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Paratek Pharmaceuticals Promotes Evan Loh, M.D. to Chief Executive Officer;
Michael Bigham to Assume Role of Executive Chairman

On June 25, 2019 Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, reported the promotion of Evan Loh, M.D., to Chief Executive Officer, effective June 25, 2019 (Press release, Paratek Pharmaceuticals, JUN 26, 2019, View Source [SID1234537272]). Dr. Loh will continue to serve on the Paratek Board of Directors. Michael Bigham, who has served as Paratek’s Chairman and CEO since 2014, will remain active with the Company in the newly created role of Executive Chairman.

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"I am honored to have the opportunity to lead Paratek through the next phase of growth as we work to continue the successful launch and commercialization of NUZYRA in the U.S and establish Paratek as the leader in the anti-infective space," said Dr. Loh "My primary focus will be on creating significant value for shareholders by maintaining a clear focus on our commercialization and life-cycle expansion opportunities for NUZYRA, and ultimately ensuring patients have access to this potential life-saving therapy."

Dr. Loh has nearly 20 years of experience as a senior executive in the pharmaceutical industry, most recently serving as Paratek’s Chief Operating Officer since January 2017 and as President and Chief Medical Officer and a member of the Board of Directors since June 2014. Prior to Paratek’s merger with Transcept Pharmaceuticals, Dr. Loh was Chief Medical Officer and Chairman of the Board of Directors of Paratek from June 2012 to June 2014. Prior to joining Paratek, Dr. Loh held multiple senior leadership roles at Pfizer and Wyeth, where he led the successful global registration programs for Torisel and Tygacil. Dr. Loh currently serves on the Board of Directors of Eiger Biopharmaceuticals, Inc. and as Chairman of the Antimicrobials Working Group. Earlier in his career, Dr. Loh served as a faculty member at both Harvard Medical School and the University of Pennsylvania School of Medicine. Dr. Loh received his A.B. from Harvard College and his M.D. from Harvard Medical School.

In connection with the appointment of Dr. Loh as Chief Executive Officer, Michael Bigham will remain with Paratek and assume the role of Executive Chairman where he will continue to provide strategic guidance and leadership for the organization.

"I would like to thank Evan for his steadfast service and consummate professionalism over the years. He has worked in close partnership with me these past five years as we built Paratek from a small private company into a leading public antibiotics company with two approved antibiotics, NUZYRA and SEYSARA." said Mr. Bigham. "Evan and the team have demonstrated an ability to discover, develop and successfully launch new medicines. I look forward to

continue working closely with Evan, in partnership with Adam and Randy, to lead Paratek into the next phase of its growth."

Adam Woodrow has been promoted to President and will retain his current Chief Commercial Officer title. He will continue to lead the commercial organization to advance the U.S. launch of NUZYRA and will assume responsibility for the company’s business development initiatives. Mr. Woodrow joined Paratek in 2014 and has been instrumental in building Paratek’s commercial organization and in executing the launch of NUZYRA. Prior to Paratek, Mr. Woodrow launched or led the global strategic marketing and commercial teams for a variety of products including Tygacil, ciprofloxacin, Zosyn, Xeljanz, Enbrel, Zyvox, ReFacto, Benefix and Vyndaqel.

In addition, Randy Brenner has been promoted to Chief Development & Regulatory Officer. Randy joined Paratek in 2015 as a member of the Executive Team, leading the regulatory, quality and manufacturing activities for NUZYRA’s development and approval. Mr. Brenner’s role will now be expanded to include the development and medical functions for Paratek. Prior to joining Paratek, Mr. Brenner was Global Head of Regulatory at Shire and held multiple senior regulatory leadership roles for Pfizer and Wyeth, where he was responsible for more than 20 new product approvals globally.

