AVEO Announces Submission of Responses to the EMA Day 120 List of Questions for Marketing Authorization Application for Tivozanib in Renal Cell Carcinoma

On November 28, 2016 AVEO Oncology (NASDAQ:AVEO) reported that its development partner, EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has submitted its responses to the European Medicines Agency (EMA) Day 120 List of Questions (Press release, AVEO, NOV 28, 2016, View Source [SID1234516807]). The Day 120 List of Questions were issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA) for tivozanib for the first-line treatment of advanced renal cell carcinoma (RCC). The next step in the filing process, the EMA Day 180 List of Outstanding Issues, is expected in the first quarter of 2017.

“This submission represents an important step forward in working toward an anticipated first half 2017 European approval decision, one of three potential key tivozanib-related milestones during this period,” said Michael Bailey, president and chief executive officer of AVEO. “Given tivozanib’s unique activity and safety profile, we believe the first line RCC market in Europe represents a meaningful commercial opportunity, and we look forward to working with EUSA Pharma to fully elucidate this potential. In addition to a potential European approval decision, we expect to have initial results from the Opdivo combination TiNivo study in RCC and may see milestones from Ophthotech for tivozanib in acute macular degeneration in the first half of 2017.”

Can-Fite Reports Financial Results for Nine Months Ended September 30, 2016 & Provides Clinical Update

On November 25, 2016 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, reported financial results for the nine months ended September 30, 2016 and updates on its drug development programs (Filing, Q3, Can-Fite BioPharma, 2016, NOV 25, 2016, View Source [SID1234516799]).

Clinical Development Program and Corporate Highlights Include:

● Piclidenoson (CF101) – EMA Clearance Received for Phase III Trials in Rheumatoid Arthritis & Psoriasis to Commence in 2017

Rheumatoid Arthritis: Piclidenoson is being developed as a first line therapy and replacement for the current gold standard, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. The Company plans to submit its study protocol to Institutional Review Boards (IRBs) of clinical sites in the first quarter of 2017.

Rheumatoid arthritis is a treatment market forecast to reach $38.5 billion by 2017.

Psoriasis: Can-Fite reached an agreement with the European Medicines Agency (EMA) on the final design of a global pivotal Phase III trial for Piclidenoson in the treatment of psoriasis. The Phase III trial, expected to commence enrollment in the second half of 2017, will investigate the efficacy and safety of Piclidenoson compared to placebo as its primary endpoint and as compared to apremilast (Otezla) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis.

During the third quarter, Can-Fite received a Notice of Allowance from the European Patent Office indicating the patent titled, "Pharmaceutical Composition Comprising A3 Adenosine Receptor Agonist (IB-MECA/CF-101) for Treatment of Psoriasis" will be granted.

The Journal of Drugs in Dermatology published data in August from Can-Fite’s Phase II/III trial of Piclidenoson in the treatment of moderate to severe psoriasis. The study is titled "Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial."

The psoriasis market is forecast to be $8.9 billion in 2018.

● Namodenoson (CF102) – Distribution deal in South Korea; Ongoing Phase II in Liver Cancer & Phase II NAFLD/NASH Protocol Submitted to IRB

In October, Can-Fite signed a distribution agreement with Chong Kun Dang Pharmaceuticals (CKD) for the exclusive right to distribute Namodenoson for the treatment of liver cancer in South Korea. The deal includes up to $3,000,000 in upfront and milestone payments, plus a percentage of royalties on net sales in the low twenties. CKD also negotiated for a right of first refusal to distribute Namodenoson for other indications for which Can-Fite develops Namodenoson.

Liver Cancer: Can-Fite continues to enroll and dose patients in its global Phase II study of Namodenoson in the treatment of hepatocellular carcinoma, the most common form of liver cancer. A total of approximately 78 patients are expected to be enrolled in the U.S., Europe, and Israel.

Molecular Medicine Report published an article titled, "A3 adenosine receptor agonist, CF102, protects against hepatic ischemia/reperfusion injury following partial hepatectom" during the third quarter. The article reports the results of preclinical studies conducted by Can-Fite, showing Namodenoson protects the liver from ischemia/reperfusion injury and regenerates liver cells following partial hepatectomy.

