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Alligator Bioscience to Host Conference Call to Provide Full Year Report 2017 Business Update

On February 12, 2019 Alligator Bioscience reported that it will publish its report for the year ended 31 December 2017 (Press release, Alligator Bioscience, FEB 12, 2018, https://alligatorbioscience.se/en/alligator-bioscience-to-host-conference-call-to-provide-full-year-report-2017-business-update/ [SID1234538680]). All interested parties are invited to participate in a telephone conference, which will include a presentation of the Full Year Report, on the same day at 1:15 PM CET. The event will be hosted by CEO Per Norlén and the presentation will be held in English.

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When: 1:15 pm CET Friday 16 February 2018

To participate in the telephone conference, please use the dial in details shown below:

SE: +46856642664

UK: +442030089802

US: +18558315945

The presentation can also be reached at:
View Source

The conference call will be made available on the company´s website after the call: View Source

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected].

The information was submitted for publication, through the agency of the contact person set out above, at 1:30 p.m. CET on 12 February 2018.

Can-Fite BioPharma Announces New Pre-Clinical Data Supporting a Novel Anti-NASH Mechanism of Action for Namodenoson

On February 12, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address liver and inflammatory diseases, reported that pre-clinical studies show Namodenoson’s novel mechanism of action which entails de-regulation of 3 key signaling pathways which mediate the etiology and pathology of NAFLD/NASH and are responsible for the anti-inflammatory and anti-fibrogenic effect in the liver (Press release, Can-Fite BioPharma, FEB 12, 2018, View Source [SID1234524644]).

Pre-clinical studies were conducted in hepato-stellate cells in vitro and in an experimental NASH CCL4 model, showing that in both systems, the molecular mechanism of action of Namodenoson was conferred by decreased expression levels of the signaling protein phosphoinositol-3-phosphate (PI3K) which controls 3 downstream signal transduction pathways, the Wnt, NF-kB and α-SMA, which control liver inflammation and liver fibrosis. The detailed data is scheduled to be presented at the 2018 International Liver Congress (ILC), which is the annual meeting of the European Association for the Study of the Liver (EASL) (View Source).

The Company is currently conducting a Phase II trial with its drug candidate Namodenoson for the treatment of 60 patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). There is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025. Can-Fite’s 12-week study has been designed by leading Key Opinion Leaders in the area of NASH and liver diseases in the US including the company CAB members, Dr. Scott Friedman, Chief of the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai in New York; Dr. Arun Sanayal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine; Dr. Rifaat Safadi, Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center and Dr. Stephen A. Harrison, the Medical Director of Pinnacle Clinical Research.

Namodenoson has been tested in over 100 subjects with other liver diseases, with clinical data suggesting a very favorable safety profile.

"We believe that the anti-inflammatory and anti-fibrogenic effects of Namodenoson, together with the favorable safety profile to date make it a promising drug candidate for the treatment of NAFLD/NASH," stated Prof. Rifaat Safadi.

About NAFLD/NASH

NAFLD is characterized by excess fat accumulation in the form of triglycerides (steatosis) in the liver. According to a study published in Hepatology, an estimated 17%-33% of the population in the U.S. has NAFLD, with a higher prevalence in people with type II diabetes. Incidence is increasing based on rising obesity rates. NAFLD includes a range of liver diseases, with NASH being the more advanced form, manifesting as hepatic injury and inflammation. According to the NIH, the incidence of NASH in the U.S. is believed to affect 2-5% of the population. The spectrum of NAFLDs resembles alcoholic liver disease; however, they occur in people who drink little or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer. By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.

About Namodenoson (CF102)

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect is believed to account for the excellent safety profile of the drug. Can-Fite has received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma

AVID BIOSERVICES AND ONCOLOGIE ENTER INTO ASSET ASSIGNMENT AND PURCHASE AGREEMENT FOR AVID’S PS-TARGETING PROGRAM INCLUDING BAVITUXIMAB

On February 12, 2018 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP) ("Avid") and Oncologie, Inc. reported that the companies have entered into an Asset Assignment and Purchase Agreement for Avid’s phosphatidylserine (PS)-targeting program including bavituximab (Press release, Peregrine Pharmaceuticals, FEB 12, 2018, View Source [SID1234523979]). Bavituximab is an investigational immune-modulatory monoclonal antibody that targets PS, a phospholipid that inhibits the ability of immune cells to recognize and fight tumors. In addition to bavituximab, the deal includes Avid’s other PS-targeting antibodies, including betabodies, as well as certain other assets and licenses useful and/or necessary for the potential commercialization of bavituximab.

