On September 23, 2015 MedImmune, the global biologics research and development arm of AstraZeneca, and Tanabe Research Laboratories U.S.A., Inc. (TRL), a subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), reported that they have entered into a strategic collaboration and licensing agreement under which TRL will use MedImmune’s pyrrolobenzodiazepine (PBD)-based warhead and linker technology to generate monospecific and bispecific antibody-drug conjugates (ADCs) for investigation in various cancers (Press release, Mitsubishi Tanabe Pharma, SEP 22, 2015, View Source [SID:1234507530]).

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Under the agreement, TRL will exclusively license MedImmune’s next generation PBDs. The companies will partner to combine MedImmune’s PBD technology with TRL’s antibodies to develop next generation ADCs against a number of cancer targets. MedImmune will receive an upfront payment, development and commercial milestone payments, as well as single digit royalties on worldwide net sales.

MTPC will be responsible for the pre-clinical research, development, manufacturing and later-stage activities, including global commercialization. MedImmune has the option to an exclusive license for the development and commercialization of the programs in the United States and Europe at the conclusion of a Phase Ib trial.

ADCs are a developing area of cancer drug technology that offers selective targeting of cancer cells. MedImmune’s proprietary PBD technology provides cytotoxic agents, or warheads, for attachment to specific cancer-targeting antibodies. This targeted ADC approach has the potential to optimize the delivery of the cancer drug to the tumor. MedImmune has an active internal ADC pipeline with candidates nearing the clinic, and TRL has an active program of mono- and bispecific-antibodies targeting cancer cells.

"We are very pleased to join forces with MedImmune to further exploit our proprietary tumor specific antibodies," said Naoki Sakurai, Ph.D, Chief Executive Officer, TRL. "This is an important start for our pioneering work in the field of mono- and bi-specific therapeutic ADCs and we are excited to explore innovative therapeutic approaches in collaboration with one of the world’s leading biotech companies," added Roland Newman, Ph.D., Chief Scientific Officer, TRL.

Ronald Herbst, Vice President, Oncology Research & Development, MedImmune, said, "Developing next generation antibody-drug conjugates, including our proprietary PBD technology, is one of our key strategic areas of focus in oncology. Today’s collaboration with Tanabe Research Laboratories supports our efforts to grow our ADC portfolio through both internal activities and external partnerships, with the goal of generating novel treatments to meaningfully improve the lives of cancer patients."

On September 23, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported updated safety and preliminary efficacy data on its proprietary drug candidate MOR202 from an ongoing phase 1/2a study (Press release, MorphoSys, SEP 22, 2015, View Source [SID:1234507519]). MOR202 is a fully human HuCAL antibody targeting CD38, a highly expressed and validated target in multiple myeloma. The clinical data, which will be presented at the 15th International Myeloma Workshop in Rome, Italy, September 23th-26th, confirm the very good overall safety profile previously reported at this year’s ASCO (Free ASCO Whitepaper) meeting. The update also includes promising first results from the highest dose escalation cohort of 16 mg/kg of MOR202 weekly plus dexamethasone and from the recently initiated combination arms with the immunomodulatory drugs (IMiDs) pomalidomide and lenalidomide.

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As of August 24, 2015, 50 heavily pretreated patients with relapsed/refractory multiple myeloma had received MOR202 with and without dexamethasone and in a few cases in combination with pomalidomide or lenalidomide as part of a recently initiated second part of the study. MOR202 continued to demonstrate long-lasting tumor control, as well as signs of activity. In addition to the earlier reported very good partial response (VGPR) in a cohort dosed weekly with 4 mg/kg of MOR202 plus dexamethasone, a minor response (MR) in the 8 mg/kg MOR202 weekly plus dexamethasone cohort further improved into a partial response (PR). A first MR was observed in one patient in an ongoing cohort at the highest dose level, of 16 mg/kg MOR202 plus dexamethasone. The first evaluable patient in the ongoing combination cohort of 8 mg/kg MOR202 plus pomalidomide and dexamethasone achieved a PR already after the first cycle. In the ongoing combination cohort of 8 mg/kg MOR202 plus lenalidomide and dexamethasone, one patient showed a MR after the first cycle. In total, the data shows one VGPR, two PRs and two MRs so far.