Liver cancer drugs are expected to generate $1.4 billion in sales in 2019.

NAFLD/NASH: In conjunction with world renowned Key Opinion Leaders in the field of liver diseases, Can-Fite completed the study design of its upcoming Phase II trial of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).

This Phase II clinical trial protocol was submitted to leading Institutional Review Boards (IRB) in Israel. Top medical centers in Israel, including Hadassah Medical Center and Rabin Medical Center are expected to participate in the planned study by enrolling and treating patients.

By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.

● CF602 – Broad Patent Estate in Sexual Dysfunction & Other Indications

A Notice of Allowance was granted to Can-Fite by the U.S. Patent and Trademark Office in November for the Company’s patent application covering A3 adenosine receptor (A3AR) ligands for use in the treatment of erectile dysfunction. The patent addresses methods for treating erectile dysfunction with different A3AR ligands including Can-Fite’s erectile dysfunction drug candidate, CF602. With this new broader patent protection, Can-Fite has made a strategic decision to investigate additional compounds, owned by the Company, for the most effective and safest profile in this indication. As such, the Company will postpone its planned Investigational New Drug (IND) submission for this indication.

"Today Can-Fite stands poised to enter two pivotal Phase III trials in autoimmune disease where there is a clear need for an effective oral drug that can be taken safely, on a long-term basis. In the treatment of liver diseases, we look forward to completing our Phase II trial in liver cancer and commencing a Phase II trial in NAFLD/NASH. We believe our small molecule oral drug candidates offer very clear advantages over other drugs on the market that patients cannot tolerate longer term due to safety and IV administration issues. Along with benefits to patients, it is our strong belief that our drug candidates will improve healthcare economics and create growing value for our shareholders," stated Can-Fite CEO Dr. Pnina Fishman.

Revenues for the nine months ended September 30, 2016 were NIS 0.64 million (U.S. $0.17 million) compared to NIS 0.54 million (U.S. $0.14 million) in the first nine months of 2015. The increase in revenue was due to the recognition of a portion of the NIS 5.14 million (U.S. $1.36 million) upfront payment received in March 2015 under the distribution agreement with Cipher Pharmaceuticals.

Research and development expenses for the nine months ended September 30, 2016 were NIS 15.45 million (U.S. $4.11 million) compared with NIS 9.58 million (U.S. $2.55 million) for the same period in 2015. Research and development expenses for the first nine months of 2016 comprised primarily of expenses associated with the Phase II study for CF102, preclinical study for CF602, as well as expenses for ongoing studies of CF101. The increase is due to costs associated with preparations of the aforementioned studies.

General and administrative expenses were NIS 7.88 million (U.S. $2.1 million) for the nine months ended September 30, 2016 compared to NIS 6.79 million (U.S. $1.81 million) for the same period in 2015. The increase is primarily due to an increase in share based compensation expense.

Financial income, net for the nine months ended September 30, 2016 aggregated NIS 3.12 million (U.S. $0.83 million) compared to financial expenses, net of NIS 4.7 million (U.S. $1.25 million) for the same period in 2015. The increase in financial income, net in the first nine month of 2016 was mainly due to a decrease in the fair value of warrants that are accounted for as financial liability as compared to an increase in the fair value of these warrants in the same period in 2015. In addition, the increase in financial income, net in the first nine months of 2016 was offset by an increase in financial expenses due to exchange rate differences as compared to insignificant financial income from exchange rate differences and capital issuance expenses for the same period in 2015.

Can-Fite’s net loss for the nine months ended September 30, 2016 was NIS 19.56 million (U.S. $5.2 million) compared with a net loss of NIS 20.53 million (U.S. $5.46 million) for the same period in 2015. The decrease in net loss for the first nine month of 2016 was primarily attributable to an increase in financial income, net offset by an increase in research and development expenses.

