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Agios Pharmaceuticals Announces that Celgene Exercised its Option to License AG-221 Under Global Strategic Collaboration

On June 13, 2014 Agios Pharmaceuticals reported that its partner Celgene has exercised its option to an exclusive worldwide license to AG-221, an oral, first-in-class, potent inhibitor of the mutant IDH2 protein. Under the terms of the agreement, the option to license extended to Celgene through the end of Phase 1, but AG-221 has been exercised early based on the Phase 1 data generated to date (Press release Agios Pharmaceuticals, JUN 13, 2014, View Source;p=RssLanding&cat=news&id=1939718 [SID:1234500652]). AG-221 is currently in a Phase 1 dose escalation study in patients that harbor an IDH2 mutation with advanced hematologic malignancies, including acute myeloid leukemia (AML).

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"We are pleased with Celgene’s decision to license AG-221, as we believe it reflects the strength of our progress with this product candidate and underscores Agios’ and Celgene’s commitment to precision medicine," said David Schenkein, M.D., chief executive officer of Agios. "Celgene brings global reach, significant expertise and financial resources to the AG-221 program, and we look forward to our continued collaboration to increase the scope and efforts directed to IDH2 and broadly advance this important potential cancer medicine."

"Agios’ AG-221 candidate is simultaneously advancing convergent fields, including cancer metabolism, epigenetics and precision medicine. The emerging Phase 1 clinical data validate the preclinical and mechanistic work on IDH2 mutations in AML, and most importantly, advance a highly promising drug candidate for treatment of molecularly selected patients," said Thomas Daniel, M.D., president of research & early development at Celgene. "Celgene looks forward to deploying our worldwide development capabilities in hematological malignancies and to working with Agios to accelerate development."

Agios and Celgene entered into a global strategic collaboration in April 2010 to develop new therapeutics targeting cancer metabolism. By exercising its exclusive option under the terms of the agreement, Celgene gains worldwide development and commercialization rights for AG-221. Agios, in addition to contributing its scientific and translational expertise, will continue to conduct early clinical development and regulatory activities within the AG-221 development program in collaboration with Celgene. Celgene is responsible for all development costs for AG-221. Agios is eligible for up to $120 million in milestone payments and a tiered royalty on any net sales. Agios also has the right to conduct a portion of any commercialization activities for AG-221 in the United States.

AG-221 is part of Agios’ IDH portfolio that also includes the IDH1 mutant inhibitor AG-120, which the company continues to develop and is in Phase 1 clinical trials in advanced solid tumors and hematologic malignancies. Agios retains U.S. rights to the IDH1 program, and Celgene has an exclusive option to ex-U.S. rights for the program. Agios continues to advance its discovery and research of cancer metabolism targets.

Vantictumab Placed on Partial Clinical Hold by FDA Following Voluntary Halt by OncoMed

On June 13, 2014 OncoMed Pharmaceuticals reported discussion with the U.S. Food and Drug Administration (FDA) about vantictumab’s (anti-Fzd7, OMP-18R5) and Fzd8-Fc (OMP-54F28) Phase 1 Wnt pathway programs (NCT01973309; NCT01957007; NCT02005315; NCT01345201) (Press release OncoMed, JUN 13, 2014, View Source [SID:1234500577]). The FDA informed the company that a partial clinical hold has been placed on Phase 1 clinical trials of vantictumab until revised protocols have been submitted and concurred with. The company reported that, according to the FDA, this action is being taken in view of OncoMed’s decision to voluntarily halt enrollment and dosing in the ongoing vantictumab Phase 1 trials.

The FDA concurred with OncoMed’s plan to continue dosing of a patient in the single-agent Phase 1a vantictumab clinical trial who has remained on treatment for greater than 700 days progression free without significant drug-related adverse effects. The FDA also concurred with OncoMed’s plan to continue dosing a patient in the single-agent Phase 1a Fzd8-Fc clinical trial who has remained on treatment for greater than 390 days progression free without significant drug-related adverse effects.

“As we announced this morning, we are analyzing the data in hand with the investigators and academic bone expert advisors to assess the adverse events observed in these trials and develop revised clinical trial protocols. Today’s discussion with the FDA advanced the process to determine the best path forward. We remain committed to evaluating vantictumab and Fzd8-Fc as possible therapies for cancer patients,” stated Paul J. Hastings, Chairman and CEO of OncoMed.

TeraDiscoveries Announces Name Change to Cloud Pharmaceuticals, Inc.

On June 12, 2014 TeraDiscoveries, Inc., a bio-therapeutics company focused on cloud-based drug design and development, reported that effective immediately, it has changed its corporate name to Cloud Pharmaceuticals, Inc (Press release, TeraDiscoveries, JUN 12, 2014, View Source [SID1234635437]).

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Cloud Pharmaceuticals designs new drugs and drug candidates and accelerates the development process by implementing new, innovative cloud computing technology in place of traditional methods. The company manages the development of multiple drug candidates through an extensive network of partners.

"The worldwide pharmaceutical industry is in need of new drugs that target smaller market segments. They need to be developed faster, have novel IP, and offer greater drug safety, efficacy, and affordability," says Ed Addison, company president and CEO. "Our approach uses cloud technology and high-performance computing to efficiently calculate which of all possible molecules are the best drug candidates. This reduces cost, decreases development time, and creates novel molecules with therapeutic value. Our new name more aptly reflects our approach and value proposition."

