Meet the BioPharma Vet Frantically Raising Cash for His Biotech Startup Engage Therapeutics

August 18, 2017
By Mark Terry, BioSpace.com Breaking News Staff

Greg Mayes founded Engage Therapeutics to find a better preventive approach for his son’s epilepsy. It’s not that big a stretch—up until December 2016, Mayes was the chief operating officer of Advaxis in Princeton, NJ, and remains its chief business officer and board member. Before Advaxis, he was president and general counsel of Unigene Laboratories, and from 2001 to 2005 was senior counsel for AstraZeneca (AZN). He knows how to do this. But he’s been surprised at how difficult it is to raise money for Engage.

Engage Therapeutics is trying to take a promising inhaler technology for epilepsy into clinical trials. To keep the company afloat and fund the trial, Mayes needs to raise $21 million—by the end of August—and still needs to raise about $7 million.

Rebecca Robbins, writing for STAT, says, “Mayes is billing his treatment as a would-be EpiPen for epilepsy, a way for patients to stop a seizure in its tracks when they feel one coming on. (He estimates there are about 200,000 such patients in the U.S. who can recognize early warning signs minutes or days before they have a seizure but don’t have any very fast-acting options to prevent it.)”

The treatment is called Staccato alprazolam, and mixes two already-approved products, a generic form of benzodiazepine that markets under Xanax, and the inhaler, which was approved in 2012 to administer an antipsychotic medication.

In a proof-of-concept study by Alexza Pharmaceuticals, researchers induced seizures in five patients using flashing lights. They used the inhaler with varying dosages of the drug. The drug appeared effective within 30 seconds, and in four of the patients, there was no detective seizure activity two minutes after inhaling the drug.

Although that certainly sounds promising, at least in a very limited way in a very small test group, neurologists are sensibly skeptical. Ronald Lesser, a Johns Hopkins epilepsy specialist not involved in the treatment development, told STAT that because the treatment hadn’t been tested in patients having real, unprovoked seizures, it was hard to read into how valuable and effective it was. And it also would need to be determined whether the treatment was better than existing treatments.

The inhaler was developed by Alexza, which is wholly owned by a company in Barcelona, Spain called Ferrer. The company is evaluating whether the device can be used for other diseases, such as for pain relief in cancer patients, or for sleep medications for individuals who wake up in the middle of the night. Alexza licensed development rights to Mayes. Alexza is eligible for milestone and royalty payments if anything comes of Mayes’ company.

Robbins writes, “The licensing deal with Alexza is why Mayes has a deadline at the end of August to line up investors for his Series A round: Alexza wants to get the inhaler into the clinic soon for epilepsy, and if Mayes can’t bring together enough investor money, Alexza could reassess its plans.”

Which has Mayes zigzagging the country and working the phones to convince investors to throw in with him. His goal is to fund a Phase IIb clinical trial of 100 patients with uncontrolled seizures. They would stay in an in-patient setting for up to week, and be given an inhaler with either a placebo or different dosages of the drug. They would be monitored for how long their seizure lasts.

He estimates the $21 million would take the company through the end of 2019 with the clinical trial wrapped up, data analyzed and submitted to the U.S. Food and Drug Administration (FDA) for feedback. If he can take Engage through that step, he can go for another round of financing, go public, or look for someone to buy the company.

Although Mayes recently picked up a big investor, and renegotiated terms with Alexza to decrease the amount of money he needs to raise this month by $4 million, he still needs to raise about $7 million.

“What we tell people is: We’re cautiously optimistic we can get this done, but it’s not a done deal,” Mayes told STAT.

And the clock is ticking.