Precigen Announces First Patient Dosed in Phase 1/1b Study of PRGN-3006 UltraCAR-T™ in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) or Higher Risk Myelodysplastic Syndrome (MDS)

On June 26, 2019 Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, reported that the first patient has been dosed with PRGN-3006, a first-in-class investigational therapy using Precigen’s non-viral UltraCAR-T therapeutic platform (Press release, Intrexon, JUN 26, 2019, View Source [SID1234537270]). PRGN-3006 UltraCAR-T is an autologous chimeric antigen receptor T (CAR-T) cell therapy under investigation for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndrome (MDS) (clinical trial identifier: NCT03927261).

PRGN-3006 utilizes Precigen’s transformative UltraCAR-T therapeutic platform, which eliminates ex vivo expansion and reduces manufacturing time to fewer than two days following non-viral gene transfer at the cancer center. PRGN-3006 UltraCAR-T is a multigenic CAR-T cell treatment utilizing Precigen’s advanced non-viral gene delivery system to co-express a chimeric antigen receptor, membrane-bound interleukin‐15 (mbIL15), and a kill switch for better precision and control in targeting relapsed or refractory AML and higher risk MDS. The study is conducted in collaboration with the Moffitt Cancer Center.

"The first patient dosed using Precigen’s UltraCAR-T therapeutic platform is an important milestone for our company," said Helen Sabzevari, PhD, President of Precigen. "Timing is critical for this patient population and the ability to manufacture PRGN-3006 UltraCAR-T overnight without ex vivo expansion accelerates timing to provide treatment to patients."

"AML is an aggressive disease with very poor prognosis," said James J. Mulé, PhD, Associate Center Director and Michael McGillicuddy, Endowed Chair in Melanoma Research/Treatment at the Moffitt Cancer Center. "The first patient dosed with investigational PRGN-3006 UltraCAR-T represents a significant development for this challenging patient population with high unmet medical need."

The PRGN-3006 UltraCAR-T clinical study is a single center, nonrandomized, investigator‐initiated Phase 1/1b safety and tolerability study. The safety and tolerability of PRGN‐3006 UltraCAR-T will be assessed following intravenous administration of escalating doses in patients with relapsed or refractory AML or higher risk MDS.

"AML and MDS patients have few treatment options, and time is critical when selecting the best treatment path," said David A. Sallman, MD, lead investigator for the PRGN-3006 study at the Moffitt Cancer Center. "We are hopeful that this study will be the beginning of the development of a therapeutic that may result in a critically needed new safe and efficacious treatment option that allows for rapid treatment."

About Acute Myeloid Leukemia (AML)
AML is a cancer that starts in the bone marrow, but most often moves into the blood1. Though considered rare, AML is among the most common types of leukemia in adults2. In 2019, it is estimated that 21,450 new cases of AML will be diagnosed in the US2. AML is uncommon before the age of 45, and the average age of diagnosis is about 682. The prognosis for patients with AML is poor with an average 5‐year survival rate of approximately 25 percent overall and less than a 5 percent 5‐year survival rate for patients older than 653. Amongst elderly AML patients (≥ 65 years of age) median survival is short, ranging from 3.5 months for patients 65 to 74 years of age to 1.4 months for patients ≥ 85 years of age3.

About Myelodysplastic Syndromes (MDS)
MDS are cancerous conditions of the bone marrow4 generally found in adults in their 70s5. Incidence in the US is not known for sure, but estimates range from 10,000 each year and higher5. Sometimes referred to as pre-leukemia, about 1 in 3 MDS patients progress to AML4. As diseases of the bone marrow, MDS outlook is not based on the size of a tumor or tumor metastasis, and other factors are used to predict outlook and inform the treatment plan. Some factors have been combined to develop scoring systems, such as the Revised International Prognostic Scoring System (IPSS-R)6. Using the IPSS-R6, median survival for MDS patients can be estimated to vary from less than one year for the "very high" IPSS-R risk group to more than eight years for the "very low" IPSS-R group7.

