Baxalta Announces Preliminary Merger Consideration Election Results

On May 23, 2016 Baxalta Incorporated (NYSE:BXLT) reported the preliminary results of the elections made by its stockholders as to the form of stock consideration to be received in Baxalta’s merger with Shire plc (LSE: SHP, NASDAQ: SHPG) (Press release, Baxalta, MAY 23, 2016, View Source [SID:1234512711]).

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As previously announced, upon the consummation of the merger, each outstanding Baxalta share will be converted into the right to receive:

(i) $18.00 in cash, and
(ii) either 0.1482 of a Shire American Depositary Share (a "Shire ADS"), with each Shire ADS representing three ordinary shares of Shire, or if a Baxalta stockholder elects, 0.4446 of an ordinary share of Shire.
Based on available information, the exchange agent for the election process has advised that, as of the election deadline of 5:00 p.m. Eastern Time on May 20, 2016, holders of approximately 41,803,203 Baxalta shares, or approximately 6.10% of the outstanding Baxalta shares, elected to receive ordinary shares of Shire rather than Shire ADSs.

Baxalta stockholders who made an ordinary share election will be unable to sell or otherwise transfer their shares unless the ordinary share election was properly revoked prior to the election deadline or unless the merger agreement is terminated. Baxalta stockholders who did not make an ordinary share election or who properly revoked any such election prior to the election deadline will, by default, receive Shire ADSs in the merger.

MD Anderson and Varian Expand Relationship with Acquisition of TrueBeam Systems

On May 23, 2016 Varian Medical Systems (NYSE: VAR) reported that The University of Texas MD Anderson Cancer Center signed an agreement to acquire six TrueBeam linear accelerators (Press release, InfiMed, MAY 23, 2016, View Source [SID:1234512712]). Scheduled for delivery over the next 24 months, the six TrueBeam systems will be added to the 24 Varian linear accelerators already treating patients at the cancer center.

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"We have been able to deliver critical cancer treatments to thousands of cancer patients as well as collaborate on strong translational research programs and clinical trial support through Varian’s technology," said Steve Hahn, chair, Division of Radiation Oncology at MD Anderson Cancer Center. "The additional TrueBeam systems will enable us to make advanced cancer care accessible to even more patients."

Varian’s TrueBeam system is an advanced medical linear accelerator capable of fast and precise image-guided radiotherapy and radiosurgery. The system is equipped with a high dose delivery rate that enables most treatments to be completed faster than was possible with earlier generations of radiotherapy technology. It incorporates numerous technical innovations that dynamically synchronize imaging, patient positioning, motion management, and dose delivery during a treatment procedure. TrueBeam has been designed to advance the treatment of lung, breast, intracranial, prostate, head and neck, and other types of cancer.

"Varian is proud of its years of working with MD Anderson," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "We have worked together to improve the quality and effectiveness of cancer care for patients who come from all over the world for treatment. TrueBeam opens the door to some exciting cutting-edge treatment capabilities that will be made available to patients in coming years."

The order for the systems was booked in March during the second quarter of the company’s fiscal year 2016.

Novocure Enrolls Last Patient in PANOVA Trial of Tumor Treating Fields Plus Chemotherapy in Advanced Pancreatic Cancer

On May 23, 2016 Novocure (NASDAQ: NVCR) reported that the last patient has been enrolled in the PANOVA trial, a phase 2 pilot trial testing Tumor Treating Fields (TTFields) plus chemotherapy in 40 patients with advanced pancreatic cancer (Press release, NovoCure, MAY 23, 2016, View Source [SID:1234512714]). The final data collection date will be six months after the last patient in.

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"The first cohort of the PANOVA trial demonstrated the safety and feasibility of combining TTFields with gemcitabine in pancreatic cancer," said Dr. Marc Kueng, Senior Internist and Medical Oncologist at the Cantonal Hospital of Fribourg in Switzerland. "The combination with nab-paclitaxel has a strong scientific rationale and is compliant with the current standard of care. We are looking forward to opening a randomized-controlled study testing the efficacy of TTFields in this difficult disease."

