Iotivibart

LONDON, UK I March 12, 2025 I ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced positive findings from the company’s EMBRACE phase IIb study. 1 The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants. These results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S. Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said :”As leaders in long-acting injectable innovation, we are building on the positive patient and physician experience we have with Cabenuva and pioneering the next generation of long-acting treatment options. The EMBRACE study demonstrated that VH109, a CD4-binding broadly neutralising antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through six months. We’re looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens.” Results from the EMBRACE study at the six-month primary endpoint showed that 96% of participants receiving VH109 60mg/kg intravenously (IV) and 88% receiving VH109 3000mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group. VH109 was administered in both arms every four months, combined with monthly CAB LA. Confirmed virologic failure was observed in two participants from each VH109 group. Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher, compared to none in the standard-of-care group when measured at month six. VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. Adverse events specific to the use of study medication were reported in 64% of the IV group and 65% of the SC group, with 16% of participants in the SC group experiencing grade 3-4 adverse events (erythema). No participants in the IV group experienced a grade 3-4 adverse event. Based on the favourable results seen in the trial, ViiV Healthcare will be progressing a six-month IV formulation of VH109 in combination with CAB LA for further evaluation in an EMBRACE part two trial. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information . Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References 1 Taiwo, B et al. VH3810109 (N6LS) Efficacy and Safety in Adults Who Are Virologically Suppressed: The EMBRACE Study. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA SOURCE: ViiH Healthcare

ViiV plans to make a regimen selection for treatment next year.\n GSK’s ViiV Healthcare has shared clinical data on three potential long-acting HIV treatments, providing a look at how its plans to create a six-month regimen are shaping up.ViiV, which is majority owned by GSK with Pfizer and Shionogi as shareholders, has identified demand for long-acting HIV treatments that are less burdensome for patients. With Gilead fighting hard for market share, ViiV is racing on multiple fronts to meet the demand. The company used the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco to share data on three parts of its plan.Wednesday, ViiV published phase 2b data on its investigational broadly neutralizing antibody N6LS. The study randomized 134 adults living with HIV to receive the CD4-binding antibody intravenously or subcutaneously or continue on pre-baseline, standard-of-care antiretroviral therapy. Patients in the N6LS groups received the antibody every six months and long-acting cabotegravir every month.After six months, 96% of people on intravenous N6LS, also called VH109, maintained HIV-1 RNA levels below 50 copies/mL. The result in the standard of care group was identical. However, only 88% of people on subcutaneous N6LS maintained HIV-1 RNA levels below the threshold. Confirmed virologic failure was seen in two patients from each N6LS group. Tolerability was worse in the subcutaneous group, with 16% of patients having grade 3 or 4 redness of the skin. The results informed ViiV’s decision to take a six-month intravenous formulation of N6LS into part two of the trial. Halozyme provided the technology that enabled subcutaneous delivery.ViiV shared the N6LS data the day after publishing results from studies of two other molecules that could form part of its six-month treatment regimen. The N6LS trial used monthly cabotegravir long-acting as its integrase strand transfer inhibitor (INSTI), but ViiV could combine the antibody with its third-generation candidate VH184 down the line.At CROI, ViiV showed viral load dropped after 22 adults, who had not previously received antiretroviral therapy, started on VH184. The study provided early evidence that the INSTI can drive down viral load without causing drug resistance mutations or serious side effects. But more work is needed to show the asset can be the backbone of ViiV’s regimen, starting with a phase 1 trial of long-acting formulations.ViiV is considering N6LS and its investigational capsid inhibitor VH499 as potential partners for VH184 in its planned six-month treatment regimen. The company shared data on VH499 at CROI, linking the asset to falls in the viral loads of 23 adults who received the candidate in a phase 2 trial. One person on the low dose developed a single mutation associated with reduced susceptibility to capsid inhibitors. ViiV said the data support further development of VH499 as a potential long-acting antiretroviral for HIV treatment. A phase 1 trial is assessing long-acting formulations of the capsid inhibitor. Data from studies of VH499 and N6LS will inform the decision about which molecule to combine with VH184.Talking on a GSK earnings call last month, ViiV Chairman David Redfern said (PDF) “the aim is to look at that data this year and then make a regimen selection for treatment ... next year.” ViiV could potentially start running pivotal studies in 2027, Redfern said.