AIDS Clinical Trial Group Presents Results from Phase 1 Study of ModeX Trispecific Antibody for the Treatment and Prevention of HIV
ModeX Therapeutics, an OPKO Health company, releases positive results from a Phase 1 clinical study of SAR441236, a trispecific broadly neutralizing antibody against HIV, showing promising safety and pharmacokinetic data. The study demonstrated a similar half-life to standard monoclonal antibodies, minimal anti-drug antibodies, and consistent pharmacokinetics across all dosing regimens.
Positive
Positive safety and pharmacokinetic data from Phase 1 clinical study of SAR441236
Similar half-life to standard monoclonal antibodies
Minimal anti-drug antibodies observed
Consistent pharmacokinetics across all dosing regimens
Promising potential for long-lasting treatment and prevention of HIV infection
Collaboration between ModeX and the Vaccine Research Center of the NIH resulted in the development of SAR441236
The recent announcement of Phase 1 clinical study results for SAR441236, a trispecific broadly neutralizing antibody against HIV, is a significant advancement in HIV treatment research. The study's findings that the antibody has a comparable half-life to standard monoclonal antibodies and shows minimal anti-drug antibodies are promising for the drug's efficacy and safety profile. The ability of SAR441236 to bind to three different sites on the HIV virus and its engineered amino acid modifications for half-life extension indicate a sophisticated design that could enhance its therapeutic potential.
From a medical research perspective, the implications of such a development are profound. The current standard of care for HIV involves daily antiretroviral therapy (ART), which, while effective, requires strict adherence to maintain viral suppression. A long-acting treatment option like SAR441236 could provide a more convenient and potentially more effective approach, particularly for patients facing challenges with daily medication adherence. Additionally, the capability of such multispecific antibodies to target multiple strains of HIV and possibly activate the immune system against latent virus populations hints at the potential for a functional cure—a highly sought-after goal in HIV research.
For investors in OPKO Health and stakeholders in ModeX Therapeutics, the positive results from the Phase 1 study of SAR441236 represent a critical value inflection point. The successful demonstration of safety and pharmacokinetics in human subjects validates the investment in research and development and positions the company favorably for future financing and partnership opportunities. As the drug progresses through the clinical pipeline, its potential market value is likely to increase, especially given the unmet need for long-acting HIV treatments.
However, it's important to note that the drug is still in the early stages of development and further clinical trials will be necessary to confirm its efficacy and safety. The costs associated with these trials can be substantial and the outcome is uncertain. Nonetheless, if SAR441236 continues to show promise, it could capture a significant share of the HIV treatment market, which is a key driver for the company's long-term revenue growth and stock performance.
The introduction of a trispecific antibody like SAR441236 is a noteworthy event in the field of epidemiology. Broadly neutralizing antibodies have the potential to change the landscape of HIV prevention and treatment by offering a more durable response to the virus. The pharmacokinetic data indicating a half-life of around 38 days suggests that patients could potentially receive treatment on a monthly basis, which could improve adherence and reduce the likelihood of viral resistance developing.
Moreover, the ability of such antibodies to potentially induce long-term remission of HIV infection could significantly reduce the virus's impact on public health. As HIV continues to evolve, the flexibility of a multispecific antibody to combat a wide range of variants is particularly valuable. While the study's focus on safety and pharmacokinetics is a preliminary step, the potential implications for epidemic control and reduction in disease transmission are substantial and warrant close monitoring as clinical trials progress.
03/05/2024 - 08:52 AM
• Study delivers first clinical safety and pharmacokinetic data as proof of concept for the use of multispecific antibodies in humans • Candidate showed similar half-life to standard monoclonal antibodies and minimal anti-drug antibodies
WESTON, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), today announced results from a Phase 1 clinical study of SAR441236, its trispecific broadly neutralizing antibody against the human immunodeficiency virus (HIV), at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado. These clinical data are the first reported for a trispecific antibody and specifically provide support for the further development of multispecific, multivalent antibodies against HIV as a differentiated approach to addressing HIV infection.
