part of its restructuring and winding down, the company has repaid in full its outstanding secured loan obligation to MidCap Financial, secured lender to the company, in the approximate amount of $6.6 million.