Precigen : Advancing Medicine with PrecisionTM
Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cellular therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. Precigen also follows the science opportunistically in pursuit of promising programs in emerging therapeutics. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. Precigen was founded as a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and leverages a diverse portfolio of technology platforms to advance human health. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

Precigen’s UltraCAR-TTM Therapeutic Platform
Precigen’s UltraCAR-T platform has the potential to disrupt the CAR-T treatment landscape by increasing patient access through shortening manufacturing time, decreasing manufacturing-related costs, and improving outcomes using advanced approaches for precise tumor targeting and control of the immune system. The platform brings several key advancements: 1) Non-viral gene transfer using multigenic vectors for expression of multiple effector genes leads to better precision and control of tumor targeting and eliminates the need for virus; 2) Sustained persistence and desired phenotype of infused UltraCAR-T helps address T-cell exhaustion, a common issue with current CAR-T therapies; 3) T-cell control by incorporation of kill switch technology to potentially improve the safety profile; and 4) Rapid manufacturing of UltraCAR-T cells using our proprietary non-viral gene transfer process, which eliminates the need for ex vivo propagation, thus dramatically reducing wait times for patients from weeks to fewer than two days.

Actinium Poster Detailing Actinium-225 Labeled Daratumumab Selected in Top Poster Award Competition at 2019 Society of Nuclear Medicine and Molecular Imaging Annual Meeting

On June 26, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that a poster detailing Actinium’s preclinical work with the CD38 antibody daratumumab, a blockbuster therapy marketed as Darzalex by Johnson & Johnson for patients with Multiple Myeloma, labeled with the radioisotope Ac-225 or Actinium-225 has been selected as a top poster at SNMMI for inclusion in a competitive poster competition at the 2019 Society of Nuclear Medicine and Molecular Imaging Annual Meeting (Press release, Actinium Pharmaceuticals, JUN 26, 2019, View Source [SID1234537269]). The poster titled, "225AC-CD38 antibody targeting is effective and well tolerated in experimental models of lymphoma and multiple myeloma" was selected from more than 1,100 posters that were presented at this year’s SNMMI and awarded second place in the Oncology: Basic, Translational & Therapy track (Click here for poster).

Highlights from the poster include:

Ac-225 labeled daratumumab, at an equimolar concentration, demonstrated superior antitumor activity to naked daratumumab in DAUDI lymphoma tumor xenograft model and provided a survival benefit
Tumor cell death in cell culture was increased as much as ten-fold following exposure to Ac-225 labeled daratumumab, approaching one-hundred percent cell death in certain cell lines
Immunoreactivity for the target antigen CD38 was similar to naked daratumumab demonstrating that arming the antibody with Ac-225 preserved daratumumab’s CD38 targeting ability
Dr. Dale Ludwig, Actinium’s Chief Scientific Officer, presented the poster at SNMMI.

Actinium’s AWE or Antibody Warhead Enabling technology platform generated the Ac-225 daratumumab ARC or Antibody Radiation-Conjugate. Actinium’s AWE platform is covered by know-how and trade secrets that cover the generation, development, methods of use and manufacturing of ARC’s. Actinium’s AWE intellectual property portfolio is comprised of 28 patent families and over 100 issued and pending patents having useful life extending out as far as 2039.

Dr. Ludwig commented, "We are honored that our poster was recognized for this competition from the over 1,100 posters and great work that was presented at this year’s SNMMI. It was apparent from SNMMI that the radiopharmaceutical field, particularly targeted radiotherapies, is experiencing significant growth and rapid innovation. Actinium is dedicated to staying at the forefront of the field. Our commitment is evidenced by our expanded research efforts that have resulted in a significant number of new patent filings and presentations at international conferences. Further, our active research collaboration with Astellas Pharma is ongoing and we are working to complete the third and final module of the program. Through our AWE technology platform, we have demonstrated the ability to utilize multiple isotopes with multiple targeting agents to generate potent ARCs, giving us unmatched breadth and abilities in therapeutics discovery and development. Together with Actinium’s clinical experience and comprehensive supply chain capabilities, we can offer partners and collaborators a turnkey solution from R&D to the clinic and beyond."

