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Progenitor Life Sciences, LLC Engages Maxim Group LLC to Explore Strategic Transactions in Immuno-Oncology

On August 1, 2016 Progenitor Life Sciences LLC, developer of proprietary technologies for producing induced-pluripotent stem cells (iPSCs) and natural killer (NK) cells from adult donors for use as universally compatible ‘off-the-shelf’ cellular immuno-therapies, reported it has retained Maxim Group LLC as its exclusive financial advisor (Press release, Progenitor Cell Therapy, AUG 1, 2016, View Source [SID:1234514165]). Maxim will assist the Company in identifying and negotiating partnerships that could result in a wide range of strategic transactions.

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Progenitor CEO Gary R. Sams stated, "Our approach using proprietary iPSC and immunocompatibility technologies to generate universal donor/recipient-compatible chimeric antigen receptor T cells and NK cells (CAR-T and CAR-NK cells) is truly unique and efficient. Our technologies provide developers of CAR therapies a competitive advantage by enabling rapid, high throughput production and functional screening of CAR-expressing immune cells. Because our cell lines are generated with non-disruptive DNA insertion technology, they are more reliable and offer a potentially greater margin of safety for use in cell-based therapies. The agreement with Maxim Group will enhance our ability to establish strategic partnerships and collaborations with companies in the immuno-oncology sector that would benefit significantly from our unique capabilities."

GenSpera Announces Name Change to Inspyr Therapeutics

On August 1, 2016 GenSpera, Inc. (OTC/QB: GNSZ), a clinical-stage biotechnology company developing a novel prodrug therapeutic for the treatment of cancer, reported that it will change its corporate name to Inspyr Therapeutics, Inc. and will begin trading on OTC/QB under the ticker symbol NSPX effective August 2, 2016 (Press release, GenSpera, AUG 1, 2016, View Source [SID:1234514164]). The Company will also unveil a new corporate website at www.inspyrtx.com.

"The changing of our corporate name is a first step in a number of upcoming actions that will define our path forward and our focus on building shareholder value," said Peter E. Grebow, Ph.D., Interim Chairman. "Our new corporate name, Inspyr Therapeutics, reflects the significant potential we see with the novel prodrug mipsagargin and our Company’s future potential."

PDL BioPharma Completes Second Tranche Payment Under Royalty Transaction with ARIAD Pharmaceuticals

On August 1, 2016 PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) reported that it has funded the second tranche of $50 million to ARIAD Pharmaceuticals, Inc. (ARIAD) (NASDAQ: ARIA) which was due on the first anniversary of the closing date under the terms of the ARIAD Royalty Agreement (Press release, PDL BioPharma, AUG 1, 2016, View Source [SID:1234514163]). This agreement was entered into in July 2015, in exchange for royalties on the net revenues of Iclusig (ponatinib). As a result of the second tranche payment, under the terms of the ARIAD Royalty Agreement, PDL’s royalty percentage will increase to 5.0% of the U.S. and European net revenues of Iclusig and 5.0% of the payments ARIAD receives elsewhere in the world until December 31, 2018 (subject to agreed-upon annual maximum payments). Beginning January 1, 2019 and thereafter, the royalty rate will increase to 6.5% in all jurisdictions and continue until December 31, 2033, subject to a put option of PDL upon the occurrence of specified events and a call option of ARIAD.

In May of 2016, PDL and ARIAD agreed to amend the ARIAD Royalty Agreement, as a result of ARIAD’s share purchase agreement with Incyte Corporation (Incyte), to include net sales of Iclusig made by Incyte once it takes over ARIAD’s commercialization operations with respect to Iclusig in the European Union and certain other countries. In addition, the Company and ARIAD agreed to restructure future funding under the Royalty Agreement such that ARIAD’s option to draw up to an additional $100 million between January and July of 2016 was reduced to a maximum amount of up to an additional $40 million, which can be drawn at ARIAD’s option in July of 2017.