Under terms of the agreement, Avid will receive an aggregate of $8 million in upfront payments from Oncologie paid over a period of six months from the execution date of the agreement and will be eligible to receive up to $95 million in development, regulatory and commercialization milestones. Oncologie will be responsible for all future research, development and commercialization of bavituximab, and related intellectual property costs, with Avid receiving royalties on net sales that are upward tiering into the mid-teens. As part of the deal, Oncologie will also enter into an agreement with Avid for future contract development and manufacturing activities in support of bavituximab. Roth Capital Partners acted as financial advisor to Avid in this transaction, rendering a Fairness Opinion to its board of directors.

"Partnering our PS-targeting program including bavituximab with a biopharmaceutical company focused on therapeutics in oncology has long been a key corporate objective and we have engaged in discussions with a broad range of potential collaborators throughout the course of the development program. Oncologie is a company with a deep understanding of cancer biomarkers that might be particularly relevant to bavituximab and we believe they have the resources and expertise to maximize the potential of the program," said Roger J. Lias, Ph.D., president and chief executive officer of Avid. "Importantly, this deal marks the completion of our transition to a dedicated CDMO, while providing additional capital, both upfront and potentially downstream, to support our CDMO business."

"We are pleased to add bavituximab as our new lead development program through this agreement with Avid," said Laura E. Benjamin, Ph.D., chief executive officer of Oncologie. "We believe that PS targeting possesses significant promise in the treatment of cancer and look forward to highlighting the therapeutic potential of the approach through innovative clinical trials. To this end, we intend to continue ongoing collaborations with the current investigators who are overseeing investigator-initiated trials, as well as NCCN-sponsored studies, designed to evaluate the immune modulating potential of bavituximab."

Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors, as well as by sending an alternate immune activating signal. PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Importantly, bavituximab has also demonstrated a favorable safety and tolerability profile across several clinical trials conducted to date, which may offer the compound a key advantage as the evolving cancer treatment landscape continues to shift to a combination therapy approach. The ability to be added to a range of other cancer therapies without causing added safety concerns may position bavituximab favorably as a component of combination treatments.

MabVax Therapeutics Announces Positive Interim Data from Expanded Cohort in Phase 1 Trial Evaluating MVT-5873 in Combination with First-Line Chemotherapy in Pancreatic Cancer

On February 12, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported positive interim results from the Company’s ongoing Phase 1 trial evaluating MVT-5873 in combination with standard of care chemotherapy in patients newly diagnosed with pancreatic and other CA19-9 positive malignancies (Press release, MabVax, FEB 12, 2018, View Source [SID1234523919]). At the dose tested, all six patients in the cohort had meaningful reductions in tumor volume by RECIST.

In the Phase 1 study, MabVax’s MVT-5873, a fully human antibody, was given in combination with nab-paclitaxel and gemcitabine to patients newly diagnosed with CA19-9 positive pancreatic cancer. MVT-5873 at a dose of 0.125 mg/kg when added to first-line chemotherapy was generally well tolerated by all subjects. The Company reported that all six patients had measurable tumor reductions, with four patients meeting the criteria for partial response (PR) and two patients meeting the criteria for stable disease (SD). These results help confirm results reported from a group of patients treated earlier. Patient CA19-9 levels, which are a prognostic indicator of the disease state, were markedly reduced in all subjects with this combination therapy. The Company plans to enroll additional patients at this dose to further explore safety and potential response.

"We are highly encouraged by the continued positive response across all of the initial patients at this dose of MVT-5873. We are enrolling additional patients at this dose level to confirm our early clinical results with a goal to determine if these clinically meaningful initial results can continue to be replicated in a larger patient population. With additional confirmatory data, we could establish the potential of combining MVT-5873 with first line therapy in very difficult to treat cancer patients," commented David Hansen, MabVax’s President and Chief Executive Officer.