Innate Pharma announces publication of IPH4102 Phase I clinical trial results for CTCL in the Lancet Oncology

On June 26, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported the online publication in The Lancet Oncology of the results from the completed Phase I dose-escalation and expansion clinical trial of IPH4102 in advanced CTCL patients (Press release, Innate Pharma, JUN 26, 2019, View Source [SID1234537267]). The Lancet Oncology publication can be accessed here.

"We are very pleased with the publication of our IPH4102 Phase I results in a top tier, peer-reviewed medical journal," said Pierre Dodion, Chief Medical Officer of Innate Pharma. "The specific mode of action of IPH4102 and its therapeutic potential in advanced T-cell lymphoma, now available to the broader Lymphoma community, demonstrate that targeting of KIR3DL2 by IPH4102 result in a combination of high and durable responses, a favorable safety profile and a substantial improvement in quality of life in Sézary syndrome. The IPH4102 Phase I study design included several innovative features including a smaller cohort of patients at the lowest dosages and intra-patient dose escalation which allowed for the optimization of the overall study execution. Based on these Phase I clinical trial data, we launched the TELLOMAK Phase II clinical trial in June 2019, which simultaneously could enable the registration of IPH4102 in Sézary syndrome and allow us to explore its potential in broader patient populations of T-cell lymphoma such as Mycosis fungoides (MF) and peripheral T-cell lymphoma (PTCL)."

Rafael Pharmaceuticals Enters into Out-Licensing Agreement with Ono Pharmaceutical to Accelerate Clinical Development and Commercialization of Cancer Drug Candidate CPI-613® (devimistat) in Japan and Other Asian Countries

On June 25, 2019 Rafael Pharmaceuticals, a leader in the growing field of cancer metabolism-based therapeutics, reported that it has entered into an out-licensing agreement with Ono Pharmaceutical Co., Ltd. ("Ono"), a pharmaceutical company committed to creating innovative medicines. (Press release, Ono, JUN 25, 2019, View Source [SID1234574183]). The exclusive license agreement is for the development and commercialization of CPI-613 (devimistat), Rafael’s first-in-class clinical lead compound, which targets cancer metabolism enzymes, as well as its other related compounds.

Under the terms of the agreement, Rafael will receive a one-time upfront payment of approximately $12.9 million USD and up to an additional approximately $150.3 million USD if certain development and commercial milestones are achieved. Rafael will also receive low-double digit royalties based on net sales of the Products in Japan, South Korea, Taiwan and ASEAN (Association of Southeast Asian Nations) countries. ONO will have exclusive rights to develop and commercialize the Products for all indications in ONO’s territory. Rafael continuously retains all exclusive rights to develop and commercialize the Products outside of ONO’s territory.

"It is a true honor to partner with ONO, which is one of the oldest pharmaceutical companies in Japan with an abundance of experience in drug discovery and development," said Sanjeev Luther, President and CEO of Rafael. "With ONO’s extensive expertise and deep roots in the region, we hope that devimistat can help fill a major gap in oncology therapeutics in Japan and other Asian countries. It is our ongoing mission to have a meaningful impact on the lives of cancer patients around the globe, and ONO enables us to have even greater reach."

"Devimistat has shown tremendous promise in clinical trials, and partnering with ONO allows us to extend the benefits of the drug to large patient populations in Asia," said Howard Jonas, Chairman of Rafael. "ONO has demonstrated an impressive track record in drug development and commercialization in Asian countries, specifically in oncology, which makes them a natural fit as our partner."

"We are very delighted to collaborate on devimistat with Rafael, a leader in the growing field of cancer metabolism-based therapeutics," said Gyo Sagara, President, Representative Director of ONO. "Devimistat has shown promising efficacy and safety in the previous clinical trials, and we believe that devimistat will be a new treatment option to patients suffering from devastating cancers in Asian countries."