Joining the Anti-PD-L1 Cancer Drug Market, Syndax Inks Deal With Genentech, Closes on $80 Million Series C Round
August 26, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Waltham, Mass.-based Syndax Pharmaceuticals Inc. announced today that it signed a clinical collaboration agreement with Genentech , part of the Roche Group. The collaboration focuses on the development of entinostat as a combination therapy for various cancers.
The two companies will evaluate the safety, tolerability and preliminary efficacy of entinostat, Syndax’s drug that targets specific regulatory immune cells, in combination with Genentech’s atezolizumab (MPDL3280A), an anti-PD-L1 compound, in patients with triple-negative breast cancer.
“Clinical development collaborations with industry leaders are an essential element of our strategy to realize the full potential of entinostat and position Syndax at the forefront of next-generation immuno-oncology therapy,” said Briggs Morrison, chief executive officer of Syndax in a statement. “This collaboration expands our emerging immuno-oncology program into an important new indication. We are looking forward to collaborating with Genentech to study atezolizumab and entinostat in a breast cancer population with few treatment options.”
Anti-PD-L1 is an increasingly promising area in cancer drug research. The PD-1/PD-L1 pathway has been identified in cancer as significant in assisting tumors avoid being destroyed by the body’s immune systems. Compounds that disrupt the pathway show promise for a number of different cancer therapies.
On July 13, 2015, Genentech announced positive results for atezolizumab against urothelial bladder cancer. The drug had received a second Breakthrough Designation by the U.S. Food and Drug Administration (FDA) on Feb. 2, 2015.
On June 2, 2015, Amgen (AMGN) announced a collaboration with Roche (RHHBY) on a Phase Ib clinical trial to evaluate talimogene laherparepvec combined with atezolizumab for triple-negative breast cancer and colorectal cancer with liver metastases.
In May, Amgen inked a deal with Merck & Co. to expand its collaboration on talimogene with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.
Late last year, in November, Pfizer Inc. and Merck KgaA , announced they were working on an anti-PD-L1 antibody to treat non-small cell lung cancer, ovarian cancer and Merkel cell carcinoma. Pfizer paid Merck an upfront fee of $850 million, as well as up to $2 billion in regulatory and commercial milestone payments.
Bristol-Myers Squibb Company also is working on anti-PD-L1 drugs, specifically Prostvac, Bavarian Nordic A/S ’s investigational Phase III prostate-specific antigen (PSA)-targeting cancer immunotherapy. Bristol-Myers is planning a Phase II study of Prostvac with Yervoy, which is a PD-1 inhibitor.
Bristol-Myers’s drug, Opdivo (nivolumab) is a PD-1 pathway inhibitor used to treat metastatic melanoma. It was approved by the FDA in 2014.
In March, Syndax entered into a collaboration deal with Merck to evaluate entinostat with Keytruda in either advanced non-small cell lung cancer or melanoma.
Syndax, a privately-held company, is being run by Briggs Morrison, who stepped up to act as chief executive officer in June. Prior to joining Syndax, Morrison was chief medical officer and head of global late-stage drug development for AstraZeneca PLC . Morrison was preceded by Arlene Morris.
Earlier this week, Syndax announced that it had completed an $80 million Series C financing round. The round was led by Fidelity Management & Research Company and Delos Capital Fund LP. Participating investors were EcoR1 Capital, OrbiMed, Jennison Associates on behalf of certain clients, Tavistock Life Sciences, Arrowpoint Partners, Cormorant Asset Management, BioMed Ventures and several undisclosed top-tier mutual funds. Existing investors also participated, including Domain Associates, MPM Capital, RusnanoMedInvest (RMI) and Forward Ventures.
“Over the past 12 to 18 months, there have been significant preclinical data generated by Syndax and leading researchers suggesting that entinostat, in addition to its own anti-cancer activity, may enhance the activity of immune checkpoint inhibitors,” said Morrison in a statement. “Following the positive results from our Phase IIb clinical trial, ENCORE 301, entinostat received breakthrough therapy designation from the FDA in advanced HR+ breast cancer. Given these findings, Syndax has been steadily expanding its entinostat clinical development program, exploring its use as an immunotherapy in combination with a number of investigational and approved medicines.”