As of September 30, 2016, Can-Fite had cash and cash equivalents of NIS 37.57 million (U.S. $10 million) as compared to NIS 66.03 million (U.S. $17.57 million) at December 31, 2015. The decrease in cash during the nine months ended September 30, 2016 is due to operating expenses.

For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on September 30, 2016 (U.S. $1 = NIS 3.758).

The Company’s consolidated financial results for the nine months ended September 30, 2016 are presented in accordance with International Financial Reporting Standards.

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Kymab secures US$100 million Series C funding

On November 24, 2016 Kymab Group Limited ("Kymab"), a leading monoclonal antibody biopharmaceutical group, reported that it has successfully secured a US$100 million (£81 million) Series C financing (Press release, Kymab, NOV 24, 2016, View Source [SID1234537010]). The financing was led by new investors ORI Healthcare Fund L.P. ("ORI Fund") with participation by Shenzhen Hepalink Pharmaceutical Co., Ltd ("Hepalink") as well as follow-on investments from existing shareholders: Wellcome Trust, Bill & Melinda Gates Foundation, Malin Corporation plc, CF Woodford Equity Income Fund and Woodford Patient Capital plc.

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The funds will enable Kymab to advance its proprietary pipeline of first-in-class therapeutic human monoclonal antibodies the first of which is commencing clinical development in 2017.

"We are delighted to welcome new investors ORI Fund and Hepalink and would like to thank our existing investors for their continued support in our goal of building Kymab into a sustainable global biopharmaceutical company with a pipeline of products in four main therapeutic areas: immuno-oncology, auto-immunity, haematology and infectious disease," says Dr Dave Chiswell, CEO of Kymab.

"ORI Fund and Hepalink bring deep experience of the pharmaceutical industry. Hepalink has a global reach for their products and have biologics manufacturing capability in the US. This investment will help us maximise the potential of the Kymab pipeline as we develop and commercialise monoclonal antibody medicines for patients world-wide."

"We are very fortunate to have the opportunity to invest in Kymab which is equipped with world class technologies, world class programs, a world class team and world class investors," says Ms Simone Song, Senior Partner of ORI Fund. "We look forward to working with Dave and his team to fully realise the potential of Kymab as it enters into the clinic with a global presence."

"We have had a biologics strategy for a number of years and believe Kymab has one of the most comprehensive humanised transgenic antibody platforms which is already delivering first-in-class antibodies," explains Mr Li Li, President and Chairman of Hepalink. "We are pleased to invest in a world leading antibody company and look forward to potential collaborative opportunities with Kymab"

Kymab is using the Kymouse transgenic human antibody platform to discover and develop fully human monoclonal antibody drugs. Data published in Nature Biotechnology demonstrate that the Kymouse technology yields an antibody library constituted from 100 trillion different antibodies. From this deep library rare high-quality antibodies can be selected and developed into therapeutics.

Five of the top ten best-selling drugs are antibodies. This is because antibodies are natural products with exquisite specificity and potency, and generally have superior safety profiles. The challenge has been to capture the full human antibody repertoire and to recapitulate all its attributes.

The Series C follows the US$120 million Series A and B financings.

Notes to Editors
Issued 24 November, 2016

NINLAROTM ?ixazomib? Receives Conditional Approval from the European Commission to Treat Multiple Myeloma

On November 24, 2016 Takeda Pharmaceutical Company Limited （TSE: 4502） reported that the European Commission has granted conditional marketing authorization for NINLAROTM （ixazomib） capsules, indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy (Press release, Takeda, NOV 24, 2016, View Source [SID1234516792]). The decision to approve NINLARO as the first and only oral proteasome inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency （EMA） Committee for Medicinal Products （CHMP） for Human Use in September 2016.

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"For myeloma patients living in Europe, the approval of NINLARO means we have a new and effective treatment option available when we relapse," said Bob Munro, a patient with multiple myeloma from the United Kingdom. "I applaud the European Commission for recognising the additional benefit that NINLARO will bring to patients, who not only want treatment options that are effective and tolerable, but also appreciate the convenient option of taking an oral treatment. I strongly hope this will be made available by national health systems across Europe as soon as possible."

