December 17, 2018
Eli Lilly is set to begin clinical trials within the year on a Swiss drugmaker’s anti-dementia treatment, announcing a licensing and collaboration agreement that could be worth up to $1.7 billion.
AC Immune SA says its lead molecule, ACI-3024, has shown that it can inhibit aggressive tau proteins — thought to be a key to dementia — in preclinical models. Under the new agreement, announced last week, Lilly will pay $80 million up front and another $50 million in exchange for a note that can be converted to equity, so that Lilly can use AC Immune’s Morphomer platform technology to build trials around ACI-3024.
AC Immune can also earn another $60 million in “near-term development milestones.” Additional development, regulatory and commercial milestones could bring the value of the deal up to $1.7 billion, Lilly announced.
AC Immune will conduct Phase I trials for ACI-3024 beginning next year, and Lilly will fund and lead any further development. Lilly will retain worldwide rights to any commercial Alzheimer’s or dementia products but AC Immune will keep some unspecified development rights for orphan indications and will share development and marketing rights for treatments beyond Alzheimer’s.
FDA Lifts Hold, Approves Roche’s Combo Therapy for Lung Cancer
Roche is claiming a delayed victory after the FDA approved its anti-lung cancer drug Tecentriq in combination with Avastin and chemotherapy.
The combination therapy had posted impressive results from its Phase III “IMpower 150” trials. In the triple-armed experiments, 1,202 patients with metastatic non-squamous non-small cell lung cancer (and who lacked EGRF or ALK generic tumor aberrations) were given one of three possible treatments:
- Tecentriq (atezolizumab) plus carboplatin and paclitaxel;
- Tecentriq plus Avastin (niraparib) plus carboplatin and paclitaxel; or
- Avastin plus carboplatin and paclitaxel.
The Tecentriq/Avastin and chemo combination offered significant improvements for the patients who took it. It shrank tumors in 55 percent of its patients. The overall survival rate of people in that group was 19.2 months compared to the 14.7 months for patients in the other arms. The progression-free survival rate for patients in the Tecntriq/Avastin and chemo group was 29 percent longer than patients in the Avastin and chemotherapy arm.
The FDA had delayed approval of the combination therapy in September to ask a few more questions. The Swiss drugmaker announced approval last week.
Tecentriq is a monoclonal antibody designed to bind with PD-L1 proteins on tumors and tumor-infiltrating immune cells. Avastin is an antibody that binds to vascular endothelial growth factor proteins and is designed to choke off a tumor’s blood flow.
Anti-Enzyme Drug Helps Ease Withdrawal, Reduce Use for Cannabis Addicts
An experimental anti-enzyme drug has proved effective at reducing cannabis addicts’ symptoms and even uses, Yale researchers say.
PF-04457845 is a fatty acid amide hydrolase inhibitor that breaks down anandamide, a naturally occurring chemical that acts on the brain’s cannabinoid receptors just as cannabis does.
In a randomized, Phase II trial of 70 men who had already been diagnosed as cannabis addicts or abusers, patients who were given PF-04457845 used cannabis less and experienced fewer withdrawal symptoms, such as trouble sleeping, at their 4-week followup, compared to men in the placebo group, lead researcher Deepak Cyril D’Souza of Yale University’s School of Medicine Announced last week.
The experimental treatment was “well tolerated” but future trials will hone in on safety and efficacy, D’Souza says. His team’s findings were published in The Lancet Psychiatry.
FDA Orders MacroGenics to Pause Enrollment on Anti-Cancer Treatment
The FDA has put a partial hold on two separate early-stage clinical trials for MacroGenics’ anti-cancer monocolonal antibody MGD009 after patients showed evidence of liver problems, the company has announced.
MacroGenics is sponsoring a Phase I, open-label, dose escalation, cohort expansion trial of MGD009 that had already recruited 114 patients. It’s also testing a combination of MGD009 and another treatment, MGA012, on 165 patients with advanced solid tumors in a Phase I open-label, dose escalation trial that began in February.
Some patients taking MGD009 showed elevated transaminases in their liver function tests. The company says that the problems “have been otherwise uncomplicated and short-lived” and will augment the trials with care to deal with any ongoing liver problems. The Rockville, Md.-based company believes the side effects are cytokine-mediated events.