On June 26, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported the pricing of an underwritten public offering of 4,750,000 shares of its common stock, offered at a price of $26.00 per share (Press release, Odonate Therapeutics, JUN 26, 2019, View Source [SID1234537275]). In addition, Odonate has granted the underwriters a 30-day option to purchase up to an additional 712,500 shares of its common stock on the same terms and conditions. All shares of common stock sold in the offering are being sold by Odonate. The offering is expected to close on or about June 28, 2019, subject to customary closing conditions.

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The gross proceeds from the proposed underwritten public offering are expected to be $123.5 million before deducting customary underwriting discounts and offering expenses. Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development and regulatory activities relating to tesetaxel, as well as for working capital and general corporate purposes.

Jefferies and Cowen are acting as joint book-running managers. LifeSci Capital is acting as lead manager for the offering.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-229785), which became effective on February 28, 2019. A final prospectus supplement relating to and describing the terms of the offering will be filed with the Securities and Exchange Commission (SEC). The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering can be made only by means of a prospectus supplement and an accompanying base prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]) or Cowen and Company, LLC (c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717; telephone: 631-274-2806; email: [email protected]).

On June 26, 2019 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported that it has begun making its next-generation Percepta Genomic Sequencing Classifier (GSC) available to physicians, providing them with expanded lung cancer risk information that can further guide next steps for patients with suspicious lung nodules, as compared to the original Percepta test (Press release, Veracyte, JUN 26, 2019, View Source [SID1234537273]). The RNA whole-transcriptome sequencing-based test is Veracyte’s first commercial product to emerge since entering into the long-term strategic lung-cancer collaboration with Johnson & Johnson Innovation LLC*, which was announced in January 2019.

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"Lung nodules are often challenging to diagnose using traditional tools, which can lead to unnecessary invasive procedures or to delayed treatment," said Giulia Kennedy, Ph.D., Veracyte’s chief scientific and medical officer. "The ability to use genomic testing – such as the Percepta GSC – to determine which patients need intervention and those who may be safely monitored with routine imaging can help improve patient outcomes."

Veracyte’s commercial introduction of the Percepta GSC follows the May 2019 presentation of clinical data showing that the genomic test down-classifies patients with suspicious lung nodules to "low risk" with a negative predictive value of 91 percent. This means these patients have a low likelihood of cancer and may therefore avoid unnecessary invasive procedures. The findings also show that the test up-classifies patients to high risk with a positive predictive value of 65 percent, suggesting that there is a higher likelihood these patients have cancer, which can help guide next intervention steps. The American College of Chest Physicians recommends lung nodule patients with a low risk of cancer undergo monitoring with CT imaging and that patients with a risk of 65 percent or greater undergo surgical treatment. The Percepta GSC study involved 412 lung-nodule patients whose results were inconclusive following bronchoscopy, a common nonsurgical procedure to assess lung nodules for cancer. The new study findings were shared during the American Thoracic Society 2019 International Conference.

The Percepta GSC utilizes machine learning and is built on novel "field of injury" science – which identifies genomic changes associated with lung cancer in current or former smokers using a simple brushing of the person’s airway. The test is performed on a sample from the patient’s main lung airway, which is collected during a bronchoscopy. Veracyte estimates that approximately 360,000 bronchoscopies are currently performed each year to evaluate suspicious lung nodules for cancer and that up to 60 percent of these produce inconclusive results.

"We are excited to make the Percepta GSC available to physicians as an important tool that will help them further guide next steps for patients undergoing evaluation for suspicious lung nodules," said Bonnie Anderson, Veracyte’s chairman and chief executive officer.

Veracyte is collaborating with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration is accelerating two key lung cancer programs for Veracyte, including the commercialization of its Percepta classifier on the company’s RNA whole-transcriptome sequencing platform well as the development of the first non-invasive nasal swab test for early lung cancer detection. Veracyte continues to expect to unveil early data for the nasal swab test later this year. Under terms of the agreement, Veracyte and the Lung Cancer Initiative at Johnson & Johnson will combine clinical study cohorts involving more than 5,000 patients with multiple years of clinical outcome data. Veracyte will contribute bronchial and nasal samples from its clinical trials, which are part of the company’s extensive lung cancer-focused biorepository.

Lung cancer is the leading cause of cancer deaths worldwide. In the United States, lung cancer causes more than 154,000 deaths each year – more than the next three most prevalent cancers combined. Because lung cancer is difficult to diagnose before it has metastasized, only 16 percent of cases are detected at an early stage, when the disease is more treatable. Lung cancer’s five-year survival rate is only 18 percent, much lower than that of other common cancers. Approximately 80 percent of lung cancer deaths are caused by smoking.

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.

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).

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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.

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).

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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."