Transgene Announces Option for TG4010 Not Exercised

On April 28, 2014 Transgene reported that Novartis has informed the Company that it will not exercise its option for the global development and commercialization rights to TG4010 MUC1 targeted cancer immunotherapy (Press release, Transgene, APR 28, 2014, View Source [SID:1234502167]). As a result, Transgene retains all rights to the program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We regret that Novartis has chosen not to use its exclusivity period to opt-in and become our global partner for TG4010," said Philippe Archinard, Chairman and Chief Executive Officer of Transgene. He added: "We are committed to start a Phase 3 trial in advanced lung cancer as rapidly as possible as the data obtained with this cancer immunotherapy are compelling, and we are well financed to move our plans forward.

In parallel, we will now be actively looking for a partner to co-develop and commercialize TG4010. A variety of global players active in the field of cancer immunotherapy have already expressed interest in the program."

Plans for the Phase 3 part of the TIME trial in MUC1+ patients with Stage IV non-small cell lung cancer (NSCLC) are well advanced, and Transgene is working to move into Phase 3 in the second half of this year, contingent on discussions with regulatory authorities.

The data from the Phase 2b part of the TIME trial continue to mature; Transgene expects detailed results to be presented at a major medical meeting later this year.

Teva and OncoGenex Announce Top-Line Survival Results of Phase III SYNERGY Trial Evaluating Custirsen in Combination with First-line Docetaxel and Prednisone for Metastatic Castrate-Resistant Prostate Cancer

On April 28, 2014 Teva and OncoGenex reported results from the Phase III SYNERGY trial (NCT01188187), a randomized, open-label, two-arm study comparing the combination of custirsen and standard first-line docetaxel/prednisone therapy to docetaxel/prednisone alone in men with metastatic castrate-resistant prostate cancer (CRPC) (Press release Teva, APR 28, 2014, View Source [SID:1234500475]).
Top-line survival results indicate the addition of custirsen to standard first-line docetaxel/prednisone therapy did not meet the primary endpoint of a statistically significant improvement in overall survival (OS) in men with metastatic CRPC, compared to docetaxel/prednisone alone (median survival 23.4 months vs 22.2 months, respectively; hazard ratio 0.93 and one-sided p-value 0.207).
The adverse events (AEs) observed for custirsen were similar to its known AE profile.
Full efficacy and safety data from SYNERGY will be submitted for presentation at an upcoming scientific conference.

Agenus Announces Collaboration and License Agreement with Merck for Novel Checkpoint Antibody-based Cancer Immunotherapies

On April 28, 2014 Agenus reported that the company has entered into a collaboration and license agreement with Merck & Co through a subsidiary, for the discovery and development of therapeutic antibodies to immune checkpoints for the treatment of cancer (Press release Agenus, APR 28, 2014, View Source [SID:1234500473]). Under the terms of the agreement, Agenus will discover and optimize fully human antibodies against two undisclosed Merck checkpoint targets using the 4-Antibody Retrocyte Display platform. Merck will be responsible for clinical development and commercialization of candidates generated under the collaboration.
Under the terms of the agreement, Agenus is eligible to receive approximately $100 million in potential payments associated with the completion of certain clinical, regulatory and commercial milestones for two candidates from Merck. In addition, Agenus is eligible to receive royalty payments on worldwide product sales.

Development pipeline table

(Company Pipeline AstraZeneca, APR 24, 2014, View Source;blobheader=application%2Fpdf&blobheadername1=Content-Disposition&blobheadername2=MDT-Type&blobheadervalue1=inline%3B+filename%3DDevelopment-pipeline-table.pdf&blobheadervalue2=abinary%3B+charset%3DUTF-8&blobkey=id&blobtable=MungoBlobs&blobwhere=1285670352026&ssbinary=true [SID:1234500465])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


AstraZeneca PLC first quarter results 2014

On April 24, 2014 AstraZeneca reported that AZD9291 has been granted Breakthrough Therapy designation by the US FDA for the treatment of patients with metastatic, EGFR T790M mutation-positive, non-small cell lung cancer (NSCLC) whose NSCLC has progressed during treatment with an FDA-approved, EGFR tyrosine kinase inhibitor (Press release AstraZeneca, APR 24, 2014, View Source;first-quarter-results-2014 [SID:1234500464]).