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Celldex Therapeutics Initiates METRIC, an Accelerated Approval Study of Glembatumumab Vedotin in Patients with Triple Negative Breast Cancer

On December 2, 2013 Celldex Therapeutics announced that it has launched a randomized study (METRIC) of Glembatumumab vedotin (CDX-011) in patients with metastatic triple negative breast cancers that over-express glycoprotein NMB (gpNMB) (Press release Celldex Therapeutics, DEC 2, 2013, View Source [SID:1234500219]). Initial sites are now open to screen patients in the United States. Additional sites in the United States and in Canada and Australia will open in early 2014. The study is expected to include up to 100 sites and will enroll approximately 300 patients.
The company also plan to further expand the clinical development program for Glembatumumab vedotin in 2014 by initiating additional studies in other cancers known to express gpNMB including melanoma and squamous cell lung cancer.
The METRIC study is a pivotal, open-label, prospectively controlled, randomized study of Glembatumumab vedotin in patients with metastatic gpNMB-expressing triple-negative breast cancer. Eligible patients must have received no more than 1 prior line of chemotherapy for advanced disease and therapy must have included a taxane and anthracycline. Patients will be randomized (2:1) to receive Glembatumumab vedotin or capecitabine. Study treatment will continue until disease progression or intolerance with tumor assessments performed at six week intervals for six months and nine week intervals thereafter. The primary objective is to evaluate the anti-cancer activity of Glembatumumab vedotin as measured by the objective response rate (ORR) and duration of progression-free survival (PFS). The study is designed to enable Celldex to apply for registration with positive results for either endpoint. Secondary endpoints include duration of response, overall survival, safety and tolerability. The Company will also assess improvements in quality of life and/or cancer-related pain as exploratory endpoints.
Patients will be stratified as follows:
* No prior chemotherapy for advanced disease vs. 1 prior line of chemotherapy for advanced disease
* "Resistant" to anthracycline therapy (i.e., progression-free interval of ≤ 6 months after completing treatment) vs. "Exposed" to anthracycline therapy (i.e., progression-free interval of > 6 months after completing treatment)
Clinical Data Supporting Glembatumumab vedotin in Triple Negative Breast Cancer
In the Phase 2 EMERGE study, final data supported an overall survival benefit in specific sub-groups of breast cancer patients with tumors that over-express gpNMB. Treatment of patients with both triple negative breast cancer and over-expression of gpNMB showed a high overall response rate (ORR) of 33% (n=12) when treated with Glembatumumab vedotin. In comparison, no responses (n=4) were seen in patients with both triple negative breast cancer and over-expression of gpNMB with standard chemotherapies. In this same patient population, the median overall survival (OS) for patients treated with Glembatumumab vedotin was 10 months vs. 5.5 months (p= 0.003) and progression free survival (PFS) was 3 months for the Glembatumumab vedotin arm vs. 1.5 months for the control arm (p=0.008), respectively. The most common adverse event was rash.

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CRT, University of Manchester and GlaxoSmithKline work together to generate new cancer drugs

On November 29, 2013 CRT, the commercial arm of Cancer Research UK, and the University of Manchester reported a research agreement with GlaxoSmithKline (GSK) to generate new cancer drugs in the field of epigenetics (Press release, Cancer Research Technology, 29 29, 2013, View Source [SID1234523246]).

Under the agreement, scientists in the Drug Discovery Unit at the Cancer Research UK Manchester Institute, at the University of Manchester, will create potential new drugs which target a key protein involved in epigenetic regulation. Cancer epigenetics is the study of molecular modifications which cause changes to the gene activity in cancer cells – but which do not involve a change in the DNA sequence*.

Dr Donald Ogilvie head of the Drug Discovery Unit at Cancer Research UK’s Manchester Institute and part of Manchester Cancer Research Centre, said: "Epigenetic mechanisms are an increasingly important area of cancer research. Directly targeting these mechanisms using our drug discovery platform will provide exciting new opportunities in treating the disease – translating Cancer Research UK’s world-class research into cancer treatments and ultimately providing new options for cancer patients."

GSK will provide starting materials for the project, and have exclusive option rights to molecules discovered under the collaboration. Cancer Research Technology is eligible to receive development milestone payments as the compounds advance, and royalty payments on net sales of products that result from the collaboration. Cancer Research Technology has the right to develop the molecules further if GSK declines to do so.

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "This important agreement with GSK brings a fresh opportunity to tap into the most exciting areas of emerging cancer biology, and to develop new compounds and different approaches to stop cancer progressing.

"This partnership shows that by combining the experience and skills from industry and academia it is possible to develop projects that may otherwise have taken years to implement – speeding up the development of potential new treatments for cancer."

Teva Announces Additional Regulatory Exclusivity for TREANDA® (Bendamustine HCI) for Injection

On November 27, 2013 Teva reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for TREANDA through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen (Press release Teva, NOV 27, 2013, View Source;p=irol-newsArticle&ID=1880493 [SID:1234500816]). Orphan status is granted to therapies intended to treat diseases or conditions that affect fewer than 200,000 patients in the United States. With the previously granted six months of pediatric exclusivity for TREANDA, regulatory exclusivity for this indication is now extended through April 2016.

