HOOKIPA Takes Charge of Gilead-partnered HIV Program


HOOKIPA Pharma's shares have soared after the company stated it had amended and restated a collaboration and license agreement with Gilead Sciences to develop immunotherapies against human immunodeficiency virus (HIV). 

HOOKIPA and Gilead initially teamed up in 2018, with Gilead licensing exclusive rights to HOOKIPA’s versatile arenaviral platform to develop immunotherapies for HIV and hepatitis B virus (HBV). Gilead retained the rights to TheraT and Vaxwave technologies to develop and globally commercialize vaccines against HIV and HBV.

Under the original terms of the agreement, the companies agreed to collaborate through a joint research phase, granting Gilead the rights for further development after completion. Now, HOOKIPA will be responsible for the advancement of the HIV program by completing a Phase Ib clinical trial that Gilead will fund in an upfront payment and equity purchases. After completing the Phase Ib clinical trial, Gilead has exclusive rights to assume further development of the program.

“We are pleased to enter into this amended agreement with Gilead which includes provisions that we believe benefit both parties, and we hope ultimately the HIV community,” Joern Aldag, chief executive officer at HOOKIPA, said in a press release. “Gilead is helping to advance our novel arenaviral platform technology, which has the potential to complement Gilead’s overall research strategies for cures of HIV and HBV." 

The HBV portion of the agreement remains unchanged and will continue to move forward. The project has since moved into preclinical development, and Gilead plans to move the program to the Investigational New Drug-enabling stage sometime in 2022. This program supports the clinical entry of an alternating two-vector arenaviral therapeutics to treat HBV.

The objective of the HIV program is to utilize arenavirus vectors to treat, cure or prevent HIV. Arenaviral vectors produce a unique advantage in immunotherapy by inducing strong T-cell responses. The joint program reached its first research milestone in January 2019 by HOOKIPA designing and delivering 14 research-grade vectors to Gilead along with the characterization of the vectors and a data package for the HIV program. In January 2020, the companies announced that the therapeutic vaccines for both HIV and HBV therapies were advancing toward clinical entry, having tested multiple arenaviral vectors expressing HIV and HBV immunogens. The companies stated that they optimized each vector for potential preclinical immunogenicity, safety and manufacturability.

The HBV program met its first research milestones in May 2019, with HOOKIPA delivering 10 research-grade vectors to Gilead, including the vectors’ characterization and a data package. At the time, the vectors were to be subjected to further pre-clinical testing to validate a clinical candidate.

In addition to promoting arenaviral therapeutics in treating infectious diseases, HOOKIPA announced in October 2021 that it had published the benefits of the treatment in certain types of cancer. In a peer-reviewed article published in Frontiers in Oncology, HOOKIPA reported that its versatile arenavirus platform is a promising strategy for developing potent, tumor-specific T cell responses.

The therapy provides an accessible treatment for patients as it is delivered intravenously and is less invasive than some intratumoral approaches required by other viral therapies. The review provided clinical data from the company’s ongoing HB-201/HB-202 trial, utilizing arenaviral therapeutics in the treatment of patients with human papillomavirus 16 (HPV16+) cancers. The data indicated the therapeutic was highly immunogenic and showed the therapy was better than current second-line standard of care in the patients.                  

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