- Merck KGaA has amended a 2015 drug development deal with synthetic biology developer Intrexon, trading rights to potential CAR-T therapies in exchange for equity.
- Intrexon will issue German Merck $150 million in stock and a $25 million convertible note for stock in either Intrexon or its wholly-owned subsidiary, Precigen. It will also get a $25 million cash investment.
- The new terms allow Merck KGaA to "maintain an investment in the rapidly advancing oncology field of CAR-T, while focusing its R&D efforts," the German drugmaker said in a Thursday statement.
The rejiggered deal terms suggest that while Merck KGaA still has confidence in Intrexon's technology, it's not so strong as to prompt the German drugmaker to further develop it in-house.
Intrexon investors may have drawn similar conclusions, as they sold off more than 2.4 million shares on Thursday. The Maryland-based biotech's stock was down 1.3% by market's close, and fell an another 3% to $6.87 apiece in mid-morning trading Friday. Shares have fallen 41% in the last year.
Signed in March 2015, the original deal between the companies gave Merck KGaA access to Intrexon's RheoSwitch Therapeutic System, which aims to use molecular switches for regulating gene expression. Intrexon was responsible for all platform and product development until Investigational New Drug filing, with Merck KGaA nominating targets of interest.
German Merck forked over $115 million upfront through the agreement, and by the third quarter of 2015 selected the first two CAR-T targets in hematologic and solid tumor malignancies. In April 2017, Intrexon announced the partnership would also start to incorporate another technology platform called Sleeping Beauty, which centered on non-viral gene integration.
Precigen, which focuses on gene and cellular therapies, will now pick up development of the CAR-T portfolio. The clinical-stage biopharma has Phase 1 trials underway for CD33-CAR-T in relapsed and refractory acute myeloid leukemia, and also has other clinical projects in recessive dystrophic epidermolysis bullosa, localized scleroderma and heart failure.
It's not clear whether there have been problems with the R&D process, or whether Merck KGaA simply decided it would rather take a step back from this deal. The company still has an stake in immuno-oncology through a partnership with Pfizer for Bavencio (avelumab), though the drug has trailed behind other checkpoint inhibitors.
Bavencio, a PD-L1 blocking antibody, is conditionally approved in metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial carcinoma, but other indications have proved elusive.
In JAVELIN Ovarian 200, a Phase 3 study in patients with platinum-resistant or refractory ovarian cancer, Bavencio monotherapy or combination therapy didn't meet the overall or progression-free survival outcomes. Neither the Phase 3 JAVELIN Lung 200 nor the Phase 3 JAVELIN Gastric 100 met their overall survival goals. Merck KGaA and Pfizer are running a number of other clinical trials in first- and second-line treatments, as a monotherapy and combination therapy.
More positively, the companies did find success in JAVELIN Renal 101, which tested Bavencio together with Pfizer's Inlyta (axitinib).