— Oral administration of PRTX007 exhibits favorable safety profile, rapid conversion to TLR7 agonist PRX034, and activation of the innate immune system, without an increase in proinflammatory factors —

SAN DIEGO, February 14, 2022 – Primmune Therapeutics, a biotech company harnessing the power of the innate immune system to treat cancers and viral diseases, presented interim data related to PRTX007, a novel, orally administered, small molecule toll-like receptor 7 (TLR7) specific agonist that is currently in Phase 1 development, at the Conference on Retroviruses and Opportunistic Infections (CROI). Oral administration of PRTX007 in this first-in-human study of healthy volunteers exhibited a favorable safety profile, rapid absorption and conversion to TLR7 agonist PRX034, and activation of the innate immune system, without causing inflammation.

“PRTX007 is being developed to harness the power of the innate immune system by targeting TLR7, without increasing cytokines that can result in hyperinflammation and can harm patients,” said James Appleman, Ph.D., Co-Founder and Chief Scientific Officer at Primmune Therapeutics. “We look forward to continuing the development of PRTX007 to address current unmet needs of patients with cancers and viral infections.”

Highlights of this data, presented in a poster titled “Interim Analysis of a Phase 1 Study of PRTX007: Safety, PK, and PD Response,” include:

  • Oral administration of PRTX007 resulted in efficient systemic delivery and well-behaved pharmacokinetics of agonist PRX034
  • TLR7-mediated immune response was shown to be dose and exposure-dependent
  • TLR7-mediated immune induction of IFN-gene products and other TLR7-associated cytokines was observed without increases in NF-κB mediated biosynthesis of proinflammatory cytokines IL-6, TNF⍺, IL-1β
  • Data demonstrate a favorable safety profile for PRTX007

Full details of the presentation can be found here.

About PRTX007

PRTX007 is Primmune’s lead TherAjuvant™, a combination of therapeutic and adjuvant mechanisms of action. PRTX007 is designed to provide immediate benefit to patients through controlled stimulation of the innate immune response while also potentiating long-term effective innate and adaptive immune responses. PRTX007 uniquely engages TLR7 and targeted immune cells without increasing levels of proinflammatory factors like IL-6, TNFα and IL-1β via NF-κB. TherAjuvants™ differ from other small molecule approaches in that they engage the patient’s immune system rather than acting at virally encoded targets or endogenous tumor cell proteins. PRTX007 is being rapidly advanced towards clinical trials for cancer and viral diseases.

About Primmune Therapeutics

Primmune Therapeutics is harnessing the power of the innate immune system to develop small molecule, orally administered toll-like receptor 7 (TLR7) agonists as immunotherapies as TherAjuvants™ for the treatment of cancers and viral diseases. For more information, please visit https://www.primmunerx.com/.

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