This Phase 1 clinical trial is an open-label, multi-center nonrandomized study evaluating the safety and recommended Phase 2 dose of MVT-5873 in combination with a standard of care chemotherapy in subjects with pancreatic and other CA19-9 positive malignancies. Secondary objectives include evaluating tumor response rate by RECIST 1.1, duration of response, and to determine pharmacokinetics. This study utilizes a conventional 3+3 design to identify the recommended Phase 2 dose. Dr. Eileen O’Reilly, Associate Director of the David M. Rubenstein Center for Pancreatic Cancer Research, attending physician, member at Memorial Sloan Kettering Cancer Center and Professor of Medicine at Weill Cornell Medical College is the lead investigator in the MVT-5873 Phase 1 clinical trial.

For additional information about the Phase 1 MVT-5873 clinical trial, please visit clinicaltrials.gov, and reference Identifier NCT 02672917.

NICE recommends FOTIVDA®? (tivozanib) as a new, first-line treatment for advanced renal cell carcinoma

On February 12, 2018 EUSA Pharma (EUSA), reported that the National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending tivozanib as a first-line treatment option for advanced renal cell carcinoma (aRCC) in line with its licensed indication (Press release, EUSA Pharma, FEB 12, 2018, View Source [SID1234523911]). Tivozanib was licensed by the European Commission (EC) in August 20171 and is an oral, once-daily, potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI). VEGFR-TKIs work by reducing the supply of blood to the tumour – denying it the food and oxygen it would need to grow in size.2

In arriving at its positive recommendation, NICE considered data from the global, open-label, randomised, multi-centre Phase III trial (TiVO-1)3 which evaluated the efficacy and tolerability of tivozanib compared to a currently available comparator VEGFR-TKI (sorafenib) in the treatment of 517 patients with aRCC. Patients treated with tivozanib experienced superior progression-free survival (PFS) (11.9 vs. 9.1 months in the overall population and 12.7 vs. 9.1 months in treatment naïve patients) versus sorafenib.3 There was also an improved side effect profile with tivozanib, with only 14% (versus 43% with sorafenib) requiring a dose reduction due to adverse events (AEs).3 In addition, fewer people on tivozanib experienced burdensome side effects, such as diarrhoea (23% vs 33%), and hand-foot syndrome (14% vs 54%).3

Dr Lisa Pickering, Consultant Medical Oncologist at St George’s Hospital, London, commented: This is excellent news for patients with aRCC. A key treatment goal is to enable patients to live without their cancer progressing for longer periods of time – we cannot cure their cancer but we can help to preserve normal living for as long as possible. That is why I’m delighted that NICE has recommended tivozanib as a treatment option."

Around 12 people in the UK die every day of kidney cancer, with more than 40% of cases in England diagnosed at a late (advanced) stage. Kidney cancer is expected to be one of the fastest increasing cancers over the next 10 years, as a result of the UK’s ageing population, and with smoking and a rise in obesity also playing a part.4

Nick Turkentine, Chief Executive of Kidney Cancer UK, said: "With over 12,500 new cases of kidney cancer being diagnosed every year this is a great result for people with aRCC and the overall fight with the disease. It is vitally important patients have access to effective, well-tolerated treatments, so they can spend more precious time with their families and loved ones. We applaud EUSA Pharma, NICE and NHS England for making this happen."

Patients with advanced renal cell carcinoma (aRCC) who may benefit from treatment with tivozanib will be able to access it from today as the final guidance is published, and should be able to have immediate access through the CDF.

Lee Morley, EUSA Pharma’s Chief Executive Officer commented "We are very pleased that NICE are recommending the use of Fotivda for the first line treatment of advanced Renal Cell Carcinoma and that Fotivda will be funded immediately in England and Wales, meaning physicians and patients can experience the benefits of Fotivda. Fotivda has the potential to become an important new first-line therapy and the recommendation by NICE is a great achievement for the EUSA team delivering on their mission to improve the lives of those patients suffering from cancer."