The European Commission followed the CHMP’s recommendation to approve NINLARO based on data from the pivotal Phase 3 TOURMALINE-MM1 trial, which demonstrated that NINLARO plus lenalidomide and dexamethasone increased the length of progression-free survival by about six months, or 40 percent, in patients with relapsed and refractory multiple myeloma when compared with placebo, lenalidomide and dexamethasone. The study also showed that the progression-free survival benefit observed in the NINLARO regimen extended across pre-specified subgroups of patients. Follow-up analyses for overall survival are planned for 2017.

"With the approval of NINLARO by the European Commission, physicians across the region will have the option to prescribe an all-oral triplet regimen to treat patients with multiple myeloma who have received at least one prior therapy," said Philippe Moreau, MD, Head of the Hematology Department at the University Hospital of Nantes, France. "In the TOURMALINE-MM1 study, we saw a clinically meaningful six-month improvement in progression-free survival with NINLARO, evidence that has supported its approval in Europe. As a hematologist, I welcome the availability of this treatment to address a devastating disease like multiple myeloma."

"When developing NINLARO, Takeda Oncology’s scientists sought to formulate an efficacious and unique oral proteasome inhibitor with a manageable safety profile. NINLARO delivers the proven efficacy of a proteasome inhibitor in a convenient once-weekly pill that can be taken at home," said Christophe Bianchi, M.D., President, Takeda Oncology. "NINLARO has the potential to help European patients with relapsed multiple myeloma by removing some of the barriers that can stand in the way of optimal treatment. With NINLARO, our hope is that many patients will be able to continue therapy until disease progression. Following the European Commission’s approval, we will continue to study NINLARO in a variety of settings in the hopes that we can bring this medicine to as many of the patients who may benefit from it as possible."

As a result of the European Commission decision, NINLARO is now approved for use across the European Economic Area, which includes the European Union’s 28 member states as well as Norway, Liechtenstein and Iceland. In addition, NINLARO is licensed for use in the U.S., Canada, Israel, Australia and Venezuela, and Takeda has submitted marketing authorization applications for NINLARO to a number of additional regulatory authorities around the world.

About NINLAROTM （ixazomib） capsules
NINLAROTM （ixazomib） is an oral proteasome inhibitor which is also being studied across the continuum of multiple myeloma treatment settings as well as systemic light-chain （AL） amyloidosis. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval. NINLARO was approved by the U.S. Food and Drug Administration （FDA） in November 2015 following a priority review. In the U.S., NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Ixazomib was granted orphan drug designation in multiple myeloma in both the U.S. and Europe in 2011 and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory systemic light-chain （AL） amyloidosis in 2014.

The comprehensive ixazomib clinical development program, TOURMALINE, further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. TOURMALINE includes a total of five ongoing pivotal trials – four, which together are investigating every major multiple myeloma patient population, and one in light-chain amyloidosis:

TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant （ASCT）
TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT; this study is currently enrolling
TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis; this study is currently enrolling
In addition to the TOURMALINE program, ixazomib is being evaluated in multiple therapeutic combinations for various patient populations in investigator initiated studies globally.

NINLAROTM （ixazomib）: Global Important Safety Information

SPECIAL WARNINGS AND PRECAUTIONS
Thrombocytopenia has been reported with NINLARO （28％ vs. 14％ in the NINLARO and placebo regimens, respectively） with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. It did not result in an increase in hemorrhagic events or platelet transfusions. Monitor platelet counts at least monthly during treatment with NINLARO and consider more frequent monitoring during the first three cycles. Manage with dose modifications and platelet transfusions as per standard medical guidelines.

Gastrointestinal toxicities have been reported in the NINLARO and placebo regimens respectively, such as diarrhea （42％ vs. 36％）, constipation （34％ vs. 25％）, nausea （26％ vs. 21％）, and vomiting （22％ vs. 11％）, occasionally requiring use of antiemetic and anti-diarrheal medications, and supportive care.

