After backing away from an HIV treatment collaboration with Hookipa Pharma last fall, Gilead is back in the saddle. The two have amended their license agreement in a deal that gives the Austrian biotech $15 million upfront and up to $237 million in biobucks.
Gilead paid Hookipa $4 million for a one-time preclinical milestone last month under their original 2018 pact, but the Big Pharma decided to opt out of taking the immunotherapy into the clinic, Hookipa disclosed in November 2021. The walk back had no impact on their research tie-up in hepatitis B, or HBV, which is preparing for pre-clinical studies this year.
Now, Gilead has changed its mind about the HIV immunotherapy and is dishing out $15 million upfront, plus a $5 million equity investment and could eventually hand over $30 million more in equity financing at Hookipa’s discretion before the last day of 2023.
Hookipa’s shares skyrocketed nearly 50% to $1.98 apiece as of 10:40 a.m. ET on Wednesday.
But wait, there’s more. Hookipa will lead a phase 1b trial of the arenaviral immunotherapy. Then, if Gilead chooses to further develop the treatment, the California pharma will pay a $10 million program completion fee, up to another $162.5 million in development milestones and as much as $65 million in commercialization biobucks, Hookipa disclosed in a Securities and Exchange Commission filing.
The updated pact provides “external validation for [Hookipa’s] platform and cash to help more comfortably bridge to upcoming potentially de-risking readouts,” RBC Capital Markets analysts wrote in a note. This now provides Hookipa with enough cash “well into 2023,” the analysts noted.
For Gilead, the amended tie-up could provide the longtime HIV drugmaker with an innovation boost. The pharma’s HIV product sales increased 7% year-over-year to $4.5 billion in the fourth quarter of 2021, thanks to higher demand for Biktarvy, but sales of the company’s other HIV meds Truvada and Atripla tanked 58% and 29%, respectively, Gilead disclosed Feb. 1.
Gilead also hit a major snag in the clinic two months ago when the FDA put 10 clinical trials on hold for the injectable treatment lenacapavir due to concerns over vial quality. The hold impacted early-, mid- and late-stage trials. It did not impact studies of the oral formulation of lenacapavir.
That major setback came a week after Merck’s HIV program suffered 13 clinical holds.
In recent weeks, though, the HIV treatment landscape has hit some new milestones. Moderna began testing its messenger RNA technology in an HIV vaccine, and Excision BioTherapeutics brought its CRISPR-based therapy into the clinic after it showed signs of clearing the virus in mice. Further yet, researchers said they cured a woman of HIV this week, marking just the third claimed “cure” since HIV was discovered in the ’80s.