Cloud Pharmaceuticals is helping to transform the pharmaceutical and biotechnology industries to enable personalized medicine, niche buster drugs, and rapidly developed blockbusters for difficult targets. The company uses a method originally developed at Duke University called Inverse Design to quickly scan virtual chemical libraries to find the strongest inhibitors of a specific biological target. The process identifies novel drug candidates that feature good clinical trial properties and demonstrate low probability of toxic side effects.

MorphoSys and Merck Serono Enter Strategic Immuno-Oncology Collaboration

On June 12, 2014 MorphoSys and Merck KGaA reported that they have signed an agreement to discover and develop therapeutic antibodies against undisclosed immune checkpoints (Press release MorphoSys, JUN 12, 2014, View Source [SID:1234500664]).

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Under the terms of the agreement, MorphoSys and Merck Serono, the biopharmaceutical division of Merck, will join forces to develop therapies that modulate the immune system’s natural ability to fight tumors. MorphoSys, a leader in fully human antibody technologies, will apply its proprietary Ylanthia antibody phage library and technology platform to identify antibodies against the targets of interest. Merck Serono with its strong portfolio and capabilities in the field of immuno-oncology and clinical development will be fully responsible for execution of development from Phase I onwards.

"The establishment of partnerships with companies with innovative technology platforms is an integral part of Merck Serono’s strategy to further expand upon our already diverse immuno-oncology portfolio," said Dr. Helen Sabzevari, Senior VP of Immuno-Oncology at Merck Serono. "Combining Merck Serono’s extensive expertise in immuno-oncology with MorphoSys’s next-generation antibody technology provides us with an exciting opportunity to rapidly generate novel therapies with a clear potential to benefit cancer patients."

"Therapeutic agents in the immuno-oncology field are set to transform cancer therapy, and we are delighted to work with Merck Serono in this area", commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "We believe that our Ylanthia technology has the potential to provide truly differentiated antibodies against the targets that will be the subject of the collaboration. Merck Serono’s expertise in immuno-oncology, together with their strength in developing and commercializing therapeutic antibodies make them an ideal partner for MorphoSys."

With this partnership, Merck Serono, is committed to strengthen its existing portfolio of cancer immunotherapies that work as monotherapies or in combination with other therapeutic modalities. The company’s immuno-oncology pipeline assets currently investigated in clinical trials span from Phase 1 to Phase 3 for the treatment of different cancer types, including tecemotide, a MUC1 antigen-specific cancer immunotherapy, the two immunocytokines NHS-IL2 (MSB0010445) and NHS-IL12 (MSB0010360), and the monoclonal antibody anti-PD-L1 (MSB0010718C). Beyond this, Merck Serono has built a robust pre-clinical pipeline in the three innovation clusters therapeutic cancer vaccines, cancer stem cells, and tumor immunotolerance.

Under the terms of the co-development and license agreement, MorphoSys will co-fund research & development costs with the option to opt-out at predefined stages. MorphoSys will be eligible to receive development and commercial milestone payments, and in addition, tiered royalties on product sales that will reflect the extent of MorphoSys co-funding. Merck Serono will have sole responsibility for commercializing of any resulting products. Further financial details are not being disclosed.

Lilly Announces Top-Line Results Of Phase III Hepatocellular Carcinoma Trial

On June 11, 2014 Eli Lilly reported that the Phase III REACH trial (NCT01140347) of CYRAMZA (ramucirumab) in patients with hepatocellular carcinoma, also known as liver cancer, did not meet its primary endpoint; overall survival favored the CYRAMZA arm but was not statistically significant (Press release Eli Lilly, JUN 11, 2014, View Source [SID:1234500572]). Encouraging single-agent CYRAMZA activity was observed, with meaningful improvements in key secondary endpoints of progression-free survival, overall response rate and time to progression.
The global, randomized, double-blind REACH trial compared CYRAMZA plus best supportive care to placebo plus best supportive care as a second-line treatment in patients with hepatocellular carcinoma (HCC) after being treated with sorafenib in the first-line setting. The top-line safety data were consistent with what was seen in previous single-agent CYRAMZA studies. The most common ( > 5% incidence) grade > /=3 adverse events occurring at a higher rate on the CYRAMZA arm compared to the control arm were hypertension and asthenia (fatigue).

“Although the REACH study did not achieve statistical significance for survival, we are encouraged by the efficacy seen overall, especially in specific subpopulations. We plan to discuss these results with regulatory authorities,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology.

Liver cancer is a very difficult-to-treat tumor type and no Phase III study has been able to demonstrate improved survival in the second-line setting. This is an area of very high unmet need for which there are no approved therapies.

Lilly plans to present data from the REACH trial at a scientific meeting later this year.

CYRAMZA has been granted Orphan Drug Designation for treatment of hepatocellular carcinoma in the U.S. and EU. Orphan drug status is given – in the U.S. by the FDA’s Office of Orphan Products Development (OOPD) and in the EU by the European Commission – to medicines that have demonstrated promise for the treatment of rare diseases.