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OncoGenex Regains Rights to Custirsen from Teva

On April 27, 2015 OncoGenex Pharmaceuticals reported that its wholly owned subsidiary, OncoGenex Technologies Inc., executed a termination agreement with Teva under which OncoGenex will regain rights to custirsen, an investigational compound currently in Phase 3 clinical development as a treatment for prostate and lung cancers. This transfer of rights occurs in connection with the termination of the 2009 collaboration agreement between OncoGenex and Teva (Press release, OncoGenex Pharmaceuticals, APR 27, 2015, View Source [SID:1234503186]).

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"OncoGenex is excited to move forward with the clinical investigation of custirsen in patients with advanced cancers who desperately need new treatment options," said Scott Cormack, President and CEO of OncoGenex. "The finalization of this agreement gives OncoGenex control of custirsen’s development, including the ability to move forward with plans to modify the ENSPIRIT trial design and statistical analysis plan to enable the trial to continue with fewer patients, increased confidence in success and shorter time to regulatory submission."

The agreement between the two parties to terminate the collaboration includes a $23.2 million payment from Teva.

This payment reflects a $27 million advance reimbursement amount less $0.8 million for expenses incurred by Teva in 2015 prior to the termination date as well as a $3 million holdback amount that may be used to settle additional expenses incurred by Teva related to the continued development of custirsen as well as certain indemnity claims. One half of the then remaining balance of the holdback amount will be released to OncoGenex in October 2015 with a further half of the then remaining amount paid in January 2016. Any final remaining amount will be released in April 2016.

In addition, OncoGenex will take over responsibility for all custirsen expenses, including those related to the ENSPIRIT trial, as well as manufacturing and regulatory activities for custirsen programs that were previously managed by Teva.

The company recently reported that as of December 31, 2014, it had $47.1 million in cash, cash equivalents and short-term investments, excluding the advance reimbursement payment from Teva. OncoGenex expects that the $23.2 million payment from Teva and the Company’s current resources should enable the completion of the AFFINITY trial through data readout in late 2015 or early 2016, allow for the continuation of the ENSPIRIT trial through the second interim futility analysis expected in mid-2015, and facilitate the achievement of key apatorsen clinical milestones, such as the completion of patient enrollment in the Borealis-2 trial and final data from the Spruce and Rainier clinical trials.

Additional terms of the agreement with Teva can be found in the Company’s Current Report on Form 8-K filed today and available at View Source

Celgene to Acquire Quanticel Pharmaceuticals

On April 27, 2015 Celgene and Quanticel Pharmaceuticals reported a definitive share purchase agreement under which Celgene Corporation will acquire Quanticel (Press release, Celgene, APR 27, 2015, View Source [SID:1234503184]). Through the agreement, Celgene will have full access to Quanticel’s proprietary platform for the single-cell genomic analysis of human cancer, as well as Quanticel’s lead programs that target specific epigenetic modifiers to advance Celgene’s pipeline of innovative cancer therapies.

The acquisition culminates a 2011 strategic alliance between Celgene and Quanticel. Over the course of the three-and-a-half year alliance, Quanticel industrialized its single-cell platform for analysis of tumor cellular content and applied it to novel target discovery and the generation of high-quality drug candidates. Multiple drug candidates from Quanticel are expected to enter the clinic in early 2016.

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"This acquisition brings into Celgene a highly productive, innovative organization deploying a unique platform of high strategic value" said Tom Daniel, M.D., President of Research and Early Development for Celgene Corporation. "More than acquiring the great team, the novel technology, and the drug candidates, the deal validates an innovative approach to building organizational capabilities."

"Celgene made clear from the start that they valued both our technology and our team, and this resulted in an extremely collaborative and productive partnership over the past three years," said Steve Kaldor, Ph.D., chief executive officer at Quanticel. "We look forward to supporting the continued maturation of our pipeline and platform as a part of the Celgene organization."

"Culmination of this innovative strategic alliance between Celgene and Quanticel demonstrates the ability of corporate partners to successfully collaborate and advance the discovery of new therapies," said Brad Bolzon, managing director of Versant Ventures, an investor in Quanticel.