Peripheral neuropathy was reported with NINLARO （28％ vs. 21％ in the NINLARO and placebo regimens, respectively）. The most commonly reported reaction was peripheral sensory neuropathy （19％ and 14％ in the NINLARO and placebo regimens, respectively）. Peripheral motor neuropathy was not commonly reported in either regimen （＜ 1％）. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

Peripheral edema was reported with NINLARO （25％ vs. 18％ in the NINLARO and placebo regimens, respectively）. Evaluate patients for underlying causes and provide supportive care, as necessary. Adjust the dose of dexamethasone per its prescribing information or the dose of NINLARO for severe symptoms.

Cutaneous reactions occurred in 19％ of patients in the NINLARO regimen compared to 11％ of patients in the placebo regimen. The most common type of rash reported in both regimens was maculo-papular and macular rash. Manage rash with supportive care, dose modification or discontinuation.

Hepatotoxicity, drug-induced liver injury, hepatocellular injury, hepatic steatosis, and hepatitis cholestatic have been uncommonly reported with NINLARO. Monitor hepatic enzymes regularly and adjust dose for Grade 3 or 4 symptoms.

Pregnancy- NINLARO can cause fetal harm. Advise male and females patients of reproductive potential to use contraceptive measures during treatment and for an additional 90 days after the final dose of NINLARO. Women of childbearing potential should avoid becoming pregnant while taking NINLARO due to potential hazard to the fetus. Women using hormonal contraceptives should use an additional barrier method of contraception.

Lactation- It is not known whether NINLARO or its metabolites are excreted in human milk. There could be potential adverse events in nursing infants and therefore breastfeeding should be discontinued.

SPECIAL PATIENT POPULATIONS
Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.

Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease （ESRD） requiring dialysis. NINLARO is not dialyzable and, therefore, can be administered without regard to the timing of dialysis.

DRUG INTERACTIONS
Co-administration of strong CYP3A inducers with NINLARO is not recommended.

ADVERSE REACTIONS
The most frequently reported adverse reactions （≥ 20％） in the NINLARO regimen, and greater than in the placebo regimen, were diarrhea （42％ vs. 36％）, constipation （34％ vs. 25％）, thrombocytopenia （28％ vs. 14％）, peripheral neuropathy （28％ vs. 21％）, nausea （26％ vs. 21％）, peripheral edema （25％ vs. 18％）, vomiting （22％ vs. 11％）, and back pain （21％ vs. 16％）. Serious adverse reactions reported in ≥ 2％ of patients included thrombocytopenia （2％） and diarrhea （2％）. For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1％ of patients in the NINLARO regimen.

For US Prescribing Information:
View Source
For Canada Product Monograph:
View Source

About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of monoclonal plasma cells, or myeloma cells, becomes cancerous and multiplies. These malignant plasma cells have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with approximately 39,000 new cases in the EU and 114,000 new cases globally per year.

Xenetic Biosciences to Host Quarterly Update Conference Call and Webcast

On November 23, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that the Company’s management team will host a quarterly update conference call with a live webcast for investors, analysts and other interested parties (Press release, Xenetic Biosciences, NOV 23, 2016, View Source [SID1234537808]).

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During the conference call, the Company will provide a corporate update and discuss the clinical and regulatory progress for its in-house product candidates, as well as those being developed with Xenetic’s biotechnology and pharmaceutical partners. Xenetic’s current in-house product pipeline includes Virexxa (sodium cridanimod), which is being evaluated for the treatment of endometrial cancer and triple negative breast cancer, and ErepoXen, a polysialylated form of erythropoietin (EPO), a hormone created by the kidneys to maintain red blood cell production and prevent anemia. Xenetic is also currently evaluating OncoHist for the treatment of acute myeloid leukemia (AML) in refractory patients and refractory non-Hodgkin lymphoma (NHL).

Conference Call and Webcast Information

Xenetic management will host a conference call for investors, analysts and other interested parties on Wednesday, November 30, 2016 at 8:30 a.m. ET. The conference call and live webcast will be accompanied by presentation slides.

To participate in the call, please dial (877) 407-6914 (domestic) or (201) 493-6709 (international). The live webcast and accompanying slides will be available by accessing the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends.