HiFiBiO Therapeutics, a clinical-stage multinational biotherapeutics company focused on the development of novel antibodies in immunomodulation, announced a partnership agreement with South Korea-based ABL Bio to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients. The two companies will join forces to drive the development of this innovative antibody by leveraging their unique R&D strengths and complementary market access.

HiFiBiO rapidly discovered, engineered and developed HFB30132A in less than six months. The company submitted an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) on August 25th and is planning a US Phase I single-IV administration ascending dose study to assess the safety, tolerability and pharmacokinetics in healthy volunteers in the coming months. This Phase I study will be followed by global late-stage clinical trials in COVID-19 patients in late 2020.

“This strategic partnership with ABL Bio is another showcase of our conviction of open innovation to fast-track life-saving therapies for patients in need,” said Jeff He, Chief Operating Officer at HiFiBiO Therapeutics. “Bringing the program from discovery into the clinic in such a short period of time was only made possible through our collaborations with clinicians, CROs, contract development and manufacturing organizations, and other research institutes along the way. With this ABL partnership in place, we are now well-positioned to rapidly advance HFB30132A through clinical development.”

“It will take a global effort to end the worldwide coronavirus pandemic,” said Sang Hoon Lee, PhD, CEO of ABL Bio. “Together with HiFiBiO, we plan to accelerate program development to bring a safe and effective treatment to the world as soon as possible.”

HFB30132A binds the SARS-CoV-2 viral spike protein with high affinity and has demonstrated potent neutralization of live virus infections in vitro and in vivo, including the well-described mutant D614G. Based on preclinical results, this antibody is expected to have fewer potential adverse events and higher distribution to lung and mucosal tissues than traditional therapeutic monoclonal antibodies. Additionally, it has demonstrated a longer half-life than non-engineered antibodies. HFB30132A is currently positioned to function as a monotherapy, both to provide immediate defense against an active infection and to proactively prevent one. HiFiBiO will continue to employ its open innovation approach beyond current collaborations to develop this promising antibody drug against COVID-19 as both mono and combination therapies.

About ABL Bio

ABL Bio, Inc., is a South Korean biotechnology company dedicated to developing antibody therapeutics for immuno-oncology and neurodegenerative diseases. Our company was founded in 2016 and listed on the Korean stock exchange (KOSDAQ) in 2018. With our deep expertise in bispecific antibodies and distinguished R&D personnel, ABL Bio has developed its own set of productive BsAb platforms – ‘Grabody-T,’ ‘Grabody-I,’ and ‘Grabody-B.’ Our company discovered ABL001, the first bispecific antibody to undergo clinical trials in South Korea. Currently in Phase 1b/2a clinical studies in oncology, ABL001 targets VEGF and DLL4 and is anticipated to be the cornerstone for anti-angiogenic, cancer therapy. In the neurodegenerative disorder space, we have developed 'Grabody-B' platform, which is designed to maximize blood-brain barrier (BBB) penetrance. 'Grabody-B' is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration, such as Parkinson's disease. For more information, please visit www.ablbio.com.

About HiFiBiO Therapeutics

HiFiBiO Therapeutics is transforming the field of immunotherapy by combining proprietary single-cell profiling technologies with advanced data intelligence and deep knowledge of immune system biology. This approach enables the development of novel antibody therapies that are paired with biomarkers to predict patient response. HiFiBiO Therapeutics is working actively to address unmet medical needs around the world through its own innovative pipeline programs and open-innovation partnerships with world-renowned industry and academic researchers.