"The MOR202 data have matured nicely since we presented the program at this year’s ASCO (Free ASCO Whitepaper) conference and we expect an even more comprehensive picture as the trial progresses. First results from the combination cohorts with lenalidomide and pomalidomide confirm the synergistic potential we have demonstrated in preclinical studies using our antibody together with these two IMiDs. This bodes well for the future development of MOR202," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

The data to be presented at the International Myeloma Workshop 2015 show that MOR202 was safe and tolerable and could be administered as a 2-hour infusion. Infusion-related reactions occurred in 15 patients (30%). Only one out of these 15 patients received dexamethasone as co-medication and experienced an infusion-related reaction (grade 1). In the absence of dexamethasone, all infusion reactions were grade 1-2 except for one patient with grade 3, mainly limited to the first infusion. The maximum tolerated dose has not been reached.

"The antibody continues to show a balanced safety and tolerability profile and the preliminary efficacy seen so far with MOR202 as single agent and in combinations is promising. Considering the low rate of infusion reactions, even in cohorts without dexamethasone, the short infusion time and other aspects, MOR202 may turn out to be an excellent choice in terms of safety and tolerability," commented Dr. Marc-Steffen Raab, Group Leader Experimental Therapies for Hematologic Malignancies at the Heidelberg University Hospital and the German Cancer Research Center DKFZ.

The study is ongoing and MorphoSys plans to provide a further update at a medical conference later this year.

The IMW poster can be downloaded from the Company’s website:

Poster #0156

Raab et al.: A phase I/IIa study of the human CD38 antibody MOR202 (MOR03087) in relapsed or refractory multiple myeloma

The poster presentation will take place on Friday Sep 25th, 6:40pm to 7:40pm CEST.

On September 22, 2015 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS) reported that it plans to host a conference call and webcast on Thursday, September 24, 2015, to provide an update on the safety and tolerability profile of RAD1901, a selective estrogen receptor degrader, from the completed Phase I study of RAD1901 in 52 healthy volunteers (Press release, Radius, SEP 22, 2015, View Source [SID:1234507517]).

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On November 5-9, 2015, Radius plans to present one poster with an oral presentation from its investigational drug RAD1901 clinical development program at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) Meeting in Boston, MA. The title of the poster and oral presentation is:

— RAD1901, an orally available selective estrogen receptor down regulator, has potent anti-tumor activity in in vitro and in vivo models of ER+ breast cancer

On December 8-12, 2015, Radius also plans to present three posters from its investigational drug RAD1901 clinical development program at the San Antonio Breast Cancer Symposium ("SABCS") in San Antonio, TX. The titles of the three poster presentations at SABCS are as follows:

— RAD1901, a Novel Oral, Selective Estrogen Receptor Degrader ("SERD") with Single Agent Efficacy in ER+ Primary Patient Derived ERS1 Mutant Xenograft Model

— A Phase 1 Dose Escalation Study of RAD1901, an Oral Selective Estrogen Receptor Degrader, in Healthy Postmenopausal Women

— A Phase 1 Study of RAD1901, a Novel, Orally Available, Selective Estrogen Receptor Degrader, for the Treatment of ER Positive Advanced Breast Cancer

On November 17, 2015, Radius will host an Investor Day in New York City. A SAVE the DATE Card with further details will be sent out soon.

On September 22, 2015 Exelixis, Inc. (NASDAQ:EXEL) reported its slate of activities at the European Cancer Congress (ECC) 2015, which will be held September 25-29, 2015 in Vienna, Austria (Press release, Exelixis, SEP 22, 2015, View Source;p=RssLanding&cat=news&id=2089675 [SID:1234507516]). As previously announced, data from clinical trials of cabozantinib and cobimetinib will be the subject of three presentations at the meeting. The company will also host a live investor/analyst webcast on Saturday, September 26.

