- Novel arenaviral therapeutic vaccine, developed in collaboration with Gilead Sciences, Inc. (Gilead), to be evaluated as a potential component of a curative regimen for human immunodeficiency virus (HIV)
- HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead
- Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial
NEW YORK, NY, USA and VIENNA, Austria I July 01, 2024 I HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that the first person has been dosed in a Phase 1b clinical trial of HB-500, an investigational therapeutic vaccine for the treatment of HIV. As a result, HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead.
The Phase 1b clinical trial (NCT06430905) will evaluate the safety and tolerability, reactogenicity, and immunogenicity to repeated doses of HB-500 in participants with HIV on suppressive antiretroviral treatment. The Phase 1b design comprises two dose escalation cohorts that will be randomized to receive HB-500 or placebo. The first participant was dosed on July 1, 2024, and enrollment is ongoing.
“HIV impacts the daily lives of millions globally, with no known curative treatment. While current treatments effectively block viral replication and can prevent progression to AIDS, they have not been shown to clear the virus from people living with HIV, requiring lifelong treatment,” said Joern Aldag, Chief Executive Officer of HOOKIPA. “We have previously published impressive findings in our preclinical studies of HB-500, and we are happy to have begun the Phase 1b trial. Our team has worked tirelessly, alongside our great collaboration partners at Gilead, to reach this point, and we are excited to take an important step toward finding a curative treatment for HIV.”
HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial. Gilead has the exclusive right to assume further development of the program thereafter. HB-500 is one of two separate developmental programs in HOOKIPA’s collaboration and license agreement with Gilead.
About HB-500
HB-500 comprises two genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus, respectively. The HB-500 vectors have been engineered to deliver HIV antigens derived from parts of key, immunogenic regions of HIV type 1 (HIV-1) proteins that are highly conserved within HIV-1 clade B variants. The designed immunogens differ from each other by their amino acid sequence allowing for coverage of >80% of circulating HIV-1 viral variants.
About HIV
HIV is one of the world’s most formidable public health challenges. It is estimated there are more than 38 million people living with HIV worldwide. The virus infects and kills immune cells, and without effective ongoing treatment leaves the individual increasingly immunocompromised over time. While effective treatments have significantly extended the lives of people living with HIV and reduced the transmission of the virus, there is no cure for HIV or AIDS.
About HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, KRAS-mutated cancers, and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead.
Find out more about HOOKIPA online at www.hookipapharma.com.
SOURCE: Hookipa
Post Views: 583
- Novel arenaviral therapeutic vaccine, developed in collaboration with Gilead Sciences, Inc. (Gilead), to be evaluated as a potential component of a curative regimen for human immunodeficiency virus (HIV)
- HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead
- Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial
NEW YORK, NY, USA and VIENNA, Austria I July 01, 2024 I HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that the first person has been dosed in a Phase 1b clinical trial of HB-500, an investigational therapeutic vaccine for the treatment of HIV. As a result, HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead.
The Phase 1b clinical trial (NCT06430905) will evaluate the safety and tolerability, reactogenicity, and immunogenicity to repeated doses of HB-500 in participants with HIV on suppressive antiretroviral treatment. The Phase 1b design comprises two dose escalation cohorts that will be randomized to receive HB-500 or placebo. The first participant was dosed on July 1, 2024, and enrollment is ongoing.
“HIV impacts the daily lives of millions globally, with no known curative treatment. While current treatments effectively block viral replication and can prevent progression to AIDS, they have not been shown to clear the virus from people living with HIV, requiring lifelong treatment,” said Joern Aldag, Chief Executive Officer of HOOKIPA. “We have previously published impressive findings in our preclinical studies of HB-500, and we are happy to have begun the Phase 1b trial. Our team has worked tirelessly, alongside our great collaboration partners at Gilead, to reach this point, and we are excited to take an important step toward finding a curative treatment for HIV.”
HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial. Gilead has the exclusive right to assume further development of the program thereafter. HB-500 is one of two separate developmental programs in HOOKIPA’s collaboration and license agreement with Gilead.
About HB-500
HB-500 comprises two genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus, respectively. The HB-500 vectors have been engineered to deliver HIV antigens derived from parts of key, immunogenic regions of HIV type 1 (HIV-1) proteins that are highly conserved within HIV-1 clade B variants. The designed immunogens differ from each other by their amino acid sequence allowing for coverage of >80% of circulating HIV-1 viral variants.
About HIV
HIV is one of the world’s most formidable public health challenges. It is estimated there are more than 38 million people living with HIV worldwide. The virus infects and kills immune cells, and without effective ongoing treatment leaves the individual increasingly immunocompromised over time. While effective treatments have significantly extended the lives of people living with HIV and reduced the transmission of the virus, there is no cure for HIV or AIDS.
About HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, KRAS-mutated cancers, and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead.
Find out more about HOOKIPA online at www.hookipapharma.com.
SOURCE: Hookipa
Post Views: 583
