The CEACAM5-targeting ADC was initially created by ImmunoGen and licensed to Sanofi as part of a broad research collaboration (Filing 10-K , ImmunoGen, AUG 28, 2014, View Source [SID:1234500837]).
IMGN779 is a CD33-targeting antibody with a DNA-acting payload agent, DGN462, which is under development by ImmuGen for the treatment of acute myeloid leukemia.

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Cancer, brain; Cancer, breast
It is in a Phase I MTD study in healthy volunteers for the treatment of metastatic breast cancer, including breast cancer brain metastases (BCBM) (Press release Radius, AUG 28, 2014, View Source [SID:1234501003]). The study is designed to evaluate the tolerability, safety and pharmacokinetics of RAD1901, and also use 18F-fluroestradiol positron emission tomography to provide a pharmacodynamic assessment of estrogen receptor turnover following RAD1901 treatment. Levels of RAD1901 in cerebrospinal fluid samples taken from the study subjects will be measured to confirm that RAD1901 has crossed the blood brain barrier.

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On August 26, 2014 BeiGene reported that it has dosed the first patient in a Phase 1 study of BGB-3111 for the treatment of cancer (Press release BeiGene, AUG 26, 2014, View Source [SID:1234501202]). BGB-3111 is an investigational, oral, highly selective and potent inhibitor of Bruton tyrosine kinase (BTK), a critical component of B-cell receptor (BCR) signaling which plays an important role in B-cell malignancies.
"We are excited to begin this first-in-human trial of BGB-3111, which we feel has the potential to be a best-in-class BTK inhibitor based on our preclinical results to date," said Dr. Jason Yang, Senior Vice President and Head of Clinical Development at BeiGene. "With the strong support of our experienced team of investigators, we look forward to conducting this study and assessing dosing, PK and safety results, with the potential for early anti-tumor activity as we move toward the trial’s expansion phase later this year."
The Phase 1a dose escalation portion of study will be conducted at 4 Australian sites, followed by a 1b expansion phase which will enroll disease-specific cohorts at the maximally-tolerated or biologically-relevant dose. BeiGene currently expects to finish the dose escalation portion in the second quarter of 2015, with data readout for the expansion stage expected by the end of 2015 or beginning of 2016.
"I am very pleased to be involved in the clinical development of this exciting new anti-cancer drug," commented Dr. Constantine Tam, lead investigator for the trial at the Peter MacCallum Cancer Centre in Melbourne. "BTK inhibitors have demonstrated impressive clinical activity in several B-cell malignancies, and BGB-3111 shows the potential for significant advantages over previous BTK inhibitors in preclinical studies. We hope these advantages will continue to translate into a stronger activity and safety profile as BGB-3111 advances through the clinic."
"We have continued to rapidly accelerate our research development plan, with three promising candidates against different targets entering the clinic within the past 9 months," commented John V. Oyler, CEO of BeiGene. "As our first wholly-owned program to enter clinical studies, BGB-3111 is yet another validation of our novel translational research platform and a reflection of our ability to execute on significant
clinical milestones – both on our lead partnered programs and our proprietary compounds. We look forward to advancing our additional promising preclinical candidates in the months ahead, and expect to bring up to several new small molecules/biologics into the clinic within the next year."
BeiGene is currently investigating two other small molecule inhibitors in clinical development as part of a strategic partnership with Merck Serono: BGB-283, a second-generation B-RAF inhibitor which entered a Phase 1 study in November 2013; and BGB-290, a PARP inhibitor which entered a Phase 1 study in July 2014.