The prospective, single-arm study includes two cohorts of 20 patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received prior chemotherapy or radiation therapy. Novocure presented data from the first cohort of the trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Gastrointestinal Cancers Symposium in January 2016.

Data from the first cohort demonstrated the safety of the combined treatment, and also suggest improved survival and response rate among patients who received TTFields therapy with gemcitabine compared to a historical control of patients who received gemcitabine alone. PANOVA patients who received TTFields therapy plus first-line gemcitabine experienced a median progression free survival of 8.3 months compared to 3.7 months for a historical control of gemcitabine alone, and a median overall survival of 14.9 months compared to 6.7 months for a historical control. Median one-year survival was 55 percent compared to 22 percent for a historical control. Of the 19 of 20 evaluable tumors, 30 percent had partial responses compared to 7 percent with gemcitabine alone and another 30 percent had stable disease. Novocure accelerated planning for a phase 3 clinical trial in pancreatic cancer after obtaining results for the first cohort of PANOVA.

The PANOVA trial was expanded in January 2015 to include a second cohort of 20 patients testing TTFields plus gemcitabine and nab-paclitaxel. Preclinical models have demonstrated increased cancer cell sensitivity when TTFields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel.

"Our preclinical research of TTFields therapy combined with taxane-based chemotherapies demonstrated a synergistic effect," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "Given that synergy, we are optimistic about what the second cohort will show when nab-paclitaxel is added to the treatment regimen and look forward to sharing the results."

About Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer death in the U.S. The National Cancer Institute estimated that about 48,960 people would be diagnosed with pancreatic cancer and about 40,560 people would die from the disease in 2015. Five-year survival among pancreatic cancer patients is less than 6 percent. Tumor Treating Fields (TTFields) therapy is not approved for the treatment of pancreatic cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for pancreatic cancer has not been established.

TG Therapeutics, Inc. Announces Clinical Data Presentations at the Upcoming 21st European Hematology Association Annual Congress

On May 20, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 21st European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, to be held from June 9 – 12, 2016 in Copenhagen, Denmark (Press release, TG Therapeutics, MAY 20, 2016, View Source [SID:1234512627]).

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Presentations Include:

Title: Long-term follow-up of the next generation PI3K-delta inhibitor TGR-1202 demonstrates safety and high response rates in CLL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P207
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Anthony Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: Long-term follow-up of the next generation PI3Kδ inhibitor TGR-1202 demonstrates safety and high response rates in NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P315
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Owen A. O’Connor, MD, PhD, Columbia University Medical Center, NY, NY

Title: Preliminary results of a Phase I/Ib study of ibrutinib in combination with TGR-1202 in patients with relapsed/refractory CLL or MCL
Abstract Number: E1053
E-poster Presentation
Presenter: Matthew S. Davids MD, Dana-Farber Cancer Institute, Boston, MA

A copy of the EHA (Free EHA Whitepaper) abstracts were made available yesterday, May 19, 2016 through the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

8-K – Current report

On May 20, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 21st European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, to be held from June 9 – 12, 2016 in Copenhagen, Denmark (Filing, 8-K, TNI BioTech, MAY 20, 2016, View Source [SID:1234512626]).

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Presentations Include:

Title: Long-term follow-up of the next generation PI3K-delta inhibitor TGR-1202 demonstrates safety and high response rates in CLL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P207
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Anthony Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: Long-term follow-up of the next generation PI3Kδ inhibitor TGR-1202 demonstrates safety and high response rates in NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P315
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Owen A. O’Connor, MD, PhD, Columbia University Medical Center, NY, NY

Title: Preliminary results of a Phase I/Ib study of ibrutinib in combination with TGR-1202 in patients with relapsed/refractory CLL or MCL
Abstract Number: E1053
E-poster Presentation
Presenter: Matthew S. Davids MD, Dana-Farber Cancer Institute, Boston, MA

A copy of the EHA (Free EHA Whitepaper) abstracts were made available yesterday, May 19, 2016 through the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.