The acquisition is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the agreement terms, Celgene will acquire Quanticel for an upfront payment of $100 million in cash. Up to an additional $385 million in contingent payments may be achieved upon research, development, and regulatory advances related to Quanticel’s research and development platform. The acquisition of Quanticel Pharmaceuticals, Inc. is expected to be accounted for as a purchase transaction and Celgene anticipates that the acquisition will be neutral to 2015 adjusted diluted earnings guidance.

10-Q – Quarterly report [Sections 13 or 15(d)]

Biogen Idec has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Biogen Idec, APR 24, 2015, View Source [SID1234503183]).

Novel Drug Discovery Project for the Treatment of Cancer Added to NEOMED’s Portfolio

On April 24, 2015 NEOMED reported that in collaboration with McGill University, it is embarking on a new drug discovery project that targets cancer (Press release, NEOMED, APR 24, 2015, View Source [SID1234527384]). Executed in collaboration with lead investigator Michael Witcher of the Lady Davis Institute at the Jewish General Hospital, McGill University, the project aims to identify small molecule inhibitors of poly (ADP-ribose) glycohydrolase (PARG) – an enzyme that plays a key role in DNA damage repair and in the transformation of normal cells to cancer cells, promoting their growth and invasive capability. PARG is elevated in cancers of the breast, lungs, prostate, and acute lymphoblastic leukemia. The inhibition of PARG aims to repress cancer growth and to sensitize cancer cells to DNA damage therapy.

"Cancer is a devastating disease that is a major focus of academic and pharmaceutical research. At NEOMED, we’re looking forward to conducting an exciting project together with Dr. Witcher on this important and challenging cancer target," said Kemal Payza, Project Director at NEOMED.

"The collaboration between NEOMED and my lab has been organic from the start," stated Dr. Michael Witcher. "Innovative ideas fly around whenever the team meets, and I am confident this drug discovery program will have major clinical benefits."

Lilly’s CYRAMZA® (ramucirumab) Receives Fourth FDA Approval

On April 24, 2015 Eli Lilly has received its fourth U.S. Food and Drug Administration (FDA) approval for CYRAMZA (ramucirumab) (Press release, Eli Lilly, APR 24, 2015, View Source [SID:1234503179]). CYRAMZA (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

"CYRAMZA now has approvals in advanced or metastatic forms of three of the world’s most common and deadly cancers – gastric, non-small cell lung, and colorectal – with four FDA approvals received in just over a year," said Sue Mahony, Ph.D., senior vice president and president, Lilly Oncology. "This progress is encouraging and supports our ongoing development program for CYRAMZA. Achieving today’s milestone is another example of Lilly’s commitment to people living with gastrointestinal cancers."

Dr. Mahony added, "We are also pleased with the efficient and collaborative reviews we had with the FDA on these submissions." While granted a standard review, this application for CYRAMZA in mCRC was reviewed and approved in approximately nine weeks following its submission to the FDA. All three supplemental applications for CYRAMZA received FDA approval within six months from the time of submission.

The approval is based on the Phase III trial known as RAISE, which compared CYRAMZA plus FOLFIRI to placebo plus FOLFIRI in people with mCRC who had disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Efficacy endpoints in the trial included the major efficacy outcome measure of overall survival (OS) and the supportive efficacy outcome measure of progression-free survival (PFS). The labeling for CYRAMZA contains Boxed Warnings for: hemorrhage, including severe and sometimes fatal events; gastrointestinal (GI) perforation, a potentially fatal event; and impaired wound healing. CYRAMZA should be permanently discontinued in patients who experience severe bleeding or a GI perforation. CYRAMZA should be withheld prior to surgery and discontinued if a patient develops wound healing complications. See the Important Safety Information at the end of this press release and the Prescribing Information.

For patients receiving CYRAMZA treatment, Lilly is committed to offering patient assistance programs. Patients, physicians, pharmacists, or other healthcare professionals with additional questions about CYRAMZA should contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or visit www.lilly.com. Healthcare professionals may also find additional product information on CYRAMZA at www.CYRAMZA.com.

About CYRAMZA (ramucirumab)
In the U.S., CYRAMZA (ramucirumab) is approved for use as a single agent or in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with docetaxel (a type of chemotherapy) as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved with FOLFIRI (a type of chemotherapy) as a therapy for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

CYRAMZA is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. CYRAMZA inhibited angiogenesis in an in vivo animal model.