The study enrolled 52 participants and was conducted by the AIDS Clinical Trials Group (ACTG), a clinical trials network funded by the National Institute of Allergy and Infectious Diseases, NIH. The observed antibody half-life was 38 ± 10 days. The antibody was safe and well-tolerated at all dose levels and via both intravenous and subcutaneous administration. Dosing ranged from 0.3 mg/kg to 30 mg/kg with up to 4 administrations, and observed pharmacokinetics remained consistent in all dosing regimens.
Broadly neutralizing antibodies such as SAR441236 are of interest for their novel mechanisms that may offer longer-lasting treatment and prevention to a wide range of HIV strains as the virus continues to evolve. Their complex interactions with other components of the immune system may also offer opportunities for long-term remission of HIV infection.
“This study represents a milestone in the development of multispecific antibodies, demonstrating key parameters of pharmacokinetics and safety. The study’s full data set inform our ongoing development of multispecific antibodies to prevent or treat HIV infection,” said Dr. John Mascola, Chief Scientific Officer of ModeX. “Existing oral antiretroviral therapies are a powerful tool in the fight against HIV, but multispecific antibodies offer long-lasting preventative and treatment options against a broad swathe of variants, with the possibility of activating the immune system against the latent virus population to effect a functional cure.”
The development of SAR441235 is a result of a collaboration between ModeX and the Vaccine Research Center of the National Institute of Allergy and Infectious Disease, NIH. SAR441236 binds to three parts of HIV simultaneously and is engineered with amino acid modifications in its Fc-region for half-life extension. In preclinical studies, the candidate provided protection against multiple strains of simian HIV in vivo and showed broad neutralizing activity against a wide range of viral strains in vitro . Further analyses from the clinical study are ongoing, including analyses of antiviral efficacy in viremic participants and effects on the HIV-1 reservoir (infected cells that do not actively produce virus) in aviremic participants. These clinical data on an HIV multispecific antibody inform the future advancement of such antibodies for the prevention and treatment of HIV and provide strong rationale for the development of current and future antibody products.
About ModeX Therapeutics www.modextx.com .
About OPKO Health, Inc. www.opko.com .
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding whether the data presented support further development as a differentiated approach to addressing HIV infection, the expected benefits of utilizing broadly neutralizing antibodies in the treatment and prevention of HIV strains or whether they would offer opportunities for long-term remission of HIV infection or whether multispecific antibodies offer better or longer lasting preventative and treatment options against HIV variants or other viruses, whether these antibodies or any multispecific antibodies will be successfully developed or commercialized, expectations regarding market potential, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, including the risks that the any clinical trials or studies utilizing these or other multispecific antibodies against HIV or other viruses may not be successful or achieve the expected results or effectiveness, and may not generate data that would support the approval or marketing products for the indications being studied, that others may develop superior products and that multispecific antibody treatments may not have advantages or prove to be superior over presently marketed products or products introduced in the future. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Contacts: Investors: ybriggs@lhai.com bvoss@lhai.com Media: media@modextx.com
What are the key findings from the Phase 1 clinical study of SAR441236 by ModeX Therapeutics?
The study demonstrated positive safety and pharmacokinetic data, showing a similar half-life to standard monoclonal antibodies, minimal anti-drug antibodies, and consistent pharmacokinetics across all dosing regimens.
How many participants were enrolled in the Phase 1 clinical study of SAR441236?
The study enrolled 52 participants.
What is the observed antibody half-life in the Phase 1 clinical study of SAR441236?
The observed antibody half-life was 38 ± 10 days.
What are the potential benefits of broadly neutralizing antibodies like SAR441236 in treating HIV?
Broadly neutralizing antibodies offer long-lasting treatment and prevention against a wide range of HIV strains and may provide opportunities for long-term remission of HIV infection.
Who is the Chief Scientific Officer of ModeX Therapeutics and what did he say about the study results?
Dr. John Mascola, the Chief Scientific Officer of ModeX, stated that the study represents a milestone in the development of multispecific antibodies and provides key parameters of pharmacokinetics and safety.