Emergent BioSolutions Completes Spin-Off of Aptevo Therapeutics

On August 01, 2016 Emergent BioSolutions Inc. (NYSE:EBS) reported that it has completed its previously announced spin-off of Aptevo Therapeutics Inc (Press release, Emergent BioSolutions, AUG 1, 2016, View Source [SID:1234514159]). (Nasdaq:APVO) through the distribution of all of the shares of Aptevo common stock to the holders of Emergent BioSolutions common stock. As a result of the spin-off, Aptevo is now an independent public company and listed on the Nasdaq Global Select Market under the ticker symbol "APVO."

"Completion of this spin-off is a significant milestone for both Emergent and Aptevo that allows each company to tailor its business strategy to best address opportunities within its target market," said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. "We are excited about Aptevo’s potential and extend our best wishes for success to Aptevo’s management team and board of directors."

As previously announced, Emergent stockholders of record as of the close of business on July 22, 2016, the record date for the distribution, received one share of Aptevo common stock for every two shares of Emergent common stock held as of the record date, plus cash in lieu of any fractional shares. No action or payment by Emergent stockholders was required to receive Aptevo shares.

As a result of the completion of the distribution, the conversion rate under the indenture governing Emergent’s 2.875% convertible senior notes due 2021 will be adjusted in accordance with the terms of the indenture, with the ten-trading day valuation period contemplated by the indenture commencing today and ending on August 12, 2016. The new conversion rate will be determined and announced promptly following the end of the ten-trading day valuation period.

MEI Pharma’s Pracinostat Receives Breakthrough Therapy Designation from FDA for Treatment in Combination with Azacitidine of Patients with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Chemotherapy

On August 1, 2016 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational drug Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are ≥75 years of age or unfit for intensive chemotherapy (Press release, MEI Pharma, AUG 1, 2016, View Source [SID:1234514156]). In addition, agreement has been reached with the FDA on the Company’s proposed Phase III study design.

The Breakthrough Therapy Designation is supported by data from a Phase II study of Pracinostat plus azacitidine in elderly patients with newly diagnosed AML, not candidates for induction chemotherapy, which showed a median overall survival of 19.1 months and a complete response (CR) rate of 42% (21 of 50 patients). These data compare favorably to a Phase III study of azacitidine (AZA-AML-0011), which showed a median overall survival of 10.4 months with azacitidine alone and a CR rate of 19.5% in a similar patient population. The combination of Pracinostat and azacitidine was generally well tolerated, with no unexpected toxicities. The most common grade 3 4 treatment-emergent adverse events included febrile neutropenia, thrombocytopenia, anemia and fatigue.

"This designation speaks to both the serious unmet need for AML patients unfit to receive intensive chemotherapy and the promise of Pracinostat to address this need," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "With this designation, the FDA recognizes that our preliminary clinical data demonstrate that Pracinostat may result in a substantial improvement in the lives of AML patients over available therapy. We have worked closely with the FDA to get to this point and now focus on executing our Phase III study and bringing Pracinostat to market as quickly and efficiently as possible."

According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. A Breakthrough Therapy Designation has all the benefits of the fast track program together with more intensive guidance on an efficient drug development program and an organizational commitment involving senior managers.

About Pracinostat

Pracinostat is a potent oral inhibitor of a group of enzymes called histone deacetylases, or HDACs. HDACs belong to a larger set of proteins collectively known as epigenetic regulators that can alter gene expression by chemically modifying DNA or its associated chromosomal proteins. Abnormal activity of these regulators is believed to play an important role in cancer and other diseases. Pracinostat has been tested in multiple Phase I and Phase II clinical studies in advanced hematologic diseases and solid tumor indications. The results of these studies suggest that Pracinostat has potential best-in-class pharmacokinetic properties when compared to other oral HDAC inhibitors, with side effects often associated with drugs of this class, including fatigue and myelosuppression.

About AML

Acute myeloid leukemia (also known as acute myelogenous leukemia) is the most common acute leukemia affecting adults, and its incidence is expected to continue to increase as the population ages. The American Cancer Society estimates about 20,830 new cases of AML per year in the U.S., with an average age of about 67 years. Treatment options for AML remain virtually unchanged for nearly 40 years. Front line treatment consists primarily of chemotherapy, while the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend hypomethylating agents azacitidine or decitabine as low intensity treatment options for AML patients over the age of 60 who are unsuitable for induction therapy.