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METEOR Data to be Presented during the ECC 2015 Presidential Session I

As previously announced, detailed data from METEOR will be presented at the ECC as a late-breaking abstract in the Presidential Session I on Saturday, September 26, 2015. The details of the presentation are as follows:

• Abstract 4LBA: Late-Breaking Abstract: Cabozantinib versus Everolimus in Patients with Advanced Renal Cell Carcinoma: Results of the Randomized Phase 3 METEOR Trial

Toni K. Choueiri, M.D.
Presidential Session I
Saturday, September 26, 2015
Session from 14:30-16:40 CEST (8:30-10:40 a.m. EDT); presentation expected to begin at 16:20 CEST (10:20 a.m. EDT)

On September 22, 2015 Medtronic’s (NYSE: MDT) Minimally Invasive Therapies Group reported that it has recently launched a 2,500-patient, international study to assess real-world impact of its superDimension(TM) navigation system (Press release, Medtronic, SEP 22, 2015, View Source;p=RssLanding&cat=news&id=2089421 [SID:1234507514]). The Company developed the study to support and validate the superDimension system, which the Company hopes will become the global standard-of-care for obtaining lung tissue biopsies from the periphery of the lungs1.

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The LungGPS(TM) technology used in the superDimension system is the first of its kind to enable Electromagnetic Navigation Bronchoscopy procedures (also known as ENB procedures). ENB procedures provide a minimally invasive approach to access difficult-to-reach areas of the lung, which can aid in the diagnosis of lung disease and thereby lead to earlier, personalized treatment – potentially saving lives.

With a historical lack of effective, non-invasive diagnostic technologies, lung cancer remains the number one cancer killer in the world, accounting for more cancer deaths than breast, colon and prostate cancer combined2.

Up to 75 centers around the globe will enroll patients in the single-arm, multi-center post-market observational study, known as NAVIGATE, to evaluate the diagnostic performance of ENB procedures. The study will also determine how often physicians use the technology to successfully obtain biopsy samples from the surrounding lymph nodes and place fiducial markers or dyes to guide subsequent procedures to ablate or remove lung tumors.

The first enrolled patient underwent an ENB procedure at Pulmonary and Critical Care Associates of Baltimore, in Maryland on April 16, 2015. Patients will be followed for 24 months.

"With the introduction of ENB procedures, we can now navigate through the lung allowing us to screen for cancer and other diseases without surgery," said Erik Folch, MD, interventional pulmonologist at Beth Israel Deaconess Medical Center in Boston, and co-National Lead Investigator of the NAVIGATE study. "With this minimally invasive diagnostic approach now available, we are able to manage thousands of patients with suspicious lung nodules that show up on computerized tomography (CT) scans without resorting to surgery. This important study holds the key to determining the real-world impact of this minimally invasive approach that, I believe, could significantly reduce the mortality of lung cancer."

The ENB procedure allows patients to avoid surgery for benign disease and other invasive procedures like transthoracic needle aspiration.

"As lung cancer screening initiatives increase and we find more suspicious lung nodules, it is especially critical to provide minimally invasive diagnostic options earlier so patients can receive treatment sooner and have better chances of long-term survival," said Sandeep Khandhar, MD, a CVTSA thoracic, surgical director of thoracic oncology at Inova in Falls Church, Virginia and co-National Lead Investigator of the NAVIGATE study. "We are at a crucial time where diagnostic and surgical technologies have advanced to a level where I believe there could be a significant shift in patient outcomes and many patients can go on to lead long, active and healthy lives after a lung cancer diagnosis, which was almost unheard of even 10 years ago."

"Medtronic is committed to providing innovative diagnostic and therapeutic solutions for lung disease that have the potential to transform care and improve outcomes for patients worldwide," said Michael Tarnoff, MD, vice president and chief medical officer, Minimally Invasive Therapies Group at Medtronic. "We hope the NAVIGATE study will help confirm the impact of ENB procedures that we have seen in over 50,000 cases performed at more than 600 hospitals commercially and as part of prior clinical trials. Given the results seen to date, we are confident that this approach has the potential to become a recommended global standard of care to aid in diagnosis of peripheral lung lesions."

According to the American Lung Association, lung cancer is the leading cause of cancer-related deaths in the United States3. In its early stages, lung cancer presents few, if any, symptoms. As a result, diagnosis for the vast majority of lung cancer patients happens in the late stages, causing long-term survival rates to drastically decline. When diagnosed early, an estimated 85 percent of lung cancer cases appear at a more curable stage4. Early detection and immediate treatment dramatically increases the typical long-term survival rate from 15 percent at five years3 to 88 percent at 10 years4.

The superDimension system has received FDA 510(k) clearance in the United States, CE Mark in Europe and it has also been approved for use in numerous international markets.

Additional information about the NAVIGATE study and sites enrolling can be found at View Source