"Since 2008, TREANDA has played a significant role in the treatment of patients with iNHL that has progressed," said Bill Campbell, Vice President and General Manager, Teva Oncology. "We are pleased the FDA has recognized our commitment to treating patients with this rare form of cancer."

TREANDA is also indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). TREANDA has orphan drug exclusivity for this indication through March 2015. With the previously granted six months of pediatric exclusivity for TREANDA, regulatory exclusivity for this indication lasts until September 20, 2015.

Net sales for Treanda in the United States through the third quarter of 2013 were $531 million.

Boston Strategics Announces Oncology Drug Development Partnership with FUJIFILM Pharmaceuticals U.S.A.

On November 26, 2013 Boston Strategics reported a new drug development partnership with FUJIFILM Pharmaceuticals U.S.A., Inc. (FPHU), Boston, MA, a global pharmaceutical development center of FUJIFILM Corporation, Tokyo, Japan (Press release, Boston Strategics, NOV 26, 2013, View Source [SID:1234501881]). This strategic collaboration is the first of its kind between a Japanese pharmaceutical company and a pharmaceutical research and development provider, creating a novel and comprehensive approach to global pharmaceutical development.

Under this agreement, Boston Strategics will be the primary provider for FPHU global drug development services and resources for FPHU Oncology programs. This agreement will build on Boston Strategic strengths covering the spectrum from preclinical and early clinical development through Phase I and II human Proof-of-Concept (POC). Utilizing Boston Strategics’ internal oncology development expertise and ability to identify and collaborate with the best resources around the world, FPHU will expand its global reach in oncology drug development.

Boston Strategics will optimize and execute the global strategy of FPHU Oncology drug development programs. In this capacity, Boston Strategics will leverage its "True Open InnovationTM" network to deliver superior outcomes, using highly efficient execution strategies and proven partners, such as the University of Texas MD Anderson Cancer Center, Houston TX (MD Anderson).

"True Open InnovationTM overcomes any limitations by reducing the need for large infrastructure, and draws on critical drug development expertise based on the unique needs of a particular program," says Keizo Koya, Ph.D., CEO of Boston Strategics. "Our strong business relationships with our global resource networks are poised to assist pharmaceutical/biotech companies with strategy and launch of quality global drug development programs, and rapidly execute them to the next decision step/value inflection point. We are deeply committed to giving a new pharmaceutical R&D platform for FPHU, which look for an innovative and efficient way of globally developing their unique oncology pipelines. Entering into a special alliance of Boston Strategics this year with MD Anderson, a world leader in cancer treatment and oncology research, Boston Strategics will use this opportunity to provide global clinical development supports for FPHU."

The ultimate goal of this unique partnership is to develop FUJIFILM’s oncology drug candidates globally using innovative approaches coupled with industry benchmark-beating timelines, quality, and financial investment.

Tanabe Research Laboratories and Mitsubishi Tanabe Pharma Nominate First Bispecific FynomAb for Preclinical Development and Exercise an Option for a Second Bispecific FynomAb Program

On November 21, 2013 Covagen and Tanabe Research Laboratories U.S.A, Inc. (TRL), a fully owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), reported that they expanded their strategic research collaboration. MTPC and TRL have nominated a first bispecific FynomAb for formal preclinical development which triggered an undisclosed milestone payment (Press release Mitsubishi Tanabe Pharma, NOV 21, 2013, View Source [SID:1234501611]). MTPC and TRL also exercised an option for a second bispecific FynomAb program based on the parties’ research and licensing agreement signed in October 2012. Under the agreement, Covagen will use its proprietary Fynomer-antibody platform to generate bispecific antibodies (FynomAbs) against a second target pair selected by TRL and MTPC.

"We believe Covagen’s FynomAb platform is a source of innovative bispecific antibodies with excellent biophysical properties that will allow more effective treatment of inflammatory and oncologic diseases," said Roland Newman, Ph.D., chief scientific officer of TRL. "We look forward to continuing our cooperative work with the Covagen team as we advance the first FynomAb into preclinical development and look towards discovery of the second FynomAb as part of this expanded collaboration.".

Through payment of an undisclosed option fee, MTPC secured global, exclusive rights to bispecific FynomAbs against a second target pair in oncology. Under the agreement, MTPC will fund all research activities and be solely responsible for the development, manufacturing and global commercialization activities. Upon achievement of certain research, development and regulatory milestones, Covagen is entitled to receive payments of up to €108.25 million for the second program as well as tiered royalties on worldwide net sales of products resulting from the collaboration.

"The expansion of our collaboration with MTPC and TRL provides substantial validation of Covagen’s bispecific FynomAb technology as we advance several therapeutic programs toward the clinic in 2014 and 2015," said Julian Bertschinger, Ph.D., chief executive officer of Covagen.

Dragan Grabulovski, Ph.D., chief scientific officer of Covagen, added, "The expansion to a second bispecific FynomAb program is the result of the successful discovery and early preclinical development of the FynomAb from the original collaboration. This FynomAb was generated less than one year after initiating the joint research collaboration and showed excellent activity in pre-defined in vitro and in vivo studies. Our work with the MTPC and TRL team has been extremely productive, and we are eager to continue development of both projects."