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On August 25, 2014 Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson, reported that it has acquired Covagen AG (Press release Johnson & Johnson, AUG 25, 2014, View Source [SID:1234501612]). The opportunity was identified and facilitated through the Johnson & Johnson Innovation Center in London. The company’s lead product, COVA 322, a bispecific anti-tumor necrosis factor (TNF)-alpha/anti-interleukin (IL)-17A FynomAb, is in Phase 1b study for psoriasis and holds potential as a treatment for a broad range of inflammatory diseases including rheumatoid arthritis. Covagen develops FynomAbs, multi-specific protein therapeutics, by fusing its fully human Fynomer binding proteins to antibodies. Fynomers are small binding proteins engineered to bind to target molecules with the same affinity and specificity as antibodies. The tailored architecture and novel mode of action of FynomAb therapeutics may offer enhanced efficacy in the treatment of a broad range of inflammatory diseases and other conditions. Financial terms of the transaction have not been disclosed.

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"Our goal is to translate advancements in immunology science into next-generation therapies that improve patient outcomes," said Susan B. Dillon, Ph.D., Global Therapeutic Area Head, Immunology, Janssen Research & Development, LLC. "Our interest in Covagen stems from the company’s scientific acumen, their novel FynomAb platform, and the potential of COVA 322, a bispecific designed to achieve better control of inflammation by blocking two key cytokines that have been implicated in disease pathogenesis and progression. We look forward to progressing COVA 322 development, and to further expanding the potential of multispecific biologics for immunologic and other diseases. This exciting opportunity underscores the value of co-locating scientific innovation leads at our regional hubs in thriving life science communities as part of our strategy to identify and realize new opportunities and build long-term competitive advantage."

Covagen will maintain a research presence in Zurich-Schlieren, Switzerland, and will continue to focus on the further development and application of the Fynomer technology. "We are very excited to further develop our pipeline and innovative FynomAb platform as part of Janssen," said Julian Bertschinger, Ph.D., co-founder and former CEO of Covagen. "Janssen’s tremendous knowledge in the research and development of biologics provides us with a great environment to develop novel FynomAb-based therapeutics addressing unmet medical needs."

Covagen was co-founded in 2007 by Julian Bertschinger, Ph.D., and Dragan Grabulovski, Ph.D. as a spin-off company of ETH Zurich, Switzerland.

On August 25, 2014 Insys Therapeutics reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioblastoma multiforme (GBM), the most common and most aggressive malignant primary brain tumor in humans (Press release Insys Therapeutics, AUG 25, 2014, View Source [SID:1234500716]).

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"We are pleased to have received orphan drug designation for this aggressive and often incurable form of brain cancer. We look forward to advancing development of this product and offering a potential efficacious treatment for patients," said Michael L. Babich, President and Chief Executive Officer.

In addition to receiving ODD, Insys has recently entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute (CPMCRI) based in San Francisco to license CPMCRI’s patent rights related to the usage of cannabinoids for the treatment of GBM.

In concert with the aforementioned exclusive licensing agreement, Insys is collaborating with Dr. Sean McAllister at CPMCRI with respect to his pre-clinical research focusing on the ability of CBD to sensitize GBM to current standard of care chemotherapy treatment. "Based on previous research conducted with CBD to treat brain tumors, we believe that there is supportive evidence for the use of CBD as an adjunct treatment in GBM and eagerly anticipate the results from our in-vivo models to further support clinical studies in humans," said Dr. McAllister.

Insys, which has more than seven years of research and development experience in the pharmaceutical cannabinoid space, manufactures pharmaceutical dronabinol (THC) and pharmaceutical CBD, both of which are cannabinoids, at its FDA-inspected and Drug Enforcement Administration (DEA) approved facility, located in Round Rock, Texas. The company recently submitted a Drug Master File (DMF #28255) for its CBD active pharmaceutical ingredient and believes that it is the only U.S.-based company with the capacity to produce pharmaceutical cannabinoids in scalable quantities.

Insys was previously granted ODD to its pharmaceutical CBD for the treatment of Lennox-Gastaut Syndrome and Dravet Syndrome, both rare forms of epilepsy. Insys is also evaluating the potential use of pharmaceutical CBD in several additional indications, including: adult epilepsy; chemotherapy-induced peripheral neuropathy; and addiction in cocaine, amphetamines and opioids. Insys intends to pursue orphan drug designation for other indications that may qualify.

Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as certain financial incentives that can help support its development.