Big pharma, Partnering, Pharma

Merck forms pharma partnering with Amgen, Pfizer and Incyte

Posted on 06 February 2014

Tags: , , , ,

Merck  has signed three separate pharma partnering clinical collaboration agreements, through subsidiaries, with Amgen Inc., Incyte Corporation and Pfizer Inc. to evaluate novel combination regimens with MK-3475, Merck’s investigational anti-PD-1 immunotherapy.

The financial terms of the agreements were not disclosed.

“Merck clinical scientists intend to explore the potential of our PD-1 inhibitor across a wide range of cancers, both as monotherapy and in combination,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “These new collaborations with Amgen, Incyte and Pfizer underscore our shared determination to evaluate treatment regimens with the potential to provide meaningful benefits to patients suffering from cancer.”

Planned investigations include:

Pfizer and Merck will evaluate in Phase I/II clinical studies the safety and efficacy of MK-3475 in combination with Pfizer’s small molecule kinase inhibitor axitinib (INLYTA®) in patients with renal cell carcinoma, and separately MK-3475 plus PF-05082566 (PF-2566), an investigational immuno-oncology agent that targets the human 4-1BB receptor, in multiple cancer types.

Incyte and Merck will collaborate on a randomized, double-blind placebo controlled Phase I/II study to evaluate the safety and efficacy of a regimen combining MK-3475 with Incyte’s investigational immunotherapy agent, INCB24360, an indoleamine 2, 3-dioxygenase (IDO) inhibitor, in patients with previously treated metastatic and recurrent NSCLC, among other advanced or metastatic cancers.

Amgen and Merck will evaluate MK-3475 in combination with Amgen’s investigational oncolytic immunotherapy talimogene laherparepvec in a Phase I/II study in patients with previously untreated advanced melanoma.

Separately, Merck announced it will start a new Phase I “signal finding” study to evaluate the safety and efficacy of MK-3475 monotherapy in 20 different PD-L1-positive solid tumor types that have not been studied previously (clinical trials identifier: NCT02054806).

About MK-3475

Many tumors are able to evade the immune system through a mechanism that exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an investigational, highly selective anti-PD-1 immunotherapy designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer, essentially by releasing a brake on the immune system.

MK-3475 is being studied in 13 clinical trials estimated to enroll more than 4,000 patients across more than 30 types of cancer including: bladder, colorectal, gastric, head and neck, melanoma, non-small and small cell lung, renal, pancreatic, prostate, triple negative and estrogen-receptor positive HER 2-negative breast, gynecologic, and hematological malignancies, among others. Additional trials, both as monotherapy and in combination with other cancer therapies, are planned. For information on Merck’s clinical trials please visit http://www.merck.com/clinical-trials/.

Breakthrough Therapy designation for MK-3475 in advanced melanoma was granted by the U.S. Food and Drug Administration in April 2013. Merck announced in January the initiation of a rolling submission of a Biologics License Application for MK-3475 in advanced melanoma in the U.S. The company expects to complete the submission in the first half of 2014.

For further deal information visit Current Agreements (subscription required)

Related

Report: Partnering Deals and Alliances with Amgen

Report: Partnering Deals and Alliances with Merck & Co

Browse: Complete Current Partnering report catalog

View: Current Partnering’s Partnering Scorecard – view top life science partnering deals by value

View: Current Partnering’s Deal Metrics – the latest deal trend infographics for life science deal making

View: Current Partnering’s Big Pharma Deal Making Scorecard – latest trends in big pharma deal making activity

View: Current Partnering’s Big Biotech Deal Making Scorecard – latest trends in big biotech deal making activity

Signup: Current Partnering Dealmakers Update – weekly newsletter providing the latest life science industry deal news, deal making trends, partnering events – sign up now

Signup: Current Agreements Deals Review – monthly newsletter - reviewing the previous month’s life science deal making – partnering, M&A and financing – sign up now

Subscribe: Current Agreements life sciences partnering, M&A and financing deals database – find out more

Follow us on: LinkedIn Current Partnering | LinkedIn Business Development Network | @Currentpartner on Twitter

Print Friendly, PDF & Email

Leave a Reply