An old epilepsy med gets oral liquid formulation nod; PMV pairs up ASCO standout with Keytruda
The FDA approved an oral liquid formulation of the drug zonisamide, originally made by Eton Pharmaceuticals and currently owned by Azurity Pharmaceuticals.
The nod gives Azurity the ability to market Zonisade as an adjunctive therapy for treating partial seizures in adults and kids 16 years and older who have epilepsy. The green light comes after three double-blind and placebo-controlled clinical studies of the drug, which is administered once or twice a day. Zonisamide was originally approved in the early 2000s as a capsule for treating partial epileptic seizures and has been marketed by a variety of companies, including the former Irish biotech Elan Pharmaceuticals, Japanese drugmaker Eisai and Sumitomo Dainippon. In 2010, Elan and Eisai agreed to pay $214.5 million to resolve allegations of off-label marketing of Zonegran.
Eton sold the oral liquid formulation of the drug to Azurity as part of a February 2021 deal, worth up to $45 million in payments, including $5 million when the drug is launched.
“This is now the eighth product approval that our team has contributed to, and we are excited for Azurity to bring the product to patients. The proceeds from the launch milestone will be used to further grow our rare disease portfolio,” Eton CEO Sean Brynjelsen said in a statement. For Azurity, the nod adds to a long list of FDA-approved products across cardiovascular, CNS, endocrinology and orphan diseases. — Kyle LaHucik
PMV Pharma’s early-stage ASCO standout trial gets a new combo arm with Merck’s Keytruda
PMV Pharmaceuticals will test its small molecule targeting p53 in combination with Merck’s Keytruda as part of the biotech’s ongoing Phase I/II PYNNACLE trial in patients with advanced solid tumors.
The combo arm will enroll about 36 patients whose solid tumors have a p53 Y220C mutation. PMV will lead the trial and Merck will provide its anti-PD-1 therapy.
Shares of the Cranbury, NJ-based biotech skyrocketed in late May when PMV said initial data on the monotherapy arm of the trial showed a partial response in 3 out of 10 patients in the higher dose cohort. At ASCO in early June, the company presented more detailed data showing six confirmed partial responses among 25 patients. Two more patients had unconfirmed partial responses. — Kyle LaHucik
Erasca nets another clinical trial partnership with Eli Lilly
Jonathan Lim’s cancer play Erasca, which is funded by some deep VC pockets, announced on Monday that it has netted a clinical trial collaboration with Eli Lilly to test another one of its candidate alongside Lilly’s anti-EGFR antibody Erbitux (cetuximab).
The deal will see Erasca, which stands for “erase cancer,” get support for its ongoing Phase I/IIb trial, a proof-of-concept trial evaluating its candidate ERAS-601, an oral SHP2 inhibitor, alone and with Erbitux for both the treatment of triple wild-type metastatic colorectal cancer and HPV-negative advanced head and neck squamous cell carcinoma.
For the trial, Lilly is supplying Erbitux at no cost.
This is not the first deal that Erasca has netted with larger pharmas as the biotech has previously signed similar agreements with Lilly and Pfizer, respectively, to evaluate Erbitux and Braftovi (encorafenib) in combination with Erasca’s ERK1/2 inhibitor.
“We are pleased to enter another clinical trial collaboration with Lilly to explore cetuximab in combination with ERAS-601, our SHP2 inhibitor, in EGFR-driven cancers that are highly dependent on RAS/MAPK signaling,” Lim said. — Tyler Patchen