On May 24, 2016 Fortress Biotech reported positive data from its phase I/II study of CNDO-109- activated allogeneic natural killercells in acute myeloid leukemia (AML) (Press release, UCLB, MAY 24, 2016, View Source [SID:1234512720]). Schedule your 30 min Free 1stOncology Demo!
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Originally developed in the laboratory of Professor Mark Lowdell from the UCL Department of Haematology,biopharmaceutical company Fortress Biotech obtained exclusive worldwide rights from UCL Business PLC to develop and commercialise CNDO-109, a lysate (disrupted CTV-1 cells, cell membrane fragments, cell proteins and other cellular components) that activates donor NK cells ex vivo.
AML is a cancer of the myeloid line of blood cells characterised by the rapid growth of abnormal white blood cells. Once diagnosed with AML, patients typically receive induction and consolidation chemotherapy, with the majority achieving complete remission. However, roughly 70 to 80 per cent of patients who first complete remission will relapse, and the overall five-year survival rate is less than 25 per cent.
With three high-risk patients treated at the higher dose units having remained in complete remission for two years, data suggest that CNDO-109-activated allogeneic natural killer cells are safe and well-tolerated, and capable of extending complete remissions in high-risk acute myeloid leukemia patients.
Author: [email protected]
MorphoSys and MD Anderson Cancer Center Join Forces for the Development of Novel Oncology Therapeutics
On May 24, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and The University of Texas MD Anderson Cancer Center reported a long-term strategic alliance for the discovery and development of novel therapeutic antibodies against cancer (Press release, MorphoSys, MAY 24, 2016, View Source [SID:1234512718]). Schedule your 30 min Free 1stOncology Demo! MorphoSys will work with MD Anderson’s Oncology Research for Biologics and Immunotherapy Translation (ORBIT) unit, a platform of MD Anderson’s Moon Shots Program with a combination of industry and academic science expertise in the development of monoclonal antibodies.
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Collaborating on numerous targets in a variety of oncology indications, the partners will work together to identify, validate and develop novel anti-cancer antibodies through to clinical proof of concept. MorphoSys will apply its proprietary Ylanthia technology to generate and optimize fully human antibody candidates against jointly selected targets. The parties will collaborate in target validation and preclinical drug development to quickly bring selected candidates into the clinic.
"We are excited to join forces with MD Anderson, one of the world’s most respected cancer research and care institutions, to work on bringing cancer treatment to a new level," said Dr Simon Moroney, Chief Executive Officer of MorphoSys. "This partnership combines MD Anderson’s expertise with our strength in developing innovative antibodies based on our Ylanthia technology platform. This deal is another step in the execution of our strategy of building an oncology pipeline of optimized therapeutic antibodies against innovative targets, with the goal of improving outcomes for cancer patients."
MD Anderson also will conduct in collaboration with MorphoSys early clinical trials of therapeutic antibody candidates with the goal of obtaining proof of concept, utilizing its translational medicine capabilities to optimize development.
"ORBIT is committed to bringing ground-breaking monoclonal antibodies into the clinic that can significantly benefit cancer patients", said Carlo Toniatti, M.D., Ph.D., executive director of ORBIT. "This alliance is designed to complement our drug discovery and clinical strengths and quickly and effectively develop potentially disruptive anti-cancer therapies for patients worldwide."
The long-term collaboration, licensing and co-development alliance will embrace multiple targets and programs. During the five-year research phase of the partnership, the parties will select innovative targets and apply their respective expertise and technologies to generate and validate antibody candidates against these targets. During the development phase of the collaboration, the parties will jointly develop antibodies through clinical proof of concept. Thereafter, MorphoSys has options to continue development of selected antibodies through later clinical stages.
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.
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.
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.